The Pharmaceutical Journal
Vol 270 No 7237 p269
22 February 2003

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Letters to the Editor

Paediatric pharmacy

Putting children first

From Professor H. McNulty, FRPharmS

In their Broad Spectrum article (PJ, 14 December 2002, p843) Chi-Loon Cheung and colleagues draw attention in an emotive way to the risks of and need for safer paediatric medicines. The authors' aims are laudable but they appear not to understand the Medicines Act or the legal rights and responsibilities of pharmacists and prescribers in devising some unrealistic solutions.

The Medicines Act was introduced in 1968 after the thalidomide tragedy had highlighted gaps in controls relating to the manufacture, marketing and supply of medicines. In 1968, many medicines were dispensed in the pharmacy, rather than manufactured and thus could not be licensed. The Act (section 10) allows for pharmacists in pharmacies to make and dispense medicines without the need for a licence (market authorisation). In reality many manufactured products issued from pharmacies are unlicensed medicines at the point of use because both relabelling and repackaging are licensable activities.

The Act gives pharmacists the role of controlling the sale and supply of medicines not on the general sale list. Therefore, we should ensure there are safe systems and procedures for supplying quality medicines under pharmacist supervision and for safe and secure handling of medicines in institutions we may supply.

The term market authorisation implies exactly what it is. The Medicines Act restricts marketing, manufacture, dealing and promotion, but not the prescribing of products, beyond who may do this and how. Few of us will see a product licence/market authorisation; the data sheet/summary of product characteristics (SPC), which must be compatible with the licence/authorisation is the nearest we will get. Many SPCs, however, are written defensively with long lists of side effects, etc. There are other problems with the authors' ideas since:

• SPCs of the same products made by different manufacturers may not be identical

• Provision of SPCs is only a legal requirement when a product is actively marketed so not all SPCs are readily accessible. They are sent to prescribers and not necessarily to pharmacists

• Generic products may not have SPCs and may not be licenced for new doses, new uses, etc. If they were licenced how much would these products then cost?

• SPCs may be changed without notice to pharmacists

The Medicines Act was not intended to do the things the authors propose and it gives us unique roles and responsibilities that should not be put at risk by ill-informed debate, especially when there are few, if any, reported cases of patients being adversely affected from unlicensed use of medicines approved by pharmacists. Tony Nunn has written more eloquently on using unlicensed and off label medicines¹ and has made more practical suggestions for dealing with this issue. He states: "There is little evidence for increased risk from unlicensed use of medicines."

Nevertheless improvements in licensing or marketed products and more research in children are needed and will help reduce risks. The Neonatal and Paediatric Pharmacists Group (NPPG) has progressed matters with the Royal College of Paediatrics and Child Health (RCPCH), developing a joint formulary 'Medicines for Children'² and jointly tackling the problems with the Medicines Control Agency and European Medicines Evaluation Agency. The NPPG and RCPCH have issued joint guidance to trusts, accepting unlicensed use is necessary and suggesting that drug and therapeutics committees should approve new unlicensed uses and require outcome data from clinicians on usage.¹

Paediatric pharmacists and prescribers are thus likely to be better placed than some others in dealing with unlicensed products or in the use of licensed products outside the terms of the licence. Sensible solutions have been suggested to manage similar risks in psychiatry³ and there are problems in other patient groups where SPCs offer little advice, such as the pregnant and those needing palliative care.

The law allows doctors to prescribe whatever is needed for their patients' treatment, licenced or not, even thalidomide. Provided that a pharmacist approves the prescription and supplies the product for the individual patient and systems such as those suggested by Nunn operate, then the potential risks should be minimised. Doctors and health authorities should be told this and must not be led to believe, as it seems from the article they are believing, that they must only use licensed products or treat licensed indications. Implementing this policy would certainly damage far more patients and undermine our roles. Doctors and health authorities should also be reminded that we are experts on medicines and it is our duty not to dispense or supply a product that would put patients, prescribers or authorities at risk, be it unlicensed or not.

Howard McNulty
Visiting Professor
Department of Pharmaceutical Sciences
University of Strathclyde

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