Conjoint Professor, South Western Clinical School, University of New South Wales, Sydney, NSW, Australia; Professor, Medical School, Griffith University, Broadbeach, Qld, Australia; Professor, Chair, Medical Law, Sechenov, Moscow First State University, Moscow, Russia.
Seizure. 2021 Oct;91:515-519. doi: 10.1016/j.seizure.2021.03.016. Epub 2021 Mar 17.
This paper reviews the potential legal ramifications of prescribing or dispensing generics for people with epilepsy (PWE) and the international perspective.
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.
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.
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.
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.
本文回顾了为癫痫患者 (PWE) 开处或提供仿制药可能带来的法律后果，以及国际视角。
抗癫痫药物 (ASM) 控制了约 70%的癫痫发作。仿制药替代品必须尊重与“母体”药物的生物等效性相差 -20%至+25%，但不进行相互测试。第一个仿制药可能反映 -20%，而第二个则为 +25%，几乎减半或加倍生物等效性。虽然一些国家的医生在开 ASM 时有拒绝仿制药替代的选择，但这并不总是被“中介机构”所遵守。使用商品名，无论是特定仿制药还是母体化合物，都会排除替代的可能性，特别是如果禁止替代的话。
如果患者在没有意识到潜在风险的情况下被给予仿制药替代品，并因此遭受严重后果，他们可能会对医疗疏忽提起诉讼。这一责任在于供应方和未能发出警告，无论是医生、药剂师还是机构。如果药剂师无视医生的指示，也有可能存在专业不当行为。
在美国，针对制造商的诉讼失败了，但针对开处方者或配药者的诉讼仍然可能。虽然更倾向于使用仿制药，但美国医生仍然有权拒绝品牌替代。其他司法管辖区也同样提倡使用仿制药，一些地区强制要求使用，但大多数地区都提供拒绝品牌替代的选择。
仿制药替代，特别是对 PWE，可能会带来严重的伤害。有责任警告这些风险。提供者有责任发出警告，从而实现知情同意。
