Interactive Techniques for Learning Pharmacovigilance

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Chapter: Pharmacovigilance: Teaching and Learning Pharmacovigilance

For a clinician noticing an adverse drug effect during their management of pharmacotherapy, the act of filling in an ADR report represents an important opportunity for learning.



For a clinician noticing an adverse drug effect during their management of pharmacotherapy, the act of filling in an ADR report represents an important opportunity for learning. Too frequently, this opportunity for learning is lost.

Regrettably in most settings, insufficient resources are available to allow routine interaction between the reporting clinician and staff of the national/regional authority who record and codify such reports. Certainly for those reported events where there is a suspicion that a significant new signal may be involved, such feedback and interaction has become more prevalent in recent years. However for events that appear superficially to be more mundane, effec-tive educational interaction with monitoring authori-ties rarely occurs.

There may be many ways to remedy this lost opportunity, and certainly in some local institutional settings, discussion of, and interaction about ADR reports becomes a matter of routine. Such arrangements need to be purposefully fostered. Multi-disciplinary hospital drug and therapeutics advisory committees can be a useful forum for such learning, and in settings where high-level clinical pharmacy practice is in place, the clinical pharmacy practitioner can be an empowering influence to catalyse discussion about, and learning from any jointly observed incident.

Encouragement of more formal interactive local learning circles represents a further important oppor-tunity to be fostered: such circles have taken many forms in Europe with 10 countries being judged to have ‘substantial activities’ in this format. In partic-ular, such multidisciplinary groups have been in place amongst community-based practitioners in the Netherlands for more than 25 years and have proven themselves to be effective in gaining changes in history taking, communication with patients, follow-up decisions and drug prescribing (van Eijk et al., 2001; Beyer et al., 2003).


Higher levels of ongoing educational attainment are now being required for the maintenance of professional practice accreditation by many profes-sional authorities associated with medical and allied health disciplines. These developments provide an opportunity for more disciplined approaches to phar-macovigilance learning and education at the clini-cal practitioner level. In particular, interactive audit and feedback requirements within continuing medical education programmes are becoming more prevalent, and this form of Continuing Medical Education offers many opportunities for personal exploration of unex-pected drug-related events in relation to established pharmacovigilance knowledge.


After many years as a concept being subjected solely to research, a considerable number of countries have now begun developing interactive, one-on-one public interest–oriented academic detailing programmes for primary care practitioners. Such programmes have largely been oriented to providing commercially unbiased information concerning therapeutic and diagnostic issues. Social marketing, or the ‘sell-ing’ of patient outcome–improving ideas/evidence according to perceived needs of individual prac-titioners, is central to this academic detailing concept.

Ongoing initiatives of this kind aimed at public health improvement have been established in a vari-ety of countries including the United Kingdom, Belgium, Canada and Australia. Generally speaking, these programmes have fostered supportive relation-ships with primary care practitioners, which have then spear-headed application of additional educational and behaviour-changing initiatives.

In Australia, a National Prescribing Service has been extending academic detailing–led programmes throughout the Australian continent. These programmes have aimed for the improvement of general practitioner (GP) discrimination in their use of pharmacotherapies as well as for overall better health outcomes (NPS, 2005). The GP– academic–detailer relationships have then been used to increase credibility and uptake of a range of other NPS-initiated practice improvement programmes.

The central approach taken in these service-oriented programmes has often been to deliver key clinical behaviour-change messages targeting achievement of the most judicious balance of benefit and risk associ-ated with pharmacotherapies (May and Rowett, 2000). In this context, these public interest programmes provide an effective vehicle for the delivery of phar-macovigilance learning into primary care practice: steps need to be taken to integrate findings from pharmacovigilance studies into the activities of such groups.

One of the features of one-to-one social marketing– driven encounters is the opportunity for the place-ment of constantly evolving evidence about risks and benefits of pharmaceuticals into a context of uncertainty. This context of scientific uncertainty then joins seamlessly with the professional’s daily expe-rience of uncertainty in their own clinical practice (McWhinney, 1997). Another of the central tenets of the academic detailing model is the acknowledgement of both sides of controversial issues (Soumerai and Avorn, 1990).

This interactive presentation of pharmacovigilance messages stands in contrast with conventional use of the printed word for such communications: static delivery of this information in letters or label warn-ings frequently needs qualification for it to be entirely true and fair.

Academic detailing–spearheaded initiatives are ideal carriers for pharmacovigilance messages, plac-ing complex information into a context that reliably modulates individual clinical practice.


The use of reminders was also characterized by Bloom as an additional effective interactive tech-nique for achieving clinical practice professional behaviour change. The steady increase in the adoption of electronic systems of record keeping in health-care practice (including primary care) has created the opportunity for broader use of electronic reminders in computer-based prescription management software. These systems have been found to be generally effec-tive in issues such as drug dosage selection and also for providing general triggers for prudent monitor-ing of ongoing pharmacotherapies (Hunt et al., 1998). An increasingly broad understanding is being gained of barriers to the use of such systems in routine clini-cal care: further improvement of their dovetailing into operational patterns of clinical care will increase their usefulness over time.

The potential for the integration of electronic cautionary notes into such systems offers a further opportunity for translating pharmacovigilance-derived knowledge into practice. The critical nature of the functional design and operational ease-of-use of such software-based reminder systems remains a key chal-lenge for their developers (Patterson et al., 2005). Such reminder systems are most practical for phar-macovigilance messages where only few uncertainties exist about the nature of the response called for by practitioners: unfortunately, such circumstances are relatively unusual. The deterministic nature of much currently available software limits its usefulness for educationally effective delivery of electronic reminder warnings.

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