When a new retail pharmacy business (RPB) is being opened, or an existing RPB is being closed down, a wide range of issues need to be considered and addressed. These include all of the practical and legal issues associated with premises, suppliers, contracts and so on. For example, when opening a new RPB, it is very likely that a Community Pharmacy Contractor Agreement with the HSE would need to be obtained, and when closing the HSE must be notified of the closure.
In this article I will focus on one very important aspect, which are the requirements under The Pharmacy Act 2007 (as amended) when it comes to the opening and closing of an RPB. This the first port of call before getting to other legal issues such as dealing the wholesalers, applying for a HSE-PCRS Pharmacy Contractor Agreement, and so on.
A person wishing to open a pharmacy must apply to the Pharmaceutical Society of Ireland (PSI – the Pharmacy Regulator) to register the RPB at least 60 days before it is opened and have the application processed and registered in accordance with statutory rules before it may operate. This generally takes 60 days, although there is a more expensive ‘fast-tracked’ process, which takes less than 30 days.
The application contains information such as details of the ownership of the proposed RPB, the services it intends to provide, evidence of insurance or indemnity cover and floor plans of the proposed premises. Where the proposed RPB will be owned by a company, a copy of the Certificate of Incorporation and the Memorandum and Articles of Association or Constitution must also be submitted.
Various statements must be submitted with the application. These include details of the arrangements that the pharmacy owner has put in place for registered pharmacists employed in the RPB, to ensure that those pharmacists obtain and maintain appropriate experience in the practice of pharmacy, and undertake appropriate continuing professional development. A statement setting out the arrangements that the pharmacy owner has put in place in respect of the segregation, storage and disposal of any medicinal products, including veterinary medicinal products, that have expired or that have been accepted as a return under Regulation 6(3) of the Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. 488 of 2008) must also be submitted.
A pharmacy owner cannot legally operate a pharmacy without a supervising pharmacist and superintendent pharmacist. The application must specify the name of the appointed supervising pharmacist who is to oversee the RPB at the premises, their PSI registration number and a statement setting out their three-year minimum post-registration experience, pursuant to section 27 of the Act. The details of the appointed superintendent pharmacist, who must also have three-year minimum post registration experience, should also be provided in the application with this person being responsible for the professional and clinical management of a pharmacy and administration of the sale and supply of medicinal products.
Company secretaries, and those with legal authority for pharmacies, have the responsibility to ensure the accuracy of information provided to the PSI in the registration process. If a pharmacy is owned by a company as defined in the Companies Act 2014, continued registration of the RPB must be ensured by the company secretary, a director, or another person legally authorised to act on behalf of the pharmacy ownership. The company secretary is responsible for ensuring the efficient administration of the company and compliance with statutory and regulatory requirements.
As part of the application process, the PSI may visit the proposed RPB and carry out an inspection of the premises. If an inspection is required, the pharmacy owner will be notified of this in advance. The Act gives the PSI powers of inspection as part of the regulatory role in the interests of public health and safety. The Authorised Officers of the PSI will carry out an inspection and provide a report after the inspection visit. The report will indicate the standards and requirements that have been met, and any items to be addressed, with a time period for their completion.
The 2008 regulations provide that the PSI must consider the application within a period not exceeding 30 days from the date of receipt of the application. Where the PSI requires verification of anything contained in the application, or further information, it will notify the applicant of their request in writing. If the pharmacy’s application is successful, the PSI will issue a certificate of registration to the pharmacy owner which will be valid for 12 months from the date of registration. This certificate, and the certificate of registration of the supervising pharmacist, should be displayed prominently in the pharmacy, in such a way that it is visible to members of the public from the public pharmacy area.
The pharmacy owner or superintendent pharmacist must notify the Registrar of the PSI of any changes in the registered pharmacists or pharmaceutical assistants specified in the application for registration. Any material changes made, or proposed to be made, to the RPB, must also be notified to the Registrar and the appropriate fee paid, if applicable.
When a pharmacy owner wishes to close their RPB, it is important that they do so in accordance with s.59 of the Act and the Retail Pharmacy Business and Registration Rules 2008 (as amended).
The pharmacy owner must notify the PSI of their intention to close and submit an application for cancellation of registration. The registration cannot be cancelled until the application is satisfactorily processed. If the pharmacy owner omits to notify or submit the application for cancellation and the RPB closes, they remain bound by their responsibilities as an owner under the Act (including the payment of fees), so long as the registration of the pharmacy concerned remains in place.
There are three specific areas which must be given considerable attention when closing an RPB.
Firstly, it is vital that patients’ access to records and continuity of care is facilitated. Patients and the public should be notified of the proposed closure as early in the closure process as possible. For planned closures this should occur where possible at least 12 weeks, and no later than four weeks, before the actual closure. For unplanned closures, where exceptional circumstances apply, a shorter timeframe may be deemed acceptable following consultation with the PSI. Public notices which inform both patients and members of the public that the RPB is closing should be displayed in the premises. Local prescribers and other healthcare professionals should be informed of the closure and provided with the contact details of the person holding the prescription and other records.
Where the RPB is putting a system in place to transfer patient records, such as prescriptions, to another RPB, patient consent for these arrangements should, where practicable, be sought and given. If the records are not being transferred, then a custodian of the records must be appointed, and their contact details must be provided to patients and local prescribers. Adequate and appropriate arrangements should be put in place in order to assure patients (and the public), that any records relating to them that were held in the pharmacy will remain confidential and under appropriate professional control and, insofar as practicable, that they will be kept in a manner whereby future access will be available to them should the need arise.
All electronic records should also be accessible for an appropriate timeframe following the closure of the RPB. Pharmacy owners and superintendent pharmacists must also adhere to all other relevant record-keeping requirements post pharmacy closure, including those set out in the Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008); the Medicinal Products (Prescription and Control of supply) Regulations 2003 (S.I. No. 540 of 2003)(as amended); and the Misuse of Drugs Regulations 1988 (S.I. No. 328 of 1988) (as amended). Prescriptions and other records normally held in a RPB are also covered by the provisions of the Data Protection Acts 1988 and 2003 and related legislation. It is important to ensure that the requirements of this legislation are complied with when handling patient records, following the closure of an RPB.
Secondly, the disposal of medicinal products, including veterinary medicinal products and non-prescription medicinal products, must be carried out in a manner that will not result in any danger to public health or risk to the environment. The destruction and disposal of controlled drugs should be carried out in accordance with the PSI’s Guidelines on the Disposal of Medicinal Products within an RPB. The destruction of Schedule 2 controlled drugs must be witnessed in compliance with the requirements of Regulation 22 of the Misuse of Drugs Regulations 1988 (S.I. No. 328 of 1988) (as amended). If such products are not disposed of accordingly, this may constitute an offence under the Act. The controlled drugs register should be retained for a period of two years from the date of the final destruction entry by the owner of the pharmacy or the appointed custodian of such records.
Thirdly, signs and public descriptions relating to the RPB should be removed at the time of the closure. This includes all signs, which contain the words pharmacy, chemist, pharmacist or any related words. The certificate of registration of the RPB should be removed following the closure of the pharmacy and must be returned to the PSI within 14 days of the cancellation of the pharmacy’s registration.
Helpful guidance from the PSI is available by way of the Guide to cancelling your pharmacy registration (available at thepsi.ie), and remember of course too, that the IPU Professional Services Department provides support to members going through this process, or considering opening or closing an RPB (contact pharmacists@ipu.ie).
There are important legal requirements when opening and closing a pharmacy. This reflects the important role that the pharmacy plays in the local community and the vital role it plays in the provision of healthcare and continuity of care for its patients.
About the author: David Phelan is head of the Commercial Team at Hayes solicitors, and advises extensively on business and regulatory issues, including particular experience advising pharmacists and other regulated professionals. Contact dphelan@hayes-solicitor.ie.
David Phelan
Partner and Head of Commercial and Business, Hayes solicitors LLP
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