Bitter pill for pharmacists as risk of liability rises

Issued by Fleishman-Hillard Johannesburg

25 Feb 2009

Substituting branded for generic medicines may result in litigation

South African pharmacists are caught between a rock and a hard place. On the one hand, they are forced by law to substitute branded prescribed medicines with cheaper generics. On the other hand, they receive little or no guidance on these dispensing decisions from the powers-that-be. This places them in an “invidious” legal position, says Neil Kirby, Director at Werksmans Incorporating Jan S. de Villiers.

“There is no doubt that the advent of generic substitution has exposed the pharmacist to a greater degree of liability in terms of fulfilling his or her legal duties,” says Kirby, a specialist in healthcare and life sciences law. “The risks and dangers are amplified because the pharmacist is obliged to overrule certain medicine-related decisions made by other healthcare practitioners. For this reason, the pharmacist's decisions are very keenly watched by the law and the healthcare community.”

Kirby says that new sections of the Medicines Act dealing with generic substitution have added significantly to the legal burden borne by dispensers of medicines, mainly registered pharmacists. “Section 22F in particular heightens the risk of making the wrong dispensing decision - and hence of committing an offence or being found negligent.”

This is because primary responsibility for generic substitution decisions now rests almost exclusively with the pharmacist. “Firstly, if the law requires it, the pharmacist is duty bound to override the decision of the prescribing practitioner by dispensing a generic substitute for a branded product. Secondly, the pharmacist has almost no clear guidance as to how to proceed in order to avoid liability if things go wrong,” Kirby says.

The dilemma facing pharmacists stems from the legal obligation they have to substitute cheaper generic medicines for prescribed branded medicines. “Failure to do so is an offence under the Medicines Act, punishable by a heavy fine or imprisonment of up to 10 years.”

Kirby says there are only four circumstances in which a pharmacist can legally avoid generic substitution: when the patient has expressly forbidden this, when the prescribing physician has written the words ‘No substitution' on the prescription, when the retail price of the generic medicine is higher than that of the branded medicine, or where the prescribed product has been declared not substitutable by the Medicines Control Council.

“In all other circumstances, the pharmacist has no choice but to dispense a generic substitute,” he says. “What compounds the situation is that nowhere is any detail to be found as to which generic medicines are the equivalents of particular branded medicines. Neither the Medicines Act nor the regulations shed any light on generic equivalents, and no guidance has been forthcoming from the Medicines Control Council.”

As a result, pharmacists have no choice but to rely on their own sources of knowledge and expertise when dispensing generic substitutes - hence the issue of liability.

“If things go wrong and the patient suffers harm as a result of the pharmacist's decision, the question then arises as to whether the pharmacist could be liable for damages,” Kirby says.

The short answer is that if a pharmacist has failed, refused or neglected to discharge his or her legal duty, and a patient is harmed as a result, the pharmacist will be exposed to liability in the South African law of delict. “Consequently, a pharmacist may be required to pay a significant amount of damages to a patient who is harmed by the negligent generic substitution of a medicine,” he says.

Given the lack of regulatory clarity on generic substitutes, the best course for pharmacists is to be fully aware of all their legal duties and to expand their own expertise of medicines, compound reactions and interactions of medicines. “And it goes without saying that pharmacists should have a full understanding of their legal duties, not just in terms of the Medicines Act but also the Pharmacy Act and regulations and the National Health Act.”