Generic Substitution and Advice to Patients -Potential Legal Medicine Consequences - From A (Australia) to U (United Kingdom or United States of America)

Abstract

Introduction: This paper reviews the potential legal ramifications of prescribing or dispensing generics for people with epilepsy (PWE) and the international perspective.

Special considerations: Anti-seizure medications (ASM) control ~70% of seizures. Generic alternatives must respect -20% to +25% of the bioequivalence of the 'parent' medication but are not tested, one against another. The first generic may reflect -20% and the next +25%, almost halving or doubling the bioequivalence. While doctors in some countries, prescribing ASM, have the option to deny generic substitution, this may not always be respected by the 'learned intermediary'. Use of trade name, be it of a specific generic or the parent compound, obviates the potential for substitution, especially if prohibiting substitution.

Legal consequences attached to brand substitution: Patients given a generic substitute, without warning of potential risks who experience serious consequences, may litigate for medical negligence. This responsibility rests with the provision and failure to warn, be it doctor, pharmacist or institution. Where a pharmacist ignores a doctor's instruction, there is also the potential of professional misconduct.

International perspective: In the USA, litigation against manufacturers failed but litigating against prescribers or dispensers remains possible. While generic substitution is preferred, US doctors retain the right to reject brand substitution. Other jurisdictions likewise advocate generics, some mandating the same, but most offer the option to refuse brand substitution.

Conclusions: Generic substitution, particularly for PWE, has the potential for serious harm. There is a duty of care to warn of such risks. It is the responsibility of the provider to so warn, thereby achieving informed consent.

Keywords: Adverse Effects; Generic Substitution; Informed Consent; Liability.