The education and training needs of both professional pharmacovigilists and also clinical practitioners have been significantly influenced by recent social developments.
CONCLUSIONS
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.
Related Topics
TH 2019 - 2024 pharmacy180.com; Developed by Therithal info.