The Pharmaceutical Journal
Vol 273 No 7317 p378
18 September 2004

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When is quality and safety assured?

By Geoff Crumplin and Joy Wingfield

The Royal Pharmaceutical Society’s Code of Ethics and Standards contains the simple statement: “Pharmacists’ prime concern, irrespective of their sphere of work, must be for the wellbeing and safety of patients and the public.” This, clearly, requires a pharmacist to give absolute priority to the quality and safety of medicines given over to clinical use. However, recently introduced policies in the NHS appear to challenge the way in which pharmacists are required to assess the quality and safety of medicines.

It has been the long-standing policy of the Society and the Medicines and Healthcare products Regulatory Agency that medicines handed in to a pharmacy from a patient’s home should not be reissued for clinical use because the storage conditions are unknown and the quality and safety of the medicines cannot be guaranteed. This is an unambiguous policy. It protects the wellbeing and safety of patients against the clinical use of medicines of unassured quality and safety, while also providing the pharmacist with indemnity against patients receiving medicines of unassured quality and safety through the reissuing of medicines received from domiciliary storage.

How can we reconcile this familiar policy with practices recently introduced to the NHS by the Department of Health (DoH) and the Audit Commission? In the interests of cost-effective medicines management the Audit Commission document ‘A spoonful of sugar’ recommends the use of patients’ own medicines in hospitals. These are to be “ reissued” to patients after inspection by properly trained staff — a policy endorsed by the DoH in ‘A vision for pharmacy in the new NHS’. This policy implicitly states that, after visual inspection by suitably qualified staff, medicines received from domiciliary storage can be of a guaranteed quality and sufficiently safe for clinical use. Although there is a clear limitation to the reissuing of patients’ own medicines, it is impossible to escape the fact that the reissued medicines will have been received from uncharacterised domiciliary storage. After inspection, medicines suitable for reissue are only differentiated from unsuitable medicines by a correspondence of the name of the patient with that on the dispensing label.

Although we can regard reissuing NHS hospital patients with their own medicines as a sensible and cost-effective measure, it does represent a significant divergence from established practice. Such reissuing requires a pharmacist selectively to exercise professional judgement with regard to the safety and quality of medicines received from domiciliary storage — a judgement specifically prohibited by Society policy under any other circumstance. The fact that a pharmacist is precluded from exercising such professional judgement under any other circumstance demands answers to the following questions:

How does the reissuing policy protect “the wellbeing and safety of patients” against the clinical use of a medicine of potentially compromised quality and safety? The storage conditions to which the medicines have been exposed are unknown. Therefore there is a presumed possibility that the quality and safety of the medicines may have been compromised.

How does the reissuing policy indemnify the responsible pharmacist against a patient receiving a medicine where quality and safety are compromised? There appears to be an exclusive reliance on the legal ownership of the medicine to provide indemnity to the responsible pharmacist. The pharmacist accepts responsibility for guaranteeing the quality and safety by only reissuing medicines after inspection — a responsibility for which there is no apparent indemnity (because the storage conditions are unknown and the quality and safety of the medicines cannot be guaranteed).

Has the DoH redefined the ultimate determinant of the quality and safety of medicines in terms of a correspondence of names rather than evidence of quality and safety? The Audit Commission recommendations only provide a restricted set of criteria for excluding any domiciliary sourced medicine from reissue. In contrast, the Society’s policy permits no reissue of medicines from identical sources. Hence any medicine received from a domiciliary source, which cannot be excluded from reissue by the Audit Commission criteria, is considered of acceptable quality and safety exclusively on the basis of a correspondence of names.

If the quality and safety of medicines can be guaranteed for patients whose name corresponds with the dispensing label, it must surely follow that any medicine similarly sourced and inspected must be of equal quality and safety.

Does the selective reissuing of medicines received from domiciliary storage represent a form of discrimination? There are two contrasting versions of discrimination in this policy:

· If the quality and safety of medicines from a domiciliary source cannot be guaranteed sufficiently to permit charitable donation, then it must follow that NHS patients reissued with their own medicines are offered a lower standard of protection than that required for patients in the world’s poorest communities

· If the quality and safety of medicines from a domiciliary source can be guaranteed for reissue to selected NHS hospital patients, then it is discriminatory to preclude charitable donation of similar medicines on the grounds of potentially compromised quality and safety

In the UK, medicines to a value in excess of £500m are destroyed annually so it is no wonder that the reissuing of patients’ own medicines in NHS hospitals is considered an attractive measure. However, the possibility of redirecting selected medicines from domiciliary sources to charitable organisations (as an alternative to expensive incineration) has always been embargoed because the quality and safety cannot be guaranteed. The reissuing policy in NHS hospitals now suggests that the quality and safety of such medicines can be guaranteed.

Although the reissuing of medicines for anyone other than the originally intended patient has not been sanctioned in the UK, advances in the protective properties of packaging have been sufficient to persuade other countries of the retained quality, efficacy and safety of reissued medicines. In the US domestic recycling programmes are already being trialled and controlled reissuing for overseas donation is already legitimate.¹

In view of the conflict between the Society’s determination of the unassured quality and safety of domiciliary sourced medicines and the NHS’s acceptance of the assured quality and safety of identically sourced medicines, should we discontinue reissuing in NHS hospitals, or should we permit controlled reissuing of domiciliary sourced medicines (perhaps for charitable purposes)?

Reference

1. Pomerantz JM. Recycling expensive medication: why not? Medscape General Medicine 2004. Available here (accessed on 14 September 2004).