PIASA news: Lively discussion on pharmacovigilance at PIASA conference

It was well attended, with approximately 111 delegates welcomed by Kobus Venter, CEO, Janssen Cilag and Chairperson of the Regulatory and Clinical Committee of PIASA

A strong panel of speakers with divergent viewpoints came from all spheres, including academic, regulatory, industry, the South African Department of Health (DoH) and the World Health Organisation (WHO). They covered the spectrum of reporting on adverse drug events, from the practical aspects of implementing pharmacovigilance from both an industry and a regulatory authority perspective, to guidelines for investigating and reporting unexpected side effects.

Keynote speaker Professor Ralph Edwards from the WHO Centre in Uppsala, Sweden, gave delegates an international perspective on the latest trends in safety and pharmacovigilance around the globe.

A panel representing different areas of expertise was asked to discuss how the pharmaceutical industry and the MRA can work together to improve drug safety from product development to post-marketing surveillance.

Another discussion focused on important issues such as what the MRA does with the data submitted, problems with spontaneous reporting, company access to safety reports, unit standards for pharmacovigilance officers, and the possibility of establishing a professional body for pharmacovigilance officers.

Massive task

“The task of monitoring the safety of medicines on an ongoing basis is a massive one, and communications between the regulators, the manufacturers and the public are vital,” says Maureen Kirkman, Head: Scientific and Regulatory Affairs, PIASA. “While clinical trials give an indication of expected side- effects, which are then included in the package insert of the medicine when it is marketed, medicines being used in the marketplace in much greater numbers of patients with various concomitant conditions may result in reports ofunexpected events depending on the response of the individual with the condition being treated or possibly interactions with other medications”

Spontaneous reporting is the core data-generating tool of international pharmacovigilance, relying on healthcare professionals (and sometimes consumers) to identify and report any suspected adverse drug reaction to a national pharmacovigilance centre or to the manufacturer.

Because spontaneous reports are almost always submitted voluntarily, a major weakness is under-reporting. Another issue is that overworked medical personnel may not always see reporting as a priority. If the symptoms are not serious, they may not notice them at all. And even if the symptoms are serious, they may not be recognised as the effect of a particular medicine.

Even so, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance and form the core of the World Health Organisation Database, which includes around 3.7 million reports (as at September 2006), growing annually by an estimated 250 000.

Calling the conference a success, PIASA found the participation of so many a bolstering effect in its ongoing quest to sustain a favourable environment for the continued development of the pharmaceutical industry in South Africa.

Issued on behalf of the Pharmaceutical Industry Association of South Africa, PO Box 12123, Vorna Valley 1686.
Prepared by Inzalo Communications in association with Grace Communications.

For further information, contact Vicki Ehrich, Chief Operating Officer, PIASA, Tel 011 265 2106 or 082 453 4367 or
Bridget von Holdt, Inzalo Communications, Tel 011 646 9992/ 082 610 0650, Fax 011 646 9938.