First published in the July 2018 edition of the IPU Review as commissioned by the Irish Pharmacy Union

Pharmacists who provide services on behalf of the Primary Care Reimbursement Service ("PCRS") agree to a number of terms and conditions as part of the Community Pharmacy Contractor Agreement (the "Contract") which was last updated in 2010. Through Clause 7 of the Contract, the pharmacy contractor agrees to allow inspections as directed by the CEO of the HSE to be conducted on the pharmacy premises.

This article is a brief overview of inspections under the Contract, how a pharmacy might prepare for an inspection and how such inspections may be conducted.

Inspections under the contract

A PCRS-related inspection can arise "at any reasonable time" in two circumstances:
(i) A pharmacist that is nominated by the CEO arrives at the pharmacy to inspect the "accommodation, the dispensing equipment, prescription forms and records used for the purpose of this agreement including the medicines kept on the premises…" (emphasis added). Where an examination of records is involved, the inspecting pharmacist can be accompanied by other persons nominated by the CEO.
(ii) The CEO can make a specific or general request of the Pharmaceutical Society of Ireland ("PSI") to inspect a community pharmacy and the pharmacy services provided.

Duty to facilitate inspections

These inspections are framed around the pharmacy contractor being required by the Contract to allow the inspection to take place. Accordingly, contractors should pay close attention to Clause 15 which deals with a suspected failure to comply with any term of the Contract followed by investigations by a complaints committee under Clause 16. Complaints that are upheld can result in a number of recommendations ranging from admonishment, to deduction of monies due to the contractor under the scheme and, ultimately, the termination of the Contract.

Points to note

The provisions relating to inspection under the Contract are lacking in detail but there are some things to consider:

• The Contract refers to inspections being conducted "at any reasonable time" – this allows for inspections to be unannounced and would suggest that they are most likely to take place during normal opening hours but could conceivably be conducted immediately before / after the pharmacy opens for business – i.e. any time when staff could be on site.
• Where the inspector is a pharmacist nominated by the CEO , the wording in the Contract suggests that their inspection is limited to only PCRS-related documentation, medication and systems / equipment.
• Where the inspector is from the PSI further to a request of the HSE's CEO , then it would appear that the inspection could relate to and / all pharmacy operations, depending on the nature and any specifics of the request made by the CEO.

Because the PCRS-related inspection would likely to be more restricted than a general inspection carried out by the PSI as the regulator of pharmacies, issues such as the scope of the inspection become very relevant.

Preparing for an inspection

There are steps you can take in anticipation of an inspection, beyond of course being compliant with your clinical and contractual obligations and ensuring that your PCRS-related documentation, systems and records are up-to-date. However, some additional steps you can take might include:

Put a response policy in place

Pharmacies are run on the basis of SOPs so it should come as no surprise that having an operating policy on dealing with inspections is suggested. This will help ensure a calm and consistent response on behalf of your business when one takes place. As any member of staff may be the first point of contact in the event of an inspection, it is important that they all have access to a document providing key information and that they receive relevant training. This policy might include such matters as:

• The types of inspection that can take place, ensuring that inspectors should be greeted calmly and professionally,
• Requesting sight of the inspector's authorisation documents which should be copied for future reference,
• Identifying key members of staff / management to be contacted in the event of an inspection (see response team, below),
• The contact details for relevant representatives in the IPU should queries arise in the course of the inspection. In exceptional cases, you may wish to have regard to your external legal advisors so it’s a good idea to also have their contact details to hand, and
• How they should deal with being asked any questions.

Appoint your response team

A response team would ideally be made up of those individuals with sufficient seniority to make key decisions and command the assistance of their relevant teams.

• The size and composition of your response team will clearly depend on the size of your business but it should clearly include a director / supervising pharmacist.
• Consider appointing both a primary and secondary contact for each response team member in case of holidays/absences/difficulties in reaching individuals on the day.
• Depending on the size of your business, it may be helpful to appoint a team leader with overall control and responsibility for liaising with the inspection team who can deal with them on the day and any follow up points after the inspection is completed.

When an inspection happens

Once the inspectors have been greeted, allocated to a designated room/area and have presented their credentials, there are a number of steps to be considered.

Immediate steps

• Establish which of the inspectors is in charge and to whom queries should be directed.
• Engage with the lead inspector where possible to understand the scope of the inspection – this may well be clearly set out in the notice that they should provide upon arrival.

Cooperation

• As set out above, the terms of the contract require a contracting pharmacist to allow an inspection to take place so inspectors should be treated in an open and co-operative manner which includes facilitating reasonable requests for access, documents and information.
• Depending on your PCRS operations, the inspectors may be entitled to search individual offices, desks, filing cabinets, computers (including desktops, laptops, servers and tablets) and any other place used for PCRS purposes.

Shadowing inspectors

If an inspector seeks to undertake a physical search of the premises, it is prudent to arrange for him/her to be accompanied at all times by someone who is sufficiently senior and familiar with the rules in this area and the scope of the PCRS's powers. A carefully written, factual record should be made of where they go, what they look at and who they speak to.

Questioning

• The inspectors may ask questions of any employee but these questions should be limited to enabling the inspection to take place.
• If a member of staff is being questioned, they should be accompanied by a work colleague to take a record of the questions asked and the answers provided.
• If in doubt of the nature of the question being asked, you should contact the IPU or your legal representative.

Documents

• Inspectors are permitted to take copies of documentation that is within the scope of their investigation so it is important to know which documents you are obliged to share and those documents that you should not share. Relevant considerations include the scope of the search and relevance.
• The best approach for a pharmacist is to take copies of any documentation being taken by the inspectors - this will enable you to later seek legal advice if you have any queries as to whether any document taken by the PCRS is relevant or within scope.

Before the inspectors leave

• This is your opportunity to double check that you are aware of exactly what the inspectors have noted and the documents they have taken during their visit. You should use the opportunity to have a short debrief with the inspectors if they are willing and ask for a copy of the inspectors' record of the visit (this may be provided to you anyway at a later stage).
• You should also seek to establish what will happen next, when the inspectors will be in touch and if there are any positive actions that the organisation should take in the interim.

Conclusion

An inspection is a delicate balancing act between the duty of a contracting pharmacist under the PCRS Contract to facilitate the HSE inspectors while respecting the right to enjoy fair procedures in the conduct of that inspection. Preparing for an inspection is key to ensure everyone involved is aware of the extent, and limits, of their obligations. In the event of an inspection, you should contact Derek Reilly, Contract Manager with the IPU or one of his colleagues and / or your own legal advisors.

About the authors

The DAC Beachcroft Dublin Regulatory, Professional & Public Law team is lead by Gary Rice, Partner and has advised the IPU and its members for many years with respect to all regulatory aspects of pharmacy practice. For more information, please contact Gary or any member of his team: