Postpone the Responsible Pharmacist (RP) regulations

The Department of Health has had enacted legislation that puts in place from 1st October 2009 new rules regarding the safe and effective running and control of UK pharmacies in so far as it relates to medicines. The new arrangements require:-

An individually named pharmacist to sign on as a Responsible Pharmacist (RP) and take statutory responsibility for not only the sale and supply of medicines, but also for the safe and effective running of the entire pharmacy in so far as it relates to medicines. The pharmacy may only operate if there is an RP signed on to take such responsibility.

The operation of a pharmacy is defined and this wider definition now includes not only the sale and supply of medicines to the public, but also – the dispensing of medicines, the taking in of medicines from suppliers, making up of any preparations e.g. methadone, MDS or even bulk supplies of ointments and even certain dealings with wholesalers.

Expert legal opinion has clearly indicated that these are substantially enhanced responsibilities which introduce a raft of new professional and even some criminal sanctions which now apply in the event that RPs do not observe the regulations.

After a consultation process run by the Department of Health pharmacists were promised in parliament that they would be provided with the appropriate training so that they could be confident and competent to undertake these new responsibilities. The profession was promised that it would not be pushed at a rate which was faster than it wanted to go with enough time being given to properly take on these new responsibilities, learn about the new legislation and put procedures in place to implement them.

Unfortunately as this process has proceeded anomalies and exceptions have been discovered which make it most unlikely that pharmacists will be ready to implement the regulations on 1st October 2009. Furthermore, the Royal Pharmaceutical Society's Responsible Pharmacist toolkit which was recently issued by the RPSGB has resulted in even more confusion amongst pharmacists.

The most serious anomaly, from a patient perspective, is that pharmacies will have to close during any rest break taken by the Responsible Pharmacist (RP), unless another pharmacist is on hand to take over as the RP. This is because the RP consultation – despite many warnings being provided and much evidence being submitted, did not take into account the Health and Safety and Employment legislation which require workers to take complete physical and mental rest breaks during the working day. Instead, the RP must not only remain signed on (and therefore still be professionally active) but must also be contactable whilst away from the pharmacy. Consequently, if a rest break is to be held then the RP must be able to sign off for the duration rendering the pharmacy inoperable.

There are many other anomalies which need to be addressed before these regulations become workable and are able to deliver some beneficial advances in pharmacy practice.

Despite a recent European Court of Justice judgement ruling that it is best for the protection of the general public if only pharmacists own pharmacies we in the UK have a system where anyone can own a pharmacy and many are owned by supermarkets and pan-European wholesalers with vertically integrated business models. This, as ruled by the ECJ, can lead to pressure being applied to non-owner pharmacists both employees and locums to put commerce before patient safety. The RP regulations do go some way to address this as clearly the power is being handed to the individual pharmacist and moved away from employers – so the RP arrangements could be a powerful force in providing additional public protection. However, as written they leave the individual pharmacist still vulnerable to this pressure and more than ever liable in the event that something goes wrong with little or no liability falling on the owners. Consequently as it stands, these regulations may not provide the public protection needed.

These concerns have been expressed to the Royal Pharmaceutical Society, but currently the Council of the Society supports this legislation.

On July 10th, the Pharmacists' Defence Association launched a survey to assess the current feelings amongst the pharmacy population towards the RP regulations. Within one week more than 2,000 pharmacists had responded. Initial results show that more than 90% of pharmacists feel that there has been no appropriate training made available to enable them to take on these new responsibilities. Of the 74% who have even seen the Responsible Pharmacist toolkit provided by the RPSGB; 91% have stated that it is either unhelpful or only partially helpful. 22% of pharmacists have claimed that they will either retire from pharmacy work on October 1st or will seek not to work for a while until they can assess the operational impact of these regulations. With regards to the proposed commencement date of October 1st; 93% have stated that the profession will either not be ready at all, or will only be partially ready.

The outcome of all of these problems is that if these regulations are allowed to go live on October 1st 2009, then they will result in confusion, frustration and will inevitably be detrimental to the public.

In signing this petition you agree that the regulations as currently enacted are incoherent and not sufficiently robust to provide the protection the public needs. This petition seeks a delay to their implementation so that these matters can be addressed and that subsequently, the necessary training can be delivered.