Risk medication errors are estimated to impact 1.5

Risk management is a pivotal concept for the pharmaceutical
industry addressing the continued need
for evolving interventions to improve the safety of how
pharmaceuticals are licensed, sold and used (Fetterman et al. 2003). The importance of
risk management is highlighted with recent estimates in the
USA where medication errors are estimated to impact 1.5 million patients
per year, with 400,000 preventable adverse events, resulting in as many 7,000 deaths each
year equating to at least $3.5 billion in extra medical costs (Institute of
Medicine. 2007). The recent surge in
regulatory activity surrounding risk management presents unique challenges,
and requires seeking emerging initiatives, guidance and
precedents by health authorities prioritising the creation
of effective frameworks for assessing risk, redesigning
interventions, and monitoring to improve the safety profile of pharmaceuticals.
Failure to design and execute a proficient program leads to
delays in product approvals, limitations in licensing, and/or eventual
product withdrawal due to continued adverse events (Fetterman et al. 2003), and in many cases, leads to
increased media and legislative attention coinciding to high-visibility,
reputation-shattering and costly outcomes to pharmaceutical companies (Burke, 2007).  

 

The growing trend in self-medication for the treatment of common
ailments has widened the exposure of non-prescription
medications amongst consumers, creating a global concern for national
health authorities posing significant safety limitations on pharmaceutical
companies (Brass et al. 2011). There
are clashing views on the subject, for example, many professional
groups consider all medicines as potential sources of risk
therefore without expert supervision, or restrictions for effective drugs, the
possibility of misdiagnosis, masking more serious conditions, harmful
interactions with other medicines taken concurrently leading to poor clinical
outcomes are augmented (Oster et al., 1990;
Barber, 1993; Blenkinsopp and Bradley, 1996).  However, pharmaceutical organisations
are passionate to encourage self-medication, and to promote medicines
as bearers of benefit as opposed to risk, increasing their availability on
the markets encourages consumers to self-medicate alleviating economic
pressures on health services. As a result, these two opposing
ideologies may ultimately have a contradictory and confusing impact on the
consumers and health regulatory authorities (Brass
et al. 2011; Vuckovic and Nichter, 1997). In this
case, the need for a robust risk-management system is critical in the control
and regulation of non-prescription medicines. 

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