Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world

Nardi, Roberto; Masina, Marco; Cioni, G; Leandri, Paolo; Zuccheri, Paola

doi:10.4081/itjm.2014.399

Cited by 7 publications

(7 citation statements)

References 35 publications

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“…Doubts were raised in the literature regarding clinical equivalence of generic drugs after substitution versus their brand-name counterpart in several therapeutic fields. [7][8][9][10][11][12][13][14][15][16][17] A recent meta-analysis including studies of generic and brandname cardiovascular drugs did not show a significant difference in terms of safety or tolerability between the 2 types of drug. 18 However, a systematic review of editorials addressing generic drug substitution in cardiology depicted a majority of negative views on clinical equivalence.…”

Section: Leclerc Et Al Generics Commercialization and Adverse Eventsmentioning

confidence: 99%

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Leclerc

Blais

Rochette

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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To achieve substantial healthcare cost reductions, the provincial government of Quebec, Canada, promotes generic substitutions and restricts access to brand-name drugs by economical and administrative strategies. 5 Once generic analogs become available, market is then shared between brand-name and generics, but little is published about the rate of this market sharing, neither regarding the clinical impact of generics commercialization. Generic and brand-name drugs are assumed to be clinically equivalent and are used interchangeably once approved Background-Once the patent of a brand-name drug expires, generic drugs are commercialized, and substitution from brand-name to generics may occur. Generic drug equivalence is evaluated through comparative bioavailability studies. Few studies have assessed outcomes after generic drug commercialization at a population level. We evaluated the impact of 3 generic angiotensin II receptor blockers commercialization on adverse events: hospitalizations or emergency room consultations. Methods and Results-This is an interrupted time series analysis using the Quebec Integrated Chronic Disease Surveillance System. Rates of adverse events for losartan, valsartan, and candesartan users (N=136 177) aged ≥66 years were calculated monthly, 24 months before and 12 months after generics commercialization. Periods before and after generics commercialization were compared by negative binomial segmented regression models. Sensitivity analyses were also conducted. For all users, there was a monthly mean rate of 100 adverse events for 1000 angiotensin II receptor blocker users before and after generic commercialization.

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Section: Leclerc Et Al Generics Commercialization and Adverse Eventsmentioning

confidence: 99%

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Leclerc

Blais

Rochette

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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“…Although GADs and BNDs are considered clinically equivalent and used interchangeably once approved by health system authorities, many questions have been raised for many drug classes about the clinical equivalence of GADs versus their BNDs. [1][2][3][4][5][6][7][8][9][10] The bioequivalence of brand and generic products usually refers to oral medications, where the majority of the concerns surround the rate and extent of absorption of these products. 5 For intravenous products, this concern is usually not likely to be an issue with maximum concentrations, where the time to the maximum concentration is considered to be similar.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Differences in brand versus generic esmolol in the treatment of perioperative supraventricular tachycardia and hypertension: A pilot study

Αρέθα

Kiekkas

Sioulas³

et al. 2020

SAGE Open Medicine

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Background: Once a patent expires, generic analogue drugs are alternatives to brand name drugs. Because bioequivalence/biodistribution problems have been reported for many generic analogue drugs, we prospectively evaluated 31 patients to reveal the differences in the doses used and the efficacy and adverse events of two different intravenous esmolol formulations. Methods: This was a prospective observational pilot study. Our aim was to reveal the possible differences in the required doses between two different formulations (brand name drug vs generic analogue drug) of intravenous esmolol in beats per minute, systolic blood pressure, diastolic blood pressure and mean arterial pressure in intra- and postoperative patients with supraventricular tachycardia and hypertension. The patients were categorised into two groups according to the medication they received (brand name drug or generic analogue drug). Results: Esmolol was given to 31 patients (16 generic analogue drug and 15 brand name drug). Although there was a statistically significant difference in bolus (mg/kg) and continued (mg/kg/h) drug dose used (brand name drug/generic analogue drug, mean (standard deviation), 0.3 (0.1) vs 0.38 (0.1), p = 0.03 for bolus dose, and 0.22 (0.09) vs 0.29 (0.08) for continued dose at 10 min (p = 0.03), 0.19 (0.06) vs 0.24 (0.05) at 20 min (p = 0.01) and 0.14 (0.05) vs 0.18 (0.05) at 30 min (p = 0.02)), there were no time-related statistical significant differences in the reduction rates of the two drugs (p = 0.47). There were no time-related statistically significant differences between the two groups in systolic blood pressure, diastolic blood pressure, mean arterial pressure and beats per minute, nor in their adverse events. Conclusion: In this pilot study, smaller doses were given for controlling the patient’s haemodynamics when a brand name drug was used. Because there were no significant time-related differences in the reduction rates of the two drugs nor in any haemodynamic differences between the two groups, optimal titration of the drug used could effectively control the patient’s haemodynamics. The adverse events were also similar in both groups.

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“…The use of generic pharmaceutical products is then promoted, in order to reduce costs and increase access to healthcare [ 6 ]. But, despite highlighting the need for rigorous quality and safety assessments for pharmaceutical products in order to achieve these goals, the quality of pharmaceutical products available in the market in many developing countries varies, in part because of the lack of clear and specific requirements for generic pharmaceutical products [ 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

Definition and Classification of Generic Drugs Across the World

Alfonso-Cristancho

Andía

Barbosa³

et al. 2015

Appl Health Econ Health Policy

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Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30 % of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

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Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world

Cited by 7 publications

References 35 publications

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Differences in brand versus generic esmolol in the treatment of perioperative supraventricular tachycardia and hypertension: A pilot study

Definition and Classification of Generic Drugs Across the World

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