Generic substitution in the treatment of epilepsy: Patient and physician perceptions

Berg, Michel J.; Gross, Robert A.; Haskins, Lisa S.; Zingaro, Wendy M.; Tomaszewski, Kenneth J.

doi:10.1016/j.yebeh.2008.06.001

Cited by 93 publications

(101 citation statements)

References 11 publications

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“…Findings in this study are compatible with those in the existing literature [27][28][29]. For example, some studies proved that there is a lack of confidence among healthcare professionals in the therapeutic equivalence of all available generic substitutions [28,29].…”

Section: Discussionsupporting

confidence: 90%

“…The majority [96% (95% CI 91-98)] of participating patients confirmed that they had undergone a kidney transplant more than a year ago. In addition, more than two-thirds were taking more than seven medications [44% (95% CI 36-52) were taking between 7 and 9 medications and 27% (95% CI [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] were taking more than nine medications]. In addition, 74/147 participants [50.34% (95% CI 42-59)] were highly educated (graduated from college, university or postgraduate) and 73/147 participants [49.66% (95% CI 41-58)] were less educated (graduated from secondary school, vocational training or sixth forms) ( Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…For example, some studies proved that there is a lack of confidence among healthcare professionals in the therapeutic equivalence of all available generic substitutions [28,29]. Small differences in some particular medicines during manufacturing could theoretically result in a risk of significant adverse effects or loss of efficacy [14][15][16].…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

A survey to determine the views of renal transplant patients on generic substitution in the UK

Ameri

Whittaker

Tucker

et al. 2011

Transplant International

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Summary 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.

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Section: Discussionsupporting

confidence: 90%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A survey to determine the views of renal transplant patients on generic substitution in the UK

Ameri

Whittaker

Tucker

et al. 2011

Transplant International

View full text Add to dashboard Cite

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“…33 This objection was then followed by a large Epilepsy Foundation survey of more than 1000 individuals with epilepsy. 34 This survey found that seizures worsened for 59% of individuals who had switched from brand-name to generic AEDs. The survey findings were further underscored when Berg et al 35 published a retrospective analysis of breakthrough seizures in individuals who had switched from brand-name to generic AEDs.…”

Section: Suicide Behavior and Ideationmentioning

confidence: 94%

Antiepileptic Drugs 2012: Recent Advances and Trends

Sirven

Noe

Hoerth

et al. 2012

Mayo Clinic Proceedings

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There are now 24 antiepileptic drugs (AEDs) approved for use in epilepsy in the United States by the Food and Drug Administration. A literature search was conducted using PubMed, MEDLINE, and Google for all English-language articles that discuss newly approved AEDs and the use of AEDs in epilepsy in the United States from January 1, 2008, through December 31, 2011. Five new agents were identified that have come onto the market within the past 2 years. Moreover, 3 trends involving AEDs have become clinically important and must be considered by all who treat patients with epilepsy. These trends include issues of generic substitution of AEDs, pharmacogenomics predicting serious adverse events in certain ethnic populations, and the issue of the suicide risk involving the entire class of AEDs. This article discusses the most recent AEDs approved for use in the United States and the 3 important trends shaping the modern medical management of epilepsy.

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“…Nonetheless, skepticism about generic drugs persists. It is highest among certain categories of drugs, including ''narrow therapeutic index'' drugs in which patients require precise doses to achieve clinical benefit without incurring toxicity [4,5]. Controversy related to generic drugs also flares in the context of generic drugs approved using product-specific determinations of therapeutic equivalence, in which the FDA approves a generic version using testing individualized to the physicochemical and pharmacokinetic characteristics of the drug at issue.…”

Section: Introductionmentioning

confidence: 99%

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

Kesselheim

Gagne

2015

Drug Saf

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Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brandname drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via productspecific determinations of therapeutic equivalence.

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Generic substitution in the treatment of epilepsy: Patient and physician perceptions

Cited by 93 publications

References 11 publications

A survey to determine the views of renal transplant patients on generic substitution in the UK

A survey to determine the views of renal transplant patients on generic substitution in the UK

Antiepileptic Drugs 2012: Recent Advances and Trends

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

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