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Responsible pharmacist regulations are open to interpretation

From Mr I. D. Kemp, MRPharmS

I attended the British Pharmaceutical Conference hoping to get an insight into how the responsible pharmacist regulations would work in practice, but to no avail. The fact that the UK health departments will need to issue factual guidance confirms that they accept the regulations are open to interpretation, which means a high court judge is likely to establish some dodgy case law in the future. However, the reason given for having new regulations was that the old ones had been corrupted by case law.

Rob Darracott is correct in drawing attention to several practical issues but pharmacists must ensure that all their issues are addressed, not just those of the Company Chemists’ Association. Let me set the ball rolling with a simple example.

It seems generally accepted that an airline-style preflight check is a good starting point. But what if there is an issue with staffing levels? For the pilot, it is simple, because each type of aircraft has its designated staffing levels and staff must be qualified for that type of aircraft. Anything less and the pilot does not take off but the passengers may not simply board another aircraft, because it may already have its full quota of passengers. It is not so easy for pharmacists because the Royal Pharmaceutical Society has always avoided giving hard and fast rules on staffing, so it is a matter of opinion. What if the superintendent pharmacist’s opinion is different from the responsible pharmacist’s opinion? Could pharmacists be sued for breach of contract if they fail to open the pharmacy?

The airline model also fails on the matter of safety. Is it safer to close the pharmacy or are more patients likely to suffer from not getting access to medicines or from using a nearby pharmacy, where the responsible pharmacist suddenly has to deal with more patients than expected when he or she agreed to accept responsibility at the beginning of the shift?

Currently, I would inform my area manager if there was a staffing level issue, hoping that extra staff might be available. But, as of 1 October 2009, would the mere admission of a problem mean that, in law, I should not allow the pharmacy to open. What about pandemic influenza? The law cannot change and we are bound to be short-staffed. So does that mean there will be fewer pharmacies open than it would be under current regulations?

It was clear that Mark Koziol felt sidelined in the debate but the Society, the Department of Health and the CCA should not forget that large numbers of pharmacists have their professional indemnity insurance through the Pharmacist’s Defence Association. If my insurer tells me to close the pharmacy, it does not matter what the advice is from elsewhere. The pharmacy will be closed.

Ian D. Kemp
Halifax, West Yorkshire

Citation: The Pharmaceutical Journal URI: 10032795

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