The Twenty-sixth Annual Meeting of the National Centres participating in the WHO International Drug Monitoring Programme was held in December, in New Delhi, India. Members present at the meeting were assigned to one of four working groups (A, B, C and D), with all working groups focusing on one common issue: Improving Adverse Drug Reaction (ADR) Reporting. In general, the working groups represented countries with advanced, moderately developed or no systems for drug safety monitoring. We present a summary of the recommendations from the four groups in two parts: recommendations for working groups A & B are presented in this issue and those from working groups C & D will be presented in the next issue of the newsletter.
This group discussed the impact of education and feedback on reporting habits.
The group recommended that there should be post-graduate training to improve reporting and that pharmacovigilance programmes should form part of the accreditation criteria. Consultant physicians should be encouraged to fill in spontaneous reporting forms when they come across ADRs during ward rounds. This will act as a positive reinforcement to medical students. Case reports should be published in easily accessible journals. The Regional/National Pharmacovigilance Centres should develop websites that are easy to understand and contain straightforward guidelines in a simple language. Feedback Personal feedback including acknowledgement of reports and brief comment or communication on reports was considered important in stimulating reporting habits; a new spontaneous reporting form should be included with each letter of acknowledgement. A more general version of acknowledgement would be to include the reports in drug bulletins and journals. A somewhat different approach would have to be followed in providing feedback to consumers; it should involve general statements which are balanced and avoid discussion of specific causal relationship, with a call on patients to contact their physicians if they suspect an ADR or in cases of doubt.
DISCUSSION: Countries with established pharmacovigilance systems already have a culture of reporting. Education is therefore important to create a culture of reporting in those countries where pharmacovigilance systems are new or poorly established. Towards this, websites are useful but have resource implications. It may not be possible to allocate sufficient time for pharmacovigilance teaching in the undergraduate curriculum. However, pharmacovigilance can be tagged onto other areas dealing with medicines and their safety. It is vital to stress the importance of feedback and where possible, allow a public dissemination of discussions that go on between a patient and his/her physician without classifying them as ‘privileged’ information.
This group examined the sources of case reports in various countries to get an idea of where most reports come from.
In all countries most reports come from physicians. Industry is also a big source of reports in several countries. Mandatory reporting by healthcare professionals is not always effective; perhaps it is time to focus on creating a ‘culture’ of reporting. Consumer reporting could provide valuable information on ADRs related to OTC as well as traditional and complementary medicines. Consumer reports may not be thorough but are nevertheless important. The group called for consumer reporting either directly to the National Centre or, preferably through physicians or, to the National Regulatory Authority, as might be appropriate. A different approach might be essential for each country since organizational differences exist across countries, for example, the presence (or absence of) regional reporting centres in addition to a national pharmacovigilance centre in some, the same centre functioning as the focal point for pharmacovigilance as well as poisons related information in some others, etc.
However, there is a need to be wary of media attention on consumer reports. Further, consumers should be dissuaded from the mistaken notion that they can get compensation by reporting suspected ADRs. The quality of consumer reports can be improved through appropriate education of consumers, to identify true ‘ADRs’ as opposed to expected side effects. Towards this, Patient Information Leaflets (PILs) should provide relevant, concise and precise patient information; the product inserts provided by companies under the directives of drug regulators are often cumbersome in being too ‘thorough’ and confusing. PILs should strive to have a balance between highlighting potential problems and stating the obvious, in a language that the general population can easily understand.
Ultimately, for pharmacovigilance to be more effective, it should be seen as an amalgamation of two activities - regulatory activity and clinical practice. The frequency of reporting to the WHO ADR database could well affect the timeliness of identifying important signals and subsequent regulatory action, if any.
Final recommendations by the group were as follows:
a) Emphasize reporting by health professionals as an important source of signals.
b) Develop mechanisms for consumer reporting.
c) Provide information to patients through patient information leaflets.
d) Educate public health workers on ADR reporting.
e) Expedite reporting to the WHO global ADR database.