Joy Wingfield on community pharmacists'patient safety responsibilities

Published: 15/01/2004, Volume II4, No. 5888 Page 32

Few of us would argue with government policy to secure quality in the NHS, and even fewer would challenge the vision of the National Patient Safety Agency (HSJ supplement, 13 November 2003).

However, for those private sector professionals contracted to provide NHS services, there may be some snags. For community pharmacies, these arise both from the commercial environment in which they operate and the workings of the Medicines Act 1968.

In general, an individual cannot be compelled to answer a question that may incriminate them. By extension, providing information to an official body concerning facts that, on the face of it, could be evidence of a criminal offence would be regarded by most as unwise.Yet this is precisely what is now being expected of community pharmacies.

Primary care trusts are accountable for performancemanaging NHS activity in the private sector, including the dispensing of prescriptions by community pharmacies.

Disclosure of patient safety (ie error) information creates serious and very real risks to those who provide the data. The individual pharmacist is exposed to direct and personal risk of prosecution and professional discipline; the business is exposed to negative media attention with attendant damage to reputations and share values. The collation of patient safety data acquires the same sensitivity as air travel safety data for airlines because users of private sector providers of NHS services can vote with their feet.

The dispensing of prescriptions in community pharmacy is entirely under the control of the pharmacy contractor. A dispensing error is therefore peculiarly likely to be the sole 'fault' of the pharmacy contractor. Unlike most other errors in the health service, almost all dispensing errors constitute a criminal offence under section 64 of the Medicines Act. Every prescription must be dispensed exactly as written. In this way, every dispensing error could warrant investigation as a matter for prosecution.Moreover, the offence is absolute and involves strict liability: there is no defence available within the act unless it can be proved that the error simply did not happen. Though the Royal Pharmaceutical Society has now stated its intention to seek an amendment to the law, this is likely to take a considerable time to achieve.

The Department of Health has accepted the recommendations of Professor Sir Ian Kennedy's Bristol inquiry.He said that, provided NHS staff properly reported errors or failures, they should be immune from disciplinary action.

However, such immunity would not apply if a criminal offence were committed. This response appears to assume that all criminal offences require mens rea - a guilty mind - which is simply not the case for absolute offences.

The RPS employs inspectors who will, in the case of dispensing errors, consider whether the facts of the case would justify prosecution.Moreover, chief medical officer Professor Sir Liam Donaldson's report, Making Amends, suggests that 'legal privilege would be provided for reports and information identifying adverse events, except where information was not recorded in the medical record' (legal privilege confers protection from wider disclosure beyond the original recipient).

How will this be applied to pharmacy records, given that community pharmacy has little immediate prospect of being linked in to NHS integrated care records? The NPSA has made it clear that it only requires anonymous data on patient safety incidents and does not seek to identify patient, professional or organisation.

What about PCTs? How will they manage performance of their contractor pharmacies if information is anonymous? How will they foster a supportive and 'fair blame' culture?

The interpretation of error reports is rife with opportunities for misinterpretation and illconsidered conclusions.

Attempting to compare numbers - or numbers per pharmacy or numbers per prescriptions dispensed - may overlook fundamental questions of how errors are defined and what criteria are applied to their recording and/or reporting. It is entirely possible for high numbers of errors to be reported from a contractor who is trying hard to learn from mistakes, and a low number could reflect a practice where little effort at all is being made to audit.

Would every PCT be happy to indemnify pharmacy contractors for any commercial damage which may result from leakage of dispensing quality data or misinterpretation by the media?

Collection and analysis of error data is immensely valuable. Only by aggregation of consistently described data, collected over lengthy periods, is it possible to identify trends, types of errors, circumstances, associated individuals, staffing levels, and so on.

Many causes of errors arise within the system and are best addressed by those in control, be they a singlehanded owner/proprietor or a large company. There may be even more that could be learned from the amalgamation of data from all contractors in a given area, but some protection from the consequences of self-incrimination should be in place first.

The new NHS contract for pharmacy services, expected from April, is likely to include a requirement to provide information on failures and mistakes to the relevant primary care organisation.How will this information be used? Who will interpret it and have access to it?

Will every primary care organisation be ensuring that information provided for audit purposes is not also used to mount further investigations?

Will they be prepared to resist demands for discovery from the media or the public?

Resolution of, and guidance on, these points will be needed to avoid compromising the value of collated data from pharmacy contractors, and the opportunity to address important patient safety issues in the community.

Further information

Chief medical officer's report www. doh. gov. uk/makingamends

Joy Wingfield is professor of pharmacy law and ethics, Nottingham University school of pharmacy.