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Published 9 July 2018
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.
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.
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.
The provisions relating to inspection under the Contract are lacking in detail but there are some things to consider:
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.
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:
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:
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.
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.
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.
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.
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:
+353 (0)1 231 9654
+353 (0)86 042 4405
+353 (0)123 19669
+353 (0) 12319691
+353 (0)1 231 9675
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