Bib Pharma Monopoly: Why Consumers Keep Landing on "Park Place" and How the Game is Rigged.

PubMed

Levy, Mark S

Now, more than ever before, pharmacologists are contributing medical advances to confront ravaging disease. They are developing drugs to mitigate the effects of Alzheimer’s, HIV, multiple sclerosis, and various forms of cancer. To capitalize on the opportunity, brand-name pharmaceutical firms are patenting these drugs, consequently guarding formulas and, with it, profits. Patents grant brand-name firms market exclusivity, which essentially allows them to set their own prices. Even though brand-name firms are investing some of their capital to cultivate new drugs, they also are enjoying gigantic revenue streams, absurd profit margins, and seemingly unfettered control of their respective markets. Consequently, sick patients are unable to afford their medication; high prices are bankrupting consumers in the absence of reasonably-priced generic alternatives. Despite the fact that generic drugs contain identical ingredients, cure the same symptoms, and cost 70% less, brand-name drugs persistently dominate their generic counterparts. Indeed, brand-name firms are improperly preventing generic market entry. Without generic competition, no watchdog exists to curb big pharma’s prohibitive prices. Despite the Supreme Court’s fleeting fix in FTC v. Actavis, which condemned reverse payment settlements that precluded competition, brand-name firms are employing other tactics predatorily to extend their market exclusivity and charge consumers unaffordable prices. To prevent brand-name abuse and help infirm patients afford their medication, this Comment proposes that courts apply federal antitrust law to brand-name firms that attempt to monopolize a pharmaceutical market through anticompetitive means, particularly by abusing Risk Evaluation & Mitigation Strategies (REMS) and by "product hopping." To combat exclusionary conduct, courts should mirror the “rule of reason” framework set forth in Actavis and apply an "enhanced" version specifically tailored to the pharmaceutical industry, giving stronger credence to generic challengers. In addition to finding brand-name tactics exclusionary, this Comment also proposes that courts adopt a bright-line rule prohibiting brand-name firms from exploiting the "legitimate business" defense to immunize their destructive conduct. The current framework perpetuates abuse and grants brand-name firms ostensibly indefinite monopolies. Analyzing brand-name defensive tactics under federal antitrust law would facilitate generic market entry and consequently moderate drug prices. Even after sacrificing their entire financial portfolios, patients are still unable to afford their medication. This Comment interprets Actavis as prohibiting the “legitimate business” defense and provides a remedy to deserving consumers by preventing REMS abuse and product hopping, fostering generic competition, and tempering excessive drug prices.

Nomenclature and traceability debate for biosimilars: small-molecule surrogates lend support for distinguishable nonproprietary names.

PubMed

Chao, Jingdong; Skup, Martha; Alexander, Emily; Tundia, Namita; Macaulay, Dendy; Wu, Eric; Mulani, Parvez

2015-03-01

The purpose of the present study was to investigate the traceability of adverse events (AEs) for branded and generic drugs with identical nonproprietary names and to consider potential implications for the traceability of AEs for branded and biosimilar biologics. Adverse event reports in the Food and Drug Administration AE Reporting System (FAERS) were compared with those in a commercial insurance claims database (Truven Health MarketScan(®)) for 2 drugs (levetiracetam and enoxaparin sodium) with manufacturing or prescribing considerations potentially analogous to those of some biosimilars. Monthly rates of branded- and generic-attributed AEs were estimated pre- and post-generic entry. Post-entry branded-to-generic AE relative rate ratios were calculated. In FAERS, monthly AE rate ratios during the post-generic period showed a pattern in which AE rates for the branded products were greater than for the generic products. Differences in rates of brand- and generic-attributed AEs were statistically significant for both study drugs; the AE rate for the branded products peaked at approximately 10 times that of the generic levetiracetam products and approximately 4 times that of the generic enoxaparin sodium products. In contrast, monthly ratios for the MarketScan data were relatively constant over time. Use of the same nonproprietary name for generic and branded products may contribute to poor traceability of AEs reported in the FAERS database due to the significant misattribution of AEs to branded products (when those AEs were in fact associated with patient use of generic products). To ensure accurate and robust safety surveillance and traceability for biosimilar products in the United States, improved product identification mechanisms, such as related but distinguishable nonproprietary names for biosimilars and reference biologics, should be considered.

Comparative effectiveness and costs of generic and brand-name gabapentin and venlafaxine in patients with neuropathic pain or generalized anxiety disorder in Spain.

PubMed

Sicras-Mainar, Antoni; Rejas-Gutiérrez, Javier; Navarro-Artieda, Ruth

2015-01-01

To explore adherence/persistence with generic gabapentin/venlafaxine versus brand-name gabapentin/venlafaxine (Neurontin(®)/Vandral(®)) in peripheral neuropathic pain (pNP) or generalized anxiety disorder (GAD), respectively, and whether it is translated into different costs and patient outcomes in routine medical practice. A retrospective, new-user cohort study was designed. Electronic medical records (EMR) of patients included in the health plan of Badalona Serveis Assistencials SA, Barcelona, Spain were exhaustively extracted for analysis. Participants were beneficiaries aged 18+ years, followed between 2008 and 2012, with a pNP/GAD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code, who initiated treatment with generic or brand-name gabapentin or venlafaxine. Assessments included 1-year treatment persistence and adherence (medication possession ratio), health care costs, and reduction in severity of pain and anxiety symptoms. A total of 2,210 EMR were analyzed; 1,369 on gabapentin (brand 400; generic 969) and 841 on venlafaxine (brand 370 and generic 471). Brand-name gabapentin and venlafaxine were both significantly associated with longer persistence than generic: 7.3 versus 6.3 months, P<0.001; and 8.8 versus 8.1 months, P<0.05, respectively. Brand-name was associated with higher adherence: 86.5% versus 81.3%, P<0.001; and 82.1% versus 79.0%, P<0.05, respectively. Adjusted average costs were higher with generic compared with brand: €1,277 versus €1,057 (difference of €220 per patient; P<0.001) for gabapentin; and €1,110 versus €928 (difference of €182 per patient; P=0.020) for venlafaxine, both because of more use of medical visits and concomitant medication. Compared with generic, brand-name was associated with higher reduction in pain (7.8%; P<0.001) and anxiety (13.2%; P<0.001). Patients initiating brand-name gabapentin or venlafaxine were more likely to adhere and persist on treatment of pNP or GAD, have lower health care costs, and show further reduction of pain and anxiety symptoms than with generic drugs in routine medical practice.

Private expenditures on brand name prescription drugs after generic entry.

PubMed

Balaban, Dahlia Y; Dhalla, Irfan A; Law, Michael R; Bell, Chaim M

2013-10-01

Generic drugs offer a less expensive and therapeutically equivalent alternative to brand name drugs. Nevertheless, many Canadian private drug plans continue to pay for brand name drugs even after generics become available. The objective of this study was to quantify the excess spending resulting from this practice. We used the IMS Brogan PharmaStat database to study private-plan drug spending in Ontario from 2000 to 2009. We focused on three widely used drug classes: proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRIs), and angiotensin-converting enzyme (ACE) inhibitors. For each specific molecule, we determined the difference between what private plans spent on the brand name version and what would have been spent if an available generic version of the same molecule had been purchased instead. We found that prescriptions paid for by private drug plans were often filled with brand name drugs after generics became available. This led to excess private spending of more than Can$107.8 million for these three drug classes over our study period: Can$54.4 million for PPIs, Can$32.4 million for SSRIs and Can$21.0 million for ACE inhibitors. Brand name drugs continue to be reimbursed by Canadian private drug plans at higher prices even after less expensive generic alternatives are available. By mandating generic substitution, substantial cost savings on benefit plans could be achieved.

Information provided by generic and brand-name pharmaceutical manufacturers in response to a request.

PubMed

Fernandez-Llimos, Fernando; Vazquez Gomez, Isabel

2007-12-01

To assess the medical information provided by manufacturers in response to a specific request, and to compare the responses between generic and brand-name companies. Community pharmacy in Spain. A systematic request for product monographs was made between 1999 and 2002 to manufacturers registering new medicines in Spain. A standardised letter was sent to the medical affairs departments. If there was no reply after 3 months, a second standardised letter was sent requesting the monograph. Blood derivatives, intravenous medicines, and radiological contrast agents were excluded. The delay that occurred in receiving information and the type of material sent in response to the request was compared between the two types of companies. About of 833 medicines from 185 manufacturers were registered during the time period studied. After applying exclusion criteria, 805 medicines, including 419 (52.0%) generic and 386 (48.0%) brand-name products, were analyzed. No replies were received for 242 (30.0%) requests 183 (43.7%) generics and 59 (15.3%) brand-names; P < 0.005). We received 369 (65.5% of 533) replies after the first request: 140 of 236 (59.3%) generics and 229 of 327 (70.0%) brand-names (P = 0.009). The average response delay was 9.7 days [CI95%: 8.65-10.68]. There was a statistically significant difference between generic and brand-name companies after the first request (P = 0.001), but not after the second request (P = 0.312). Brand-name manufacturers reply more often, more quickly, and with better quality information than generic manufacturers.

Perception of the value of generic drugs in São Paulo, Brazil.

PubMed

Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

2016-02-01

The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

Generic Drugs: The Same Medicine for Less Money

MedlinePlus

Generic Drugs: The Same Medicine for Less Money What is a generic drug? A generic is a copy of a brand-name drug. A brand- name drug has a patent. When ... benefit to your health, and you will save money. 7KH IHGHUDO )RRG DQG 'UXJ $GPLQLVWUDWLRQ )'$ UHJXODWHV ERWK ...

Comparative analysis of the cost and effectiveness of generic and brand-name antibiotics: the case of uncomplicated urinary tract infection.

PubMed

Lin, Yu-Shiuan; Jan, I-Shiow; Cheng, Shou-Hsia

2017-03-01

Generic medications used for chronic diseases are beneficial in containing healthcare costs and improving drug accessibility. However, the effects of generic drugs in acute and severe illness remain controversial. This study aims to investigate treatment costs and outcomes of generic antibiotics prescribed for adults with a urinary tract infection in outpatient settings. The data source was the Longitudinal Health Insurance Database of Taiwan. We included outpatients aged 20 years and above with a urinary tract infection who required one oral antibiotic for which brand-name and generic products were simultaneously available. Drug cost and overall healthcare expense of the index consultation, healthcare cost during a 42-day follow-up period, and treatment failure rates were the main dependent variables. Data were compared between brand-name and generic users from the entire cohort and a propensity score-matched samples. Results from the entire cohort and propensity score-matched samples were similar. Daily antibiotic cost was significantly lower among generic users than brand-name users. Significant lower total drug claims of the index consultation only existed in patients receiving the investigated antibiotics, while the drug price between brand-name and generic versions were relatively large (e.g., >50%). The overall healthcare cost of the index consultation, healthcare expenditure during a 42-day follow-up period, and treatment failure rates were similar between the two groups. Compared with those treated with brand-name antibiotics, outpatients who received generic antibiotics had equivalent treatment outcomes with lower drug costs. Generic antibiotics are effective and worthy of adoption among outpatients with simple infections indicating oral antibiotic treatment. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation.

PubMed

Piovani, Daniele; Clavenna, Antonio; Cartabia, Massimo; Bortolotti, Angela; Fortino, Ida; Merlino, Luca; Bonati, Maurizio

2015-02-01

The aim of this study was to investigate the rate of recurrent prescriptions and hospital admissions in children receiving a brand name or generic antibiotic prescription. The data source was a database of reimbursed prescriptions. Outpatient children/adolescents <18 years old (Lombardy Region, Italy) were included. The observational period was February-April 2010. A recurrence was defined as an antibiotic prescription occurring within 28 days after an index prescription. The rate of recurrent prescriptions and hospital admissions was calculated for generic/brand name formulations and for each age strata (0-5, 6-11, and 12-17 years old) for four antibiotics: amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor. The percentage of therapy switches was calculated. Cochran-Mantel-Haenszel test was used to compare the age-adjusted outcomes. In all, 17.5% (57 346) of children received at least one recurrent prescription. The rate of recurrent prescriptions was slightly lower in children receiving any generic (OR 0.96; 95%CI 0.93-0.98), compared with any brand name, antibiotic. The percentage of hospital admissions occurring in children initially treated with a brand name (1.01%; 95%CI 0.98-1.08) or generic (1.03%; 0.96-1.06) antibiotic was not different (p = 0.43). For children receiving amoxicillin clavulanate, the hospital admission rate was slightly higher in the brand name group (p = 0.002), while no differences were found for the other active substances. Children treated with generic antibiotics had no worse safety and effectiveness outcomes when compared with those receiving brand name ones. These results provide additional evidence on the safety of generic antibiotics. Copyright © 2014 John Wiley & Sons, Ltd.

Differences in Peripheral Blood Lymphocytes between Brand-Name and Generic Tacrolimus Used in Stable Liver Transplant Recipients.

PubMed

Kim, Jong Man; Kwon, Choon Hyuck David; Joh, Jae-Won; Sinn, Dong Hyun; Choi, Gyu-Seong; Park, Jae Berm; Kang, Eun-Suk; Lee, Suk-Koo

2017-01-01

In this study, peripheral blood lymphocytes were compared between a brand-name and a generic tacrolimus group in stable liver transplant recipients. Sixteen patients who underwent ABO-compatible living donor liver transplants between 2012 and 2013 and had stable graft function were included in this study. Ten patients received brand-name tacrolimus and 6 patients received generic tacrolimus. CD3, CD4, CD8, γδ, CD4+FoxP3+, and CD3-CD56+ T cells were analyzed in peripheral blood obtained preoperatively and 4, 8, 12, and 24 weeks after liver transplantation. Categorical variables were compared using a χ2 test or Fisher exact test, and continuous variables were compared using the Mann-Whitney U test. Regarding the baseline and perioperative characteristics, there were no statistically significant differences between the 2 groups. Immunosuppression also was not different. Subtype analysis of T-cell populations carried out in parallel showed similar levels of CD3, CD4, CD8, and γδT cells with brand-name tacrolimus and generic tacrolimus in stable liver transplant recipients. However, the levels of CD4+Foxp3+ and CD3-CD56+ T cells were higher in the brand-name tacrolimus group than in the generic tacrolimus group 8 weeks after transplantation (p < 0.05). The level of CD4+Foxp3+ T cells was higher in the brand-name tacrolimus group than in the generic tacrolimus group after transplantation. This finding showed that brand-name tacrolimus could have more potential immunosuppressive activity than generic tacrolimus regarding the contribution of CD4+Foxp3+ T cells to graft tolerance in liver transplant recipients. © 2017 S. Karger AG, Basel.

Antiretroviral Drugs Used in the Treatment of HIV Infection

MedlinePlus

... on April 12, 2018. Multi-class Combination Products Brand Generic Name Pediatric Use Approval Date Time to ... can be found at Drugs@FDA or DailyMed . Brand Name Generic Name Pediatric Use Approval Date Time ...

[Two cases of pulmonary aspergilosis, which deteriorated with generic itraconazole].

PubMed

Saito, Wakana; Shishikura, Yutaka; Nishimaki, Katsushi; Kikuchi, Tadashi; Sasamori, Kan; Kikuchi, Yoshihiro; Miki, Hiroshi

2014-07-01

We experienced two cases of pulmonary aspergillosis, which deteriorated during treatment with generic itraconazole (ITCZ) because of low plasma concentration. One case was chronic pulmonary aspergillosis and the other was allergic bronchopulmonary aspergillosis (ABPA). Treatment of both cases was started with a brand-name-ITCZ, and changed to a generic ITCZ. Deterioration of pulmonary aspergillosis occurred after 8 months and 9 months from change to generic ITCZ respectively. In the first case, the ITCZ-plasma concentration was 46.9 ng/mL and of OH-ITCZ 96.5 ng/mL with generic ITCZ at the dose of 300 mg/day, but increased to 1,559.7 ng/mL and to 2,485.0 ng/mL with the brand-name-ITCZ 300 mg/day, respectively. In the second case, the ITCZ-plasma concentration was 27.2 ng/mL and of OH-ITCZ 20.1 ng/mL with 150 mg/day for generic ITCZ, but reached 857.3 ng/mL and to 1,144.2 ng/ml with the brand-name-ITCZ 300 mg/day, respectively. After treatment failure, the first case was changed to voriconazole, then brand-name-ITCZ 300 mg/day, and the second case to the brand-name-ITCZ 300 mg/day, with successful clinical course. Plasma concentrations of ITCZ can differ significantly depending on the patient or type of ITCZ. The ITCZ-plasma concentration should be controlled after changing from a brand-name-ITCZ to a generic ITCZ.

Urethritis

MedlinePlus

... Information Drug Information, Search Drug Names, Generic and Brand Natural Products, Search Drug Interactions Pill Identifier Commonly ... Information Drug Information, Search Drug Names, Generic and Brand Natural Products, Search Drug Interactions Pill Identifier News & ...

Reference pricing with endogenous generic entry.

PubMed

Brekke, Kurt R; Canta, Chiara; Straume, Odd Rune

2016-12-01

Reference pricing intends to reduce pharmaceutical expenditures by increasing demand elasticity and stimulating generic competition. We develop a novel model where a brand-name producer competes in prices with several generics producers in a market with brand-biased and brand-neutral consumers. Comparing with coinsurance, we show that reference pricing, contrary to policy makers' intentions, discourages generic entry, as it induces the brand-name producer to price more aggressively. Thus, the net effect of reference pricing on drug prices is ambiguous, implying that reference pricing can be counterproductive in reducing expenditures. However, under price regulation, we show that reference pricing may stimulate generic entry, since a binding price cap weakens the aggressive price response by the brand-name producer. This may explain mixed empirical results on the competitive effects of reference pricing. Finally, we show that reference pricing may be welfare improving when accounting for brand preferences despite its adverse effects on entry and prices. Copyright © 2016 Elsevier B.V. All rights reserved.

A cross-sectional survey of pharmacists to understand their personal preference of brand and generic over-the-counter medications used to treat common health conditions.

PubMed

Patel, Mira; Slack, Marion; Cooley, Janet; Bhattacharjee, Sandipan

2016-01-01

Consumers are hesitant in choosing generic medications as they are under the assumption that they are not as safe nor effective as brand medications. However, pharmacists do have the education and training to know that this is not the case. The aim of this study was to determine pharmacists' preference of generic versus brand over-the-counter (OTC) medication for their personal use as self-treatment for various health symptoms. A prospective, cross sectional study was conducted on 553 licensed pharmacists who were presumed to have expertise in the use of generic and brand name OTC medications. In a single Southwestern state in the United States, from December 2014 to January 2015, a web-based questionnaire was sent to pharmacists to explore their preference of brand and generic medications based on various health symptoms. Thirty-one brand-generic medication pairs were used to identify which medication type pharmacists preferred when asked about nine health symptoms. Frequency counts of pharmacists' preference of a brand medication or a generic OTC medication overall and for each of the nine health symptoms were determined. Chi-squared analyses and one-way ANOVA were conducted to determine if there were any differences between the preferences of brand and generic OTC medications across each symptom. The study overall showed that pharmacists preferred generic OTC medications to brand OTC medications (62 to 5 %, respectively). Based on an 11-point rating scale, pharmacists were likely to take OTC generic medications (as their choice of self-treatment) when presented with health symptoms (mean = 7.32 ± 2.88). In addition, pharmacists chose generic OTC medications over brand medications regardless of health symptoms (p < 0.001). Pharmacists who have expertise in medications were shown to prefer using generic OTC medications rather than brand name OTC medications for self-treating a variety of health symptoms. These study findings support the theory that expertise affects preference for generic versus brand name OTC medications. This information can be used to provide consumers the evidence needed to make well-informed choices when choosing between brand and generic medications.

Glossary of Managed Care Definitions

MedlinePlus

... Generic drug : a medicine that is the chemical equivalent of a brand-name drug. Generic drugs are typically less costly to consumers than equivalent brand-name drugs. Grievance : a complaint brought to ...

Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease

PubMed Central

Kesselheim, Aaron S.; Misono, Alexander S.; Lee, Joy L.; Stedman, Margaret R.; Brookhart, M. Alan; Choudhry, Niteesh K.; Shrank, William H.

2009-01-01

Context Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. Objectives To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Data Sources Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Study Selection Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. Data Extraction We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors’ positions on generic substitution as negative, positive, or neutral. Results We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of α-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was −0.03 (95% confidence interval, −0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Conclusions Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs. PMID:19050195

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

PubMed

Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

2018-06-01

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01). Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

Smell and Taste Disorders

MedlinePlus

... Information Drug Information, Search Drug Names, Generic and Brand Natural Products, Search Drug Interactions Pill Identifier Commonly ... Information Drug Information, Search Drug Names, Generic and Brand Natural Products, Search Drug Interactions Pill Identifier News & ...

Evaluation of generic and branded herbicides : technical report.

DOT National Transportation Integrated Search

2015-03-01

As with other generic brand products in the marketplace, generic herbicides often have a lower initial product cost than : their brand-name counterparts. While the purchase price of herbicides is important to TxDOT, it is essential to look at : more ...

Exploration of approaches to adjusting brand-name drug prices in Mainland of China: based on comparison and analysis of some brand-name drug prices of Mainland and Taiwan, China.

PubMed

Weng, Geng; Han, Sheng; Pu, Run; Pan, Wynn H T; Shi, Luwen

2014-01-01

Under the circumstance of the New Medical Reform in Mainland of China, lowering drug prices has become an approach to relieving increase of medical expenses, and lowering brand-name medication price is a key strategy. This study, by comparing and analyzing brand-name medication prices between Mainland of China and Taiwan, explores how to adjust brand-name medication prices in Mainland of China in the consideration of the drug administrative strategies in Taiwan. By selecting brand-name drug with generic name and dose types matched in Mainland and Taiwan, calculate the average unit price and standard deviation and test it with the paired t-test. In the mean time, drug administrative strategies between Mainland and Taiwan are also compared systematically. Among the 70 brand-name medications with generic names and matched dose types, 54 are at higher prices in Mainland of China than Taiwan, which is statistically significant in t-test. Also, among the 47 medications with all of matched generic names, dose types, and manufacturing enterprises, 38 are at higher prices in Mainland than Taiwan, and the gap is also statistically significant in t-test. In Mainland of China, brand-name medication took cost-plus pricing and price-based price adjustment, while in Taiwan, brand-name medication took internal and external reference pricing and market-based price adjustment. Brand-name drug prices were higher in Mainland of China than in Taiwan. The adjustment strategies of drug prices are scientific in Taiwan and are worth reference by Mainland of China.

Choice of generic versus brand-name antidepressants in a regulated prescription drug market: evidence from Taiwan.

PubMed

Liu, Ya-Ming; Ou, Huang-Tz; Yang, Yen-Kuang

2014-12-01

A health care system in which there is no separation between prescription and dispensation, combined with a regulated prescription drug market, leads to various generic substitution mechanisms for antidepressants. We investigated the determinants of generic versus brand-name antidepressant choices in a regulated prescription market where physicians both prescribe and dispense drugs. Using data from a sample of one million individuals selected randomly from the registry of National Health Insurance beneficiaries in 2010, and all claims for these one million enrollees between January 1997 and December 2011, we employed logistic regression to examine the choice of generic versus brand-name antidepressants in the Taiwanese prescription drug market. Access to various antidepressant brands varies according to the accreditation level and type of ownership of the healthcare provider. Private healthcare providers and those with lower accreditation levels were more likely to prescribe generic antidepressants compared to their brand-name counterparts. The diversity of products and competition in the molecule market was positively associated with the probability of prescribing generic antidepressants. In a regulated prescription drug market with no separation between prescription and dispensation, the substitution of generic antidepressant prescriptions in place of brand-name prescriptions is likely driven by drug and provider market characteristics, rather than by lowering costs. The allocation of different types of ownership and accreditation levels of healthcare providers may lead to unequal access to various brands of antidepressants. Policies for improving the treatment of depression should take into account the structure of molecule and provider markets as important factors in determining the choice and utilization of antidepressants, in a healthcare system where physicians both prescribe and dispense drugs. Other psychotropic drug classes should be investigated to explore the effect of molecule and provider characteristics on the utilization of various classes of medication.

0-6733 : evaluation of generic and branded herbicides.

DOT National Transportation Integrated Search

2012-08-01

As with other products in the marketplace, : generic herbicides often have a lower initial : product cost than their brand-name : counterparts.Herbicide formulations are : patented for 17 years with proprietary rights for : name, formula, and product...

Generic switch after ramipril patent expiry is not associated with decreased pharmacy refill compliance: a retrospective study using the DAPI database.

PubMed

Ude, Miriam; Schuessel, Katrin; Quinzler, Renate; Leuner, Kristina; Müller, Walter E; Schulz, Martin

2011-09-01

For treatment success in chronic diseases such as hypertension, adequate adherence to long-term pharmacotherapy is a prerequisite. The purpose of this study was to evaluate whether switching from brand name ramipril to a generic product after patent expiry may negatively affect patients' refill compliance. Claims data for ambulatory prescriptions within the statutory health insurance system were evaluated. Patients were included if they had filled a ramipril prescription (index) for either brand name or generic ramipril products between September 2003 and June 2004. Patients had to be continuously treated with ramipril for at least 12 months before and after the index date. Patients with a change from brand name to generic product or vice versa during follow-up after the index date were excluded from the analyses, as were patients who could not be unequivocally allocated to characteristics of covariates. Refill compliance was analysed by calculating the medication possession ratio (MPR), assuming that patients were prescribed one unit dose per day (MPR(UD)). In total, 142,690 and 79,191 patients were classified as brand name or generic therapy, respectively. Median MPR(UD) values were 0.95 and 0.96 (P < 0.001). In a logistic regression model adjusting for covariates, the probability for noncompliance (MPR(UD) < 0.8) was marginally lower in the generic compared with the brand name group (odds ratio 0.926, 99% confidence interval 0.901-0.951, P < 0.001). These results suggest that refill compliance is not negatively affected by a physician-induced switch from brand name to generic ramipril products after patent expiry.

Strategies That Delay Market Entry of Generic Drugs.

PubMed

Vokinger, Kerstin Noëlle; Kesselheim, Aaron S; Avorn, Jerry; Sarpatwari, Ameet

2017-11-01

Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs ("reverse payment" settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA). To address such tactics, the federal government can interpret existing patenting standards more strictly and promote certain types of patent challenges to ensure that patents are granted or upheld only for true innovations. Congress can enact pending legislation that would help discourage reverse payment settlements and compel brand-name manufacturers to share drug samples for bioequivalence testing. Finally, the FDA can provide earlier guidance on bioequivalence determinations for complex generic products and adopt the presumption that late-filed citizen petitions should be summarily rejected.

Physicians’ generic drug prescribing behavior in district hospitals: a case of Phitsanulok, Thailand

PubMed Central

Plianbangchang, Pinyupa; Jetiyanon, Kanchalee; Suttaloung, Charawee; Khumchuen, Lalida

2010-01-01

Generic prescribing is a sound approach to contain health care costs. However, little is known about physicians’ prescribing patterns in the Thai context. Objective: To explore physicians’ generic prescription patterns in district hospitals. Methods: Data was collected from three of the eight district hospitals between January and December 2008 (final response rate 37.5%). All participating hospitals were between 30 and 60-bed capacity. The researchers reviewed 10% of total outpatient prescriptions in each hospital. Results: A total of 14,500 prescriptions were evaluated. The majority of patients were under universal health coverage (4,367; 30.1%), followed by senior citizens’ health insurance (2,734; 18.9%), and civil servant medical benefit schemes (2,419; 16.7%). Ten thousand six hundred and seventy-one prescriptions (73.6% of total prescriptions) had at least one medication. Among these, each prescription contained 2.85 (SD=1.69) items. The majority of prescriptions (7,886; 73.9%) were prescribed by generic name only. Drugs prescribed by brand names varied in their pharmacological actions. They represented both innovator and branded-generic items. Interestingly, a large number of them were fixed-dose combination drugs. All brand name prescriptions were off patented. In addition, none of the brand-name drugs prescribed were categorized as narrow therapeutic range or any other drug that had been reported to have had problems with generic substitution. Conclusion: The majority of prescriptions in this sample were written by generic names. There is room for improvement in brand name prescribing patterns. PMID:25126136

Generic drugs in Brazil: known by many, used by few.

PubMed

Bertoldi, Andréa D; Barros, Aluísio J D; Hallal, Pedro C

2005-01-01

This study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city. The outcomes were: the proportion of generics in total medicines used; theoretical and practical knowledge about generics; and strategies used to buy medicines on medical prescriptions. The recall period for drug utilization was 15 days. The proportion of generics in total medicines was 3.9%. While 86.0% knew that generics cost less and 70.0% that the quality is similar to brand name medicines, only 57.0% knew any packaging characteristics that distinguish generics from other medicines. The highest proportion of generic drug utilization was in the antimicrobial pharmacological group. A brand name medicine (with a brand similar to the generic name) was mistakenly classified as a generic through photos by 48.0% of the interviewees. Among subjects who bought medicines in the 15-day period, 18.9% reported buying a generic, but this result should be interpreted with caution, because the population frequently fails to differentiate between generics and other medicines.

Clinical and economic consequences of treating patients with peripheral neuropathic pain with brand name or generic drugs in routine clinical practice: The effects of age and sex.

PubMed

Navarro-Artieda, R; Rejas-Gutiérrez, J; Pérez-Paramo, M; Sicras-Mainar, A

2018-04-01

We aimed to analyse the effects of age and sex on pain and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio [MPR]), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4%≥65 years]; 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, P<.001; 86.5% vs 81.3% MPR, P<.001). Lower healthcare costs were observed in patients using brand-name gabapentin in both age groups (<65 and ≥65). Mean difference in cost per patient amounted to €221 (95%CI: 59-382) and €217 (95%CI: 51-382) in the <65 and ≥65 age groups, respectively (P<.01). Mean difference in cost among men amounted to €197 (63-328), while mean difference in cost among women amounted to €239 (96-397) (P=.005 and P=.004, respectively). Compared with EFG, brand treatment showed greater pain relief: 13.5% (10.9-16.2) and 10.8% (8.2-13.5) in <65 and ≥65year patients, respectively (P<.001), and 10.7% (8.2-13.2) and 13.8% (11.0-16.5) in women and men respectively (P<.001). Regardless of sex and age, patients who started PNP treatment with brand name medication showed greater persistence and adherence to treatment than those taking generic drugs. Brand name treatment also involved lower healthcare costs, and greater pain relief. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

PubMed

Rostron, Allen

2011-02-01

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

Generic medications for you, but brand-name medications for me.

PubMed

Keenum, Amy J; Devoe, Jennifer E; Chisolm, Deena J; Wallace, Lorraine S

2012-01-01

Because generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics. This study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid). We recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications. The average age of the women (n=172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics. Awareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers-both physicians and pharmacists-infrequently discussed generic substitution with them. Copyright © 2012 Elsevier Inc. All rights reserved.

Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence.

PubMed

Gagne, Joshua J; Polinski, Jennifer M; Jiang, Wenlei; Dutcher, Sarah K; Xie, Jing; Lii, Joyce; Fulchino, Lisa A; Kesselheim, Aaron S

2016-08-01

US Food and Drug Administration approval for generic drugs relies on demonstrating pharmaceutical equivalence and bioequivalence; however, some drug products have unique attributes that necessitate product-specific approval pathways. We evaluated rates of patients' switching back to brand-name versions from generic versions of four drugs approved via such approaches. We used data from Optum LifeSciences Research Database to identify patients using a brand-name version of a study drug (acarbose tablets, salmon calcitonin nasal spray, enoxaparin sodium injection, and venlafaxine extended release tablets) or a control drug. We followed patients to identify switching to generic versions and then followed those who switched to identify whether they switched back to brand-name versions. We calculated switch and switch-back rates and used Kaplan-Meier and log-rank tests to compare rates between study and control drugs. Our cohort included 201 959 eligible patients. Brand-to-generic switch rates ranged from 66 to 106 switches per 100 person-years for study drugs and 80 to 110 for control drugs. Rates of switch-back to brand-name versions ranged from 5 to 37 among study drugs and 3 to 53 among control drugs. Switch-back rates were higher for venlafaxine vs. sertraline (p < 0.01) and calcitonin vs. alendronate (p = 0.01). Switch-back rates were lower for venlafaxine vs. paroxetine (p < 0.01) and acarbose vs. nateglinide (p < 0.01). Rates were similar for acarbose vs. glimepiride (p = 0.97) and for enoxaparin vs. fondiparinux (p = 0.11). As compared to control drugs, patients were not more likely to systematically switch back from generic to brand-name versions of the four study drugs. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamad Izham Mohamad; Hassali, Mohamad Azmi; Sharrad, Adheed Khalid; Shafie, Asrul Akmal; Babar, Zaheer-Ud-Din

2015-01-01

General objective To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. Methods A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach’s alpha was found to be 0.62. Results Responses were obtained from 236 final-year Doctor of Pharmacy students (n=85 from a publicly funded institute; n=151 from a privately funded institute). When comparing a brand-name medicine to a generic medicine, pharmacy students scored poorly on bioequivalence limits. More than 80% of the students incorrectly answered that all the products that are rated as generic equivalents are therapeutically equivalent to each other (P<0.04). Half of the students agreed that a generic medicine is bioequivalent to the brand-name medicine (P<0.001). With regard to quality, effectiveness, and safety, more than 75% of the students disagreed that generic medicines are of inferior quality and are less effective than brand-name medicines (P<0.001). More than 50% of the students disagreed that generic medicines produce more side effects than brand-name medicines (P<0.001). Conclusion The current study identified a positive perception toward generic medicines but also gaps in the understanding of generic medicines. Pharmacy students lacked a thorough understanding of the concepts of bioequivalence. Pharmacy academia should address these issues, which will help build confidence in generic medicines and increase the generic medicine use in Pakistan. PMID:26028981

Brand name or generic? What are the health professionals prescribed for treating diabetes? A longitudinal analysis of the National Health Insurance reimbursement database.

PubMed

Liou, Wen-Shyong; Hsieh, Shu-Ching; Chang, Wai-Yuan; Wu, Grace Hui-Min; Huang, Hsu-Shan; Lee, Chuanfang

2013-07-01

This study aimed to explore whether physicians prescribe more brand-name oral hypoglycemic agents (OHA) for diabetic patients with medical training background (MP) than for general patients (GP). A longitudinal analysis of 1,000,000 National Health Insurance cohorts of 1998-2008 was conducted. Univariate and multivariate models were performed to assess the associations of the outcome (the ratio of brand-name/generic odds in the MP group to that in the GP group) and the covariates, including patient medical training background, characteristics of patient, prescriber, and medical settings, and market competition. A generalized estimating equation method was used to control the dependency of longitudinal data. A total of 46,850 diabetic patients were prescribed with 2,703,149 OHA prescriptions during the study period. Compared with GP, MP had 1.37 times greater odds of being prescribed with brand-name instead of generic OHA, among whom pharmacists and physicians had the highest odds ratios of 2.78 (95%CI, 1.05-7.36) and 1.68 (95%CI, 0.99-2.85), respectively. Patients' diabetes severity, prescribers' level of experience, medical settings that were publicly owned, had a higher accreditation level, and were located in a higher urbanized area, lower market competition, and earlier dates of prescription were positively associated with brand-name prescription. Among all medical sub-specialties, cardiologists were more likely to prescribe brand-name OHA. This study is the first to demonstrate how a patients' medical training background, in addition to the characteristics of patients, prescribers, and medical settings, and market competition might influence physicians' prescribing choice of brand-name or generic OHA. Copyright © 2013 John Wiley & Sons, Ltd.

Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

PubMed Central

Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

2012-01-01

Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

[Access to drugs and the situation of the pharmaceutical market in Ecuador].

PubMed

Ortiz-Prado, Esteban; Galarza, Claudio; León, Fernando Cornejo; Ponce, Jorge

2014-07-01

In the area of public health, it is fundamental to understand the structure and dynamics of the Ecuadorian pharmaceutical market, its segmentation between the public and private sectors, and its relationship with supply and demand, both for generic and brand-name drugs. To achieve this, an observational descriptive study was conducted with information obtained from the available scientific, institutional, technical-administrative, and economic databases. Furthermore, the scientific information concerning the Ecuadorian and regional pharmaceutical market was reviewed through the PubMed and Ovid search engines. In Ecuador, 69.6% of dispensed drugs are brand-name and 30.4% are generics. Of all registered drugs in the country, 1,829 (13.6%) are considered over-the-counter and 11,622 (86.4%) are for sale under medical prescription. In terms of sales, 93.15% correspond to brand-name drugs and only 6.85% to generics. Ninety percent of the pharmacies are located in urban areas and only 10% in rural areas. In the last five years, prices have increased by 12.5% for brand-name drugs and 0.86% for generics. Brand-name drugs are dispensed and consumed 2.3 times more than generics. The majority of pharmacies are located in urban areas, showing that there is a relationship between purchasing power and access to drugs. Although the regulatory authority stipulates that 13% of drugs should be over-the-counter, approximately 60% of the population acquires drugs without a medical prescription.

Postabsorption concentration peaks with brand-name and generic verapamil: a double-blind, crossover study in elderly hypertensive patients.

PubMed

Saseen, J J; Porter, J A; Barnette, D J; Bauman, J L; Zajac, E J; Carter, B L

1997-06-01

The pharmacokinetic actions, bioequivalence, and cardiovascular effects of two verapamil products were studied in a randomized, double-blind, crossover study in eight elderly hypertensive patients (median age, 69.5 years; range, 60-79 years) given brand-name or generic immediate-release verapamil in 120-mg twice-daily doses for 14 days. Blood pressures, heart rates, P-R intervals; and serum concentrations of R-/S-verapamil and norverapamil were measured multiple times in patients during the last day of each therapy. Median blood pressure decreased more with generic verapamil than with the brand-name drug, with the largest difference occurring at 0.5 hours (137/74 mmHg versus 144.5/80.5 mmHg; P = 0.05 and 0.091, respectively). Pharmacokinetic parameters were not different for the two products (P < 0.01). However, the generic product, compared with the brand-name drug, had mean area under the concentration-time curve (time 0 to 12 hours) ratios (90% CI) of 1.09 (0.78-1.52), 1.16 (0.87-1.55) and 1.11 (0.81-1.52) for R-, S-, and total verapamil. Seventy concentration peaks (31 with the brand-name drug, 39 with the generic drug) appeared between 8 and 24 hours. Median percentages of increase of these peaks, compared with those of previous concentrations, were 48.3% and 36.3% for brand-name and generic drugs, respectively. Fifty of the 70 peaks (71%) were associated with a stereospecific concentration peak of norverapamil and, temporally, with meals. Our findings suggest that whereas the two verapamil products may not be bioequivalent by Food and Drug Administration criteria, the observed differences in effects were not clinically significant in this elderly population. Multiple concentration peaks after absorption were observed in all patients with both verapamil products and were perhaps related to enterohepatic recirculation.

Generic substitution: micro evidence from register data in Norway.

PubMed

Dalen, Dag Morten; Furu, Kari; Locatelli, Marilena; Strøm, Steinar

2011-02-01

The importance of prices, doctor and patient characteristics, and market institutions for the likelihood of choosing generic drugs instead of the more expensive original brand-name version are examined. Using an extensive dataset extracted from The Norwegian Prescription Database containing all prescriptions dispensed to individuals in February 2004 and 2006 on 23 different drugs (chemical substances) in Norway, we find strong evidence for the importance of both doctor and patient characteristics for the choice probabilities. The price difference between brand and generic versions and insurance coverage both affect generic substitution. Moreover, controlling for the retail chain affiliation of the dispensing pharmacy, we find that pharmacies play an important role in promoting generic substitution. In markets with more recent entry of generic drugs, brand-name loyalty proves to be much stronger, giving less explanatory power to our demand model.

[General awareness and use of generic medication among citizens of Tubarão, state of Santa Catarina, Brazil].

PubMed

Blatt, Carine Raquel; Trauthman, Silvana Cristina; Schmidt, Edegar Henrique; Marchesan, Samuel; da Silva, Luana May; Martins, João Luiz

2012-01-01

Although generic medication has been introduced in the country to offer an accessible alternative to brand-name medication, it represents only 14% of sales in number of units within the pharmaceutical market. The aim of this work was to research the level of awareness and the use of generic products among residents of the municipality of Tubarão, State of Santa Catarina, Brazil. A transversal study was carried out with a sample of 234 interviewees, distributed among municipal areas. With regard to use, the majority of those interviewed had used generic medication, and half of them had at least one such product in their home. To verify awareness of different types of medication, pictures with the generic, brand name and similar packaging for paracetamol and atenolol were shown and 91% were able to identify all products correctly. To be of higher economic standing, already having used generic products, believing that the generic medication has the same effect as the brand name medication, finding generic products in drugstores easily and being accustomed to buy generic products, were factors that were positively associated with the correct identification.

Encouraging generic use can yield significant savings.

PubMed

Zimmerman, Christina

2012-11-01

Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

Strategic options for brand-name prescription drugs when patents expire.

PubMed

Mehta, S C; Mehta, S S

1997-01-01

Pharmaceutical companies face a very hostile competitive environment from generic drugs once the patents on their brand name drugs expire. Depending on the country, such patents usually last 10-15 years but no sooner do the patents expire then copies of off-patent brand name drugs, called generics, are introduced, generally by smaller-size and lesser known companies, at significantly lower prices. As health care costs escalate all over the world, efforts to control medication costs have created a major market for generic prescription drugs, particularly in government funded hospitals and in dispensing general practitioner markets of the Asia Pacific and the third world. The world market for generics is estimated at US$20 billion, doubling in only five years and capturing over 30% of the market share. Because of adverse effects on sales and profitability due to the launching of generics, most research based companies that produce original brand-name patented drugs are forced to take counter measures to overcome this problem, particularly when R&D costs for new patents are skyrocketing. This paper develops a brief perspective on this problem and then examines the experiences of many multinational companies in the Singapore market in dealing with the problem. While several different approaches are identified, only one company experience appeared to work successfully and this is discussed in relative detail.

Brands or generics: the dilemma of pharmaceutical marketing in a developing country.

PubMed

Quraeshi, Z A; Luqmani, M; Malhotra, N

1983-01-01

A significant issue in pharmaceutical marketing in many developing countries is whether drugs should be sold by generic or by brand names. In Pakistan, legislation prohibited the sale of brand name drugs in order to increase price competition, and strengthen the market position of indigenous manufacturers to compete against multinationals. However, the government's objectives were not achieved for reasons discussed in the article. The Pakistan case has implications for multinational firms and for other developing countries in similar situations.

Clinical experience with generic levetiracetam in people with epilepsy

PubMed Central

Chaluvadi, Siresha; Chiang, Sharon; Tran, Larry; Goldsmith, Corey E.; Friedman, David E.

2015-01-01

SUMMARY Purpose To describe the clinical outcomes of a compulsory switch from branded to generic levetiracetam (LEV) among people with epilepsy (PWE) in an outpatient setting. Methods We conducted a retrospective chart review of 760 unduplicated consecutive adult patients attending a tertiary care epilepsy clinic at Ben Taub General Hospital. On November 1, 2008 hospital policy required all patients receiving branded LEV to be automatically switched to generic LEV. We calculated the proportion of patients switching back to branded LEV and reasons for the switch back. Key Findings Of the 260 patients (34%) being prescribed LEV (generic and brand name) during the study period, 105 (42.9%) were switched back to brand name LEV by their treating physicians. Reasons for switch back included increase in seizure frequency (19.6% vs. 1.6%; p < 0.0001) and adverse effects (AEs) (3.3%). AEs included headache, fatigue, and aggression. Patient age was associated with switchback when controlling for gender, epilepsy classification, and treatment characteristics [relative risk (RR) 2.44; 95% confidence interval (CI) 2.09–2.84; p < 0.05)]. An increase in seizure frequency subsequent to generic substitution was associated with polytherapy compared to monotherapy (3.225; 1.512–6.880; p < 0.05). Significance A significant proportion of patients in our cohort on generic LEV required switch back to the branded drug. Careful monitoring is imperative because a compulsory switch from branded to generic LEV may lead to poor clinical outcomes, with risk of AEs and increased seizure frequency. PMID:21426334

Product-line extensions and pricing strategies of brand-name drugs facing patent expiration.

PubMed

Hong, Song Hee; Shepherd, Marvin D; Scoones, David; Wan, Thomas T H

2005-01-01

This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, and American Druggist, respectively. Market success was defined as whether an original drug brand was listed in the top 100 prescriptions most frequently dispensed before facing generic entry. Product-line extension was defined as the appearance of another product that a company introduces within the same market after its existing product. Drug prices were average wholesale prices from the Drug Topics Red Book. The relationship between product-line extension and market success was examined using a logistic regression analysis. The price rigidity to entry was tested using a panel regression analysis. A total of 27 drug brands lost their patents between 1987 and 1992. Drug brands that achieved market success were 16 times more likely to be extended than were those that did not (OR=16, 95% confidence interval, 2.12-120.65). The price rigidity to entry existed in drug brands with extensions (beta=2.65%, P <0.033), but not in those brands without extensions (beta=-2.40%, P <0.001). This study provided some support for the alternative explanation to brand loyalty that a new product-line extension introduced for an original brand helps the original price be rigid despite the entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act.

Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review

PubMed Central

van der Meersch, Amélie; Dechartres, Agnès; Ravaud, Philippe

2011-01-01

Background Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. Objective To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. Methodology/Principal Findings PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic and brand-name drugs. We excluded case studies, pharmaco-economic evaluations, and validation dosage assays of drugs. We evaluated whether important information about funding, methodology, location of trials, and participants were reported. We also assessed whether the criteria required by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) to conclude bioequivalence were reported and that the conclusions were in agreement with the results. We identified 134 potentially relevant articles but eliminated 55 because the brand-name or generic drug status of the reference drug was unknown. Thus, we evaluated 79 articles. The funding source and location of the trial were reported in 41% and 56% of articles, respectively. The type of statistical analysis was reported in 94% of articles, but the methods to generate the randomization sequence and to conceal allocation were reported in only 15% and 5%, respectively. In total, 65 articles of single-dose trials (89%) concluded bioequivalence. Of these, 20 (31%) did not report the 3 criteria within the limits required by the FDA and 11 (17%) did not report the 2 criteria within the limits required by the EMA. Conclusions/Significance Important information to judge the validity and relevance of results are frequently missing in published reports of trials assessing generic drugs. The quality of reporting of such trials is in need of improvement. PMID:21858184

Prescriptions and Insurance Plans

MedlinePlus

... drugs $ Level 2 Preferred $$ Level 3 Non-preferred brand-name drugs $$$ The more dollar signs in the ... co-pay amount. What’s the difference between a brand-name drug and a generic drug? When a ...

Examining patterns in medication documentation of trade and generic names in an academic family practice training centre.

PubMed

Summers, Alexander; Ruderman, Carly; Leung, Fok-Han; Slater, Morgan

2017-09-22

Studies in the United States have shown that physicians commonly use brand names when documenting medications in an outpatient setting. However, the prevalence of prescribing and documenting brand name medication has not been assessed in a clinical teaching environment. The purpose of this study was to describe the use of generic versus brand names for a select number of pharmaceutical products in clinical documentation in a large, urban academic family practice centre. A retrospective chart review of the electronic medical records of the St. Michael's Hospital Academic Family Health Team (SMHAFHT). Data for twenty commonly prescribed medications were collected from the Cumulative Patient Profile as of August 1, 2014. Each medication name was classified as generic or trade. Associations between documentation patterns and physician characteristics were assessed. Among 9763 patients prescribed any of the twenty medications of interest, 45% of patient charts contained trade nomenclature exclusively. 32% of charts contained only generic nomenclature, and 23% contained a mix of generic and trade nomenclature. There was large variation in use of generic nomenclature amongst physicians, ranging from 19% to 93%. Trade names in clinical documentation, which likely reflect prescribing habits, continue to be used abundantly in the academic setting. This may become part of the informal curriculum, potentially facilitating undue bias in trainees. Further study is needed to determine characteristics which influence use of generic or trade nomenclature and the impact of this trend on trainees' clinical knowledge and decision-making.

Express your social self: cultural differences in choice of brand-name versus generic products.

PubMed

Kim, Heejung S; Drolet, Aimee

2009-12-01

This research examined cultural differences in the patterns of choices that reflect more social characteristics of a chooser (e.g., social status). Four studies examined the cultural difference in individuals' tendency to choose brand-name products (i.e., high-status options) over generic products (i.e., low-status options) and the underlying reasons for these differences. Compared to European Americans, Asian Americans consistently chose brand-name products. This difference was driven by Asian Americans' greater social status concerns. Self-consciousness was more strongly associated with the brand-name choices of Asian Americans (vs. European Americans), and experimentally induced social status led Asian Americans (vs. European Americans) to make more choices concordant with self-perception. These findings highlight the importance of considering external and social motivations underlying the choice-making process.

News media coverage of medication research: reporting pharmaceutical company funding and use of generic medication names.

PubMed

Hochman, Michael; Hochman, Steven; Bor, David; McCormick, Danny

2008-10-01

The news media are an important source of information about medical research for patients and even some physicians. Little is known about how frequently news articles report when medication research has received funding from pharmaceutical companies or how frequently news articles use generic vs brand medication names. To assess the reporting of pharmaceutical company funding and generic medication name use in news articles about medication studies and to determine the views of newspaper editors about these issues. We reviewed US news articles from newspaper and online sources about all pharmaceutical company-funded medication studies published in the 5 most prominent general medical journals between April 1, 2004, and April 30, 2008. We also surveyed editors at the 100 most widely circulated newspapers in the United States. The percentage of news articles indicating when studies have been pharmaceutical company-funded and the percentage that refer to medications by their generic vs brand names. Also the percentage of newspaper editors who indicate that their articles report pharmaceutical company funding; the percentage of editors who indicate that their articles refer to medications by generic names; and the percentage of newspapers with policies about these issues. Of the 306 news articles about medication research identified,130 (42%; 95% confidence interval [CI], 37%-48%) did not report that the research had received company funding. Of the 277 of these articles reporting on medications with both generic and brand names, 186 (67%; 95% CI, 61%-73%) referred to the study medications by their brand names in at least half of the medication references. Eighty-two of the 93 (88%) newspaper editors who responded to our survey reported that articles from their publications always or often indicated when studies had received company funding (95% CI, 80%-94%), and 71 of 92 (77%) responding editors also reported that articles from their publications always or often referred to medications by the generic names (95% CI, 67%-85%). However, only 3 of 92 newspapers (3%) had written policies stating that company funding sources of medical studies be reported (95% CI 1%-9%), and 2 of 93 (2%) newspapers had written policies stating that medications should be referred to by their generic names (95% CI 1%-8%). News articles reporting on medication studies often fail to report pharmaceutical company funding and frequently refer to medications by their brand names despite newspaper editors' contention that this is not the case.

Generic versus brand-name drugs used in cardiovascular diseases.

PubMed

Manzoli, Lamberto; Flacco, Maria Elena; Boccia, Stefania; D'Andrea, Elvira; Panic, Nikola; Marzuillo, Carolina; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo; Ioannidis, John P A

2016-04-01

This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.

Preference for brand-name buprenorphine is related to severity of addiction among outpatients in opioid maintenance treatment.

PubMed

Binder, Philippe; Messaadi, Nassir; Perault-Pochat, Marie-Christine; Gagey, Stéphanie; Brabant, Yann; Ingrand, Pierre

2016-01-01

As a form of opioid maintenance treatment, high-dose buprenorphine is increasingly being used in the United States. On the French market since 1996, it is the most commonly prescribed and frequently employed opioid maintenance treatment. For unknown reasons, the brand-name form is used far more often than the generic form (76-24%). The objective was to show that the patients' levels of addiction were differentiated according to the form of buprenorphine currently being used and to their previous experience of a different form. An observational study in 9 sites throughout France used self-assessment questionnaires filled out in retail pharmacies by all patients to whom their prescribed buprenorphine treatment was being delivered. The 151 canvassed pharmacies solicited 879 patients, of whom 724 completed the questionnaires. Participants were statistically similar to non-participants. The patients using the brand-name form subsequent to experience with the generic form exhibited a more elevated addiction severity index and a higher dosage than brand-name form users with no experience of a different form. Compared to generic users, their doses were higher, their was addiction more severe, and their alcohol consumption was more excessive; they were also more likely to make daily use of psychotropic substances. However, the level of misuse or illicit consumption was similar between these groups. Preferring the brand-name buprenorphine form to the generic form is associated with a higher level of severe addiction, a more frequent need for daily psychotropics, and excessive drinking; but the study was unable to show a causal link.

Tiered co-payments, pricing, and demand in reference price markets for pharmaceuticals.

PubMed

Herr, Annika; Suppliet, Moritz

2017-12-01

Health insurance companies curb price-insensitive behavior and the moral hazard of insureds by means of cost-sharing, such as tiered co-payments or reference pricing in drug markets. This paper evaluates the effect of price limits - below which drugs are exempt from co-payments - on prices and on demand. First, using a difference-in-differences estimation strategy, we find that the new policy decreases prices by 5 percent for generics and increases prices by 4 percent for brand-name drugs in the German reference price market. Second, estimating a nested-logit demand model, we show that consumers appreciate co-payment exempt drugs and calculate lower price elasticities for brand-name drugs than for generics. This explains the different price responses of brand-name and generic drugs and shows that price-related co-payment tiers are an effective tool to steer demand to low-priced drugs. Copyright © 2017 Elsevier B.V. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hichwa, B.P.; Pun, D.D.; Wang, D.

A multielemental analysis to determine the trace metal content of generic and name-brand aspirins and name-brand lipsticks was done via proton induced x-ray (PIXE) measurements. The Hope College PIXE system is described as well as the target preparation methods. The trace metal content of twelve brands of aspirin and aspirin substitutes and fourteen brands of lipstick are reported. Detection limits for most elements are in the range of 100 parts per billion (ppb) to 10 parts per million (ppm).

Some drugs more equal than others: pseudo-generics and commercial practice.

PubMed

Probyn, Andrew J

2004-11-08

This article analyses the impact of the Department of Health and Ageing's brand price premium policy for some products listed on the Pharmaceutical Benefits Scheme. The policy, introduced in 1990, allows pharmaceutical companies to charge patients an out-of-pocket expense for post-patent brands of pharmaceuticals. One of the policy's intended goals was to increase consumer awareness of price differentials between competing brands, with a view to encouraging greater use of cheaper generic products. More than fourteen years since its introduction, it is debatable whether the policy has achieved this aim. This article looks at how the brand price premium policy can be exploited by global pharmaceutical giants to entrench big-name brands in the Australian pharmaceutical market and, in some cases, prevent 'true' competition from generic pharmaceuticals. This is being done through the establishment of 'pseudo-generics' that are sourced from the same factory floor as the original product.

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market.

PubMed

Coelho Neto, José; Lisboa, Fernanda L C

2017-07-01

Viagra and Cialis are among the most counterfeited medicines in many parts of the world, including Brazil. Despite the many studies that have been made regarding discrimination between genuine and counterfeit samples, most published works do not contemplate generic and similar versions of these medicines and also do not explore excipients/adjuvants contributions when characterizing genuine and suspected samples. In this study, we present our findings in exploring ATR-FTIR spectral profiles for characterizing both genuine and questioned samples of several generic and brand-name sildenafil- and tadalafil-based tablets available on the Brazilian market, including Viagra and Cialis. Multi-component spectral matching (deconvolution), objective visual comparison and correlation tests were used during analysis. Besides from allowing simple and quick identification of counterfeits, results obtained evidenced the strong spectral similarities between generic and brand-named tablets employing the same active ingredient and the indistinguishability between samples produced by the same manufacturer, generic or not. For all sildenafil-based and some tadalafil-based tablets tested, differentiation between samples from different manufacturers, attributed to slight variations in excipients/adjuvants proportions, was achieved, thus allowing the possibility of tracing an unknown/unidentified tablet back to a specific manufacturer. Copyright © 2017 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

Competition in prescription drug markets: the roles of trademarks, advertising, and generic names.

PubMed

Feldman, Roger; Lobo, Félix

2013-08-01

We take on two subjects of controversy among economists-advertising and trademarks-in the context of the market for generic drugs. We outline a model in which trademarks for drug names reduce search costs but increase product differentiation. In this particular framework, trademarks may not benefit consumers. In contrast, the generic names of drugs or "International Nonproprietary Names" (INN) have unquestionable benefits in both economic theory and empirical studies. We offer a second model where advertising of a brand-name drug creates recognition for the generic name. The monopoly patent-holder advertises less than in the absence of a competitive spillover.

Cost variability of suggested generic treatment alternatives under the Medicare Part D benefit.

PubMed

Patel, Rajul A; Walberg, Mark P; Tong, Emily; Tan, Florence; Rummel, Ashley E; Woelfel, Joseph A; Carr-Lopez, Sian M; Galal, Suzanne M

2014-03-01

The substitution of generic treatment alternatives for brand-name drugs is a strategy that can help lower Medicare beneficiary out-of-pocket costs. Beginning in 2011, Medicare beneficiaries reaching the coverage gap received a 50% discount on the full drug cost of brand-name medications and a 7% discount on generic medications filled during the gap. This discount will increase until 2020, when beneficiaries will be responsible for 25% of total drug costs during the coverage gap. To examine the cost variability of brand and generic drugs within 4 therapeutic classes before and during the coverage gap for each 2011 California stand-alone prescription drug plan (PDP) and prospective coverage gap costs in 2020 to determine the effects on beneficiary out-of-pocket drug costs. Equivalent doses of brand and generic drugs in the following 4 pharmacological classes were examined: angiotensin II receptor blockers (ARBs), bisphosphonates, HMG-CoA reductase inhibitors (statins), and proton pump inhibitors (PPIs). The full drug cost and patient copay/coinsurance amounts during initial coverage and the coverage gap of each drug was recorded based on information retrieved from the Medicare website. These drug cost data were recorded for 28 California PDPs. The highest cost difference between a brand medication and a Centers for Medicare Medicaid Services (CMS)-suggested generic treatment alternative varied between $110.53 and $195.49 at full cost and between $51.37 and $82.35 in the coverage gap. The lowest cost difference varied between $38.45 and $76.93 at full cost and between -$4.11 and $18.52 during the gap. Medicare beneficiaries can realize significant out-of-pocket cost savings for their drugs by taking CMS-suggested generic treatment alternatives. However, due to larger discounts on brand medications made available through recent changes reducing the coverage gap, the potential dollar savings by taking suggested generic treatment alternatives during the gap is less compelling and will decrease as subsidies increase.

Financial incentives and physicians' prescription decisions on the choice between brand-name and generic drugs: evidence from Taiwan.

PubMed

Liu, Ya-Ming; Yang, Yea-Huei Kao; Hsieh, Chee-Ruey

2009-03-01

This paper tests the hypothesis of whether or not financial incentives affect a physician's prescription decision on the choice of generic versus brand-name drugs within a system in which physicians prescribe and dispense drugs. By using data obtained from Taiwan and focusing on diabetic patients, our empirical results provide several consistent findings in support of the hypothesis that profit incentives do affect the physician's prescribing decision, suggesting that physicians act as imperfect agents. An important implication of our findings is that rent seeking for profit margin between the reimbursement and the acquisition price instead of reducing costs is the major driving force behind generic substitution. As a result, the providers instead of the payers or consumers reap the financial benefits of generic substitution.

Medicines information in medical journal advertising in Australia, Malaysia and the United States: A comparative cross-sectional study

PubMed Central

Othman, Noordin; Vitry, Agnes Isabelle; Roughead, Elizabeth Ellen

2010-01-01

Objective: The aim of this study was to compare the provision of medicines information in medical journal advertising in Australia, Malaysia and the United States. Methods: A consecutive sample of 85 unique advertisements from each country was selected from the advertisements published between January 2004 to December 2006 in three widely circulated medical journals and one prescribing reference manual. The availability of brand name and generic name, indication, contraindications, dosage, side-effects, warnings, interactions and precautions was compared between the three countries. Results: We examined 255 distinct advertisements for 136 pharmaceutical products. Journal advertising in Australia, Malaysia and the US usually provided brand names and generic names (range 96 -100%). Information on dosage was significantly less likely to be mentioned (32%) in the US than in Australia (92%) and Malaysia (48%) (P < 0.001). Warning information was significantly less likely to be provided in Australia (5%) than in the US (81%) and Malaysia (9%) (P < 0.001). Apart from information on brand name, generic name, warnings and dosage, other product information significantly less likely to be provided in journal advertising in Malaysia than in Australia and the US (P < 0.001). Similar trends in the provision of product information for the same medicines published in these countries were noted. Brand name and generic name were always provided in the three countries (100%). However, information on the negative effects of medicines was less frequently provided in Malaysia than in Australia and the US. Conclusions: Journal advertising in Australia, Malaysia and the US failed to provide complete product information. Low quality of information provided in Malaysia indicates the need for effective regulation of provision of medicines information in journal advertising. Different standards of medicines information provided in these three countries suggest that pharmaceutical promotion needs to be better controlled at the international level. PMID:23093878

Drugs Approved for Neuroblastoma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

PubMed

Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

2015-07-06

The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.

Drugs Approved for Retinoblastoma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.

PubMed

Kesselheim, Aaron S; Eddings, Wesley; Raj, Tara; Campbell, Eric G; Franklin, Jessica M; Ross, Kathryn M; Fulchino, Lisa A; Avorn, Jerry; Gagne, Joshua J

2016-01-01

Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians' perceptions of the FDA's generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA's process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13-26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.

Evaluation of the clinical and economic impact of a brand name-to-generic warfarin sodium conversion program.

PubMed

Witt, Daniel M; Tillman, Donald J; Evans, Christy M; Plotkin, Tatyana V; Sadler, Melanie A

2003-03-01

Substitution of generic warfarin initially was discouraged because of concerns regarding therapeutic failure or toxicity. Although subsequent research with AB-rated (i.e., bioequivalent) warfarin did not confirm initial concerns, the issue is not settled for all clinicians. We sought to provide additional information regarding the clinical and economic impact of warfarin conversion by analyzing a real-life sample of patients receiving long-term anticoagulation therapy who were switched from brand name to generic warfarin. Patients who had been taking warfarin for at least 180 days and had received uninterrupted oral anticoagulation 90 days before and 90 days after switching to generic warfarin were included. The switch date was based on the first time generic warfarin was dispensed from our pharmacies. The primary end point was the calculated amount of time each patient's international normalized ratio (INR) values were within the patient-specific target INR range in the 90 days before and after the switch. Data regarding adverse events and medical resource utilization were also collected. Pharmacoeconomic analyses were performed. The analysis included 2299 patients. The overall difference in calculated time INR values were below (22.6% before vs 26.1% after switch, p<0.0001) and within (65.9% before vs 63.3% after switch, p=0.0002) the therapeutic INR range was statistically but not clinically significant. Only 28.0% of patients experienced a change in therapeutic INR control of 10% or less, 33.1% experienced INR control that improved by greater than 10%, and 38.9% experienced INR control that worsened by more than 10%. The difference in total treatment costs associated with brand name and generic warfarin was 3128 dollars/100 patient-years in favor of the generic product. Sensitivity analyses revealed that cost savings associated with warfarin conversion in this health care system were highly dependent on the difference between warfarin costs and cost of treating anticoagulation-related adverse events. Most of these patients were successfully switched from brand name to generic warfarin. However, supplemental INR monitoring is warranted when one warfarin product is substituted for another to allow timely detection of those patients who experience significant changes in anticoagulation response.

Generic antibiotics in Japan.

PubMed

Fujimura, Shigeru; Watanabe, Akira

2012-08-01

Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk particle and amount of solubilizer. The Japanese government hopes to increase the diffusion rate of generic drugs (in terms of quantity) from 20.2 % in 2010 to 30 % or more in 2012, and therefore it will be necessary to clarify the advantages of generic antibiotics in terms of expenditure and equivalency with the branded drugs.

Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them?

PubMed Central

2011-01-01

Background In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product. Discussion Since their introduction the regulations have been a source of contention between the generic and the brand-name industry. While the regulations have generated a considerable amount of work for the Federal Court of Canada both sides dispute the interpretation of the "win rate" in the court cases. Similarly, there is no agreement on whether multiple patents on single drugs represent a legitimate activity by the brand-name industry or an "evergreening" tactic. The generic industry's position is that the regulations are being abused leading to the delay in the introduction of lower cost generic products by as much as 8 years. The brand-name companies counter that the regulations are necessary because injunctions against the introduction of generic products are frequently unavailable to them. The regulations were amended in 2006 and again in 2008 but both sides continue to claim that the regulations favour the other party. The battle around the regulations also has an international dimension with interventions by PhRMA, the trade association representing the United States based multinational companies, arguing that the regulations are not stringent enough and that Canada needs to be placed on the U.S. Priority Watch List of countries. Finally, there are multiple costs to Canadian society as a result of the NOC regulations. Summary Despite the rhetoric there has been almost no empiric academic research done into the effect of the regulations. In order to develop rational policy in this area a number of key research questions have been formulated. PMID:21435247

Drugs Approved for Bone Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Vulvar Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Esophageal Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Endometrial Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Kaposi Sarcoma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Malignant Mesothelioma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Skin Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Gestational Trophoblastic Disease

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gestational trophoblastic disease. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Liver Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Drugs Approved for Penile Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Drugs Approved for Stomach (Gastric) Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for stomach (gastric) cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Vaginal Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Drugs Approved for Soft Tissue Sarcoma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for soft tissue sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Patient socioeconomic determinants of the choice of generic versus brand name drugs in the context of a reference price system: evidence from Belgian prescription data.

PubMed

Farfan-Portet, Maria-Isabel; Van de Voorde, Carine; Vrijens, France; Vander Stichele, Robert

2012-06-01

The generic reference price system (RPS) can impose a financial penalty for patients using a brand name drug instead of its generic alternative. Previous studies on the impact of the RPS have not considered the potentially differential effect of using generic alternatives for individuals with a different socioeconomic background. However, patients' characteristics might determine their overall knowledge of the existence of the system and thus of the financial burden to which they may be confronted. The association between patients' characteristics and the use of generic drugs versus brand name drugs was analyzed for ten highly prescribed pharmaceutical molecules included in the Belgian generic reference price system. Prescriptions were obtained from a 10% sample of all general practitioners in 2008 (corresponding to 120,670 adult patients and 368,101 prescriptions). For each pharmaceutical molecule, logistic regression models were performed, with independent variables for patient socioeconomic background at the individual level (work status, having a guaranteed income and being entitled to increased reimbursement of co-payments) and at the level of the neighborhood (education). The percentage of generic prescriptions ranged from 24.7 to 76.4%, and the mean reference supplement in 2008 ranged from €4.3 to €37.8. For seven molecules, higher use of a generic alternative was associated with either having a guaranteed income, with receiving increased reimbursement of co-payments or with living in areas with the lowest levels of education. Globally, results provided evidence that the generic RPS in Belgium does not lead to a higher financial burden on individuals from a low socioeconomic background.

Generic substitution of antihypertensive drugs: does it affect adherence?

PubMed

Van Wijk, Boris L G; Klungel, Olaf H; Heerdink, Eibert R; de Boer, Anthonius

2006-01-01

Generic substitution is an important opportunity to reduce the costs of pharmaceutical care. However, pharmacists and physicians often find that patients and brand-name manufacturers have doubt about the equivalence of the substituted drug. This may be reflected by decreased adherence to therapy. To assess the association between generic substitution and nonadherence to antihypertensive drugs. We conducted a matched cohort study between January 1, 1999, and December 31, 2002. Data were obtained from PHARMO, a record linkage system containing drug-dispensing records from community pharmacies and linked hospital discharge records of approximately 950,000 people in The Netherlands. Residents of 30 medium-sized cities who initiated antihypertensive drug therapy were potential subjects. Refill adherence with antihypertensive drugs after substitution was determined; those with refill adherence below 80% were considered nonadherent. Four hundred sixty-three patients with a substitution in therapy and 565 controls, matched on age, gender, therapy start date, duration of use, and generic product code, were identified. Of the patients who switched from brand-name to generic formulations ("substituted"), 13.6% were nonadherent, and of the non-substituted patients (those who did not switch to generic), 18.7% were nonadherent (OR 0.68; 95% CI 0.48 to 0.96). The association was absent in males. None of the patients discontinued the medication. No differences in hospitalizations for cardiovascular disease in the 6 months after the substitution were observed. Generic substitution of antihypertensive drugs does not lead to lower adherence or more discontinuation and cardiovascular disease-related hospitalizations compared with brand-name therapy. When a less-expensive antihypertensive generic equivalent becomes available, generic substitution should be considered to achieve economic benefits.

Pricing of drugs with heterogeneous health insurance coverage.

PubMed

Ferrara, Ida; Missios, Paul

2012-03-01

In this paper, we examine the role of insurance coverage in explaining the generic competition paradox in a two-stage game involving a single producer of brand-name drugs and n quantity-competing producers of generic drugs. Independently of brand loyalty, which some studies rely upon to explain the paradox, we show that heterogeneity in insurance coverage may result in higher prices of brand-name drugs following generic entry. With market segmentation based on insurance coverage present in both the pre- and post-entry stages, the paradox can arise when the two types of drugs are highly substitutable and the market is quite profitable but does not have to arise when the two types of drugs are highly differentiated. However, with market segmentation occurring only after generic entry, the paradox can arise when the two types of drugs are weakly substitutable, provided, however, that the industry is not very profitable. In both cases, that is, when market segmentation is present in the pre-entry stage and when it is not, the paradox becomes more likely to arise as the market expands and/or insurance companies decrease deductibles applied on the purchase of generic drugs. Copyright © 2012 Elsevier B.V. All rights reserved.

Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs.

PubMed

Bohn, J; Kortepeter, C; Muñoz, M; Simms, K; Montenegro, S; Dal Pan, G

2015-05-01

Spontaneous adverse event reports constitute an important source of information on previously unknown adverse reactions to marketed medicines. However, the dynamics of such reporting following generic introduction are poorly understood. Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of product-identifying information contained therein. The majority of reports were sent by innovator drug manufacturers while few were sent by generic manufacturers, even when generics accounted for >90% of dispensed prescriptions. We manually reviewed narratives from 2,500 reports and found that the suspect product type (brand or generic) could not be determined in 84% of reports, while generic products (16%) were identified more often than brand-name products (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices. © 2015 American Society for Clinical Pharmacology and Therapeutics.

Drugs Approved for Gastrointestinal Stromal Tumors

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gastrointestinal stromal tumors (GIST). The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Generic drug names and social welfare.

PubMed

Lobo, Félix; Feldman, Roger

2013-06-01

This article studies how well International Nonproprietary Names (INNs), the "generic" names for pharmaceuticals, address the problems of imperfect information. Left in private hands, the identification of medicines leads to confusion and errors. Developed in the 1950s by the World Health Organization, INNs are a common, global, scientific nomenclature designed to overcome this failure. Taking stock after sixty years, we argue that the contribution of INNs to social welfare is paramount. They enhance public health by reducing errors and improving patient safety. They also contribute to economic efficiency by creating transparency as the foundation of competitive generic drug markets, reducing transaction costs, and favoring trade. The law in most countries requires manufacturers to designate pharmaceuticals with INNs in labeling and advertising. Generic substitution is also permitted or mandatory in many countries. But not all the benefits of INNs are fully realized because prescribers may not use them. We advocate strong incentives or even legally binding provisions to extend the use of INNs by prescribing physicians and dispensing pharmacists, but we do not recommend replacing brand names entirely with INNs. Instead, we propose dual use of brand names and INNs in prescribing, as in drug labeling.

Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product.

PubMed

Huvelle, Sophie; Godet, Marie; Hecq, Jean-Daniel; Gillet, Patricia; Jamart, Jacques; Galanti, Laurence M

2016-01-01

The objectives of this study were to determine if the preparation of vancomycin hydrochloride in advance of infusion could improve the quality of the drug, time management of drug delivery, cost savings of drug delivery, and to investigate the long-term stability of vancomycin hydrochloride (brand name Vancocin®) infusion in glucose 5% polyolefin bags versus the generic (Vancomycine®) at 5°C ± 3°C. Five bags of each infusion 1 g/100 mL vancomycin hydrochloride in 5% glucose (Vancocin ® and Vancomycine®) were stored up to 57 days at 5°C ± 3°C. A visual inspection and pH measurement were performed periodically during the storage, and the concentrations were measured by high-performance liquid chromatography-diode array detection. No color change or precipitation in the solution was observed throughout the study period. As recommended by the U.S. Food and Drug Administration, the lower confidence limit at 95% of the concentration for the solutions remained superior to 90% of the initial concentration up to 43 days for the brand vancomycin (Vancocin®) infusion (96% ± 2%) and up to 57 days for the generic (Vancomycine®) (95% ± 4%). The solutions prepared either from brand or generic vancomycin hydrochloride were chemically stable more than one month (43 days for the brand and 57 days for the generic solution) and could be prepared in advance in a centralized intravenous additive service facility. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Brand name to generic substitution of antiepileptic drugs does not lead to seizure-related hospitalization: a population-based case-crossover study.

PubMed

Polard, Elisabeth; Nowak, Emmanuel; Happe, André; Biraben, Arnaud; Oger, Emmanuel

2015-11-01

There is still controversy on brand-to-generic (B-G) antiepileptic drugs (AEDs) substitution. To assess association between B-G AED substitution and seizure-related hospitalization, we designed a case crossover using the French National Health Insurance Database. We identified a cohort of adult patients who filled a prescription in 2009-2011 for AEDs with at least one brand name and one generic form. The outcome date was defined as the date of hospitalization, coded G40.x or G41.x, with a G40/G41 hospitalization-free period of at least 1 year. Patients with a medical history of cancer and women who gave birth in 2009-2011 were excluded. We required individuals to have regular dispensations of AEDs within the year preceding the outcome date. Free patients were defined as patients who had only brand name dispensations before the control period. Eight thousand three hundred seventy nine patients (mean age ± standard deviation, 52.7 ± 18.8 years; sex ratio male/female, 1.27) were analyzed. Discordant pairs were 491 with B-G substitution in the control period only and 478 with B-G substitution in the case period only; odds ratio (95% confidence interval) 0.97 (0.86-1.10). No statistically significant interaction was detected among the four prespecified subgroup analyses (gender, age strata, free or non-free, and strict AED monotherapy or not). Controlling for non-seizure-related hospitalizations made no material difference. Sensitivity analyses yielded similar results. Brand-to-generic AED substitution was not associated with an elevated risk of seizure-related hospitalization. Copyright © 2015 John Wiley & Sons, Ltd.

Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes.

PubMed

Andermann, Frederick; Duh, Mei Sheng; Gosselin, Antoine; Paradis, Pierre Emmanuel

2007-03-01

Compulsory generic substitution of antiepileptic drugs (AEDs) may lead to adverse effects in epilepsy patients because of seizure recurrence or increased toxicity. The study objectives were (a) to quantify and compare the switchback rates from generic to brand-name AEDs versus non-AEDs, and (b) to assess clinical implications of switching from branded Lamictal to generic lamotrigine (LTG) and whether signals exist suggesting outcome worsening. By using a public-payer pharmacy-claims database from Ontario, Canada, switchback rates from generic to branded AEDs [Lamictal, Frisium (clobazam; CLB), and Depakene (VPA; divalproex)] were calculated and compared with non-AED long-term therapies, antihyperlipidemics and antidepressants, in January 2002 through March 2006. We then assessed pharmacy utilization and AED dosage among LTG patients switching back to branded Lamictal compared with those staying on generic formulation. The 1,354 patients (403 monotherapy, 951 polytherapy) were prescribed generic LTG, of whom 12.9% switched back to Lamictal (11.7% monotherapy, 13.4% polytherapy). Switchback rates of other AEDs were approximately 20% for CLB and VPA. The switchback rates for AEDs were substantially higher than for non-AEDs (1.5-2.9%). Significant increases in LTG doses were observed after generic substitution for those who did not switch back (6.2%; p<0.0001). The average number of codispensed AEDs and non-AED drugs significantly increased (p<0.0001) after LTG generic entry, especially in the generic group. These results reflect poor acceptance of switching AEDs to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use.

Drugs Approved for Leukemia

Cancer.gov

This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Wilms Tumor

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Head and Neck Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for head and neck cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Should utility incumbents be able to extend their brand name to competitive retail markets? An economic perspective

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abel, J.R.; Clements, M.E.

As retail competition begins, at least for the short run, there should be policy restrictions on an incumbent utility`s ability to extend its brand to an affiliated marketer. However, a utility-affiliated marketer should be permitted to compete in a newly deregulated market using a generic or self-developed brand name. If extending a brand name from an incumbent utility to an affiliated marketer does in fact create real barriers to entry in the retail market, competition will be crippled in this market and consumers will suffer. More important, deregulation will appear to have failed in the electric power market--a consequence withmore » effects reaching past the electricity industry to other industries considering deregulation as a viable policy choice. However, if real barriers to entry are not erected by this type of brand name extension, the industry may suffer from lower quality products, less service, and reduced innovation if policymakers prohibit brand name extension.« less

Patient adherence to generic versus brand statin therapy after acute myocardial infarction: Insights from the Can Rapid Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines Registry.

PubMed

O'Brien, Emily C; McCoy, Lisa A; Thomas, Laine; Peterson, Eric D; Wang, Tracy Y

2015-07-01

Statins reduce mortality after acute myocardial infarction, but up to half of patients discontinue statin use within 1 year of therapy initiation. Although cost may influence medication adherence, it is unknown whether use of generic versus brand statins influences adherence. We linked detailed inhospital clinical data for 1421 non-ST-segment elevation myocardial infarction patients discharged on a statin in 2006 to Medicare Part D medication claims records to examine postdischarge medication use. One-year statin adherence was defined using the proportion of days covered with optimal adherence ≥80%. We examined the association of brand versus generic statin prescription and 1-year adherence after adjusting for demographics, clinical factors, predischarge lipid values, prior statin use, and socioeconomic status. Overall, 65.5% of statin fills were for brand-name statins. There were few baseline differences in demographics and clinical factors among generic versus brand users. Patient copay amounts were higher for brand versus generic statins (median = $25 vs $5, P < .001), yet the mean proportion of days covered over 1 year was similar (71.5% vs 68.9%; P = .97; unadjusted odds ratio 1.15 [95% CI 0.96-1.37]). Proportion of days covered ≥80% was low for both generic (56.2%) and brand statins (55.9%; P = .93). Statin adherence rates remained similar between generic and brand users after adjusting for demographics, clinical risk factors, lipid value, prior statin use, and socioeconomic status. In a cohort of older non-ST-segment elevation myocardial infarction patients, we found no evidence that use of generic versus brand drug was associated with higher adherence to statins at 1 year after hospital discharge. Copyright © 2015 Elsevier Inc. All rights reserved.

Determinants of Market Exclusivity for Prescription Drugs in the United States.

PubMed

Kesselheim, Aaron S; Sinha, Michael S; Avorn, Jerry

2017-11-01

The high prices of brand-name prescription drugs are a growing source of controversy in the United States. Manufacturers of brand-name drugs can command high prices because they are protected from generic competition by two types of government-granted monopoly rights. The first are patents on the drugs that generally define the basic period of brand-name-only sales. The second is awarded at the time of US Food and Drug Administration (FDA) approval and usually defines the minimum time until a generic can be sold. The initial patents last for 20 years and may be extended to account for time spent in clinical trials and regulatory review; other laws prevent approval of other manufacturers' versions of new drugs for about 6 to 7 years, and for new biologics for 12 years. Overall, most new drugs receive about 12 to 16 years of market exclusivity from both kinds of monopoly protection combined. We reviewed the peer-reviewed medical and health policy literature to identify studies that described the different types of patent protection and regulatory exclusivities that shield brand-name prescription drugs from competition and thus help to sustain high drug prices. We also identified potential policy reforms intended to modify exclusivity periods to address public health needs by balancing drug affordability and industry revenue. The goal of policy in this area should be to ensure that drug market exclusivity periods provide for fair return on investment but do not indefinitely block availability of lower-cost generic drugs.

Genericization: A Theory of Semantic Broadening in the Marketplace.

ERIC Educational Resources Information Center

Clankie, Shawn M.

2000-01-01

Genericization theory developed as a response to claims from outside of linguistics that generic use in brand names (for example, using Kleenex as a generic noun for all facial tissues, or Xerox for all photocopiers) is the result of marketing factors or misuse by consumers. This paper examines the linguistic factors that create an environment…

Idiopathic Interstitial Pneumonias

MedlinePlus

... 50 More than 60% Pulmonary rehabilitation Lung transplantation Pirfenidone or nintedanib 50–70% die in 5 years. ... In This Article Generic Name Select Brand Names Pirfenidone ESBRIET nintedanib OFEV Interstitial Lung Diseases Overview of ...

Drugs Approved for Pancreatic Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Lung Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Breast Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Bladder Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-Infected Ugandan Adults

PubMed Central

Byakika-Tusiime, Jayne; Chinn, Leslie W.; Oyugi, Jessica H.; Obua, Celestino; Bangsberg, David R.; Kroetz, Deanna L.

2008-01-01

Background Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of lamivudine, stavudine and nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®). Methodology/Principal Findings An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received lamivudine (150 mg), stavudine (40 mg), and nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC0–12h and Cmax. Bioequivalence was defined as a geometric mean ratio between the generic and brand name within the 90% confidence interval of 0.8–1.25. The geometric mean ratios and the 90% confidence intervals were: stavudine Cmax, 1.3 (0.99–1.71) and AUC0–12h, 1.1 (0.87–1.38); lamivudine Cmax, 0.8 (0.63–0.98) and AUC0–12h, 0.8 (0.65–0.99); and nevirapine Cmax, 1.1 (0.95–1.23) and AUC0–12h, 1.1 (0.95–1.31). The generic formulation was not statistically bioequivalent to the brand formulations during steady state, although exposures were comparable. A mixed random effects model identified about 50% intersubject variability in the pharmacokinetic parameters. Conclusions/Significant Findings These findings provide support for the use of Triomune in resource-limited settings, although identification of the sources of intersubject variability in these populations is critical. PMID:19096711

Price and welfare effects of a pharmaceutical substitution reform.

PubMed

Granlund, David

2010-12-01

The price effects of the Swedish pharmaceutical substitution reform are analyzed using data for a panel of all pharmaceutical product sold in Sweden in 1997-2007. The price reduction due to the reform was estimated to average 10% and was found to be significantly larger for brand-name pharmaceuticals than for generics. The results also imply that the reform amplified the effect that generic entry has on brand-name prices by a factor of 10. Results of a demand estimation imply that the price reductions increased total pharmaceutical consumption by 8% and consumer welfare by SEK 2.7 billion annually. Copyright © 2010 Elsevier B.V. All rights reserved.

In vitro disintegration studies of weekly generic and branded risedronate sodium formulations available in Canada.

PubMed

Walker, A D; Adachi, J D

2011-09-01

The aim of this study was to evaluate the in vitro disintegration of the five newly available Canadian generic risedronate 35 mg tablets compared to the innovator (branded) product, ACTONEL * *ACTONEL is a registered trade name of Warner Chilcott Company, LLC. (risedronate sodium) 35 mg. Tablets were inspected for colour and appearance. Disintegration times were determined using United States Pharmacopeia 33 (USP33-NF 28) methods. Disintegration onset time was also evaluated. The mean disintegration onset time values for the generic risedronate 35 mg tablets ranged from 2 to 29 seconds, and the mean disintegration completion times ranged from 81 to 260 seconds. The mean disintegration onset and completion time values for the ACTONEL 35 mg tablets were 23 and 43 seconds respectively. Four out of the five generic tablets tested had shorter disintegration onset times than the branded product; two of the generic tablet products had very fast disintegration onset times i.e. 2-3 seconds. Disintegration completion time for all five generic products tested was longer than that observed for the branded product; two generic products had disintegration completion time values five to six times longer than the branded product. Differences in the in vitro disintegration times were observed between the generic risedronate 35 mg tablets commercially available in Canada and the branded product, ACTONEL. The rapid disintegration onset times of two generic products may be important as this could increase the possibility of drug exposure in both the mouth and the esophagus during swallowing, resulting in unwanted localized irritation. However, it should be noted that an in vitro/in vivo correlation has not been established. Until such studies are completed it may be important to be aware of such in vitro disintegration differences when evaluating patients with newly presenting upper gastrointestinal complaints upon being switched from the branded product to generic formulations.

Perception and attitude of general practitioners regarding generic medicines in Karachi, Pakistan: A questionnaire based study

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad; Masood, Imran; Low, Bee Yean; Shafie, Asrul Akmal; Babar, Zaheer-ud-din

2012-01-01

Objectives: In developing countries out-of-pocket payments (OOP) are as high as 80% of healthcare spending. Generic medicines can be instrumental in reducing this expenditure. The current study is aimed to explore the knowledge, perception, and attitude of general practitioners towards generic medicines in Karachi, Pakistan. Methods: This exploratory, descriptive study was conducted on a sample of 289 randomly selected general practitioners who were dispensing at their private clinics in Karachi, Pakistan. The questionnaires were distributed and collected by hand. Data was entered to SPSS version 17. Fischer’s exact test was applied to see the association between variables. Results: A total of 206 questionnaires were included in the study. A response rate of 71.3% was achieved. Out of 206 respondents, 139 (67.5%) were male while 67 (32.5%) respondents were female. Close to three quaters of the respondents (n= 148; 71.8%) showed correct knowledge about generic medicines being a ‘copy of the brand name medicines’ and ‘interchangeable with brand name medicines’ (n= 148; 71.8%). In terms of safety, the majority of respondents (n=85; 41.26%) incorrectly understood that the generic medicines are less safe than brand name medicines. The total percentage of correct responses was seen in 53% of the respondents. More than half of the respondents agreed that locally manufactured medicines are of the same effectiveness as brand name medicines (n=114; 55.4%). Male practitioners with practice experience of 11-15 years showed positive perception towards the quality of multinational products. The Majority of respondents believed that their prescribing decision is influenced by medical representatives (n=117; 56.8%). More than three-quarters of the respondents expressed their wish to prescribe low cost medicines in their practice (n=157; 76.2%). More than one third of the respondents expressed their uneasiness to prescribe products from all local manufacturers (n=72; 35%). Conclusion: There were gaps identified in the knowledge of respondents. Although good perception and attitude were noted among the respondents, dissemination of information regarding generic medicines may perhaps strengthen generic prescribing. There is a need to introduce ‘Quality by Design’ concept in local manufacturing units. This, in turn, can inculcate confidence in prescribers towards locally manufactured generic medicines. PMID:23093896

Types of Blood Pressure Medications

MedlinePlus

... Generic name Common brand names hydralazine hydrochloride Apresoline* minoxidil Loniten*† Some noted possible side effects of vasodilators: ... This drug isn't usually used by itself. Minoxidil (Loniten)* is a potent drug that's usually used ...

Drugs Approved for Testicular Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Cervical Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Rhabdomyosarcoma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

Drugs Approved for Hodgkin Lymphoma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Myeloproliferative Neoplasms

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

[Bioequivalence and generics of index drugs with narrow therapeutic margins].

PubMed

Le Corre, Pascal

2010-02-01

The market share of generic drugs in France is quite low compared to that in other European countries. Because the scientific aspects of bioequivalence that govern the use of generics are sometimes described ambiguously in the literature, they are not always perceived clearly by health professionals. This lack of clarity may be an obstacle to their use. Two drugs are considered bioequivalent if the upper and lower limits of the 90% confidence interval (90% CI) of the generic-to-brand ratio for the area under the curve (AUC) and for the maximum plasma concentration (Cmax) are included in the [-20%, +25%] interval. This interval applies to the 90% CI of the ratios of the AUC (or Cmax) and not directly to the ratio of their values. Hence, it is wrong to consider that there is a -20% to + 25% variation in the AUC (and thus in the bioavailability) between a generic and a brand-name drug. This mistake can sometimes be seen in the medical literature, however, with incorrect extrapolations. The bioequivalence is defined for a generic in relation to a brand-name drug. Consequently, two different generics of the same proprietary drug do not automatically meet the criteria for bioequivalence. Their interchangeability can present problems, especially for drugs with a narrow therapeutic index, that is, those that have a<2-fold difference between the minimum toxic concentration and minimum effective concentration in blood. More restrictive criteria have been proposed for narrow therapeutic index drugs, but there is currently no international consensus on the subject. Determining individual bioequivalence would require modified study protocols to guaranty the interchangeability of the brand-name and generic drugs so that a patient taking one formulation could change to another that would provide the same efficacy and safety. Some antiepileptic drugs have biopharmaceutical and pharmacokinetic properties inducing high levels of intraindividual variability, which can cause problems. According to the French drug agency (AFSSAPS), however, a link between epileptic attacks and treatment with generic drugs has not been established. The economic evaluation of generics should go beyond the simple comparison of the sales price, especially for drugs with a narrow therapeutic range for which therapeutic drug monitoring (plasma assays) can be used. Copyright 2009 Elsevier Masson SAS. All rights reserved.

The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects.

PubMed

Faasse, Kate; Cundy, Tim; Gamble, Greg; Petrie, Keith J

2013-01-01

Generic medications are associated with reduced perceived effectiveness, increased perceived adverse effects, and increased rates of nonadherence compared with brand-name medications. This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects. Sixty-two university students participated in a study purportedly testing the effectiveness of fast-acting β-blocker medications in reducing preexamination anxiety. All tablets were placebos. In session 1, all participants received a yellow tablet ("Betaprol"). In session 2, participants were randomly allocated to receive Betaprol (no change condition) or a white tablet labeled either as "Novaprol" (branded change condition) or "Generic" (generic change condition). Blood pressure and state anxiety were measured before and after tablet ingestion. Side effects attributed to medication were assessed. The no change group showed significantly greater decreases in systolic blood pressure (mean [M] [standard deviation] = -7.72 mm Hg, standard error [SE] = 1.45) than the branded change (M = -2.75 mm Hg, SE = 1.44, p = .02) and generic change (M = -3.26 mm Hg, SE = 1.45, p = .03) groups. The no-change group showed significantly greater decreases in state anxiety (M = -1.53, SE = 0.33) than the branded change (M = -0.50, SE = 0.33, p = .03) and generic change (M = -0.52, SE = 0.33, p = .04) groups. Significantly more side effects were attributed to the medication in the generic change (M = 1.83, SE = 0.23) (but not the branded change) condition when compared with the no change condition (M = 0.87, SE = 0.31, p = .03). Medication formulation change, particularly to generic medication, seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects.

42 CFR 425.706 - Minimum necessary data.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) The claim payment type. (9) Date of birth and death, if applicable. (10) TIN. (11) NPI. (b) The.... (6) Days supplied. (7) Brand name. (8) Generic name. (9) Drug strength. (10) TIN. (11) NPI. (12...

42 CFR 425.706 - Minimum necessary data.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) The claim payment type. (9) Date of birth and death, if applicable. (10) TIN. (11) NPI. (b) The.... (6) Days supplied. (7) Brand name. (8) Generic name. (9) Drug strength. (10) TIN. (11) NPI. (12...

42 CFR 425.706 - Minimum necessary data.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) The claim payment type. (9) Date of birth and death, if applicable. (10) TIN. (11) NPI. (b) The.... (6) Days supplied. (7) Brand name. (8) Generic name. (9) Drug strength. (10) TIN. (11) NPI. (12...

Prescription Drug Benefits: Cost Management Issues for Medicare

PubMed Central

Fox, Peter D.

2003-01-01

Little attention has been devoted in policy circles as to how Medicare would manage an outpatient prescription drug benefit. This article, first, discusses the role of the pharmacy benefits manager (PBM), the entity that processes claims and otherwise helps administer the benefit. It then discusses the major decisions that will be necessary regarding such matters as: which drugs should be covered; how broad should the pharmacy network be; whether there should be incentives to obtain generic rather than brand-name drugs when available; for drugs with no generic equivalent, should there be incentives to obtain less expensive, medically appropriate brand-name drugs; and how should prescription drug utilization be managed. PMID:15124374

Effects of Switching from Depakene to Generic Valproic Acid on Individuals with Mental Retardation.

ERIC Educational Resources Information Center

Vadney, Victor J.; Kraushaar, Kevin W.

1997-01-01

Comparison of brand-name Depakene with generic valproic acid medication to control seizures in 64 subjects with mental retardation living in an intermediate care facility found no statistically significant differences in seizures or blood levels. Results suggest use of the generic medication can result in substantial cost savings. (Author/DB)

Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Multiple Myeloma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Colon and Rectal Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for use in colon cancer and rectal cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Consumer choice between common generic and brand medicines in a country with a small generic market.

PubMed

Fraeyman, Jessica; Peeters, Lies; Van Hal, Guido; Beutels, Philippe; De Meyer, Guido R Y; De Loof, Hans

2015-04-01

Generic medicines offer an opportunity for governments to contain pharmaceutical expenditures, since generics are generally 10%-80% lower in price than brand medicines. Belgium has a small generic market that takes up 15% of the total pharmaceutical market in packages sold. To determine the knowledge of consumers about the different available packages of a common over-the-counter medicine (acetaminophen) with regard to price advantage, quality, and effectiveness in a country with a small generic market. We conducted an online survey in the general Flemish population using a questionnaire with 25 statements. The questionnaire also contained 2 informative interventions. First, we showed the price per package and per tablet that the patient would pay in the pharmacy. Second, we provided the respondent with general information about generic medication (equivalence, effectiveness, price, and recognition). Before and after the interventions, we probed for preferences and knowledge about the different packages. Multivariate logistic models were used to examine the independent effects of consumer characteristics on responses to the survey statements. We obtained a sample of 1,636 respondents. The general attitude towards generic medication was positive-only 5% would rather not use a generic. Nevertheless, only 17% of the respondents were able to recognize a generic medicine. Older consumers (aged 60 years and above) were more often confused about the different packages (OR = 2.59, 95% CI = 1.76-3.80, P ≤ 0.001). Consumers without a higher education degree tended to be more doubtful about the difference in effectiveness and quality between the different brands (OR = 0.59, 95% CI = 0.44-0.79, P ≤ 0.001). Consumer recognition of the name of the active substance of acetaminophen was poor. When different brands were displayed, possible price advantage seemed to be an important motive to switch to a cheaper brand. Consumers generally found medicines to be too expensive; however, consumers with medical or paramedical training had a different opinion. Two main recommendations can be made to increase the knowledge and enhance the trust in cheaper equivalent medicines. First, highlighting the name of the active substance on the label of medicine packages can reduce confusion and avoid health risks, especially among older consumers. Second, new investments or reallocation of budgets should be considered in order to provide consumers with authoritative information on the bioequivalence and price differences between the different available brands. This would be a cost-effective and potentially cost-saving investment for health care payers.

Early Impact Of The Affordable Care Act On Oral Contraceptive Cost Sharing, Discontinuation, And Nonadherence.

PubMed

Pace, Lydia E; Dusetzina, Stacie B; Keating, Nancy L

2016-09-01

The oral contraceptive pill is the contraceptive method most commonly used by US women, but inconsistent use of the pill is a contributor to high rates of unintended pregnancy. The relationship between consumer cost sharing and consistent use of the pill is not well understood, and the impact of the elimination of cost sharing for oral contraceptive pills in a mandate in the Affordable Care Act (ACA) is not yet known. We analyzed insurance claims for 635,075 women with employer-sponsored insurance who were initiating use of the pill, to examine rates of discontinuation and nonadherence, their relationship with cost sharing, and trends before and during the first year after implementation of the ACA mandate. We found that cost sharing for oral contraceptives decreased markedly following implementation, more significantly for generic than for brand-name versions. Higher copays were associated with greater discontinuation of and nonadherence to generic pills than was the case with zero copayments. Discontinuation of the use of generic or brand-name pills decreased slightly but significantly following ACA implementation, as did nonadherence to brand-name pills. Our findings suggest a modest early impact of the ACA on improving consistent use of oral contraceptives among women initiating their use. Project HOPE—The People-to-People Health Foundation, Inc.

Differences in the rheological properties and mixing compatibility with heparinoid cream of brand name and generic steroidal ointments: The effects of their surfactants.

PubMed

Kitagawa, Shuji; Yutani, Reiko; Kodani, Rhu-Ichi; Teraoka, Reiko

2016-01-01

Most steroidal ointments contain propylene glycol (PG) and surfactants, which improve the solubility of corticosteroids in white petrolatum. Surfactants aid the uniform dispersal of PG within white petrolatum. Since the surfactants used in generic ointments are usually different from those used in brand name ointments, we investigated the effects of surfactants on the rheological properties of three brand name ointments and six equivalent generic ointments. We detected marked differences in hardness, adhesiveness, and spreadability among the ointments. Further examinations of model ointments consisting of white petrolatum, PG, and surfactants revealed that the abovementioned properties, especially hardness and adhesiveness, were markedly affected by the surfactants. Since steroidal ointments are often admixed with moisturizing creams prior to use, we investigated the mixing compatibility of the ointments with heparinoid cream and how this was affected by their surfactants. We found that the ointments containing glyceryl monostearate demonstrated good mixing compatibility, whereas those containing non-ionic surfactants with polyoxyethylene chains exhibited phase separation. These results were also consistent with the findings for the model ointments, which indicates that the mixing compatibility of steroidal ointments with heparinoid cream is determined by the emulsifying capacity of the surfactants in their oily bases.

Effect of generic drug competition on the price of prescription drugs in Ontario.

PubMed Central

Lexchin, J

1993-01-01

OBJECTIVE: To analyse the potential effect of generic drug competition on prices in Ontario to assess the costs and benefits associated with Bill C-22 (An Act to amend the Patent Act). DESIGN: Comparison of the cost of the least and most expensive versions of all products sold by more than one manufacturer in 1991. The number of brand-name and generic drug companies marketing each of the products was recorded. RESULTS: Of 1599 products 437 (27.3%) were made by more than one company. Almost half (44.6%) of the 437 were sold by two companies. The more companies that sold a drug the greater the difference in price between the least and most expensive versions. Similarly, as the proportion of generic drug companies in competition increased, the greater the price difference. When competition was between generic drug companies only, the price spread was smaller than when it was between brand-name drug companies only. CONCLUSIONS: Generic drug competition can result in savings to the Ontario Drug Benefit Plan. A more in-depth analysis of the potential savings is necessary to fully assess the costs and benefits associated with Bill C-22. PMID:8439888

40 CFR 721.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... concentration in air at 0.5 milligrams or less per liter of air (LC50). CAS Number means Chemical Abstracts..., trade name, brand name, or generic chemical name used to identify a chemical substance other than by its... Office of Pollution Prevention and Toxics means the Director of the EPA Office of Pollution Prevention...

40 CFR 721.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... concentration in air at 0.5 milligrams or less per liter of air (LC50). CAS Number means Chemical Abstracts..., trade name, brand name, or generic chemical name used to identify a chemical substance other than by its... Office of Pollution Prevention and Toxics means the Director of the EPA Office of Pollution Prevention...

40 CFR 721.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... concentration in air at 0.5 milligrams or less per liter of air (LC50). CAS Number means Chemical Abstracts..., trade name, brand name, or generic chemical name used to identify a chemical substance other than by its... Office of Pollution Prevention and Toxics means the Director of the EPA Office of Pollution Prevention...

40 CFR 721.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... concentration in air at 0.5 milligrams or less per liter of air (LC50). CAS Number means Chemical Abstracts..., trade name, brand name, or generic chemical name used to identify a chemical substance other than by its... Office of Pollution Prevention and Toxics means the Director of the EPA Office of Pollution Prevention...

Authorized generic drugs, price competition, and consumers' welfare.

PubMed

Berndt, Ernst R; Mortimer, Richard; Bhattacharjya, Ashoke; Parece, Andrew; Tuttle, Edward

2007-01-01

The growing frequency of authorized generics has important implications for the welfare of prescription drug consumers. Authorized generic entry could affect the timing of generic entry, brand-name and generic prices, and generic penetration. We reviewed 1999-2003 data and found that generic entry in the absence of short-run exclusivity restrictions benefits consumers through lower short-run prices. We suggest that these benefits likely also result from authorized generics. We posit that long-run prices and shares are likely essentially unaffected by authorized generics and that potential costs to consumers from any delayed generic entry are likely small.

Advertising and generic market entry.

PubMed

Königbauer, Ingrid

2007-03-01

The effect of purely persuasive advertising on generic market entry and social welfare is analysed. An incumbent has the possibility to invest in advertising which affects the prescribing physician's perceived relative qualities of the brand-name and the generic version of the drug. Advertising creates product differentiation and can induce generic market entry which is deterred without differentiation due to strong Bertrand competition. However, over-investment in advertising can deter generic market entry under certain conditions and reduces welfare as compared to accommodated market entry.

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

PubMed

Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

2018-02-01

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Generic and Brand-Name l-Thyroxine Are Not Bioequivalent for Children With Severe Congenital Hypothyroidism

PubMed Central

Carswell, Jeremi M.; Gordon, Joshua H.; Popovsky, Erica; Hale, Andrea

2013-01-01

Context: In the United States, generic substitution of levothyroxine (l-T4) by pharmacists is permitted if the formulations are deemed to be bioequivalent by the Federal Drug Administration, but there is widespread concern that the pharmacokinetic standard used is too insensitive. Objective: We aimed to evaluate the bioequivalence of a brand-name l-T4 (Synthroid) and an AB-rated generic formulation (Sandoz, Princeton, NJ) in children with severe hypothyroidism. Design: This was a prospective randomized crossover study in which patients received 8 weeks of one l-T4 formulation followed by 8 weeks of the other. Setting: The setting was an academic medical center. Patients: Of 31 children with an initial serum TSH concentration >100 mU/L, 20 had congenital hypothyroidism (CH), and 11 had autoimmune thyroiditis. Main Outcome Measures: The primary endpoint was the serum TSH concentration. Secondary endpoints were the free T4 and total T3 concentrations. Results: The serum TSH concentration was significantly lower after 8 weeks of Synthroid than after generic drug (P = .002), but thyroid hormone levels did not differ significantly. Subgroup analysis revealed that the difference in TSH was restricted to patients with CH (P = .0005). Patients with CH required a higher l-T4 dose (P < .0004) and were younger (P = .003) but were not resistant to thyroid hormone; 15 of 16 CH patients had severe thyroid dysgenesis or agenesis on imaging. The response to generic vs brand-name preparation remained significant when adjusted for age. Conclusions: Synthroid and an AB-rated generic l-T4 are not bioequivalent for patients with severe hypothyroidism due to CH, probably because of diminished thyroid reserve. It would therefore seem prudent not to substitute l-T4 formulations in patients with severe CH, particularly in those <3 yr of age. Our results may have important implications for other severely hypothyroid patients in whom precise titration of l-T4 is necessary. PMID:23264396

[Evaluation of Gastric Mucosal Injury Model Animals of Rebamipide Formulation--Study of Therapeutic Equivalence].

PubMed

Abe, Noriaki; Funato, Hiroki; Hirata, Ayumu; Nakai, Megumi; Iizuka, Michiro; Shiraishi, Hisashi; Jobu, Kohei; Yagi, Yusuke; Kadota, Aki; Ogi, Kyoko; Yokota, Junko; Miyamura, Mitsuhiko

2016-01-01

The introduction of generic drugs is promoted from the perspective of medical economics. In this context, we need to understand not only the bioequivalence of generic drugs specified in "the Guidelines for Bioequivalence Studies of Generic Products", but also formulation properties to consider their effect on pharmacological therapy. We evaluated the pharmaceutical characteristics of rebamipide formulations, a brand-name drug and two generic drugs, and their clinical functionality by using rat models of gastric mucosal injury induced by non-steroidal anti-inflammatory drugs (NSAIDs). Pharmaceutical evaluation showed significant differences in hardness. The inter-lot variation was small in all rebamipide formulations. In the clinical functionality study, biochemistry test values 7 d after the administration of rebamipide showed no differences among formulations. Higher levels of mucosal fluid secretion and antioxidative enzymes were observed in the groups administered rebamipide than in the control group. The levels of lipid peroxide were lower in the groups administered rebamipide than the control group. Multivariate analysis showed slight divergence between the brand-name and generic drugs. In future, it will be necessary to select generic drugs after careful consideration of bioequivalence, clinical functionality, and therapeutic equivalence by reviewing scientific evidence such as indication and formulation design, not to mention stable provision.

Fatty Liver

MedlinePlus

... Drug Information, Search Drug Names, Generic and Brand Natural Products, ... fat to accumulate in liver cells by causing the body to synthesize more fat or by processing (metabolizing) and excreting fat more slowly. As a ...

Errors and omissions in hospital prescriptions: a survey of prescription writing in a hospital

PubMed Central

Calligaris, Laura; Panzera, Angela; Arnoldo, Luca; Londero, Carla; Quattrin, Rosanna; Troncon, Maria G; Brusaferro, Silvio

2009-01-01

Background The frequency of drug prescription errors is high. Excluding errors in decision making, the remaining are mainly due to order ambiguity, non standard nomenclature and writing illegibility. The aim of this study is to analyse, as a part of a continuous quality improvement program, the quality of prescriptions writing for antibiotics, in an Italian University Hospital as a risk factor for prescription errors. Methods The point prevalence survey, carried out in May 26–30 2008, involved 41 inpatient Units. Every parenteral or oral antibiotic prescription was analysed for legibility (generic or brand drug name, dose, frequency of administration) and completeness (generic or brand name, dose, frequency of administration, route of administration, date of prescription and signature of the prescriber). Eight doctors (residents in Hygiene and Preventive Medicine) and two pharmacists performed the survey by reviewing the clinical records of medical, surgical or intensive care section inpatients. The antibiotics drug category was chosen because its use is widespread in the setting considered. Results Out of 756 inpatients included in the study, 408 antibiotic prescriptions were found in 298 patients (mean prescriptions per patient 1.4; SD ± 0.6). Overall 92.7% (38/41) of the Units had at least one patient with antibiotic prescription. Legibility was in compliance with 78.9% of generic or brand names, 69.4% of doses, 80.1% of frequency of administration, whereas completeness was fulfilled for 95.6% of generic or brand names, 76.7% of doses, 83.6% of frequency of administration, 87% of routes of administration, 43.9% of dates of prescription and 33.3% of physician's signature. Overall 23.9% of prescriptions were illegible and 29.9% of prescriptions were incomplete. Legibility and completeness are higher in unusual drugs prescriptions. Conclusion The Intensive Care Section performed best as far as quality of prescription writing was concerned when compared with the Medical and Surgical Sections. Nevertheless the overall illegibility and incompleteness (above 20%) are unacceptably high. Values need to be improved by enhancing the safety culture and in particular the awareness of the professionals on the consequences that a bad prescription writing can produce. PMID:19439066

Errors and omissions in hospital prescriptions: a survey of prescription writing in a hospital.

PubMed

Calligaris, Laura; Panzera, Angela; Arnoldo, Luca; Londero, Carla; Quattrin, Rosanna; Troncon, Maria G; Brusaferro, Silvio

2009-05-13

The frequency of drug prescription errors is high. Excluding errors in decision making, the remaining are mainly due to order ambiguity, non standard nomenclature and writing illegibility. The aim of this study is to analyse, as a part of a continuous quality improvement program, the quality of prescriptions writing for antibiotics, in an Italian University Hospital as a risk factor for prescription errors. The point prevalence survey, carried out in May 26-30 2008, involved 41 inpatient Units. Every parenteral or oral antibiotic prescription was analysed for legibility (generic or brand drug name, dose, frequency of administration) and completeness (generic or brand name, dose, frequency of administration, route of administration, date of prescription and signature of the prescriber). Eight doctors (residents in Hygiene and Preventive Medicine) and two pharmacists performed the survey by reviewing the clinical records of medical, surgical or intensive care section inpatients. The antibiotics drug category was chosen because its use is widespread in the setting considered. Out of 756 inpatients included in the study, 408 antibiotic prescriptions were found in 298 patients (mean prescriptions per patient 1.4; SD +/- 0.6). Overall 92.7% (38/41) of the Units had at least one patient with antibiotic prescription. Legibility was in compliance with 78.9% of generic or brand names, 69.4% of doses, 80.1% of frequency of administration, whereas completeness was fulfilled for 95.6% of generic or brand names, 76.7% of doses, 83.6% of frequency of administration, 87% of routes of administration, 43.9% of dates of prescription and 33.3% of physician's signature. Overall 23.9% of prescriptions were illegible and 29.9% of prescriptions were incomplete. Legibility and completeness are higher in unusual drugs prescriptions. The Intensive Care Section performed best as far as quality of prescription writing was concerned when compared with the Medical and Surgical Sections.Nevertheless the overall illegibility and incompleteness (above 20%) are unacceptably high. Values need to be improved by enhancing the safety culture and in particular the awareness of the professionals on the consequences that a bad prescription writing can produce.

Informational content of official pharmaceutical industry web sites about treatments for erectile dysfunction.

PubMed

Waack, Katherine E; Ernst, Michael E; Graber, Mark A

2004-12-01

In the last 5 years, several treatments have become available for erectile dysfunction (ED). During this same period, consumer use of the Internet for health information has increased rapidly. In traditional direct-to-consumer advertisements, viewers are often referred to a pharmaceutical company Web site for further information. To evaluate the accessibility and informational content of 5 pharmaceutical company Web sites about ED treatments. Using 10 popular search engines and 1 specialized search engine, the accessibility of the official pharmaceutical company-sponsored Web site was determined by searching under brand and generic names. One company also manufactures an ED device; this site was also included. A structured, explicit review of information found on these sites was conducted. Of 110 searches (1 for each treatment, including corresponding generic drug name, using each search engine), 68 yielded the official pharmaceutical company Web site within the first 10 links. Removal of outliers (for both brand and generic name searches) resulted in 68 of 77 searches producing the pharmaceutical company Web site for the brand-name drug in the top 10 links. Although all pharmaceutical company Web sites contained general information on adverse effects and contraindications to use, only 2 sites gave actual percentages. Three sites provided references for their materials or discussed other treatment or drug options, while 4 of the sites contained profound advertising or emotive content. None mentioned cost of the therapy. The information contained on pharmaceutical company Web sites for ED treatments is superficial and aimed primarily at consumers. It is largely promotional and provides only limited information needed to effectively compare treatment options.

Cigarette advertising and onset of smoking in children: questionnaire survey.

PubMed

While, D; Kelly, S; Huang, W; Charlton, A

1996-08-17

To investigate uptake of smoking in a cohort of 11 to 12 year olds related to awareness of advertised cigarette brands named. Self completed questionnaires administered to whole classes of schoolchildren in June 1993 and June 1994. Primary, middle, and secondary schools in the north and south of England. 1450 pupils aged 11 and 12 years at the time of the first survey. Onset of smoking and brands smoked by the second survey related to cigarette brands named in the first one. Less advertised brands were used as the base for calculating odds ratios. Girls who named the most advertised brands-namely, Benson and Hedges alone (odds ratio = 2.50, 95% confidence interval = 1.18 to 5.30) or Benson and Hedges and Silk Cut (2.15, 1.04 to 4.42) in the first survey were at greatest risk of taking up smoking by the second one. The difference was similar but not significant for boys. Boys and girls who named the least advertised brands in the first survey were at no greater risk of taking up smoking by the second survey than those who named no brands (boys odds ratio = 0.49 (0.24 to 1.01); girls 0.79 (0.38 to 1.62)). New smokers were more likely to smoke any available brand (29.5%) or a less advertised brand such as Embassy (24.6%) than the most advertised ones, Benson and Hedges (19.7%) and Silk Cut (14.8%). Established smokers were more selective, only 15% smoking any available brand and 38.3% smoking Benson and Hedges. Cigarette advertising appears to increase children's awareness of smoking at a generic level and encourages them to take up the behaviour, beginning with any cigarettes which are available and affordable.

The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

PubMed Central

Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

2013-01-01

Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

Is switching from brand name to generic formulations of phenobarbital associated with loss of antiepileptic efficacy?: a pharmacokinetic study with two oral formulations (Luminal(®) vet, Phenoleptil(®)) in dogs.

PubMed

Bankstahl, Marion; Bankstahl, Jens P; Löscher, Wolfgang

2013-10-09

In human medicine, adverse outcomes associated with switching between bioequivalent brand name and generic antiepileptic drug products is a subject of concern among clinicians. In veterinary medicine, epilepsy in dogs is usually treated with phenobarbital, either with the standard brand name formulation Luminal(®) or the veterinary products Luminal(®) vet and the generic formulation Phenoleptil(®). Luminal(®) and Luminal(®) vet are identical 100 mg tablet formulations, while Phenoleptil(®) is available in the form of 12.5 and 50 mg tablets. Following approval of Phenoleptil(®) for treatment of canine epilepsy, it was repeatedly reported by clinicians and dog owners that switching from Luminal(®) (human tablets) to Phenoleptil(®) in epileptic dogs, which were controlled by treatment with Luminal(®), induced recurrence of seizures. In the present study, we compared bioavailability of phenobarbital after single dose administration of Luminal(®) vet vs. Phenoleptil(®) with a crossover design in 8 healthy Beagle dogs. Both drugs were administered at a dose of 100 mg/dog, resulting in 8 mg/kg phenobarbital on average. Peak plasma concentrations (Cmax) following Luminal(®) vet vs. Phenoleptil(®) were about the same in most dogs (10.9 ± 0.92 vs. 10.5 ± 0.77 μg/ml), and only one dog showed noticeable lower concentrations after Phenoleptil(®) vs. Luminal(®) vet. Elimination half-life was about 50 h (50.3 ± 3.1 vs. 52.9 ± 2.8 h) without differences between the formulations. The relative bioavailability of the two products (Phenoleptil(®) vs. Luminal(®) vet.) was 0.98 ± 0.031, indicating that both formulations resulted in about the same bioavailability. Overall, the two formulations did not differ significantly with respect to pharmacokinetic parameters when mean group parameters were compared. Thus, the reasons for the anecdotal reports, if true, that switching from the brand to the generic formulation of phenobarbital may lead to recurrence of seizures are obviously not related to a generally lower bioavailability of the generic formulation, although single dogs may exhibit lower plasma levels after the generic formulation that could be clinically meaningful.

Is switching from brand name to generic formulations of phenobarbital associated with loss of antiepileptic efficacy?: a pharmacokinetic study with two oral formulations (Luminal® vet, Phenoleptil®) in dogs

PubMed Central

2013-01-01

Background In human medicine, adverse outcomes associated with switching between bioequivalent brand name and generic antiepileptic drug products is a subject of concern among clinicians. In veterinary medicine, epilepsy in dogs is usually treated with phenobarbital, either with the standard brand name formulation Luminal® or the veterinary products Luminal® vet and the generic formulation Phenoleptil®. Luminal® and Luminal® vet are identical 100 mg tablet formulations, while Phenoleptil® is available in the form of 12.5 and 50 mg tablets. Following approval of Phenoleptil® for treatment of canine epilepsy, it was repeatedly reported by clinicians and dog owners that switching from Luminal® (human tablets) to Phenoleptil® in epileptic dogs, which were controlled by treatment with Luminal®, induced recurrence of seizures. In the present study, we compared bioavailability of phenobarbital after single dose administration of Luminal® vet vs. Phenoleptil® with a crossover design in 8 healthy Beagle dogs. Both drugs were administered at a dose of 100 mg/dog, resulting in 8 mg/kg phenobarbital on average. Results Peak plasma concentrations (Cmax) following Luminal® vet vs. Phenoleptil® were about the same in most dogs (10.9 ± 0.92 vs. 10.5 ± 0.77 μg/ml), and only one dog showed noticeable lower concentrations after Phenoleptil® vs. Luminal® vet. Elimination half-life was about 50 h (50.3 ± 3.1 vs. 52.9 ± 2.8 h) without differences between the formulations. The relative bioavailability of the two products (Phenoleptil® vs. Luminal® vet.) was 0.98 ± 0.031, indicating that both formulations resulted in about the same bioavailability. Conclusions Overall, the two formulations did not differ significantly with respect to pharmacokinetic parameters when mean group parameters were compared. Thus, the reasons for the anecdotal reports, if true, that switching from the brand to the generic formulation of phenobarbital may lead to recurrence of seizures are obviously not related to a generally lower bioavailability of the generic formulation, although single dogs may exhibit lower plasma levels after the generic formulation that could be clinically meaningful. PMID:24107313

Impact of Cost Sharing on Therapeutic Substitution: The Story of Statins in 2006.

PubMed

Li, Pengxiang; Schwartz, J Sanford; Doshi, Jalpa A

2016-11-11

Cost sharing is widely used to encourage therapeutic substitution. This study aimed to examine the impact of increases in patient cost-sharing differentials for brand name and generic drugs on statin utilization on entry into the Medicare Part D coverage gap. Using 5% Medicare Chronic Condition Warehouse files from 2006, this quasi-experimental study examined patients with hyperlipidemia who filled prescriptions for atorvastatin or rosuvastatin between January and March 2006. Propensity score matching and difference-in-difference regressions were used to compare changes in statin utilization for the study group (patients who were not eligible for low-income subsidies [non-LIS] and had generic-only gap coverage) to those of a control group (LIS patients who faced the same cost sharing before and during the Part D coverage gap). In the final sample, 801 patients in the study group were matched to 801 patients in the control group. We found that, compared to the control group, the study group had a larger decline in any monthly brand-name statin use (-0.24 30-day fills, P<0.001). This was only partially offset by increased monthly generic statin use (+0.06 30-day fill, P<0.001), with an overall drop in any monthly statin use (-0.18 30-day fills, P<0.001). Overall adherence with statins declined (OR 0.81, P<0.001), and statin discontinuation increased (OR 1.62, P<0.001) in the study group as compared to the control group. Increases in cost-sharing differentials for brand name and generic drugs on coverage gap entry were associated with discontinuation of statins in Medicare Part D patients with hyperlipidemia. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies.

PubMed

Kersnik, J; Peklar, J

2006-12-01

Over the recent years there has been a steady 7% yearly increase in prescribing costs, which accounts for 17% of the Slovene national health care budget. Substitution of branded products by generic equivalents can offer savings. General practitioners (GPs) are often concerned about the quality of generic products and possible legal liabilities associated with their use. We wanted to examine the attitudes of GPs in Slovenia towards generic drug prescribing. We conducted a postal survey of a random sample of 200 out of 800 GPs in Slovenia from the National Health Insurance Institute database. GPs were asked 21 questions regarding their knowledge on generic drugs, awareness of prescribing costs, prices of generic drugs relative to brand name drugs and their attitude towards use of generic drugs. The 117 (58.5%) replies we received represent 15% of the GP population in Slovenia. 66.1% of GPs considered rising costs of medicines to be a serious problem for the health care budget. Each week, over 50% of GPs experienced demands from patients for specific drugs and the majority of GPs usually met their patients' demands or requests from hospital consultants for branded products. 38.3% of GPs did not take price into consideration when prescribing drugs. The majority of GPs (88.9%) perceived generics to have the same effectiveness as branded drugs. One quarter of GPs would prescribe more generics if additional clinical trials were presented. 37.3% would follow advice of academic detailers and 30.3% expected the generics to be even cheaper than they were. Independent detailing was welcomed by 63.8% of GPs because of the big influence of the pharmaceutical industry on the prescribing habits. 15.5% thought that the industry had a tremendous impact on their prescribing patterns. Slovene GPs are aware of the cost of prescribed drugs. They are willing to accept independent academic detailing to improve their prescribing and are willing to increase generic drugs under certain conditions.

Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored

PubMed Central

López, René; Arriagada, Elizabeth; Carrasco, René; Gallardo, Natalia; Lorca, Eduardo

2017-01-01

Background. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results. Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62 ± 0.90 versus 1.75 ± 0.92 mg/dL (p < 0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion. Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians. PMID:28246556

Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored.

PubMed

González, Fernando; López, René; Arriagada, Elizabeth; Carrasco, René; Gallardo, Natalia; Lorca, Eduardo

2017-01-01

Background . Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods . Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results . Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62 ± 0.90 versus 1.75 ± 0.92 mg/dL ( p < 0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion . Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians.

Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

PubMed Central

Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be further explored. PMID:28152215

Generic and therapeutic substitutions in the UK: are they a good thing?

PubMed Central

Duerden, Martin G; Hughes, Dyfrig A

2010-01-01

There is considerable interest and debate concerning the place of generic substitution (switching from a brand to generic product); and on therapeutic substitution, that is, switching to a cheaper, but apparently equivalent, product, usually within the drug class. Generic substitution by pharmacists is standard practice in UK hospital settings, and is being proposed for implementation in primary care. Although most prescriptions are already written generically (83% in the community in England in 2008), there are still cost savings that could be made if generic medicines are substituted against prescriptions written by branded name or by getting prescribers to adhere to advice to prescribe generically. Therapeutic substitution is more contentious, as direct evidence to support equivalence is normally lacking. However, the price differential between established drugs whose patents have expired and for which generics are available and newer, branded medicines within the same therapeutic class, makes therapeutic substitution an attractive application of cost-minimization analysis for the more efficient use of healthcare resources. Here we explore the tension that exists between the clinical appropriateness and safety of switching from an individual patient perspective and the consideration of value for money which is required to maximize population health from a health service perspective. Although substitution may affect individual patients (such as, for instance, reduced adherence, increased potential for medication error), it might be a price worth paying given the opportunity cost associated with the use of medicines that are clinically no better than cheaper alternatives. PMID:20716231

Are patients' pejorative representations of buprenorphine associated with their level of addiction and of misuse?

PubMed

Vanderkam, Paul; Gagey, Stéphanie; Ingrand, Pierre; Perault-Pochat, Marie-Christine; Brabant, Yann; Blanchard, Clara; Tudrej, Benoit; Messaadi, Nassir; Binder, Philippe

2018-04-27

In France, buprenorphine is at once the most widely prescribed and the most commonly misused opioid maintenance treatment (OMT). Unlike other medicines, it is seldom prescribed as a generic drug. Several studies have underlined the influence of the patient's representations when choosing brand-name rather than generic forms. We aim to prove a link between these pejorative representations and misuse, a higher degree of addiction and a preference for brand-name products. An observational study carried out at 11 sites in France using self-assessment questionnaires filled out in dispensing pharmacies by patients having come to them for buprenorphine delivery. Analysis was based on 806 usable questionnaires. There indeed exists a significant correlation between pejorative representations of OMT by means of buprenorphine, and a higher degree of addiction and misuse (p < .0001 for each). Preference for the brand-name product is correlated with the representation of OMT as a "trap" (p = .020). Our results underscore the existence of a link between patients' negative representations of their OMT and their drug-taking behavior. Prescribing physicians should consequently take these representations into account to more precisely identify the relevant behaviors and help their patients to evolve positively. Copyright © 2018 Elsevier B.V. All rights reserved.

Effects of a consumer driven health plan on pharmaceutical spending and utilization.

PubMed

Parente, Stephen T; Feldman, Roger; Chen, Song

2008-10-01

To compare pharmaceutical spending and utilization in a consumer driven health plan (CDHP) with a three-tier pharmacy benefit design, and to examine whether the CDHP creates incentives to reduce pharmaceutical spending and utilization for chronically ill patients, generic or brand name drugs, and mail-order drugs. Retrospective insurance claims analysis from a large employer that introduced a CDHP in 2001 in addition to a point of service (POS) plan and a preferred provider organization (PPO), both of which used a three-tier pharmacy benefit. Difference-in-differences regression models were estimated for drug spending and utilization. Control variables included the employee's income, age, and gender, number of covered lives per contract, election of flexible spending account, health status, concurrent health shock, cohort, and time trend. Results. CDHP pharmaceutical expenditures were lower than those in the POS cohort in 1 year without differences in the use of brand name drugs. We find limited evidence of less drug consumption by CDHP enrollees with chronic illnesses, and some evidence of less generic drug use and more mail-order drug use among CDHP members. The CDHP is cost-neutral or cost-saving to both the employer and the employee compared with three-tier benefits with no differences in brand name drug use. © Health Research and Educational Trust.

There`s a right way to buy exterior house paint and this is the season for it

Treesearch

Mark Knaebe

1998-01-01

Exterior house paint has undergone some changes in recent years. Designers now have their own brands. And on a technical front, water-based paint now outstrips oil-based paint in quality and durability. You have six decisions to make1 stain versus paint...oil versus latex... type of latex...type of finish...quality level...and brand-name versus generic.

The influence of need for cognition and principal display panel factors on over-the-counter drug facts label comprehension.

PubMed

Catlin, Jesse R; Pechmann, Cornelia; Brass, Eric P

2012-01-01

Nearly all work aimed at optimizing the ability of labeling to communicate over-the-counter (OTC) drug information has focused on back-of-the-package characteristics, such as the Drug Facts label. The effects of front of the package, or principal display panel (PDP) factors, have largely been neglected by researchers. Similarly, heterogeneity in consumers' approach to new information has received scant attention in the context of OTC drugs. This preliminary study tested the hypothesis that display of a drug's brand name on the PDP and individuals' need for cognition influence comprehension of Drug Facts label information. University students (n = 212) that had experienced heartburn but not used the drug class being studied constituted the primary analysis cohort. Students were randomly assigned to review one of two PDPs (brand name or generic), followed by a Drug Facts label and a series of questions related to selection and usage of the drug. Participants with low need for cognition were influenced by the brand name PDP, as those exposed to a PDP featuring a brand (vs. generic) spent less time reading the Drug Facts label and demonstrated lower comprehension of the label information on proper drug selection. These findings suggest that further research is needed to understand the impact of PDP contents and cognitive characteristics of consumers on the communication of OTC drug information. Health care providers should consider communication strategies that account for the challenges patients face in using OTC drugs properly.

How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry

DTIC Science & Technology

1998-07-01

inpatient settings, so the esti- mate may underrepresent those channels of distribu- tion. Countable units appear to yield an estimate of generic market...eight larger generic firms owned by a brand-name company ( Rugby , Ham- ilton, and Warner-Chilcott) have been sold or dis- banded in recent years.66...15 companies had annual sales of over $100 million for the drags in the retail pharmacy data set in 1994. Rugby , which was owned by Hoechst Marion

Can increases in CHIP copayments reduce program expenditures on prescription drugs?

PubMed

Sen, Bisakha; Blackburn, Justin; Morrisey, Michael; Becker, David; Kilgore, Meredith; Caldwell, Cathy; Menachemi, Nir

2014-01-01

The primary aim is to explore whether prescription drug expenditures by enrollees changed in Alabama's CHIP program, ALL Kids, after copayment increases in fiscal year 2004. The subsidiary aim is to explore whether non-pharmaceutical expenditures also changed. Data on ALL Kids enrollees between 1999-2007, obtained from claims files and the state's administrative database. We used data on children who were enrolled between one and three years both before and after the changes to the copayment schedule, and estimate regression models with individual-level fixed effects to control for time-invariant heterogeneity at the child level. This allows an accurate estimate of how program expenditures change for the same individual following copayment changes. Primary outcomes of interest are expenditures for prescription drugs by class and brand-name and generic versions. We estimate models for the likelihood of any use of prescription drugs and expenditure level conditional on use. Following the copayment increase, the probability of any expenditure decline by 5.8%, brand name drugs by 6.9%, generic drugs by 7.4%. Conditional on any use, program expenditures decline by 7.9% for all drugs, by 9.6% for brand name drugs, and 6.2% for generic drugs. The largest declines are for antihistamine drugs; the least declines are for Central Nervous System agents. Declines are smaller and statistically weaker for children with chronic health conditions. Concurrent declines are also seen for non-pharmaceutical medical expenditures. Copayment increases appear to reduce program expenditures on prescription drugs per enrollee and may be a useful tool for controlling program costs.

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport® or Prograf® preparations of tacrolimus

PubMed Central

Connor, Andrew; Prowse, Andrew; Newell, Paul; Rowe, Peter A.

2013-01-01

Background The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf®) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf® to a generic formulation (Adoport®) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf® with those receiving Adoport®. Methods Data regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed. Results A total of 48 patients received Prograf® and 51 received Adoport®. At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups. Conclusions This is the first study to compare the clinical outcomes of patients receiving Adoport® with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf® or Adoport® from the time of renal transplantation. These early outcome data therefore support the use of Adoport® in place of Prograf® as a potential cost-saving measure. PMID:27818747

Comparative cost evaluation of brand name and generic ophthalmology medications in Ontario.

PubMed

Popovic, Marko; Chan, Clara; Lattanzio, Nisha; El-Defrawy, Sherif; Schlenker, Matthew B

2018-04-01

Medication cost for the same indication can vary considerably and can affect patient compliance. In this comparative cost analysis of commonly prescribed ophthalmology medications, the differences in cost between generic and brand name medications as well as different medications within an individual drug class were evaluated. Eye preparations from the Ontario Drug Benefit Formulary were identified, and further agents commonly prescribed by ophthalmologists were included. The standardized prescription drug cost, which includes the cost of the medication, mark-up, and dispensing cost, was provided by Ontario Shoppers Drug Mart stores in July 2016 for 103 common medications using typical dosages and durations. Based on medication class, the highest and lowest cost medications were antiallergy agents (Zaditor [ketotifen], Vasocon [naphazoline]), antibiotic ophthalmic solutions (Vigamox [moxifloxacin], generic ciprofloxacin), oral antibiotics (Cipro [ciprofloxacin], generic cephalexin), antibiotic ophthalmic ointments (generic erythromycin, Tobrex [tobramycin]), antiviral treatment (Valtrex [oral valacyclovir], Viroptic [topical trifluridine]), blepharitis treatment (Zithromax [oral azithromycin], generic oral tetracycline), beta-adrenergic inhibitors (Timoptic [topical timolol], generic topical timolol), topical prostaglandin analogues (Xalatan [latanoprost], generic travoprost), oral carbonic anhydrase inhibitors (methazolamide, acetazolamide), topical carbonic anhydrase solutions (Trusopt preservative-free [dorzolamide], Azopt [brinzolamide]), topical alpha-adrenergic agonists (Alphagan [brimonidine], generic brimonidine), topical muscarinic agonists (Isopto carpine [pilocarpine], Diocarpine [pilocarpine]), topical combination glaucoma agents (Cosopt [dorzolamide-timolol], generic dorzolamide-timolol), topical lubricants (Lacri-lube, Isopto tears), topical nonsteroidal anti-inflammatory drugs (Acuvail [ketorolac], Ilevro [nepafenac]), and steroids (Durezol [difluprednate], Pred mild [prednisolone]). Substantial cost differences exist between ophthalmology medications of the same class. We encourage ophthalmologists to be aware of the associated costs of the medications they prescribe and to use this information in their decision making. Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Brand Medications and Medicare Part D: How Eye Care Providers' Prescribing Patterns Influence Costs.

PubMed

Newman-Casey, Paula Anne; Woodward, Maria A; Niziol, Leslie M; Lee, Paul P; De Lott, Lindsey B

2018-03-01

To quantify costs of eye care providers' Medicare Part D prescribing patterns for ophthalmic medications and to estimate the potential savings of generic or therapeutic drug substitutions and price negotiation. Retrospective cross-sectional study. Eye care providers prescribing medications through Medicare Part D in 2013. Medicare Part D 2013 prescriber public use file and summary file were used to calculate medication costs by physician specialty and drug. Savings from generic or therapeutic drug substitutions were estimated for brand drugs. The potential savings from price negotiation was estimated using drug prices negotiated by the United States Veterans Administration (USVA). Total cost of brand and generic medications prescribed by eye care providers. Eye care providers accounted for $2.4 billion in total Medicare part D prescription drug costs and generated the highest percentage of brand name medication claims compared with all other providers. Brand medications accounted for a significantly higher proportion of monthly supplies by volume, and therefore, also by total cost for eye care providers compared with all other providers (38% vs. 23% by volume, P < 0.001; 79% vs. 56% by total cost, P < 0.001). The total cost attributable to eye care providers is driven by glaucoma medications, accounting for $1.2 billion (54% of total cost; 72% of total volume). The second costliest category, dry eye medications, was attributable mostly to a single medication, cyclosporine ophthalmic emulsion (Restasis, Allergan, Irvine, CA), which has no generic alternative, accounting for $371 million (17% of total cost; 4% of total volume). If generic medications were substituted for brand medications when available, $148 million would be saved (7% savings); if generic and therapeutic substitutions were made, $882 million would be saved (42% savings). If Medicare negotiated the prices for ophthalmic medications at USVA rates, $1.09 billion would be saved (53% savings). Eye care providers prescribe more brand medications by volume than any other provider group. Efforts to reduce prescription expenditures by eye care providers should focus on increasing the use of generic medications, primarily through therapeutic substitutions. Policy changes enabling Medicare to negotiate prescription drug prices could decrease costs to Medicare. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts.

PubMed

Yeh, James S; Franklin, Jessica M; Avorn, Jerry; Landon, Joan; Kesselheim, Aaron S

2016-06-01

Pharmaceutical industry payments to physicians may affect prescribing practices and increase costs if more expensive medications are prescribed. Determine the association between industry payments to physicians and the prescribing of brand-name as compared with generic statins for lowering cholesterol. Cross-sectional linkage of the Part D Medicare prescriptions claims data with the Massachusetts physicians payment database including all licensed Massachusetts physicians who wrote prescriptions for statins paid for under the Medicare drug benefit in 2011. The exposure variable was a physician's industry payments as listed in the Massachusetts database. The outcome was the physician's rate of prescribing brand-name statins. We used linear regression to analyze the association between the intensity of physicians' industry relationships (as measured by total payments) and their prescribing practices, as well as the effects of specific types of payments. Among the 2444 Massachusetts physicians in the Medicare prescribing database in 2011, 899 (36.8%) received industry payments. The most frequent payment was for company-sponsored meals (n = 639 [71.1%]). Statins accounted for 1 559 003 prescription claims; 356 807 (22.8%) were for brand-name drugs. For physicians with no industry payments listed, the median brand-name statin prescribing rate was 17.8% (95% CI, 17.2%-18.4%). For every $1000 in total payments received, the brand-name statin prescribing rate increased by 0.1% (95% CI, 0.06%-0.13%; P < .001). Payments for educational training were associated with a 4.8% increase in the rate of brand-name prescribing (P = .004); other forms of payments were not. Industry payments to physicians are associated with higher rates of prescribing brand-name statins. As the United States seeks to rein in the costs of prescription drugs and make them less expensive for patients, our findings are concerning.

Effects of an e-Prescribing interface redesign on rates of generic drug prescribing: exploiting default options.

PubMed

Malhotra, Sameer; Cheriff, Adam D; Gossey, J Travis; Cole, Curtis L; Kaushal, Rainu; Ancker, Jessica S

2016-09-01

Increasing the use of generic medications could help control medical costs. However, educational interventions have limited impact on prescriber behavior, and e-prescribing alerts are associated with high override rates and alert fatigue. Our objective was to evaluate the effect of a less intrusive intervention, a redesign of an e-prescribing interface that provides default options intended to "nudge" prescribers towards prescribing generic drugs. This retrospective cohort study in an academic ambulatory multispecialty practice assessed the effects of customizing an e-prescribing interface to substitute generic equivalents for brand-name medications during order entry and allow a one-click override to order the brand-name medication. Among drugs with generic equivalents, the proportion of generic drugs prescribed more than doubled after the interface redesign, rising abruptly from 39.7% to 95.9% (a 56.2% increase; 95% confidence interval, 56.0-56.4%; P < .001). Before the redesign, generic drug prescribing rates varied by therapeutic class, with rates as low as 8.6% for genitourinary products and 15.7% for neuromuscular drugs. After the redesign, generic drug prescribing rates for all but four therapeutic classes were above 90%: endocrine drugs, neuromuscular drugs, nutritional products, and miscellaneous products. Changing the default option in an e-prescribing interface in an ambulatory care setting was followed by large and sustained increases in the proportion of generic drugs prescribed at the practice. Default options in health information technology exert a powerful effect on user behavior, an effect that can be leveraged to optimize decision making. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

[Generic drug substitution].

PubMed

Tamir, Orly; Halkin, Hillel; Shemer, Joshua

2006-09-01

The rapidly rising health care expenditures, attributed mainly to the high cost of prescription drugs, have led governments around the world to look to generics as a means of containing costs in the pharmaceutical market. Generic drugs provide a less expensive alternative to brand name drugs due to the elimination of the need to perform lengthy and costly clinical trials, as required for innovative drugs. Essentially, generic substitution of drugs may be performed only after showing unequivocally that the generic formulation is identical in its active ingredients, strength, and route of administration as its innovative counterpart, and that they are bioequivalent to each other. Although the two are in essence the same, generic substitution is occasionally a controversial matter.

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

PubMed

Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar between AG and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be explored further. © 2017 Pharmacotherapy Publications, Inc.

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

PubMed Central

Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

2018-01-01

Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine-benazepril capsules), with an overall rate of 8.2 per 100 person years across all drug products. Adjusted switchback rates were consistently lower for patients who switched from branded to authorized generic drug products compared with branded to generic drug products in the primary cohort (pooled hazard ratio 0.72, 95% confidence interval 0.64 to 0.81). Similar results (0.75, 0.62 to 0.91) were observed in the replication cohort. Conclusion Switching from branded to authorized generic drug products was associated with lower switchback rates compared with switching from branded to generic drug products. PMID:29615391

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected P<0.01. A total of 27,150 events with lamotrigine, 13,950 events with carbamazepine, and 5077 events with oxcarbazepine were reported, with generics accounting for 27%, 41%, and 32% of reports, respectively. Although RORs for the majority of known AEs were different between brand and generics for all three drugs of interest (Breslow-Day P<0.001), RORs generally were similar for AG and generic comparisons. Generic lamotrigine and carbamazepine were more commonly involved in reports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted P<0.01. Similar AED reporting rates were observed for the AG and generic comparisons for most outcomes and drugs, suggesting that brands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of Medicare Part D coverage gap on medication and medical treatment among elderly beneficiaries with depression.

PubMed

Zhang, Yuting; Baik, Seo Hyon; Zhou, Lei; Reynolds, Charles F; Lave, Judith R

2012-07-01

Maintenance antidepressant pharmacotherapy in late life prevents recurrent episodes of major depression. The coverage gap in Medicare Part D could increase the likelihood of reducing appropriate use of antidepressants, thereby exposing older adults to an increased risk for relapse of depressive episodes. To determine whether (1) beneficiaries reduce antidepressant use in the gap, (2) the reduction in antidepressant use is similar to the reduction in heart failure medications and antidiabetics, (3) the provision of generic coverage reduces the risk of reduction of medication use, and (4) medical spending increases in the gap. Observational before-after study with a comparison group design. A 5% random sample of US Medicare beneficiaries 65 years or older with depression (n = 65,223) enrolled in stand-alone Part D plans in 2007. Antidepressant pharmacotherapy, physician, outpatient, and inpatient spending. Being in the gap was associated with comparable reductions in the use of antidepressants, heart failure medications, and antidiabetics. Relative to the comparison group (those who had full coverage in the gap because of Medicare coverage or low-income subsidies), the no-coverage group reduced their monthly antidepressant prescriptions by 12.1% (95% CI, 9.9%-14.3%) from the pregap level, whereas they reduced use of heart failure drugs and antidiabetics by 12.9% and 13.4%, respectively. Those with generic drug coverage in the gap reduced their monthly antidepressant prescriptions by 6.9% (95% CI, 4.8%-9.1%); this decrease was entirely attributable to the reduction in the use of brand-name antidepressants. Medicare spending on medical care did not increase for either group relative to the comparison group. The Medicare Part D coverage gap was associated with modest reductions in the use of antidepressants. Those with generic coverage reduced their use of brand-name drugs and did not switch from brand-name to generic drugs. The reduction in antidepressant use was not associated with an increase in nondrug medical spending.

Web-based survey to assess the perceptions of managed care organization representatives on use of copay subsidy coupons for prescription drugs.

PubMed

Nemlekar, Poorva; Shepherd, Marvin; Lawson, Kenneth; Rush, Sharon

2013-10-01

Promotion of prescription drug coupons and vouchers by pharmaceutical manufacturers has increased in recent years. These coupons and vouchers usually subsidize patients' cost-sharing obligations. In other words, drug companies pay for a patient's portion of the drug cost, and the remaining cost is paid by the patient and the patient's health plan. This practice is normally used for brand name drugs but can and has been used for generic drugs. Copayments (also known as copays), and especially high copays for higher cost drugs, are used by managed care organizations (MCOs) to place a higher financial burden on patients and also provide an appreciation of the medication cost. At the same time, tiered copay plans offer incentives, in the form of lower copays, to use available equivalent generic alternatives or lower cost brand name drugs, instead of high cost brand name drugs. With higher tiered copays for brand name drugs being offset by coupons, little is known about MCO representatives' perceptions about the use of copay subsidy coupons for brand name prescription drugs. To assess health plan managers' and pharmacy benefit managers' (PBMs) perceptions about the use of prescription drug copay subsidy coupons. A 28-item online survey instrument was used to collect data from health plan and PBM representatives. A sample of 834 MCO representatives was selected from the Academy of Managed Care Pharmacy membership directory. Pharmacists, managers, directors, and executive officers working in pharmacy, formulary, and clinical pharmacy operations were selected for the survey. Respondents from non-MCO settings and government-sponsored health plans were excluded from the survey. A total of 122 surveys were returned after 3 emails (i.e., an invitation and 2 reminder emails) of which 105 were usable surveys, giving a response rate of 13.7%. A 5-point, 11-item Likert scale (1 = Strongly Disagree and 5 = Strongly Agree) was used to measure respondents' perceptions toward prescription drug coupons. Some items referred to coupons used repeatedly over a year to get copay discounts (i.e., long-term use coupons) whereas some items referred to coupons distributed for trial purposes (i.e., short-term use coupons). Of the 105 respondents, 100 (95.2%) agreed that copay subsidy coupons encouraged nonpreferred brand name drugs over preferred brand name drugs. A total of 102 (97.2%) respondents agreed that brand name drug coupons undermined tiered formulary structure. Ninety-two (87.6%) respondents agreed that short-term use coupons increased plan sponsor's costs while 96 (91.5%) respondents agreed that sponsor cost increased with long-term use coupons. A total of 68 (64.8%) agreed that short-term use coupons should be eliminated whereas 78 (74.3%) respondents agreed that long-term use coupons should be eliminated. Among MCOs' many business activities are efforts to contain rising pharmacy costs. The results of this survey indicate that MCO representatives believe that incentive programs such as prescription drug coupons and vouchers lead to an increase in brand name drug utilization, which undermines their formulary controls and, in turn, can be expected to increase overall health care costs.

Drug Bioavailability Data: (Un)Available.

ERIC Educational Resources Information Center

Capomacchia, Anthony C.; And Others

1979-01-01

The obtainability of drug bioavailability data from both brand-name and generic-drug manufacturers was studied to document the relative change in availability to pharmacy students of drug bioavailability data between 1978 and 1976 for drugs exhibiting bioavailability problems. The results indicate no major change. (JMD)

Do generic firms and the Spanish public purchaser respond to consumer price differences of generics under reference pricing?

PubMed

Puig-Junoy, Jaume; Moreno-Torres, Iván

2010-12-01

To assess the impact of competition on the consumer price and the average price paid by the National Health System (NHS) under reference pricing in the Spanish generic market. Descriptive analysis of the time trend in consumer prices before and after the application of reference pricing for the eight most sold active ingredients from 1997 to 2009. The entry of a generic at a lower consumer price than that of the brand-name pharmaceutical or the first generic does not cause a voluntary reduction in the consumer price of either the brand drug or the first generic, either before or after the application of RP. Generic entry at a lower consumer price than previously existing pharmaceuticals always causes a slight reduction in the average price paid by the NHS; however, the average price paid by the NHS is always notably higher than the lowest, the difference being greater in relative terms under reference pricing. The Spanish RP system results in very little consumer price competition between generic firms, price reduction thus being limited to regulatory measures. NHS purchases show little sensitivity to price differences between equivalent drugs priced at or below the reference price. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Changes in Retail Prices of Prescription Dermatologic Drugs From 2009 to 2015.

PubMed

Rosenberg, Miranda E; Rosenberg, Steven P

2016-02-01

Physicians from many specialties as well as primary care prescribe dermatologic medications; as insurance formularies become increasingly restrictive and more patients are covered with high-deductible insurance plans, many patients are forced to pay high retail prices to obtain their medications. To determine the changes in the prices of commonly prescribed dermatologic medications since 2009 and to identify trends in price increases for different classes of drugs. Four national chain pharmacies received surveys requesting price data on commonly prescribed dermatologic drugs in 2009, 2011, 2014, and 2015. The initial survey requested information on 72 brand-name drugs. Subsequent surveys increased to eventually include 120 additional brand-name drugs and their generic alternatives when available. Owing to the frequency of prescription, diseases treated, or unusual price increases, 19 brand-name drugs surveyed in all 4 years were selected for final price trend analysis, which was conducted from August 1 to 15, 2015. Retail prices of topical and systemic drugs for the treatment of various dermatologic conditions. Prices of surveyed brand-name drugs increased rapidly between 2009 and 2015. Of the 19 brand-name drugs analyzed, the retail prices of 7 drugs more than quadrupled during the study period. Among these 19 drugs, the mean price increase was 401% during the 6-year survey period, with the majority of the price increases occurring after 2011. Prices of topical antineoplastic drugs had the greatest mean absolute and percentage increase ($10,926.58 [1240%]). Prices of drugs in the antiinfective class had the smallest mean absolute increase ($333.99); prices of psoriasis medications had the smallest mean percentage increase (180%). Prices of acne and rosacea medications increased a mean of 195%, and prices of topical corticosteroids increased a mean of 290% during the study period. Selected generic drugs surveyed in 2011 and 2014 also increased a mean of 279% during the 3-year period. The price of prescription dermatologic drugs rose considerably from 2009 to 2015, with the vast majority of price increases occurring after 2011. Percent increases for multiple, frequently prescribed medications greatly outpaced inflation, national health expenditure growth, and increases in reimbursements for physician services.

Do users of risperidone who switch brands because of generic reference pricing fare better or worse than non-switchers? A New Zealand natural experiment.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2015-11-01

This study evaluated patient health outcomes and any impact on healthcare costs consequent to the implementation of generic reference-pricing of risperidone in New Zealand using national datasets. Reference pricing risperidone reduced the price of the originator brand by 50 % as well as overall expenditure on risperidone tablets. Half of all patients made a single switch to generic risperidone, with the remainder making multiple switches between brands. 1.5 % made a switch-back to the originator brand. No difference was found in use of healthcare services between switchers and non-switchers of the originator brand or versus the comparator group. This refutes the available literature on brand-to-generic and generic-to-generic switching.

Before the Transplant

MedlinePlus

... effects Other medications Generic and brand name drugs Post-transplant tests Infections and immunity Lifestyle changes Health concerns Back ... certain window of time. Be ready for medical tests and possibly a long wait for ... 6: Care Your medical team manages your post-transplant care. They will help you understand the ...

Resource use and cost implications of switching among warfarin formulations in atrial fibrillation patients.

PubMed

Kwong, Winghan Jacqueline; Kamat, Siddhesh; Fang, Christy

2012-12-01

Despite the uncertainty surrounding the safety of switching warfarin formulations, limited data exist on the resource use and costs associated with this switching pattern. To evaluate health care resource use and costs associated with switching warfarin formulations among patients with atrial fibrillation (AF) in a managed care organization. Patients diagnosed with AF (ICD-9 427.31) between July 2004 and August 2008 and who received warfarin therapy were identified in the HealthCore Integrated Research Database and categorized into 3 groups: users of generic warfarin formulations from a single drug manufacturer (generic-only group), users of branded warfarin formulations only (brand-only group), and patients who used generic and branded warfarin therapy interchangeably or who may have used generic drugs from 1 or more manufacturers (generic/brand switching group). Patients were followed 12 months or longer after their index warfarin prescription date to compare all-cause resource use and costs using multivariable regression analysis. The analysis included 12,908 patients: 71.82% were in the genericonly group, 9.61% were in the brand-only group, and 18.57% were in the generic/brand switching group. Patients in the generic/brand switching group were more likely to be hospitalized (relative risk [RR] = 1.43, p < 0.0001) or to use emergency department services (RR = 1.20, p < 0.01), compared to the brand-only users. Hospitalizations were more likely (RR = 1.26, p < 0.001) to occur among generic-only users versus brand-only users. Adjusted mean pharmacy costs per member per month were lower in the generic/brand switching group compared to the brand-only group ($257 vs $273, p = 0.038), but inpatient costs were higher ($1250 vs $972, p < 0.001), resulting in higher ($2125 vs $1847, p < 0.001) total costs. Generic-only users had lower pharmacy costs compared to brand-only users ($246 vs $273, p < 0.001), but total health care costs trended to be higher in the generic-only group ($1957 vs $1847, p = 0.053). The use of both generic and branded formulations of warfarin interchangeably, or the use of generics from more than 1 manufacturer, was associated with increased use of all-cause health care resources and total costs in patients with AF.

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

[Three types of brand name loyalty strategies set up by drug manufacturers].

PubMed

PréMont, Marie-Claude; Gagnon, Marc-André

2014-11-01

The recent restructuring of the pharmaceutical industry has led to three new types of promotional strategies to build patient loyalty to brand name drugs: loyalty through rebates, patient support, and compassion programs. Loyalty through rebates seeks to keep patients on a brand name drug and prevent their switch to the generic equivalent. Loyalty through patient support provides aftersales services to help and support patients (by phone or home visits) in order to improve adherence to their treatments. Finally, compassion programs offer patients access to drugs still awaiting regulatory approval or reimbursement by insurers. When and if the approval process is successful, the manufacturer puts an end to the compassion program and benefits from a significant cohort of patients already taking a very expensive drug for which reimbursement is assured. The impact of these programs on public policies and patients' rights raises numerous concerns, among which the direct access to patients and their health information by drug manufacturers and upward pressure on costs for drug insurance plans.

Patients' perceptions of generic drugs in Greece.

PubMed

Skaltsas, Leonora N; Vasileiou, Konstantinos Z

2015-11-01

The use of generic drugs is growing increasingly around the world and in Greece, in particular, in order to reduce pharmaceutical expenditure. However, patients' perceptions and attitudes about generics have only partially been studied so far in Greece. This study aimed to examine the factors that influence the attitude of patients and consumers regarding generic drugs. A questionnaire survey of 364 patients visiting a pharmacy was conducted. The questionnaire consisted of 29 questions, including questions regarding their knowledge about generics, the reasons for using them, their previous experience, their willingness for generic substitution, and the factors behind these choices. Nearly half of the participants in the survey know the term 'generic' and that it has a lower price compared to the brand name drug. Their views on safety and efficacy vary significantly and the main source of information on generics is the media and the internet. The lack of knowledge is the main barrier for attitudes of doctors. Health professionals play the most influential role for the substitution of a branded drug by a generic, followed by the cost of the generic. Almost half of the patients know about generic drugs, with their lower price being the most popular feature which most patients are familiar with. It seems that primarily the doctor and, subsequently the pharmacist play the most important role in a patient's decision to replace his/her medicine with a generic. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions.

PubMed

Shrank, William H; Hoang, Tuyen; Ettner, Susan L; Glassman, Peter A; Nair, Kavita; DeLapp, Dee; Dirstine, June; Avorn, Jerry; Asch, Steven M

2006-02-13

A large proportion of Americans are enrolled in 3-tier pharmacy benefit plans. We studied whether patients enrolled in such plans who receive generic or preferred brand-name agents when initiating chronic therapy were more adherent to treatment than those who received nonpreferred brand-name medications. We analyzed pharmacy claims filled between October 1, 2001, and October 1, 2003, from a large health plan for 6 classes of chronic medications: 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, calcium channel blockers, oral contraceptives, orally inhaled corticosteroids, angiotensin receptor blockers, and angiotensin-converting enzyme inhibitors. We measured adherence as the proportion of days covered (PDC) in each drug class during the first year of therapy. We evaluated how the formulary status of the initial prescription (generic, preferred, or nonpreferred) influenced PDC and adequate adherence, defined as PDC greater than 80%, over the subsequent year. A total of 7532 new prescriptions were filled in 1 of the classes evaluated: 1747 (23.2%) for nonpreferred medications, 4376 (58.1%) for preferred drugs, and 1409 (18.7%) for generic drugs. After controlling for patient sociodemographic characteristics and drug class, PDC was 12.6% greater for patients initiated on generic medications vs nonpreferred medications (58.8% vs 52.2%; P<.001). The PDC was 8.8% greater for patients initiated on preferred vs nonpreferred medications (56.8% vs 52.2%; P<.001). Patients initiated on generic and preferred medications had 62% and 30% greater odds, respectively, of achieving adequate adherence compared with those who received nonpreferred medications. In 3-tier pharmacy benefit plans, prescribing generic or preferred medications within a therapeutic class is associated with improvements in adherence to therapy.

Comparison of adherence to generic multi-tablet regimens vs. brand multi-tablet and brand single-tablet regimens likely to incorporate generic antiretroviral drugs by breaking or not fixed-dose combinations in HIV-infected patients.

PubMed

Rwagitinywa, Joseph; Lapeyre-Mestre, Maryse; Bourrel, Robert; Montastruc, Jean-Louis; Sommet, Agnès

2018-03-05

Adherence to antiretroviral (ARV) is crucial to achieve viral load suppression in HIV-infected patients. This study aimed to compare adherence to generic multi-tablet regimens (MTR) vs. brand MTR likely to incorporate ARV drugs without breaking fixed-dose combinations (FDC) and brand single-tablet regimens (STR) likely to incorporate generics by breaking the FDC. Patients aged of 18 years or over exposed to one of the generic or the brand of lamivudine (3TC), zidovudine/lamivudine (AZT/TC), nevirapine (NVP), or efavirenz (EFV), or the brand STR of efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). Adherence was measured by medication possession ratio (MPR) using both defined daily dose (DDD) and daily number of tablet recommended for adults (DNT). Adherence to generic MTR vs. brand MTR and brand STR was compared using Kruskal-Wallis. The overall median adherence was 0.97 (IQR 0.13) by DNT method and 0.97 (0.14) by DDD method. Adherence in patients exposed to generic MTR (n = 165) vs. brand MTR (n = 481) and brand STR (n = 470) was comparable by DNT and DDD methods. In conclusion, adherence to generic MTR was high and comparable with adherence to brand MTR and to STR. Utilization of DDD instead DNT to measure the MPR led to small but nonsignificant difference that has no clinical impact. © 2018 Société Française de Pharmacologie et de Thérapeutique.

Searching online to buy commonly prescribed psychiatric drugs.

PubMed

Monteith, Scott; Glenn, Tasha

2018-02-01

The use of online pharmacies to purchase prescription drugs is increasing. The patient experience when searching to buy commonly prescribed psychiatric drugs was investigated. Using the search term "buy [drug name] online" in Google, 38 frequently prescribed drugs, including 13 with a high potential for abuse, were searched by brand and generic names. The first page of results were analyzed, including with pharmacy certification checkers and ICANN WHOIS. Search results for all drugs yielded 167 pharmacies, of which 147 (88%) did not require a prescription. Considering all searches, the average number of pharmacies requiring a prescription was 2.7 for a brand name drug and 2.4 for a generic name. A phrase like "buy without a prescription" usually appeared on the search results page. All results for drugs with a high potential for abuse were for illegal pharmacies. Information from certification agencies was often conflicting. Most pharmacies were registered internationally. Patients searching online to purchase prescription psychiatric drugs are presented predominantly with illegal pharmacies, and find conflicting certification data. Patient education should address typical search results. Societal pressures may increase the use of online pharmacies including prescription drug costs, stigma, loss of trust in expert opinion, and the changing patient role. Copyright © 2017 Elsevier B.V. All rights reserved.

Association of authorized generic marketing with prescription drug spending on antidepressants from 2000 to 2011.

PubMed

Cheng, Ning; Banerjee, Tannista; Qian, Jingjing; Hansen, Richard A

Prior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices. Longitudinal analysis of the household component of the Medical Expenditure Panel Survey. Interview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months. Nationally representative sample of the U.S. civilian noninstitutionalized population, focusing on people using 1 of 5 antidepressant drugs that became generically available between 2000 to 2011. Drugs and dose/formulations with versus without an authorized generic drug marketed. Multiple linear regression models with lagged variables evaluated the effect of an authorized generic on average inflation-adjusted brand and generic price, adjusting for payment sources, generic entry time, competitor price, and year. During 2000-2011, annual brand antidepressant utilization decreased from 51.47 to 7.52 million prescriptions, and generic antidepressant utilization increased from 0 to 88.83 million prescriptions. Over time, payment per prescription for brand prescriptions increased 25% overall, and generic payments decreased 70% for all payer types. With unadjusted data, after generic entry the average brand price decreased $0.59 per year with and $3.62 per year without an authorized generic in the market. Average generic prices decreased $10.30 per year with and $8.47 per year without an authorized generic in the market. In multiple regression models with lagged variables adjusted for heteroscedasticity, payer source, time since generic entry, competitor price, and year, authorized generics significantly reduced average payment for generic (-$3.03) and brand (-$60.64) prescriptions, and over time this price change slowly diminished. Availability of an authorized generic was associated with reduced average generic and brand price in the antidepressant market, supporting prior evidences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

The Medicaid Rebate: Changes in Oncology Drug Prices After the Affordable Care Act.

PubMed

Bonakdar Tehrani, Ali; Carroll, Norman V

2017-08-01

Prescription drug spending is a significant component of Medicaid total expenditures. The Affordable Care Act (ACA) includes a provision that increases the Medicaid rebate for both brand-name and generic drugs. This study examines the extent to which oncology drug prices changed after the increase in the Medicaid rebate in 2010. A pre-post study design was used to evaluate the correlation between the Medicaid rebate increase and oncology drug prices after 2010 using 2006-2013 State Drug Utilization Data. The results show that the average annual price of top-selling cancer drugs in 2006, adjusted for inflation and secular changes in drug prices, have increased by US$154 and US$235 for branded and competitive brand drugs, respectively, following the 2010 ACA; however, generic oncology drug prices showed no significant changes. The findings from this study indicate that oncology drug prices have increased after the 2010 ACA, and suggest that pharmaceutical companies may have increased their drug prices to offset increases in Medicaid rebates.

Comparison of the Effects of a Brand-name Drug and Its Generic Drug on the Quality of Life of Alzheimer's Disease Patients.

PubMed

Sakakibara, Mikio; Kido, Mitsuhiko; Kuribayashi, Jun; Okada, Hiroshi; Igarashi, Ataru; Kamei, Hiroyuki; Nabeshima, Toshitaka

2015-08-31

The pharmacological effects of generic (GE) donepezil are the same as Aricept, its brand-name counterpart. However, little is known as to whether these two drugs provide the same quality of life (QOL). The study subjects were patients with Alzheimer's disease who were taking donepezil hydrochloride tablets, and were selected by visiting either the local pharmacies or the patients' homes. We chose the brand-name drug Aricept and its GE form donepezil to investigate, from a long-term caregiver's perspective, the influence of both drugs on the patients' QOL. An EuroQol-5 Dimension (EQ-5D) was used to assess the QOL of patients with Alzheimer's disease, before and after various Aricept and/or donepezil regimens. Patients were divided into four groups: first time users of Aricept (n=43), first time users of GE donepezil (n=45), users refilling previous prescriptions of Aricept (n=51), and users switching from Aricept to GE donepezil (n=51). The average change in the EQ-5D utility indices rose significantly in the patients starting a new regimen of Aricept and its GE drug. The patients continuing an existing regimen of Aricept showed no significant differences, even after Aricept was switched to a GE drug. The QOL of patients starting a new regimen of Aricept and its GE drug improved. The QOL was maintained upon switching to the GE drug form.

The Daniel K. Inouye College of Pharmacy Scripts

PubMed Central

Sumida, Wesley K; Taniguchi, Ronald; Juarez, Deborah Taira

2016-01-01

Prescription drugs have reduced morbidity and mortality and improved the quality of life of millions of Americans. Yet, concerns over drug price increases loom. Drug spending has risen relatively slowly over the past decade because many of the most popular brand-name medicines lost patent protection. In the near future, there will be fewer low-cost generics coming into the market to offset the rising prices of brand-name drugs. Drug expenditures are influenced by both volume and price. This article focuses on how drug prices are set in the United States and current trends. Drug prices are determined through an extremely complicated set of interactions between pharmaceutical manufacturers, wholesalers, retailers, insurers, pharmacy benefit managers (PBMs), managed care organizations, hospitals, chain stores, and consumers. The process differs depending on the type of drug and place of delivery. Rising drug prices have come under increased scrutiny due to increased cost inflation and because many price increases come as a result of mergers and acquisitions of generic drug companies or changes in ownership of brand name drug manufacturers. Other countries have reigned in drug prices by negotiating with or regulating pharmaceutical manufacturers. The best long-term solution to rising drug prices is yet to be determined but the United States will continue to debate this issue and the discussions will get more heated if drug expenditures continue to rise at a rapid rate (ie, increasing 13% in 2014 from the previous year). PMID:26870605

The Daniel K. Inouye College of Pharmacy Scripts: Prescription Drug Pricing.

PubMed

Sumida, Wesley K; Taniguchi, Ronald; Juarez, Deborah Taira

2016-01-01

Prescription drugs have reduced morbidity and mortality and improved the quality of life of millions of Americans. Yet, concerns over drug price increases loom. Drug spending has risen relatively slowly over the past decade because many of the most popular brand-name medicines lost patent protection. In the near future, there will be fewer low-cost generics coming into the market to offset the rising prices of brand-name drugs. Drug expenditures are influenced by both volume and price. This article focuses on how drug prices are set in the United States and current trends. Drug prices are determined through an extremely complicated set of interactions between pharmaceutical manufacturers, wholesalers, retailers, insurers, pharmacy benefit managers (PBMs), managed care organizations, hospitals, chain stores, and consumers. The process differs depending on the type of drug and place of delivery. Rising drug prices have come under increased scrutiny due to increased cost inflation and because many price increases come as a result of mergers and acquisitions of generic drug companies or changes in ownership of brand name drug manufacturers. Other countries have reigned in drug prices by negotiating with or regulating pharmaceutical manufacturers. The best long-term solution to rising drug prices is yet to be determined but the United States will continue to debate this issue and the discussions will get more heated if drug expenditures continue to rise at a rapid rate (ie, increasing 13% in 2014 from the previous year).

Impact of the introduction of generic latanoprost on glaucoma medication adherence.

PubMed

Stein, Joshua D; Shekhawat, Nakul; Talwar, Nidhi; Balkrishnan, Rajesh

2015-04-01

To assess possible changes in medication adherence to prostaglandin analog (PGA) regimens among patients with open-angle glaucoma (OAG) after the initial introduction of generic PGAs. Longitudinal cohort analysis. Patients older than 40 years with OAG continuously enrolled in a nationwide managed-care network during 2009-2012 who used PGAs. Mean adherence rates were calculated for topical PGA use during the 18 months before the introduction of generic latanoprost (September 2009-February 2011) and the 18 months after generic latanoprost became available (July 2011-December 2012). The rates were compared between persons who continued to use brand-name PGAs once generic latanoprost became available and others who switched to generic latanoprost. Multivariable logistic regression identified variables associated with an improvement or worsening of adherence of ≥25%. Mean adherence rates and odds of 25% or more improved or worsened adherence (with 95% confidence intervals [CIs]). A total of 8427 patients met the study eligibility criteria. Compared with persons switching to generic latanoprost, patients who continued taking brand name PGAs were 28% less likely to have improved adherence (odds ratio [OR], 0.72; 95% CI, 0.55-0.94) and 39% more likely to have reduced adherence (OR, 1.39; 1.04-1.86) of ≥25%. Improved adherence after the generic drug's introduction was also associated with higher monthly medication copay in the pregeneric period (P = 0.02), lower copay after introduction of the generic drug (P < 0.0001), and black race (OR, 1.25; 95% CI, 1.04-1.50). Six-hundred twelve patients (7.3%) discontinued all antiglaucoma interventions when generic latanoprost became available. Given that cost can significantly deter adherence, switching patients to generic medications may help improve patients' drug-regimen adherence. A considerable number of patients discontinued glaucoma drug use altogether when generic latanoprost became available. Ophthalmologists should work with insurers and pharmacists to prevent such discontinuation of use as generic forms of other PGA agents become available. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Brand loyalty, patients and limited generic medicines uptake.

PubMed

Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie

2014-06-01

The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Generic substitution of anti-epileptic drugs. A needed battle?

PubMed

Al-Baradie, Raidah S

2008-07-01

The clinical and economic consequences of generic antiepileptic drug (AED) substitution are not yet fully understood. Generic substitution may increase pharmacy utilization, but it may not always save health care costs for AEDs. The AEDs are relatively cheap, but high volumes of prescriptions mean that substantial drug-budget savings may be possible by switching from innovator brands to cheaper generic drugs. Such savings have been achieved in many other treatment areas. However, more caution may be needed for epilepsy because of the narrow therapeutic index, low solubility, and non-linear pharmacokinetics of some AEDs. This means that the ranges of bioequivalence that are authorized for generic formulations do not offer the same results regarding effectiveness and safety as those obtained by brand name drugs. This is why seizure control should not be sacrificed on the basis of cost alone, as the major endpoint in treating epilepsy with AEDs is seizure control without adverse effects. Switching to the cheapest generic AED may offer drug-budget savings that outweigh any risk to patient safety. But to date, this cost-benefit analysis has not been carried out. We propose that all changes to established principles of treating epilepsy are evidence based and that the risks of switching are clearly defined.

Brand and generic use of inhalation medication and frequency of switching in children and adults: A population-based cohort study.

PubMed

Engelkes, Marjolein; van Blijderveen, Jan C; Overbeek, Jetty A; Kuiper, Josephine; Herings, Ron C M; Sturkenboom, Miriam C J M; de Jongste, Johan C; Verhamme, Katia M C; Janssens, Hettie M

2017-11-29

The expiration of patents of brand inhalation medications and the ongoing pressure on healthcare budgets resulted in a growing market for generics. To study the use of brand and generic inhalation medication and the frequency of switching between brand and generic and between devices. In addition, we investigated whether switching affected adherence. From dispensing data from the Dutch PHARMO Database Network a cohort aged ≥ 5 years, using ≥ 1 year of inhalation medication between 2003 and 2012 was selected. Switching was defined as changing from brand to generic or vice versa. In addition, we studied change in aerosol delivery device type (e.g., DPI, pMDI, and nebulizers). Adherence was calculated using the medication possession ratio (MPR). The total cohort comprised 70,053 patients with 1,604,488 dispensations. Per calendar year, 5% switched between brand and generic inhalation medication and 5% switched between devices. Median MPRs over the first 12 months ranged between 33 and 55%. Median MPR over the total period was lower after switch from brand to generic and vice versa for formoterol (44.5 vs. 42.1 and 63.5 vs. 53.8) and beclomethasone (93.8 vs. 59.8 and 81.3 vs. 55.9). Per year, switching between brand and generic inhalation medication was limited to 5% of the patients, switching between device types was observed in 5% as well. Adherence to both generic and brand inhalation medication was low. Effect of switching on adherence was contradictory; depending on time period, medication and type, and direction of switching. Further research on reasons for switching and potential impact on clinical outcomes is warranted.

OSTEOPOROSIS DRUGS MARKETED IN THE UNITED STATES: GENERIC COMPETITION, PRICING STRUCTURE, AND DISPERSION AMONG PAYERS.

PubMed

Balkhi, Bander; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa

2016-01-01

Despite the cost of pharmaceuticals, studies assessing prices of osteoporosis drugs are lacking. This study examined trends in prices of osteoporosis drugs in the United States in the period 1988-2014, assessed pricing structure of osteoporosis drugs, and evaluated price trends before and after generic drugs market entry. Data were derived from the U.S. Food and Drug Administration, the RedBook, the Centers for Medicare & Medicaid Services, and the Federal Supply Schedule (FSS). Descriptive statistics and segmented linear regression analyses were performed. In the period 1988-2014, osteoporosis drug prices increased faster than the inflation. The average wholesale price (AWP) of generic products at market entry represented 90 percent of the AWP for the corresponding brand. Prices of brand products continued to increase after generic entry. Drug prices showed a significant variation when compared with the brand AWP. The brand wholesale acquisition cost (WAC) was typically set at 83.3 percent of the AWP. Community pharmacies acquired osteoporosis brand drugs at a median of 80.5 percent of the brand AWP. Significant reductions in brand AWP were observed for Medicare Part B (78.5 percent of the brand AWP), generic National Average Drug Acquisition Cost (33.7 percent), and FSS (22.5 percent). There are significant differences in the manufacturer prices, pharmacy acquisition costs and reimbursement rates of osteoporosis drugs. Pharmaceutical companies listed prices are higher than the pharmacy actual estimated acquisitions costs, and the prices used for reimbursement to providers. Generic drugs entry significantly drives down prices; still, prices of branded drugs facing generic competition continued to increase after generic market entry.

Cost sharing and branded antidepressant initiation among patients treated with generics.

PubMed

Buxbaum, Jason D; Chernew, Michael E; Bonafede, Machaon; Vlahiotis, Anna; Walter, Deborah; Mucha, Lisa; Fendrick, A Mark

2018-04-01

To determine the relationship between consumer cost sharing for branded antidepressants and the initiation of branded therapy among patients with major depressive disorder (MDD) filling a prescription for generic MDD medication.  Retrospective cross-sectional analyses. Patients aged 18 to 64 years with MDD who filled a generic antidepressant were identified in commercial claims data for 2012 to 2014. For each year-specific analysis, an average cost-sharing index for branded antidepressants at the level of the plan was computed. Multivariable models were used to estimate the relationship between plan-level cost sharing for branded antidepressant medications and the filling of branded prescriptions, with demographic and clinical variables as covariates. For patients with MDD filling a generic prescription, increases in branded cost sharing were associated with significant decreases in the likelihood of filling a branded antidepressant in each year (P <.001). Results in 2012 imply that a shift from the 0th to 90th percentile in the branded cost-sharing index corresponded with a 9.5% decrease in the relative likelihood of a branded fill among patients receiving a generic antidepressant. The corresponding figures for 2013 and 2014 were 9.3% and 3.5%, respectively. In MDD, patients and clinicians who dutifully adhere to guidelines requiring a trial of first-line medication may ultimately require therapy with alternate agents to achieve adequate disease control. A "reward the good soldier" benefit design would lower cost sharing for higher-tier evidence-based therapies when clinically indicated. Results suggest that narrowing the gap in cost sharing between branded and generic medications following a trial of a generic agent might improve access to second-line treatment in MDD.

Cost-Effectiveness of Evaluating the New Technologies.

ERIC Educational Resources Information Center

Kastner, Theodore A.

1997-01-01

This commentary on a study comparing use of the brand name drug Depakene with generic valproic acid to control seizures in people with mental retardation focuses on issues of cost-effectiveness. It notes existing guidelines for pharmacoeconomic evaluation and suggests a possible model to include a threshold price (per quality-adjusted life year)…

76 FR 2691 - Prescription Drug Products Containing Acetaminophen; Actions To Reduce Liver Injury From...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-14

... drug products that are labeled for prescription use and marketed under approved new drug applications... acetaminophen under the brand name Darvocet as well as in many generic products. On November 19, 2010, FDA... not cause gastro-intestinal discomfort and/or bleeding. However, despite its wide use, long acceptance...

A Guide to Computer Adaptive Testing Systems

ERIC Educational Resources Information Center

Davey, Tim

2011-01-01

Some brand names are used generically to describe an entire class of products that perform the same function. "Kleenex," "Xerox," "Thermos," and "Band-Aid" are good examples. The term "computerized adaptive testing" (CAT) is similar in that it is often applied uniformly across a diverse family of testing methods. Although the various members of…

Comparison of the antiplatelet effect of two clopidogrel bisulfate formulations: Plavix and generic-Egitromb.

PubMed

Komosa, A; Siller-Matula, J M; Kowal, J; Lesiak, M; Siniawski, A; Mączyński, M; Michalak, M; Mularek-Kubzdela, T; Grajek, S

2015-01-01

Due to expansion of the pharmaceutical market it seems necessary to prove the efficacy of the generic drugs. The aim of this study is to compare the effects of two clopidogrel formulations: brand-name-Plavix and generic drug - Egitromb. This is a prospective, randomized study comparing two groups of patients treated with two clopidogrel: brand-name Plavix and generic drug- Egitromb. The 53 consecutive patients with stable coronary artery disease qualifying for coronary angiography and PCI were enrolled in this trial. They were randomized into two groups. In the group A (n = 28) patients received Egitromb 300 mg at admission followed by 8 days of 75 mg Egitromb daily. In the group B (n = 25) patients received Plavix 300 mg on the admission followed by 8 days of 75 mg Plavix maintenance therapy. Blood samples for multiple electrode aggregometry testing were drawn at baseline, 5 hours and 8 days after taking the loading dose. Median values of platelet aggregation inhibition did not differ between the Plavix and Egitromb groups when assessed at baseline: 239AU/min (IQR:329) vs. 209 (IQR:406; p = 0.894), 5 hours after loading: 183 AU/min (IQR:107) vs. 165 (IQR:171; p = 0.831) or at day 8: 174 AU/min (IQR:133) vs. 211 (IQR:133; p = 0.332. The study showed no difference in the therapeutic effect of two clopidogrel formulations (Egitromb and Plavix).

Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers.

PubMed

Baribeault, David

2011-08-01

Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved generic product Nulecit (generic SFG) and the branded product Ferrlecit (branded SFG) are bioequivalent. In this open-label study, 240 healthy volunteers in a fasting state were assigned randomly to a single 10-min intravenous (IV) infusion of 125 mg of generic or branded SFG. Total and transferrin-bound iron concentrations were determined for the 36-h period after infusion and corrected for pretreatment levels. Maximum concentration (Cmax) and area under the concentration-time curve of 0 to 36 h (AUC[0-36]) were compared between the two products. Demonstration of bioequivalence required that the 90% confidence intervals of each parameter evaluated for generic SFG were within 80% to 125% of the corresponding values for branded SFG. Uncorrected and baseline-corrected mean serum concentrations of total serum iron during the 36-h assessment period were similar for generic and branded SFG. For total serum iron, the geometric mean ratios of corrected Cmax and AUC[0-36] were 100%. For transferrin-bound iron, the geometric mean ratios were 87% for corrected Cmax and 92% for corrected AUC[0-36]. All associated 90% confidence intervals were within the range of 80% to 125%. A new generic SFG in complex for IV infusion is bioequivalent to the branded SFG in complex for IV infusion. The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the branded product.

Investigation of the efficacy of generic and brand-name tiotropium bromide in the management of chronic obstructive pulmonary disease: A randomized comparative trial.

PubMed

Panahi, Yunes; Ghanei, Mostafa; Behzadi, Mohammad; Salehi, Maryam; Soflaei, Sara Saffar; Sahebkar, Amirhossein

2016-03-01

The beneficial effects of tiotropium bromide, a long acting anticholinergic bronchodilator, in the management of chronic obstructive pulmonary disease have been shown in previous studies. The present study aimed to compare the efficacy and safety of generic (Tiova®) and brand-name (Spiriva®) tiotropium preparations in patients with COPD. In this randomized double-blind parallel-group trial, 79 patients with documented COPD were assigned to Tiova® or Spiriva® for a period of 4 weeks. Assessment of pulmonary function (using spirometry), quality-of-life (using St. George respiratory Questionnaire [SGRQ]) and severity of respiratory symptoms (using breathlessness, cough and sputum scale [BCSS]) was performed at baseline and at the end of treatment period. There were significant increases in FEV1 and reductions in FVC by the end of study in both Tiova® and Spiriva® groups. FEV1/FVC ratio did not change significantly neither in the Tiova® nor in Spiriva® group. Overall SGRQ score as well as subscale scores of symptoms, activity and impacts were improved by both drugs. In the BCSS scale, the frequency and severity of three main symptoms (dyspnea, cough and sputum) was decreased by both drugs. Baseline as well as post-treatment values of spirometric parameters, SGRQ and BCSS scores was comparable between the groups, apart from a lower post-treatment frequency of cough and sputum in the Spiriva® versus Tiova® group. There was no report of adverse events in either of the study groups. The findings of this comparative trial showed equivalent efficacy and safety of Spiriva® and Tiova® in lessening the symptoms as well as improving the quality of life in patients with COPD. This finding has an important translational value given the significantly lower costs of generic versus brand-name products.

Generic versus branded medicines: An observational study among patients with chronic diseases attending a public hospital outpatient department

PubMed Central

Das, Manisha; Choudhury, Supriyo; Maity, Somnath; Hazra, Avijit; Pradhan, Tirthankar; Pal, Aishee; Roy, Ranendra Kumar

2017-01-01

Background: The concept of generic prescription is widely accepted in various parts of the world. Nevertheless, it has failed to gain popularity in India due to factors such as nonavailability and distrust on the product quality. However, since 2012, the Government of West Bengal, India, has initiated exclusive generic drug outlets called “fair price medicine shop” (FPMS) inside the government hospital premises in a “public-private-partnership” model. This study was undertaken to evaluate the experience and attitude of patients who were consuming generic drugs purchased from these FPMS. Materials and Methods: It was a questionnaire-based cross-sectional study where we have interviewed 100 patients each consuming generic and branded drugs, respectively. The perceived effectiveness, reported safety, medication adherence, cost of therapy, and availability of drugs was compared between two mentioned groups. Medication adherence was estimated through Drug Attitude Inventory-10. Results: 93% of generic and 87% branded drug users believed that their drugs were effective (P = 0.238) in controlling their ailments. No significant difference (9% generic, 10% branded drug users, P = 1.000) was observed in reported adverse effects between generic and branded drug users. 82% and 77% of patients were adherent generic and branded drugs, respectively (P = 0.289). As expected, a significantly lower cost of generic drugs was observed compared to its branded counterpart. Conclusion: The policy of FPMS implemented by the Government of West Bengal, India appeared to be promising in terms of perceived effectiveness, safety, and adherence of generic drugs from FPMS compared to drugs purchased from open market retailers. Therefore, this study might act as an impetus for the policy-makers to initiate similar models across the country. PMID:28250671

Analyzing generic and branded substitution patterns in the Netherlands using prescription data.

PubMed

Pechlivanoglou, Petros; van der Veen, Willem Jan; Bos, Jens H; Postma, Maarten J

2011-04-27

As in other societies, pharmaceutical expenditures in the Netherlands are rising every year. As a consequence, needs for cost control are often expressed. One possible solution for cost control could come through increasing generic substitution by pharmacists. We aim to analyse the extent and nature of substitution in recent years and estimate the likelihood of generic or branded substitution in Dutch pharmacies in relation to various characteristics. We utilized a linked prescription dataset originating from a general practitioner (GP) and a pharmacy database, both from the northern Netherlands. We selected specific drugs of interest, containing about 55,000 prescriptions from 15 different classes. We used a crossed generalized linear mixed model to estimate the effects that certain patient and pharmacy characteristics as well as timing have on the likelihood that a prescription will eventually be substituted by the pharmacist. Generic substitution occurred at 25% of the branded prescriptions. Generic substitution was more likely to occur earlier in time after patent expiry and to patients that were older and more experienced in their drug use. Individually owned pharmacies had a lower probability of generic substitution compared to chain pharmacies. Oppositely, branded substitution occurred in 10% of generic prescriptions and was positively related to the patients' experience in branded use. Individually owned pharmacies were more likely to substitute a generic drug to a branded compared to other pharmacies. Antidepressant and PPI prescriptions were less prone to generic and more prone to branded substitution. Analysis of prescription substitution by the pharmacist revealed strong relations between substitution and patient experience on drug use, pharmacy status and timing. These findings can be utilised to design further strategies to enhance generic substitution.

Effects of reference pricing in pharmaceutical markets: a review.

PubMed

Galizzi, Matteo Maria; Ghislandi, Simone; Miraldo, Marisa

2011-01-01

This work aims to provide a systematic and updated survey of original scientific studies on the effect of the introduction of reference pricing (RP) policies in Organisation for Economic Co-operation and Development (OECD) countries. We searched PubMed, EconLit and Web of Knowledge for articles on RP. We reviewed studies that met the inclusion criteria established in the search strategy. From a total of 468 references, we selected the 35 that met all of the inclusion criteria. Some common themes emerged in the literature. The first was that RP was generally associated with a decrease in the prices of the drugs subject to the policy. In particular, price drops seem to have been experienced in virtually every country that implemented a generic RP (GRP) policy. A GRP policy applies only to products with expired patents and generic competition, and clusters drugs according to chemical equivalence (same form and active compound). More significant price decreases were observed in the sub-markets in which drugs were already facing generic competition prior to RP. Price drops varied widely according to the amount of generic competition and industrial strategies: brand-named drugs originally priced above RP values decreased their prices to a greater extent. A second common theme was that both therapeutic RP (TRP) and GRP have been associated with significant and consistent savings in the first years of application. A third general result is that generic market shares significantly increased whenever the firms producing brand-named drugs did not adopt one of the following strategies: lowering prices to RP values; launching new dosages and/or formulations; or marketing substitute drugs still under patent protection. Finally, concerning TRP, although more evidence is needed, studies based on a large number of patient-level observations showed no association between the RP policy and health outcomes.

The risks and costs of multiple-generic substitution of topiramate.

PubMed

Duh, M S; Paradis, P E; Latrémouille-Viau, D; Greenberg, P E; Lee, S P; Durkin, M B; Wan, G J; Rupnow, M F T; LeLorier, J

2009-06-16

To investigate clinical and economic consequences following generic substitution of one vs multiple generics of topiramate (Topamax; Ortho-McNeil Neurologics, Titusville, NJ). Medical and pharmacy claims data of Régie de l'Assurance-Maladie du Québec from January 2006 to October 2007 were used. Patients with epilepsy treated with topiramate were selected. An open-cohort design was used to classify the observation period into periods of brand, single-generic, and multiple-generic use. One-year generic-switch and switchback-to-brand rates were estimated using Kaplan-Meier methodology. Medical resource utilization and costs were compared among the three periods using multivariate regression analysis. In total, 948 patients were observed during 1,105 person-years of brand use, 233 person-years of single-generic use, and 92 person-years of multiple-generic use. A total of 23% of generic users received at least two different generic versions. Compared to brand use, multiple-generic use was associated with higher utilization of other prescription drugs (incidence rate ratio [IRR] = 1.27, 95% confidence interval [CI] = 1.24-1.31), higher hospitalization rates (0.48 vs 0.83 visit/person-year, IRR = 1.65, 95% CI = 1.28-2.13), and longer hospital stays (2.6 vs 3.9 days/person-year, IRR = 1.43, 95% CI = 1.27-1.60), but the effect was less pronounced in single-generic use (hospitalization: IRR = 1.08, 95% CI = 0.88-1.34, length of stay: IRR = 1.12, 95% CI = 1.03-1.23). The risk of head injury or fracture was nearly three times higher (hazard ratio = 2.84, 95% CI = 1.24-6.48) following a generic-to-generic switch compared to brand use. The total annualized health care cost per patient was higher in the multiple-generic than brand periods by C$1,716 (cost ratio = 1.21, p = 0.0420). Multiple-generic substitution of topiramate was significantly associated with negative outcomes, such as hospitalizations and injuries, and increased health care costs.

Comparing Tolerability and Efficacy of Generic versus Brand Alendronate: A Randomized Clinical Study in Postmenopausal Women with a Recent Fracture

PubMed Central

van den Bergh, Joop P. W.; Bouts, Marian E.; van der Veer, Eveline; van der Velde, Robert Y.; Janssen, Marcel J. W.; Geusens, Piet P.; Winkens, Bjorn; Oldenhof, Nico J. J.; van Geel, Tineke A. C. M.

2013-01-01

Introduction An increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate. Methods In a randomized double-blinded single centre cross-over study in 37 postmenopausal women (mean age 65.4±6.4 years) with osteoporosis were treated with generic and branded alendronate during 24 (2x12) weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale (GSRS) and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide (CTX) and procollagen type I N-terminal propeptide (PINP). No wash out period was allowed (ethical reasons). Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models. Results There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 (estimated mean difference (B): 0.40; 95%CI: 0.05 to 0.74, p = 0.024). The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate (p < 0.001). Mean level of CTX was significantly lower with branded at week 4 (B: 121.3; 95%CI: 52.0 to 190.5), but not at week 12 (B: 53.6; 95%CI:-3.7 to 110.9). No significant differences were found for PINP at week 4 or 12. Conclusions Bone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent fracture. Trial Registration Dutch Trial Register NTR number 1867 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1867 PMID:24205135

Economic savings versus health losses: The cost-effectiveness of generic antiretroviral therapy in the United States

PubMed Central

Walensky, Rochelle P.; Sax, Paul E.; Nakamura, Yoriko M.; Weinstein, Milton C.; Pei, Pamela P.; Freedberg, Kenneth A.; Paltiel, A. David; Schackman, Bruce R.

2013-01-01

Background US HIV treatment guidelines recommend branded once-daily, one-pill efavirenz/emtricitabine/tenofovir as preferred first-line antiretroviral treatment (ART). With the anticipated approval of generic efavirenz in 2012 in the US, the cost of a once-daily, three-pill alternative (generic efavirenz, generic lamivudine, tenofovir) will decrease, but adherence and virologic suppression may be reduced. Objectives To assess the clinical impact, costs, and cost-effectiveness of the generic-based three-pill regimen compared to the branded, co-formulated regimen. To project the potential national savings in the first year of a switch to generic-based ART. Design Mathematical simulation of HIV disease. Data Sources Published data from US clinical trials and observational cohorts. Target Population HIV-infected patients eligible to start on or switch to an efavirenz-based generic ART regimen. Time Horizon Lifetime, One-year Perspective US health system Interventions No ART (for comparison), Three-pill Generic ART, and Branded ART Outcome Measures Quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICER, $/quality-adjusted life expectancy [QALY]). Results of Base-Case Analysis Compared to No ART, Generic ART has an ICER of $21,100/QALY. Compared to Generic ART, Branded ART increases lifetime costs by $42,500, and per-person survival gains by 0.37 QALYs, for an ICER of $114,800/QALY. Estimated first-year savings, if all eligible US patients start on or switch to Generic ART, are $920 million. Results of Sensitivity Analysis Most plausible assumptions about Generic ART efficacy and costs lead to Branded ART ICERs >$100,000/QALY. Limitations The efficacy and price reduction associated with generics are unknown; estimates are intended to be conservative. Conclusions Compared to a slightly less effective generic-based regimen, the cost-effectiveness of first-line Branded ART exceeds $100,000/QALY. Generic-based ART in the US could yield substantial budgetary savings to HIV programs. PMID:23318310

Impact of medicare part D plan features on use of generic drugs.

PubMed

Tang, Yan; Gellad, Walid F; Men, Aiju; Donohue, Julie M

2014-06-01

Little is known about how Medicare Part D plan features influence choice of generic versus brand drugs. To examine the association between Part D plan features and generic medication use. Data from a 2009 random sample of 1.6 million fee-for-service, Part D enrollees aged 65 years and above, who were not dually eligible or receiving low-income subsidies, were used to examine the association between plan features (generic cost-sharing, difference in brand and generic copay, prior authorization, step therapy) and choice of generic antidepressants, antidiabetics, and statins. Logistic regression models accounting for plan-level clustering were adjusted for sociodemographic and health status. Generic cost-sharing ranged from $0 to $9 for antidepressants and statins, and from $0 to $8 for antidiabetics (across 5th-95th percentiles). Brand-generic cost-sharing differences were smallest for statins (5th-95th percentiles: $16-$37) and largest for antidepressants ($16-$64) across plans. Beneficiaries with higher generic cost-sharing had lower generic use [adjusted odds ratio (OR)=0.97, 95% confidence interval (CI), 0.95-0.98 for antidepressants; OR=0.97, 95% CI, 0.96-0.98 for antidiabetics; OR=0.94, 95% CI, 0.92-0.95 for statins]. Larger brand-generic cost-sharing differences and prior authorization were significantly associated with greater generic use in all categories. Plans could increase generic use by 5-12 percentage points by reducing generic cost-sharing from the 75th ($7) to 25th percentiles ($4-$5), increasing brand-generic cost-sharing differences from the 25th ($25-$26) to 75th ($32-$33) percentiles, and using prior authorization and step therapy. Cost-sharing features and utilization management tools were significantly associated with generic use in 3 commonly used medication categories.

Patients' Preferences for Generic and Branded Over-the-Counter Medicines: An Adaptive Conjoint Analysis Approach.

PubMed

Halme, Merja; Linden, Kari; Kääriä, Kimmo

2009-12-01

: Despite increased use of generic medicines, little is known about either the attitudes of patients towards them or the decision-making process surrounding them. Young adults use over-the-counter (OTC) analgesics relatively often. : To assess the preferences of patients for generic and branded OTC pain medicines, to identify clusters with different preference structures, and to estimate the price elasticity of a generic alternative among university students. : Finnish university students (n = 256; students in courses at the Helsinki School of Economics) responded to an adaptive conjoint analysis (ACA) questionnaire on the choice between branded and generic OTC ibuprofen products. Product attributes of price, brand, onset time of effect, place of purchase and source of information were included in the questionnaire on the basis of the literature, a focus group and a previous pilot study. Several socioeconomic and health behavior descriptors were employed. Individual-level utility functions were estimated, preference clusters were identified, and the price elasticity of the generic medicine was assessed. : Five clusters with characteristic individual-level preferences and price elasticity but few differences in socioeconomic background were detected. Approximately half of the respondents were strongly price sensitive while the others had other preferences such as brand or an opportunity to buy the medicine at a pharmacy or to have a physician or a pharmacist as an information source. : The study provided new information on the concomitant effects of brand, price and other essential product attributes on the choice by patients between branded and generic medicines.

Healthcare Costs Associated with Switching from Brand to Generic Levothyroxine

PubMed Central

Katz, Michael; Scherger, Joseph; Conard, Scott; Montejano, Leslie; Chang, Stella

2010-01-01

Background Controversy exists over the true therapeutic equivalence of branded and generic levothyroxine—the drug of choice for treating hypothyroidism—so professional societies recommend against switching between different formulations of the drug and suggest that patients who do switch be monitored. Payers typically encourage switching to generic drugs because of lower drug acquisition costs. Objective To evaluate the impact of switching levothyroxine formulations on actual healthcare costs. Methods Patients with hypothyroidism and at least 6 months of branded levothyroxine therapy were identified from a large healthcare claims database. Patients who subsequently switched to another levothyroxine formulation and could be followed for 6 months postswitch were matched to demographically similar patients who were continuous users of branded levothyroxine. Pre- and postswitch healthcare costs for each group were compared. Results The savings in prescription drug costs after switching from branded to generic levothyroxine are offset by increases in costs for other healthcare services, such that switching is actually associated with an increase, not a decrease, in total healthcare costs. Conclusion In the absence of cost-savings, there is no clear rationale for switching patients from brand to generic levothyroxine. PMID:25126314

Generic atorvastatin is as effective as the brand-name drug (LIPITOR®) in lowering cholesterol levels: a cross-sectional retrospective cohort study.

PubMed

Loch, Alexander; Bewersdorf, Jan Philipp; Kofink, Daniel; Ismail, Dzafir; Abidin, Imran Zainal; Veriah, Ramesh Singh

2017-07-17

In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin. This cross-sectional, retrospective cohort study was conducted at the University of Malaya Medical Centre from 1 May 2013 until 30 May 2013. We analyzed the lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) of 629 patients before and at least 3 months after switching them from proprietary atorvastatin (Lipitor ® ) to generic atorvastatin (atorvastatin calcium from Ranbaxy Laboratories, Inc.). We also investigated if there was any difference in the effectiveness of both atorvastatin formulations in various ethnic groups. 266 patients were included in this study. When comparing the median values we found no statistically significant differences (Wilcoxon signed-rank test; p < 0.05) between proprietary and generic atorvastatin in lowering total cholesterol (4.60 mmol/l pre-transition vs. 4.50 mmol/l post-transition; p = 0.583), LDL-cholesterol (2.42 mmol/l vs. 2.41 mmol/l; p = 0.923) and triglycerides (1.50 mmol/l vs. 1.50 mmol/l; p = 0.513). While there was a statistically significant (p = 0.009) difference in HDL-cholesterol levels favouring proprietary atorvastatin, the extent of this change (1.26 mmol/l vs. 1.25 mmol/l) was deemed not to be clinically relevant. There was no statistically significant difference when analyzing the effects on various ethnic groups. Substituting proprietary atorvastatin for its generic formulation atorvastatin calcium does not result in a less effective management of hyperlipidemia. Our findings lend support to the approach of lowering health care costs by switching patients from branded drugs to their less expensive generic analogues.

A pharmaco-economic analysis of patients with schizophrenia switching to generic risperidone involving a possible compliance loss.

PubMed

Treur, Maarten; Heeg, Bart; Möller, Hans-Jürgen; Schmeding, Annette; van Hout, Ben

2009-02-18

As schizophrenia patients are typically suspicious of, or are hostile to changes they may be reluctant to accept generic substitution, possibly affecting compliance. This may counteract drug costs savings due to less symptom control and increased hospitalization risk. Although compliance losses following generic substitution have not been quantified so far, one can estimate the possible health-economic consequences. The current study aims to do so by considering the case of risperidone in Germany. An existing DES model was adapted to compare staying on branded risperidone with generic substitution. Differences include the probability of non-compliance and medication costs. Incremental probability of non-compliance after generic substitution was varied between 2.5% and 10%, while generic medication costs were assumed to be 40% lower. Effect of medication price was assessed as well as the effect of applying compliance losses to all treatment settings. The probability of staying on branded risperidone being cost-effective was calculated for various outcomes of a hypothetical study that would investigate non-compliance following generic substitution of risperidone. If the incremental probability of non-compliance after generic substitution is 2.5%, 5.0%, 7.5% and 10% respectively, incremental effects of staying on branded risperidone are 0.004, 0.007, 0.011 and 0.015 Quality Adjusted Life Years (QALYs). Incremental costs are euro757, euro343, -euro123 and -euro554 respectively. Benefits of staying on branded risperidone include improved symptom control and fewer hospitalizations. If generic substitution results in a 5.2% higher probability of non-compliance, the model predicts staying on branded risperidone to be cost-effective (NICE threshold of 30,000 per QALY gained). Compliance losses of more than 6.9% makes branded risperidone the dominant alternative. Results are sensitive to the locations at which compliance loss is applied and the price of generic risperidone. The probability that staying on branded risperidone is cost-effective would increase with larger compliance differences and more patients included in the hypothetical study. The model predicts that it is cost-effective to keep a patient with schizophrenia in Germany on branded risperidone instead of switching him/her to generic risperidone (assuming a 40% reduction in medication costs), if the incremental probability of becoming non-compliant after generic substitution exceeds 5.2%.

The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing

PubMed Central

Al Ameri, Mubarak Nasser; Nayuni, Nanda; Anil Kumar, K.G.; Perrett, David; Tucker, Arthur; Johnston, Atholl

2011-01-01

Introduction Dissolution is the amount of substance that goes into solution per unit time under standardised conditions of liquid/solid interface, solvent composition and temperature. Dissolution is one of the most important tools to predict the in-vivo bioavailability and in some cases to determine bioequivalence and assure interchangeability. Aim To compare the differences in dissolution behaviour of solid dosage forms between innovators (reference products) and their generic counterparts (tested products). Methods Four replicates for each batch of 37 tested medicines was carried out using A PT-DT70 dissolution tester from Pharma Test. A total of 13 branded medicines and 24 generic counterparts were obtained locally and internationally to detect any differences in their dissolution behaviour. They were tested according to the British Pharmacopeia, European Pharmacopeia and the US Pharmacopeia with the rate of dissolution determined by ultra-violet Spectrophotometery. Results Most tested medicines complied with the pharmacopoeial specifications and achieved 85% dissolution in 60 min. However, some generic medicines showed significant differences in dissolution rate at 60 and 120 min. Many generic medicines showed a slower dissolution rate than their branded counterparts such as the generic forms of omeprazole 20 mg. Some showed an incomplete dissolution such as the generic form of nifedipine 10 mg. Other generics showed faster dissolution rate than their branded counterpart such as the generic forms of meloxicam 15 mg. Moreover, some generics from different batches of the same manufacturer showed significant differences in their dissolution rate such as the generic forms of meloxicam 7.5 mg. Nevertheless, some generic medicines violated the EMA and the FDA guidelines for industry when they failed to achieve 85% dissolution at 60 min, such as the generic form of diclofenac sodium 50 mg. Conclusion Most medicines in this study complied with the pharmacopeial limits. However, some generics dissolved differently than their branded counterparts. This can clearly question the interchangeability between the branded and its generic counterpart or even among generics. PMID:25755988

Economic aspects of drug substitution

PubMed Central

Salehi, Hossein; Schweitzer, Stuart O.

1985-01-01

One of the major directions of health policy is the attempt to contain expenditures on pharmaceuticals by encouraging substitution of generic for brand name drug products. Yet, a major marketing survey of prescribing and dispensing patterns in California in 1977 found relatively little drug substitution occurring, and in fact substitution of more expensive products occurred more frequently than did substitution of less expensive products. This article tests alternative models of pharmacy dispensing behavior to better explain substitution patterns and it estimates price functions to measure the extent to which cost savings on generic products are passed on to consumers. PMID:10311162

New strategic directions for Caribbean CSM project.

PubMed

1986-01-01

Recent changes in the strategy of the Caribbean Contraceptive Social Marketing Project emphasize the condom, under the brand name, Panther. Since 1984, CCSMP began marketing their Perle rand of oral contraceptive, since dropped, in Barbados, St. Vincent and St. Lucia. Now wider commercial connections are envisioned, with support by CCSMP to promote generic brands. The Panther condom campaign will include an array of mass media, point-of-purchase and sporting event advertising. Pharmacies report that Panther is selling as well as the leading commercial brand. CCSMP is looking to introduce an ultra-thin condom and a vaginal foaming tablet. Market research, involving physicians and users as well as retail audits, indicates that although population in numbers alone is not a serious problem in the Caribbean, early pregnancy is a concern in the area.

A population-based study of the use of selective serotonin reuptake inhibitors before and after introduction of generic equivalents.

PubMed

Bolton, James M; Dahl, Matthew; Sareen, Jitender; Enns, Murray W; Leslie, William D; Collins, David M; Alessi-Severini, Silvia

2012-04-01

Generic drugs are less expensive than their branded equivalents, but receive limited promotion. This study sought to examine how user rates of individual selective serotonin reuptake inhibitors (SSRIs) changed after the introduction of their generic equivalents. Administrative health and census data were used to examine the rates of use of all 6 SSRIs from 1996 to 2009 in the province of Manitoba (population of 1.2 million). The primary outcome measure was a comparison of the rates of use in the pre- and post-generic periods, using generalized estimating equations. Secondary analyses were stratified by specialty of physician prescriber. Escalating rates of use of branded SSRIs in the pre-generic period significantly decreased after generic versions became available (all Ps < 0.001). Incident use of sertraline and paroxetine continued to decrease throughout the post-generic period (1.5% and 1.9% quarterly decreasing rates, respectively). During the years when generic sertraline, fluoxetine, and fluvoxamine were available, their use declined while branded paroxetine and citalopram use continued to increase. Use of branded citalopram, sertraline, and paroxetine prescribed by general practitioners (GPs) increased at rates significantly higher than when prescribed by psychiatrists (all Ps < 0.001). The introduction of cheaper generic alternatives of SSRIs paradoxically resulted in their use diminishing rather than increasing. With the exception of escitalopram, branded SSRIs tended to be preferentially used, compared with available less expensive generic SSRIs. These patterns were more pronounced for prescriptions by GPs.

Clinical tolerability of generic versus brand beta blockers in heart failure with reduced left ventricular ejection fraction: a retrospective cohort from heart failure clinic.

PubMed

Chanchai, Rattanachai; Kanjanavanit, Rungsrit; Leemasawat, Krit; Amarittakomol, Anong; Topaiboon, Paleerat; Phrommintikul, Arintaya

2018-01-01

Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients. We performed a retrospective cohort analysis in HFrEF patients who received either generic or brand beta-blocker in Chiang Mai Heart Failure Clinic. The primary endpoint was the proportion of patients who received at least 50% target dose of beta-blocker between generic and brand beta-blockers. Adverse events were secondary endpoints. 217 patients (119 and 98 patients received generic and brand beta-blocker, respectively) were enrolled. There were no differences between groups regarding age, gender, etiology of heart failure, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), rate of receiving angiotensin converting enzyme inhibitor (ACEI), angiotensin recepter blocker (ARB), or spironolactone. Patients receiving brand beta-blockers had lower resting heart rate at baseline (74.9 and 84.2 bpm, p  = .001). Rate of achieved 50% target dose and target daily dose did not differ between groups (40.4 versus 44.5% and 48.0 versus 55.0%, p  > .05, respectively). Rate of side effects was not different between groups (32.3 versus 29.5%, p  > .05) and the most common side effect was hypotension. Conclusion: This study demonstrated that beta-blocker tolerability was comparable between brand and generic formulations. Generic or brand beta-blockers should be prescribed to HFrEF patients who have no contraindications.

Clinical tolerability of generic versus brand beta blockers in heart failure with reduced left ventricular ejection fraction: a retrospective cohort from heart failure clinic

PubMed Central

Chanchai, Rattanachai; Kanjanavanit, Rungsrit; Leemasawat, Krit; Amarittakomol, Anong; Topaiboon, Paleerat; Phrommintikul, Arintaya

2018-01-01

Abstract Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients. We performed a retrospective cohort analysis in HFrEF patients who received either generic or brand beta-blocker in Chiang Mai Heart Failure Clinic. The primary endpoint was the proportion of patients who received at least 50% target dose of beta-blocker between generic and brand beta-blockers. Adverse events were secondary endpoints. 217 patients (119 and 98 patients received generic and brand beta-blocker, respectively) were enrolled. There were no differences between groups regarding age, gender, etiology of heart failure, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), rate of receiving angiotensin converting enzyme inhibitor (ACEI), angiotensin recepter blocker (ARB), or spironolactone. Patients receiving brand beta-blockers had lower resting heart rate at baseline (74.9 and 84.2 bpm, p = .001). Rate of achieved 50% target dose and target daily dose did not differ between groups (40.4 versus 44.5% and 48.0 versus 55.0%, p > .05, respectively). Rate of side effects was not different between groups (32.3 versus 29.5%, p > .05) and the most common side effect was hypotension. Conclusion: This study demonstrated that beta-blocker tolerability was comparable between brand and generic formulations. Generic or brand beta-blockers should be prescribed to HFrEF patients who have no contraindications. PMID:29379674

State generic substitution laws can lower drug outlays under Medicaid.

PubMed

Shrank, William H; Choudhry, Niteesh K; Agnew-Blais, Jessica; Federman, Alex D; Liberman, Joshua N; Liu, Jun; Kesselheim, Aaron S; Brookhart, M Alan; Fischer, Michael A

2010-07-01

To stem the rising costs of medications provided to patients enrolled in Medicaid, states have implemented varying policies about generic substitution. These policies differ in the extent to which pharmacists or patients can influence which medications they choose. Using national Medicaid data, we evaluated the relationship between different generic substitution policies and the use of generic simvastatin, a cholesterol-lowering drug, after the patent for the brand-name equivalent, Zocor, expired. States that implemented policies requiring patients' consent prior to generic substitution experienced rates of substitution that were 25 percent lower than those of states that did not require patient consent. By eliminating patient consent requirements, state Medicaid programs could expect to save more than $100 million in coverage for three top-selling medications that are nearing patent expiration. Although these consent requirements are probably intended to increase patient autonomy, policy makers should consider the sizable opportunity costs.

The economic consequences of generic substitution for antiepileptic drugs in a public payer setting: the case of lamotrigine.

PubMed

Duh, Mei Sheng; Andermann, Frederick; Paradis, Pierre Emmanuel; Weiner, Jennifer; Manjunath, Ranjani; Crémieux, Pierre-Yves

2007-08-01

Generic substitution of antiepileptic drugs (AEDs) may increase pharmacy utilization, thus counterbalancing per-pill savings. The purpose of our study was to analyze the economic impact of government-mandated switching from branded to generic lamotrigine. Patients in a Canadian public pharmacy claims database using branded lamotrigine (Lamictal GlaxoSmithKline, UK) in 2002 converted to generic lamotrigine in 2003 and were observed from July 2002 to March 2006. Patients used branded lamotrigine for >or=90 days pre-generic entry and had >or=1 claim for generic lamotrigine post-generic entry. For the generic period, observed per-patient monthly drug costs were calculated as the sum of costs for lamotrigine, other AEDs, and non-AEDs. Expected per-patient drug costs were estimated assuming lamotrigine dose and other prescription drug utilization in the generic period were identical to those observed during the brand period. Differences between observed and expected costs were compared. Among 1,142 branded lamotrigine users, overall average monthly drug costs per person were expected to decrease by $30.55 due to lower pill costs. Instead, they fell by $11.98 from the brand to the generic periods (p < 0.001). Because of dosage changes, lamotrigine costs decreased by $29.92 instead of the anticipated $33.87 (p < 0.001). Increased pharmacy utilization caused other AED costs to rise by $6.29 versus the expected $0.36 (p < 0.001), while non-AED drug cost increased by $11.64 rather than by $2.95 (p < 0.001). We concluded that conversion to generic lamotrigine resulted in lower than expected cost savings. Further research is necessary to determine whether this is due to reduced effectiveness and/or tolerability. Payers may weigh smaller-than-expected cost reductions against a possible decrease in effectiveness to assess the relevance of mandatory generic switching of lamotrigine.

The impact on health outcomes and healthcare utilisation of switching to generic medicines consequent to reference pricing: the case of lamotrigine in New Zealand.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2014-10-01

Many countries have implemented generic reference pricing and substitution as methods of containing pharmaceutical expenditure. However, resistance to switching between medicines is apparent, especially in the case of anti-epileptic medicines. This study sought to exploit a nation-wide policy intervention on generic reference pricing in New Zealand to evaluate the health outcomes of patients switching from originator to generic lamotrigine, an anti-epileptic medicine. A retrospective study using the national health collections and prescription records was conducted comparing patients who switched from originator brand to generic lamotrigine with patients who remained on the originator brand. Primary outcome measures included switch behaviour, changes in utilisation of healthcare services at emergency departments, hospitalisations and use of specialist services, and mortality. Approximately one-quarter of all patients using the originator brand of lamotrigine switched to generic lamotrigine, half of whom made the switch within 60 days of the policy implementation. Multiple switches (three or more) between generic and brand products were evident for around 10% of switchers. Switch-back rates of 3% were apparent within 30 days post-switch. No difference in heath outcome measures was associated with switching from originator lamotrigine to a generic equivalent and hence no increased costs could be found for switchers. Switching from brand to generic lamotrigine is largely devoid of adverse health outcomes; however, creating an incentive to ensure a greater proportion of patients switch to generic lamotrigine is required to achieve maximal financial savings from a policy of generic reference pricing.

Sharing, samples, and generics: an antitrust framework.

PubMed

Carrier, Michael A

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.

Is generic rifaximin still a poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy volunteers.

PubMed

Blandizzi, Corrado; Viscomi, Giuseppe Claudio; Marzo, Antonio; Scarpignato, Carmelo

2014-07-01

Rifaximin is an antibiotic, locally acting in the gastrointestinal tract, which may exist in different crystal as well as amorphous forms. The branded rifaximin formulation contains the polymorph rifaximin-α, whose systemic bioavailability is very limited. This study was performed to compare the pharmacokinetics of this formulation with that of a generic product, whose composition in terms of solid state forms of the active pharmaceutical ingredient was found to be different. Two tablets (2×200mg) of branded and generic formulations were given to 24 healthy volunteers of either sex, according to a single-blind, randomized, two-treatment, single-dose, two-period, cross-over design. Plasma and urinary samples were collected at preset times (for 24h or 48h, respectively) after dosing, and assayed for rifaximin concentrations by high-performance liquid chromatography-mass spectrometry. Rifaximin plasma and urine concentration-time profiles showed relevant differences when generic and branded rifaximin were compared. Most pharmacokinetic parameters were significantly higher after administration of generic rifaximin than after rifaximin-α. In particular, the differences for Cmax, AUC and cumulative urinary excretion between the generic formulation and the branded product ranged from 165% to 345%. The few adverse events recorded were not serious and not related to study medications. The results of the present investigation demonstrate different systemic bioavailability of generic and branded formulations of rifaximin. As a consequence, the therapeutic results obtained with rifaximin-α should not be translated sic et simpliciter to the generic formulations of rifaximin, which do not claim containing only rifaximin-α and will display significantly higher systemic absorption in both health and disease. Copyright © 2014 Elsevier Ltd. All rights reserved.

Branded versus generic clopidogrel in cardiovascular diseases: a systematic review.

PubMed

Caldeira, Daniel; Fernandes, Ricardo M; Costa, João; David, Cláudio; Sampaio, Cristina; Ferreira, Joaquim J

2013-04-01

In the United States, patent for branded Plavix has recently expired. Some studies have compared branded and generic clopidogrel in terms of pharmacokinetic parameters in healthy volunteers, but data on patients and clinical outcomes are scarce. We aimed to review efficacy and safety data from studies comparing Plavix with generic clopidogrel in patients with cardiovascular disease. Electronic databases were searched (from inception to May 2012) for prospective studies evaluating branded versus generic clopidogrel in patients with cardiovascular diseases. Studies' characteristics and data estimates were retrieved. Pooled risk ratio (RR) and 95% confidence intervals (95% CIs) were estimated through a random-effects model. Three studies evaluating 760 patients were included: 2 randomized controlled trials and 1 cohort study. The RR for major cardiovascular events was 1.01 (95% CI, 0.67-1.52). Incidence of adverse events was similar between Plavix and generic (RR 0.85; 95% CI, 0.49-1.48). The risks of mortality, bleeding, and drug discontinuation were also not different between groups. There are a limited number of studies comparing Plavix and generic clopidogrel in patients with cardiovascular diseases and reporting hard clinical end points. The available evidence is therefore limited and does not support the existence of differences in efficacy or safety between branded and generic clopidogrel.

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization

PubMed Central

Sun, Dajun; Rouse, Rodney; Patel, Vikram; Wu, Yong; Zheng, Jiwen; Karmakar, Alokita; Patri, Anil K.; Keire, David; Ma, Jia; Jiang, Wenlei

2018-01-01

The objective of this study was to evaluate physicochemical equivalence between brand (i.e., Ferrlecit) and generic sodium ferric gluconate (SFG) in sucrose injection by conducting a series of comparative in vitro characterizations using advanced analytical techniques. The elemental iron and carbon content, thermal properties, viscosity, particle size, zeta potential, sedimentation coefficient, and molecular weight were determined. There was no noticeable difference between brand and generic SFG in sucrose injection for the above physical parameters evaluated, except for the sedimentation coefficient determined by sedimentation velocity analytical ultracentrifugation (SV-AUC) and molecular weight by asymmetric field flow fractionation-multi-angle light scattering (AFFF-MALS). In addition, brand and generic SFG complex products showed comparable molecular weight distributions when determined by gel permeation chromatography (GPC). The observed minor differences between brand and generic SFG, such as sedimentation coefficient, do not impact their biological activities in separate studies of in vitro cellular uptake and rat biodistribution. Coupled with the ongoing clinical study comparing the labile iron level in healthy volunteers, the FDA-funded post-market studies intended to illustrate comprehensive surveillance efforts ensuring safety and efficacy profiles of generic SFG complex in sucrose injection, and also to shed new light on the approval standards on generic parenteral iron colloidal products. PMID:29303999

Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar.

PubMed

Awaisu, Ahmed; Kheir, Nadir; Ibrahim, Mohamed Izham Mohamed; El-Hajj, Maguy; Hazi, Huda; Khudair, Nada; Barazi, Raja

2014-04-01

The practice of generic medicines prescribing, dispensing and substitution in developing countries has been controversial among healthcare professionals, particularly due to issues on quality, safety and efficacy. These controversies are as a result of inter-country differences in policies and laws as well as individualized knowledge and attitudes of pharmacists pertaining to generic medicines. This study primarily aims to assess the knowledge, attitudes, and practices of community pharmacists in Qatar towards generic medicines. Community pharmacy settings throughout the State of Qatar. A cross-sectional study using a pretested paper-based survey was conducted among a random sample of community pharmacists in Qatar. The data were analyzed using IBM-SPSS(®) version 20. Both descriptive and inferential statistical analyses were applied. Knowledge, attitudes, and practices of generic medicines pertaining to regulatory standards, safety, efficacy, quality, and future policies. Results A total of 160 surveys were distributed to community pharmacists of which 118 were returned (response rate, 74 %). The mean total score of generic medicines knowledge among the pharmacists was 6.8 ± 1.6 (maximum possible score was 10). Years of practice as well as place of obtaining academic degree did not influence knowledge score. Approximately 72 % of the pharmacists supported generic substitution for brand name drugs in all cases where a generic medicine is available and the majority (93 %) agreed that pharmacists should be given generic substitution right. Nearly 61 % of the pharmacists considered lack of proven bioequivalence to original brands as an important barrier for selecting generic medicines and 55 % rated "lack of policy for directing the practice of generic medicine" as an important barrier. In order to enhance the quality use of and to promote the practice of generic medicines in Qatar, an educational program should be implemented. A national generic medicine policy and guidelines are warranted in the State of Qatar.

FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).

PubMed

Hui, Yuk Fung

2003-01-01

In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry.

How Abbott’s Fenofibrate Franchise Avoided Generic Competition

PubMed Central

Downing, Nicholas S.; Ross, Joseph S.; Jackevicius, Cynthia A.; Krumholz, Harlan M.

2013-01-01

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug’s history: Abbott, the maker of branded fenofibrate, has produced several bioequivalent reformulations, which dominate the market even though generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on our healthcare system. Abbott maintained its dominance of the fenofibrate market, in part, through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented substitution with generics of older generation products. As soon as direct generic competition seemed likely at the new dose level where substitution would be allowed, Abbott would launch another reformulation and the cycle would repeat. Our objective, using the fenofibrate example, is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications without demonstrating the superiority of next generation products. PMID:22493409

Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise.

PubMed

Downing, Nicholas S; Ross, Joseph S; Jackevicius, Cynthia A; Krumholz, Harlan M

2012-05-14

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug's history: Abbott Laboratories, the maker of branded fenofibrate, has produced several bioequivalent reformulations that dominate the market, although generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on the US health care system. Abbott Laboratories maintained its dominance of the fenofibrate market in part through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first-generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented their substitution with generics of older-generation products. As soon as direct generic competition seemed likely at the new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. Based on the fenofibrate example, our objective is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications, without demonstrating the superiority of next-generation products.

Impact of the Minimum Pricing Policy and introduction of brand (generic) substitution into the Pharmaceutical Benefits Scheme in Australia.

PubMed

McManus, P; Birkett, D J; Dudley, J; Stevens, A

2001-01-01

To describe the effects of introducing the Minimum Pricing Policy (MPP) and generic (brand) substitution in 1990 and 1994 respectively on the dispensing of Pharmaceutical Benefits Scheme (PBS) prescriptions both at the aggregate and individual patient level. The relative proportion of prescriptions with a brand premium and those at benchmark was examined 4 years after introduction of the MPP and again 5 years later after generic substitution by pharmacists was permitted. To determine the impact of a price signal at the individual level, case studies involving a patient tracking methodology were conducted on two drugs (fluoxetine and ranitidine) that received a brand premium. From a zero base when the MPP was introduced in 1990, there were 5.4 million prescriptions (17%) dispensed for benchmark products 4 years later in 1994. At this stage generic (brand) substitution by pharmacists was then permitted and the market share of benchmark brands increased to 45% (25.2 million) by 1999. In the patient tracking studies, a significantly lower proportion of patients was still taking the premium brand of fluoxetine 3 months after the introduction of a price signal compared with patients taking paroxetine which did not have a generic competitor. This was also the case for the premium brand of ranitidine when compared to famotidine. The size of the price signal also had a marked effect on dispensing behaviour with the drug with the larger premium (fluoxetine) showing a significantly greater switch away from the premium brand to the benchmark product. The introduction in 1990 of the Minimum Pricing Policy without allowing generic substitution had a relatively small impact on the selection of medicines within the Pharmaceutical Benefits Scheme. However the effect of generic substitution at the pharmacist level, which was introduced in December 1994, resulted in a marked increase in the percentage of eligible PBS items dispensed at benchmark. Case studies showed a larger premium resulted in a greater shift of patients from drugs with a brand premium to the benchmark alternative.

Lack of efficacy during the switch from brand to generic allopurinol.

PubMed

De Vuono, Antonio; Scicchitano, Francesca; Palleria, Caterina; Russo, Emilio; De Sarro, Giovambattista; Gallelli, Luca

2013-07-01

We report for the first time the lack of therapeutic effects after the switch from a brand formulation of allopurinol to a generic one. A 56-year-old man, with a 5 years history of well-treated gout arthropathy with allopurinol (Zyloric(®) 300 mg/die), developed acute gout arthropathy after the switch from the brand formulation of allopurinol to a generic one. Clinical evaluation and laboratory findings confirmed the diagnosis of acute gout arthropathy. Generic formulation of the drug was dismissed and Zyloric(®) was administered with an improvement of both clinical symptoms and laboratory findings. In conclusion, even if generic formulations are considered to have the same effects in comparison to the brand one, more data are necessaries in order to well define their effectiveness and rationale use. Copyright © 2013 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Economic impact of generic substitution of lamotrigine: projected costs in the US using findings in a Canadian setting.

PubMed

LeLorier, Jacques; Duh, Mei Sheng; Paradis, Pierre Emmanuel; Latrémouille-Viau, Dominick; Lefebvre, Patrick; Manjunath, Ranjani; Sheehy, Odile

2008-04-01

Generic substitution may not always save health care costs for antiepileptic drugs (AED). (1) To examine the economic impacts of generic substitution of lamotrigine in Canada; and (2) to convert observed Canadian costs to a United States (US) setting. Health claims from Québec's health plan (RAMQ) between 08/2002 and 07/2006 were analyzed. Patients with > or = 1 epilepsy claim and treated with branded lamotrigine (Lamictal) before generic entry were selected. Health care costs ($/person-year) were compared during periods of branded and generic use of lamotrigine. Two cost-conversion methods were employed; one using purchasing power parities, US/Canada service use ratios, and exchange rate, and another employing Canadian health care utilization and US unit costs. 671 patients were observed during 1650.9 and 291.2 person-years of branded and generic use of lamotrigine, respectively. The generic-use period was associated with an increase in overall costs (2006 constant Canadian dollars) relative to brand use (C$7902 vs. C$6419/person-year; cost ratio (CR) = 1.22; p = 0.05), despite the lower cost of generic lamotrigine. Non-lamotrigine costs were 33% higher in the generic period (p = 0.013). Both conversion methods yielded increases in total projected health care costs excluding lamotrigine (2006 constant US dollars) during the generic period (Method 1: cost difference: US$1758/person-year, CR = 1.33, p = 0.01); Method 2: cost difference: US$2516, CR = 1.39, p = 0.004). Study limitations pertain to treatment differences, indicators used for conversion and possible claim inaccuracies. Use of generic lamotrigine in Canada was significantly associated with increased overall medical costs compared to brand use. Projected overall US health care costs would likely increase as well.

Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

PubMed

Bian, Boyang; Gorevski, Elizabeth; Kelton, Christina M L; Guo, Jeff J; Martin Boone, Jill E

2012-09-01

Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR₄) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR₄ = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.

Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.

PubMed

Kelton, Christina M L; Chang, Lenisa V; Guo, Jeff J; Yu, Yan; Berry, Edmund A; Bian, Boyang; Heaton, Pamela C

2014-04-01

The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA. Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible. The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative 'price' for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement. Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement. State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.

Brand versus generic dispensing trend for ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg (oral dosage forms) among pharmacies of Karachi, Pakistan.

PubMed

Zehra, Fatima; Naqvi, Atta Abbas; Tasneem, Sumbul; Ahmad, Rizwan; Ahmad, Niyaz; Shamsi, Adnan Zia; Asghar, Naqiya Ali; Khan, Ghufran Ullah

2017-01-01

Pakistan spends 0.7% of its gross domestic product on health. The public sector health-care system provides services to 22% of population thus paving the way for a dominant private sector. Patients in Pakistan mostly pay their medical expenses directly, and 64% of the health expenditures are borne by the household. Expenditure on medicine constitutes 43% of the total household expenditure. A quantitative cross-sectional study was conducted in Karachi, Pakistan, for a month. It was aimed at gathering response from different pharmacies to understand the brand versus generic dispensing trend of ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg oral dosage forms. The study employed convenience sampling and used a survey checklist. The data gathered was entered in SPSS version 22. The mean price per tablet for ciprofloxacin brand and generic was reported at Pakistani Rupees (PKR) 48.44 and PKR 26.85, respectively. The trend for dispensing ciprofloxacin highlighted a split in the market between brand (51%) and generic (49%). For levofloxacin brand and generic, the price per tablet was reported at PKR 36.50 and PKR 36.15 respectively, and despite same price, the market was dominated by generic levofloxacin (92%). Due to a price difference between brand and generic moxifloxacin, i.e., PKR 129.44 and PKR 71.91, respectively, the market was mostly occupied by the generic form (75%). Pricing mechanism must be revisited, and the authorities should take stern actions against any illegitimate price hike. The surging burden of drug expenditure on poorer sections of the society must be addressed by the government on an urgent basis.

Prescription of antibiotics and awareness of antibiotic costs by paediatricians in two hospitals in Greece.

PubMed

Maltezou, Helena C; Mougkou, Katerina; Iosifidis, Elias; Katerelos, Panos; Roilides, Emmanuel; Theodoridou, Maria

2014-02-01

Our aim was to study the antibiotic prescription practices and the knowledge about antibiotic costs, brand and generic drugs of paediatricians working in two hospitals in Greece. The 2007 national guidelines were used as the gold standard for antibiotic prescription. A total of 126 paediatricians participated in the study (50.4% response rate). The mean compliance rate with the guidelines was 50.1% (range per infection: 10.6-84.7%). The mean scores of knowledge about antibiotic costs and about brand name and generic drugs were 35.6 and 60.3%, respectively. Linear regression analysis found a significant association between the mean compliance rate with the national guidelines and the paediatricians' age (mean compliance rates were 49.1, 53.0, and 43.0% in the ≤ 30, 31-40, and > 40 years age-groups, respectively; P  =  0.003). In conclusion, five years after the first national guidelines were issued in Greece only half of the paediatricians working in hospitals comply fully with them.

"The same thing in a different box": similarity and difference in pharmaceutical sex hormone consumption and marketing.

PubMed

Sanabria, Emilia

2014-12-01

The contraceptive pill has given way to a multitude of products, kinds of packaging, and modes of administration. This article draws on work on the pharmaceutical copy, extending the analysis to differentiating between forms of administration for contraceptive medicines as well as between brand-name drugs, generics, and similares, as they are known in Brazil. It explores how Brazilian prescribers and users-within the divergent structural constraints afforded by private and public health-apprehend and negotiate distinctions between the drugs available to them. This ethnographic account of hormone use reveals new fault lines through which the pharmakon exerts its influence. The attention that industry places on pharmacodynamics as it produces new products from similar compounds suggests that pharmaceutical effects are at once symbolic and real. The article concludes with a reflection on the future of the generic form in a field increasingly crowded by branded copies. © 2014 by the American Anthropological Association.

Conformity of commercial oral single solid unit dose packages in hospital pharmacy practice.

PubMed

Thibault, Maxime; Prot-Labarthe, Sonia; Bussières, Jean-François; Lebel, Denis

2008-06-01

There are limited published data on the labelling of single unit dose packages in hospitals. The study was conducted in three large hospitals (two adult and one paediatric) in the metropolitan Montreal area, Quebec, Canada. The objective is to evaluate the labelling of commercial oral single solid unit dose packages available in Canadian urban hospital pharmacy practice. The study endpoint was the labelling conformity of each unit dose package for each criterion and overall for each manufacturer. Complete labelling of unit dose packages should include the following information: (1) brand name, (2) international non-proprietary name or generic name, (3) dosage, (4) pharmaceutical form, (5) manufacturer's name, (6) expiry date, (7) batch number and (8) drug identification number. We also evaluated the ease with which a single unit dose package is detached from a multiple unit dose package for quick, easy and safe use by pharmacy staff. Conformity levels were compared between brand-name and generic packages. A total of 124 different unit dose packages were evaluated. The level of conformity of each criterion varied between 19 and 50%. Only 43% of unit dose packages provided an easy-to-detach system for single doses. Among the 14 manufacturers with three or more unit dose packages evaluated, eight (57%) had a conformity level less than 50%. This study describes the conformity of commercial oral single solid unit dose packages in hospital pharmacy practice in Quebec. A large proportion of unit dose packages do not conform to a set of nine criteria set out in the guidelines of the American Society of Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.

Brand Suicide? Memory and Liking of Negative Brand Names

PubMed Central

Guest, Duncan; Estes, Zachary; Gibbert, Michael; Mazursky, David

2016-01-01

Negative brand names are surprisingly common in the marketplace (e.g., Poison perfume; Hell pizza, and Monster energy drink), yet their effects on consumer behavior are currently unknown. Three studies investigated the effects of negative brand name valence on brand name memory and liking of a branded product. Study 1 demonstrates that relative to non-negative brand names, negative brand names and their associated logos are better recognised. Studies 2 and 3 demonstrate that negative valence of a brand name tends to have a detrimental influence on product evaluation with evaluations worsening as negative valence increases. However, evaluation is also dependent on brand name arousal, with high arousal brand names resulting in more positive evaluations, such that moderately negative brand names are equally as attractive as some non-negative brand names. Study 3 shows evidence for affective habituation, whereby the effects of negative valence reduce with repeated exposures to some classes of negative brand name. PMID:27023872

Brand Suicide? Memory and Liking of Negative Brand Names.

PubMed

Guest, Duncan; Estes, Zachary; Gibbert, Michael; Mazursky, David

2016-01-01

Negative brand names are surprisingly common in the marketplace (e.g., Poison perfume; Hell pizza, and Monster energy drink), yet their effects on consumer behavior are currently unknown. Three studies investigated the effects of negative brand name valence on brand name memory and liking of a branded product. Study 1 demonstrates that relative to non-negative brand names, negative brand names and their associated logos are better recognised. Studies 2 and 3 demonstrate that negative valence of a brand name tends to have a detrimental influence on product evaluation with evaluations worsening as negative valence increases. However, evaluation is also dependent on brand name arousal, with high arousal brand names resulting in more positive evaluations, such that moderately negative brand names are equally as attractive as some non-negative brand names. Study 3 shows evidence for affective habituation, whereby the effects of negative valence reduce with repeated exposures to some classes of negative brand name.

Skin rash during treatment with generic itraconazole.

PubMed

De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

2014-04-01

Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.

Skin rash during treatment with generic itraconazole

PubMed Central

De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

2014-01-01

Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations. PMID:24799820

Safety and efficacy of generic drugs with respect to brand formulation.

PubMed

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-12-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

Dissolution Failure of Solid Oral Drug Products in Field Alert Reports.

PubMed

Sun, Dajun; Hu, Meng; Browning, Mark; Friedman, Rick L; Jiang, Wenlei; Zhao, Liang; Wen, Hong

2017-05-01

From 2005 to 2014, 370 data entries of dissolution failures of solid oral drug products were assessed with respect to the solubility of drug substances, dosage forms [immediate release (IR) vs. modified release (MR)], and manufacturers (brand name vs. generic). The study results show that the solubility of drug substances does not play a significant role in dissolution failures; however, MR drug products fail dissolution tests more frequently than IR drug products. When multiple variables were analyzed simultaneously, poorly water-soluble IR drug products failed the most dissolution tests, followed by poorly soluble MR drug products and very soluble MR drug products. Interestingly, the generic drug products fail dissolution tests at an earlier time point during a stability study than the brand name drug products. Whether the dissolution failure of these solid oral drug products has any in vivo implication will require further pharmacokinetic, pharmacodynamic, clinical, and drug safety evaluation. Food and Drug Administration is currently conducting risk-based assessment using in-house dissolution testing, physiologically based pharmacokinetic modeling and simulation, and post-market surveillance tools. At the meantime, this interim report will outline a general scheme of monitoring dissolution failures of solid oral dosage forms as a pharmaceutical quality indicator. Published by Elsevier Inc.

Generic alendronate use among Medicare beneficiaries: are Part D data complete?

PubMed

Yun, Huifeng; Curtis, Jeffrey R; Saag, Kenneth; Kilgore, Meredith; Muntner, Paul; Smith, Wilson; Matthews, Robert; Wright, Nicole; Morrisey, Michael A; Delzell, Elizabeth

2013-01-01

Generic alendronate was approved in the United States on February 6, 2008. Medicare beneficiaries might pay for generic alendronate out-of-pocket without having claims submitted, resulting in misclassification of generic alendronate use in Medicare data. To estimate the completeness of generic alendronate use in 2008 Medicare Part D data; to identify factors associated with staying on branded alendronate versus switching to a generic product. We identified Medicare beneficiaries highly adherent (medication possession ratio ≥80%) with branded alendronate during 1/1/06-2/6/07 ("2007 cohort") and during 1/1/07-2/6/08 ("2008 cohort"). The outcome was medication status at the end of follow-up (12/31/2007 or 12/31/2008), classified as continued branded alendronate, switched to generic alendronate, switched to another bisphosphonate or presumed discontinued bisphosphonate therapy. Cox regression estimated the hazard ratio (HR) for discontinuation in 2008 compared to 2007. Multinomial logistic regression identified factors associated with medication status for the 2008 cohort. Among 15,310 subjects using branded alendronate in the 2008 cohort, 81% switched to generic alendronate. The proportion presumably discontinuing bisphosphonate therapy was 8.9% in 2008 compared to 7.7% in the 2007 cohort (adjusted HR, 1.15; 95% confidence interval, 1.05, 1.26). Factors associated with staying on branded alendronate in 2008 were higher income, eligibility for a low income subsidy and use of Fosamax® plus vitamin D. Evaluation of Medicare prescription drug data suggests that the amount of missing claims for generic alendronate in 2008 was not substantial, and misclassification of exposure in studies examining alendronate use post-generic product availability should be minimal. Copyright © 2012 John Wiley & Sons, Ltd.

Generic entry, reformulations and promotion of SSRIs in the US.

PubMed

Huskamp, Haiden A; Donohue, Julie M; Koss, Catherine; Berndt, Ernst R; Frank, Richard G

2008-01-01

Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval. We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure. Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers' detailing expenditures but did result in a greater likelihood of DTCA outlays. The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers who introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact that pharmaceutical promotion has on demand for prescription drugs in the US, these findings have important implications for prescription drug spending and public health.

Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

PubMed

Puig-Junoy, Jaume

2012-11-01

In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

The changing patterns of dispensing branded and generic drugs for the treatment of gastroesophageal reflux disease between 2006 and 2011 in Japan: a retrospective cohort study.

PubMed

Murata, Kyoko; Hinotsu, Shiro; Hamada, Shota; Ezoe, Yasumasa; Muto, Manabu; Kawakami, Koji

2015-02-27

Despite rising healthcare costs, generic drugs are less frequently dispensed in Japan compared with other developed countries. This study aimed to describe changes in dispensing of branded and generic drugs and to explore possible factors that promote the use of generic drugs. We conducted a retrospective cohort study using a Japanese medical and pharmacy claims database. All proton pump inhibitors (PPIs) and histamine H2-receptor antagonists (H2RAs) with indications for gastroesophageal reflux disease (GERD) described on Japanese labels were included. Patterns of dispensing branded and generic drugs for the treatment of GERD between 2006 and 2011 were analyzed. Multivariate logistic regression was applied to investigate factors associated with receiving generic drugs. The study cohort included 14,590 patients (male: 50.2%, mean age: 43.1 years). Branded drugs for GERD were still frequently dispensed despite an increase in the share of generic drugs. Only 4.3% of patients who initially received branded drugs switched to generic drugs. The percentage of patients who received only generic drugs increased over time (6.5% to 22.1%). The frequency of generic drug dispensing was the highest in the setting where both prescription and dispensing were implemented in clinics (43.3%), while the lowest in the setting where both prescription and dispensing were implemented in hospitals (11.5%). Factors associated with receiving generic drugs included year of dispensing (adjusted OR 2.22, 95% CI 1.94 to 2.55 for 2009-11 v 2006-8), prescription and dispensing setting (OR 1.81, 95% CI 1.44 to 2.26 for prescription in hospitals and dispensing in community pharmacies; OR 2.21, 95% CI 1.80 to 2.72 for prescription in clinics and dispensing in community pharmacies; and OR 4.55, 95% CI 3.68 to 5.62 for prescription and dispensing in clinics v prescription and dispensing in hospitals) and H2RAs (OR 1.64, 95% CI 1.49 to 1.81 compared to PPIs). The share of generic drugs for the treatment of GERD increased over time although branded drugs for GERD were still dispensed frequently. The use of generic drugs for GERD was influenced not only by government policies but also by changes in treatment approach and the setting of prescription and dispensing.

Safety and efficacy of generic drugs with respect to brand formulation

PubMed Central

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-01-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects. PMID:24347975

Potential Clinical and Economic Impact of Switching Branded Medications to Generics.

PubMed

Straka, Robert J; Keohane, Denis J; Liu, Larry Z

2017-05-01

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003-2013 using key words of "generic switching" or "substitution" was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics

PubMed Central

Straka, Robert J.; Keohane, Denis J.; Liu, Larry Z.

2017-01-01

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003–2013 using key words of “generic switching” or “substitution” was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases. PMID:26099048

The effects of new pricing and copayment schemes for pharmaceuticals in South Korea.

PubMed

Lee, Iyn-Hyang; Bloor, Karen; Hewitt, Catherine; Maynard, Alan

2012-01-01

This study examined the effect of new Korean pricing and copayment schemes for pharmaceuticals (1) on per patient drug expenditure, utilisation and unit prices of overall pharmaceuticals; (2) on the utilisation of essential medications and (3) on the utilisation of less costly alternatives to the study medication. Interrupted time series analysis using retrospective observational data. The increasing trend of per patient drug expenditure fell gradually after the introduction of a new copayment scheme. The segmented regression model suggested that per patient drug expenditure might decrease by about 12% 1 year after the copayment increase, compared with the absence of such a policy, with few changes in overall utilisation and unit prices. The level of savings was much smaller when the new price scheme was included, while the effects of a price cut were inconclusive due to the short time period before an additional policy change. Based on the segmented regression models, we estimate that the number of patients filling their antihyperlipidemics prescriptions decreased by 18% in the corresponding period. Those prescribed generic and brand-named antihyperlipidemics declined by around 16 and 19%, respectively, indicating little evidence of generic substitution resulting from the copayment increase. Few changes were found in the use of antihypertensives. The policies under consideration appear to contain costs not by the intended mechanisms, such as substituting generics for brand name products, but by reducing patients' access to costly therapies regardless of clinical necessity. Thus, concerns were raised about potentially compromising overall health and loss of equity in pharmaceutical utilisation. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs – provision of due diligence in the treatment process

PubMed Central

Zajdel, Justyna

2013-01-01

Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on “off-label use”. The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug. PMID:24592133

Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs - provision of due diligence in the treatment process.

PubMed

Zajdel, Justyna; Zajdel, Radosław

2013-01-01

Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on "off-label use". The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug.

Questionnaire on the awareness of generic drugs among outpatients and medical staff.

PubMed

Hoshi, S; Kimura, H

2008-06-01

Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting.

PubMed

Markoula, Sofia; Chatzistefanidis, Dimitrios; Gatzonis, Stylianos; Siatouni, Anna; Siarava, Eleftheria; Verentzioti, Anastasia; Kyritsis, Athanassios P; Patsalos, Philip N

2017-05-01

The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38.4±16.2 years. Patients treated with the brand LEV (Keppra; UCB Pharma) were closely followed for a four-week period and subsequently switched to a generic LEV (Pharmaten) and followed for another four-week period. Blood samples were collected at the end of each 4-week period, during a dose interval for each formulation, for LEV concentration measurements by liquid chromatography mass spectrometry. Steady-state area under the curve (AUC) and peak plasma concentration (Cmax) data were subjected to conventional average bioequivalence analysis. Secondary clinical outcomes, including seizure frequency and adverse events, were recorded. Patients had epilepsy for a mean period of 14.1±10.6years and the mean daily LEV dose was 2583.3±763.7mg. The mean AUC±SD and Cmax±SD was 288.4±86.3(mg/L)h and 37.8±10.4mg/L respectively for brand LEV and 319.2±104.7(mg/L)h and 41.6±12.3mg/L respectively for the generic LEV. Statistic analysis showed no statistical significant difference in bioequivalence. Also, no change in seizures frequency and/or adverse events was recorded. In our clinical setting, generic LEV was determined to be bioequivalent to brand LEV. Furthermore, seizures frequency or/and adverse events were not affected upon switching from brand to generic LEV. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

An Evaluation of Health Service Impacts Consequent to Switching from Brand to Generic Venlafaxine in New Zealand under Conditions of Price Neutrality.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2015-07-01

To study the health impact on adult New Zealand patients who switch from originator brand to generic venlafaxine. The national pharmacy database was used to select patients using venlafaxine for at least 6 months. Switchers and nonswitchers were identified, and switch behavior was compared for a 12-month follow-up period. Change in health service use following switching was also compared between switchers and nonswitchers including use of the emergency department, hospital, and specialist outpatient services over the same period. Approximately 12% of all originator brand users switched to generic venlafaxine, at least half of whom continued to use the generic throughout the follow-up period to August 1, 2012. Almost 60% of new users of the generic venlafaxine, however, switched to using the originator brand. Aside from a slight reduction in the use of outpatient services among switchers, there were no significant differences in health services use between switchers and nonswitchers for either existing or new venlafaxine users. Although both products remain fully subsidized and available, there is little incentive for prescribers, pharmacists, or patients to switch to the less expensive generic brand. If savings to the national New Zealand budget are to be realized, additional policy measures should be implemented to minimize incentives for multiple and reverse switching, and prescribers, as key opinion leaders, could take the lead in promoting generics to their patients. Copyright © 2015. Published by Elsevier Inc.

Challenges for Australia's Bio/Nanopharma Policies: trade deals, public goods and reference pricing in sustainable industrial renewal

PubMed Central

Faunce, Thomas A

2007-01-01

Industrial renewal in the bio/nanopharma sector is important for the long term strength of the Australian economy and for the health of its citizens. A variety of factors, however, may have caused inadequate attention to focus on systematically promoting domestic generic and small biotechnology manufacturers in Australian health policy. Despite recent clarifications of 'springboarding' capacity in intellectual property legislation, federal government requirements for specific generic price reductions on market entry and the potential erosion of reference pricing through new F1 and F2 categories for the purposes of Pharmaceutical Benefits Scheme (PBS) assessments, do not appear to be coherently designed to sustainably position this industry sector in 'biologics,' nanotherapeutics and pharmacogenetics. There also appears to have been little attention paid in this context to policies fostering industry sustainability and public affordability (as encouraged by the National Medicines Policy). One notable example includes that failure to consider facilitating mutual exchanges on regulatory assessment of health technology safety and cost-effectiveness (including reference pricing) in the context of ongoing free trade negotiations between Australia and China (the latter soon to possess the world's largest generic pharmaceutical manufacturing capacity). The importance of a thriving Australian domestic generic pharmaceutical and bio/nano tech industry in terms of biosecurity, similarly appears to have been given insufficient policy attention. Reasons for such policy oversights may relate to increasing interrelationships between generic and 'brand-name' manufacturers and the scale of investment required for the Australian generics and bio/nano technology sector to be a significant driver of local production. It might also result from singularly effective lobbying pressure exerted by Medicines Australia, the 'brand-name' pharmaceutical industry association, utilising controversial interpretations of reward of pharmaceutical 'innovation' provisions in the Australia-US Free Trade Agreement (AUSFTA) through the policy-development mechanisms of the AUSFTA Medicines Working Group and most recently an Innovative Medicines Working Group with the Department of Health and Ageing. This paper critically analyses such arguments in the context of emerging challenges for sustainable industrial renewal in Australia's bio/nanopharma sector. PMID:17543114

Medicaid prescription limits: policy trends and comparative impact on utilization.

PubMed

Lieberman, Daniel A; Polinski, Jennifer M; Choudhry, Niteesh K; Avorn, Jerry; Fischer, Michael A

2016-01-15

Medicaid programs face growing pressure to control spending. Despite evidence of clinical harms, states continue to impose policies limiting the number of reimbursable prescriptions (caps). We examined the recent use of prescription caps by Medicaid programs and the impact of policy implementation on prescription utilization. We identified Medicaid cap policies from 2001-2010. We classified caps as applying to all prescriptions (overall caps) or only branded prescriptions (brand caps). Using state-level, aggregate prescription data, we developed interrupted time-series analyses to evaluate the impact of implementing overall caps and brand caps in a subset of states with data available before and after cap initiation. For overall caps, we examined the use of essential medications, which were classified as preventive or as providing symptomatic benefit. For brand caps, we examined the use of all branded drugs as well as branded and generic medications among classes with available generic replacements. The number of states with caps increased from 12 in 2001 to 20 in 2010. Overall cap implementation (n = 3) led to a 0.52% (p < 0.001) annual decrease in the proportion of essential prescriptions but no change in cost. For preventive essential medications, overall caps led to a 1.12% (p = 0.001) annual decrease in prescriptions (246,000 prescriptions annually) and a 1.20% (p < 0.001) decrease in spending (-$12.2 million annually), but no decrease in symptomatic essential medication use. Brand cap implementation (n = 6) led to an immediate 2.29% (p = 0.16) decrease in branded prescriptions and 1.26% (p = 0.025) decrease in spending. For medication classes with generic replacements, the decrease in branded prescriptions (0.74%, p = 0.003) approximately equaled the increase in generics (0.79%, p = 0.009), with estimated savings of $17.4 million. An increasing number of states are using prescription caps, with mixed results. Overall caps decreased the use of preventive but not symptomatic essential medications, suggesting that patients assign higher priority to agents providing symptomatic benefit when faced with reimbursement limits. Among medications with generic replacements, brand caps shifted usage from branded drugs to generics, with considerable savings. Future research should analyze the patient-level impact of these policies to measure clinical outcomes associated with these changes.

Generic and therapeutic statin switches and disruptions in therapy.

PubMed

Chapman, Richard H; Benner, Joshua S; Girase, Prafulla; Benigno, Michael; Axelsen, Kirsten; Liu, Larry Z; Nichol, Michael B

2009-05-01

The study objective was to compare dose-equivalence, adherence and subsequent switch rates among patients recently switched from a branded to generic version of the same statin (generic substitution, GS) vs. those switched from branded statin to generic version of a different statin (therapeutic substitution, TS). In a retrospective cohort analysis among adult enrollees in over 90 US health plans, the authors identified adult patients who switched from a branded to generic statin from July-December 2006 (simvastatin became generic in June 2006). Patients were classified by type of statin switch: GS (e.g., branded simvastatin --> generic simvastatin), and TS (e.g., branded atorvastatin --> generic simvastatin). Demographic and clinical data were collected from claims before switch through 6 months follow-up. Separate outcomes of interest included proportion of patients that switched to a less potent daily dose, that switched back to previous branded statin after switch, and that were at least 80% adherent during the 6 months after initial switch. Significant predictors of each clinical outcome were identified using multivariable logistic regression models, adjusting for differences between groups in covariates and potential confounders. The 6-month TS (n = 3807) and GS (n = 40,165) groups were generally similar demographically. Compared to GS, TS patients were significantly more likely to be switched to a less potent dose (26.2% vs. 0.5%, adjusted odds ratio [AOR] in patients with high-potency index medication = 83.4, p < 0.0001); 33% less likely to be adherent in the 6 months after switch (67.7% vs. 75.9%, AOR in patients with no switch in first 6 months follow-up = 0.67, p < 0.0001); and four times more likely to switch back to previous branded statin (11.3% vs. 2.9%, AOR = 4.1, p < 0.0001). This study did not account for co-payment changes, lipid measurements, or changes in pill burden. While this study did not have data on why patients had TS (e.g., for cost or clinical reasons), TS was more likely to involve a subsequent disruption to statin therapy than GS. TS could potentially lead to adverse impacts on patients' outcomes, and should be studied further.

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India.

PubMed

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus; Srinivas, Prashanth N

2017-01-01

Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients' and health workers' perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services.

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India

PubMed Central

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus

2017-01-01

Introduction Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. Methods The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. Results The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients’ and health workers’ perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Conclusion Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services. PMID:29531844

27 CFR 5.34 - Brand names.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Brand names. 5.34 Section... Spirits § 5.34 Brand names. (a) Misleading brand names. No label shall contain any brand name, which... officer finds that such brand name (when appropriately qualified if required) conveys no erroneous...

Is Every Smoker Interested in Price Promotions? An Evaluation of Price-Related Discounts by Cigarette Brands

PubMed Central

Xu, Xin; Wang, Xu; Caraballo, Ralph S.

2015-01-01

Context Raising unit price is one of the most effective ways of reducing cigarette consumption. A large proportion of US adult smokers use generic brands or price discounts in response to higher prices, which may mitigate the public health impacts of raising unit price. Objective The main purpose of this study was to evaluate the retail price impact and the determinants of price-related discount use among US adult smokers by their most commonly used cigarette brand types. Methods Data from the 2009–2010 National Adult Tobacco Survey, a telephone survey of US adults 18 years or older, was used to assess price-related discount use by cigarette brands. Price-related discounts included coupons, rebates, buy 1 get 1 free, 2 for 1, or any other special promotions. Multivariate logistic regression was used to assess sociodemographic and tobacco use determinants of discount use by cigarette brands. Results Discount use was most common among premium brand users (22.1%), followed by generic (13.3%) and other brand (10.8%) users. Among premium brand users, those who smoked 10 to 20 cigarettes per day were more likely to use discounts, whereas elderly smokers, non-Hispanic blacks, those with greater annual household income, dual users of cigarettes and other combustible tobacco products, and those who had no quit intentions were less likely to do so. Among generic brand users, those who had no quit intentions and those who smoked first cigarette within 60 minutes after waking were more likely to use discounts. Conclusions Frequent use of discounts varies between smokers of premium and generic cigarette brands. Setting a high minimum price, together with limiting the use of coupons and promotions, may uphold the effect of cigarette excise taxes to reduce smoking prevalence. PMID:26598952

Is Every Smoker Interested in Price Promotions? An Evaluation of Price-Related Discounts by Cigarette Brands.

PubMed

Xu, Xin; Wang, Xu; Caraballo, Ralph S

2016-01-01

Raising unit price is one of the most effective ways of reducing cigarette consumption. A large proportion of US adult smokers use generic brands or price discounts in response to higher prices, which may mitigate the public health impacts of raising unit price. The main purpose of this study was to evaluate the retail price impact and the determinants of price-related discount use among US adult smokers by their most commonly used cigarette brand types. Data from the 2009-2010 National Adult Tobacco Survey, a telephone survey of US adults 18 years or older, was used to assess price-related discount use by cigarette brands. Price-related discounts included coupons, rebates, buy 1 get 1 free, 2 for 1, or any other special promotions. Multivariate logistic regression was used to assess sociodemographic and tobacco use determinants of discount use by cigarette brands. Discount use was most common among premium brand users (22.1%), followed by generic (13.3%) and other brand (10.8%) users. Among premium brand users, those who smoked 10 to 20 cigarettes per day were more likely to use discounts, whereas elderly smokers, non-Hispanic blacks, those with greater annual household income, dual users of cigarettes and other combustible tobacco products, and those who had no quit intentions were less likely to do so. Among generic brand users, those who had no quit intentions and those who smoked first cigarette within 60 minutes after waking were more likely to use discounts. Frequent use of discounts varies between smokers of premium and generic cigarette brands. Setting a high minimum price, together with limiting the use of coupons and promotions, may uphold the effect of cigarette excise taxes to reduce smoking prevalence.

Long-term stability of acyclovir in 0.9% NaCl infusion polyolefin bags at 5±3°C after freeze-thaw treatment: a generic product versus the brand name.

PubMed

Dewulf, J; Galanti, L; Godet, M; Gillet, P; Jamart, J; Hecq, J-D

2015-03-01

The aim of the study was to investigate the long-term stability of acyclovir 5 mg/mL (a generic product versus the brand name) in NaCl 0.9% after storage at 5±3°C and to evaluate the influence of initial freezing and microwave thawing on this stability. Five bags of Acyclovir® Hospira 5 mg/mL (A) and five bags of Zovirax® GSK 5 mg/mL (B) were prepared under aseptic conditions and stored 3 months at -20°C, then thawed and stored 30 days at 4°C. Five bags of Acyclovir® 5 mg/mL (C) and five bags of Zovirax® 5 mg/mL (D) were also prepared under aseptic conditions and stored 30 days at 5±3°C. Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCl 12 M and NaOH 5 M before and after heating at 100°C was also performed. The concentrations were measured by HPLC-PDA. The only one forced degradation test that yielded chromatograms with degradation products peak was the test with the acid solution heated at 100°C without interference with the native product. No significant change in pH values or optic densities were seen during the study for both products. No crystals were seen with the optic microscope during the study. Acyclovir® and Zovirax® solutions were stable for at least 21 days according to the FDA recommendations. Moreover, there was no statistical difference between regression lines of those two products and two storage conditions. Under the conditions of this study, Acyclovir® 5 mg/mL in 100 mL of NaCl 0.9% infusion remains stable at least for 21 days at 5±3°C with or without freezing at -20°C during the three previous months. There is no statistical difference between the brand name and a generic product. Acyclovir may be prepared in advanced by a centralized intravenous additive service, frozen in polyolefin bags and microwave thawed before storage under refrigeration until 21 days. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

A multicenter experience with generic tacrolimus conversion.

PubMed

McDevitt-Potter, Lisa M; Sadaka, Basma; Tichy, Eric M; Rogers, Christin C; Gabardi, Steven

2011-09-27

The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

27 CFR 7.23 - Brand names.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Brand names. 7.23 Section... Beverages § 7.23 Brand names. (a) General. The product shall bear a brand name, except that if not sold under a brand name, then the name of the person required to appear on the brand label shall be deemed a...

Naming, labeling, and packaging of pharmaceuticals.

PubMed

Kenagy, J W; Stein, G C

2001-11-01

The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

The sources and popularity of online drug information: an analysis of top search engine results and web page views.

PubMed

Law, Michael R; Mintzes, Barbara; Morgan, Steven G

2011-03-01

The Internet has become a popular source of health information. However, there is little information on what drug information and which Web sites are being searched. To investigate the sources of online information about prescription drugs by assessing the most common Web sites returned in online drug searches and to assess the comparative popularity of Web pages for particular drugs. This was a cross-sectional study of search results for the most commonly dispensed drugs in the US (n=278 active ingredients) on 4 popular search engines: Bing, Google (both US and Canada), and Yahoo. We determined the number of times a Web site appeared as the first result. A linked retrospective analysis counted Wikipedia page hits for each of these drugs in 2008 and 2009. About three quarters of the first result on Google USA for both brand and generic names linked to the National Library of Medicine. In contrast, Wikipedia was the first result for approximately 80% of generic name searches on the other 3 sites. On these other sites, over two thirds of brand name searches led to industry-sponsored sites. The Wikipedia pages with the highest number of hits were mainly for opiates, benzodiazepines, antibiotics, and antidepressants. Wikipedia and the National Library of Medicine rank highly in online drug searches. Further, our results suggest that patients most often seek information on drugs with the potential for dependence, for stigmatized conditions, that have received media attention, and for episodic treatments. Quality improvement efforts should focus on these drugs.

Preferred supplier contracts in post-patent prescription drug markets.

PubMed

Blankart, Carl Rudolf; Stargardt, Tom

2016-02-22

In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

Generic Entry, Reformulations, and Promotion of SSRIs

PubMed Central

Donohue, Julie M.; Koss, Catherine; Berndt, Ernst R.; Frank, Richard G.

2009-01-01

Background Previous research has shown that a manufacturer’s promotional strategy for a brand-name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. Objective To examine the relationship between promotional expenditures, generic entry, reformulation entry, and new indication approval. Study Design/Setting We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising (DTCA), and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997 through 2004. We estimated econometric models of detailing, DTCA, and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations, and Food and Drug Administration (FDA) approval for new clinical indications for existing medications in the SSRI class. Main Outcome Measure Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications. Results Over the period 1997–2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers’ detailing expenditures but did result in a greater likelihood of DTCA outlays. Conclusion The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers that introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact pharmaceutical promotion has on demand for prescription drugs, these findings have important implications for prescription drug spending and public health. PMID:18563951

In vitro disintegration studies of weekly generic alendronate sodium tablets (70 mg) available in the US.

PubMed

Dansereau, Richard J; Crail, Debbie J; Perkins, Alan C

2009-02-01

Bisphosphonates as a class have the potential to cause upper gastrointestinal irritation. Although the generic alendronate sodium tablets are bioequivalent to the branded product, a potential concern is that the pharmaceutical attributes of the various generic formulations my affect the potential for local irritation and tolerability. The in vitro disintegration times were determined using the method described in the US Pharmacopeia 30 (USP 30). The disintegration of three generic alendronate sodium tablets 70 mg available in the United States was compared to that of the branded product. The mean disintegration times of the generic alendronate sodium tablets ranged from 9 to 10 s for the Barr lots to 108 s for the Watson lot. The disintegration time of the branded product (Fosamax) was 53 s. The three Barr lots and one Teva lot had rapid disintegration times which were similar to the disintegration standards (< 30 s) for orally disintegrating tablets. Since there is no established disintegration time for alendronate sodium tablets there can be no assurance that the generic tablets are equivalent to the branded product in terms of esophageal exposure. However, the in vitro disintegration times have not been correlated with in vivo disintegration performance. Copies of generic alendronate sodium tablets are approved based on the results of single-dose bioavailability studies in healthy subjects and this is not considered adequate to establish similar disintegration characteristics.

Bottle Characteristics of Topical International Glaucoma Medications versus Local Brands in Saudi Arabia

PubMed Central

Al-Jumaian, Nasser; Malik, Rizwan; Khandekar, Rajiv; Al-Humaidan, Abdullah; Al-Madany, Rana; Al-Qahtani, Reham; Altowairqi, Ahmed; Al-Theeb, Abdulwahab; Zaman, Babar; Al-Djasim, Leyla; Craven, E. Randy; Edward, Deepak P.

2016-01-01

WHAT IS KNOWN AND OBJECTIVE: Physical bottle characteristics differ of brand name topical glaucoma medications and local generic equivalents. This study compares the bottle characteristics of international topical glaucoma brands versus local brands from the Kingdom of Saudi Arabia. METHODS: Data were collected on bottle drum volume, drop volume, bottle squeezability, bottle tip diameter, labels and instructions, cap color coding, and clarity of the drug label. Density-based calculations of drops in bottle volume were assessed using an analytic balance. Bottle tip diameter was measured using 0.05 mm Vernier calipers. A Likert scale-based questionnaire was used to evaluate the subjective opinions of patients on bottle squeezability, clarity of usage and storage instructions, and the consistency of the cap color coding. RESULTS: The volumes of international brands were statistically significantly higher than the local brands (P < 0.001). A number of drops per bottle and tip diameter were comparable between the international local brands. Cap color coding was inconsistent for international and local brands. Patients were dissatisfied with the label font size. Patients reported that the international and local brands were similar in terms of the ease of opening the bottle, instilling a drop, and the clarity of the instructions; but the local brands were subjectively easier to squeeze than international brands. WHAT IS NEW AND CONCLUSIONS: This is the first study to compare bottle characteristics of local Saudi Arabia brands with international brands. The bottle characteristics and patient feedback were similar between the local and international topical glaucoma medications. However, there were differences between the local and international brands in drug volume, bottle squeezability. Hence, patient compliance and drop dosage may differ based on the origin of manufacture. PMID:27994392

Patients’ beliefs about generic medicines in Malaysia

PubMed Central

Wong, Zhi Y.; Hassali, Mohamed A.; Alrasheedy, Alian A.; Saleem, Fahad; Yahaya, Abdul H.; Aljadhey, Hisham

2014-01-01

Background: Acceptance of generic medicines by patients is an essential factor given that they are the end users of these medicines. In fact, adequate knowledge and positive perceptions are prerequisite to patients’ acceptance and use of generic medicines. Objective: To assess the current belief and views of patients about generic medicines in Malaysia. Method: This was a self-administered questionnaire-based study. The study was conducted with patients visiting outpatient pharmacy department at a tertiary care hospital in Malaysia. The Malaysian version of Generic Medicines Scale (GMS) was used. The GMS consists of two subscales: efficacy and similarity of generic medicines to original brand medicines. The efficacy subscale consists of 10 items while the similarity subscale consists of 6 items. The responses to the items were framed as a five-point Likert scale (1=strongly disagree to 5=strongly agree). Results: A total of 202 out of 300 patients participated in the study, giving a response rate of 67.3%. In this study, only 49% of them (n=99) knew the term ‘generic medicine’. Moreover, only 53.5% of the respondents (n=108) believed that the efficacy of generic medicines was the same as original brand medicines. In terms of quality, only 44% of the respondents (n=89) disagreed that generic medicines were of a lower quality. About one third (n=65, 32.2%) believed that generic medicines were cheaper because they were less efficacious. In terms of side effects, 44.5% of the respondents (n=90) believed that generic medicines had the same side effect profile as original brand medicines. Conclusions: The study finding showed that almost half of the respondents had negative belief in generic medicines. Similarly, many patients were not aware of the similarities and differences between generic and original brand medicines. Therefore, there is a need to provide patients with adequate information about generic medicines. PMID:25580171

Effects of hospital generic drug substitution on diabetes therapy

PubMed Central

Chen, Hui-Yin; Chang, Hui-Ru; Lang, Hui-Chu

2014-01-01

Objectives To evaluate the effects on physicians’ prescribing behavior and on the therapeutic outcome of non-insulin-dependent diabetes patients of substituting different generic brands of metformin. Methods We adopt a retrospective cohort study involving 280 type-2 diabetes patients who regularly used the outpatient services of one medical center and who had changed metformin brands five times between 2003 and 2008. The aim was to examine the effects of switching brands. The generalized estimating equation was used to determine whether drug brand switching affected patient glycated hemoglobin A1c (HbA1c) levels, their prescribed daily dose, or their adherence to medication with metformin. Results HbA1c levels increased from 7.91 to 8.34 throughout the study period, although it was found that brand switching did not adversely affect HbA1c levels after controlling for patient characteristics and the time course of the study. Furthermore, the prescribed daily dose of metformin was stable throughout the study period, and was approximately 0.8 of the defined daily dose. Finally, although adherence was significantly higher with the original metformin than with the four generic brands, patients still maintained high levels of adherence of >0.8. Conclusion Although switching between different brands of metformin slightly affected the prescribing behavior of the physicians, there was no unfavorable effect on patient HbA1c levels. Thus, the policy of substituting between different generic brands of metformin is a good cost-effective approach that does not adversely affect the quality of diabetes patient care. PMID:24511228

Encouraging the use of generic medicines: implications for transition economies.

PubMed

King, Derek R; Kanavos, Panos

2002-08-01

Generic drugs have a key role to play in the efficient allocation of financial resources for pharmaceutical medicines. Policies implemented in the countries with a high rate of generic drug use, such as Canada, Denmark, Germany, the Netherlands, the United Kingdom, and the United States, are reviewed, with consideration of the market structures that facilitate strong competition. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Their policy tools include the mix of supply-side measures and demand-side measures that are relevant for generic promotion and higher generic use. On the supply-side, key policy measures include generic drug marketing regulation that facilitates market entry soon after patent expiration, reference pricing, the pricing of branded originator products, and the degree of price competition in pharmaceutical markets. On the demand-side, measures typically encompass influencing prescribing and dispensing patterns as well as introducing a co-payment structure for consumers/patients that takes into consideration the difference in cost between branded and generic medicines. Quality of generic medicines is a pre-condition for all other measures discussed to take effect. The paper concludes by offering a list of policy options for decision-makers in Central and Eastern European economies in transition.

Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates

PubMed Central

Olszynski, Wojciech P.; Adachi, Jonathan D.; Davison, K. Shawn

2014-01-01

The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly (P < 0.05) faster for Apo-alendronate (26 ± 5.6 seconds) and Novo-alendronate (13 ± 1.1 seconds) as compared to brand alendronate (147 ± 50.5 seconds), brand alendronate plus vitamin D (378 ± 60.5 seconds), or brand risedronate (101 ± 20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies. PMID:25349772

Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates.

PubMed

Olszynski, Wojciech P; Adachi, Jonathan D; Davison, K Shawn

2014-01-01

The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly (P < 0.05) faster for Apo-alendronate (26 ± 5.6 seconds) and Novo-alendronate (13 ± 1.1 seconds) as compared to brand alendronate (147 ± 50.5 seconds), brand alendronate plus vitamin D (378 ± 60.5 seconds), or brand risedronate (101 ± 20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies.

The impact of price-cap regulations on market entry by generic pharmaceutical firms.

PubMed

Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

2017-04-01

In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

48 CFR 1910.004-70 - Brand name products or equal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Brand name products or... GOVERNORS ACQUISITION PLANNING SPECIFICATIONS, STANDARDS, AND OTHER PURCHASE DESCRIPTIONS 1910.004-70 Brand... below. (b) Citing brand name products. Brand name or equal purchase descriptions shall cite all brand...

27 CFR 5.34 - Brand names.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Brand names. 5.34 Section 5.34 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF... Spirits § 5.34 Brand names. (a) Misleading brand names. No label shall contain any brand name, which...

48 CFR 1910.004-72 - Solicitations, brand name or equal descriptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Solicitations, brand name... 1910.004-72 Solicitations, brand name or equal descriptions. (a) An entry substantially as follows... which a brand name or equal purchase description applies. Bidding on: Manufacturer's Name: Brand: No...

Electrophysiological correlates of brand names.

PubMed

Cheung, Mei-chun; Chan, Agnes S; Sze, Sophia L

2010-11-26

EEG coherence has been used extensively in the investigation of language processing of different words categories. In contrast, relatively less is known about EEG coherence pattern of processing brand names. The present study aimed to investigate EEG coherence pattern associated with brand names in English and Chinese. EEG coherence of 32 healthy normal participants during 4 reading conditions, including concrete English words, concrete Chinese characters, English brand names and their translated Chinese brand names, were computed and compared. Regardless whether it was in English or Chinese, brand names were generally associated with higher intrahemispheric beta coherence in both the left and right hemispheres than concrete words or characters. Compared to English brand names, Chinese brand names demonstrated increased interhemispheric theta coherence in the frontal and temporal cortical regions. These results suggest that brand names tend to be processed through semantic routes. Similar to proper names and nonwords, they are represented in the lexical systems of both hemispheres. In addition, English and Chinese brand names are processed similarly at the semantic level and the difference in EEG coherence patterns associated with English and Chinese brand names is more likely due to phonological and orthographic processing that are associated with English and Chinese, respectively. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Managing prescription drug costs: a case study.

PubMed

DuBois, R W; Feinberg, P E

1994-06-01

Pharmacy costs in most private insurance companies and public concerns have risen over the past several years. To address the problem of increased expenditures in its government employee pharmacy program, the State of New York sought bids from outside vendors to help it control pharmaceutical costs. The following is a case study of the tools the state employed in that effort. Over time, both prescription drug coverage and mental health and substance abuse benefits were carved out of the medical plan and are now provided under free-standing programs. In order to participate, an independent pharmacy must accept a discount of 10% off the average wholesale price of brand name drugs and 25% off the average generic price of generic drugs.

48 CFR 2811.104-70 - Brand-name or equal description.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Brand-name or equal... 2811.104-70 Brand-name or equal description. When a brand-name or equal description is used, the clause set forth in 2852.211-70, Brand-name or Equal, shall be inserted into the solicitation. ...

27 CFR 4.33 - Brand names.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Brand names. 4.33 Section... THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.33 Brand names. (a) General. The product shall bear a brand name, except that if not sold under a brand name...

When Medication Is Prescribed

MedlinePlus

... or combination of medications for the patient. Selective serotonin reuptake inhibitors (SSRIs): citalopram (brand name: Celexa) escitalopram ( ... brand names: Paxil, Pexeva) sertraline (brand name: Zoloft) Serotonin and norepinephrine reuptake inhibitors (SNRIs): venlafaxine (brand name: ...

The physical properties of generic latanoprost ophthalmic solutions are not identical.

PubMed

Kolko, Miriam; Koch Jensen, Peter

2017-06-01

To compare various characteristics of Xalatan ® and five generic latanoprost ophthalmic solutions. Drop size, volume, pH values, buffer capacity, viscosity, hardness of bottles and costs were determined. Drop sizes were measured in triplicates by micropipettes, and the number of drops counted in three separate bottles of each generic product was determined. pH values were measured in triplicates by a calibrated pH meter. Buffer capacity was exploited by titrating known quantities of strong base into 2.5 ml of each brand and interpolated to neutral pH. Kinematic viscosity was determined by linear regression of timed gravity flow from a vertical syringe through a 21-G cannula. The hardness of the bottles was evaluated by gradually increasing tension on a hook placed around each bottle until a drop was expelled reading the tension on an attached spring scale. Drop sizes and the number of drops in the bottles varied significantly between the generic drugs. The control value of pH in the brand version (Xalatan ® ) was markedly lower compared to the generic latanoprost products. Titration of Xalatan ® to neutrality required substantially more NaOH compared to the generic latanoprost products. Finally, the viscosity revealed a significant variability between brands. Remarkable differences were found in bottle shapes, bottle hardness and costs of the latanoprost generics. Generic latanoprost eye drops should not be considered identical to the original brand version as regards to drop size, volumes, pH values, buffer capacity, viscosity, hardness of bottles and costs. It is likely that these issues affect compliance and intraocular pressure (IOP)-lowering effect. Therefore, re-evaluation of the requirements for introducing generic eye drops seems reasonable. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

New Zealand patients' understanding of brand substitution and opinions on copayment options for choice of medicine brand.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2016-06-01

Objective The aim of the present study was to better understand the views and experiences of New Zealand patients on switching between brands of prescription medicines and on alternative funding options for the provision of medicines, including an increase in copayments. Methods A self-administered questionnaire was offered to selected patients through participating community pharmacies. Pharmacies were stratified according to level of deprivation of the community served before random selection and invitation for involvement in the study. Patient understanding of and rationale for brand substitution was assessed. Preference for different copayment options was elicited, together with demographic and other explanatory information. Results In all, 194 patient-completed questionnaires were returned. Some gaps in patient knowledge and understanding of brand changes were evident. Most respondents indicated a preference for the existing subsidy arrangements with little desire expressed for alternatives. Around half were willing to contribute towards paying for a choice of brand other than the subsidised brand; however, the maximum contribution nominated was disproportionately lower than real cost differences between originator brand and generics. Conclusion The findings of the present study suggest that although most patients have experienced brand changes without any problems occurring, a lack of knowledge about substitution does persist. There may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing to reinforce the benefits of the Pharmaceutical Management Agency (PHARMAC) purchasing model. What is known about the topic? Generic reference pricing is used as a mechanism to make savings to pharmaceutical budgets; however, reticence to the use of generic medicines persists. What does this paper add? Most New Zealand patients experience brand changes without any problems occurring; however, a lack of knowledge about substitution does persist. The dollar value patients indicate they would contribute for brand choice is lower than the true cost difference between brands. What are the implications for practitioners? Opportunities exist for healthcare professionals to reinforce generic policies and there may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing.

Greater first year effectiveness drives favorable cost-effectiveness of brand risedronate versus generic or brand alendronate: modeled Canadian analysis

PubMed Central

Papaioannou, A.; Thompson, M. F.; Pasquale, M. K.; Adachi, J. D.

2016-01-01

Summary The RisedronatE and ALendronate (REAL) study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data from real-world clinical practice. Using a published osteoporosis model, the researchers found risedronate to be cost-effective compared to generic or brand alendronate for the treatment of Canadian postmenopausal osteoporosis in patients aged 65 years or older. Introduction The REAL study provides robust data on the real-world performance of risedronate and alendronate. The study used these data to assess the cost-effectiveness of brand risedronate versus generic or brand alendronate for treatment of Canadian postmenopausal osteoporosis patients aged 65 years or older. Methods A previously published osteoporosis model was populated with Canadian cost and epidemiological data, and the estimated fracture risk was validated. Effectiveness data were derived from REAL and utility data from published sources. The incremental cost per quality-adjusted life-year (QALY) gained was estimated from a Canadian public payer perspective, and comprehensive sensitivity analyses were conducted. Results The base case analysis found fewer fractures and more QALYs in the risedronate cohort, providing an incremental cost per QALY gained of $3,877 for risedronate compared to generic alendronate. The results were most sensitive to treatment duration and effectiveness. Conclusions The REAL study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data taken from real-world clinical practice. The analysis supports the cost-effectiveness of risedronate compared to generic or brand alendronate and the use of risedronate for the treatment of osteoporotic Canadian women aged 65 years or older with a BMD T-score ≤−2.5. PMID:18008100

How much could be saved in Chinese hospitals in procurement of anti-hypertensives and anti-diabetics?

PubMed

Sun, Jing; Ren, Luo; Wirtz, Veronika

2016-09-01

Efficient use of government funding has been increasingly relevant for the success and sustainability of ongoing health-system reform in China; however, as there is no generic substitution policy, patients and basic health-insurance programs pay more for public-preferred brand originators. Such phenomenon is especially typical in public hospitals. The objective of this study is to estimate the potential cost savings in procurement by Chinese public hospitals when switching from brand originators of anti-hypertensive and anti-diabetic medications to their generic equivalents between 2012-2014. IMS Health volume and value consumption data (IMS China Hospitals Audit system 2012-2014) were used, which covered all Chinese hospitals with 100 beds and above. The top 60% IMS volume consumption of respective anti-hypertensive and anti-diabetic medication with unique dosage form and strength were included. The potential cost savings were calculated from a switch of brand originators with their generic equivalents on the Chinese and international market. An independent sample t-test was conducted to compare the difference of proportion of cost savings in value between the Chinese and international market. An average of 44% (US$44 million) and 87% (US$90 million) and a total of US$1.4 and 2.8 billion (2014 US$) could be saved from a switch from originator brand anti-hypertensives and anti-diabetics to domestically and internationally available generic equivalents, respectively. The differences of cost savings (in proportion) between domestic and international market were statistically significant (α = 0.005, p = 0.003, p = 0.002, p = 0.000). Expensive brand originators dominated the anti-hypertensive and anti-diabetic market in Chinese hospitals between 2012-2014. Preference of brand originators wastes a huge amount of health resources in China and these limited resources could have been used more efficiently. As one of the world's key generic suppliers, if China wants to use its health resource more efficiently on medicines, comprehensive measures are needed to address both demand-side (consumers' low trust in the quality of local generics) and supply-side barriers (health professionals' preference of brand originators).

How brand names are special: brands, words, and hemispheres.

PubMed

Gontijo, Possidonia F D; Rayman, Janice; Zhang, Shi; Zaidel, Eran

2002-09-01

Previous research has consistently shown differences between the processing of proper names and of common nouns, leading to the belief that proper names possess a special neuropsychological status. We investigate the category of brand names and suggest that brand names also have a special neuropsychological status, but one which is different from proper names. The findings suggest that the hemispheric lexical status of the brand names is mixed--they behave like words in some respects and like nonwords in others. Our study used familiar upper case brand names, common nouns, and two different types of nonwords ("weird" and "normal") differing in length, as stimuli in a lateralized lexical decision task (LDT). Common nouns, brand names, weird nonwords, and normal nonwords were recognized in that decreasing order of speed and accuracy. A right visual field (RVF) advantage was found for all four lexical types. Interestingly, brand names, similar to nonwords, were found to be less lateralized than common nouns, consistent with theories of category-specific lexical processing. Further, brand names were the only type of lexical items to show a capitalization effect: brand names were recognized faster when they were presented in upper case than in lower case. In addition, while string length affected the recognition of common nouns only in the left visual field (LVF) and the recognition of nonwords only in the RVF, brand names behaved like common nouns in exhibiting length effects only in the LVF. Copyright 2002 Elsevier Science (USA)

A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide®) to the innovator brand in critically ill patients.

PubMed

Mer, Mervyn; Snyman, Jacques Rene; van Rensburg, Constance Elizabeth Jansen; van Tonder, Jacob John; Laurens, Ilze

2016-01-01

Clinicians' skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide ® ) and the leading innovator brand (Meronem ® ) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety. Patients from different high care and intensive care units were recruited for observation when prescribed either of the meropenem brands under investigation. Blood samples were collected over 6 hours after a 30 minute infusion of the different brands. Meropenem concentration curves were established against United States Pharmacopeia standard meropenem (Sigma-Aldrich) by using standard laboratory techniques for culture of Klebsiella pneumoniae. Patients' plasma samples were tested ex vivo, using a disc diffusion assay, to confirm antimicrobial activity and estimate plasma concentrations of the two brands. Both brands of meropenem demonstrated similar curves in donor plasma when concentrations in vials were confirmed. Patient-specific serum concentrations were determined from zones of inhibition against a standard laboratory Klebsiella strain ex vivo, confirming at least similar in vivo concentrations as the concentration curves (90% confidence interval) overlapped; however, the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem. This observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on registration status as well as bioassay results, demonstrating sufficient overlap for clinical comfort. The slightly higher observed comparator meropenem concentration (4%) is still clinically acceptable due to the large therapeutic index and should ally fears of inferiority.

Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs.

PubMed

Cheng, Ning; Rahman, Md Motiur; Alatawi, Yasser; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, C David; Hansen, Richard A

2018-04-01

Several different types of drugs acting on the central nervous system (CNS) have previously been associated with an increased risk of suicide and suicidal ideation (broadly referred to as suicide). However, a differential association between brand and generic CNS drugs and suicide has not been reported. This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data. Selected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study. Disproportionality analyses with reporting odds ratios and 95% confidence intervals (CIs) were used in the FAERS analyses to quantify the association between each drug and reported suicide. For the cohort studies, Cox proportional hazards models were used, controlling for demographic and clinical characteristics as well as the background risk of suicide in the insured population. The FAERS analyses found significantly lower suicide reporting rates for brands compared with generics for all four studied products (Breslow-Day P < 0.05). In the claims- and EHR-based cohort study, the adjusted hazard ratio (HR) was statistically significant only for sertraline (HR 0.58; 95% CI 0.38-0.88). Suicide reporting rates were disproportionately larger for generic than for brand CNS drugs in FAERS and adjusted retrospective cohort analyses remained significant only for sertraline. However, even for sertraline, temporal confounding related to the close proximity of black box warnings and generic availability is possible. Additional analyses in larger data sources with additional drugs are needed.

Measuring Access to Medicines: A Survey of Prices, Availability and Affordability in Shaanxi Province of China

PubMed Central

Jiang, Minghuan; Yang, Shimin; Yan, Kangkang; Liu, Jun; Zhao, Jun; Fang, Yu

2013-01-01

Objective To measure the prices and availability of selected medicines in Shaanxi Province after the implementation of new healthcare reform in 2009. Methods Data on the prices and availability of 47 medicines were collected from 50 public and 36 private sector medicine outlets in six regions of Shaanxi Province, Western China using a standardized methodology developed by the World Health Organization and Health Action International from September to October 2010. Medicine prices were compared with international reference prices to obtain a median price ratio. Affordability was measured as the number of days’ wages required for the lowest-paid unskilled government worker to purchase standard treatments for common conditions. Findings The mean availabilities of originator brands and lowest-priced generics were 8.9% and 26.5% in the public sector, and 18.1% and 43.6% in the private sector, respectively. The public sector procured generics and originator brands at median price ratios of 0.75 and 8.49, respectively, while patients paid 0.97 and 10.16. Final patient prices for lowest-priced generics and originator brands in the private sector were about 1.53 and 8.36 times their international retail prices, respectively. Public sector vendors applied high markups of 30.4% to generics, and 19.6% to originator brands. In the private sector, originator brands cost 390.7% more, on average, than their generic equivalents. Generic medicines were priced 17.3% higher in the private sector than the public sector. The lowest-paid government worker would need 0.1 day’s wages to purchase captopril for lowest-priced generics from private sector, while 6.6 days’ wages for losartan. For originator brands, the costs rise to 1.2 days’ wages for salbutamol inhaler and 15.6 days’ wages for omeprazole. Conclusions The prices, availability and affordability of medicines in China should be improved to ensure equitable access to basic medical treatments, especially for the poor. This requires multi-faceted interventions, as well as the review and refocusing of policies, regulations and educational interventions. PMID:23936471

Measuring access to medicines: a survey of prices, availability and affordability in Shaanxi province of China.

PubMed

Jiang, Minghuan; Yang, Shimin; Yan, Kangkang; Liu, Jun; Zhao, Jun; Fang, Yu

2013-01-01

To measure the prices and availability of selected medicines in Shaanxi Province after the implementation of new healthcare reform in 2009. Data on the prices and availability of 47 medicines were collected from 50 public and 36 private sector medicine outlets in six regions of Shaanxi Province, Western China using a standardized methodology developed by the World Health Organization and Health Action International from September to October 2010. Medicine prices were compared with international reference prices to obtain a median price ratio. Affordability was measured as the number of days' wages required for the lowest-paid unskilled government worker to purchase standard treatments for common conditions. The mean availabilities of originator brands and lowest-priced generics were 8.9% and 26.5% in the public sector, and 18.1% and 43.6% in the private sector, respectively. The public sector procured generics and originator brands at median price ratios of 0.75 and 8.49, respectively, while patients paid 0.97 and 10.16. Final patient prices for lowest-priced generics and originator brands in the private sector were about 1.53 and 8.36 times their international retail prices, respectively. Public sector vendors applied high markups of 30.4% to generics, and 19.6% to originator brands. In the private sector, originator brands cost 390.7% more, on average, than their generic equivalents. Generic medicines were priced 17.3% higher in the private sector than the public sector. The lowest-paid government worker would need 0.1 day's wages to purchase captopril for lowest-priced generics from private sector, while 6.6 days' wages for losartan. For originator brands, the costs rise to 1.2 days' wages for salbutamol inhaler and 15.6 days' wages for omeprazole. The prices, availability and affordability of medicines in China should be improved to ensure equitable access to basic medical treatments, especially for the poor. This requires multi-faceted interventions, as well as the review and refocusing of policies, regulations and educational interventions.

High prices for generics in Australia - more competition might help.

PubMed

Bulfone, Liliana

2009-05-01

It is commonly believed that dispensed prices of medicines in Australia are substantially lower than those in other developed countries, particularly the US. This article reports the results of an analysis comparing dispensed prices for the most commonly prescribed and the highest cost items in Australia with dispensed prices in the US. Although a large majority of items are less expensive in Australia than in the US, Australian prices are higher for a substantial number of products, particularly generic drugs. This article examines various policies affecting the pricing of generics in Australia. It is postulated that the main cause for higher prices for a substantial number of generic products is the lack of price competition. This results from government policy which ensures that a price reduction by one company is communicated immediately to all competitors in that market along with an invitation to match the reduced price. The dominant strategy for all suppliers is to only reduce their price in response to a reduction in price by a competitor. The result is a lack of differentiation in pricing across brands of a medicine on the Schedule of Pharmaceutical Benefits. The government could improve the structure of the generics market and encourage greater competition by ceasing to disclose competitor firms' offers to other competitors. The government could conduct pricing reviews of each generic product relatively infrequently (eg, only once annually or every 18 months). At the time of the pricing review, the government would request confidential offers on price for a generic from all players in the market. Brands should then all be listed under the Pharmaceutical Benefits Scheme (PBS) at the offered price. Prices offered by the individual supplier would apply until the next pricing review. The PBS would continue to subsidise up to the price of the lowest priced brand, with brand premiums applying to all brands priced higher than the benchmark price. Such an approach would provide opportunity for players in the market to capture market share by being the lowest priced brand.

Economic impact of therapeutic substitution of a brand selective serotonin reuptake inhibitor with an alternative generic selective serotonin reuptake inhibitor in patients with major depressive disorder.

PubMed

Wu, Eric Q; Yu, Andrew P; Lauzon, Veronique; Ramakrishnan, Karthik; Marynchenko, Maryna; Ben-Hamadi, Rym; Blum, Steven; Erder, M Haim

2011-04-01

To reduce pharmacy costs, managed care organizations encourage therapeutic substitution from brand to a generic product. However, little is known about whether these cost-containment strategies can also potentially lower total expenditures for payers in treatment of major depressive disorder (MDD). To compare economic outcomes of patients with MDD who were switched from a brand selective serotonin reuptake inhibitor (SSRI) to an alternative generic SSRI for nonmedical reasons versus patients who continued on the brand SSRI. Adult MDD patients in the Ingenix Impact Database (2003-2007) were considered "switchers" if they received treatment with a brand SSRI and were later switched to an alternative generic SSRI for nonmedical reasons. Patients who remained on the brand SSRI (nonswitchers) were matched 1:1 with switchers. All-cause, mental health-related, and MDD-related rates of hospitalizations/emergency department (ED) visits and costs over 6 months were compared both descriptively and by using adjusted regression models. A subgroup analysis on patients who were switched from escitalopram (Lexapro) to an alternative generic SSRI was also performed. The study included 4449 matched pairs. Compared with nonswitchers, switchers had higher risk of all-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.15, 1.34, and 1.54, respectively; all p < 0.01) and higher risk-adjusted mental health-related and MDD-related medical costs ($219 and $222, respectively; both p < 0.05). Subgroup analysis on escitalopram showed similar results; switchers experienced higher risk of any-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.21, 1.41, and 1.53, respectively; all p < 0.01) and higher risk-adjusted MDD-related medical costs ($151; p < 0.05). Compared with patients who continued on their patented SSRIs, patients who switched to a generic SSRI incurred more resource use of hospitalizations/ED visits and higher MDD-related health-care costs. The effects of therapeutic substitution should be carefully examined, because use of generic alternatives may not be a cost-saving strategy when total health-care costs are considered.

Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use.

PubMed

Shrank, William H; Stedman, Margaret; Ettner, Susan L; DeLapp, Dee; Dirstine, June; Brookhart, M Alan; Fischer, Michael A; Avorn, Jerry; Asch, Steven M

2007-09-01

Increased use of generic medications conserves insurer and patient financial resources and may increase patient adherence. The objective of the study is to evaluate whether physician, patient, pharmacy benefit design, or pharmacy characteristics influence the likelihood that patients will use generic drugs Observational analysis of 2001-2003 pharmacy claims from a large health plan in the Western United States. We evaluated claims for 5,399 patients who filled a new prescription in at least 1 of 5 classes of chronic medications with generic alternatives. We identified patients initiated on generic drugs and those started on branded medications who switched to generic drugs in the subsequent year. We used generalized estimating equations to perform separate analyses assessing the relationship between independent variables and the probability that patients were initiated on or switched to generic drugs. Of the 5,399 new prescriptions filled, 1,262 (23.4%) were generics. Of those initiated on branded medications, 606 (14.9%) switched to a generic drug in the same class in the subsequent year. After regression adjustment, patients residing in high-income zip codes were more likely to initiate treatment with a generic than patients in low-income regions (RR = 1.29; 95% C.I. 1.04-1.60); medical subspecialists (RR = 0.82; 0.69-0.95) and obstetrician/gynecologists (RR = 0.81; 0.69-0.98) were less likely than generalist physicians to initiate generics. Pharmacy benefit design and pharmacy type were not associated with initiation of generic medications. However, patients were over 2.5 times more likely to switch from branded to generic medications if they were enrolled in 3-tier pharmacy plans (95% C.I. 1.12-6.09), and patients who used mail-order pharmacies were 60% more likely to switch to a generic (95% C.I. 1.18-2.30) after initiating treatment with a branded drug. Physician and patient factors have an important influence on generic drug initiation, with the patients who live in the poorest zip codes paradoxically receiving generic drugs least often. While tiered pharmacy benefit designs and mail-order pharmacies helped steer patients towards generic medications once the first prescription has been filled, they had little effect on initial prescriptions. Providing patients and physicians with information about generic alternatives may reduce costs and lead to more equitable care.

Exploring pharmacists' opinions regarding PHARMAC's interventions in promoting brand changes.

PubMed

Babar, Z U; Polwin, A; Kan, S W; Amerasinghe, N; McCarthy, S; Rasheed, F; Stewart, J; Lessing, C; Ragupathy, R; Scahill, S L

2015-01-01

In New Zealand, the use of generic medicines is advocated by the Pharmaceutical Management Agency of New Zealand (PHARMAC). Among other interventions, PHARMAC uses educational awareness campaigns to educate pharmacists to promote the uptake of generic medicines. However, the opinion of pharmacists regarding these interventions has not yet been evaluated. The objective of this study was to explore pharmacists' opinions regarding PHARMAC's interventions in promoting medicine brand changes. A cross-sectional study design was employed to explore pharmacists' opinions regarding brand changes. A questionnaire was sent to 500 randomly selected pharmacists in New Zealand. In second component of the study, five community pharmacies in the Auckland region were selected through convenience sampling, and a semi-structured interview was conducted with a pharmacist in each site. One-hundred and eighty seven questionnaires were returned and analyzed (response rate of 37.4%). Sixty-eight percent of pharmacists supported brand changes and 98.4% mentioned that PHARMAC is responsible for informing them of brand changes. Over half (51.3%) of pharmacists found the current interventions effective, and 39.6% were satisfied with the current brand change information provided by PHARMAC. The majority (94.7%) of pharmacists currently receive faxed information but many indicated (70.8%) that they prefer email notifications. Cilazapril was considered the least difficult medicine to substitute in the past 10 years and omeprazole the most difficult. Patient acceptance and claims about effectiveness were the main factors in determining the difficulty of brand substitution. Fewer than half of the respondents felt that interventions were implemented with enough preparation time for a brand change. The ideal lead-in time was in the range of three to six months. Pharmacists expressed a number of concerns about brand changes such as the frequency at which they occur and the lack of generic stock availability when a brand change occurs. Over one-third of respondents were satisfied with brand change information provided by PHARMAC. Cilazapril was the least difficult medicine to substitute, while omeprazole and salbutamol changes were the most difficult. Claims about effectiveness, quality and side effects were the main factors identified as barriers to generic substitution. Copyright © 2015 Elsevier Inc. All rights reserved.

Predictors of generic substitution: The role of psychological, sociodemographic, and contextual factors.

PubMed

Drozdowska, Aleksandra; Hermanowski, Tomasz

2016-01-01

Escalating pharmaceutical costs have become a global challenge for both governments and patients. Generic substitution is one way of decreasing these costs. The aim of this study was to investigate factors associated with patients' choice between generic drugs and innovator drugs. The survey was conducted in June 2013, 1000 people from across Poland were chosen as a representative population sample. The outcome (a preference for generics/a preference for innovator pharmaceuticals/no preference) was modeled by multinomial logistic regression, adjusted for several variables describing patients' sensitivity to selected generic features (price, brand, and country of origin), to third-party opinions about generics (information on generics in the mass media, opinions of health professionals (i.e. physicians, pharmacists), relatives/friends), as well as patients' personal experiences and income per household. The results supported the predictive capacity of most independent variables (except for patient sensitivity to the country of origin and to the information on generics in the mass media), denoting patients' preferences toward generic substitution. Patient sensitivity to recommendations by physicians, generic brand, and household income were the strongest predictors of the choice between generic and innovator pharmaceuticals (P < 0.001). The probability of choosing generics over innovator drugs was significantly higher among respondents with the lowest income levels, in those who were indifferent to generic brand or their physician's opinion, as well as in respondents who were sensitive to recommendations by pharmacists or attached a greater value to a past experience with generics (their own experience or that of relatives/friends). In consideration of the foregoing, awareness-raising campaigns may be recommended, supported by a variety of systemic solutions and tools to encourage generic substitution. Copyright © 2016 Elsevier Inc. All rights reserved.

[Generic drugs in the treatment of epilepsy].

PubMed

González de Dios, J; Ochoa-Sangrador, C; Sempere, A P

We discuss some controversial aspects with prescription of generic drugs (GD) and the problems concerning bioequivalence, mainly in the case of drugs with non-linear pharmacokinetics and/or narrow therapeutic rank, like the antiepileptic drugs (AED). There is considerable debate about GD in the treatment of epilepsy, with clearly advantages (cost saving) and disadvantages (loss of seizure control or drug toxicity) in prescribing generics anticonvulsants. We make a systematic review of the literature in primary (PubMed) and secondary (Tripdatabase and Cochrane Library) bibliographic databases in relation to GD and AED. The main information is about classical AED (phenytoin, carbamazepine, valproic acid and primidone) and we don't found studies in this area about the new AED. The level of evidence is, generally, weak, based on case-series and expert opinion without explicit critical appraisal (except in phenytoin with level of evidence moderate, based on some analytical studies). In Spain, at this moment, there are only two generic AED, one-classical (carbamazepine) and one-new (gabapentin). The American Academy of Neurology and Epilepsy Foundation maintains that the individual and physician should be notified and give their consent before a switch in antiepileptic medications is made, whether it involves generic substitution for brand name products, or generic to generic substitutions.

The impact on health outcome measures of switching to generic medicines consequent to reference pricing: the case of olanzapine in New Zealand.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter B

2015-06-01

New Zealand's Pharmaceutical Management Agency (PHARMAC) manages the list of medicines available for prescribing with government subsidy, within a fixed annual medicines budget. PHARMAC achieves this through a mix of pricing strategies including reference pricing. In 2011, PHARMAC applied generic reference pricing to olanzapine tablets. This study sought to evaluate change in outcome measures of patients switching from originator to generic olanzapine consequent to the introduction of the policy. A retrospective study using national health data collections was conducted. Outcome measures included medicines indicators (change in dosage, concomitant therapy and treatment cessation), health care service indicators (use of emergency departments, hospitals and specialist services), surveillance reports of adverse events, and mortality. Subsequent to the removal of funding for originator brand olanzapine tablets, 99.7% of patients meeting the inclusion criteria switched to using generic olanzapine. Limited case reports of suspected therapeutic loss were received in the study time period. No increase in use of additional oral or injectable antipsychotic medication was observed after switching, nor any increase in other unique, non-antipsychotic prescription items. However, a high incidence of multiple switching between available brands was found. No net impact of switching brands on health service utilisation or mortality was found. The study shows that a switch can be made safely from originator olanzapine to a generic brand, and suggests that switching to generics should generally be viewed more positively. Generic reference pricing achieves considerable savings and, as a pricing policy, could be applied more widely.

48 CFR 1852.210-70 - Brand name or equal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Brand name or equal. 1852... 1852.210-70 Brand name or equal. As prescribed in 1810.011-70(a), insert the following provision: Brand Name or Equal (DEC 1988) (a) As used in this provision, “brand name” means identification of products...

48 CFR 852.211-73 - Brand name or equal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Brand name or equal. 852... Brand name or equal. As prescribed in 811.104-71, insert the following clause: Brand Name or Equal (JAN 2008) (Note: As used in this clause, the term “brand name” includes identification of products by make...

27 CFR 19.643 - Brand name, kind, alcohol content, and State of distillation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Brand name, kind, alcohol... Bottle and Label Requirements Bottle Label Requirements § 19.643 Brand name, kind, alcohol content, and State of distillation. (a) Brand name and kind. The label of distilled spirits shall state the brand...

Therapeutic equivalence of antipsychotics and antidepressants - A systematic review.

PubMed

Cessak, Grzegorz; Rokita, Konrad; Dąbrowska, Marta; Sejbuk-Rozbicka, Katarzyna; Zaremba, Anna; Mirowska-Guzel, Dagmara; Bałkowiec-Iskra, Ewa

2016-04-01

The number of newly approved generic psychotropic drugs increases every year and, in many countries, their sales exceed the sales of brand-name counterparts. In order for any generic drug to receive an approval of regulatory authorities, its bioequivalence with the corresponding reference product must be demonstrated. Moreover, generic drugs must meet the same quality standards as reference drugs. However, many psychiatrists express concerns about use of generic drugs. We carried out a systematic analysis of the relevant literature indexed in PubMed and Cochrane databases. The MeSH term "generic" was combined with terms describing antipsychotic and antidepressive drugs, including their pharmaceutical names and relevant mental disorders. All 26 articles including either clinical studies or case reports have been qualified for a detailed analysis. No cases describing switches between two generics were found. Therapeutic equivalence studies evaluating antipsychotics included clozapine, olanzapine, and risperidone. The clinical status was judged to have worsened in 15.7% patients treated with clozapine. The number of relapses before and after the switch was not significantly different in patients treated with olanzapine. Two case reports showed clinical state deterioration after switch to generic risperidone. The clinical outcome after conversion to a generic antidepressant was evaluated only in one retrospective study. That study analyzed the outcomes of treatment with citalopram and revealed mental state deterioration in 11.6% of patients. Only single reports describe cases of impaired efficacy or adverse events after the switch to a generic antidepressant, including fluoxetine, mirtazapine, and venlafaxine. No cases of suicidal attempt after the switch were reported. Although the overall number of described cases is rather modest, health professionals should be aware of possible changes in the therapeutic effectiveness after changing to a generic medicine. Copyright © 2015 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Analysis of spontaneous inquiries about suspected adverse drug reactions posted by the general public on the electronic Japanese bulletin board "Yahoo! Japan Chiebukuro".

PubMed

Dobashi, Akira; Kurata, Kaori; Okazaki, Mitsuhiro; Nishizawa, Mari

2016-01-01

Spontaneous inquiries about the development of adverse drug reactions (ADRs) to medicines can be extracted based on the questions posted by the general public on the electronic Japanese bulletin board "Yahoo! Japan Chiebukuro". Our aim was to clarify the characteristics related to people's descriptions of suspected ADRs and determine the reasons for submitting a spontaneous inquiry. Fifty brand names of medicines used for inquiry extraction were chosen by selecting 35 pharmaceutical products, based on the generic names that had the highest sales in Japan. Questions containing both the brand name of one of these medicines and the term "Fukusayō" (ADR in Japanese) that were posted from July 2004 to June 2009 were extracted from the site. Among 1,419 questions extracted, 614 questions had at least one identifiable brand name of a suspected medicine, an ADR description, and the extent to which the ADR appeared to be caused by the suspected medicine(s). Among these 614 questions, 589 described in detail the symptoms/signs that the inquirers themselves or their families had experienced as ADRs. The highest number of questions was found for Paxil (525). Posts asking whether the symptoms being experienced were due to an ADR accounted for the highest number of questions. In most cases, the inquirer suspected that a single medicine led to an ADR and was seeking advice from others taking the same medicine. Our examination of spontaneous inquiries showed that people have sufficient knowledge to adequately report potential ADRs in terms of their symptoms, suspected medicines, and the disease for which the medicine was used. However, they often did not describe the start time when the ADR appeared or when the suspected medicine was started.

27 CFR 20.134 - Labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... container identifying (1) the name, trade name or brand name of the article, and (2) the name and address... identifying the name, trade name or brand name of the article. If the volume of the article in the container..., trade name or brand name of the article and the names and addresses (city and State) of the manufacturer...

Endogenous versus exogenous generic reference pricing for pharmaceuticals.

PubMed

Antoñanzas, F; Juárez-Castelló, C A; Rodríguez-Ibeas, R

2017-12-01

In this paper we carry out a vertical differentiation duopoly model applied to pharmaceutical markets to analyze how endogenous and exogenous generic reference pricing influence competition between generic and branded drugs producers. Unlike the literature, we characterize for the exogenous case the equilibrium prices for all feasible relevant reference prices. Competition is enhanced after the introduction of a reference pricing system. We also compare both reference pricing systems on welfare grounds, assuming two different objective functions for health authorities: (i) standard social welfare and (ii) gross consumer surplus net of total pharmaceutical expenditures. We show that regardless of the objective function, health authorities will never choose endogenous reference pricing. When health authorities are paternalistic, the exogenous reference price that maximizes standard social welfare is such that the price of the generic drug is the reference price while the price of the branded drug is higher than the reference price. When health authorities are not paternalistic, the optimal exogenous reference price is such that the price of the branded drug is the reference price while the price of the generic drug is lower than the reference price.

The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries between 2001 and 2011: A Descriptive Time Series Analysis

PubMed Central

Kaplan, Warren A.; Wirtz, Veronika J.; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted. PMID:24098644

The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

PubMed

Kaplan, Warren A; Wirtz, Veronika J; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

Assessing bioequivalence of generic antiepilepsy drugs.

PubMed

Krauss, Gregory L; Caffo, Brian; Chang, Yi-Ting; Hendrix, Craig W; Chuang, Kelly

2011-08-01

Patients with epilepsy are often concerned that switching between brand-name and generic formulations of antiepilepsy drugs (AEDs) may cause clinically significant changes in plasma drug concentrations. We assessed bioequivalence (BE) studies for approved generic AEDs to evaluate US Food and Drug Administration claims that: (1) generic AEDs are accurate copies of reference formulations; (2) delivery of reference formulations may be as variable as generic AEDs and so provide no increased benefit; and (3) switches between generic AED formulations are safe and effective. We determined differences in 90% confidence interval limits for total drug exposure (AUC(0-t) ) and peak concentration (Cmax) ratios of generic and reference formulations during fasting and fed BE studies. We simulated BE between generic formulations after adjusting for reference values. AUC(0-t) values of approved reference and generic formulations differed by <15% in 99% of BE studies; Cmax differed by <15% in 89% of studies. Food affected variability of Cmax but not AUC(0-t) . Intersubject variability in Cmax and AUC(0-t) was small and similar for reference and generic products. In simulated switches between 595 pairs of generic AED formulations, estimated AUC(0-t) differed by >15% for 17% of pairs; estimated Cmax differed by >15% for 39%. AEDs with low bioavailability and solubility (eg, oxcarbazepine) had the greatest variability in BE. Most generic AED products provide total drug delivery (AUC) similar to reference products; differences in peak concentrations between formulations are more common. Switches between generic AED products may cause greater changes in plasma drug concentrations than generic substitutions of reference products. Copyright © 2011 American Neurological Association.

Impact of cost sharing on prescription drugs used by Medicare beneficiaries.

PubMed

Goedken, Amber M; Urmie, Julie M; Farris, Karen B; Doucette, William R

2010-06-01

Incentive-based prescription drug cost sharing can encourage seniors to use generic medications. Little information exists about prescription drug cost sharing and generic use in employer-sponsored plans after the implementation of Medicare Part D. To compare prescription drug cost sharing across prescription insurance type for Medicare beneficiaries after Medicare Part D, to assess the impact of that cost sharing on the number of medications used, and to examine how generic utilization rates differ before and after Medicare Part D and across the type of insurance. This longitudinal study of Medicare beneficiaries aged 65 years and older used Web-based surveys administered in 2005 and 2007 by Harris Interactive((R)) to collect information on prescription drug coverage and medication use. Co-payment plans were categorized as low, medium, or high co-payment plans. Multiple regression was used to assess the impact of co-payment rank on the number of prescription drugs. t-Tests and analysis of variance were used to compare generic use over time and between coverage types. One thousand two hundred twenty and 1024 respondents completed the baseline and follow-up surveys, respectively. Among 3-tier co-payment plans, brand drug co-payments were higher for Part D plans ($26 for preferred brand and $55 for nonpreferred brand) than employer-based plans ($20 for preferred brand and $39 for nonpreferred brand). Co-payment was not a significant predictor for the number of prescription drugs. Generic use was lowest among beneficiaries in employer plans both before and after Part D. In 2007, generic use among beneficiaries with Part D was not significantly different from the generic use for beneficiaries with no drug coverage. Medicare beneficiaries in Part D had higher cost sharing amounts than those with employer coverage, but higher cost sharing was not significantly linked to lower prescription use. Generic use for Part D beneficiaries was higher than that for beneficiaries with employer coverage but the same as that for beneficiaries without drug coverage. Copyright 2010 Elsevier Inc. All rights reserved.

Migraines

MedlinePlus

... name: Excedrin Migraine); ibuprofen (one brand name: Motrin); naproxen (brand name: Aleve); and ketoprofen (brand name: Orudis ... and leaf and root extracts of the butterbur plant. What else can I do to prevent migraines? ...

75 FR 25271 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

.... One provision restricts the use of a trade or brand name of a nontobacco product as the trade or brand... manufacturers may not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product unless the trade or brand name was on both the tobacco product and a...

Impending flop for brand antiretrovirals in the emerging markets?

PubMed

Daniele, Dionisio; Daniela, Messeri

2008-01-01

Forecasts from Country choices, South-South partnerships and Clinton Foundation-UNITAID coalition show that present policies for brand ARVs are at the risk of flop in emerging South markets such as India, China, Thailand and Brazil.The dynamics explored in this article highlight the risks the originator companies are running in the emerging markets, along with their interest in direct agreements with the generic industry for the manufacturing and marketing of ARVs.Resulting information here would suggest the brand enterprises:To look for fast registration of their ARVs by regulatory authorities in all countries enlisted for differential pricing.To secure all formulations differentiated prices.To align with the Clinton-UNITAID prices for the corresponding generics.To pursue flexible negotiations with the generic companies to secure both counterparts long-term advantages.

Brand name changes help health care providers win market recognition.

PubMed

Keesling, G

1993-01-01

As the healthcare industry continues to recognize the strategic implications of branding, more providers will undertake an identity change to better position themselves in competitive markets. The paper examines specific healthcare branding decisions, the reasons prompting brand name decisions and the marketing implications for a change in brand name.

48 CFR 411.170 - Brand name or equal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Brand name or equal. 411... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.170 Brand name or equal. (a) A “brand name or equal” purchase description shall include the following type of...

48 CFR 811.104-70 - Brand name or equal purchase descriptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Brand name or equal... Requirements Documents 811.104-70 Brand name or equal purchase descriptions. (a) The specification writer may use purchase descriptions that contain references to one or more brand name products only in...

77 FR 3636 - Federal Acquisition Regulation; Brand-Name Specifications; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

... 26] RIN 9000-AK55 Federal Acquisition Regulation; Brand-Name Specifications; Correction AGENCY... Regulation (FAR) to implement the Office of Management and Budget memoranda on brand-name specifications, FAR Case 2005-037, Brand-Name Specifications, which published in the Federal Register at 77 FR 189 on...

7 CFR 1485.12 - Participation eligibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... value of resources provided by CCC for such generic promotion; or (ii) In the case of brand promotion, at least 50 percent of the total cost of such brand promotions. (b) To participate in the EIP/MAP, an entity: (1) Shall be a U.S. commercial entity that either owns the brand(s) of the agricultural commodity...

RxTerms - a drug interface terminology derived from RxNorm.

PubMed

Fung, Kin Wah; McDonald, Clement; Bray, Bruce E

2008-11-06

A good interface terminology is an essential component of any Computerized Provider Order Entry system. RxTerms is a drug interface terminology derived from RxNorm. By reorganizing the drug information into two dimensions as prescribers do when writing prescriptions and by eliminating drug names that are less likely to be needed in a prescribing environment, RxTerms helps the user to efficiently enter complete prescription orders. Preliminary evaluation of RxTerms using a list of most commonly prescribed drugs showed that its coverage was very good (99% for both generic and branded drug names). There was significant efficiency gain compared to using the unprocessed RxNorm names. RxTerms fills the gap for a free, up-to-date drug interface terminology that is linked to RxNorm, the U.S. designated standard for clinical drugs.

49 CFR 574.7 - Information requirements-new tire manufacturers, new tire brand name owners.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Information requirements-new tire manufacturers, new tire brand name owners. 574.7 Section 574.7 Transportation Other Regulations Relating to..., new tire brand name owners. (a)(1) Each new tire manufacturer and each new tire brand name owner...

48 CFR 11.104 - Use of brand name or equal purchase descriptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Use of brand name or equal....104 Use of brand name or equal purchase descriptions. (a) While the use of performance specifications is preferred to encourage offerors to propose innovative solutions, the use of brand name or equal...

48 CFR 452.211-70 - Brand Name or Equal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Brand Name or Equal. 452... FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Texts of Provisions and Clauses 452.211-70 Brand Name or Equal. As prescribed in 411.171, insert the following provision: Brand Name or Equal (NOV 1996...

48 CFR 2852.211-70 - Brand-name or equal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Brand-name or equal. 2852... Forms SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2852.211-70 Brand-name or equal. As prescribed in 2811.104-70, insert the following clause: Brand-Name or Equal (JAN 1985...

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.

PubMed

Park-Wyllie, Laura; van Stralen, Judy; Castillon, Genaro; Sherman, Stephen E; Almagor, Doron

2017-10-01

Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products. Reporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93-22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and premature loss of efficacy (shorter duration of action) was described in 98 cases (42.6%) and occurred primarily in the afternoon. Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 51 cases (22.2%). The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Does bargaining affect Medicare prescription drug plan reimbursements to independent pharmacies?

PubMed

Tang, Yuexin; Xie, Yang; Urmie, Julie M; Doucette, William R

2011-01-01

To examine how pharmacy bargaining activities affect reimbursement rates in Medicare Part D prescription drug plan (PDP) contracts, controlling for pharmacy quality attributes, market structures, and area socioeconomic status. Cross-sectional study. Six Medicare regions throughout the United States between October and December 2009. Random sample of 1,650 independent pharmacies; 321 returned surveys containing sufficient responses for analysis. Pharmacies were surveyed regarding PDP reimbursement rates, costs, and cash prices of two popular prescription drugs (atorvastatin calcium [Lipitor-Pfizer] and lisinopril, 1-month supply of a common strength), as well as pharmacy bargaining activities and quality attributes. Data also were used from the National Council for Prescription Drug Programs pharmacy database, the 2000 U. S. Census, and the 2006 Economic Census on local market structures and area socio-economic status. PDP reimbursement rates. For the brand-name drug atorvastatin calcium, the PDP reimbursement was positively related to a pharmacy's request for a contract change (β = 0.887, P < 0.05), whereas other bargaining activities were not significantly related to PDP reimbursement. However, for the generic drug lisinopril, no bargaining activities were found to be significantly related to the PDP reimbursement. Pharmacy request for a contract change was associated with higher reimbursement rates for the brand-name drug atorvastatin calcium in PDP contracts, after controlling for pharmacy quality attributes, local market structures, and area socioeconomic status; this finding likely applies to other brand-name drugs because of the structure of the contracts. Our results suggest that independent pharmacies are more likely to acquire higher reimbursement rates by engaging in active bargaining with third-party payers.

Bioequivalence of generic and branded amoxicillin capsules in healthy human volunteers

PubMed Central

Pathak, Priyanka; Pandit, Vijaya A.; Dhande, Priti P.

2017-01-01

CONTEXT: The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic inequivalence exist. AIM: This study was planned to ascertain whether bioequivalence of branded and generic amoxicillin capsule is comparable. SETTINGS AND DESIGN: An open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover oral bioequivalence study was conducted in 12 healthy, adult human subjects under fasting condition. MATERIALS AND METHODS: Serum samples, collected at 8 time points, were analyzed by a validated ultraviolet spectrophotometer method. Pharmacokinetic (PK) parameters such as area under the curve (AUC)0–t, AUC0–∞, Cmax, and Tmax were determined along with time above minimum inhibitory concentration (MIC). STATISTICAL ANALYSIS USED: The log-transformed PK parameters (Cmax, AUC0–t, AUC0–∞) were analyzed using a Two One-Sided Test ANOVA in SAS for each parameter. Tmax and MIC were analyzed by Wilcoxon rank-sum test in GraphPad Prism. RESULTS: Geometric mean ratio of Cmax fell within bioequivalence criteria. The upper and lower confidence limits of both AUC0–t and AUC0–∞ geometric mean ratio fell below bioequivalence criteria. Time above MIC of generic preparation was significantly lower than that of branded version. CONCLUSIONS: The generic capsule was not bioequivalent to the branded amoxicillin capsule. PMID:28706331

A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide®) to the innovator brand in critically ill patients

PubMed Central

Mer, Mervyn; Snyman, Jacques Rene; van Rensburg, Constance Elizabeth Jansen; van Tonder, Jacob John; Laurens, Ilze

2016-01-01

Introduction Clinicians’ skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide®) and the leading innovator brand (Meronem®) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety. Methods Patients from different high care and intensive care units were recruited for observation when prescribed either of the meropenem brands under investigation. Blood samples were collected over 6 hours after a 30 minute infusion of the different brands. Meropenem concentration curves were established against United States Pharmacopeia standard meropenem (Sigma-Aldrich) by using standard laboratory techniques for culture of Klebsiella pneumoniae. Patients’ plasma samples were tested ex vivo, using a disc diffusion assay, to confirm antimicrobial activity and estimate plasma concentrations of the two brands. Results Both brands of meropenem demonstrated similar curves in donor plasma when concentrations in vials were confirmed. Patient-specific serum concentrations were determined from zones of inhibition against a standard laboratory Klebsiella strain ex vivo, confirming at least similar in vivo concentrations as the concentration curves (90% confidence interval) overlapped; however, the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem. Conclusion This observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on registration status as well as bioassay results, demonstrating sufficient overlap for clinical comfort. The slightly higher observed comparator meropenem concentration (4%) is still clinically acceptable due to the large therapeutic index and should ally fears of inferiority. PMID:27895516

Increased Topical Generic Prices by Manufacturers: An Isolated Trend or Worrisome Future?

PubMed

Bhatt, Mehul D; Bhatt, Birju D; Dorrian, James T; McLellan, Beth N

2018-03-12

There is limited data regarding generic medication prices. Recent studies have shown price changes at the retail level, but much is not known about the pharmaceutical supply chain or price changes at the manufacturer level. We sought to examine the extent of price changes for topical generic medications. A comprehensive review of average wholesale prices (AWP) and manufacturers of topical generics and available corresponding branded medications was conducted for 2005 and 2016. A total of 51 topical chemical entities were examined. Between 2005 and 2016, the AWP of topical generics increased by 273% and the AWP of topical branded increased by 379%. The topical generic with the most price change increased by 2529%. Eight of the top twenty topical generics with the highest increase in AWP also had an increase in the number of manufacturers. These findings are not generalizable to medications used in other areas of medicine CONCLUSIONS: Topical generic prices are rapidly increasing at the manufacturer level. Copyright © 2018. Published by Elsevier Inc.

48 CFR 1910.004-73 - Offer evaluation and award, brand name or equal descriptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., brand name or equal descriptions. 1910.004-73 Section 1910.004-73 Federal Acquisition Regulations System... 1910.004-73 Offer evaluation and award, brand name or equal descriptions. An offer may not be rejected for failure of the offered product to equal a characteristic of a brand name product if it was not...

48 CFR 811.104-72 - Limited application of brand name or equal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... brand name or equal. 811.104-72 Section 811.104-72 Federal Acquisition Regulations System DEPARTMENT OF... Requirements Documents 811.104-72 Limited application of brand name or equal. If the contracting officer determines that the clause at 852.211-73, Brand name or equal, applies to only certain line items of a...

Influence of premium versus value brand names on the smoking experience in a plain packaging environment: an experimental study

PubMed Central

Skaczkowski, Gemma; Durkin, Sarah; Kashima, Yoshihisa; Wakefield, Melanie

2017-01-01

Objective To examine the effect of branding, as indicated by brand name, on evaluation of the cigarette smoking experience. Design Between-subjects and within-subjects experimental study. Participants were randomly allocated to smoke a cigarette from a pack featuring a premium brand name and a cigarette from a pack featuring a value brand name. Within each condition, participants unknowingly smoked two identical cigarettes (either two premium or two value cigarettes). Setting Australia, October 2014, 2 years after tobacco plain packaging implementation. Participants 81 current cigarette smokers aged 19–39 years. From apparently premium and value brand-name packs, 40 smokers were allocated to smoke the same actual premium cigarettes and 41 were allocated to smoke the same actual value cigarettes. Primary outcome measures Experienced taste (flavour, satisfaction, enjoyment, quality, liking, mouthfeel and aftertaste), harshness, dryness, staleness, harm/strength measures (strength, tar, lightness, volume of smoke), draw effort and purchase intent. Results Cigarettes given a premium brand name were rated as having a better taste, were less harsh and less dry than identical cigarettes given a value brand name. This pattern was observed irrespective of whether the two packs actually contained premium or value cigarettes. These effects were specific: the brand name did not influence ratings of cigarette variant attributes (strength, tar, volume of smoke, lightness and draw effort). Conclusions Despite the belief that brand names represent genuine differences between cigarette products, the results suggest that at least some of this perceived sensory difference is attributable to brand image. PMID:28093441

Name-letter branding under scrutiny: real products, new algorithms, and the probability of buying.

PubMed

Stieger, Stefan

2010-06-01

People like letters matching their own first and last name initials more than nonname letters. This name-letter effect has also been found for brands, i.e., people like brands resembling their own name letters (initial or first three). This has been termed name-letter branding effect. In the present study of 199 participants, ages 12 to 79 years, this name-letter branding effect was found for a modified design (1) using real products, (2) concentrating on product names rather than brand names, (3) using five different products for each letter of the Roman alphabet, (4) asking for the buying probability, and (5) using recently introduced algorithms, controlling for individual response tendencies (i.e., liking all letters more or less) and general normative popularity of particular letters (i.e., some letters are generally preferred more than other letters).

After years of steady growth, winds of restraint blowing on prescription-drug industry.

PubMed

Robinson, A

1995-07-01

Tough fiscal times are forcing cutbaks in many areas of health care, and the prescription-drug industry is no exception. The Pharmaceutical Manufacturers Association of Canada says Canada's brand-name drug companies face two major hurdles: restricted market access, as drug formularies limit the number of new drugs, and restricted price increases, as allowed by the Patented Medicine Prices Review Board and provincial formularies. The Canadian Drug Manufacturers Association, which represents Canada's generic-drug industry, says its message to physicians is that generic products are important agents of cost control and that the health care community is more aware of this than it once was. "If you don't maximize your savings while you can," cautions the association's Brenda Drinkwalter, "you'll never be able to afford the high-priced drugs of tomorrow".

The world wide web: exploring a new advertising environment.

PubMed

Johnson, C R; Neath, I

1999-01-01

The World Wide Web currently boasts millions of users in the United States alone and is likely to continue to expand both as a marketplace and as an advertising environment. Three experiments explored advertising in the Web environment, in particular memory for ads as they appear in everyday use across the Web. Experiments 1 and 2 examined the effect of advertising repetition on the retention of familiar and less familiar brand names, respectively. Experiment 1 demonstrated that repetition of a banner ad within multiple web pages can improve recall of familiar brand names, and Experiment 2 demonstrated that repetition can improve recognition of less familiar brand names. Experiment 3 directly compared the retention of familiar and less familiar brand names that were promoted by static and dynamic ads and demonstrated that the use of dynamic advertising can increase brand name recall, though only for familiar brand names. This study also demonstrated that, in the Web environment, much as in other advertising environments, familiar brand names possess a mnemonic advantage not possessed by less familiar brand names. Finally, data regarding Web usage gathered from all experiments confirm reports that Web usage among males tends to exceed that among females.

The Prevalence of Brand Switching Among Adult Smokers in the US, 2006–2011: Findings from the ITC US Surveys

PubMed Central

Cornelius, Monica E.; Cummings, K. Michael; Fong, Geoffrey T.; Hyland, Andrew; Driezen, Pete; Chaloupka, Frank J.; Hammond, David; O’Connor, Richard J.; Bansal-Travers, Maansi

2015-01-01

Background Recent studies have suggested that about 1 in 5 smokers report switching brands per year. However, these studies only report switching between brands. The current study estimated the rates of switching both within and between brand families and examining factors associated with brand and brand style switching. Methods Data for this analysis are from the International Tobacco Control 2006–2011 US adult smoker cohort survey waves 5–8 (N=3248). A switch between brands was defined as reporting two different cigarette brand names for two successive waves, while switching within brand was defined as reporting the same brand name, but a different brand style. Repeated measures regression was used to determine factors associated with both switch types. Results A total of 1,475 participants reported at least two successive waves of data with complete information on brand name and style. Overall switching increased from 44.9% in 2007–8 to 58.4% in 2010–11. Switching between brand names increased from 16% to 29%, while switches within the same brand name to a different style ranged from 29% to 33%. Between-brand switching was associated with younger age, lower income, non-White racial group, and use of a discount brand, whereas, within-brand switching was associated with younger age and the use of a premium brand cigarette. Conclusions Nearly half of smokers in the US switched their cigarette brand or brand style within a year. Switching between brands may be more price-motivated, while switching within brands may be motivated by price and other brand characteristics such as product length. PMID:25260750

The prevalence of brand switching among adult smokers in the USA, 2006-2011: findings from the ITC US surveys.

PubMed

Cornelius, Monica E; Cummings, K Michael; Fong, Geoffrey T; Hyland, Andrew; Driezen, Pete; Chaloupka, Frank J; Hammond, David; O'Connor, Richard J; Bansal-Travers, Maansi

2015-11-01

Recent studies have suggested that about 1 in 5 smokers report switching brands per year. However, these studies only report switching between brands. The current study estimated the rates of switching both within and between brand families and examining factors associated with brand and brand style switching. Data for this analysis are from the International Tobacco Control 2006-2011 US adult smoker cohort survey waves 5-8 (N=3248). A switch between brands was defined as reporting two different cigarette brand names for two successive waves, while switching within brand was defined as reporting the same brand name, but a different brand style. Repeated measures regression was used to determine factors associated with both switch types. A total of 1475 participants reported at least two successive waves of data with complete information on brand name and style. Overall switching increased from 44.9% in 2007-2008 to 58.4% in 2010-2011. Switching between brand names increased from 16% to 29%, while switches within the same brand name to a different style ranged from 29% to 33%. Between-brand switching was associated with younger age, lower income, non-white racial group and use of a discount brand, whereas, within-brand switching was associated with younger age and the use of a premium brand cigarette. Nearly half of smokers in the USA switched their cigarette brand or brand style within a year. Switching between brands may be more price motivated, while switching within brands may be motivated by price and other brand characteristics such as product length. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

PubMed

Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

2016-01-01

Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

Brief report on the effect of providing single versus assorted brand name condoms to hospital patients: a descriptive study

PubMed Central

Williams, James L; Christensen, Carol J; Cagle, Henry H; Homan, Chriss E

2001-01-01

Objectives This study examined condom acquisition by persons in a hospital setting when single versus assorted brand name condoms were provided. Methods Condom receptacles were placed in exam rooms of two clinics. During Phase 1, a single brand name was provided; for Phase 2, assorted brand names were added. Number of condoms taken was recorded for each phase. Results For one clinic there was nearly a two-fold increase in number of condoms taken (Phase 1 to Phase 2); for the second clinic there was negligible difference in number of condoms taken. Conclusions The provision of assorted brand name condoms, over a single brand name, can serve to increase condom acquisition. Locations of condoms and target population characteristics are related factors. PMID:11446904

Influence of premium versus value brand names on the smoking experience in a plain packaging environment: an experimental study.

PubMed

Skaczkowski, Gemma; Durkin, Sarah; Kashima, Yoshihisa; Wakefield, Melanie

2017-01-16

To examine the effect of branding, as indicated by brand name, on evaluation of the cigarette smoking experience. Between-subjects and within-subjects experimental study. Participants were randomly allocated to smoke a cigarette from a pack featuring a premium brand name and a cigarette from a pack featuring a value brand name. Within each condition, participants unknowingly smoked two identical cigarettes (either two premium or two value cigarettes). Australia, October 2014, 2 years after tobacco plain packaging implementation. 81 current cigarette smokers aged 19-39 years. From apparently premium and value brand-name packs, 40 smokers were allocated to smoke the same actual premium cigarettes and 41 were allocated to smoke the same actual value cigarettes. Experienced taste (flavour, satisfaction, enjoyment, quality, liking, mouthfeel and aftertaste), harshness, dryness, staleness, harm/strength measures (strength, tar, lightness, volume of smoke), draw effort and purchase intent. Cigarettes given a premium brand name were rated as having a better taste, were less harsh and less dry than identical cigarettes given a value brand name. This pattern was observed irrespective of whether the two packs actually contained premium or value cigarettes. These effects were specific: the brand name did not influence ratings of cigarette variant attributes (strength, tar, volume of smoke, lightness and draw effort). Despite the belief that brand names represent genuine differences between cigarette products, the results suggest that at least some of this perceived sensory difference is attributable to brand image. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Plantar Fasciitis

MedlinePlus

... medicine help? Aspirin, acetaminophen (one brand name: Tylenol), naproxen (brand name: Aleve), or ibuprofen (some brand names: ... Kids and Teens, Men, WomenTags: fasciitis, foot, heel, plant, soreness September 1, 2000 Copyright © American Academy of ...

A look back at 2009: one step forward, two steps back.

PubMed

2010-04-01

In 2009, we examined 104 new brand name products or new indications for existing products in the French edition of Prescrire. Only 3 of these 104 "innovations" provided some therapeutic advantage, while 19 had clearly unfavourable risk-benefit balances. Marketing authorisations are failing to adequately protect patients. A number of cheaper generic versions of useful drugs were introduced to the market, while BigPharma's anticompetitive practices were aimed at slowing the growth of generics manufacturers. The quality of over-the-counter drugs marketed for self-medication, especially "umbrella" brands, left much to be desired. Consumer protection is clearly not the primary concern of the European (EMA) and French (Afssaps) drug regulatory agencies. They remain too financially dependent on drug companies; hesitate to withdraw dangerous drugs from the market; and withhold drug safety data. Other signs of drug companies' excessive influence, at patients' expense, include drug pricing that bears little relation to therapeutic advantage (in oncology, for example); the financial dependence of many patient groups on drug companies; the European Commission's attempts to authorise direct-to-consumer advertising and to allow the pharmaceutical sector to tighten its grip on health information, including pharmacovigilance data. Governments must assume their responsibilities, and patients and the healthcare profession must resist BigPharma's increasing involvement in all spheres of patient care.

[Evaluation of efficacy and safety of manidipine hydrochloride among essential hypertensive patients: Substitution from branded product (Calslot) to Generic Product (Manidip)].

PubMed

Kobayashi, Hiroko; Obara, Taku; Takahashi, Norio; Takahashi, Takeshi; Igari, Yukie; Oikawa, Takuya; Saito, Shinichiro; Ohkubo, Takayoshi; Imai, Yutaka; Takahashi, Masanobu

2007-12-01

Calcium channel blockers are most commonly used in hypertensive patients in Japan. However, information on the efficacy and safety of generic calcium channel blockers is insufficient. The objective of the present study was to retrospectively evaluate the efficacy and safety of manidipine hydrochloride in 21 essential hypertensive patients (mean age; 70.6+/-10.6 years, male/female; 14/7) in Sendai Postal Services Agency Hospital who were switched (substituted) from a brand product (Calslot) to a generic product (Manidip). For this retrospective study, we used data from patient medical records and drug prescription information. Data from patients who were taking both types of manidipine hydrochloride, whose regimen were not changed for > 6 months before and after switching, and who provided informed consent were included in the analysis. Control values of blood pressure were not significantly different between before and after substitution (systolic/diastolic; from 137.9+/-9.1/78.7+/-5.4 mmHg to 137.3+/-9.1/77.8+/-6.3 mmHg, p=0.73/p=0.36). The level of patient compliance for the antihypertensive drugs was also not different between before and after substitution (from 94.0+/-8.8% to 93.1+/-9.6%, p=0.72). There were 8 cases of adverse effects before substitution and 4 after substitution. No patient stopped taking the generic drug due to an adverse effect. In conclusion, significant differences in the efficacy, safety, and patient compliance were not observed between the brand product and generic product among patients who were switched from the brand product to the generic product.

Extending or creating a new brand: evidence from a study on event-related potentials.

PubMed

Jin, Jia; Wang, Cuicui; Yu, Liping; Ma, Qingguo

2015-07-08

Brand strategy is a critical problem in new product promotion. In relation to this, producers typically have two main options, namely, brand extension and new brand creation. The current study investigated the neural basis of evaluating these brand strategies at the brain level by using event-related potentials. The experiment used a word-pair paradigm, in which the first word was either a famous beverage brand name or a newly created brand, and the second word was a product name from one of the two product categories (beverage or household appliance). Therefore, four conditions existed as follows: a famous beverage brand paired with a beverage product (BB) or with a household appliance (BH) and a newly created brand paired with a beverage product (NB) or with a household appliance (NH). Behavioral results showed that brand extension obtained a higher acceptance rate than new brand creation under the beverage product category; however, a lower acceptance rate was observed under the household appliance category. Moreover, at the brain level, BB elicited lower N400 mean amplitude than the new brand product NB, whereas BH led to higher N400 amplitude than the new brand product NH. These results showed that the likelihood of accepting a product depended on the association between the brand name and product name, and that the N400 could serve as an index of brand strategy evaluation. In addition, this study also confirmed that brand extension is not always the best brand strategy; an inappropriate extension sometimes performed worse than the creation of a new brand.

Letter-case information and the identification of brand names.

PubMed

Perea, Manuel; Jiménez, María; Talero, Fernanda; López-Cañada, Soraya

2015-02-01

A central tenet of most current models of visual-word recognition is that lexical units are activated on the basis of case-invariant abstract letter representations. Here, we examined this assumption by using a unique type of words: brand names. The rationale of the experiments is that brand names are archetypically printed either in lowercase (e.g., adidas) or uppercase (e.g., IKEA). This allows us to present the brand names in their standard or non-standard case configuration (e.g., adidas, IKEA vs. ADIDAS, ikea, respectively). We conducted two experiments with a brand-decision task ('is it a brand name?'): a single-presentation experiment and a masked priming experiment. Results in the single-presentation experiment revealed faster identification times of brand names in their standard case configuration than in their non-standard case configuration (i.e., adidas faster than ADIDAS; IKEA faster than ikea). In the masked priming experiment, we found faster identification times of brand names when they were preceded by an identity prime that matched its standard case configuration than when it did not (i.e., faster response times to adidas-adidas than to ADIDAS-adidas). Taken together, the present findings strongly suggest that letter-case information forms part of a brand name's graphemic information, thus posing some limits to current models of visual-word recognition. © 2014 The British Psychological Society.

Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin.

PubMed

Olsson, Erika; Kälvemark Sporrong, Sofia

2012-12-01

Generic drug substitution reduces costs for medicines, but the downsides include unintentional double medication, confusion and anxiety among patients. Information from pharmacists affects patients' experiences of substitution with generic drugs. The aim of this study was to explore experiences and attitudes to generic substitution among Swedish community pharmacists. An interview guide was developed. Semi-structured interviews with community pharmacists were conducted and transcribed verbatim. Analysis was inductive; extracts from the transcripts were compared and combined to form themes and subcategories. Pharmacists from a heterogeneous convenience sample of pharmacies were interviewed until data saturation had been achieved. Sixteen pharmacists were interviewed. Three main themes and twelve subcategories were identified, with the main themes being the role of the pharmacist, pharmacists' concerns regarding patients, and the generic drug. Pharmacists found it positive that generic substitution decreases the costs for pharmaceuticals but also emphasized that the switch can confuse and worry patients, which could result in less benefit from treatment. Respondents claimed that generic substitution has changed the focus in the pharmacist-patient meeting towards economics and regulations. According to the interviewed pharmacists generic substitution is not primarily an issue of generic versus brand-name products, but concerns above all the challenges that the switch implies for patients and pharmacists. To prevent known confusion and concerns among patients it is important that community pharmacists acquire the necessary tools and knowledge to manage this situation; pharmacists themselves as well as pharmacy owners and authorities share responsibility for this. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

Antiemetic Medicines: OTC Relief for Nausea and Vomiting

MedlinePlus

... used as antiemetics. These include: Bismuth subsalicylate (2 brand names: Kaopectate, Pepto-Bismol). It may help treat ... vomiting caused by motion sickness. These include dimenhydrinate (brand name: Dramamine) and meclizine hydrochloride (brand name: Dramamine ...

Head Lice

MedlinePlus

... the-counter shampoos and lotions containing pyrethrin (one brand name: Rid) or permethrin (brand name: Nix) are commonly used to treat head ... hand or by using a special comb (one brand name: LiceMeister comb) to remove them. Comb through ...

Generic penetration in the retail antidepressant market.

PubMed

Ventimiglia, Jeffrey; Kalali, Amir H

2010-06-01

In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases.

PubMed

Waning, Brenda; Kaplan, Warren; King, Alexis C; Lawrence, Danielle A; Leufkens, Hubert G; Fox, Matthew P

2009-07-01

To estimate the impact of global strategies, such as pooled procurement arrangements, third-party price negotiation and differential pricing, on reducing the price of antiretrovirals (ARVs), which currently hinders universal access to HIV/AIDS treatment. We estimated the impact of global strategies to reduce ARV prices using data on 7253 procurement transactions (July 2002-October 2007) from databases hosted by WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria. For 19 of 24 ARV dosage forms, we detected no association between price and volume purchased. For the other five ARVs, high-volume purchases were 4-21% less expensive than medium- or low-volume purchases. Nine of 13 generic ARVs were priced 6-36% lower when purchased under the Clinton Foundation HIV/AIDS Initiative (CHAI). Fifteen of 18 branded ARVs were priced 23-498% higher for differentially priced purchases compared with non-CHAI generic purchases. However, two branded, differentially priced ARVs were priced 63% and 73% lower, respectively, than generic non-CHAI equivalents. Large purchase volumes did not necessarily result in lower ARV prices. Although current plans for pooled procurement will further increase purchase volumes, savings are uncertain and should be balanced against programmatic costs. Third-party negotiation by CHAI resulted in lower generic ARV prices. Generics were less expensive than differentially priced branded ARVs, except where little generic competition exists. Alternative strategies for reducing ARV prices, such as streamlining financial management systems, improving demand forecasting and removing barriers to generics, should be explored.

7 CFR 1485.10 - General purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... participants may receive assistance for either generic or brand promotion activities. EIP/MAP participants are U.S. commercial entities that receive assistance for brand promotion activities. (c) The MAP and EIP...

Asymmetric responsiveness of physician prescription behavior to drug promotion of competitive brands within an established therapeutic drug class.

PubMed

Pedan, Alex; Wu, Hongsheng

2011-04-01

This article examines the impact of direct-to-physician, direct-to-consumer, and other marketing activities by pharmaceutical companies on a mature drug category which is in the later stage of its life cycle and in which generics have accrued a significant market share. The main objective of this article is to quantitatively estimate the impact of pharmaceutical promotions on physician prescribing behavior for three different statin brands, after controlling for factors such as patient, physician and physician practice characteristics, generic pressure, et cetera. Using unique panel data of physicians, combined with patient pharmacy prescription records, the authors developed a physician level generalized linear regression model. The generalized estimating equations method was used to account for within physician serial correlations and estimate physician population averaged effects. The findings reveal that even though on average the marketing efforts affect the brand share positively, the magnitude of the effects is very brand specific. Generally, each statin brand has its own trend and because of this, the best choice of predictors for one brand could be suboptimal for another.

After years of steady growth, winds of restraint blowing on prescription-drug industry.

PubMed Central

Robinson, A

1995-01-01

Tough fiscal times are forcing cutbaks in many areas of health care, and the prescription-drug industry is no exception. The Pharmaceutical Manufacturers Association of Canada says Canada's brand-name drug companies face two major hurdles: restricted market access, as drug formularies limit the number of new drugs, and restricted price increases, as allowed by the Patented Medicine Prices Review Board and provincial formularies. The Canadian Drug Manufacturers Association, which represents Canada's generic-drug industry, says its message to physicians is that generic products are important agents of cost control and that the health care community is more aware of this than it once was. "If you don't maximize your savings while you can," cautions the association's Brenda Drinkwalter, "you'll never be able to afford the high-priced drugs of tomorrow". Images p86-a PMID:7796380

The impact of drug samples on prescribing to the uninsured.

PubMed

Miller, David P; Mansfield, Richard J; Woods, Jonathan B; Wofford, James L; Moran, William P

2008-09-01

To determine whether drug samples are associated with physicians prescribing fewer generic, less costly medications. We conducted a retrospective study at a large university-affiliated internal medicine practice containing over 70 physicians. Using a pharmacy database, we identified all prescriptions written to uninsured or Medicaid patients that belonged to one of four classes of chronic medications. For the 9 months before and after the clinic closed its drug sample closet, we calculated the percentage of medications prescribed as generics and the mean cost of a 30-day supply of a prescription. Of 8911 prescriptions, 1973 met inclusion criteria. For uninsured patients, the percentage of medications prescribed as generics rose from 12% to 30% after the clinic closed its drug sample closet (P = 0.004). By consecutive three month periods, the percentage of prescribed generic medications rose steadily to a maximum of 40% (P < 0.001). For Medicaid patients, there was no significant change in generic prescribing (63% generic with samples versus 65% generic without samples, P = 0.42). Two factors were associated with generic prescribing in logistic regression: the absence of drug samples (OR 4.54, 95% CI 1.37-15.0) and the prescriber being an attending physician (OR 5.26, 95% CI 2.24-12.4). There was no statistically significant change in cost for either group. Physicians were three times more likely to prescribe generic medications to uninsured patients after drug samples were removed from the office. Drug samples may paradoxically lead to higher costs if physicians with access to samples prescribe more brand-name only drugs.

Objective Measures of Emotion Related to Brand Attitude: A New Way to Quantify Emotion-Related Aspects Relevant to Marketing

PubMed Central

Walla, Peter; Brenner, Gerhard; Koller, Monika

2011-01-01

With this study we wanted to test the hypothesis that individual like and dislike as occurring in relation to brand attitude can be objectively assessed. First, individuals rated common brands with respect to subjective preference. Then, they volunteered in an experiment during which their most liked and disliked brand names were visually presented while three different objective measures were taken. Participant's eye blinks as responses to acoustic startle probes were registered with electromyography (EMG) (i) and their skin conductance (ii) and their heart rate (iii) were recorded. We found significantly reduced eye blink amplitudes related to liked brand names compared to disliked brand names. This finding suggests that visual perception of liked brand names elicits higher degrees of pleasantness, more positive emotion and approach-oriented motivation than visual perception of disliked brand names. Also, skin conductance and heart rate were both reduced in case of liked versus disliked brand names. We conclude that all our physiological measures highlight emotion-related differences depending on the like and dislike toward individual brands. We suggest that objective measures should be used more frequently to quantify emotion-related aspects of brand attitude. In particular, there might be potential interest to introduce startle reflex modulation to measure emotion-related impact during product development, product design and various further fields relevant to marketing. Our findings are discussed in relation to the idea that self reported measures are most often cognitively polluted. PMID:22073192

Objective measures of emotion related to brand attitude: a new way to quantify emotion-related aspects relevant to marketing.

PubMed

Walla, Peter; Brenner, Gerhard; Koller, Monika

2011-01-01

With this study we wanted to test the hypothesis that individual like and dislike as occurring in relation to brand attitude can be objectively assessed. First, individuals rated common brands with respect to subjective preference. Then, they volunteered in an experiment during which their most liked and disliked brand names were visually presented while three different objective measures were taken. Participant's eye blinks as responses to acoustic startle probes were registered with electromyography (EMG) (i) and their skin conductance (ii) and their heart rate (iii) were recorded. We found significantly reduced eye blink amplitudes related to liked brand names compared to disliked brand names. This finding suggests that visual perception of liked brand names elicits higher degrees of pleasantness, more positive emotion and approach-oriented motivation than visual perception of disliked brand names. Also, skin conductance and heart rate were both reduced in case of liked versus disliked brand names. We conclude that all our physiological measures highlight emotion-related differences depending on the like and dislike toward individual brands. We suggest that objective measures should be used more frequently to quantify emotion-related aspects of brand attitude. In particular, there might be potential interest to introduce startle reflex modulation to measure emotion-related impact during product development, product design and various further fields relevant to marketing. Our findings are discussed in relation to the idea that self reported measures are most often cognitively polluted.

Brand-name prescription drug use among Veterans Affairs and Medicare Part D patients with diabetes: a national cohort comparison.

PubMed

Gellad, Walid F; Donohue, Julie M; Zhao, Xinhua; Mor, Maria K; Thorpe, Carolyn T; Smith, Jeremy; Good, Chester B; Fine, Michael J; Morden, Nancy E

2013-07-16

Medicare Part D and the U.S. Department of Veterans Affairs (VA) use different approaches to manage prescription drug benefits, with implications for spending. Medicare relies on private plans with distinct formularies, whereas the VA administers its own benefit using a national formulary. To compare overall and regional rates of brand-name drug use among older adults with diabetes in Medicare and the VA. Retrospective cohort. Medicare and the VA, 2008. 1,061,095 Medicare Part D beneficiaries and 510,485 veterans aged 65 years or older with diabetes. Percentage of patients taking oral hypoglycemics, statins, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) who filled brand-name drug prescriptions and percentage of patients taking long-acting insulins who filled analogue prescriptions. Sociodemographic- and health status-adjusted hospital referral region (HRR) brand-name drug use was compared, and changes in spending were calculated if use of brand-name drugs in 1 system mirrored the other. Brand-name drug use in Medicare was 2 to 3 times that in the VA: 35.3% versus 12.7% for oral hypoglycemics, 50.7% versus 18.2% for statins, 42.5% versus 20.8% for ACE inhibitors or ARBs, and 75.1% versus 27.0% for insulin analogues. Adjusted HRR-level brand-name statin use ranged (from the 5th to 95th percentiles) from 41.0% to 58.3% in Medicare and 6.2% to 38.2% in the VA. For each drug group, the 95th-percentile HRR in the VA had lower brand-name drug use than the 5th-percentile HRR in Medicare. Medicare spending in this population would have been $1.4 billion less if brand-name drug use matched that of the VA. This analysis cannot fully describe the factors underlying differences in brand-name drug use. Medicare beneficiaries with diabetes use 2 to 3 times more brand-name drugs than a comparable group within the VA, at substantial excess cost.

Brand-Name Prescription Drug Use Among Veterans Affairs and Medicare Part D Patients With Diabetes

PubMed Central

Gellad, Walid F.; Donohue, Julie M.; Zhao, Xinhua; Mor, Maria K.; Thorpe, Carolyn T.; Smith, Jeremy; Good, Chester B.; Fine, Michael J.; Morden, Nancy E.

2013-01-01

Background: Medicare Part D and the U.S. Department of Veterans Affairs (VA) use different approaches to manage prescription drug benefits, with implications for spending. Medicare relies on private plans with distinct formularies, whereas the VA administers its own benefit using a national formulary. Objective: To compare overall and regional rates of brand-name drug use among older adults with diabetes in Medicare and the VA. Design: Retrospective cohort. Setting: Medicare and the VA, 2008. Patients: 1 061 095 Medicare Part D beneficiaries and 510 485 veterans aged 65 years or older with diabetes. Measurements: Percentage of patients taking oral hypoglycemics, statins, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) who filled brand-name drug prescriptions and percentage of patients taking long-acting insulins who filled analogue prescriptions. Sociodemographic- and health status–adjusted hospital referral region (HRR) brand-name drug use was compared, and changes in spending were calculated if use of brand-name drugs in 1 system mirrored the other. Results: Brand-name drug use in Medicare was 2 to 3 times that in the VA: 35.3% versus 12.7% for oral hypoglycemics, 50.7% versus 18.2% for statins, 42.5% versus 20.8% for ACE inhibitors or ARBs, and 75.1% versus 27.0% for insulin analogues. Adjusted HRR-level brand-name statin use ranged (from the 5th to 95th percentiles) from 41.0% to 58.3% in Medicare and 6.2% to 38.2% in the VA. For each drug group, the 95th-percentile HRR in the VA had lower brand-name drug use than the 5th-percentile HRR in Medicare. Medicare spending in this population would have been $1.4 billion less if brand-name drug use matched that of the VA. Limitation: This analysis cannot fully describe the factors underlying differences in brand-name drug use. Conclusion: Medicare beneficiaries with diabetes use 2 to 3 times more brand-name drugs than a comparable group within the VA, at substantial excess cost. Primary Funding Source: U.S. Department of Veterans Affairs, National Institutes of Health, and Robert Wood Johnson Foundation. PMID:19264942

Brand-Name Prescription Drug Use Among Diabetes Patients in the VA and Medicare Part D: A National Comparison

PubMed Central

Gellad, Walid F.; Donohue, Julie M.; Zhao, Xinhua; Mor, Maria K.; Thorpe, Carolyn T.; Smith, Jeremy; Good, Chester B.; Fine, Michael J.; Morden, Nancy E.

2013-01-01

Background Medicare Part D and the Department of Veterans Affairs (VA) use different approaches to manage prescription drug benefits, with implications for spending. Medicare relies on private plans with distinct formularies, whereas VA administers its own benefit using a national formulary. Objective To compare overall and regional rates of brand-name drug use among older adults with diabetes in Medicare and VA. Design Retrospective cohort Setting Medicare and VA Patients National sample in 2008 of 1,061,095 Part D beneficiaries and 510,485 Veterans age 65+ with diabetes. Measurements Percent of patients on oral hypoglycemics, statins, and angiotensin-converting-enzyme inhibitors/angiotensin-receptor-blockers who filled brand-name drugs and percent of patients on long-acting insulin who filled analogues. We compared sociodemographic and health-status adjusted hospital referral region (HRR) brand-name use to examine local practice patterns, and calculated changes in spending if each system’s brand-name use mirrored the other. Results Brand-name use in Medicare was 2–3 times that of VA: 35.3% vs. 12.7% for oral hypoglycemics, 50.7% vs. 18.2% for statins, 42.5% vs. 20.8% for angiotensin-converting-enzyme inhibitors/angiotensin-receptor-blockers, and 75.1% vs. 27.0% for insulin analogues. Adjusted HRR brand-name statin use ranged (5th to 95th percentile) from 41.0%–58.3% in Medicare and 6.2%–38.2% in VA. For each drug group, the HRR at the 95th percentile in VA had lower brand-name use than the 5th percentile HRR in Medicare. Medicare spending in this population would have been $1.4 billion less if brand-name use matched the VA for these medications. Limitation This analysis cannot fully describe the factors underlying differences in brand-name use. Conclusions Medicare beneficiaries with diabetes use 2–3 times more brand-name drugs than a comparable group within VA, at substantial excess cost. Primary Funding Sources VA; NIH; RWJF PMID:23752663

48 CFR 1910.004-71 - Limits on the use of brand name or equal purchase descriptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Limits on the use of brand... DESCRIPTIONS 1910.004-71 Limits on the use of brand name or equal purchase descriptions. (a) General. The use of brand name or equal purchase descriptions in solicitations is intended to promote competition by...

Antihistamines: Understanding Your OTC Options

MedlinePlus

... you can buy over the counter include: Brompheniramine (brand names include Children’s Dimetapp Cold) Chlorpheniramine (brand names include Chlor-Trimeton, Actifed Cold) Dimenhydrinate (brand ...

Generic Penetration in the Retail Antidepressant Market

PubMed Central

Kalali, Amir H.

2010-01-01

In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty. PMID:20622940

Clinical outcomes associated with brand-to-generic phenytoin interchange.

PubMed

Kinikar, Shilpa A; Delate, Thomas; Menaker-Wiener, C Mindy; Bentley, William H

2012-05-01

Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. However, little within-patient evidence exists examining such interchanges. To compare within-patient seizure control before and after the interchange of a branded to a single-source generic phenytoin among patients with seizures in a managed care organization. This was a pre-post, self-controlled, retrospective study. Adults with a history of seizure who used Dilantin Kapseals 100 mg extended phenytoin sodium, USP, capsules and whose therapy was interchanged to Taro Pharmaceuticals' AB-rated generic extended phenytoin sodium capsules, USP, 100 mg between July 2007 and May 2008 were included. Study outcomes included the comparisons of the proportions of patients with at least emergency department (ED) visit/inpatient hospitalization and medical office visit/nonoffice consultation for acute seizure in the 6 months before and after interchange. Outcomes were confirmed with manual chart reviews and adjusted for potential confounding medication use. A total of 222 patients were included in the study. Patients were primarily middle-aged (mean 56 years), equally mixed by sex (47% female); most had nonintractable seizures. The majority of patients (~70%) were on phenytoin as monotherapy and had equivalent rates of purchases for potentially confounding medications in both pre- and postinterchange time periods (all p > 0.05). Low serum concentrations were detected more often in the postinterchange study period (adjusted p < 0.001). Despite this, there were low proportions of patients with confirmed seizure events that resulted in an ED visit/inpatient hospitalization in both pre- and postinterchange periods (both 6.3%, adjusted p = 0.937). The proportion of patients with confirmed seizure events diagnosed at a medical office visit was not significantly different between the preinterchange and postinterchange periods (12.2% vs 11.3%, adjusted p = 0.545). No increased proportion of seizures was observed within patients when branded phenytoin was interchanged to an AB-rated, single-source, generic equivalent. More rigorous studies should be conducted to more thoroughly evaluate patient tolerability and drug efficacy when antiepileptic drugs are interchanged from brand to generic formulations.

Knowledge, perceptions and use of generic drugs: a cross sectional study

PubMed Central

de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

2014-01-01

Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

9 CFR 317.4 - Labeling approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Devices, except for generically approved labeling authorized for use in § 317.5(b). The management of the... carcass ink brands and meat food product ink and burning brands, which comply with parts 312 and 316 of...

78 FR 61358 - Mylan, Inc., Agila Specialties Global Pte. Limited, Agila Specialties Private Limited and Strides...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-03

... multiple sclerosis. Five firms currently supply the market for methotrexate sodium preservative- free... branded manufacturer. Once multiple generic suppliers enter a market, the branded drug manufacturer...

The Impact of Price-cap Regulations on Exit by Generic Pharmaceutical Firms.

PubMed

Zhang, Wei; Guh, Daphne; Sun, Huiying; Marra, Carlo A; Lynd, Larry D; Anis, Aslam H

2016-09-01

In 1998, the Province of Ontario in Canada adopted price-cap "70/90" regulations whereby the first generic entrant was required to be priced at ≤70% of the associated brand-name product and subsequent generics were priced at ≤90% of the first generic price. The price-caps were further lowered to 50% in 2006 and 25% in 2010. This study assessed the impact of such price-cap regulations on exit by generic drug firms. Formulary (2003-2012) listings of prescription drugs covered under the Ontario Drug Benefit program were used. The formulary tracks the "status" (on formulary, discontinued by manufacturer, and delisted for other reasons) for each drug. Markets were defined based on unique active ingredient and form within Ontario. Firm exit occurred when a manufacturer discontinued all its generic drugs within a market. The exit rate was defined as the number of generic firm-market exits divided by total generic firm-market follow-up years. Poisson regression was used to compare the exit rates during the 3 policy periods ("25," "50," and "70/90"). A total of 1126 generic manufacturers paired with 290 markets were identified. The exit rate ratio during the 25% price-cap period compared with the 70%/90% period was 2.42 (95% confidence interval, 1.56-3.77). A small manufacturer or a manufacturer in a market with ≥3 competitors or in an older market was more likely to exit. Lowering the price-cap level is associated with a higher incidence of generic firm exit from markets. Continuously reducing price-caps may have the unintended consequence of forcing generic firms to exit.

Price difference as a predictor of the selection between brand name and generic statins in Japan.

PubMed

Takizawa, Osamu; Urushihara, Hisashi; Tanaka, Shiro; Kawakami, Koji

2015-05-01

This study aimed to explore the predictors of the selection between brand name drug (BR) and generic drug (GE) and to clarify the quantitative relationship about selection. We identified "incident users" who dispensed statins between April 2008 and June 2011 in commercially databases consisted of dispensing claims databases (DCD) of out-of-hospital pharmacies and hospital claims databases (HCD) of in-house pharmacies in Japan. Predictors of the selection between BR and GE, including price difference (PD), the price of BR, their interaction and percent change of the price of GE relative to BR were explored by logistic regression using DCD and HCD separately. We extracted records of 670 patients who have opportunity for selection both BR and GE. Logistic regression analysis demonstrated that PD, the price of BR, interaction between them, and prescriber affiliation were factors significantly associated with the selection in the DCD; logit (p)=9.735-0.251×PD-0.071×the price of BR+0.002×PD×the price of BR-1.816×affiliation+0.220×gender-0.008×age+0.038×monthly medical fee. PD was inversely proportional to BR choice in DCD and lead to the opposite result in HCD. Numerical simulation of selection revealed that the quantitative relationships heavily depend on situations. PD and the price of BR are predictors of the selection between BR and GE interactively in out-of-hospital pharmacies, but not in in-house pharmacies of medical facilities. Results may support policies which increase the power of out-of-hospital pharmacies for selection. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

[Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil].

PubMed

Miranda, Elaine Silva; Pinto, Cláudia Du Bocage Santos; dos Reis, André Luis de Almeida; Emmerick, Isabel Cristina Martins; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Osorio-de-Castro, Claudia Garcia Serpa

2009-10-01

A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand) generics are less available than multisource products. For most medicines (71.4%), the availability of bioequivalent generics was less than 10%. In the private sector, the average number of different bioequivalent generic versions in the outlets was far smaller than the number of versions on the market. There was a positive correlation between the number of generics on the market, or those found at outlets, and the price variation in bioequivalent generic products, in relation to the maximum consumer price. It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.

Analysis of spontaneous inquiries about suspected adverse drug reactions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”

PubMed Central

Dobashi, Akira; Kurata, Kaori; Okazaki, Mitsuhiro; Nishizawa, Mari

2016-01-01

Purpose Spontaneous inquiries about the development of adverse drug reactions (ADRs) to medicines can be extracted based on the questions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”. Our aim was to clarify the characteristics related to people’s descriptions of suspected ADRs and determine the reasons for submitting a spontaneous inquiry. Methods Fifty brand names of medicines used for inquiry extraction were chosen by selecting 35 pharmaceutical products, based on the generic names that had the highest sales in Japan. Questions containing both the brand name of one of these medicines and the term “Fukusayō” (ADR in Japanese) that were posted from July 2004 to June 2009 were extracted from the site. Results Among 1,419 questions extracted, 614 questions had at least one identifiable brand name of a suspected medicine, an ADR description, and the extent to which the ADR appeared to be caused by the suspected medicine(s). Among these 614 questions, 589 described in detail the symptoms/signs that the inquirers themselves or their families had experienced as ADRs. The highest number of questions was found for Paxil (525). Posts asking whether the symptoms being experienced were due to an ADR accounted for the highest number of questions. In most cases, the inquirer suspected that a single medicine led to an ADR and was seeking advice from others taking the same medicine. Conclusion Our examination of spontaneous inquiries showed that people have sufficient knowledge to adequately report potential ADRs in terms of their symptoms, suspected medicines, and the disease for which the medicine was used. However, they often did not describe the start time when the ADR appeared or when the suspected medicine was started. PMID:27114703

Economic evaluation of pharmacological treatments for overactive bladder from the perspective of the UK National Health Service.

PubMed

Nazir, Jameel; Posnett, John; Walker, Anna; Odeyemi, Isaac A; Hakimi, Zalmai; Garnham, Andrew

2015-05-01

To evaluate the costs and outcomes associated with different sequences of oral anti-muscarinic agents and the selective β(3)-adrenoceptor agonist, mirabegron, for the treatment of overactive bladder (OAB). A Markov model with monthly cycle length and time horizon up to 3 years was designed to compare two different sequences of up to three lines of oral therapy for OAB. Patients who discontinued one oral medication could switch to another oral medication or could discontinue treatment. Patients whose symptoms were not controlled were considered for botulinum toxin or sacral nerve stimulation. Outcomes were measured by (a) number of patients with controlled symptoms (no incontinence episodes and <8 micturitions per 24 h); (b) patients with no incontinence episodes per 24 hours; and (c) patients with <8 micturitions per 24 h. Including a third-line oral medication before considering other treatment options improved all patient outcomes, irrespective of the specific drugs used. A three-line sequence including two generic (oxybutynin first line and tolterodine extended-release second line) and one branded drug (solifenacin 5 mg third line) resulted in inferior patient outcomes at costs similar to a sequence of branded drugs (mirabegron first line, solifenacin 5 mg second line, solifenacin 10 mg third line): controlled patients (generic 29.6/1000 vs branded 38.7/1000); patients with no incontinence episodes (103.6/1000 vs 123.7/1000); patients with <8 micturitions (228.7/1000 vs 262.1/1000). Annual treatment costs per patient were similar (generic £1299 vs branded £1385). In the treatment of OAB, low-cost generic treatments are not necessarily more cost-effective than branded drugs, primarily because a better efficacy and tolerability balance improves both symptom control and persistence.

Effect of the Medicare Part D coverage gap on medication use among patients with hypertension and hyperlipidemia.

PubMed

Li, Pengxiang; McElligott, Sean; Bergquist, Henry; Schwartz, J Sanford; Doshi, Jalpa A

2012-06-05

Prior studies of the Medicare Part D coverage gap are limited in generalizability and scope. To determine the effect of the coverage gap on drugs used for asymptomatic (antihypertensive and lipid-lowering drugs) and symptomatic (pain relievers, acid suppressants, and antidepressants) conditions in elderly patients with hypertension and hyperlipidemia. Quasi-experimental study using pre-post design and contemporaneous control group. Medicare claims files from 2005 and 2006 for 5% random sample of Medicare beneficiaries. Part D plan enrollees with hypertension or hyperlipidemia aged 65 years or older who had no coverage, generic-only coverage, or both brand-name and generic coverage during the gap in 2006. Patients who were fully eligible for the low-income subsidy served as the control group. Monthly 30-day supply prescriptions available, medication adherence, and continuous medication gaps of 30 days or more for antihypertensive or lipid-lowering drugs; monthly 30-day supply prescriptions available for pain relievers, acid suppressants, or antidepressants before and after coverage gap entry. Patients with no gap coverage had a decrease in monthly antihypertensive and lipid-lowering drug prescriptions during the coverage gap. Nonadherence also increased in this group (antihypertensives: odds ratio [OR], 1.60 [95% CI, 1.50 to 1.71]; lipid-lowering drugs: OR, 1.59 [CI, 1.50 to 1.68]). The proportion of patients with no gap coverage who had continuous medication gaps in lipid-lowering medication use and antihypertensive use increased by an absolute 7.3% (OR, 1.38 [CI, 1.29 to 1.46]) and 3.2% (OR, 1.35 [CI, 1.25 to 1.45]), respectively, because of the coverage gap. Decreases in use were smaller for pain relievers and antidepressants and larger for acid suppressants in patients with no gap coverage. Patients with generic-only coverage had decreased use of cardiovascular medications but no change in use of drugs for symptomatic conditions. No measures changed in the brand-name and generic coverage groups. Results of sensitivity analyses were consistent with the main findings. Because this study was nonrandomized, unobserved differences may still exist between study groups. The Part D coverage gap was associated with decreased use of medications for hypertension and hyperlipidemia in patients with no gap coverage and generic-only gap coverage. The proposed phasing out of the gap by 2020 will benefit such patients; however, use of low-value medications may also increase. Penn-Pfizer Alliance and American Heart Association.

Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases

PubMed Central

Kaplan, Warren; King, Alexis C; Lawrence, Danielle A; Leufkens, Hubert G; Fox, Matthew P

2009-01-01

Abstract Objective To estimate the impact of global strategies, such as pooled procurement arrangements, third-party price negotiation and differential pricing, on reducing the price of antiretrovirals (ARVs), which currently hinders universal access to HIV/AIDS treatment. Methods We estimated the impact of global strategies to reduce ARV prices using data on 7253 procurement transactions (July 2002–October 2007) from databases hosted by WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Findings For 19 of 24 ARV dosage forms, we detected no association between price and volume purchased. For the other five ARVs, high-volume purchases were 4–21% less expensive than medium- or low-volume purchases. Nine of 13 generic ARVs were priced 6–36% lower when purchased under the Clinton Foundation HIV/AIDS Initiative (CHAI). Fifteen of 18 branded ARVs were priced 23–498% higher for differentially priced purchases compared with non-CHAI generic purchases. However, two branded, differentially priced ARVs were priced 63% and 73% lower, respectively, than generic non-CHAI equivalents. Conclusion Large purchase volumes did not necessarily result in lower ARV prices. Although current plans for pooled procurement will further increase purchase volumes, savings are uncertain and should be balanced against programmatic costs. Third-party negotiation by CHAI resulted in lower generic ARV prices. Generics were less expensive than differentially priced branded ARVs, except where little generic competition exists. Alternative strategies for reducing ARV prices, such as streamlining financial management systems, improving demand forecasting and removing barriers to generics, should be explored. PMID:19649366

Patent extension policy for paediatric indications: an evaluation of the impact within three drug classes in a state Medicaid programme.

PubMed

Nelson, Richard E; McAdam-Marx, Carrie; Evans, Megan L; Ward, Robert; Campbell, Benjamin; Brixner, Diana; Lafleur, Joanne

2011-05-01

The Food and Drug Administration Modernization Act (FDAMA) of 1997, Best Pharmaceuticals for Children Act (BPCA) of 2002 and Pediatric Research Equity Act of 2007 provide an extended period of 6 months of marketing exclusivity (i.e. patent extension) to prescription drug manufacturers that conduct paediatric studies. Branded drugs in the statin, ACE inhibitor and selective serotonin reuptake inhibitor (SSRI) classes were three of many classes with drugs granted patent extensions. We estimated the cost impact of the 6-month exclusivity extension policy on the Utah Medicaid drug programme by comparing actual costs to projected costs had the 6-month exclusivity extension not been granted for these drugs and thus less expensive generic alternatives been available sooner. Using these results, we then projected the cost impact of this policy on Medicaid programmes in the US during the 18 months following patent expiration. The Utah Medicaid prescription claims obtained for statins, ACE inhibitors and SSRIs included reimbursement amount, number of units dispensed, days supplied, date of service and drug strength. Actual expenditures for each drug were calculated for the 6 months before and 12 months after generic availability. The percentage difference between the brand name prescription reimbursement amount to Medicaid in the last 2 months of the 6-month extension and the generic prescription reimbursement amount to Medicaid in the first 2 months following exclusivity expiration was then calculated for each drug. This was done using data from the 5 months surrounding the exclusivity expiration by regressing the log-transformed Utah Medicaid reimbursement amount on an indicator for patent expiration, controlling for number of units, volume of sales, month filled and strength. This was used to estimate what the initial generic prescription price would have been without the 6-month patent extension and what costs would have been in the 18 months following the original expiration date if the patent extension had not been granted. Medicaid rebates were assumed to be 15.1% for branded products and 11% for generics. The 6-month extension policy was estimated to cost Utah's Medicaid $US2.2 (95% CI 1.9, 2.4) million for these three drug classes over the 18 months following the original patent expiration date (year 2007 values). Projected to the US Medicaid population, this cost was $US430 (95% CI 371, 475) million. For the individual drugs that we examined, the percentage cost decrease in reimbursement amount resulting from exclusivity expiration and generic entry ranged from 24.4% (p < 0.001) for enalapril to 3.8% (p = 0.0951) for pravastatin sodium. Makers of the branded drugs evaluated were given market exclusivity extensions for conducting studies of their medications in children. The costs found in this study are just a small portion of the total paid, which include those born by other payers. Whether the benefits of this policy outweigh these costs is an open question, but these results suggest that the costs to Medicaid and thus taxpayers are substantial.

Generic penetration in the retail atypical antipsychotic market.

PubMed

Lenderts, Susan; Kalali, Amir H; Buckley, Peter

2010-03-01

In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

Generic Penetration in the Retail Atypical Antipsychotic Market

PubMed Central

Kalali, Amir H; Buckley, Peter

2010-01-01

In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty. PMID:20436769

Impact of pharmacy benefit design on prescription drug utilization: a fixed effects analysis of plan sponsor data.

PubMed

Roebuck, M Christopher; Liberman, Joshua N

2009-06-01

To study the impact of various elements of pharmacy benefit design on both the absolute and relative utilization of generics, brands, retail pharmacy, and mail service. Panel data on 1,074 plan sponsors covering 21.6 million individuals over 12 calendar quarters (2005-2007). A retrospective analysis of pharmacy claims. To control for potential endogeneity, linear fixed effects models were estimated for each of six dependent variables: the generic utilization rate, the brand utilization rate, the generic dispensing rate (GDR), the retail pharmacy utilization rate, the mail service utilization rate, and the mail distribution rate. Most member cost-share variables were nonlinearly associated with changes in prescription drug utilization. Marginal effects were generally greater in magnitude for brand out-of-pocket costs than for generic out-of-pocket costs. Time dummies, as well as other pharmacy benefit design elements, also yielded significant results. Prior estimates of the effect of member cost sharing on prescription drug utilization may be biased if complex benefit designs, mail service fulfillment, and unmeasured factors such as pharmaceutical pipelines are not accounted for. Commonly cited relative utilization metrics, such as GDR, may be misleading if not examined alongside absolute prescription drug utilization.

Is the Brazilian pharmaceutical policy ensuring population access to essential medicines?

PubMed

Bertoldi, Andréa Dâmaso; Helfer, Ana Paula; Camargo, Aline L; Tavares, Noêmia U L; Kanavos, Panos

2012-03-21

To evaluate medicine prices, availability and affordability in Brazil, considering the differences across three types of medicines (originator brands, generics and similar medicines) and different types of facilities (private pharmacies, public sector pharmacies and "popular pharmacies"). Data on prices and availability of 50 medicines were collected in 56 pharmacies across six cities in Southern Brazil using the World Health Organization / Health Action International methodology. Median prices obtained were divided by international reference prices to derive the median price ratio (MPR). In the private sector, prices were 8.6 MPR for similar medicines, 11.3 MRP for generics and 18.7 MRP for originator brands, respectively. Mean availability was 65%, 74% and 48% for originator brands, generics and similar medicines, respectively. In the public sector, mean availability of similar medicines was 2-7 times higher than that of generics. Mean overall availability in the public sector ranged from 68.8% to 81.7%. In "popular pharmacies", mean availability was greater than 90% in all cities. Availability of medicines in the public sector does not meet the challenge of supplying essential medicines to the entire population, as stated in the Brazilian constitution. This has unavoidable repercussions for affordability, particularly amongst the lower socio-economic strata.

Impact of alternative interventions on changes in generic dispensing rates.

PubMed

O'Malley, A James; Frank, Richard G; Kaddis, Atheer; Rothenberg, Barbara M; McNeil, Barbara J

2006-10-01

To evaluate the effectiveness of four alternative interventions (member mailings, advertising campaigns, free generic drug samples to physicians, and physician financial incentives) used by a major health insurer to encourage its members to switch to generic drugs. Using claim-level data from Blue Cross Blue Shield of Michigan, we evaluated the success of four interventions implemented during 2000-2003 designed to increase the use of generic drugs among its members. Around 13 million claims involving seven important classes of drugs were used to assess the effectiveness of the interventions. For each intervention a control group was developed that most closely resembled the corresponding intervention group. Logistic regression models with interaction effects between the treatment group (intervention versus control) and the status of the intervention (active versus not active) were used to evaluate if the interventions had an effect on the generic dispensing rate (GDR). Because the mail order pharmacy was considered more aggressive at converting prescriptions to generics, separate generic purchasing models were fitted to retail and mail order claims. In secondary analyses separate models were also fitted to claims involving a new condition and claims refilled for preexisting conditions. The interventions did not appear to increase the market penetration of generic drugs for either retail or mail order claims, or for claims involving new or preexisting conditions. In addition, we found that the ratio of copayments for brand name to generic drugs had a large positive effect on the GDR. The interventions did not appear to directly influence the GDR. Financial incentives expressed to consumers through benefit designs have a large influence on their switching to generic drugs and on the less-costly mail-order mode of purchase.

48 CFR 811.104-73 - Bid samples.

Code of Federal Regulations, 2010 CFR

2010-10-01

... samples. (a) When a solicitation contains “brand name or equal” purchase descriptions, the contracting officer must not require a bidder who offers brand name products, including component parts, referenced in the descriptions to furnish bid samples of the referenced brand name products. (b) A solicitation may...

A survey to determine the views of renal transplant patients on generic substitution in the UK.

PubMed

Al Ameri, Mubarak N; Whittaker, Clare; Tucker, Arthur; Yaqoob, Magdi; Johnston, Atholl

2011-08-01

Rising healthcare costs promote the generic substitution among patients because it is identifiable costs. A key concern is that patients should be involved in the decision of switching. The aim of this study was to examine renal transplant patients' views on generic substitution in the UK. A total of 163 renal patients were surveyed using 36 multiple-choice questions at Barts and The London Renal Transplant Clinic, in the UK. Transplant recipients over 18 years, able to read and write English and willing to fill in the questionnaire were targeted; 84% of patients were conscious of the availability of generic medicines, 70% understood the terms "generic" and "branded" in relation to medicines and 54% were aware of generic substitution practice. However, 75% did not know if they were taking generics and 84% felt that generics are not equivalent or only equivalent sometimes and they were uncertain that generics had the same quality as branded medicines. Moreover, many patients admitted that they would not accept the generic substitution of ciclosporin when become available in the UK. A number of factors such as patients' education, knowledge, severity of the disease, efficacy of generic medicines and patients' involvement in decisions regarding their health appear to drive patients' attitudes towards generic substitution. © 2011 The Authors. Transplant International © 2011 European Society for Organ Transplantation.

The cost-effectiveness of temozolomide in the adjuvant treatment of newly diagnosed glioblastoma in the United States

PubMed Central

Messali, Andrew; Hay, Joel W.; Villacorta, Reginald

2013-01-01

Background The objective of this work was to determine the cost-effectiveness of temozolomide compared with that of radiotherapy alone in the adjuvant treatment of newly diagnosed glioblastoma. Temozolomide is the only chemotherapeutic agent to have demonstrated a significant survival benefit in a randomized clinical trial. Our analysis builds on earlier work by incorporating caregiver time costs and generic temozolomide availability. It is also the first analysis applicable to the US context. Methods A systematic literature review was conducted to collect relevant data. Transition probabilities were calculated from randomized controlled trial data comparing temozolomide plus radiotherapy with radiotherapy alone. Direct costs were calculated from charges reported by the Mayo Clinic. Utilities were obtained from a previous cost-utility analysis. Using these data, a Markov model with a 1-month cycle length and 5-year time horizon was constructed. Results The addition of brand Temodar and generic temozolomide to the standard radiotherapy regimen was associated with base-case incremental cost-effectiveness ratios of $102 364 and $8875, respectively, per quality-adjusted life-year. The model was most sensitive to the progression-free survival associated with the use of only radiotherapy. Conclusions Both the brand and generic base-case estimates are cost-effective under a willingness-to-pay threshold of $150 000 per quality-adjusted life-year. All 1-way sensitivity analyses produced incremental cost-effectiveness ratios below this threshold. We conclude that both the brand Temodar and generic temozolomide are cost-effective treatments for newly diagnosed glioblastoma within the US context. However, assuming that the generic product produces equivalent quality of life and survival benefits, it would be significantly more cost-effective than the brand option. PMID:23935155

Dispensing behaviour of pharmacies in prescription drug markets.

PubMed

Guhl, Dennis; Stargardt, Tom; Schneider, Udo; Fischer, Katharina E

2016-02-01

We aim to investigate pharmacies' dispensing behaviour under the existing dispensing regulations in Germany. Using administrative data, we performed a cross-sectional retrospective study to analyse whether the competitive environment and pharmacy characteristics, i.e., organisation, lead to dispensing choices aimed at by third-party payers. We specified generalised linear models with the share of imported pharmaceuticals, generic share, and share of preferred brands as dependent variables. The final dataset contained 49,260,902 prescriptions from 16,797 pharmacies. The average share of imported pharmaceuticals across the pharmacies was 18.4% (standard deviation (SD) 8.8), the average generic share was 92.8% (SD 2.1), and compliance with preferred brands was 81.3% (SD 5.9). Pharmacies with little competition used fewer imported pharmaceuticals (p<0.001), generics (p<0.001) and preferred brands (p<0.001); less organised pharmacies yielded similar results. The difference in outcomes between pharmacies in the first and 4th quartiles of the pharmacy organisation variable is 17.4% vs. 17.0% for share of imported pharmaceuticals, 92.8% vs. 92.7% for generic share and 81.9% vs. 81.1% for compliance with preferred brands. We show that pharmacies' dispensing choices meet the aims of payers at high levels. However, dispensing behaviour varies between pharmacies. Increasing competition among pharmacies and targeting pharmacies with high shares of bill auditing seem viable options to improving dispensing behaviour as defined by payers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Australian experience following plain packaging: the impact on tobacco branding.

PubMed

Greenland, Steven J

2016-12-01

Brands are critical to tobacco marketing. Industry stakeholders predicted that plain packaging, by removing key tangible branding dimensions, would restrict new products and brand differentiation. However, manufacturers respond innovatively to limit regulatory impact. This study investigates brand strategy following plain packaging's introduction to Australia. Brand portfolios were determined using 2006-15 tobacco ingredient reports. These detail the brand and variant names sold and are provided annually as part of a voluntary agreement between the Australian Government and leading manufacturers. Post-plain packaging brand ranges were verified using retail price lists and a supermarket retail audit using a method used previously to verify a period of pre-plain packaging data. The verification process identified some data inaccuracies from one manufacturer which resulted in the issuing of corrected data. After plain packaging the leading manufacturers continued with extensive brand ranges differentiated by price. All launched new products. While total brand numbers fell from 29 to 24, the mean number of variants for the leading 12 brands grew from 8.9 to 9.7. Substantial variant name modifications occurred with 50 new or modified names in 2012-13. Among leading brands, the incidence of variant colour names increased from 49.5 to 79.3%. New brands and variants were not inhibited by the introduction of plain packaging in Australia. After plain packaging, leading brand variant numbers expanded by 9 to 116 and colour variant names increased by 73.6% and became the norm-lighter colours (blue, gold and silver) dominated, perpetuating notions of less harmful cigarettes. [Correction added on 09 September 2016, after first online publication: The figures in the last sentence of the Abstract are now corrected from 'expanded by 116' to 'expanded by 9 to 116'.]. © 2016 Society for the Study of Addiction.

75 FR 3665 - Regulations under the Comprehensive Smokeless Tobacco Health Education Act; Termination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-22

... event-related objects that display the brand name, logo, or selling message of smokeless tobacco... vehicles and other event-related objects bearing smokeless tobacco brand names, logos, or selling messages... using brand names, logos, or selling messages. Given these legislative and likely regulatory changes...

48 CFR 811.104 - Use of brand name or equal purchase descriptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Use of brand name or equal purchase descriptions. 811.104 Section 811.104 Federal Acquisition Regulations System DEPARTMENT OF... Requirements Documents 811.104 Use of brand name or equal purchase descriptions. ...

49 CFR 574.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... forth the method by which new tire manufacturers and new tire brand name owners shall identify tires for... retreaded tire brand name owners shall identify tires for use on motor vehicles. This part also sets forth... manufacturers and new tire brand name owners, and by which other tire dealers and distributors shall record and...

48 CFR 452.211-71 - Equal Products Offered.

Code of Federal Regulations, 2010 CFR

2010-10-01

... in solicitations seeking offers on a “brand name or equal” basis to allow offerors the opportunity to... furnish an “equal” product, in accordance with the “Brand Name or Equal” provision of this solicitation... any): Brand Name or Equal Product identified by the Government in this solicitation: Offered Product...

30 CFR 15.7 - Approval marking.

Code of Federal Regulations, 2010 CFR

2010-07-01

... under the brand or trade name specified in the approval. (b) The wrapper of each cartridge and each case of approved explosives shall be legibly labeled with the following: the brand or trade name, “MSHA... legibly labeled with the following: the brand or trade name, “MSHA Approved Sheathed Explosive Unit”, the...

An unhealthy public-private tension: pharmacy ownership, prescribing, and spending in the Philippines.

PubMed

James, Chris D; Peabody, John; Solon, Orville; Quimbo, Stella; Hanson, Kara

2009-01-01

Physicians' links with pharmacies may create perverse financial incentives to overprescribe, prescribe products with higher profit margins, and direct patients to their pharmacy. Interviews with pharmacy customers in the Philippines show that those who use pharmacies linked to public-sector physicians had 5.4 greater odds of having a prescription from such physicians and spent 49.3 percent more than customers using other pharmacies. For customers purchasing brand-name medicines, switching to generics would reduce drug spending by 58 percent. Controlling out-of-pocket spending on drugs requires policies to control financial links between doctors and pharmacies, as well as tighter regulation of nongeneric prescribing.

An ERP-study of brand and no-name products.

PubMed

Thomas, Anika; Hammer, Anke; Beibst, Gabriele; Münte, Thomas F

2013-11-23

Brands create product personalities that are thought to affect consumer decisions. Here we assessed, using the Go/No-go Association Task (GNAT) from social psychology, whether brands as opposed to no-name products are associated with implicit positive attitudes. Healthy young German participants viewed series of photos of cosmetics and food items (half of them brands) intermixed with positive and negative words. In any given run, one category of goods (e.g., cosmetics) and one kind of words (e.g., positive) had to be responded to, whereas responses had to be withheld for the other categories. Event-related brain potentials were recorded during the task. Unexpectedly, there were no response-time differences between congruent (brand and positive words) and incongruent (brand and negative words) pairings but ERPs showed differences as a function of congruency in the 600-750 ms time-window hinting at the existence of implicit attitudes towards brand and no-name stimuli. This finding deserves further investigation in future studies. Moreover, the amplitude of the late positive component (LPC) was found to be enhanced for brand as opposed to no-name stimuli. Congruency effects suggest that ERPs are sensitive to implicit attitudes. Moreover, the results for the LPC imply that pictures of brand products are more arousing than those of no-name products, which may ultimately contribute to consumer decisions.

Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study

PubMed Central

2010-01-01

Background A rise in gastrointestinal (GI) adverse events (AEs) and a decline in bone mineral density (BMD) was observed in patients previously tolerant to brand alendronate shortly after generic versions were introduced in July 2005 to the Canadian market. The objective of our study was to quantify changes in AE rates and BMD scores, as well as associated alendronate discontinuation among patients before and after switch from brand to generic alendronate. Methods A chart review of postmenopausal women 50 years of age and older between 2003 and 2007 was conducted in two specialized tertiary care referral centers. Patients on alendronate both before and after July 2005 were included. The change in the number of AEs, changes in BMD and associated alendronate discontinuation was compared before and after the switch from brand to generic alendronate. Results 301 women with an average age of 67.6 years (standard deviation (SD) = 9.5) had a total of 47 AEs between July 2003 and December 2007 that resulted in discontinuation of the medication. There was a significant increase in the rate of AEs per patient-months-at-risk from 0.0001 before to 0.0044 after October 2005 (p < 0.001). The most common AEs were GI in nature (stomach pain, GI upset, nausea, and reflux). In addition, 23 patients discontinued alendronate due to BMD reduction after January 2006. In these patients, BMD scores were significantly reduced from their prior BMD measures (change of -0.0534, p < 0.001 for spine BMD and change of -0.0338, p = 0.01 for femur BMD). Among patients who discontinued due to BMD reduction, BMD was stable in the period prior to January 2006 (change of -0.0066, p = 0.5 for spine BMD and change of 0.0011, p = 0.9 for femur BMD); however, testing for reduction after January 2006 in BMD measures (one-sided T-test) revealed there was a significant reduction in BMD scores for both anatomic sites (change of -0.0321, p = .005 for spine, change of -0.0205, p = 0.05 for femur). Conclusions Patients who were previously stable on doses of brand alendronate experienced an increase in AEs causing discontinuation after introduction of automatic substitution to generic alendronate. In addition, reductions in BMD were observed in some patients who had stable BMDs before January 2006. Given the substantial increase in AEs, generic alendronate may not be as well tolerated as brand alendronate. PMID:20388226

Retailer branding of consumer sales promotions. A major development in food marketing?

PubMed

Hamlin, Robert P; Lindsay, Sophie; Insch, Andrea

2012-02-01

This article examines retailer branding of consumer price promotions. It discusses the mechanics of price promotions, consumers' reactions to them and the benefits that accrue to those that use them. It describes how large food retailers can now deploy branded price promotion systems that are fundamentally different to 'traditional' price promotions in both their mechanics and their effects on consumer decision processes. The article describes a field experiment that compared the performance of a food retailer's branded price promotion system with that of a generic (manufacturer) price promotion. The research involved three experiments that covered two food categories (sliced bread and margarine) and two levels of discount (10% and 20%). The results indicate that food retailers are able to attach powerful brands to their price promotion systems, and these brand heuristics can significantly increase consumer purchase intent relative to an equivalent generic/manufacturer promotion. This incremental heuristic effect was stable in both categories and for both levels of price discount studied. These results are consistent with the predictions of alternative, non-cognitive and heuristic based models of food consumer choice that have been published recently in 'Appetite'. Copyright © 2011 Elsevier Ltd. All rights reserved.

Functional Measurement Analysis of Brand Equity: Does Brand Name Affect Perceptions of Quality?

ERIC Educational Resources Information Center

Hilgenkamp, Heather; Shanteau, James

2010-01-01

This research project used Functional Measurement to examine how the brand name of consumer products impacts intended purchasing decisions. Thirty undergraduate students tested actual products from three different product categories (crayons, tissues, and tortilla chips). Each product category consisted of three different brands; one with high…

Exploring Knowledge and Perceptions of Generic Medicines Among Drug Retailers and Community Pharmacists

PubMed Central

Basak, S. C.; Sathyanarayana, D.

2012-01-01

The study was carried out to evaluate community pharmacists’ and drug retailers’ knowledge and perceptions about generic medicines. A cross-sectional descriptive study, with a questionnaire, was conducted to survey community pharmacists and drug retailers working in 39 randomly selected private pharmacies from two towns of Tamil Nadu, India. Among 66 respondents (pharmacists and drug retailers), 39 (59.1%) were drug retailers; 52 (78.8%) were self-employed; majority in the age group 31-40 (31.8%); and mostly males (83.3%). Overall, 21 respondents (31.8%) did not know what generic medicines were. About 30% of the respondents thought that generic medicines are of inferior quality compared to branded medicines. Only 63.6% of the surveyed pharmacists and drug retailers agreed that generic medicines can be considered therapeutically equivalent with the branded ones. A higher level of education had a direct relationship having correct knowledge of generic medicines (P<0.01). The majority of the respondents (80%) did not support generic substitution, even in case of prescribed medicines are not available. Many community pharmacists and drug retailers have misconceptions regarding generic medicines. Lack of knowledge may negatively affect the community pharmacists’ support towards generic medicines in India. This issue should be addressed by academicians and other relevant bodies. PMID:23798785

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

PubMed

Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

2011-02-01

To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

Prescription, Dispensation, and Generic Medicine Replacement Ratios: Influence on Japanese Medicine Costs

PubMed Central

Yokoi, Masayuki; Tashiro, Takao

2016-01-01

This study used publicly available data to examine the effect of the separation of dispensing and prescribing medicines between pharmacists in pharmacies and doctors in medical institutions (the separation system) and the generic medicine replacement ratio on the cost of various medicines in Japanese prefectures. For Japanese medical institutions, participation in the separation system is optional. Consequently, the expansion rate of the separation system for each administrative district is highly variable. In our multiple regression analysis, the dependent variables were the costs of daily medicines, specifically, total, internal, external, and injection medicines, as well as medical devices, and the independent variables were the expansion rate of the separation system and generic medicine replacement ratio. The expansion rate of the separation system showed a significant negative partial correlation with the daily costs of total, internal, and injection medicines as well as medical devices. Moreover, the rate of replacing brand name medicines with generic medicines showed a significant negative partial correlation with the daily costs of total and internal medicines. However, external and injection medicines and medical devices did not because only a few or no generic products of these types were sold in the Japanese market. Otherwise, expansion of the separation system was effective in reducing medicine costs, except in the case of external medicines. This suggests that the cost efficiency effect of the separation system does not function all the time. PMID:26234979

[Lack of bioavailability of generic lopinavir/ritonavir not prequalified by WHO marketed in Africa (Congo Brazzaville)].

PubMed

Camara, S; Zucman, D; Vasse, M; Goudjo, A; Guillard, E; Peytavin, G

2015-02-01

Although second-line generic antiretroviral drugs are of great value in developing countries there are concerns regarding their quality and safety. This study is a case report and pharmacological study in healthy volunteers. A French subject of sub-saharan origin who visited Republic of Congo received a post-exposure treatment with AZT+3TC and LPV/r (200/50 mg, Arga-L®, India) following unprotected sexual intercourse. Two days later, in France, tests showed that plasma concentrations of lopinavir and ritonavir were undetectable. The WHO prequalification list showed Arga-L® was not prequalified. A pharmacological study in healthy volunteers evaluated oral bioavailability: plasma concentrations of generic LPV/r Arga-L® and LPV/r Kaletra® (400/100 mg) were measured after one single dose at 7 days apart in four healthy volunteers. Concentrations of Arga-L® at 12 h after intake were considerably lower than those of Kaletra®, revealing very low oral bioavailability of generic lopinavir and ritonavir (<10%) compared to the brand-name drug. We found that Arga-L®, despite having adequate qualitative and quantitative drug contents, had very poor bio availability compared to Kaletra®. In order to avoid the selection and the spread of drug-resistant HIV strains, rigorous pharmacological monitoring of generic antiretroviral drugs that are not pre-qualified by WHO, but are marketed in Africa, must be a priority for health authorities.

Recognition of cigarette brand names and logos by primary schoolchildren in Ankara, Turkey.

PubMed

Emri, S; Bağci, T; Karakoca, Y; Bariş, E

1998-01-01

To assess the smoking behaviour of primary schoolchildren and their ability to recognise brand names and logos of widely advertised cigarettes, compared with other commercial products intended for children. Cross-sectional survey in classroom settings using a questionnaire designed to measure attitudes towards smoking and the recognition of brand names and logos for 16 food, beverage, cigarette, and toothpaste products. Ankara, Turkey. 1093 children (54.6% boys, 44.4% girls) aged 7-13 years (mean = 10, SD = 1), from grades 2-5. The student sample was taken from three primary schools--one school in each of three residential districts representing high, middle, and low income populations. Prevalence of ever-smoking, recognition of brand names and logos. Prevalence of ever-smoking was 11.7% overall (13.9% among boys and 9.1% among girls; p < 0.05). Children aged eight years or less had a higher prevalence of ever-smoking (19.6%) than older children (p < 0.002). Ever-smoking prevalence did not differ significantly across the three school districts. Ever-smoking prevalence was higher among children with at least one parent who smoked (15.3%) than among those whose parents did not (4.8%) (p < 0.001). Brand recognition rates ranged from 58.1% for Chee-tos (a food product) to 95.2% for Samsun (a Turkish cigarette brand). Recognition rates for cigarette brand names and logos were 95.2% and 80.8%, respectively, for Samsun; 84.0% and 90.5%, respectively, for Camel; and 92.1% and 69.5%, respectively, for Marlboro. The Camel logo and the Samsun and Marlboro brand names were the most highly recognised of all product logos and brand names tested. The high recognition of cigarette brand names and logos is most likely the result of tobacco advertising and promotion. Our results indicate the need to implement comprehensive tobacco control measures in Turkey.

27 CFR 31.155 - Records of receipt.

Code of Federal Regulations, 2010 CFR

2010-04-01

... receipt, including date of inventory for recorded gains; (3) Brand name; (4) Name of producer or bottler... identifying the producer or bottler with the brand name; (5) Kind of spirits. However, this may be omitted if the dealer keeps available for inspection a separate list or record identifying “kind” with the brand...

42 CFR 447.512 - Drugs: Aggregate upper limits of payment.

Code of Federal Regulations, 2010 CFR

2010-10-01

...: Aggregate upper limits of payment. (a) Multiple source drugs. Except for brand name drugs that are certified... applies. (b) Other drugs. The agency payments for brand name drugs certified in accordance with paragraph... brand name drugs. (1) The upper limit for payment for multiple source drugs for which a specific limit...

75 FR 28012 - Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-19

... Pesticide Registrants on False or Misleading Pesticide Product Brand Names AGENCY: Environmental Protection... Pesticide Product Brand Names.'' PR Notices are issued by the Office of Pesticide Programs (OPP) to inform... concerning pesticide product brand names that may be false or misleading, either by themselves or in...

48 CFR 811.105 - Items peculiar to one manufacturer.

Code of Federal Regulations, 2010 CFR

2010-10-01

... meet the minimum requirements of VA (see FAR 11.105) or that a “brand name or equal” purchase... particular characteristic is essential to the Government's requirements. (ii) Explain why the “brand name or... whether restrictive specifications or “brand name or equal” purchase descriptions will be included in the...

[Memantine: from the original brand to generics].

PubMed

Titova, N V

Memantine is the first clinically available glutamate antagonist, with an antagonist action at the N-methyl-D-aspartate receptors in the brain, for correction of cognitive and behavioral functions in neurodegenerative disorders. Glutamate mediated excitotoxic neuronal damage has been implicated in Alzheimer's disease (AD) and other parkinsonism-related dementias and, therefore, memantine represents a novel mode of action to counteract the glutamate-mediated excitotoxicity. In moderate to severe AD, 20 mg of memantine shows a positive effect on cognition, mood, behavior and the ability to perform activities of daily living. Long-term studies show good tolerability of memantine with an acceptable side-effect profile. In recent years, there have been a proliferation of a number of companies producing generic memantine with different trade names. In Russia, the first memantine generic drug noojerone was approved in 2010 and its use has since been supported by a growing evidence base of efficacy in real-life clinical practice. Postmarketing studies show that noojerone provides long-term and effective therapy in patients with moderate and severe Alzheimer's dementia. This observation is supported by the clinically significant therapeutic effect of noojerone on cognitive and daily functioning, behavioral and psychotic symptoms of dementia and a reduction of the burden on caregivers. This generic version of memantine is affordable and, therefore, reduces financial burden on patients and improves compliance with treatment.

Does every US smoker bear the same cigarette tax?

PubMed Central

Xu, Xin; Malarcher, Ann; O’Halloran, Alissa; Kruger, Judy

2015-01-01

Aims To evaluate state cigarette excise tax pass-through rates for selected price-minimizing strategies. Design Multivariate regression analysis of current smokers from a stratified, national, dual-frame telephone survey. Setting United States. Participants A total of 16 542 adult current smokers aged 18 years or older. Measurements Cigarette per pack prices paid with and without coupons were obtained for pack versus carton purchase, use of generic brands versus premium brands, and purchase from Indian reservations versus outside Indian reservations. Findings The average per pack prices paid differed substantially by price-minimizing strategy. Smokers who used any type of price-minimizing strategies paid substantially less than those who did not use these strategies (P < 0.05). Premium brand users who purchased by pack in places outside Indian reservations paid the entire amount of the excise tax, together with an additional premium of 7–10 cents per pack for every $1 increase in excise tax (pass-through rate of 1.07–1.10, P < 0.05). In contrast, carton purchasers, generic brand users or those who were likely to make their purchases on Indian reservations paid only 30–83 cents per pack for every $1 tax increase (pass-through rate of 0.30–0.83, P < 0.05). Conclusions Many smokers in the United States are able to avoid the full impact of state excise tax on cost of smoking by buying cartons, using generic brands and buying from Indian reservations. PMID:24861973

Generic substitution of lamotrigine among medicaid patients with diverse indications: a cohort-crossover study.

PubMed

Hartung, Daniel M; Middleton, Luke; Svoboda, Leanne; McGregor, Jessina C

2012-08-01

Controversy exists about the safety of substituting generic antiepileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient's past refills of branded lamotrigine. Multivariate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR] = 1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR = 1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not observed following the switch from brand to generic lamotrigine, although a type II error cannot be ruled out.

Comparing employer-sponsored and federal exchange plans: wide variations in cost sharing for prescription drugs.

PubMed

Buttorff, Christine; Andersen, Martin S; Riggs, Kevin R; Alexander, G Caleb

2015-03-01

Just under seven million Americans acquired private insurance through the new health insurance exchanges, or Marketplaces, in 2014. The exchange plans are required to cover essential health benefits, including prescription drugs. However, the generosity of prescription drug coverage in the plans has not been well described. Our primary objective was to examine the variability in drug coverage in the exchanges across plan types (health maintenance organization or preferred provider organization) and metal tiers (bronze, silver, gold, and platinum). Our secondary objective was to compare the exchange coverage to employer-sponsored coverage. Analyzing prescription drug benefit design data for the federally facilitated exchanges, we found wide variation in enrollees' out-of-pocket costs for generic, preferred brand-name, nonpreferred brand-name, and specialty drugs, not only across metal tiers but also within those tiers across plan types. Compared to employer-sponsored plans, exchange plans generally had lower premiums but provided less generous drug coverage. However, for low-income enrollees who are eligible for cost-sharing subsidies, the exchange plans may be more comparable to employer-based coverage. Policies and programs to assist consumers in matching their prescription drug needs with a plan's benefit design may improve the financial protection for the newly insured. Project HOPE—The People-to-People Health Foundation, Inc.

27 CFR 25.142 - Bottles.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY LIQUORS BEER Marks, Brands, and Labels § 25.142 Bottles. (a) Label requirements. Each bottle of... brewer's name, trade name or brand name includes the name of a city which is not the place where the beer...

Recognition of cigarette brand names and logos by primary schoolchildren in Ankara, Turkey

PubMed Central

Emri, S.; Bagci, T.; Karakoca, Y.; Baris, E.

1998-01-01

OBJECTIVE—To assess the smoking behaviour of primary schoolchildren and their ability to recognise brand names and logos of widely advertised cigarettes, compared with other commercial products intended for children.
DESIGN—Cross-sectional survey in classroom settings using a questionnaire designed to measure attitudes towards smoking and the recognition of brand names and logos for 16 food, beverage, cigarette, and toothpaste products.
SETTING—Ankara, Turkey.
SUBJECTS—1093 children (54.6% boys, 44.4% girls) aged 7-13 years (mean = 10, SD = 1), from grades 2-5. The student sample was taken from three primary schools—one school in each of three residential districts representing high, middle, and low income populations.
MAIN OUTCOME MEASURES—Prevalence of ever-smoking, recognition of brand names and logos.
RESULTS—Prevalence of ever-smoking was 11.7% overall (13.9% among boys and 9.1% among girls; p<0.05). Children aged eight years or less had a higher prevalence of ever-smoking (19.6%) than older children (p<0.002). Ever-smoking prevalence did not differ significantly across the three school districts. Ever-smoking prevalence was higher among children with at least one parent who smoked (15.3%) than among those whose parents did not (4.8%) (p<0.001). Brand recognition rates ranged from 58.1% for Chee-tos (a food product) to 95.2% for Samsun (a Turkish cigarette brand). Recognition rates for cigarette brand names and logos were 95.2% and 80.8%, respectively, for Samsun; 84.0% and 90.5%, respectively, for Camel; and 92.1% and 69.5%, respectively, for Marlboro. The Camel logo and the Samsun and Marlboro brand names were the most highly recognised of all product logos and brand names tested.
CONCLUSIONS—The high recognition of cigarette brand names and logos is most likely the result of tobacco advertising and promotion. Our results indicate the need to implement comprehensive tobacco control measures in Turkey.


Keywords: advertising; brand recognition; children; Turkey PMID:10093173

Cost-effectiveness Analysis of Denosumab in the Prevention of Skeletal-related Events in Patients with Prostate Cancer in Kazakhstan.

PubMed

Bektur, Carina; Nurgozhin, Talgat

2014-01-01

Bone mass loss (BML) is one of the adverse effects of oncological chemotherapy, especially in cases of hormonal types of cancer, such as a prostate cancer (PC). BML is strongly associated with skeletal-related events (SREs), therefore decreasing the quality of patient's life. Denosumab shows an advantage over zoledronic acid (ZA) in delaying the first onset of SREs and subsequent SREs in adults with PC in several phase III clinical trials. Since generic ZA recently became available, the purpose of the present study was to assess the cost-effectiveness of denosumab vs. brand or generic ZA in the prevention of SREs in Kazakhstani patients with PC. A Markov model was constructed in Tree-Age Pro 2013 software program with 4-week model cycles to analyze the cost-effectiveness of the treatments from the perspective of Ministry of Health (MoH) over a 10-year PC cohort. Direct costs (in Kazakhstani monetary units "tenge" in 2014) included costs of drug, SRE (pathologic fracture, surgery to bone, radiation to bone, spinal cord compression), and adverse events treatment. All costs were discounted for 3% per year. Effectiveness was appraised based on the number of SREs. Health states were defined according to SRE occurrence, SRE history, and death. The model assumed that a maximum of 1 SRE could occur in each cycle. Transition probabilities were derived from the relevant phase III trials. Results were present in the incremental total cost per SRE avoided. One-way sensitivity analyses were performed to examine the robustness of the model. Over the 10-year period, denosumab incurred 103,091 tenge higher costs than brand ZA, 677,133 tenge higher costs than generic ZA, and 0.58 fewer SREs per patient with PC. The estimated incremental total direct costs per SRE avoided with the use of denosumab were 177,743 tenge (instead of brand ZA) and 1,167,470 tenge (instead of generic ZA). Results were robust to one-way sensitivity analyses. With the assumption that brand and generic ZAs are equally effective in the prevention of SREs in PC patients, denosumab seems to be a cost-effective alternative for brand ZA (insignificant difference in costs - less than 5%) and a costly alternative for generic ZA from the perspective of MoH of Kazakhstan.

An ERP-study of brand and no-name products

PubMed Central

2013-01-01

Background Brands create product personalities that are thought to affect consumer decisions. Here we assessed, using the Go/No-go Association Task (GNAT) from social psychology, whether brands as opposed to no-name products are associated with implicit positive attitudes. Healthy young German participants viewed series of photos of cosmetics and food items (half of them brands) intermixed with positive and negative words. In any given run, one category of goods (e.g., cosmetics) and one kind of words (e.g., positive) had to be responded to, whereas responses had to be withheld for the other categories. Event-related brain potentials were recorded during the task. Results Unexpectedly, there were no response-time differences between congruent (brand and positive words) and incongruent (brand and negative words) pairings but ERPs showed differences as a function of congruency in the 600–750 ms time-window hinting at the existence of implicit attitudes towards brand and no-name stimuli. This finding deserves further investigation in future studies. Moreover, the amplitude of the late positive component (LPC) was found to be enhanced for brand as opposed to no-name stimuli. Conclusions Congruency effects suggest that ERPs are sensitive to implicit attitudes. Moreover, the results for the LPC imply that pictures of brand products are more arousing than those of no-name products, which may ultimately contribute to consumer decisions. PMID:24267403

The impact of tamoxifen brand switch on side effects and patient compliance in hormone receptor positive breast cancer patients.

PubMed

Zeidan, B; Anderson, K; Peiris, L; Rainsbury, D; Laws, S

2016-10-01

In 2006 Nolvadex was discontinued and replaced by a variety of alternative generic tamoxifen brands for the adjuvant treatment of breast cancer. Anecdotally, patients are switching brands and taking alternative medications to reduce treatment related symptoms. Nevertheless, more severe side effects may equate to better relapse prevention. This study evaluates generic tamoxifen adherence and its correlation with side effects and brand switch. Consecutive disease free ER positive patients (stage I-III) were invited to respond to a questionnaire. 165 of 327 questionnaires were returned (50% response). Pearson's Chi Square test was used for data analysis. 63 patients (38%) reported a switch between generic tamoxifen. 59% of all patients experienced side effects associated with tamoxifen treatment of which 53% were severe. Patients experiencing differential symptoms dependent on tamoxifen brand reported more severe side effects (p = 0.02). Non-prescribed supplements were taken by 42% of all patients with no significant improvement in climacteric symptoms (p = 0.05). The concomitant use of SSRIs appeared to have no effect on symptoms. A significant number of patients considered discontinuing tamoxifen because of the side effects (p = 0.001), yet this did not translate into discontinuation or non-adherence (p = 0.8 and 0.08 respectively). Severe tamoxifen side effects are commonly experienced by breast cancer patients and can be significantly altered by change in tamoxifen brand. Most patients will continue to take tamoxifen, despite side effects to avoid cancer relapse. Supplementation and antidepressants did not improve tamoxifen related side effects in our cohort. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Thai generic-brand dry canine foods: mutagenicity and the effects of feeding in vivo and in vitro.

PubMed

Khuntamoon, Tanyalak; Thepouyporn, Apanchanid; Kaewprasert, Sarunya; Prangthip, Pattaneeya; Pooudoung, Somchai; Chaisri, Urai; Maneesai, Phudit; Kwanbunjan, Karunee

2016-01-20

The commercial pet-food industry and the market value of the pet industry have increased. Most owners are concerned about their pets' health, and prefer commercial pet foods as their regular diet. This study thus aimed to determine whether a selection of local generic-brand dry canine foods had any potential to promote chronic disease. Five local, generic-brand, dry canine foods were studied for potential mutagenicity; the effects of long-term consumption were also observed in rats. All canine foods were extracted with distilled water and absolute ethanol. The Ames test was used to detect short-term genetic damage, using Salmonella typhimurium tester strains TA98 and TA100. Simultaneously, the long-term effects were studied in an animal model by observing rats fed with these canine foods, compared with normal rat food, for a period of 15 weeks. Using the water extracts, all dry canine foods studied showed considerable mutagenic effects on the tester strains. One brand affected both tester strains, whereas 3 showed positive to TA98, and one to TA100. With the absolute ethanol extract, three of the five brands had a considerable mutagenic effect on TA98, and another affected TA100. In the long-term test, all rats remained alive until the end of the experiment, exhibited no apparent signs of toxicity or serious illness, and maintained normal bodyweight and weight gain. Serum blood biochemistry and hematological parameters in canine food-fed rats showed some negative effects. Correspondingly, histopathological investigation of their liver and kidneys showed deterioration. Mutagenic potential and the negative potential health impacts were observed in all local-brand dry canine foods tested.

48 CFR 811.104-74 - Bid evaluation and award.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 811.104-74 Bid evaluation and award. (a) A bid offering products that differ from brand name products referenced in a “brand name or equal” purchase description must be considered for award if the contracting officer determines in accordance with the terms of the clause at 852.211-73, Brand name or equal, that the...

Is the Brazilian pharmaceutical policy ensuring population access to essential medicines?

PubMed Central

2012-01-01

Background To evaluate medicine prices, availability and affordability in Brazil, considering the differences across three types of medicines (originator brands, generics and similar medicines) and different types of facilities (private pharmacies, public sector pharmacies and “popular pharmacies”). Methods Data on prices and availability of 50 medicines were collected in 56 pharmacies across six cities in Southern Brazil using the World Health Organization / Health Action International methodology. Median prices obtained were divided by international reference prices to derive the median price ratio (MPR). Results In the private sector, prices were 8.6 MPR for similar medicines, 11.3 MRP for generics and 18.7 MRP for originator brands, respectively. Mean availability was 65%, 74% and 48% for originator brands, generics and similar medicines, respectively. In the public sector, mean availability of similar medicines was 2–7 times higher than that of generics. Mean overall availability in the public sector ranged from 68.8% to 81.7%. In “popular pharmacies”, mean availability was greater than 90% in all cities. Conclusions Availability of medicines in the public sector does not meet the challenge of supplying essential medicines to the entire population, as stated in the Brazilian constitution. This has unavoidable repercussions for affordability, particularly amongst the lower socio-economic strata. PMID:22436555

Development of a New Branded UK Food Composition Database for an Online Dietary Assessment Tool

PubMed Central

Carter, Michelle C.; Hancock, Neil; Albar, Salwa A.; Brown, Helen; Greenwood, Darren C.; Hardie, Laura J.; Frost, Gary S.; Wark, Petra A.; Cade, Janet E.

2016-01-01

The current UK food composition tables are limited, containing ~3300 mostly generic food and drink items. To reflect the wide range of food products available to British consumers and to potentially improve accuracy of dietary assessment, a large UK specific electronic food composition database (FCDB) has been developed. A mapping exercise has been conducted that matched micronutrient data from generic food codes to “Back of Pack” data from branded food products using a semi-automated process. After cleaning and processing, version 1.0 of the new FCDB contains 40,274 generic and branded items with associated 120 macronutrient and micronutrient data and 5669 items with portion images. Over 50% of food and drink items were individually mapped to within 10% agreement with the generic food item for energy. Several quality checking procedures were applied after mapping including; identifying foods above and below the expected range for a particular nutrient within that food group and cross-checking the mapping of items such as concentrated and raw/dried products. The new electronic FCDB has substantially increased the size of the current, publically available, UK food tables. The FCDB has been incorporated into myfood24, a new fully automated online dietary assessment tool and, a smartphone application for weight loss. PMID:27527214

Development of a New Branded UK Food Composition Database for an Online Dietary Assessment Tool.

PubMed

Carter, Michelle C; Hancock, Neil; Albar, Salwa A; Brown, Helen; Greenwood, Darren C; Hardie, Laura J; Frost, Gary S; Wark, Petra A; Cade, Janet E

2016-08-05

The current UK food composition tables are limited, containing ~3300 mostly generic food and drink items. To reflect the wide range of food products available to British consumers and to potentially improve accuracy of dietary assessment, a large UK specific electronic food composition database (FCDB) has been developed. A mapping exercise has been conducted that matched micronutrient data from generic food codes to "Back of Pack" data from branded food products using a semi-automated process. After cleaning and processing, version 1.0 of the new FCDB contains 40,274 generic and branded items with associated 120 macronutrient and micronutrient data and 5669 items with portion images. Over 50% of food and drink items were individually mapped to within 10% agreement with the generic food item for energy. Several quality checking procedures were applied after mapping including; identifying foods above and below the expected range for a particular nutrient within that food group and cross-checking the mapping of items such as concentrated and raw/dried products. The new electronic FCDB has substantially increased the size of the current, publically available, UK food tables. The FCDB has been incorporated into myfood24, a new fully automated online dietary assessment tool and, a smartphone application for weight loss.

Phonotactic Probability of Brand Names: I'd buy that!

PubMed Central

Vitevitch, Michael S.; Donoso, Alexander J.

2011-01-01

Psycholinguistic research shows that word-characteristics influence the speed and accuracy of various language-related processes. Analogous characteristics of brand names influence the retrieval of product information and the perception of risks associated with that product. In the present experiment we examined how phonotactic probability—the frequency with which phonological segments and sequences of segments appear in a word—might influence consumer behavior. Participants rated brand names that varied in phonotactic probability on the likelihood that they would buy the product. Participants indicated that they were more likely to purchase a product if the brand name was comprised of common segments and sequences of segments rather than less common segments and sequences of segments. This result suggests that word-characteristics may influence higher-level cognitive processes, in addition to language-related processes. Furthermore, the benefits of using objective measures of word characteristics in the design of brand names are discussed. PMID:21870135

Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports.

PubMed

Klein, Kevin; Scholl, Joep H G; Vermeer, Niels S; Broekmans, André W; Van Puijenbroek, Eugène P; De Bruin, Marie L; Stolk, Pieter

2016-02-01

Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug reaction (ADR) is identifiable by brand name and batch number. Recent studies showed that brand name identification is well established, whereas batch numbers are (still) poorly reported. We evaluated information-recording systems and practices in the Dutch hospital setting to identify determinants for brand name and batch number recording as well as success factors and bottlenecks for traceability. We surveyed Dutch hospital pharmacists with an online questionnaire on systems and practices in hospitals for recording brand names and batch numbers. Additionally, we performed an analysis of the traceability of recombinant biologics in spontaneous ADR reports (received between 2009 and 2014) from the Netherlands Pharmacovigilance Centre Lareb. The survey showed that brand names are not routinely recorded in the clinical practice of Dutch hospitals, whereas batch numbers are poorly recorded. Seventy-six percent of the 1523 ADR reports for recombinant biologics had a traceable brand name whereas 5% of these reports contained a batch number. The results suggest a possible relationship between the availability of brand and batch number information in clinical practice and the inclusion of this information in ADR reports for biologics. The limited traceability of brand names and batch numbers in ADR reports may be primarily caused by the shortcomings in the recording of information in clinical practice. We recommend efforts to improve information-recording systems as a first step to improve the traceability of biologics in ADR reporting.

Your most valuable asset. Increasing the value of your hospital through its brand.

PubMed

Petromilli, M; Michalczyk, D

1999-01-01

The authors argue that hospitals could achieve the same brand name recognition as such popular consumer product names as Coke, Nike, and GE. In fact, they say, a brand identity strategy could bring hospitals the advantage they need in a growing marketplace. Increasingly, brand recognition is becoming important in the health care world, as hospitals battle for customers. The majority of patients now choose their health plan and hospital, and they're seeking brands that provide them with the same convenience, access, and value they demand from other consumer products companies. Hospitals can create a viable brand identity strategy by defining their brand's image, maximizing their bran's positioning and patients' brand experience, communicating their brand and measuring the brand's performance.

Does humor in radio advertising affect recognition of novel product brand names?

PubMed

Berg, E M; Lippman, L G

2001-04-01

The authors proposed that item selection during shopping is based on brand name recognition rather than recall. College students rated advertisements and news stories of a simulated radio program for level of amusement (orienting activity) before participating in a surprise recognition test. Humor level of the advertisements was varied systematically, and content was controlled. According to signal detection analysis, humor did not affect the strength of recognition memory for brand names (nonsense units). However, brand names and product types were significantly more likely to be associated when appearing in humorous advertisements than in nonhumorous advertisements. The results are compared with prior findings concerning humor and recall.

Brand name confusion: Subjective and objective measures of orthographic similarity.

PubMed

Burt, Jennifer S; McFarlane, Kimberley A; Kelly, Sarah J; Humphreys, Michael S; Weatherall, Kimberlee; Burrell, Robert G

2017-09-01

Determining brand name similarity is vital in areas of trademark registration and brand confusion. Students rated the orthographic (spelling) similarity of word pairs (Experiments 1, 2, and 4) and brand name pairs (Experiment 5). Similarity ratings were consistently higher when words shared beginnings rather than endings, whereas shared pronunciation of the stressed vowel had small and less consistent effects on ratings. In Experiment 3 a behavioral task confirmed the similarity of shared beginnings in lexical processing. Specifically, in a task requiring participants to decide whether 2 words presented in the clear (a probe and a later target) were the same or different, a masked prime word preceding the target shortened response latencies if it shared its initial 3 letters with the target. The ratings of students for word and brand name pairs were strongly predicted by metrics of orthographic similarity from the visual word identification literature based on the number of shared letters and their relative positions. The results indicate a potential use for orthographic metrics in brand name registration and trademark law. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The Strategic Management of Store Brand Perceived Quality

NASA Astrophysics Data System (ADS)

Yang, Defeng

Store brand plays a vital role in the success of retailers. Perceived quality is one of important factors influencing consumers' store brand purchase intention. Store brand perceived quality is lower compared with objective quality or national brand. For this end, the purpose of this article is to examine how to manage store brand perceived quality in strategic level. This article firstly discusses how consumers evaluate product quality, and the theoretical background of the reason that store brand perceived quality is lower from the view of cue related theories. Then, consumers' store brand quality evaluation is explored. Finally, this article presents several strategic tactics to increase store brand perceived quality. These tactics include choosing store's name as store brand name, making large advertising investment, improving store brand product package, and strengthening the relationship with store brand product suppliers.

Does every US smoker bear the same cigarette tax?

PubMed

Xu, Xin; Malarcher, Ann; O'Halloran, Alissa; Kruger, Judy

2014-10-01

To evaluate state cigarette excise tax pass-through rates for selected price-minimizing strategies. Multivariate regression analysis of current smokers from a stratified, national, dual-frame telephone survey. United States. A total of 16 542 adult current smokers aged 18 years or older. Cigarette per pack prices paid with and without coupons were obtained for pack versus carton purchase, use of generic brands versus premium brands, and purchase from Indian reservations versus outside Indian reservations. The average per pack prices paid differed substantially by price-minimizing strategy. Smokers who used any type of price-minimizing strategies paid substantially less than those who did not use these strategies (P < 0.05). Premium brand users who purchased by pack in places outside Indian reservations paid the entire amount of the excise tax, together with an additional premium of 7-10 cents per pack for every $1 increase in excise tax (pass-through rate of 1.07-1.10, P < 0.05). In contrast, carton purchasers, generic brand users or those who were likely to make their purchases on Indian reservations paid only 30-83 cents per pack for every $1 tax increase (pass-through rate of 0.30-0.83, P < 0.05). Many smokers in the United States are able to avoid the full impact of state excise tax on cost of smoking by buying cartons, using generic brands and buying from Indian reservations. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Pharmacy discounts on generic medicines in France: is there room for further efficiency savings?

PubMed

Kanavos, Panos; Taylor, David

2007-10-01

In France control of pharmaceutical expenditure has been a policy priority for many years and generic policies have featured prominently on the policy agenda. Measures including reference pricing, generic substitution and international non-proprietary name (INN) prescribing have been introduced in recent years. Generic manufacturers and wholesalers may offer discounts, rebates or promotions to pharmacies in order to gain an edge over their competitors, but their true extent is unknown. To identify the amplitude of discounts on generic medicines, and whether wholesalers or generic manufacturers offer these beyond officially negotiated margins and allowable discounts, by conducting a pilot study. Data on net prices were acquired for all available presentations of 11 generic molecules selected across different therapeutic categories included in the 40 most selling generic products in 2005. Data were obtained via a questionnaire survey followed by interview with selected pharmacies (n = 4) and whole-salers (n = 2). Pharmacies and wholesalers participated in this study subject to confidentiality and anonymity. Pharmacies usually prefer to buy generic products directly from manufacturers rather than from wholesalers in order to avoid paying additional margins imposed by wholesalers. Discounts are mostly price-related and generally vary from 20 to 70% off the wholesaler selling price (WSP), on top of the officially allowed 10.74%. Discounts on the ex-factory price (EFP) are much lower, typically around 7.5%. Discounts are prohibited for branded products, beyond the officially allowed ceiling of 2.5%. While horizontal integration among pharmacies is disallowed, pharmacies may form purchasing groups allowing them to realise greater discounts from suppliers. Overall, the evidence suggests that discounts occur in France beyond what may be allowable and their extent can be significant. If general discount levels for generic medicines are as high as this pilot study suggests, then this may imply that health insurance in France may be overpaying for commodity generic medicines.

Evaluation of zero-order controlled release preparations of nifedipine tablet on dissolution test, together with cost benefit point of view.

PubMed

Sakurai, Miyuki; Naruto, Ikue; Matsuyama, Kenji

2008-05-01

Many generic drugs have been released to decrease medical expenses, but some problems have been reported with regard to bioavailability and safety. In this study, we compared three once-a-day controlled-release preparations of nifedipine by the dissolution test (one branded and two generic preparations). Although the two generic drugs were equivalent to the branded drug according to the criteria listed in the Japanese "Guideline for Bioequivalence Studies of Generic Products", there was still a possibility of problems arising. For example, side effects could be caused by a rapid increase in the blood level of nifedipine with one generic drug, while bioavailability might be inadequate with the other due to its small area under the concentration vs. time curve. When each drug was prescribed at a dosage of 20 mg once daily for two weeks, the difference in the copayment for the patient was only 10 yen. Accordingly, it is important for doctors and pharmacists to carefully consider whether such a slight difference in price is really a benefit for the patient.

48 CFR 411.170 - Brand name or equal.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Brand name or equal. 411.170 Section 411.170 Federal Acquisition Regulations System DEPARTMENT OF AGRICULTURE COMPETITION AND ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.170 Brand...

48 CFR 411.170 - Brand name or equal.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Brand name or equal. 411.170 Section 411.170 Federal Acquisition Regulations System DEPARTMENT OF AGRICULTURE COMPETITION AND ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.170 Brand...

48 CFR 411.170 - Brand name or equal.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Brand name or equal. 411.170 Section 411.170 Federal Acquisition Regulations System DEPARTMENT OF AGRICULTURE COMPETITION AND ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.170 Brand...

48 CFR 411.170 - Brand name or equal.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Brand name or equal. 411.170 Section 411.170 Federal Acquisition Regulations System DEPARTMENT OF AGRICULTURE COMPETITION AND ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.170 Brand...

Estimation of Potential Savings Through Therapeutic Substitution.

PubMed

Johansen, Michael E; Richardson, Caroline

2016-06-01

Therapeutic substitution offers potential to decrease pharmaceutical expenditures and potentially improve the efficiency of the health care system. To estimate potential savings through therapeutic substitution in terms of both overall and out-of-pocket expenditures of branded drugs when a generic in the same class with the same indication was available. Repeated cross-sectional study using the 107 132 individuals included in the nationally representative Medical Expenditure Panel Survey (2010-2012) along with their reported prescribed medicine use. The Orange Book, company financial statements, US Food and Drug Administration records, and published research were used for adjunctive information. Estimated excess expenditure due to branded drug overuse when a lower-cost generic in the same class with the same indication was available. The study included 107 132 individuals between 2010 and 2012, of whom 62.1% (95% CI, 61.4%-62.8%) reported use of any prescribed medicine. A total of 31.5% (95% CI, 30.7%-32.2%) used a medication from an included drug class, whereas 16.6% (95% CI, 16.0%-17.1%) of the population used a branded drug from the included classes compared with 24.0% (95% CI, 23.4%-24.7%) who used a generic and 9.1% (95% CI, 8.7%-9.4%) who used both. In the included drug classes, the majority of the drugs were generics, with a total of 93.5 billion standardized doses compared with 47.4 billion standardized doses of branded drugs. Total expenditure of the branded drugs accounted for $147 (95% CI, $137-$156) billion compared with $62.7 (95% CI, $58.9-$66.5) billion for the generics. Between 2010 and 2012, an estimated $73.0 (95% CI, $67.6-$78.5) billion in total excess expenditure and $24.6 (95% CI, $22.6-$26.5) billion in out-of-pocket excess expenditure was attributable to branded drug overuse. The excess was present across numerous drug classes throughout many aspects of medicine and equates to 9.6% of total and 14.1% of out-of-pocket prescribed medicine expenses. The drug classes with the highest excess expenditure included statins ($10.9 [SE, $0.41] billion), atypical antipsychotics ($9.99 [SE, $1.03] billion), proton pump inhibitors ($6.12 [SE, $0.38] billion), selective serotonin reuptake inhibitors ($6.08 [SE, $0.49] billion), and angiotensin receptor blockers ($5.53 [SE, $0.35] billion). Although therapeutic substitution is controversial, it offers a potential mechanism to significantly decrease drug costs if it can be implemented in a way that does not negatively affect quality of care.

Influence of premium vs masked cigarette brand names on the experienced taste of a cigarette after tobacco plain packaging in Australia: an experimental study.

PubMed

Skaczkowski, Gemma; Durkin, Sarah; Kashima, Yoshihisa; Wakefield, Melanie

2018-03-12

Few studies have experimentally assessed the contribution of branding to the experience of smoking a cigarette, compared with the inherent properties of the product. This study examined the influence of cigarette brand name on the sensory experience of smoking a cigarette. Seventy-five Australian smokers aged 18-39 years smoked two 'premium' cigarettes, one with the brand variant name shown and one with the brand variant name masked (which provided 'objective' ratings). Unknown to participants, the two cigarettes were identical. At recruitment, participants rated their expected enjoyment, quality and harshness of several premium cigarette brands. Branded cigarettes were rated as having a significantly more favorable taste (M(SE) = 64.14(2.21)) than masked cigarettes (M(SE) = 58.53(2.26), p = .031). Branded cigarettes were also rated as being less stale (M(SE) = 36.04(2.62)) than masked cigarettes (M(SE) = 43.90(2.60), p = .011). Purchase intent tended to be higher among those shown the branded cigarette compared to the masked cigarette (χ 2 (1) = 3.00, p = .083). Expected enjoyment and quality of the brand variant (enjoyment: b = 0.31, 95%CI = 0.11, 0.51, p < .01; quality: b = 0.46, 95%CI = 0.21, 0.72, p < .01) contributed to the perceived smoking experience more than the objective enjoyment and quality of the cigarette (enjoyment: b = 0.23, 95%CI = 0.05, 0.41, p < .05; quality: b = 0.08, 95%CI = - 0.13, 0.30, p > .05). This pattern was not observed for cigarette harshness. A premium brand variant name can enhance the subjective experience of a cigarette. Further, smokers' expectations of such brand variants contribute to the smoking experience as much, if not more than, the actual qualities of the product.

Brand names of Portuguese medication: understanding the importance of their linguistic structure and regulatory issues.

PubMed

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2015-08-01

Among other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

Brand Name Statin Prescribing in a Resident Ambulatory Practice: Implications for Teaching Cost-Conscious Medicine.

PubMed

Ryskina, Kira L; Pesko, Michael F; Gossey, J Travis; Caesar, Erica Phillips; Bishop, Tara F

2014-09-01

Several national initiatives aim to teach high-value care to residents. While there is a growing body of literature on cost impact of physicians' therapeutic decisions, few studies have assessed factors that influence residents' prescribing practices. We studied factors associated with intensive health care utilization among internal medicine residents, using brand name statin prescribing as a proxy for higher-cost care. We conducted a retrospective, cross-sectional analysis of statin prescriptions by residents at an urban academic internal medicine program, using electronic health record data between July 1, 2010, and June 30, 2011. For 319 encounters by 90 residents, patients were given a brand name statin in 50% of cases. When categorized into quintiles, the bottom quintile of residents prescribed brand name statins in 2% of encounters, while the top quintile prescribed brand name statins in 98% of encounters. After adjusting for potential confounders, including patient characteristics and supervising attending, being in the primary care track was associated with lower odds (odds ratio [OR], 0.38; P  =  .02; 95% confidence interval [CI], 0.16-0.86), and graduating from a medical school with an above-average hospital care intensity index was associated with higher odds of prescribing brand name statins (OR, 1.70; P  =  .049; 95% CI, 1.003-2.88). We found considerable variation in brand name statin prescribing by residents. Medical school attended and residency program type were associated with resident prescribing behavior. Future interventions should raise awareness of these patterns in an effort to teach high-value, cost-conscious care to all residents.

Pharma rebates, pharmacy benefit managers and employer outcomes.

PubMed

Ali, Ozden Gür; Mantrala, Murali

2010-12-01

Corporate employers contract with pharmacy benefit managers (PBMs) with the goals of lowering their employee prescription drug coverage costs while maintaining health care quality. However, little is known about how employer-PBM contract elements and brand drugmakers' rebates combine to influence a profit-maximizing PBM's actions, and the impact of those actions on the employer's outcomes. To shed more light on these issues, the authors build and analyze a mathematical simulation model of a competitive pharmaceutical market comprised of one generic and two branded drugs, and involving a PBM contracted by a corporate employer to help it lower prescription drug costs while achieving a minimum desired quality of health care for its employees. The brand drugmakers' rebate offers, the PBM's assignment of drugs to formulary tiers, and the resulting employer outcomes under varying contracts and pharma brand marketing mix environmental scenarios are analyzed to provide insights. The findings include that the pharma brands offer rebates for the PBM's ability to move prescription share away from the unpreferred brand, but reduce these offers when the PBM's contract requires it to proactively influence physicians to prescribe the generic drug alternative. Further, Pareto optimal contracts that provide the highest health benefit for a given employer cost budget for the employer are analyzed to provide managerial implications. They are found to involve strong PBM influence on physician prescribing to discourage unpreferred brands, as well as high patient copayment requirements for unpreferred brands to align the patient prescription fill probability with the formulary, while other copayment requirements provide an instrument to determine the level of desired health benefit-cost tradeoff.

Ontario’s plunging price-caps on generics: deeper dives may drown some drugs

PubMed Central

Anis, Aslam; Harvard, Stephanie; Marra, Carlo

2011-01-01

In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product’s price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive. PMID:22046229

Ontario's plunging price-caps on generics: deeper dives may drown some drugs.

PubMed

Anis, Aslam; Harvard, Stephanie; Marra, Carlo

2011-01-01

In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product's price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive.

75 FR 34448 - Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... Pesticide Registrants on False or Misleading Pesticide Product Brand Names; Extension of Comment Period... Pesticide Product Brand Names.'' This document extends the comment period for 60 days, from June 18, 2010... draft Pesticide Registration Notice (PR Notice) entitled ``False or Misleading Pesticide Product Brand...

Prescription patterns and costs of acne/rosacea medications in Medicare patients vary by prescriber specialty.

PubMed

Zhang, Myron; Silverberg, Jonathan I; Kaffenberger, Benjamin H

2017-09-01

Prescription patterns for acne/rosacea medications have not been described in the Medicare population, and comparisons across specialties are lacking. To describe the medications used for treating acne/rosacea in the Medicare population and evaluate differences in costs between specialties. A cross-sectional study was performed of the 2008 and 2010 Centers for Medicare and Medicaid Services Prescription Drug Profiles, which contains 100% of Medicare part D claims. Topical antibiotics accounted for 63% of all prescriptions. Patients ≥65 years utilized more oral tetracycline-class antibiotics and less topical retinoids. Specialists prescribed brand name drugs for the most common topical retinoids and most common topical antibiotics more frequently than family medicine/internal medicine (FM/IM) physicians by 6%-7%. Topical retinoids prescribed by specialists were, on average, $18-$20 more in total cost and $2-$3 more in patient cost than the same types of prescriptions from FM/IM physicians per 30-day supply. Specialists (60%) and IM physicians (56%) prescribed over twice the rate of branded doxycycline than FM doctors did (27%). The total and patient costs for tetracycline-class antibiotics were higher from specialists ($18 and $4 more, respectively) and IM physicians ($3 and $1 more, respectively) than they were from FM physicians. The data might contain rare prescriptions used for conditions other than acne/rosacea, and suppression algorithms might underestimate the number of specialist brand name prescriptions. Costs of prescriptions for acne/rosacea from specialists are higher than those from primary care physicians and could be reduced by choosing generic and less expensive options. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Sound Advice on Brand Names.

ERIC Educational Resources Information Center

Vanden Bergh, Bruce G.; And Others

A study was conducted to determine if brand names that begin with consonants called "plosives" (B, C, D, G, K, P, and T) are more readily recalled and recognized than names that begin with other consonants or vowels. Additionally, the study investigated the relationship between name length and memorability, ability to associate names…

40 CFR 35.936-13 - Specifications.

Code of Federal Regulations, 2010 CFR

2010-07-01

... equipment, or at least two brand names or trade names of comparable quality or utility are listed and are followed by the words “or equal.” If brand or trade names are specified, the grantee must be prepared to...

PRN 2002-X Draft: False or Misleading Pesticide Product Brand Name

EPA Pesticide Factsheets

This notice provides guidance to registrants and distributors on pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. It is a draft.

How Low-Income Subsidy Recipients Respond to Medicare Part D Cost Sharing.

PubMed

Stuart, Bruce; Hendrick, Franklin B; Xu, Jing; Dougherty, J Samantha

2017-06-01

To determine the magnitude and mechanisms of response to Medicare Part D cost sharing by low-income subsidy (LIS) recipients using oral hypoglycemic agents (OHAs) and statins. Medicare data for a 5 percent random sample of beneficiaries with diabetes enrolled in fee-for-service Part D drug plans in 2008. We evaluated the impact of differences between generic and brand cost sharing rates among cohorts of LIS and non-LIS recipients to determine if wider price spreads increased the generic dispensing rate (GDR) and reduced total drug use and cost. We found little association between cost sharing and aggregate OHA and statin use. In adjusted analyses, non-LIS beneficiaries who paid 46 percent of total OHA costs had 2.5 percent fewer OHA days supply than full benefit dual eligibles who paid just 5 percent of their therapy costs. For statins, the difference in days supply between those facing the lowest and highest cost sharing was 4.6 percent. Higher cost sharing was associated with filling fewer but larger prescriptions for both generics and brands. Higher generic and brand copays had little association with OHA and statin use among LIS recipients. This implies that modest changes in required cost sharing for these medicines would have very little substantive impact on generic dispensing or utilization patterns among LIS recipients and thus would have little effect on total program spending. At the same time, any increases in out-of-pocket costs would be expected to shift costs and place greater financial burden on low-income beneficiaries, particularly those in poor health. © Health Research and Educational Trust.

Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

PubMed

Di Paolo, Antonello; Arrigoni, Elena

2018-03-01

Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products. Rare diseases, also called orphan diseases, are a group of heterogeneous diseases that share important characteristics: in addition to their scarcity, most are severe, chronic, highly debilitating, and often present in early childhood. Finding a treatment for a rare disease is challenging. Thanks to incentives that encourage research and development programs in rare diseases, several orphan drugs are currently available. The elevated cost of orphan drugs is a highly debated issue and a cause of limited access to treatment for many patients. As patent protection and the exclusivity period of several orphan drugs will expire soon, generic versions of orphan drugs should reach the market shortly, with great expectations about their impact on the economic burden of rare diseases. However, consistent with other complex diseases, generic substitution may require thoughtful considerations and may be even contraindicated in some rare conditions. This article provides an overview of rare disease characteristics, reviews reports of problematic generic substitution, and discusses why generic substitution of orphan drugs may be challenging and should be undertaken carefully in rare disease patients.

Selegiline shortage: Causes and costs of a generic drug shortage.

PubMed

Dorsey, E R; Thompson, J P; Dayoub, E J; George, B; Saubermann, L A; Holloway, R G

2009-07-21

In September 2007, shortages of generic selegiline occurred, forcing patients to either switch to more expensive alternatives or forego treatment. We sought to evaluate prescription trends of generic selegiline and to quantify the economic impact of any resulting drug substitution of more expensive alternatives. We analyzed proprietary data from IMS Health on monthly prescriptions in the United States for selegiline and potential substitutes from February 2002 through December 2007. Linear regression was used to predict the number of expected prescriptions after August 2007 had a shortage not occurred. The main outcome measures were the changes in prescriptions filled and the economic impact of drug substitution. Prior to the shortage, total prescriptions filled for generic selegiline decreased 42%, and supply consolidated into one company, Apotex Inc., Toronto, Canada, whose market share increased from 41% to 83%. During the first 4 months of the shortage, Apotex Inc. filled 10,500 fewer prescriptions than projected and other selegiline manufacturers filled 7,400 more than projected for a net shortage of 3,100 prescriptions. The number of branded selegiline capsules filled during this period increased by 1,800 above projections, and 1,300 prescriptions for generic selegiline were not refilled or substituted. The societal cost of substituting generic selegiline with branded capsules was $75,000 over the first 4 months of the shortage. Generic drug shortages carry economic and health implications. Given ongoing consolidation in the generics drug industry, these shortages may become more common and may require heightened regulatory scrutiny of the generic drug industry.

Assessment of the physical properties and stability of mixtures of tetracycline hydrochloride ointment and acyclovir cream.

PubMed

Inoue, Yutaka; Furuya, Kayoko; Maeda, Rikimaru; Murata, Isamu; Kanamoto, Ikuo

2013-04-15

In dermatology, ointments are often mixed as part of drug therapy, but mixing often leads to incompatibility. Three combinations of tetracycline ointment (TC-o) and acyclovir cream (ACV-cr) were prepared at a TC-o:ACV-cr ratio of 1:1 using a brand-name ACV-cr and two generic ACV-cr (samples TC-o+ACV-A, TC-o+ACV-B, and TC-o+ACV-C). Microscopic examination revealed separation in TC-o+ACV-C. Viscosity and elasticity measurement indicated that the storage modulus (G') and loss modulus (G″) of each of the TC-o+ACV-cr mixtures behaved similarly to those of an ACV-cr and the loss tangent (tanδ) behaved similarly to that of a TC ointment. In addition, differences in the storage modulus (G') and loss modulus (G″) of the TC-o+ACV-cr mixtures were noted. To assess stability, each TC-o+ACV-cr mixture was stored away from direct sunlight at 25 °C and an RH of 84% and at 4 °C (in a refrigerator). HPLC revealed that the ACV content in each TC-o+ACV-cr mixture remained at 95-105% for up to 14 days under both sets of storage conditions. A decline in TC content in each TC-o+ACV-cr mixture was not noted with storage at 4 °C but was noted over time with storage at 25 °C and an RH of 84%. In addition, significant differences in the percent decline in TC content in each TC-o+ACV-cr mixture occurred with storage at 25 °C and an RH of 84%. Thus, differences in physical properties and stability may occur when combining brand-name and generic drugs, and temperature and humidity may be the cause of the TC-o's incompatibility. Crown Copyright © 2013. Published by Elsevier B.V. All rights reserved.

Access to generic drugs in the 1950s: the politics of a social problem.

PubMed Central

Facchinetti, N J; Dickson, W M

1982-01-01

From the published literature of the 1950s, the social history of anti-substitution law is analyzed in terms of sociological theory on the construction of social problems. The analysis reveals how the substitution of generic drugs for prescribed brands came to be recognized as a social problem in need of remedial legislation. The most influential party in the process was the brand-drug industry which centered the debate on matters of public health and professionalism instead of industrial profitability. The industry was able to form a coalition of interests and establish the saliency and legitimacy of the problem, even though there was no objective evidence to establish brand substitution as a hazard to health. The case fits well into the theory of social problem construction. Other issues in health care, particularly drug issues can be studied from this same perspective. PMID:7065335

Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

PubMed

Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

2017-12-28

Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of <0.05 were considered significant. A total of 302 community pharmacists were interviewed, slightly more than half were males (52.3%). The mean knowledge score of participants regarding generic medicines was (5.91 ± 1.27) where the highest score was 8 of 10. Knowledge score was not significantly influenced by any of the socio-demographic characteristics. Our data showed that most of included pharmacists in the study (95.4%) agreed that health authorities should implement bioequivalence policies prior to marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

New drugs from old.

PubMed

2006-10-01

The NHS spends over pound10 billion each year on medicines. The use of generic (patent-expired) medicines rather than branded equivalents has a key role in containing this expenditure and ensuring best value for money. On average, 4 years after the patent of a branded medicine has expired in the UK, generic equivalents will account for around half of the drug's market and cost about a quarter as much as the original brand. This represents a potentially large loss of income and, therefore, a major concern for companies that market branded products. Consequently, many use a long-term strategy known as 'lifecycle management' to minimise loss and to maximise returns from such products. This encompasses prioritising products for development, forming strategic alliances with other companies to share resourses, and utilising legal processes to protect products. One part of this strategy is the development and intensive marketing of new formulations or derivatives of existing medicines nearing the end of their patent life. Here we highlight some key examples of the impact the marketing of such products can have on patients, prescribers and the NHS.

Two-Stage Categorization in Brand Extension Evaluation: Electrophysiological Time Course Evidence

PubMed Central

Wang, Xiaoyi

2014-01-01

A brand name can be considered a mental category. Similarity-based categorization theory has been used to explain how consumers judge a new product as a member of a known brand, a process called brand extension evaluation. This study was an event-related potential study conducted in two experiments. The study found a two-stage categorization process reflected by the P2 and N400 components in brand extension evaluation. In experiment 1, a prime–probe paradigm was presented in a pair consisting of a brand name and a product name in three conditions, i.e., in-category extension, similar-category extension, and out-of-category extension. Although the task was unrelated to brand extension evaluation, P2 distinguished out-of-category extensions from similar-category and in-category ones, and N400 distinguished similar-category extensions from in-category ones. In experiment 2, a prime–probe paradigm with a related task was used, in which product names included subcategory and major-category product names. The N400 elicited by subcategory products was more significantly negative than that elicited by major-category products, with no salient difference in P2. We speculated that P2 could reflect the early low-level and similarity-based processing in the first stage, whereas N400 could reflect the late analytic and category-based processing in the second stage. PMID:25438152

78 FR 79007 - Certain Multiple Mode Outdoor Grills and Parts Thereof; Commission Determination Not To Review an...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

... Antonio, Texas; Kmart Corporation of Hoffman Estates, Illinois; Sears Brands Management Corporation, Sears... Specialty Brands, LLC, (2) change the name of Respondent Rankam Group to Rankam Metal Products Manufactory... Kamado Joe Company is a trade name for the legal entity Premier Specialty Brands, LLC; Rankam Metal...

48 CFR 36.202 - Specifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... technical societies. (c) When brand name or equal descriptions are necessary, specifications must clearly identify and describe the particular physical, functional, or other characteristics of the brand-name items...

9 CFR 381.144 - Packaging materials.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., from the packaging supplier under whose brand name and firm name the material is marketed to the... distinguishing brand name or code designation appearing on the packaging material shipping container; must....13) will be acceptable. The management of the establishment must maintain a file containing...

Statistics of co-occurring keywords in confined text messages on Twitter

NASA Astrophysics Data System (ADS)

Mathiesen, J.; Angheluta, L.; Jensen, M. H.

2014-09-01

Online social media such as the micro-blogging site Twitter has become a rich source of real-time data on online human behaviors. Here we analyze the occurrence and co-occurrence frequency of keywords in user posts on Twitter. From the occurrence rate of major international brand names, we provide examples of predictions of brand-user behaviors. From the co-occurrence rates, we further analyze the user-perceived relationships between international brand names and construct the corresponding relationship networks. In general the user activity on Twitter is highly intermittent and we show that the occurrence rate of brand names forms a highly correlated time signal.

Pruritis

MedlinePlus

... have very dry hands, put petroleum jelly (one brand name: Vaseline) on them before you go to ... short, lukewarm baths or showers. Oatmeal baths (one brand name: Aveeno) may be soothing to dry skin. ...

Topiramate

MedlinePlus

... another medication with a name similar to the brand name for topiramate. You should be sure that ... The sprinkle and extended-release capsules (Qudexy XR brand only) may be swallowed whole or opened and ...

Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.

PubMed

Grampp, Gustavo; Bonafede, Machaon; Felix, Thomas; Li, Edward; Malecki, Michael; Sprafka, J Michael

2015-03-01

This retrospective analysis assessed the capability of active and passive safety surveillance systems to track product-specific safety events in the USA for branded and generic enoxaparin, a complex injectable subject to immune-related and other adverse events (AEs). Analysis of heparin-induced thrombocytopenia (HIT) incidence was performed on benefit claims for commercial and Medicare supplemental-insured individuals newly treated with enoxaparin under pharmacy benefit (1 January 2009 - 30 June 2012). Additionally, spontaneous reports from the FDA AE Reporting System were reviewed to identify incidence and attribution of enoxaparin-related reports to specific manufacturers. Specific, dispensed products were identifiable from National Drug Codes only in pharmacy-benefit databases, permitting sensitive comparison of HIT incidence in nearly a third of patients treated with brand or generic enoxaparin. After originator medicine's loss of exclusivity, only 5% of spontaneous reports were processed by generic manufacturers; reports attributable to specific generics were approximately ninefold lower than expected based on market share. Claims data were useful for active surveillance of enoxaparin generics dispensed under pharmacy benefits but not for products administered under medical benefits. These findings suggest that the current spontaneous reporting system will not distinguish product-specific safety signals for products distributed by multiple manufacturers, including biosimilars.

The effect of formulation additives on in vitro dissolution-absorption profile and in vivo bioavailability of telmisartan from brand and generic formulations.

PubMed

Borbás, Enikő; Nagy, Zsombor K; Nagy, Brigitta; Balogh, Attila; Farkas, Balázs; Tsinman, Oksana; Tsinman, Konstantin; Sinkó, Bálint

2018-03-01

In this study, brand and four generic formulations of telmisartan, an antihypertensive drug, were used in in vitro simultaneous dissolution-absorption, investigating the effect of different formulation additives on dissolution and on absorption through an artificial membrane. The in vitro test was found to be sensitive enough to show even small differences between brand and generic formulations caused by the use of different excipients. By only changing the type of filler from sorbitol to mannitol in the formulation, the flux through the membrane was reduced by approximately 10%. Changing the salt forming agent as well resulted in approximately 20% of flux reduction compared to the brand formulation. This significant difference was clearly shown in the published in vivo results as well. The use of additional lactose monohydrate in the formulation also leads to approximately 10% reduction in flux. The results show that by changing excipients, the dissolution of telmisartan was not altered significantly, but the flux through the membrane was found to be significantly changed. These results pointed out the limitations of traditional USP dissolution tests and emphasized the importance of simultaneously measuring dissolution and absorption, which allows the complex effect of formulation excipients on both processes to be measured. Moreover, the in vivo predictive power of the simultaneous dissolution-absorption test was demonstrated by comparing the in vitro fluxes to in vivo bioequivalence study results. Copyright © 2018 Elsevier B.V. All rights reserved.

Novel participatory methods of involving patients in research: naming and branding a longitudinal cohort study, BRIGHTLIGHT.

PubMed

Taylor, Rachel M; Mohain, Jasjeet; Gibson, Faith; Solanki, Anita; Whelan, Jeremy; Fern, Lorna A

2015-03-14

Patient and public involvement (PPI) is central to research and service planning. Identifying effective, meaningful ways of involvement is challenging. The cohort study 'Do specialist services for teenagers and young adults with cancer add value?' follows young people for three years, examining outcomes associated with specialist care. Participant retention in longitudinal research can be problematic potentially jeopardising study completion. Maximising study awareness through high impact branding and publicity may improve study retention. Study names are typically generated by researchers rather than designed with patients. We aimed to involve young people in developing a brand identity and name to 'Do specialist services for teenagers and young adults with cancer add value?'. Nine young people aged 17-26 years diagnosed with cancer when aged 14-25 years participated in a one day workshop with further data collection at a patient conference. Methodology was similar to conventional branding and naming exercises and was divided into six stages. The workshop comprised five stages. Stage 1: 'What's in a brand' allowed young people to enquire why brands/logos are important, Stage 2: 'Brand Transformation' identified what young people needed to know and believe about the study when approached about participation, Stage 3: 'Brand Essence' determined how we wanted the study to be perceived by young people, Stage 4: 'What's in a name' identified potential names for the study. Stage 5: 'Logo creation' assembled the mood and feel of logos. Stage 6 was logo design and an electronic survey of 249 young people attending a patient conference. BRIGHTLIGHT was the final study name and the brand essence (or study personality) was friendly, supportive and inspiring. Four logos were designed and the final logo received 47% (n = 115) of votes. Acceptance and retention to BRIGHTLIGHT is higher than anticipated (80% versus 60%), this may be related to our integral PPI strategy. We propose this reproducible methodology as an important, enjoyable, and novel way of involving patients in research and a welcome alternative to researcher-developed acronyms. Ideally this should be carried out prior to engaging with healthcare professionals to prevent confusion around study identity.

What's in and what's out in branding? A novel articulation effect for brand names.

PubMed

Topolinski, Sascha; Zürn, Michael; Schneider, Iris K

2015-01-01

The present approach exploits the biomechanical connection between articulation and ingestion-related mouth movements to introduce a novel psychological principle of brand name design. We constructed brand names for diverse products with consonantal stricture spots either from the front to the rear of the mouth, thus inwards (e.g., BODIKA), or from the rear to the front, thus outwards (e.g., KODIBA). These muscle dynamics resemble the oral kinematics during either ingestion (inwards), which feels positive, or expectoration (outwards), which feels negative. In 7 experiments (total N = 1261), participants liked products with inward names more than products with outward names (Experiment 1), reported higher purchase intentions (Experiment 2), and higher willingness-to-pay (Experiments 3a-3c, 4, 5), with the price gain amounting to 4-13% of the average estimated product value. These effects occurred across English and German language, under silent reading, for both edible and non-edible products, and even in the presence of a much stronger price determinant, namely fair-trade production (Experiment 5).

An economic assessment of patent settlements in the pharmaceutical industry.

PubMed

Dickey, Bret; Orszag, Jonathan; Tyson, Laura

2010-01-01

This article demonstrates that in recent years, patent settlements between branded and generic manufacturers involving "reverse payments" from branded manufacturers to generic manufacturers have received close antitrust scrutiny, driven by concerns that such settlements harm consumers by delaying the entry of lower-priced generic drugs. The authors note that such settlements will be a focus of the Obama Administration's antitrust enforcement policy, yet there is a growing consensus among the courts that such settlements are anticompetitive only under narrow sets of circumstances. In this article, the authors present an analytical framework for evaluating the competitive effects of patent settlements, including those involving reverse payments, and demonstrate that these settlements can benefit consumers. Thus, the authors conclude that while continued scrutiny of such settlements is important, broad brush treatments are inappropriate and only a more individualized evaluation can correctly determine the competitive effects of a particular settlement agreement.

Medicare Part D payments for neurologist-prescribed drugs

PubMed Central

Burke, James F.; Kerber, Kevin A.; Skolarus, Lesli E.; Callaghan, Brian C.

2016-01-01

Objective: To describe neurologists' Medicare Part D prescribing patterns and the potential effect of generic substitutions and price negotiation, which is currently prohibited. Methods: The 2013 Medicare Part D Prescriber Public Use and Summary files were used. Payments for medications were aggregated by provider and drug (brand or generic). Payment, proportion of generic claims or day's supply, and median payment per monthly supply of medication were calculated by physician specialty and drug. Savings from generic substitution were estimated for brand drugs with a generic available. Medicare prices were compared to drug prices negotiated by the federal government with pharmaceutical manufacturers for the Veterans Administration (VA). Results: Neurologists comprised 13,060 (1.2%) providers with $5.0 billion (4.8%) in total payments, third highest of all specialties, with a median monthly payment of $141 (interquartile range $85–225). Multiple sclerosis drugs had the highest payments ($1.8 billion). Within neurologic disease groups ($3.4 billion in payments), 54.2%–91.8% of monthly supplies were generic, but 11.9%–71.3% of the payment was for generic medications. Generic substitution resulted in a $269 million (6.5%) payment decrease. VA pricing resulted in $1.5 billion (44.5% of $3.4 billion) in savings. Conclusions: High payment per monthly supply of medication underlies the high total neurology drug payments and is driven by multiple sclerosis drugs. Lowering drug expenditures by Medicare should focus on drug prices. PMID:27009256

Branding the Land Grant University: Stakeholders' Awareness and Perceptions of the Tripartite Mission

ERIC Educational Resources Information Center

Abrams, Katie; Meyers, Courtney; Irani, Tracy; Baker, Lauri

2010-01-01

Several land-grant institutions have adopted a name to encompass the teaching, research, and Extension components of the university, creating a brand identity for those public services. But, in the mind of stakeholders, has the connection between the tripartite mission and the brand name been made? The study reported here sought to determine…

Contact Lens Care

MedlinePlus

... your prescription expires Lens measurements The contact lens brand name and material Your doctor’s name and contact ... mail-order sellers may send you a different brand. Contact lenses may look the same, but materials ...

48 CFR 811.001 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS 811.001 Definitions. For the purposes of this part: Brand name product means a commercial product described by brand name and make or model number or other appropriate...

9 CFR 317.24 - Packaging materials.

Code of Federal Regulations, 2010 CFR

2010-01-01

... supplier under whose brand name and firm name the material is marketed to the official establishment. The... additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or... acceptable. The management of the establishment must maintain a file containing guaranties for all food...

Reference pricing system and competition: case study from Portugal.

PubMed

Portela, Conceiçăo

2009-10-01

To characterize the patterns of competition for a sample of drugs in the Portuguese pharmaceutical market before (January 2002-March 2003) and after (April 2003-June 2003) the introduction of the reference pricing system (RPS). We performed a descriptive, retrospective, longitudinal analysis, with monthly observations from January 2002 until June 2003 of 15 homogeneous groups. The groups represented the upper limit of public pharmaceutical expenditure in the RPS segment in 2003 (n=270). Measures of competition were: 1) number of presentations; 2) prescriptions' concentration in the generic and originator (brand) segments, using Herfindahl-Hirschman Index (HHI); and 3) dominant positions of market leader in the homogeneous group. A correlation analysis between the number of presentations, the HHI, and the dominant position of the market leader was performed using Pearson coefficient of correlation. The structure of the market changed with the introduction of RPS. We found an increasing number of generic presentations (from 4+/-3 to 7+/-4; mean+/-standard deviation) and a decrease in the HHI for the generics market segment (from 0.7+/-0.2 to 0.6+/-0.3). There was a negative correlation between those variables that increased after the introduction of RPS (from -0.6 to -0.8). The HHI for brands and the dominant positions remained unchanged. After the implementation of RPS, the increased competition was mainly driven by economic and social agents in the generics market segment but not in the brands market segment.

Costs in the coverage gap

MedlinePlus

... D costs won’t enter the coverage gap. Brand-name prescription drugs Once you reach the coverage ... than 35% of the plan's cost for covered brand-name prescription drugs. You get these savings if ...

Event-related potential N270 correlates of brand extension.

PubMed

Ma, Qingguo; Wang, Xiaoyi; Dai, Shenyi; Shu, Liangchao

2007-07-02

The aim of this study is to investigate the neural mechanism of extending a brand in a specific product category to other product categories. Facing two sequential stimuli in pairs consisting of beverage brand names (stimulus 1) and product names (stimulus 2) in other categories, 16 participants were asked to indicate the suitability of extending the brand in stimulus 1 to the product category in stimulus 2. These stimulus pairs were divided into four conditions depending on the product category in stimulus 2: beverage, snack, clothing, and household appliance. A negative component, N270, was recorded for each condition on the participants' scalps,whereas the maximum amplitude was observed at the frontal area. Greater N270 amplitude was observed when participants were presented with stronger conflict between the brand product category (stimulus 1) and the extension category (stimulus 2). It suggests that N270 can be evoked not only by a conflict of physical attributes (different shapes of words of brand and product names) but also by that of lexical content. From the marketing perspective, N270 can be potentially used as a reference measure in brand-extension attempts.

Drug substitution associated with a hospital stay in Belgium: a retrospective analysis of a claims database.

PubMed

Simoens, Steven; Dubois, Cécile; Spinewine, Anne; Foulon, Veerle; Paulus, Dominique

2014-04-01

This study measures the extent of drug substitution associated with a hospital stay in Belgium. Data were extracted from the 2006-2007 dataset of the Belgian Agency of Health Insurance Funds on drug use of patients hospitalized in acute hospitals. Reimbursed drugs received in ambulatory care during the 3 months prior to hospitalization were compared with drugs received during the 3 months following hospital discharge. Both a narrow definition and a broad definition were used for drug substitution. Narrow substitution (switches between generic and originator drugs) was computed for 14 drug classes for chronic conditions with the highest public expenditure. Broad substitution (changes between chemical substances within the drug class at ATC level 4, changes in brand name) was calculated for statins and proton-pump inhibitors only. The database included 17 764 patients (mean age 66 ± 17 years; 60% female). In 71% of cases an originator drug was received prior to and following hospitalization. A generic drug was received prior to and following hospitalization in 25% of cases. Some form of narrow substitution occurred in 4% of cases: a generic drug was replaced by an originator drug in 2% of cases and an originator drug was replaced by a generic drug in 2% of cases. Some form of broad substitution occurred in 25% of cases for proton-pump inhibitors and 13% of cases for statins. Hospitalization was not a trigger for changes between originator and generic versions of a drug. Broad substitution associated with a hospital stay was relatively limited for statins and proton-pump inhibitors. © 2013 Royal Pharmaceutical Society.

Hemorrhoids

MedlinePlus

... ice packs to relieve swelling. Use acetaminophen (1 brand name: Tylenol), ibuprofen (1 brand name: Motrin), or aspirin to help relieve pain. ... Childbirth Women Men Seniors Your Health Resources Healthcare Management End-of-Life Issues Insurance & Bills Self Care ...

Cough Medicine: Understanding Your OTC Options

MedlinePlus

... and expectorants. A common antitussive is dextromethorphan (some brand names: Triaminic Cold and Cough, Robitussin Cough, Vicks ... expectorant available in OTC products is guaifenesin (2 brand names: Mucinex, Robitussin Chest Congestion). How do OTC ...

Ingrown Toenails

MedlinePlus

... over the site until it heals. Take acetaminophen (brand name: Tylenol) or ibuprofen (brand name: Motrin) as needed for pain. Keep the ... Childbirth Women Men Seniors Your Health Resources Healthcare Management End-of-Life Issues Insurance & Bills Self Care ...

Pain Relievers: Understanding Your OTC Options

MedlinePlus

... NSAIDs) There are several types of NSAIDs, including: aspirin (2 brand names: Bayer, St. Joseph) ibuprofen (2 ... muscle sprains). Some products contain both acetaminophen and aspirin (2 brand names: Excedrin, Vanquish). These typically contain ...

Event-related potentials indicate that fluency can be interpreted as familiarity.

PubMed

Bruett, Heather; Leynes, P Andrew

2015-11-01

Recent evidence suggests that fluency may be capable of supporting recognition independently of familiarity. This hypothesis was further tested in the present study. 29 participants encoded name-brand and off-brand products in an incidental task. Participants then judged whether the product was old or new during two tests with products from one category (i.e., only name-brand or only off-brand products) and a mixed test (where both name-brand and off-brand products were shown). The ERP data elicited by off-brand products varied as a function of test format. During the mixed test, off-brand products were correlated with a FN400 effect, whereas a fluency ERP (old ERPs were more negative than new at parietal electrodes 225-400ms) was observed during the other test. Importantly, no FN400 was detected during this test. The ERP results suggest that viewing the off-brand products during the mixed test produced a familiarity experience; however, fluency supported recognition when viewing off-brand products on the other test. The results are strong evidence that top-down processing of visual features during recognition interprets the information relative to the context. This process results in either fluency or, in other contexts, it is interpreted as familiarity as the Discrepancy-Attribution Hypothesis (Whittlesea and Williams, 2001a, 2001b) contends. Copyright © 2015 Elsevier Ltd. All rights reserved.

16 CFR 303.17 - Use of fiber trademarks and generic names on labels.

Code of Federal Regulations, 2010 CFR

2010-01-01

... label in conjunction with the generic name of the fiber to which it relates. Where such a trademark is placed on a label in conjunction with the required information, the generic name of the fiber must appear in immediate conjunction therewith, and such trademark and generic name must appear in type or...

Generic antiepileptic drugs and associated medical resource utilization in the United States.

PubMed

Labiner, D M; Paradis, P E; Manjunath, R; Duh, M S; Lafeuille, M-H; Latrémouille-Viau, D; Lefebvre, P; Helmers, S L

2010-05-18

To evaluate whether generic substitution was associated with any difference in medical resource utilization for 5 widely used antiepileptic drugs (AEDs) in the United States. Health insurance claims from PharMetrics Database, representing over 90 health plans between January 2000 and October 2007, were analyzed. Adult patients with epilepsy, continuously treated with carbamazepine, gabapentin, phenytoin, primidone, or zonisamide, were selected. An open-cohort design was used to classify patients into mutually exclusive periods of brand vs generic use of AEDs. Pharmacy and medical utilization were compared between the 2 periods with multivariate regression analyses. Results were stratified into epilepsy-related medical services, and stable (< or = 2 outpatient visits per year and no emergency room visit) vs unstable epilepsy. Time-to-event analyses were also performed for all services and epilepsy-related endpoints. A total of 18,125 patients were observed in the stable group and 15,500 patients in the unstable group. After adjustment of covariates, periods of generic AED treatment were associated with increased use of all prescription drugs (incidence rate ratio [IRR] [95% confidence interval (CI)] = 1.13 [1.13-1.14]) and higher epilepsy-related medical utilization rates (hospitalizations: IRR [95% CI] = 1.24 [1.19-1.30]; outpatient visits: IRR [95% CI] = 1.14 [1.13-1.16]; lengths of hospital stays: IRR [95% CI] = 1.29 [1.27-1.32]). Generic-use periods were associated with increased utilization rates in stable and unstable patients and with 20% increased risk of injury, compared to periods with brand use of AEDs. Generic antiepileptic drug use was associated with significantly greater medical utilization and risk of epilepsy-related medical events, compared to brand use. This relationship was observed even in patients characterized as stable. AED = antiepileptic drug; CI = confidence interval; ER = emergency room; HR = hazard ratio; ICD = International Classification of Diseases; IRR = incidence rate ratio.

Influence of the Separation of Prescription and Dispensation of Medicine on Its Cost in Japanese Prefectures

PubMed Central

Yokoi, Masayuki; Tashiro, Takao

2014-01-01

We studied how the separation of dispensing and prescribing of medicines between pharmacies and clinics (the “separation system”) can reduce internal medicine costs. To do so, we obtained publicly available data by searching electronic databases and official web pages of the Japanese government and non-profit public service corporations on the Internet. For Japanese medical institutions, participation in the separation system is optional. Consequently, the expansion rate of the separation system for each of the administrative districts is highly variable. The data were subjected to multiple regression analysis; daily internal medicines were the objective variable and expansion rate of the separation system was the explanatory variable. A multiple regression analysis revealed that the expansion rate of the separation system and the rate of replacing brand name medicine with generic medicine showed a significant negative partial correlation with daily internal medicine costs. Thus, the separation system was as effective in reducing medicine costs as the use of generic medicines. Because of its medical economic efficiency, the separation system should be expanded, especially in Asian countries in which the system is underdeveloped. PMID:24999122

Influence of the separation of prescription and dispensation of medicine on its cost in Japanese prefectures.

PubMed

Yokoi, Masayuki; Tashiro, Takao

2014-04-07

We studied how the separation of dispensing and prescribing of medicines between pharmacies and clinics (the "separation system") can reduce internal medicine costs. To do so, we obtained publicly available data by searching electronic databases and official web pages of the Japanese government and non-profit public service corporations on the Internet. For Japanese medical institutions, participation in the separation system is optional. Consequently, the expansion rate of the separation system for each of the administrative districts is highly variable. The data were subjected to multiple regression analysis; daily internal medicines were the objective variable and expansion rate of the separation system was the explanatory variable. A multiple regression analysis revealed that the expansion rate of the separation system and the rate of replacing brand name medicine with generic medicine showed a significant negative partial correlation with daily internal medicine costs. Thus, the separation system was as effective in reducing medicine costs as the use of generic medicines. Because of its medical economic efficiency, the separation system should be expanded, especially in Asian countries in which the system is underdeveloped.

Drugs indicated for use during pregnancy.

PubMed

Lalonde, André B

2011-01-01

The Society of Obstetricians and Gynaecologists of Canada (SOGC) advocates that drugs used during pregnancy be tested exclusively in women. The SOGC holds the opinion that drugs to be used exclusively in men or in women should not be tested in a small number of men and women. The SOGC, always cautious with the choice of pharmacological treatments recommended for use during pregnancy, welcomes the increased options resulting from the introduction of generic formulations of drugs shown to be bioequivalent to currently available brand name products. These formulations provide less expensive options to Canadian women in need of drug therapy. However, the Society does not believe that drugs should be substituted without the patient and the physician both agreeing to such a change. Generic substitutions of some products may mean a potentially clinically significant difference in drug dose, possibly resulting in a changed patient effect. Furthermore, substituting a product on the basis of price alone is not acceptable.The SOGC, as an organization with the role of advising its members on clinical practice, calls on Health Canada to review its guideline on testing of drugs for vulnerable populations, especially pregnant women.

N400 as an index of uncontrolled categorization processing in brand extension.

PubMed

Wang, Xiaoyi; Ma, Qingguo; Wang, Cuicui

2012-09-06

This study examined the ERP (event-related potential) correlates of categorization processing in brand extension with irrelative task. Participants faced two sequential stimuli in a pair consisting of a soft drink brand name (S1) and a product name (S2) which comprised two categories: beverage (typical product of the brand, e.g. Coke branded soda water) and clothing (atypical product of the brand, even though sometimes it was seen in the real market, e.g. Coke branded sport wear). The N400 was recorded and more largely distributed in frontal, frontal-central and central areas when S2 was clothing compared with beverage. The study did not require the participants to evaluate that the brand extension was appropriate or not, the N400 recorded here was, therefore, irrelative to the task difficulty and the conscious categorization process. We speculated that it reflected an integration processing related with the mental category. The brand performed the role of prime which aroused the participants' association of the brand-related typical products and attributes retrieving from their long term memory. The product name activated an unconscious processing of comparison between the brand and the product. In this process, the participant treated the brand as a mental category and classified the product as a member of it. There would be a large cognitive reaction which elicited the N400 if the product's attributes were atypical to the category of the brand. These findings might help us understand the N400 component in unconscious mental categorization and supported the categorization hypotheses in brand extension theory which was crucial in consumer psychology. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

48 CFR 836.202 - Specifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... specifications. (b) During the design stage, contract architect-engineers must not use “brand name or equal” or.... This clause places bidders on notice that the “brand name or equal” provisions of the clause found at...

48 CFR 411.171 - Solicitation provisions and contract clauses.

Code of Federal Regulations, 2010 CFR

2010-10-01

... provision at 452.211-70, Brand Name or Equal, in solicitations, other than those for construction, where “brand name or equal” purchase descriptions are used. (b) Contracting officers shall insert the clause at...

Logo Effects on Brand Extension Evaluations from the Electrophysiological Perspective.

PubMed

Shang, Qian; Pei, Guanxiong; Dai, Shenyi; Wang, Xiaoyi

2017-01-01

Brand extension typically has two strategies: brand name extension (BN) and brand logo extension (BL). The current study explored which strategy (BN or BL) better enhanced the success of dissimilar brand extension and product promotion in enterprises. Event-related potentials (ERPs) were used to investigate electrophysiological processes when subjects evaluated their acceptance of the brand extension using a combined picture of S1 and S2. S1 was a famous brand presented by two identity signs (brand name and brand logo). S2 was a picture of an extension product that belonged to a dissimilar product category than S1. The behavior data showed that BL was more acceptable than BN in the dissimilar brand extension. The neurophysiology process was reflected by a less negative N2 component and a larger P300 component in the BL than in the BN. We suggested that N2 reflected a whole conflict between the brand-product combination and the long-term memory and that P300 could be regarded as the reflection of the categorization process in the working memory.

Logo Effects on Brand Extension Evaluations from the Electrophysiological Perspective

PubMed Central

Shang, Qian; Pei, Guanxiong; Dai, Shenyi; Wang, Xiaoyi

2017-01-01

Brand extension typically has two strategies: brand name extension (BN) and brand logo extension (BL). The current study explored which strategy (BN or BL) better enhanced the success of dissimilar brand extension and product promotion in enterprises. Event-related potentials (ERPs) were used to investigate electrophysiological processes when subjects evaluated their acceptance of the brand extension using a combined picture of S1 and S2. S1 was a famous brand presented by two identity signs (brand name and brand logo). S2 was a picture of an extension product that belonged to a dissimilar product category than S1. The behavior data showed that BL was more acceptable than BN in the dissimilar brand extension. The neurophysiology process was reflected by a less negative N2 component and a larger P300 component in the BL than in the BN. We suggested that N2 reflected a whole conflict between the brand-product combination and the long-term memory and that P300 could be regarded as the reflection of the categorization process in the working memory. PMID:28337121