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Risk management of unlicensed medicinal products


Allan Karr

Pharmacy Business Services Manager

University College London Hospitals NHS Trust

E: [email protected]

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

  • Develop and maintain hospital policy and procedures for managing UMPs.
  • Provide a critical, rigorous evaluation process.
  • Establish a risk-assessment scheme.

As quality-control/quality-assurance pharmacists

  • Identify all UMPs used within the hospital.
  • Quarantine UMPs upon receipt.
  • Carry out quality-control checks (eg, check label and packaging quality, review certificate of analysis, compare with specification).
  • Provide additional quality-conrol testing, if appropriate, to check specified standards.
  • Ensure that a patient-information leaflet and/or label is present, in the appropriate language(s) (eg, English in the UK case). If such items are present but not in the appropriate language(s), translation is required.
  • Decide whether to approve or reject the product.
  • Retain any documentation.

As clinical pharmacists

  • Check there is no appropriate locally licensed alternative.
  • Ensure prescriber and patient are aware of the UMP’s status.
  • Explain that delays in supply may occur due to additional risk-management processes.
  • Obtain the approval of the hospital’s drugs and therapeutic committee for new UMPs.
  • Prepare product specification.
  • Report any adverse drug reactions (ADRs) to the supplier, licensing authority and quality control network.

In procurement

  • Source suppliers offering quality product.
  • Purchase medicine according to specification.
  • Request certificate of analysis.
  • Flag up UMP on pharmacy system to ensure that those in the supply chain can identify it.

In the dispensary

  • Record batch number of product.
  • Counsel patient with appropriate clinical data

(eg, patient-information leaflets).

  • Counsel patient with supplier information to ensure continuity of clinical care.

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.

  • Clinical imperative: a UMP should preferably only be used where the risk is in proportion to the clinical treatment required. An evaluation of the clinical imperative of the disease state will establish the value of raising the treatment risk.
  • Quality control analysis: a certificate of analysis may not always be available. A decision could be made to undertake a full quality control analysis.
  • Certificate of analysis: this should be requested on all occasions, as it provides useful documented evidence regarding product quality.
  • Language of patient information leaflet: the leaflet should be reviewed and an appropriate translation obtained, if required.
  • Language of technical data: this should be reviewed and an appropriate translation obtained, if required.
  • Language of label: the label should be reviewed and, once again, an appropriate translation obtained, if required.
  • Relevant clinical information: a full literature search for appropriate evidence-based data should be undertaken.
  • The prescriber should be informed of an UMP’s status.
  • Any information on ADRs with UMPs should be circulated widely.
  • General practitioners should be informed about the UMP and provided with a useful set of data.
  • High-potency medicines – those with complex administrative schedules or more dangerous administration routes – should be reviewed more carefully than other medicines.
  • More stringent reviews should be undertaken of UMPs used on large populations of patients, since such UMPs will be inherently riskier than those used on small numbers of patients.
  • Records should be kept of such details as product source, patient and clinician, any sales, batch number, ADRs to the product sold or supplied of which the pharmacist is aware.
  • Records should be kept of details of risk assessment and risk-reduction tools used.

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.

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