Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe

Johnston, Atholl; Asmar, Roland; Dahlöf, Björn; hill, kate; Jones, David F.; Jordan, Jens; Livingston, Michael; MacGregor, G. A.; Sobanja, Michael; Stafylas, Panagiotis; Rosei, Enrico Agabiti; Zamorano, José Luís

doi:10.1111/j.1365-2125.2011.03987.x

Cited by 42 publications

(44 citation statements)

References 11 publications

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“…It is the only way to prevent drug-related problems due to GS (e.g. duplicate drug use) [34]. More stringent bioequivalence rules apply to drugs with a narrow therapeutic index, or with unpredictable (non-linear) pharmacokinetics and to poorly water-soluble drugs for which the same pharmacokinetic profile (Cmax and AUC) is required [22,35].…”

Section: Discussionmentioning

confidence: 99%

Opinions of Czech general practitioners on generic drugs and substitution

et al. 2014

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AbstractThe aim of the study was to map and analyze general practitioners` opinions of, attitudes towards and experiences with generic drugs and generic substitution (GS) in the Czech Republic. General practitioners (GPs) who took part in the annual and regional professional conferences of the Society of General Practice in the period from November 2008 until March 2009 were asked to complete the 28-item questionnaire concerning the issue of generic drugs and GS. Questions were organized in 5 sections aimed at assessing the attitude towards GS, understanding the legislation and opinions on statements related to GS. All data were analyzed using descriptive statistics and correlations were tested by selected parametric and non-parametric tests. Total of 263 completed questionnaires were returned (mean age of 52.2 years (SD=13.7), 177 (67.3%) females and 248 (94.3%) GPs having a practice specialization). 99 (37.6%) respondents have considered generic drugs to be bioequivalent to the respective brand name drugs. 121 (46.0%) respondents believed that generic drugs are of lower quality than brand name drugs. None of respondent showed acquaintance with all the legal rules for GS. Awareness of the legislation and attitude towards GS correlated with the age (p<0.001). In conclusion, distrust among GPs in generic drugs derives from poor knowledge and personal experiences.

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Section: Discussionmentioning

confidence: 99%

Opinions of Czech general practitioners on generic drugs and substitution

et al. 2014

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“…In an American study a significant proportion of patients whose cholesterol lowering medication was switched from atorvastatin to simvastatin thereafter received lower therapeutic doses, potentially impairing the quality of care and effectiveness [14]. But in some cases also the appropriateness of generic substitution is still controversially discussed [15,16]. Even when therapeutic doses and conversion factors are carefully considered the substitution may lead to critical changes in the exposure with additives [17,18] and – given the generally accepted range of bioequivalence – switching may cause considerably differing exposures to the active compound, which may be relevant for drugs with a narrow therapeutic window [15].…”

Section: Discussionmentioning

confidence: 99%

Development and evaluation of a computerised clinical decision support system for switching drugs at the interface between primary and tertiary care

Pruszydlo

Walk-Fritz

Hoppe-Tichy

et al. 2012

BMC Med Inform Decis Mak

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BackgroundUpon admission to a hospital patients’ medications are frequently switched to alternative drugs compiled in so called hospital drug formularies. This substitution process is a laborious and error-prone task which should be supported by sophisticated electronic tools. We developed a computerised decision support system and evaluated benefit and potential harm associated with its use.MethodsBased on a multi-step algorithm we identified drug classes suitable for exchange, defined conversion factors for therapeutic interchange, built a web-based decision support system, and implemented it into the computerised physician order entry of a large university hospital. For evaluation we compared medications manually switched by clinical pharmacists with the results of automated switching by the newly developed computer system and optimised the system in an iterative process. Thereafter the final system was tested in an independent set of prescriptions.ResultsAfter iterative optimisation of the logical framework the tool was able to switch drugs to pharmaceutical equivalents and alternatives; in addition, it contained 21 different drug classes for therapeutic substitution. In this final version it switched 91.6% of 202 documented medication consultations (containing 1,333 drugs) automatically, leaving 8.4% for manual processing by clinical professionals. No incorrect drug switches were found.ConclusionA large majority (>90%) of drug switches performed at the interface between primary and tertiary care can be handled automatically using electronic decision support systems, indicating that medication errors and workload of healthcare professionals can be considerably reduced.

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“…Previous authors have reviewed the manufacturing and approval process for generics, speculating on what issues might arise once such agents are introduced [28,29]. Now in Mexico the COFEPRIS (Regulatory Agency in Health) has established the regulatory framework for assessing generics or biosimilar.…”

Section: Discussionmentioning

confidence: 99%

“…The comparability of efficacy is assessed via non-clinical comparative in vitro and in vivo studies, followed by clinical efficacy studies [29]. In this study, the comparable efficacy was evaluated through the pharmacokinetic study.…”

Section: Discussionmentioning

confidence: 99%

Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon

Betzabe¹,

Manuel²,

Rafael³

et al. 2015

CRJ

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Abstract:Capecitabine is an orally administered chemotherapeutic agent used in the treatment of numerous cancers including colon, colorectal, ovarian, breast and pancreatic. Considering the importance of generic drugs in Health Care Systems, it is essential that its quality, safety and efficacy be compared with the corresponding innovator product. The objective of the study was to compare the pharmacokinetics and relative bioequivalence between two tablet (500 mg) formulations of capecitabine in Mexican patients with cancer of colon. The study was designed as open, prospective, randomized, two-way, crossover bioequivalence trial. A single oral dose of 2000 mg capecitabine was administered on two separate days to 24 patients. After each administration, serial blood samples were collected for up 8 hr. The washout between the two administrations was 3 days. Capecitabine was determined in plasma using LC/MS-MS. No statistically significant differences in C max , AUC 0-t , and AUC 0-α were found between the test and innovator formulations. Both products were well tolerated by the patients, with no serious adverse events. The generic capecitabine was pharmacokinetic bioequivalent with the innovator formulations.

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Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe

Cited by 42 publications

References 11 publications

Opinions of Czech general practitioners on generic drugs and substitution

Opinions of Czech general practitioners on generic drugs and substitution

Development and evaluation of a computerised clinical decision support system for switching drugs at the interface between primary and tertiary care

Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon

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