Home Access to Pharmacies
There are many organisations, whose staff have statutory rights of entry into pharmacies. Set out below are the major organisations that you might expect to seek entry to the premises, and details of their powers. The list is not comprehensive, and from time to time, pharmacists may encounter other persons with powers of entry.
The exercise of powers of entry is restricted to those persons who are properly authorised. In each case, the person should have written evidence of his authority, and pharmacists should check credentials before permitting access to the premises.
Primary Care Trusts
Within the pharmacist's terms of service, a pharmacist shall allow persons authorised in writing by the PCT to enter and inspect his pharmacy at any reasonable time for the purpose of ascertaining whether or not the pharmacist is complying with the requirements of their terms of service.
Within the PCC Community Pharmacy Assurance Framework, there are tips for PCTs conducting visits to pharmacies. Where the pharmacist requests it, the LPC can be present at the inspection.
Any visit should be planned carefully so as not to impact negatively on the day-to-day running of the pharmacy. Patients of pharmacies do not require appointments therefore any inspection teams should not necessarily expect to have the pharmacist devoted to them during any visit, nor should any inspection disrupt the concentration of pharmacy staff in the provision of care to patients.
Local Involvement Networks
The NHS (Pharmaceutical Services) Regulations 2005 were amended on 1 April 2008 to remove references to the Patients Forums and hence to remove the duty to co-operate with Patients Forum inspections. The duty is replaced with a requirement to co-operate with the new Local Involvement Networks as set out in the Local Involvement Networks (Duty of Services-Providers to Allow Entry) Regulations 2008.
These Regulations impose a duty on pharmacy contractors (and other specified NHS providers) requiring them to allow authorised representatives of local involvement networks to enter and view premises owned or controlled by the pharmacy contractor and to allow authorised representatives to observe the carrying-on of certain activities on such premises.
The duty does not apply if the presence of an authorised representative would compromise the effective provision of care services or the privacy or dignity of any person; or to premises or any parts of premises when care services are not being provided on those premises or parts of premises; or if in the opinion of the pharmacy contractor the authorised representative in seeking to enter and view the premises and observe the carrying-on of activities is not acting reasonably and proportionately.
When permitting authorised representatives to view the activities being undertaken in a pharmacy, care must be taken not to breach the rights of privacy of patients and the public using the pharmacy. For example, the authorised representatives cannot sit in on an MUR consultation, and they should not be in a position where they can read details from the patient medication record computer screen or from prescriptions being dispensed. Other sensible precautions to protect the privacy of patients may be necessary.
The Regulations also require the authorised representative not to compromise the provision of care services or the privacy or dignity of any person, so they will comply with sensible precautions intended to protect patient privacy. The individual who is authorised must produce written evidence that he is authorised by a local authority under section 221(1) of the Local Government and Public Involvement in Health Act 2007.
NHS Counter Fraud Service
The Counter Fraud Service is part of the Counter Fraud and Security Management Service (CFSMS) and was established in September 1998. Its role is to reduce all losses to fraud and corruption in the NHS.
The Pharmaceutical Fraud team carry out most of their investigations from their offices, and by contacting patients and other health professionals. However, once they have reasonable suspicion of fraud, they will probably involve the police, and to facilitate this, they have signed a memorandum of understanding with the Association of Chief Police Officers.
The local, PCT based, counter fraud specialists can enter pharmacies, with police officers on a Magistrates' warrant, providing they have been included on the warrant. If they are not mentioned on the warrant, they can enter the premises only with the consent of the pharmacist (or other person in charge).
Fraud is a serious offence. The police could seize documents which they reasonably believe to be required of evidence of an offence. Computers could also be taken (or, where facilities exist - images of computer hard drives can be taken).
Following a consultation carried out by the Department of Health in 2007, a Code of Practice has been published which applies to the exercise of powers by authorised persons from the Counter Fraud and Security Management Service. This Code came into force on 10 April 2008. See link below.
Police (Controlled Drugs)
A constable or other person authorised by the Secretary of State has power for the purposes of enforcement of the Misuse of Drugs Act 1971, to enter pharmacy premises and to demand production of any books or documents relating to dealing in controlled drugs, and to inspect books, documents and stocks of controlled drugs. This applies to all controlled drugs, not just those in Schedule 2 to the Misuse of Drugs Regulations 2001.
In addition, the Misuse of Drugs Regulations requires the pharmacy to produce any register, book or document required to be kept under the Regulations. Because the private prescription register is not required to be kept under the Regulations, there is not an automatic right to examine this, although if the officer wished to exercise his general rights of enforcement under the Act, he could demand production.
Pharmacists must be mindful that any disclosure of information about a patient or a doctor, should be legitimate. Matters relating to controlled drugs are clearly legitimate matters to discuss, but other medical treatment is not.
The routine inspection of controlled drug records is now undertaken by the Inspectors of the Royal Pharmaceutical Society of Great Britain (see below), however, pharmacies may be visited by police officers who are carrying out investigations involving controlled drugs.
RPSGB Inspectors
The RPSGB is under a duty and has powers to enforce, certain parts of the Medicines Act 1968. Any person authorised in writing by the RPSGB has a power to enter premises to ascertain whether there is or has been any contravention of the provisions of the Act. The persons authorised also have a power to inspect, take samples and to seize goods and documents.
The RPSGB Inspectors are also authorised by the Medicines and Healthcare Regulatory Products Agency, in relation to wholesale and manufacturing matters, within pharmacies.
The RPSGB Inspectors who are pharmacists (not all of them are pharmacists) are also authorised under the Poisons Act 1972, which provides powers at all reasonable times, to enter a pharmacy (and indeed any other premises) for the purpose of enforcement of the Poisons Act 1972, the Poisons Rules 1982 and certain provisions, relating to membership certificates, of the Pharmacy Act 1954.
The RPSGB Inspectors are also responsible for carrying out routine inspections relating to controlled drugs, a role that has been transferred from the former Police Chemist Inspection Officers.
Although the RPSGB do not have a right to demand entry to premises other than where medicines are sold or supplied, for example, residential property, they are able to apply to a Magistrate to obtain a warrant if necessary.
Healthcare Commission (Commission for Healthcare Audit & Inspection - CHAI)
The Healthcare Commission is an independent body, set up to promote and drive improvement in the quality of healthcare and public health. It was established under the Health and Social Care (Community Health and Standards) Act 2003.
Its main duties in England are to:
The Commission is also to be given a new role in 2006 releated to the oversight of the monitoring of controlled drugs.
It does not normally inspect pharmacies, although it has the power to do so. Persons authorised in writing by the Commission may at any reasonable time, enter and inspect premises owned or controlled by a service provider and used for purposes connected with the services provided.
Unlike the visitors mentioned so far, the persons authorised by the Healthcare Commission are not able to demand admission to premises unless reasonable notice has been given of the intended entry. Like the Patients' Forum, persons authorised by the Healthcare Commission cannot enter premises used as residential accommodation without having first obtained the consent of the persons residing in the accommodation.
Persons authorised by the Healthcare Commission may inspect and take copies of any documents which appear to him necessary for the purposes of the review, inspection or investigation.
HM Revenue & Customs (HMRC)
HMRC officers will most commonly be encountered in relation to VAT, but are also involved in the legislation relating to excise duties (e.g. spirits, including IMS and ethanol use in medicines).
For the purpose of exercising any powers under the Finance Acts an authorised person may at any reasonable time enter premises used in connection with the carrying on of a business and inspect any goods found on them. An authorised person can also demand production for inspection any documents relating to the goods or services.
If it appears to him to be necessary to do so, an authorised person may, at a reasonable time and for a reasonable period, also remove any document produced and shall, on request, provide a receipt for any document so removed. Where a document removed by an authorised person is reasonably required for the proper conduct of a business he shall, as soon as practicable, provide a copy of the document, free of charge, to the person by whom it was produced or caused to be produced.
If the authorised person suspects that a fraud offence of a serious nature has been or is being committed, he can apply to a Magistrate for a warrant, which will allow entry at any time stated within the warrant, and using force if necessary. During entry under a warrant, the officer can seize and remove any documents or other things which he has reasonable cause to believe may be required as evidence. He may also search persons on the premises that he has reasonable cause to believe may be in possession of any such documents or other things
Health and Safety Inspectors
Health and safety legislation is enforced by inspectors from the Health and Safety Executive (HSE) or by inspectors from the local authority.
Inspectors have the right to enter any workplace without giving notice. The Inspector could inspect the workplace, the work activities, the management of health and safety, and to check that the owner is complying with health and safety law.
The inspector has a right to speak to employees, to take photographs, and make copies of documents. They can also take away equipment either for examination or as evidence.
They must, on request, produce their identification, before being allowed entry to the premises.
The inspector may provide employees with information where necessary for the purpose of keeping them informed about matters affecting their health, safety and welfare. As with RPSGB Inspectors, any information or guidance provided by the Inspectors should be given due consideration, as following such guidance is likely to provide a useful safeguard for the business against challenge under the legislation. The Inspectors have wide powers and discretion, and it is clearly better to adopt guidance since this is usually given where there are minor breaches, than to invite formal enforcement action.
Health and Safety legislation impacts on the behaviour not only of the owner of the business, but also every employee. Therefore in serious cases, employees as well as owners could be reported for prosecution by Inspectors.
Some matters of health and safety, for example fire precautions in the workplace, are enforced by other enforcement bodies. In the case of fire precautions, the fire service can appoint Inspectors, who will always be in uniform. They enforce the Fire Precautions Act 1971 and in particular the Fire Precautions (Workplace) Regulations 1997. As well as giving advice, these Inspectors can issue enforcement notices requiring immediate attention.
Trading Standards (Weights and Measures)
The former ‘weights and measures' Inspectors are now known as Trading Standards Officers, which reflects their wider remit of enforcement of legislation relating to foodstuffs, consumer protection and fair trading.
They are responsible for enforcement of:
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Consumer Protection Act
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Health and Safety at Work Act
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Medicines Act
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Poisons Act Trade Descriptions Act
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Food Safety Act
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Business Names Act
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Supply of Goods and Services Act
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Sunday Trading Act
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Weights and Measures Act
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others not so relevant to pharmacy.
The Inspectors are appointed locally and are restricted to working within their geographical area.
Because the officers enforce a wide range of provisions, they have powers under the different legislative regimes. For example, under the Food Safety Act, an authorised officer on producing, if required, an authenticated document showing his authority, has a right at all reasonable hours to enter any premises within the authority's area for the purpose of ascertaining whether there is or has been any contravention of the provisions of the Food Safety Act or its regulations.
Admission to any private dwelling-house requires 24 hours' notice of the intended entry to be given to the occupier. A Magistrates' warrant, will authorise entry without notice, and by force if necessary.
An authorised officer may inspect any records (in whatever form they are held) relating to a food business and, where kept by means of a computer may require the records to be produced in a form in which they may be taken away.
Similar provisions apply to the other Acts.
Although there are duties under the Medicines Act 1968 and the Poisons Act 1972 (see RPSGB Inspectors above), the enforcement of these by trading standards officers is restricted to non pharmacy premises.
Further information and relevant websites
RPSGB guidance on visits to pharmacies in England by external monitoring bodies
Further information can be obtained by visting the following websites:
Healthcare Commission
Counter Fraud and Security Management Service
Health and Safety Executive
Contact PSNC's Head of Regulation Stephen Lutener at PSNC's Aylesbury office for any further information needed relating to definition of changes in regulations and other relevant legislation.
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