From member feedback, we know that the very mention of the RP regulations and the way in which they were introduced, still causes many pharmacists to suffer an increase in blood pressure.
Despite considerable protestation, the RP regulations went live in October 2009 and since then it has become clear that the RP regulations have created many significant operational problems. Last summer, we wrote to the Pharmacy Minister Earl Howe asking that he suspend them altogether until such time as they could be repaired.
Whilst we may not have got a suspension, what we did get was a commitment for their review. At the request of the government, this summer, the RP review is being undertaken by the Royal Pharmaceutical Society.
We have already included on pages 6 to 8 a list of forward policy recommendations on where we ultimately see both the RP regulations and supervision. The RP review process however will be all about understanding the problems with the current regulations. For the benefit of members who may wish to participate, we bring them up to speed with the issues where members have required the most support. We hope that you will find these insights helpful.
Repair the foundations
It is important to consider the real fundamental flaws.
Let us make no mistake, the intention behind the implementation of these regulations was they were to be used as a foundation upon which remote supervision could be delivered. The old arrangements for supervision, where a pharmacist was expected to be present have been replaced by a new concept; that a pharmacy can only operate lawfully if there is a RP who guarantees the safe and effective running of the pharmacy by signing on. The regulations specifically provide that RPs do not have to be present as long they are signed on. Currently the absence is restricted to two hours, but this may change depending on the outcome of the forthcoming remote supervision consultation. The main fundamental flaw that exists is that this entire mechanism relies on the signed on RP being genuinely satisfied that the pharmacy operates safely and effectively and that it continues to be so during any absence. This is where the theoretical principles meet with reality and fail abysmally.
Such a plan would require that;
- The RP could operate with the appropriate level of professional authority and autonomy to take charge and determine the conditions of the pharmacy to a point where they felt that the pharmacy was truly safe and effective.
- It could only be the RP who could make the decision to be absent and that the RP would take the decision only if they were satisfied that the pharmacy was indeed safe and effective in their
absence.
From the experiences of the PDA, the plans have failed in all of these respects.
Give RPs the appropriate authority
It is obvious that the owners and multiples in particular will not allow employees and locums the levels of autonomy that enable them to determine such matters. Many of the disciplinary activities that require our support occur because RPs are forlornly trying to secure the safe and effective running of the pharmacy, whilst their employers are claiming that they are just being disruptive and unhelpful.
It is evident that whilst RPs must enjoy statutory authority for certain issues, it is unrealistic to make them solely responsible, it is ludicrous that the regulations do not also make owners of the pharmacy accountable for a considerable number of other matters relating to their business.
The fact that RPs are currently accountable for the safe and effective running of the pharmacy, but that they are not really in charge is a situation that means that any public protection that was supposed to have been provided through the regulations is not being delivered and neither can it be if things are left as they are.
If we are to remedy this, then we need to ensure that the RP is given the proper level of autonomy and authority to take charge of matters that they can realistically be held accountable for – matters that involve the care of the patient. We also need to reintroduce the accountability of the superintendent for matters more relevant to the operation of the business. We have described some remedies on pages 6 to 8.
Prevent the unintended consequences
The wording of the regulations must not produce unintended consequences that represent danger to the public and pharmacists alike. In practice, we have encountered numerous situations where RPs are being held responsible for matters for over which they have no control. An example is where an RP is being disciplined because other members of staff have stolen from the pharmacy and the employer holds the RP accountable because the RP is responsible for the safe and effective running of the pharmacy. In another case the police are citing RP regulations to hold a
RP responsible for matters that are beyond their control and which only the owner can be reasonably held responsible for ( such as an inadequate CD cupboard). Surely, the Department of Health could not have anticipated these unintended consequences of their RP regulations. With the benefit of hindsight, these must now be dealt with.
Rethink the absence provision
When the original RP consultation was taking place the government hoped that the absence provision would allow pharmacists to develop new roles outside of the pharmacy. It also said that no pharmacist would ever be obliged by an employer to leave the pharmacy. Discussions in Parliament in 2006 recognised that a pharmacy without a pharmacist would not be as good as a
pharmacy with one present and focused upon the need to use clear signage notifying the public of any absence. The view was expressed that an absence could only be used for professional purposes and that a record stating the reasons for the absence needed to be made.
Despite assurances in parliament, not a single one of these measures made their way into the regulations. Consequently, there is no protection in the regulations which can prevent certain
multiple employers from ruthlessly exploiting the absence provisions to reduce operational costs.
In reality, it is the employer that has taken control of the absence provision. Literally thousands of pharmacists are finding each day that their employer has already determined when their absence will be.
They are simply told that they will attend for certain hours and not attend for others and that they are to sign on irrespective. Whether the RP can secure the safe and effective running of the pharmacy is not really the employers concern, unless of course something goes wrong, in which
case the RP would be disciplined for failing in that respect. During the professional debate that led to the current regulations the employers managed to ensure that reason for absence need not be recorded.
In some cases, RPs are even told that because their absence is not really considered to be gainful employment, that they will not get any pay during their absence – despite the fact that unless they
sign on, the pharmacy would not be able to operate at all. So much for the government’s seminal argument that a signed on RP guarantees the safe and effective running of the pharmacy – this is
why we believe that the RP debacle resembles the famous childrens story about the emperor’s new clothes!
The important message that needs to be brought home to the government during the review is that any absence of a pharmacist leaves the pharmacy in a less safe condition. Absences should be kept to an absolute minimum and additional legal/regulatory and professional rules are required to ensure that the use of the absence provision can only be decided by the RP.
Furthermore, the review process must re-visit the original founding principles;
- RPs can never be obliged to be absent by employers
- Reasons for absences must be recorded
- Signage must be displayed notifying the public if a pharmacist is absent.
No issues here?
The biggest hurdle to any RP review is that various organizations are served well by the current regulations. Certain employers would obviously prefer for things to stay as they are. Other organizations – those that refused to support a delay in October 2009 may see any changes as evidence of their previous ineptitude. The best way to undermine a review is to argue that the regulations have bedded in well and are not causing any real problems. Consequently, a genuine review process must be forced to scratch below the surface. Recently, the PDA held some focus groups and it became apparent that even some members of the PDA had begun to take the view that the regulations were probably quite innocuous – nothing more than an exercise in paperwork.
Frighteningly, a significant group stated that in general, lip service is being paid to the regulations where some name – any name is being put into the RP register just to keep it completed. In many instances, non pharmacist staff were completing the RP record, often putting in the name of the pharmacist that has not yet arrived for duty, or worse still, are able to change records, retrospectively signing on certain pharmacists for periods when they were not actually there. Those pharmacists that accede to such a regime, tended not to encounter friction in the workplace. It is in the pharmacies where the RPs try to operate according to the letter of the law that the real conflicts begin to emerge.
It is easy to see what happens if this direction of travel is allowed to proceed.
The review process will require 2000 pharmacists to be interviewed. We would urge any pharmacists who are asked to participate in the RP review to familiarize themselves again with the true scope and purpose of the regulations. Furthermore, they should study the new range of criminal and professional offences that the regulations have created and most importantly of all, they should study some of the unworkable requirements such as;
- Reading and accepting the pharmacy SOPs prior to signing on at 9.00am.
- Reviewing and amending the SOPs in the event of a critical incident.
- Signing on ONLY if they are satisfied that they can secure the safe and effective running of the pharmacy.
This is the one big opportunity that we have to make a difference – let us hope that this review is a genuine attempt by the government to put right the mistakes of the past.