Google
RSS Feeds RSS | Views on ITInews | contact | terms of use | privacy 
 


Editorial Categories:

FINANCIAL SERVICES
ADVISERS & BROKERS
BANKING & BONDS
BUSINESS MANAGEMENT
COLUMNISTS
CONSUMER AFFAIRS
CRIME & FRAUD
ECONOMY & GLOBAL
EDUCATION & TRAINING
ESTATES & WILLS
HEALTHCARE INSURANCE
INDUSTRY & LEGISLATION
INSURANCE
INVESTING
LEGAL AFFAIRS
LIABILITY INSURANCE
LIFE INSURANCE
MARKETING
PEOPLE & COMPANIES
POLITICS
PROPERTY
RETIREMENT PROVISION
REVIEWS
ROAD ACCIDENT FUND
SHARES & UNIT TRUSTS
SHORT-TERM INSURANCE
TAXATION
TECHNOLOGY
VIEWS & LETTERS


Forthcoming Events:

No Upcoming Events



Save by getting insurance quotes


Proudly South AfricanInforming Consumers and Financial Advisors since 1988 | Click Here to Advertise
Car, household, life and business insurance quotes

News Article : Bitter pill for pharmacists as risk of liability rises
Category: Healthcare Insurance : Medicines
Author:Neil Kirby
Email:[email protected]
Posted:26 Feb 2009

 Email this article Comment on this Article  Print this article

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 (Pictured right), 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."

Comments:
There are no comments at this stage. Be the first to comment!
Please Login To Comment On an Article - Click here To Login

ITInews invites comments at the foot of each of its articles in which readers can respond freely - anonymously if they wish - to various topical issues and industry debates. However, comments submitted by readers that are defamatory or deemed, by the editors, to be racist or obscene will be deleted from the database. Furthermore, ITInews's editor would like to caution potential posters on its websites that while it welcomes robust debate, it will not hesitate to make the IP addresses of the authors of such defamatory statements available to the authorities, in the event of a court order compelling them to do so.



Get car, home, life and business insurance quotes in 3 easy steps



Join us today

Insurance Quotes


Car Insurance Quotes
Household Insurance Quotes
Business Insurance Quotes
Funeral Insurance Quotes
Life Insurance Quotes

Read the InsuranceQuotes Blog

Healthcare Insurance - Medicines
Aids
Medical Schemes
Medicines
State Healthcare

More in Healthcare Insurance : Medicines
World first medication management system launches Khayelitsha pilot
The battle against TB has a new ally
Historic opportunity for DOHA round to eliminate taxes and tariffs on medicines
Broader discussion could save the Doha Development Agenda and end taxes on essential medicines
Healthcare
Medicines and the single price
Healthcare
Single exit price for medicines introduced

Join ITInews in supporting Helpnet.org.za

Available Recruitment:
No Vacancies Listed...


ITM Website Design Cape Town
Copyright © 2005 - 2015 ITInews Online Publications (Pty) Ltd. All rights reserved Insurance Times & Investments Online and ITInews. ..::ISSN 1995-1256::.. No part of the materials including graphics or logos, available in this Web site may be copied, photocopied, reproduced, translated or reduced to any electronic medium or machine-readable form, in whole or in part, without specific permission from ITInews Online Publications (Pty) Ltd. Distribution for commercial purposes is prohibited.