The PDA is generally supportive of the General Pharmaceutical Council’s proposals but they do not go far enough in addressing the SOP-led culture that has damaged the profession and is beginning to harm public interest.
The PDA agrees with the GPhC that a ‘tick box’ approach to regulation is not the way forward, but warns that more SOPs could be the result of the current proposals and these often stand in the way of patient centred practice. PDA Chairman Mark Koziol comments: “The standards consultation has stayed relatively silent on the issue of SOPs, indicating perhaps that it too recognises limited benefits from such an approach. However, we would have preferred the GPhC to have taken a more proactive stance in confirming the limited contexts in which SOPs should be relied upon and that in the vast majority of cases the professional judgement of the pharmacist is where the true benefit to patients emerges.”
The seismic shift in regulation that is being proposed will create ambiguity that could allow some pharmacy operators more latitude than the regulator intends. While it can be safely assumed that healthcare professionals will act in patients’ best interests, with less than 40 per cent of UK pharmacy premises in the hands of pharmacists the majority of premises and pharmacists are subject to a different style of commercial pressure, which often compromises their professional autonomy. A 2009 European Court of Justice decision gives member states the right to determine how they regulate pharmacy to ensure that the professional independence of the pharmacist is not circumvented. The PDA believes that this gives the GPhC the right to implement a regulatory regime that ensures that pharmacists can operate with professional autonomy for the benefit of the patient.
By focussing on a risk based approach, this consultation is an opportunity for the GPhC to promote a different way of demonstrating good practice and compliance with standards. But the GPhC and the profession as a whole do not currently have enough experience of risk based assessment to make the proposed regulatory methods work effectively. “Movement from a regime that is heavily supported by guidance to one in which guidance is sparse will result in confusion and conflict as it has in other professions,” warns Mr Koziol.
The PDA further argues that Pharmacy medicines must not be allowed to be available for self-selection, as the GPhC proposes. “This would be tantamount to disbanding the P category altogether and would allow the larger retailers to successfully argue that there remains no public interest in having such a medicines category at all,” says Mr Koziol. ” Imagine a situation where a pharmacist is trying to prevent the sale of an inappropriate medicine to a patient desperately intent on buying it come what may. Currently, a pharmacist may simply refuse such a sale as it is out of reach of the patient, under self-selection proposals this would be very difficult to accomplish. The GPhC should play an important role in protecting the public interest, but if it allows P medicines to go on self-selection then we believe that this would represent a dereliction of its duty in its role as public interest guardian,” he says.
Premises standards are at the root of a substantial proportion of incidents that cause harm to the public and the PDA makes 15 recommendations to further develop standards, including:
- Strengthen those provisions that ensure the independence of the pharmacist
- Ensure that commercial pressures to not take precedence over professional ethics
- Define the limits of control from non-registrants, and in particular curtail the power of non-pharmacist managers to change operational parameters to the detriment of patient safety
- Ensure that certain standards, such as requiring employers grant staff appropriate rest breaks, remain unambiguous and distinct and do not become vague principles
- Protect the public by ensuring that Pharmacy only medicines are not sold via self-selection
- Clearly separate the elements of the premises that are the responsibility of the owner from those that are under the control of the responsible pharmacist
- Requiring corporations that have a pharmacy interest to have a senior level accountable manager who is held accountable at the most senior level of the company for patient safety in so far as it relates to the pharmacy operation.