Guidelines for Retail Pharmacy Businesses
All retail pharmacy businesses must be conducted in compliance with the provisions of the Pharmacy Act 2007 and the Regulation of Retail Pharmacy Businesses Regulations 2008.
The Regulation of Retail Pharmacy Businesses Regulations 2008 set out certain requirements to be complied with by persons carrying on a retail pharmacy business on the sourcing, storage, sale, supply and keeping of records, in respect of medicinal products. Requirements relating to staff, premises, equipment and procedures are also stipulated. In addition, the Regulations specify responsibilities that must be discharged by the pharmacy owner, superintendent pharmacist and supervising pharmacist:
The PSI has produced the following guidelines to facilitate compliance with the requirements of these Regulations.
Keeping of Records in Respect of Medicinal Products
The purpose of these guidelines is to facilitate compliance with Regulation 12 of the Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. 488 of 2008) in relation to the keeping of records when conducting a retail pharmacy business. The requirements for some other important records that ensure safe pharmacy practice are also detailed.
Pharmacists are the healthcare professionals authorised in legislation for the safe keeping and supply of medicinal products to patients. The keeping of accurate records which clearly show when prescription-only medicines are supplied, and to whom, is a key requirement of this role. The keeping of appropriate records also supports the provision of safe and quality services to patients, allows for continuity of patient care and assists the provision of evidence-based healthcare, good professional practice and management of the medicines supply chain.
Counselling and Medicine Therapy Review
Prior to the dispensing and supply of a prescribed medicinal product, a pharmacist must review the prescription having regard to the pharmaceutical and therapeutic appropriateness of the medicine therapy for the patient. These guidelines are intended to assist pharmacists in fulfilling this responsibility by outlining what to consider when performing a therapeutic assessment of a prescription and counselling the patient on their prescribed medicine, in order to optimise the use of medicines and safety of patients.
These guidelines detail the equipment needed for the safe and effecitve dispensing of medicines, including extemporaneously prepared medicines. It also details the reference materials that must be present on site within the pharmacy and the requirements that must be met for the controlled drug safe/cabinet.
These guidelines detail the standards and requirements for the internal and external pharmacy premises, including guidance on the space and layout of the dispensary, storage areas within the pharmacy and the external appearance of the premises.
Sourcing of Medicinal Products
These guidelines highlight the requirement to source medicinal products from authorised manufacturers or wholesalers in order to assure the safety, quality and efficacy of such products. The guidelines also detail the types of marketing authorisation a medicinal product may hold and how this can be identified from the information on the product packaging.
Disposal of Medicinal Products
These guidelines detail the requirements for the disposal and destruction of controlled drugs, including those which are expired or non-conforming, and those returned by patients. The guidelines also give information on how to safely store waste medicinal products in a pharmacy premises until such time as they can be removed from the premises by an appropriate waste management company.
Supply of Non-Prescription Medicinal Products containing Codeine
This guidance sets out the criteria to be adhered to by pharmacists, with a view to ensuring the safe supply of non-prescription codeine medicines to patients. The guidance also deals with the situation where a pharmacist suspects that a patient is abusing and/or misusing these products. The HSE Helpline, freephone 1800 459 459, provides a confidential support and information service to people seeking information or assistance with problems related to drug misuse and also maintains a nationwide database of services.
Patient Consultation Area
These guidelines outline the requirements for a consultation area in a pharmacy and the standard expected by the PSI.
Other Useful Guidelines and Resources
As well as the guidelines above, which are contained in the online and hard copy Pharmacy Practice Guidance Folder, the PSI has produced the following guidelines and resources with which pharmacy owners, superintendent pharmacists and supervising pharmacists should familiarise themselves.
Storage of Medicinal Products
Please note that the Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business, published in May 2011, have been separated into three separate documents. Guidelines on the Sourcing of Medicinal Products for Sale or Supply by a Retail Pharmacy Business and Guidelines on the Disposal of Medicinal Products for a Retail Pharmacy Business have been reviewed and redesigned and are available to view above. The Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business are currently under review' however, the previous version can be viewed in the original document below and will be updated in due course.
Security Assessment Template
This template has been created by the PSI, in conjunction with An Garda Síochána to aid pharmacy owners and superintendent pharmacists in assessing the security of their pharmacies.
Safe Keeping of Medicines and Records during Pharmacy Cleaning and/or Merchandising
This document sets out the circumstances and conditions that must be in place where cleaning and merchandising is undertaken when the pharmacy is closed to the public and it is impracticable for a pharmacist to be physically present.
Advertising, Promotion and Pricing Transparency of Medicinal Products
Pharmacy Practice Guidance Manual
In 2008, the PSI published a Pharmacy Practice Guidance Manual which is
intended to assist pharmacists and pharmacy owners conduct a self-audit
of their pharmacy practice. As indicated in the text of this manual,
many parts have now been superseded by updated guidance.
The PSI will continued to issue guidelines to facilitate
compliance with the requirements of the Regulations of Retail Pharmacy Businesses Regulations 2008. This will include:
- Management and Supervision of a pharmacy (Regulation 5)
- Counseling in the supply of Medicinal Products other than on Foot of a Prescription (Regulation 10)
- Record keeping when Conducting a Pharmacy (Regulation 12)