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Chapter: Pharmacovigilance: Teaching and Learning Pharmacovigilance

The education and training needs of both professional pharmacovigilists and also clinical practitioners have been significantly influenced by recent social developments.


The education and training needs of both professional pharmacovigilists and also clinical practitioners (as those who need to learn watchfulness about the therapies they administer) have been significantly influenced by recent social developments. The contemporary public health focus on better manage-ment of risk in use of pharmaceuticals has contributed to a renaissance of thinking about pharmacovigilance. This new thinking is embodied in the transition from thinking primarily about drug ‘safety’ to more consis-tent thinking about balancing and managing both risks and benefits of pharmaceuticals in individual patient care.

These developments have been propelled by the recent elaboration of significant harms that can be caused by health services in general and pharmaceu-ticals in particular.

The Erice Declaration of 1997 by the most respected figures associated with the field of pharmacovigilance clearly enunciated international aspirations for more effective communication of drug ‘safety’ information (Anon, 1998). However, as has been shown through expressions of deep public concern about recent high-profile drug withdrawals from the global market, the effectiveness of these communications now needs careful scrutiny.

Within the health professions, these developments demand action to improve clinical education and training on how to better manage both risks and benefits associated with drug therapies. Action is needed in this regard at the level of both the learners and the teachers of pharmacovigilance. To purpose-fully communicate the meaning of risks of therapy uncovered through good pharmacovigilance practice, it is necessary to place these messages within a framework acknowledging balance that clinicians and their patients must achieve between both risks and benefits.

The movement to measure and improve quality in healthcare (particularly as it refers to pharma-cotherapeutics) is especially relevant in this regard. A clear understanding of the nature and direction of the quality-in-healthcare field is going to become increasingly important. Pharmacovigilance profes-sionals need to be able to share with proponents of this significant global movement, the benefit of their experiences of success and failure in timely identifi-cation, evaluation and communication of risks asso-ciated with drug use in therapeutics.

Pharmacovigilance has been relatively successful at the macro level of government regulation in achiev-ing the removal of pharmaceuticals deemed ‘unsafe’: however, it has been rather less successful in dealing with pharmaceuticals that have less florid negative effects, particularly those balanced by aggregate clinical benefit. Certainly in the matter of pharmacovigi-lance communication with clinical practitioners about drugs with more marginal levels of risk, attempts to communicate such risks in the absence of paral-lel communication about acknowledged benefits have met with only limited success. This is a lesson which those advocating improved quality of healthcare need to absorb.

The spontaneous ADR report is going to continue to be a key link between teachers and learners of phar-macovigilance: it provides vital raw material for clar-ification of the extent and nature of risks of specific drug therapies. The aspiration for improved individual clinical watchfulness for adverse effects from phar-maceuticals draws attention to the point that closer educational attention also needs to be paid to the act of prescribing itself.

It is notable that despite the fact that so many patient–physician interactions conclude with a prescription for pharmacotherapy being handed to the patient, relatively little attention is generally paid to sound training for this key clinical function. Prescribing of course is an action that prefigures the discipline of pharmacovigilance itself. Scrutiny of the conventional healthcare literature of the past 15 years reveals very little systematic investigation of the educational needs or determinants for the act of prescribing.

Whilst at least two published curricula are avail-able for training prescribers (de Vries et al., 1995; NPS, 2002), the systematic investigation of whether presumed ‘appropriate’ prescribing results in better or safer care remains in its infancy (Kazandjian, 2004; Paton and Lelliott, 2004). Indeed a persuasive case has been made by Dowie that the lack of an infal-lible, ‘if–then’ prescriptive basis for specific clini-cal decision-making will always confound attempts to associate better care with particular patterns of phar-macotherapy usage (Dowie, 2004).

However, it is clear that the paradigm of benefit and risk from pharmaceuticals, and the prudent manage-ment of these dimensions of drug effect now needs to become a basis for therapeutics training for all health professionals. Equally important is the subse-quent shared and informed decision-making between prescriber and patient that provides proof of sound management of the balance of benefits and risks from drug therapies.

Keeping or establishing pharmacovigilance educa-tion on these lines will enhance the impact that can be achieved by the discipline on the health of the public.

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