The Royal Pharmaceutical Society of Great Britain is unique among healthcare professions in having an Inspectorate and has found considerable benefit to the public and to the profession in its maintenance. The Society maintains the Inspectorate under Section 9 of the Poisons Act 1972, which places a duty on the Society to enforce the provisions of the Poisons Act, and to do so by inspection of registered retail pharmacy premises.
The Inspectorate has been in existence for over 70 years to ensure that the Society fulfils its statutory enforcement duties and to help ensure that professional standards of practice are maintained. In addition to enforcement duties under the Poisons Act, the Society has been given the duty by the Secretary of State for the enforcement of many provisions of the Medicines Act 1968 relating to the retail sale and supply of human medicines and powers under the Veterinary Medicines Regulations in relation to the sale and/or supply of veterinary medicinal products from registered pharmacies.
There are currently 26 RPSGB inspectors covering Great Britain. Twenty four inspectors are pharmacists and the other two are investigators with substantial experience in the field of pharmacy regulation. Pharmacy inspectors have responsibility for an average of 500 registered retail pharmacies, the large majority of which are community pharmacies. Inspectors are divided into three regional groups with a regional lead inspector appointed. For a list of the regional groups, click on the link below:
The inspectors visit pharmacies regularly to ensure that legal requirements and professional standards of practice are observed. The Inspectorate’s functions encompass investigation, enforcement, education and advice. While the inspectors act as advisers and enforcers of the Code of Ethics, they do not have statutory powers of enforcement in this area. Similarly, the inspectors do not have enforcement authority in relation to the Misuse of Drugs Act 1971, but are able to provide valuable advice to assist pharmacists with compliance.
Following agreement with the Government and the Scottish Executive, and to avoid duplication of inspection of other agencies, the Society’s inspectors are to include inspection of Controlled Drugs into their routine visits of community pharmacies in England from January 2007, and in Scotland from March 2007. For guidance on the inspectors' new role in monitoring Controlled Drug use, click on the link below:
In addition to their role in the maintenance of discipline and standards, the inspectors work closely with many outside agencies including the police, the Primary Care Organisation, the Healthcare Commission and the Medicines and Healthcare products Regulatory Agency to ensure effective liaison with other enforcement authorities.
In the future the Society will be the regulatory body for pharmacy technicians and will maintain a statutory register of pharmacy technicians. It is expected that the Inspectorate's functions of investigation, advice and education will apply to both pharmacists and technicians (although, in general, statutory enforcement functions will remain limited to pharmacists, bodies corporate and officers of bodies corporate).
If you have general queries, the staff of the Society's legal and ethical information service (020 7572 2308; e-mail ftp@rpsgb.org) will be able to assist, but if you wish to speak directly with your inspector, please do not hesitate to contact him or her on the number listed in the links below.
The Society inspectors routinely visit all retail pharmacy premises registered with the Society. Currently, inspectors try and visit registered pharmacies every two to three years. Some registered pharmacies may receive more frequent visits where it is felt that further support and guidance is required at the pharmacy in order to ensure compliance with relevant legislation, the Code of Ethics or any Codes of Practice issues by the Society.
In the majority of cases the local inspector will send a notification of intent to visit to the pharmacist in charge of the pharmacy, prior to the visit. Inspectors will always aim to give at least two weeks’ notice of a routine visit, although, for operational reasons, this is not always possible and it is inevitable that some inspection visits will be unnotified.
The intention of the notification letter is to allow pharmacists some time to prepare for the inspection visit and ensure that they have the appropriate documentation available for inspection. Notice is not generally given when a visit is made to a pharmacy for the purpose of investigation of a complaint. The notification letter will include a form (Form A, see links below) for completion prior to the inspection visit. This form provides the inspector with an idea of the type of services being offered at the pharmacy and the level of training of staff employed at the pharmacy. Completion of the form prior to the inspection visit is to ensure that inspection visits are carried out in the most expeditious and efficient manner, with minimum disruption to work flow within the pharmacy.
During the course of a routine visit, the Inspector will work from a checklist (see link below). This is to ensure consistency of approach between inspection visits. While the checklist cannot be exhaustive, it indicates the main areas that the Inspector will be looking at within the pharmacy. There is nothing to prevent the Inspector checking other areas of practice not included on the checklist.
During the course of a visit, the Inspector may signpost some of the resource tools available to pharmacists (see links below), which may assist them with achieving a high standard of practice.
From January 2007, at the end of each routine visit, the Inspector will produce a short report on the Controlled Drugs aspect of the visit, indicating the areas inspected and identifying any areas of non compliance, any improvements to practice required and any good practice that has been identified. A copy of this Controlled Drugs report will be left with the pharmacist in charge and where appropriate a copy will also be forwarded to the owner of the pharmacy or the Superintendent Pharmacist.
All requests for disclosure of reports of inspections should be made to the owner of the pharmacy, in the first instance. Requests for disclosure made to the Society will be considered on a case by case basis and there may be a charge levied for any report disclosed.
The outcome of the routine visit will inform the interval before the next visit and follow up visits may be performed, where it is deemed necessary.
The notification letter form (Form A), the Inspectors' checklist for routine monitoring and inspection visits, the Society's standards checklist for registered pharmacy premises, and a series of resource tools are available here as PDF files. Click on the links below:
The Society’s inspectors carry out investigations into complaints against pharmacists and pharmacy owners, the majority of which have come from members of the public, and many of which have been settled by visiting the pharmacies and providing advice on improving procedures. Visits to pharmacies following complaints may involve many hours/days work. Depending on the nature of the complaint the inspector may need to obtain witness statements from patients and other members of the public. They may also be required to interview pharmacists, their employees or owners of pharmacies in accordance with the provisions of the Police and Criminal Evidence Act 1984 and the relevant Codes of Practice made under that Act. The inspector may also need to seize evidence, in accordance with their powers under the Medicines Act 1968.
On rare occasions, inspectors may be required to carry out covert surveillance during the course of an investigation into alleged criminal offences and/or alleged misconduct. Any covert surveillance undertaken is conducted in accordance with the Regulation of Investigatory Powers Act 2000, relevant Codes of Practice made under the legislation and the Society’s policy on covert surveillance.
For the Society's policy on covert surveillance, click on the link below.