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Pharmacy Business Services Manager
University College London Hospitals NHS Trust
Unlicensed medicinal products (UMPs) are by definition riskier to prescribe, dispense and administer than licensed medicines. Despite this established higher risk profile, the general view seems to be that UMPs are like the weather – everyone talks about it, but no one does anything about it. To make this issue harder to ignore, demand for UMPs used by hospitals appears to be growing rather than shrinking. The limited amount of risk-management activity currently observable may not be acceptable in the future, as those involved in developing clinical governance arrangements will inevitably want to tackle this issue as well. Thus, it is becoming increasingly important for hospital staff to develop effective risk-management strategies.
Why are UMPs so important to pharmacy?
Managing these UMPs is starting to represent a significant component of hospital and pharmacy workload, which includes all the additional measures required to ensure UMPs are used in the safest possible manner. This is because clinical information available about UMPs’ efficacy and adverse effects tends to be limited, and product quality may be unknown. Specialist paediatric hospitals may be particularly affected by UMPs, more so than traditional general hospitals: in the former case many unlicensed medicines will inevitably be in use because such medicines are targeted towards adults, so do not meet the special needs of this patient group.
The need for a UMP may arise for various reasons, such as special formulation for an individual patient or to replace a discontinued licensed product. UMP supply and demand is intrinsically harder to manage than licensed medicines. Also – certainly in the UK – GPs are generally reluctant to prescribe UMPs, producing disproportionate workload and level of clinical risk for the hospital sector.
What existing roles can pharmacy play?
Often, hospitals’ clinical governance arrangements cause managers to take more notice of UMP risk management issues. Pharmacy services and their integrated systems will have to be designed to cope with medicines for which limited clinical information is available and product quality is often unknown. However, pharmacists within the pharmacy service can offer a range of important governance roles that will reduce the risk of UMPs for their patients and their organisation.
Pharmacists on drug and therapeutic committees
As quality-control/quality-assurance pharmacists
As clinical pharmacists
In the dispensary
(eg, patient-information leaflets).
What is our risk-reduction role?
Due to the unlicensed nature of these products, any adverse patient event may increase the risk of legal action being taken against the host hospital. Pharmacy services are ideally situated to develop a range of possible risk-reduction tools for use after an UMP risk assessment has been made. The purpose of these risk-reduction tools is to implement effective action, which will lower the opportunity of a patient being adversely affected by an UMP.
What risk-reduction tools can we use?
There is a range of tools most pharmacy services could use to reduce the risk of an adverse event due to UMP use.
Hospitals needing to use UMPs may need significantly more resources devoted to risk assessment and reduction than now. Whatever resources there are, pharmacy managers may need to decide whether they treat this issue differently from the weather and perhaps not just talk about it, but initiate a comprehensive risk-management process.