The Pharmaceutical Journal
Vol 270 No 7251 p747
31 May 2003

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Letters to the Editor

Unlicensed medicines

A plea for clarification

From Professor H. McNulty, FRPharmS

I make a plea for clarification of the term "unlicensed use" since it is ill-defined but increasingly features in your columns and in the media. Chi Cheung and colleagues (PJ, 8 March, p334) raised the potential distress caused by unlicensed use of medicines, though they now accept some unlicensed use is necessary. Recent awareness of the subject is rising but offers no clear definition of what is intended.

The children's national service framework refers to unlicensed medicines and "off-label" use (yet another piece of confusing terminology in this area since label information is limited) as having implications for clinical governance (PJ, 19 April, p539). Its interest is in the need to have more licensed commercially manufactured products wherever possible.

Department of Health Controls Assurance standards say: "Unlicensed medicines should only be used where a licensed alternative is not available and pharmaceutical quality assurance has been demonstrated for both the procurement and use of such products". I hope the interpretation of this does not promote stock pack supply rather than individually dispensed products.

Medicines Control Agency Guidance Note 14 on unlicensed medicines states it does not apply to unlicensed products made in a pharmacy, repackaged products, reconstituted intravenous additives or licensed products used "off-label".

The term unlicensed covers a number of different scenarios with widely ranging risk profiles. It potentially covers all dispensed items, assembled and repacked stock products, reconstituted products, and specials manufactured for individual patients. Product safety and quality for these are within our areas of professional responsibility and guaranteed by our pharmacy label.

The term unlicensed could equally apply to off-label use (use outside the licence of a licensed product), such as use of formulations by non-licensed routes, use of licensed products in higher or lower doses, use in non-approved indications, and use outside licensed ages or modified formulations, such as crushing tablets. Some of these are low risk but choosing the wrong injection route or dosage could be fatal. Again our pharmacy label can guarantee these have been checked for the patient, but the use of manufacturers' stock packs rather than individually dispensed products in hospital increases the chance of such practices occurring outside pharmaceutical influence.

High risk unlicensed products may include those made outside the pharmacy, such as novel specials, use of chemicals in formulations or self imported products that bypass pharmacy and quality assurance systems.

Even the word use is ambiguous — it can relate to use by pharmacists or other professionals to produce a dispensed product or dose form or the use of the product in patients.

As Cheung et al say, the use of licensed products does provide some confidence, but so should our professional skills and services. There are other standards that offer product safeguards that also apply to dispensed products — the Medicines Act specifies the British Pharmacopoeia and European Pharmacopoeia standards, the NHS Act quotes the Drug Tariff, etc. There are drug alerts and withdrawals of licensed products to remind us not to depend on licenses unquestioningly. Some standardisation of licensed information will be required to help Cheung et al achieve their goal because similar products (such as generics) may have conflicting doses, age ranges, side effects, etc.

Clarification of the terms and the high-risk areas will make it easier to develop solutions to individual problems. The Society should take a lead here to ensure our professional role is not undermined in any potential legislative changes and also aid teaching and practice in this area where many dilemmas may arise within and beyond paediatrics.

Howard McNulty
Visiting Professor
Department of Pharmaceutical Sciences
University of Strathclyde

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