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Retail Pharmacy
Chapter 10
Retail Pharmacy THE NATURE OF THE CONTROL The operation of a pharmacy is subject to a number of laws, which deal with ownership and with the activities carried on in the premises. In excess of 200 different pieces of legislation exist. This chapter deals only with those directly relevant to the establishment and running of the professional practice.
HISTORY The Pharmacy Act 1852 established a system of control over the practice of pharmacy by requiring registration as a ‘chemist and druggist’ or a ‘pharmaceutical chemist’. Passing an exam entitled the person to registration and to the right to sell poisons. The Pharmacy and Poisons Act 1933 compelled all pharmacists to become members of the then Pharmaceutical Society of Great Britain (PSGB). The Statutory Committee system was established to disqualify persons from membership and hence from being an ‘authorised seller of poisons’. The Pharmacy Act 1954 removed the connection between poisons and pharmacy (which had been present since the Arsenic Act 1851) and dealt only with the profession of pharmacy. In 2006 the Department of Health published a report, The Regulation of Non-medical Healthcare Professionals, which recommended considerable change to the regulation of the profession. This report became known as the ‘Foster Report’. In 2007 the Pharmacists and Pharmacy Technicians Order SI 2007 No. 289, made under powers in Section 60 of the Health Act 1999, made changes to the Royal Pharmaceutical Society of Great Britain (RPSGB) which reflected the Foster Report. The Order made changes to the registers, introduced new statutory committees, brought in new ‘fitness to practise’ powers and procedures and extended regulation to pharmacy technicians. In the same year a government White Paper announced further changes, in particular splitting the regulatory function from the professional one. Pharmacy Law and Practice. DOI: http://dx.doi.org/10.1016/B978-0-12-394289-0.00010-2 © 2013 Elsevier BV. All rights reserved.
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The Pharmacy Order 2010, SI No. 231, established a new regulator for pharmacy, the General Pharmaceutical Council (GPhC), and set out the arrangements, in Great Britain, for the professional regulation of pharmacists, pharmacy technicians and registered pharmacy premises. Details of processes for registering pharmacists, pharmacy technicians and pharmacy premises are set out in accompanying rules. The change took effect on 27 September 2010. Part IV of the Medicines Act 1968, which deals with pharmacies, has been extensively amended. Section 9 of the Poisons Act 1972 (c.66), in respect of the regulation and inspection of registered pharmacies in Great Britain, is amended. The Pharmacists and Pharmacy Technicians Order 2007 was repealed by the Pharmacy Order 2010.
REGISTERED PHARMACY The GPhC (Registration) Rules Order of Council 2010 SI No. 1617 came into force on 27 September 2010. These ‘Registration Rules’ set out the rules for registration of premises and professionals. Section 74(1) of the Medicines Act 1968 defines a ‘registered pharmacy’ as: (a) in relation to Great Britain, premises entered in the register required to be kept under Article 19 of the Pharmacy Order 2010 for the purposes of Sections 74A and 74J of the Medicines Act 1968; and (b) in relation to Northern Ireland, premises entered in the register required to be kept under Section 75(34) of the Medicines Act 1968.
The Registrar of the GPhC is required to keep a register of premises in Great Britain where the business meets the requirements of Section 74B. According to the GPhC website, ‘The GPhC will only register pharmacy premises if the principal activity at the premises is the retail sale or supply of pharmacy (P) medicines and/or prescription only medicines (POMs).’ The Registrar of the Pharmaceutical Society of Northern Ireland (PSNI) is required to keep a similar register for premises in Northern Ireland. Applications to enter premises in the register of premises are made in writing to the Registrar. For registered pharmacies the Register will include: address of the premises; name and address of the person carrying on a retail pharmacy business (RPB) at the premises; ● name under which the business trades; ● date of first and any subsequent entry in the Register; ● period for which the entry is valid; ● any conditions which attach to the entry; ● any annotations in respect of specialisations; ● ●
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where the owner of the business is a body corporate, the name and home address of the superintendent pharmacist; ● details of any improvement notices issued under Article 13 of the Pharmacy Order 2010; ● recording information in the Welsh language, where appropriate; ● marking the Register to distinguish those premises which have temporary registration under emergency registration provisions (Section 74J of the Medicines Act 1968). ●
RETAIL PHARMACY BUSINESS (RPB) The Medicines Act and the Human Medicines Regulations 2012 use the term ‘RPB’. This is defined as: a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the retail sale of medicinal products that are not subject to general sale.
In other words, a business is an ‘RPB’ if it is: a business which consists of the retail sale of POM or P medicine, or a business which includes the retail sale of POM or P medicine, and ● it is not part of the professional practice of a doctor or dentist. ● ●
The phrase ‘registered pharmacy’ refers to the premises, and the term ‘RPB’ refers to the professional practice of a pharmacist who sells medicines and dispenses prescriptions.
Who May Own a Pharmacy? Section 69 of the MA 1968 lists the persons who can operate a pharmacy. An RPB may be lawfully carried on by: (a) (b) (c) (d)
a pharmacist a partnership of pharmacists a ‘body corporate’ a ‘representative’ of a pharmacist.
There are a number of additional conditions for each circumstance outlined above.
Partnerships In England, Wales and Northern Ireland, partnerships can only carry on a pharmacy if all the partners are registered pharmacists. In Scotland, the partnership running the pharmacy must have one partner who is a pharmacist, but the rest need not be qualified as pharmacists.
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One of the partners who is a pharmacist or another pharmacist must be the ‘responsible pharmacist’ at those premises. The Limited Liability Partnership Act 2000 came into force on 6 April 2001. The limited liability partnership is a hybrid of partnerships and companies. Limited liability partnerships are treated by the Medicines Act as companies rather than partnerships and therefore they may include non-pharmacist members. They need to appoint a superintendent pharmacist. The general law relating to partnerships is discussed in Chapter 29.
Body Corporate This is a term applied to any association of individuals which is so constituted as to acquire a collective legal personality. The law recognises that some groups of people ought to be treated as a single individual, which is a separate ‘legal entity’ from those who make up the group. There are two types of ‘body corporate’: (1) A ‘corporation sole’. The Crown, Ministers and an archbishop are examples. The idea of a ‘body corporate’ enables the post to be sued instead of the person who holds the post for the time being. (2) A ‘corporation aggregate’. There are various types, including: (i) public corporations such as the BBC (ii) cooperative societies (iii) mutual building societies (iv) private limited companies (v) public limited companies. The most important and numerous are private limited companies. Generally speaking, where the term ‘body corporate’ is used the term ‘company’ can replace it. The business of keeping, preparing and dispensing P medicines and POMs must be under the management of a superintendent pharmacist.
Superintendent (1) The superintendent must be a pharmacist. (2) He or she must not act in a similar capacity for any other body corporate. (3) He or she must send a statement to the Registrar stating whether or not he or she is a member of the board of the body corporate. (4) The statement must be in writing, signed by the superintendent and signed on behalf of the body corporate. Representative A representative of a pharmacist may carry on the pharmacy in certain circumstances (Section 72). These are: (a) Where the pharmacist has died (b) Where he or she has become bankrupt
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(c) He or she becomes a person who lacks capacity (within the meaning of the Mental Capacity Act 2005) to carry on the business, or in Scotland, a guardian or judicial factor is appointed for the representative on the ground that he or she suffers from mental disorder, or in Northern Ireland, a committee, receiver or guardian is appointed in the case under the Lunacy Regulation (Ireland) Act 1871. The representative is: (a) The executor or administrator of a deceased pharmacist. For the first 3 months after the death any person beneficially interested in the estate may carry on the business. (b) The trustee in bankruptcy (or similar). (c) The donee of an enduring or a lasting power of attorney (or similar) of a mentally incapacitated pharmacist. The representative may carry on business for a period of 5 years after the death of a pharmacist or for 3 years in any other case. The name and address must be notified to the Registrar of the GPhC. There must be a ‘responsible pharmacist’ at all premises where the retail sale or supply of P medicine and POM occurs.
RESPONSIBLE PHARMACIST The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 20081 came into force on 1 October 2009. A ‘responsible pharmacist’ must be in charge of the sale or supply of P medicine and POM by retail or as dispensed medicines at each of the premises. The responsible pharmacist must be: (a) the superintendent mentioned in Subsection (1)(a) of this section, or (b) a pharmacist subject to the directions of the superintendent. A ‘responsible pharmacist’ must be in charge of the part of the business at those premises which concerns: (a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and (b) the supply at those premises of such products in circumstances corresponding to retail sale. A notice must be conspicuously displayed at those premises stating: (a) the name of the responsible pharmacist for the time being, (b) the number of the registration under Part 4 of the Pharmacy Order 2010 or in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and
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(c) the fact that he or she is for the time being in charge of the business at those premises. The responsible pharmacist must be: (a) the person carrying on the business, or (b) if the business is carried on by a partnership, one of the partners or, in Scotland, one of the partners who is a person registered in Part 1 of the register maintained under Article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners), or (c) another pharmacist. Guidance for owners and superintendent pharmacists who employ responsible pharmacists can be found here.2
Retail Sale Regulation 8(3) of the Human Medicines Regulations 2012 defines ‘retail sale’ as the sale of a substance or an article to a person who buys it other than to sell it, supply it, administer it or cause it to be administered in the course of business. Regulation 8(3) states: In these Regulations, references to selling by retail, or to retail sale, are references to selling a product to a person who buys it otherwise than for a purpose specified in Regulation 18(8).
The purposes in Regulation 18(8) are: (a) selling or supplying the product; or (b) administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.
Wholesale Dealing Wholesale dealing means selling or supplying a product (or procuring or holding or exporting) to another European Economic Area (EEA) state for someone else to sell or supply or administer it to a human being in the course of business. Regulation 8(2) states: In these Regulations references to distribution of a product by way of wholesale dealing are to be construed in accordance with Regulation 18(7) and (8). Regulation 18(7): In these Regulations a reference to distributing a product by way of wholesale dealing is a reference to: (a) selling or supplying it; or (b) procuring or holding it or exporting it to another EEA State for the purposes of sale or supply, to a person who receives it for a purpose within paragraph (8).
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(8) Those purposes are (a) selling or supplying the product; or (b) administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.
Supply in Circumstances Corresponding to Retail Sale Regulation 8(4) defines this ‘as a supply otherwise than a sale of a substance or article to a person who buys it other than to sell it, supply it, administer it or cause it to be administered in the course of business.’ Regulation 8(4) states: In these Regulations, references to supplying anything in circumstances corresponding to retail sale are references to supplying it, otherwise than by way of sale, to a person who receives it otherwise than for a purpose specified in regulation 18(8).
Supply of NHS Medicines Legally, the supply of medicines on an NHS script is not a sale. This has been considered by the courts on two occasions. In 1965, the House of Lords considered whether the Minister of Health could import medicines for which Pfizer Corp. held patents in this country. In dealing with this, they decided that there was no sale of medicines by a hospital to a patient (Pfizer Corporation v. Minister of Health, 1965, 1 AER, 450). In 1968 a court had to deal with contaminated medicine supplied to a patient. The case was brought under the Food and Drugs Act, which required that the medicine had been sold to the complainant. The court decided that the pharmacy had a contract with the then Executive Council for the supply of services. The pharmacy was paid remuneration for the services, and there was not a sale of medicine to the Executive Council (Appleby v. Sleep, 1968, 2 AER, 265). Dispensing Only Pharmacies The definition of an RPB, taken originally from Section 132 of the Medicines Act and repeated in the Human Medicines Regulations, suggests that a business where no retail sales took place (that is which only dispensed NHS scripts) would not be an RPB. But Regulation 220 also restricts the supply of P medicine and POM to an RPB in a registered pharmacy. The phrase ‘supply in circumstances corresponding to retail sale’ covers the supply of dispensed medicines in the NHS. Therefore, even dispensingonly pharmacies have to be registered, because the operation of such pharmacies can only be as part of an ‘RPB’. The legislation does not envisage a pharmacy where no retail sales occur.
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Sale or supply of medicinal products not subject to general sale. 220—(1) Unless paragraph (2) applies, a person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is not subject to general sale. (2) This paragraph applies if: (a) P is a person lawfully conducting a retail pharmacy business; (b) the product is sold, supplied, or offered for sale or supply, on premises that are a registered pharmacy; and (c) P or, if the transaction is carried out on P’s behalf by another person, that other person is, or acts under the supervision of, a pharmacist. (3) This regulation is subject to Chapter 3.
Register of Pharmacists A pharmacist is a person whose name is entered in the Register of Pharmacists. This was established originally by the Pharmacy Act 1852, but now exists, in Great Britain, as a result of the Pharmacy Order 2010. For Northern Ireland, the Register is maintained under a requirement in Section 9 of the Pharmacy and Poisons Act (Northern Ireland) 1925.
Restricted Titles The use of some professional titles is restricted by Article 38 of the Pharmacy Order 2012. Only pharmacists entered in the GPhC Register may ‘take or use’ the title Pharmacist or fferyllydd (its equivalent in the Welsh language). Similarly, the title ‘pharmacy technician’ or ‘technegydd fferylliaeth’ (its equivalent in the Welsh language) is restricted to persons whose name is entered as a pharmacy technician in Part 2 or 5 of the Register. The use of ‘prescribed specialist titles’ is also restricted. A prescribed specialist title, in the case of a pharmacist, is a title which the Council prescribes by rules as being one that is only to be used by a registrant with a particular annotation. The abbreviations MRPharmS and FRPharmS are the approved abbreviations indicating membership and fellowship of the Royal Pharmaceutical Society. The GPhC does not specify any post-nominals to indicate registration as a pharmacist, although the title ‘pharmacist’ is itself restricted. Additionally, Section78 of the MA 1968 specifies that no one may use any of these titles in connection with a retail business (or a business which consists of or includes a supply in circumstances corresponding to retail sale) unless the premises are a registered pharmacy or a hospital: Chemist, chemist and druggist, druggist, dispensing chemist, and dispensing druggist
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In Northern Ireland the titles Member of the PSNI and Fellow of the PSNI are restricted. The Department of Health had stated that there will be no restriction on individuals who have left the register from referring to themselves as ‘former’ or ‘retired’ pharmacists.
Pharmacy The use of the term ‘pharmacy’ is restricted to a registered pharmacy or the pharmacy department of a hospital or health centre. (Section 78(4) of the MA 1968) Its use in circumstances which cannot be confused with the operation of a pharmacy is still unclear. In 1998 the Society considered whether or not to instigate proceedings against a restaurant called ‘Pharmacy’, but it did not take any action in court. The restaurant subsequently closed.
Use of Title by Companies Companies operating an RPB may use the title ‘pharmacy’ in connection with the premises. Companies may also use the following titles: chemist and druggist druggist ● dispensing chemist ● dispensing druggist. ● ●
A body corporate may only use the title ‘chemist’ if the superintendent is a member of the board. It may use ‘pharmacy’ even though the superintendent is not on the board. Representatives may use any title which the pharmacist was entitled to use.
European Union Nationals Article 7 of the European Commission (EC) Directive 85/433 (which deals with the mutual recognition of the qualifications of EC pharmacists) allows nationals of Member States of the EC to use the lawful academic titles of their home state. They may do this if they are registered with the GPhC.
Evidence of Registration The name and registration number of the responsible pharmacist at each of the premises must be ‘conspicuously displayed’ together with the fact that he or she is for the time being in charge of the business at those premises. (Sections 70, 71, 72 MA 68 as amended)
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Pharmacy Staff The GPhC document ‘Standards for pharmacy owners and superintendent pharmacists of retail pharmacy businesses’3 states: Employees must be supported when carrying out their professional and legal duties. They must be provided with training and development opportunities to strengthen and improve their knowledge, skills and competencies. You must make sure that staff are employed, managed and trained appropriately.
You must when employing, managing or leading others: Make sure your staff have or will undertake appropriate training to attain the skills, knowledge and competency, including sufficient language competence for their role; ● Be satisfied that staff understand their individual roles and responsibilities, including the activities and decisions which have and have not been delegated to them; ● Be satisfied that there are appropriate policies setting out the number of staff and their required experience and that they are made known to relevant staff. ●
Pharmacy Technicians The GPhC regulates pharmacy technicians by: approving qualifications for pharmacists and pharmacy technicians; accrediting education and training providers; ● maintaining a register of properly qualified pharmacists and pharmacy technicians and pharmacy premises; ● setting standards for professional, fitness to practise and ethical standards; ● setting and promoting standards for the safe and effective practice of pharmacy at registered pharmacies, ensuring all registrants maintain their knowledge by completing continuing professional development; ● monitoring pharmacy professionals’ fitness to practice. ● ●
From 1 July 2011, all pharmacy technicians must be registered with the GPhC. This is a legal requirement to practise as a pharmacy technician in the United Kingdom. The definition of practising set out in the Pharmacy Order 2010 reflects a broad interpretation of pharmacy practice. For the purposes of this Order, a person practises as a pharmacist or a pharmacy technician if, whilst acting in the capacity of or purporting to be a pharmacist or a pharmacy technician, that person undertakes any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of health care.
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Standard Operating Procedures In January 2005 the RPSGB made it a requirement for pharmacies to have standard operating procedures in place for the dispensing process, including the transfer of prescribed items to patients. The requirement is now found in the GPhC standards. The GPhC document ‘Standards for pharmacy owners and superintendent pharmacists of retail pharmacy businesses’ states that the superintendent or owner must: Make sure there are standard operating procedures for all aspects of the safe and effective provision of pharmacy services, and these are maintained and regularly reviewed Be satisfied that procedures respect and protect confidential information about patents and employees in accordance with current legislation, relevant codes of practice and professional guidelines.
Self-Assessment Questions 1. What is an RPB? Answer: A business is an ‘RPB’ if it is: ● a business which consists of the retail sale of POM or P medicine, or ● a business which includes the retail sale of POM or P medicine, and ● it is not part of the professional practice of a doctor or dentist. The legislation, for example the Human Medicines Regulations, frequently uses this term to refer to the professional practice of a pharmacist who sells medicines and dispenses prescriptions. 2. What is the difference between pharmacy ownership in England and Scotland? Answer: In England, Wales and Northern Ireland partnerships can only carry on a pharmacy if all the partners are registered pharmacists. In Scotland the partnership running the pharmacy must have one partner who is a pharmacist, but the rest need not be qualified as pharmacists. One of the partners who is a pharmacist or another pharmacist must be the ‘responsible pharmacist’ at those premises. 3. What are the main responsibilities of a ‘responsible pharmacist’? Answer: A ‘responsible pharmacist’ must be in charge of the part of the business at those premises which concerns the retail sale and supply at those premises of medicinal products (whether they are on a general sale list or not).
ADDITIONAL RESOURCES 1. http://www.legislation.gov.uk/uksi/2008/2789/made 2. http://www.pharmacyregulation.org/sites/default/files/GPhC%20RP%20Owners%201%20 3%20FINAL.pdf 3. http://www.pharmacyregulation.org/sites/default/files/Standards%20for%20owners%20 and%20superintendent%20pharmacist%20of%20retail%20pharmacy%20businesses%20s.pdf
Retail Pharmacy THE NATURE OF THE CONTROL The operation of a pharmacy is subject to a number of laws, which deal with ownership and with the activities carried on in the premises. In excess of 200 different pieces of legislation exist. This chapter deals only with those directly relevant to the establishment and running of the professional practice.
HISTORY The Pharmacy Act 1852 established a system of control over the practice of pharmacy by requiring registration as a ‘chemist and druggist’ or a ‘pharmaceutical chemist’. Passing an exam entitled the person to registration and to the right to sell poisons. The Pharmacy and Poisons Act 1933 compelled all pharmacists to become members of the then Pharmaceutical Society of Great Britain (PSGB). The Statutory Committee system was established to disqualify persons from membership and hence from being an ‘authorised seller of poisons’. The Pharmacy Act 1954 removed the connection between poisons and pharmacy (which had been present since the Arsenic Act 1851) and dealt only with the profession of pharmacy. In 2006 the Department of Health published a report, The Regulation of Non-medical Healthcare Professionals, which recommended considerable change to the regulation of the profession. This report became known as the ‘Foster Report’. In 2007 the Pharmacists and Pharmacy Technicians Order SI 2007 No. 289, made under powers in Section 60 of the Health Act 1999, made changes to the Royal Pharmaceutical Society of Great Britain (RPSGB) which reflected the Foster Report. The Order made changes to the registers, introduced new statutory committees, brought in new ‘fitness to practise’ powers and procedures and extended regulation to pharmacy technicians. In the same year a government White Paper announced further changes, in particular splitting the regulatory function from the professional one. Pharmacy Law and Practice. DOI: http://dx.doi.org/10.1016/B978-0-12-394289-0.00010-2 © 2013 Elsevier BV. All rights reserved.
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The Pharmacy Order 2010, SI No. 231, established a new regulator for pharmacy, the General Pharmaceutical Council (GPhC), and set out the arrangements, in Great Britain, for the professional regulation of pharmacists, pharmacy technicians and registered pharmacy premises. Details of processes for registering pharmacists, pharmacy technicians and pharmacy premises are set out in accompanying rules. The change took effect on 27 September 2010. Part IV of the Medicines Act 1968, which deals with pharmacies, has been extensively amended. Section 9 of the Poisons Act 1972 (c.66), in respect of the regulation and inspection of registered pharmacies in Great Britain, is amended. The Pharmacists and Pharmacy Technicians Order 2007 was repealed by the Pharmacy Order 2010.
REGISTERED PHARMACY The GPhC (Registration) Rules Order of Council 2010 SI No. 1617 came into force on 27 September 2010. These ‘Registration Rules’ set out the rules for registration of premises and professionals. Section 74(1) of the Medicines Act 1968 defines a ‘registered pharmacy’ as: (a) in relation to Great Britain, premises entered in the register required to be kept under Article 19 of the Pharmacy Order 2010 for the purposes of Sections 74A and 74J of the Medicines Act 1968; and (b) in relation to Northern Ireland, premises entered in the register required to be kept under Section 75(34) of the Medicines Act 1968.
The Registrar of the GPhC is required to keep a register of premises in Great Britain where the business meets the requirements of Section 74B. According to the GPhC website, ‘The GPhC will only register pharmacy premises if the principal activity at the premises is the retail sale or supply of pharmacy (P) medicines and/or prescription only medicines (POMs).’ The Registrar of the Pharmaceutical Society of Northern Ireland (PSNI) is required to keep a similar register for premises in Northern Ireland. Applications to enter premises in the register of premises are made in writing to the Registrar. For registered pharmacies the Register will include: address of the premises; name and address of the person carrying on a retail pharmacy business (RPB) at the premises; ● name under which the business trades; ● date of first and any subsequent entry in the Register; ● period for which the entry is valid; ● any conditions which attach to the entry; ● any annotations in respect of specialisations; ● ●
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where the owner of the business is a body corporate, the name and home address of the superintendent pharmacist; ● details of any improvement notices issued under Article 13 of the Pharmacy Order 2010; ● recording information in the Welsh language, where appropriate; ● marking the Register to distinguish those premises which have temporary registration under emergency registration provisions (Section 74J of the Medicines Act 1968). ●
RETAIL PHARMACY BUSINESS (RPB) The Medicines Act and the Human Medicines Regulations 2012 use the term ‘RPB’. This is defined as: a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the retail sale of medicinal products that are not subject to general sale.
In other words, a business is an ‘RPB’ if it is: a business which consists of the retail sale of POM or P medicine, or a business which includes the retail sale of POM or P medicine, and ● it is not part of the professional practice of a doctor or dentist. ● ●
The phrase ‘registered pharmacy’ refers to the premises, and the term ‘RPB’ refers to the professional practice of a pharmacist who sells medicines and dispenses prescriptions.
Who May Own a Pharmacy? Section 69 of the MA 1968 lists the persons who can operate a pharmacy. An RPB may be lawfully carried on by: (a) (b) (c) (d)
a pharmacist a partnership of pharmacists a ‘body corporate’ a ‘representative’ of a pharmacist.
There are a number of additional conditions for each circumstance outlined above.
Partnerships In England, Wales and Northern Ireland, partnerships can only carry on a pharmacy if all the partners are registered pharmacists. In Scotland, the partnership running the pharmacy must have one partner who is a pharmacist, but the rest need not be qualified as pharmacists.
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One of the partners who is a pharmacist or another pharmacist must be the ‘responsible pharmacist’ at those premises. The Limited Liability Partnership Act 2000 came into force on 6 April 2001. The limited liability partnership is a hybrid of partnerships and companies. Limited liability partnerships are treated by the Medicines Act as companies rather than partnerships and therefore they may include non-pharmacist members. They need to appoint a superintendent pharmacist. The general law relating to partnerships is discussed in Chapter 29.
Body Corporate This is a term applied to any association of individuals which is so constituted as to acquire a collective legal personality. The law recognises that some groups of people ought to be treated as a single individual, which is a separate ‘legal entity’ from those who make up the group. There are two types of ‘body corporate’: (1) A ‘corporation sole’. The Crown, Ministers and an archbishop are examples. The idea of a ‘body corporate’ enables the post to be sued instead of the person who holds the post for the time being. (2) A ‘corporation aggregate’. There are various types, including: (i) public corporations such as the BBC (ii) cooperative societies (iii) mutual building societies (iv) private limited companies (v) public limited companies. The most important and numerous are private limited companies. Generally speaking, where the term ‘body corporate’ is used the term ‘company’ can replace it. The business of keeping, preparing and dispensing P medicines and POMs must be under the management of a superintendent pharmacist.
Superintendent (1) The superintendent must be a pharmacist. (2) He or she must not act in a similar capacity for any other body corporate. (3) He or she must send a statement to the Registrar stating whether or not he or she is a member of the board of the body corporate. (4) The statement must be in writing, signed by the superintendent and signed on behalf of the body corporate. Representative A representative of a pharmacist may carry on the pharmacy in certain circumstances (Section 72). These are: (a) Where the pharmacist has died (b) Where he or she has become bankrupt
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(c) He or she becomes a person who lacks capacity (within the meaning of the Mental Capacity Act 2005) to carry on the business, or in Scotland, a guardian or judicial factor is appointed for the representative on the ground that he or she suffers from mental disorder, or in Northern Ireland, a committee, receiver or guardian is appointed in the case under the Lunacy Regulation (Ireland) Act 1871. The representative is: (a) The executor or administrator of a deceased pharmacist. For the first 3 months after the death any person beneficially interested in the estate may carry on the business. (b) The trustee in bankruptcy (or similar). (c) The donee of an enduring or a lasting power of attorney (or similar) of a mentally incapacitated pharmacist. The representative may carry on business for a period of 5 years after the death of a pharmacist or for 3 years in any other case. The name and address must be notified to the Registrar of the GPhC. There must be a ‘responsible pharmacist’ at all premises where the retail sale or supply of P medicine and POM occurs.
RESPONSIBLE PHARMACIST The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 20081 came into force on 1 October 2009. A ‘responsible pharmacist’ must be in charge of the sale or supply of P medicine and POM by retail or as dispensed medicines at each of the premises. The responsible pharmacist must be: (a) the superintendent mentioned in Subsection (1)(a) of this section, or (b) a pharmacist subject to the directions of the superintendent. A ‘responsible pharmacist’ must be in charge of the part of the business at those premises which concerns: (a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and (b) the supply at those premises of such products in circumstances corresponding to retail sale. A notice must be conspicuously displayed at those premises stating: (a) the name of the responsible pharmacist for the time being, (b) the number of the registration under Part 4 of the Pharmacy Order 2010 or in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and
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(c) the fact that he or she is for the time being in charge of the business at those premises. The responsible pharmacist must be: (a) the person carrying on the business, or (b) if the business is carried on by a partnership, one of the partners or, in Scotland, one of the partners who is a person registered in Part 1 of the register maintained under Article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners), or (c) another pharmacist. Guidance for owners and superintendent pharmacists who employ responsible pharmacists can be found here.2
Retail Sale Regulation 8(3) of the Human Medicines Regulations 2012 defines ‘retail sale’ as the sale of a substance or an article to a person who buys it other than to sell it, supply it, administer it or cause it to be administered in the course of business. Regulation 8(3) states: In these Regulations, references to selling by retail, or to retail sale, are references to selling a product to a person who buys it otherwise than for a purpose specified in Regulation 18(8).
The purposes in Regulation 18(8) are: (a) selling or supplying the product; or (b) administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.
Wholesale Dealing Wholesale dealing means selling or supplying a product (or procuring or holding or exporting) to another European Economic Area (EEA) state for someone else to sell or supply or administer it to a human being in the course of business. Regulation 8(2) states: In these Regulations references to distribution of a product by way of wholesale dealing are to be construed in accordance with Regulation 18(7) and (8). Regulation 18(7): In these Regulations a reference to distributing a product by way of wholesale dealing is a reference to: (a) selling or supplying it; or (b) procuring or holding it or exporting it to another EEA State for the purposes of sale or supply, to a person who receives it for a purpose within paragraph (8).
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(8) Those purposes are (a) selling or supplying the product; or (b) administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.
Supply in Circumstances Corresponding to Retail Sale Regulation 8(4) defines this ‘as a supply otherwise than a sale of a substance or article to a person who buys it other than to sell it, supply it, administer it or cause it to be administered in the course of business.’ Regulation 8(4) states: In these Regulations, references to supplying anything in circumstances corresponding to retail sale are references to supplying it, otherwise than by way of sale, to a person who receives it otherwise than for a purpose specified in regulation 18(8).
Supply of NHS Medicines Legally, the supply of medicines on an NHS script is not a sale. This has been considered by the courts on two occasions. In 1965, the House of Lords considered whether the Minister of Health could import medicines for which Pfizer Corp. held patents in this country. In dealing with this, they decided that there was no sale of medicines by a hospital to a patient (Pfizer Corporation v. Minister of Health, 1965, 1 AER, 450). In 1968 a court had to deal with contaminated medicine supplied to a patient. The case was brought under the Food and Drugs Act, which required that the medicine had been sold to the complainant. The court decided that the pharmacy had a contract with the then Executive Council for the supply of services. The pharmacy was paid remuneration for the services, and there was not a sale of medicine to the Executive Council (Appleby v. Sleep, 1968, 2 AER, 265). Dispensing Only Pharmacies The definition of an RPB, taken originally from Section 132 of the Medicines Act and repeated in the Human Medicines Regulations, suggests that a business where no retail sales took place (that is which only dispensed NHS scripts) would not be an RPB. But Regulation 220 also restricts the supply of P medicine and POM to an RPB in a registered pharmacy. The phrase ‘supply in circumstances corresponding to retail sale’ covers the supply of dispensed medicines in the NHS. Therefore, even dispensingonly pharmacies have to be registered, because the operation of such pharmacies can only be as part of an ‘RPB’. The legislation does not envisage a pharmacy where no retail sales occur.
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Sale or supply of medicinal products not subject to general sale. 220—(1) Unless paragraph (2) applies, a person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is not subject to general sale. (2) This paragraph applies if: (a) P is a person lawfully conducting a retail pharmacy business; (b) the product is sold, supplied, or offered for sale or supply, on premises that are a registered pharmacy; and (c) P or, if the transaction is carried out on P’s behalf by another person, that other person is, or acts under the supervision of, a pharmacist. (3) This regulation is subject to Chapter 3.
Register of Pharmacists A pharmacist is a person whose name is entered in the Register of Pharmacists. This was established originally by the Pharmacy Act 1852, but now exists, in Great Britain, as a result of the Pharmacy Order 2010. For Northern Ireland, the Register is maintained under a requirement in Section 9 of the Pharmacy and Poisons Act (Northern Ireland) 1925.
Restricted Titles The use of some professional titles is restricted by Article 38 of the Pharmacy Order 2012. Only pharmacists entered in the GPhC Register may ‘take or use’ the title Pharmacist or fferyllydd (its equivalent in the Welsh language). Similarly, the title ‘pharmacy technician’ or ‘technegydd fferylliaeth’ (its equivalent in the Welsh language) is restricted to persons whose name is entered as a pharmacy technician in Part 2 or 5 of the Register. The use of ‘prescribed specialist titles’ is also restricted. A prescribed specialist title, in the case of a pharmacist, is a title which the Council prescribes by rules as being one that is only to be used by a registrant with a particular annotation. The abbreviations MRPharmS and FRPharmS are the approved abbreviations indicating membership and fellowship of the Royal Pharmaceutical Society. The GPhC does not specify any post-nominals to indicate registration as a pharmacist, although the title ‘pharmacist’ is itself restricted. Additionally, Section78 of the MA 1968 specifies that no one may use any of these titles in connection with a retail business (or a business which consists of or includes a supply in circumstances corresponding to retail sale) unless the premises are a registered pharmacy or a hospital: Chemist, chemist and druggist, druggist, dispensing chemist, and dispensing druggist
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In Northern Ireland the titles Member of the PSNI and Fellow of the PSNI are restricted. The Department of Health had stated that there will be no restriction on individuals who have left the register from referring to themselves as ‘former’ or ‘retired’ pharmacists.
Pharmacy The use of the term ‘pharmacy’ is restricted to a registered pharmacy or the pharmacy department of a hospital or health centre. (Section 78(4) of the MA 1968) Its use in circumstances which cannot be confused with the operation of a pharmacy is still unclear. In 1998 the Society considered whether or not to instigate proceedings against a restaurant called ‘Pharmacy’, but it did not take any action in court. The restaurant subsequently closed.
Use of Title by Companies Companies operating an RPB may use the title ‘pharmacy’ in connection with the premises. Companies may also use the following titles: chemist and druggist druggist ● dispensing chemist ● dispensing druggist. ● ●
A body corporate may only use the title ‘chemist’ if the superintendent is a member of the board. It may use ‘pharmacy’ even though the superintendent is not on the board. Representatives may use any title which the pharmacist was entitled to use.
European Union Nationals Article 7 of the European Commission (EC) Directive 85/433 (which deals with the mutual recognition of the qualifications of EC pharmacists) allows nationals of Member States of the EC to use the lawful academic titles of their home state. They may do this if they are registered with the GPhC.
Evidence of Registration The name and registration number of the responsible pharmacist at each of the premises must be ‘conspicuously displayed’ together with the fact that he or she is for the time being in charge of the business at those premises. (Sections 70, 71, 72 MA 68 as amended)
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Pharmacy Staff The GPhC document ‘Standards for pharmacy owners and superintendent pharmacists of retail pharmacy businesses’3 states: Employees must be supported when carrying out their professional and legal duties. They must be provided with training and development opportunities to strengthen and improve their knowledge, skills and competencies. You must make sure that staff are employed, managed and trained appropriately.
You must when employing, managing or leading others: Make sure your staff have or will undertake appropriate training to attain the skills, knowledge and competency, including sufficient language competence for their role; ● Be satisfied that staff understand their individual roles and responsibilities, including the activities and decisions which have and have not been delegated to them; ● Be satisfied that there are appropriate policies setting out the number of staff and their required experience and that they are made known to relevant staff. ●
Pharmacy Technicians The GPhC regulates pharmacy technicians by: approving qualifications for pharmacists and pharmacy technicians; accrediting education and training providers; ● maintaining a register of properly qualified pharmacists and pharmacy technicians and pharmacy premises; ● setting standards for professional, fitness to practise and ethical standards; ● setting and promoting standards for the safe and effective practice of pharmacy at registered pharmacies, ensuring all registrants maintain their knowledge by completing continuing professional development; ● monitoring pharmacy professionals’ fitness to practice. ● ●
From 1 July 2011, all pharmacy technicians must be registered with the GPhC. This is a legal requirement to practise as a pharmacy technician in the United Kingdom. The definition of practising set out in the Pharmacy Order 2010 reflects a broad interpretation of pharmacy practice. For the purposes of this Order, a person practises as a pharmacist or a pharmacy technician if, whilst acting in the capacity of or purporting to be a pharmacist or a pharmacy technician, that person undertakes any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of health care.
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Standard Operating Procedures In January 2005 the RPSGB made it a requirement for pharmacies to have standard operating procedures in place for the dispensing process, including the transfer of prescribed items to patients. The requirement is now found in the GPhC standards. The GPhC document ‘Standards for pharmacy owners and superintendent pharmacists of retail pharmacy businesses’ states that the superintendent or owner must: Make sure there are standard operating procedures for all aspects of the safe and effective provision of pharmacy services, and these are maintained and regularly reviewed Be satisfied that procedures respect and protect confidential information about patents and employees in accordance with current legislation, relevant codes of practice and professional guidelines.
Self-Assessment Questions 1. What is an RPB? Answer: A business is an ‘RPB’ if it is: ● a business which consists of the retail sale of POM or P medicine, or ● a business which includes the retail sale of POM or P medicine, and ● it is not part of the professional practice of a doctor or dentist. The legislation, for example the Human Medicines Regulations, frequently uses this term to refer to the professional practice of a pharmacist who sells medicines and dispenses prescriptions. 2. What is the difference between pharmacy ownership in England and Scotland? Answer: In England, Wales and Northern Ireland partnerships can only carry on a pharmacy if all the partners are registered pharmacists. In Scotland the partnership running the pharmacy must have one partner who is a pharmacist, but the rest need not be qualified as pharmacists. One of the partners who is a pharmacist or another pharmacist must be the ‘responsible pharmacist’ at those premises. 3. What are the main responsibilities of a ‘responsible pharmacist’? Answer: A ‘responsible pharmacist’ must be in charge of the part of the business at those premises which concerns the retail sale and supply at those premises of medicinal products (whether they are on a general sale list or not).
ADDITIONAL RESOURCES 1. http://www.legislation.gov.uk/uksi/2008/2789/made 2. http://www.pharmacyregulation.org/sites/default/files/GPhC%20RP%20Owners%201%20 3%20FINAL.pdf 3. http://www.pharmacyregulation.org/sites/default/files/Standards%20for%20owners%20 and%20superintendent%20pharmacist%20of%20retail%20pharmacy%20businesses%20s.pdf