A focus on Hospital RP issues

It is well known that the RP regulations were primarily designed for application in the community setting. However, as the RP regulations came nearer, it became clear that the RP regulations would impact upon hospital pharmacy practice to a much greater extent than anyone had previously imagined.

The RP regulations create a number of new operational requirements that must be met by RPs and create new criminal offences for those who fail to observe these; such as for not making a record and for not keeping the record for five years. It is obvious that these regulations were all about being able to hold individual pharmacists to account in the event of a problem.

Bearing in mind that the profession has just about had its fill of needless exposure to criminal convictions and the fact that our research showed that the profession was just not ready for these new regulations, the PDA called for a delay to the implementation of the regulations in July 2009. This call for a delay was backed by a petition, which attracted more than 5,000 pharmacist signatures. A delay would have given a period where the profession could try and bed in the regulations away from the threat of professional and criminal sanction.

When the RPSGB council came to consider this, they asked whether the Guild of Healthcare Pharmacists felt that hospital pharmacy was ready to implement the regulations. Surprisingly, the Guild position was that it was quite content for the regulations to go forward on October 1st. Sadly, the Guild chose not to support a call for the delay, notwithstanding the exposure of hospital pharmacists to criminal sanctions that the regulations would produce. The RPSGB Council then voted not to support the PDA's call for a delay and the RP regulations went live on October 1st 2009.

Since then, there have been growing concerns being expressed by hospital pharmacists about these regulations and we decided to establish whether this is a localised problem or something much broader. Members will have seen that we have undertaken various surveys and member feedback initiatives. This feature takes a snapshot view of how the RP regulations are currently perceived by hospital pharmacists. The results of our findings are worrying and they bring us to conclude that the RP regulations serve no useful purpose in hospital pharmacy. The capacity of hospital pharmacy to be able to observe the RP regulations to the letter of the law is limited and as a consequence, some hospital pharmacy departments are not at all able to meet the requirements. This exposes pharmacists to the prospect of criminal and professional sanction. Worse still, where attempts to comply with the regulations are being observed they significantly hinder hospital pharmacy operations and in some cases even lead to the closure of some patient services. We examine specific aspects of our findings;

Insufficient preparation leads to a lack of clarity and perception.

The various government departments commenced some additional RP work to focus on hospital practice in the summer of 2009. The hospital RP toolkit was not released until the end of August, leaving just a few weeks before the implementation date. This meant that many senior managers were not ready to induct their departments in time for the initial start date. Surveys have shown that many hospital pharmacists did not receive a briefing about the RP regulations before October 1st, what is worse is that nine months later, a significant number (in excess of 40% of respondents) claim that they have still not had an RP induction.

Whilst the absence of an induction is obviously problematic, it is becoming apparent that some senior managers are still not at all clear about the regulations.

Comments from some senior managers which have been received by the PDA include;

• "This is all about one pharmacist signing other pharmacists in and out on a rota system."
• "The RP regulations do not change anyone's culpability, I would still be made answerable for any errors." "These regulations make no difference to those signing on as RPs."
• The fact that this is a wider problem is confirmed by responses that we are receiving from many more junior pharmacists when they confirm that their concerns are not being addressed by management;
• "When we organise meetings to try and get some answers about RP, there is clearly a great deal of confusion."
• "We are just not being offered the full legal implications of the role of the RP."
• "The Chief Pharmacist told us that it didn't really make any difference to us, we raised some objections, but they did not listen."
• "The dispensary manager is a technician and could not answer all the issues that we raised."
• "I have been lulled into a false sense of security as I have never been told what I am signing up to do."

Clearly, there is also evidence to show that many pharmacists do fully understand the regulations, however, in those cases, they are frequently able to offer powerful testimony as to their operational unworkability.

A general review of the many responses that we have received show that many hospital pharmacists just don't know what they don't know. This has led to many of them acquiescing to being RPs because it is the 'done thing' and because it is expected of them - they do not want to be seen by management as being awkward. Even the most basic examination of the regulations will confirm that the RP regulations are anything but "business as usual", requiring RPs to take new statutory responsibility for significant aspects of the pharmacy operation and for them to comply with specific operational activities. We are not supportive of the application of the RP regulations in the hospital setting, but we nevertheless advise pharmacists who have not had an RP induction, or where there is a lack of clarity about the regulations, that they are facing unacceptable risks and may find themselves the focus of both criminal and professional investigations, which some prior planning could have otherwise mitigated.

We urge all senior pharmacists to establish what their hospital's 'RP' policy actually is and to ensure that it is fully compliant with the regulations. Once that is established, then this should be communicated to all those affected by it in an unambiguous way.

Any departments that have not yet provided a formal induction of the RP regulations should seek to urgently address this.

What about insurance arrangements?

Some pharmacists, when they complain about the lack of information from senior management about RP regulations, are simply being told "Don't worry, the trust's vicarious liability will cover you all."

What they are saying is that if a pharmacist falls foul of the RP regulations and ends up with a criminal, professional or employment sanction, then the Trust will stand up to defend the pharmacist. This advice is seriously misinformed. That this suggestion could even be contemplated, demonstrates that those who make it have no idea of what an employment, criminal or professional investigation can look like. From the many thousands of cases handled annually by the PDA, we can confirm that no hospital pharmacist should be satisfied with such a response as in reality, employers will be much more interested in making sure that their reputations remain intact. Indeed, if a hospital pharmacist is the subject of sanctions due to falling foul of the RP regulations, judging by the results of surveys that we are receiving, it is very likely that we will be seeking to draw Trusts into the firing line for a lack of proper preparation for these regulations.

The unworkability of the regulations.

It is now obvious that aspects of the regulations do not fit easily in the hospital pharmacy setting. This 'misfit' situation manifests itself in numerous ways.

• Junior staff are left to sign on as RPs simply because they spend more time in the dispensary. However, because they tend to have a hierarchy of more senior staff in managerial positions above them, they cannot exercise the professional control that the regulations would require them to. It is therefore inappropriate to expect them to deliver and review departmental protocols and to hold them responsible for securing the safe and effective running of the pharmacy. However, this is what the RP regulations are holding them to account for.
  "The dispensary is managed by technicians who are in positions of authority, they tell me what to do even if I as RP disagree, they are also in charge of all of the other dispensary staff."

• RPs are often not in a position to make any clinical interventions on prescriptions as the clinical pharmacy input is being made remotely (usually on the wards). Consequently, many pharmacists are very reluctant to sign on as RPs as the regular functioning of the hospital pharmacy service mitigates against the intended application of the regulations.

• Our surveys are showing that routinely, RP registers are not being maintained, as is required by the RP regulations, resulting in many departments operating unlawfully. In some hospitals, certain individuals are even given a specific mop up role where they sit down to fill in the gaps by entering lists of pharmacist names into the RP register. Whilst this may be a pragmatic approach, it makes a complete mockery of the regulations.
  "I have been given the job of RP monitor, it is my job to fill in the names."

• Because of the regulations, some patient services such as out of hours supplies to other hospitals have been reduced. Others, such as specialist satellites or even satellite pharmacies in community hospitals have been closed down making life more difficult for patients. It would appear that these regulations are of no benefit to hospital pharmacists and that they are also impacting in ways which were not anticipated on patients.

The RP situation in hospitals is a subject that could fill an entire magazine. However, we feel that the words expressed to us by one member sum up the position when she says that;

"The RP regulations have significantly hindered hospital pharmacy by adding unnecessary work and affecting certain operations like supplying external organisations. I believe that they have added no benefit at all to the public. As a junior pharmacist in the organisation, I seriously think that this regulation needs to be reviewed as a situation where I sign on as being responsible for safe and effective operations which are outside of my control and beyond my competency is unlikely to be beneficial to the patient, the profession or the organisation."

Once all of the data has been analysed, the PDA intends to make contact with the Pharmacy Minister asking that he exempts hospital pharmacy from the regulations. In the meantime, we ask that all hospital pharmacist members participate in our ongoing surveys, as the more information that we can gather, the greater will be our chance of securing some positive outcomes.