Home > PJ > The Society

The Pharmaceutical Journal Vol 266 No 7145 p590-596
April 28, 2001

The Society

Code of Ethics revision

To be presented for adoption by the annual general meeting of the Royal Pharmaceutical Society on May 16

Part 1: Pharmacists' ethics
Part 2: Standards of professional performance
Part 3: Service specifications

Part 1: Pharmacists' ethics

The public places great trust in the knowledge, skills and professional judgment of pharmacists. This trust requires pharmacists to ensure and maintain, throughout their career, high standards of personal and professional conduct and performance, up-to-date knowledge and continuing competence relevant to their sphere of practice whether or not they work in direct contact with the public.

The Royal Pharmaceutical Society of Great Britain seeks to safeguard and promote the interests of the public and the profession by identifying the key responsibilities of a pharmacist.

Ethics has been described as the systematic study of moral choices; it concerns the values that lie behind them, the reasons people give for them and the language used to describe them. Ethical decision making is the process whereby one recognises that a problem needs to be overcome or a difficult choice made, identifies the possible courses of actions, chooses one, takes it and then accepts responsibility.

The exercise of professional judgment requires identification and evaluation of the risks and benefits associated with possible courses of action. On occasions there may not be a right or wrong answer. Different people may reach different decisions on a single set of circumstances and each may be justifiable.

Many of the issues pharmacists are called upon to resolve are unambiguous and the decision will be obvious. However, when faced with ethical dilemmas pharmacists are expected to use their professional judgment in deciding on the most appropriate course of action. They must be able to justify their decisions to their peers, and to any person or organisation which may be affected by their actions, including individual patients, the public, the National Health Service, their employers, and other health care professionals. Pharmacists may be accountable to any of these.

Disreputable behaviour or breach of a professional responsibility or requirement identified in the Code could form the basis of a complaint of professional misconduct. The Society's disciplinary committees, in considering whether or not action should follow, take into consideration the circumstances of an individual case and do not regard themselves as being limited to those matters which are mentioned in this document.

Key responsibilities of a pharmacist

Pharmacists understand the nature and effect of medicines and medicinal ingredients, and how they may be used to prevent and treat illness, relieve symptoms or assist in the diagnosis of disease. Pharmacists in professional practice use their knowledge for the wellbeing and safety of patients and the public.

At all times pharmacists must act in the interests of patients and other members of the public, and seek to provide the best possible health care for the community in partnership with other health professions. Pharmacists must treat all those who seek their professional services with courtesy, respect and confidentiality. Pharmacists must respect patients' rights to participate in decisions about their care and must provide information in a way in which it can be understood.
Pharmacists must ensure that their knowledge, skills and performance are of a high quality, up to date, evidence based and relevant to their field of practice.
Pharmacists must ensure that they behave with integrity and probity, adhere to accepted standards of personal and professional conduct and do not engage in any behaviour or activity likely to bring the profession into disrepute or undermine public confidence in the profession.

Part 2: Standards of professional performance

» Personal responsibilities / Professional competence / Confidentiality

A. Personal responsibilities

Pharmacists' prime concern, irrespective of their sphere of work, must be for the wellbeing and safety of patients and the public. Some roles pharmacists undertake attract specific professional responsibilities. For example, pharmacists who own a pharmacy, superintendent pharmacists, or pharmacist managers in hospitals and trusts must ensure that procedures designed to minimise risks are formulated and applied. Pharmacists providing professional services in any sphere of practice must ensure that their own work procedures are safe and effective.

The public and the profession are entitled to expect that pharmacists providing services will comply with the specific professional responsibilities associated with them and comply with any other accepted codes of practice and statutory requirements applicable to their sphere of practice.

A.1 Pharmacists providing professional services

Pharmacists assuming responsibility for any pharmacy function whether as an employee, locum, adviser or otherwise are professionally accountable for all decisions to supply a medicine or offer advice, and must ensure that:

(a) they only accept work where they have the requisite skills and fitness for the tasks to be performed. All pharmacists must establish sufficient information about the work to enable an assessment to be made;

(b) they undertake continuing professional development relevant to their professional duties;

(d) they do not work in conditions that do not enable them to comply with the key responsibilities of a pharmacist;

(e) the requisite facilities, equipment and materials are accessible to enable the provision of the service to professionally accepted standards;

(f) if any tasks are to be delegated they are delegated to persons competent to perform them, for example, any assistant who is given delegated authority to sell medicines under a protocol should have undertaken, or be undertaking, an accredited course relevant to their duties;

(g) they and other staff work within standard operating procedures where these exist;

(h) they agree terms and conditions and abide by them;

(i) they honour commitments to provide professional services unless this is impossible. If they are not able to honour a commitment the pharmacy owner or other responsible person must be informed at the earliest opportunity in order that alternative arrangements may be made;

(j) they take action to report to the prescriber and relevant authorities, suspected adverse drug reactions where this is likely to assist in the future treatment of the patient, or the future use of the medicine;

(k) before accepting employment pharmacists must disclose any factors which may affect their ability to provide services. Where pharmacists' religious beliefs or personal convictions prevent them from providing a service they must not condemn or criticise the patient and they or a member of staff must advise the patient of alternative sources for the service requested;

(l) if they become aware that a person has received pharmaceutical care of a standard less than the person had a right to expect they provide, if possible, an explanation of what happened, whether or not they are the person responsible;

(m) they report to the Society concerns that a pharmacist's professional competence or ability to practise may be impaired and put the public at risk.

A.2 Pharmacists who own a pharmacy, superintendent pharmacists and pharmacist managers in hospitals and trusts or other fields of practice

Before assuming the role of pharmacist owner, superintendent pharmacist or pharmacist manager in a hospital or trust pharmacists must be satisfied that they are able to comply with the responsibilities set out below. Pharmacist owners, superintendent pharmacists and pharmacist managers in hospitals and trusts or other fields of practice have a personal professional responsibility:

(a) to ensure the observance of all legal and professional requirements in relation to pharmaceutical aspects of the business. They are responsible for ensuring that a retrievable record of the pharmacist taking responsibility for the provision of each pharmacy service is maintained and that an identifiable pharmacist is accountable for all activities of non-pharmacists involved in the provision of pharmacy services;

(b) to ensure that all professional activities undertaken by them or under their control are covered by adequate professional indemnity arrangements;

(c) to satisfy themselves that the supplier, the source and the quality of any medicines or pharmaceutical ingredients are reputable. Medicines must normally be obtained from licensed wholesalers, the manufacturer or via a central purchasing or inter-branch transfer system. Records must be kept of the source of all medicines obtained by any other means and of measures taken to ensure the safety and efficacy of them. This standard is not intended to cover loans from professional colleagues;

(d) to ensure that all staff are informed of the professional activities they are expected to undertake. Clear instructions should be provided, designed to identify and minimise risks and reviewed regularly. Where possible standard operating procedures should be drafted;

(e) not to seek to impose conditions on pharmacists which may adversely affect their ability to comply with their professional and legal duties;

(f) to ensure that adequate support staff and information about the pharmacy are provided to enable all pharmacists, including temporary staff and locums, to perform their duties effectively;

(g) to satisfy themselves that pharmacists employed or engaged by them are aware of the need to undertake continuing professional development relevant to their professional duties;

(h) to ensure that pharmacists and other staff employed by them or under their management have the requisite knowledge, skills and fitness to perform work delegated to them and comply with work instructions;

(i) to ensure that pharmacists and other staff employed by them are sufficiently competent in English. Competency in other languages common to the area is desirable;

(j) to ensure that working conditions, facilities, equipment and materials enable the provision of services to professionally accepted standards;

(k) to have procedures to deal with incidents where there is a threat to the health of a patient or the public and review practices in the light of incidents;

(l) to ensure that effective measures are in place for protecting the confidentiality of person identifiable data;

(m) to ensure that an effective complaint handling procedure exists, whereby all complaints are dealt with promptly, constructively and honestly;

(n) to report to the Society concerns that a pharmacist's professional competence or ability to practise may be impaired and put the public at risk;

(o) to notify the Society in writing of any changes in the ownership of registered pharmacy premises, or superintendent pharmacist of a body corporate.

A.3 Preregistration tutors and pharmacists supervising preregistration trainees

Preregistration tutors and preregistration managers must ensure that section XX of the Society�s Byelaws, relating to preregistration training, is complied with.

Tutors and preregistration managers must ensure that:

(a) preregistration trainees they assess understand and comply with the key responsibilities of a pharmacist and are competent. The public may be put at risk if a tutor or manager confirms the competence of a trainee who has not attained the required standard;

(b) preregistration trainees receive wide-ranging experience of professional practice;

(d) preregistration trainees are properly supervised, in particular in relation to their responsibilities for services to the public;

(e) the progress of preregistration trainees is reviewed regularly, with honest and constructive feedback;

(f) preregistration trainees are encouraged to self-appraise their performance;

(g) reports of trainees� performance provided to the Society are honest and objective;

(h) they reflect on work processes and outcomes, evaluate their own performance and take action to develop their expertise and knowledge.

B. Professional competence

The public, the profession and the NHS expect pharmacists to develop their professional performance to provide a high level of care to patients.

(a) Pharmacists must continually review the skills and knowledge required for their field of practice, identifying those skills or knowledge most in need of development or improvement and audit their performance as part of the review.

(b) Pharmacists must, each year, undertake a minimum of 30 hours� continuing education structured to meet their personal needs, and be able to provide evidence of such.

(c) Pharmacists must be ready and able to provide information and advice about any medicine supplied by them or under their authority.

(d) Pharmacists giving advice to prescribers, patients and others must be able to demonstrate competence and knowledge of medicines within the relevant therapeutic class.

(e) Pharmacists must be alert to potential adverse drug reactions and drug interactions and respond accordingly.

C. Confidentiality

The public expects pharmacists and their staff to respect and protect confidentiality. This duty extends to any information relating to an individual which pharmacists or their staff acquire in the course of their professional activities. Confidential information includes personal details and medication, both prescribed and non-prescribed.

Pharmacists must ensure that:

(a) the confidentiality of information acquired in the course of their professional activities is respected and protected, and is disclosed only with the consent of the individual other than in the circumstances defined below in (b).

(b) information is disclosed without the patient�s consent only in the following circumstances:

(i) where the patient�s parent, guardian or carer has consented to the disclosure and the patient�s apparent age or health makes them incapable of consent;

(ii) Pharmacists should be aware that information about services provided to adolescents should not normally be disclosed to their parents.

(iii) where disclosure of the information is to a person or body empowered by statute to require such a disclosure;

(iv) where disclosure is directed by a coroner, judge or other presiding officer of a court, Crown Prosecution Office in England and Wales and Procurator Fiscal in Scotland;

(v) to a police officer or NHS Fraud Investigation Officer who provides in writing confirmation that disclosure is necessary to assist in the prevention, detection or prosecution of serious crime;

(d) they do not disclose information relating to the prescribing practices of identifiable prescribers or their practices, other than for the necessary purposes of the NHS or other health care provider, unless the prescriber has given his written informed consent to the disclosure;

(e) access to confidential information within the pharmacy is restricted to those who require that information and who are themselves subject to an obligation of confidentiality;

(f) the requirements of data protection legislation for data collection and use are complied with;

(g) confidential information is effectively protected against improper disclosure when it is disposed of, stored, transmitted or received;

(h) pharmacy computer and manual systems which include patient specific information incorporate access control systems to minimise the risk of unauthorised or unnecessary access to the data. Pharmacy computer systems which include patient specific information and which are linked to the internet or other networks must incorporate measures such as data encryption to eliminate the risk of unauthorised access to confidential data.

Part 3: Service specifications

» Publicity, promotion and information
» Stock
» Pharmacy premises and facilities
» Supply of prescribed medicines
» Patient medication records
» Repeat medication services
» Prescription collection services
» Delivery services
» On-line pharmacy services
» Sales of pharmacy medicines
» The supply of emergency hormonal contraception as a pharmacy medicine
» Complementary therapies and mediciness

» Health care information and advice
» Diagnostic testing and health screening
» Emergencies
» Collection and disposal of pharmaceutical waste
» Advisory services to nursing and residential homes
» Domiciliary oxygen services
» Services to drug misusers
» Needle and syringe exchange schemes
» Extemporaneous preparation/compounding
» Aseptic dispensing services from non-licensed units
» Patient group discussions

The application of the key professional responsibilities described in Part 1 to the following activities indicates that the provision of these services should incorporate the following professional requirements. Pharmacists should build upon these requirements when developing professional services to enable the public to receive services that reflect the best possible pharmaceutical practice. These service specifications must be read in conjunction with each other to ensure that in providing a service account is taken of all relevant professional requirements.

When providing any professional service pharmacists should ensure that the tenets of clinical governance are followed:

that an identifiable pharmacist is accountable for all activities undertaken;
that they and staff providing services are suitably trained and competent to perform the tasks required;
that any necessary equipment and suitable facilities are available for the provision of the service and that these are maintained in good order;
that risk assessment and management procedures have been identified and are followed;
that adequate records are maintained to enable the service to be monitored.

The following service specifications cover a range of services; some are core services which will be provided by the majority of pharmacies, others are additional professional services which pharmacists may wish to be involved in.

1. Publicity, promotion and information

It is in the public interest for pharmacies to provide information about their opening hours and services available. Any information or publicity material regarding pharmacy services must be accurate and honest. The public and the profession would not expect any products or services advertised or otherwise promoted, to be injurious to health when properly and responsibly used.

(a) All information and publicity for goods and services must be legal, decent and truthful; be presented and distributed in a manner so as not to bring the profession into disrepute; and not abuse the trust or exploit the lack of knowledge of the public.

(b) Information and promotional material relating to professional services must be compatible with the role of pharmacists as skilled and informed advisers about medicines, common ailments, general health care and well being. It should be presented so as to allow the recipient to decide independently whether or not to use a service and should not disparage the professional services of other pharmacies or pharmacists.

(c) Pharmacists must not make any unsolicited approach, for promotional purposes, directly to a member of the public by way of a telephone call, e-mail, or visit made without prior appointment.

(d) Pharmacists must ensure that promotions (materials and campaigns) for medicines aimed at the public:

(i) emphasise the special nature of medicines;

(ii) do not make any medicinal claim not capable of substantiation;

(iii) are consistent with the summary of product characteristics approved by the Medicines Control Agency as part of the licensing procedures;

(iv) do not promote a medicine by way of endorsement by a pharmacist., or comparison with other products. A pharmacist may recommend a product in response to a request for advice from an individual patient;

(v) do not promote inappropriate or excessive consumption or use of medicines or their misuse, injudicious or unsafe use which may be injurious to health.

(d) Pharmacists may advertise the prices at which they sell medicines and price discounts. Promotions for pharmacy medicines which seek to persuade consumers to obtain medicines that are not wanted or quantities substantially in excess of those wanted are considered to be professionally unacceptable.*

* At present almost all proprietary medicines are subject to resale price maintenance (RPM) controls imposed by contract as permitted by legislation, and price discounting of these medicines could result in legal action being taken to secure compliance with the contractual provisions. This provision of the Code of Ethics does not override or affect RPM; it reflects the provisions of new competition law.

2. Stock

The public and the profession are entitled to expect all stock to be obtained from a reputable source and be of high quality and fit for the intended purpose.

(a) Pharmacists must not purchase or supply any medicines, food supplement or health care related product where they have reason to doubt its quality or safety.

(b) Pharmacists must report to the Royal Pharmaceutical Society, the Medicines Control Agency, Veterinary Medicines Directorate or the marketing authorisation holder any instance where they suspect that they have been offered or have been supplied with counterfeit or defective medicines. Such medicines must be isolated from other pharmacy stock and withheld from sale or supply.

(c) Pharmacy stock must be stored under suitable conditions appropriate to the nature and stability of the product concerned. Particular attention must be paid to protection from contamination, sunlight, atmospheric moisture and adverse temperatures. During storage medicines must be retained in the manufacturer�s original packaging. Pharmacists must exercise their knowledge of stability of materials to segregate for disposal any substances that are likely to have deteriorated, or have been in stock for unduly long periods or have reached their expiry dates.

(d) All stocks of medicines in the pharmacy must have batch and expiry details. Medicines may only be removed from blister or foil packs at the time of dispensing to assist an individual patient.

(e) Medicines returned to a pharmacy from a patient�s home, a nursing or residential home must not be supplied to any other patient.

(f) Pharmacists must not purchase for sale on registered pharmacy premises, any product which may be injurious to public health or bring the profession into disrepute. This includes tobacco products other than nicotine replacement therapies, alcohol and products intended to mask signs of alcohol or drug consumption.

3. Pharmacy premises and facilities

The profession expects all parts of pharmacy premises to be kept clean and orderly to reflect the professional health care image of pharmacy, and to facilitate a safe system of work. The public is entitled to expect that any part of premises from which professional services are provided is readily identifiable and well maintained. The public and the profession expect a pharmacy offering professional services to have the resources to ensure competent provision of the service. These requirements apply to both registered retail pharmacy premises and hospital pharmacies.

(a) Premises must be safe for the public and people working there. All statutory requirements must be complied with, eg, health and safety, occupier's liability, disability discrimination legislation, etc, and high standards of hygiene must be ensured.

(b) A designated area reserved for pharmacy services should be easily identifiable and arranged to enable services to be provided efficiently. Arrangements for the sale of pharmacy medicines must ensure that the sale is made by a pharmacist or a person acting under the supervision of a pharmacist. Pharmacy medicines must not be accessible to the public by self-selection.

(c) The size and organisation of the dispensary must reflect the volume and work flow, and facilitate effective communication and supervision.

(d) Refrigerators used for pharmaceutical stock must be capable of storing products between 2C and 8C. They must be equipped with a maximum/minimum thermometer which is checked on each day the pharmacy is open and the maximum and minimum temperatures recorded. Appropriate action must be taken to rectify any identified deficiency.

(e) Arrangements must be made for the regular collection and safe disposal of pharmaceutical waste and other refuse.

4. Supply of prescribed medicines

4.1 Dispensing procedures in community pharmacies and for hospital outpatients

The public is entitled to expect the service to be accurate, accessible and reasonably prompt, and the medicines to be of appropriate quality, with a sufficiently long expiry date to cover the course of treatment, and to be suitably packaged and labelled for the intended recipient. The profession expects pharmacists to seek to maintain adequate stock holdings.

(a) Dispensing must be under the supervision of a pharmacist, who must be available to intervene and advise.

(b) Every prescription must be professionally assessed by a pharmacist to determine its suitability for the patient. Pharmacists must ensure that the patient receives sufficient information and advice to enable the safe and effective use of the medicine.

(c) Pharmacists must implement procedures to minimise the risks of dispensing errors or contamination of medicines, incorporating checks to reduce special risks associated with particular products.

(d) Where a product is ordered on a prescription a pharmacist must supply a product with a marketing authorisation, where such a product exists and is available, in preference to an unlicensed medicine or food supplement.

(e) Except in an emergency, pharmacists must not substitute any other product for a specifically named product without the approval of the patient or carer and the prescriber, or a hospital drug and therapeutics committee.

(f) All solid dose and all oral and external liquid preparations must be dispensed in reclosable child resistant containers unless:

(i) the medicine is in an original pack or patient pack such as to make this inadvisable;

(ii) the patient has difficulty in opening a child resistant container;

(iii) a specific request is made that the product shall not be dispensed in a child resistant container; or

(iv) no suitable child resistant container exists for a particular liquid preparation;

(v) the patient has been assessed as requiring a compliance aid.

(g) Labelling of dispensed products must be clear and legible and include the details required by the labelling regulations under the Medicines Act and where appropriate any cautionary and advisory labelling recommended by the current British National Formulary.

(h) Where it is not possible to dispense a prescription in its entirety, the patient, their carer or representative, should be informed at the outset and be given the opportunity to take the prescription to another pharmacy. A legible note detailing the name and quantity of the medication outstanding must be provided and a record kept in the pharmacy. Wherever possible the patient, their carer or representative, must be informed when the balance will be available for collection.

(i) Dispensed medicines should normally be supplied directly to the patient or their carer in the pharmacy, where there is an opportunity for face-to-face contact, and the pharmacist has access to records and references which enable him to provide the best pharmaceutical service. Service Specification 8 must be complied with whenever dispensed medicines are not to be handed over in the pharmacy direct to the patient, their carer or representative.

4.2 Medicines for hospital inpatients

Patients, hospital staff and management teams are entitled to expect pharmacists involved in the supply of medicines to ensure that the systems in place are adequate to assure the safe and accurate supply and usage of medicines.

This service specification applies to all supplies of medicines for hospital in-patients whether supplied as ward stocks or on an individual named patient basis.

(a) Pharmacists must adopt procedures to support appropriate use of medicines and minimise the risks of dispensing errors or contamination of medicines, incorporating checks to reduce special risks associated with particular products.

(b) Medication must be clearly and legibly labelled.

(c) Sufficient information must be provided to ensure that all medicines supplied to in-patients are likely to be used safely, effectively and appropriately. Patient information leaflets must be available to the ward.

(d) Medicines brought in to hospital by patients remain the property of the patient; they must not be supplied to anyone else.

(e) All medicines returned from a ward or hospital department must be examined under the direction of a pharmacist, to assess their suitability for being returned into stock. Date expired medicines must be destroyed.

5. Patient medication records

The public is entitled to expect the best available pharmaceutical care from pharmacies. In order to provide that care, pharmacists and their staff need timely and accurate information to be held on pharmacy computer systems or in manual records.

Patients are entitled to expect that any information stored about them will be pertinent, accurate and up to date, stored securely and treated as confidential and used only for the purpose for which it is was obtained.

Pharmacists must be aware that individual patients have a right, under data protection legislation, to inspect records held about them provided that suitable notice is given.

The pharmacy patient medication record system must:

(a) be notified to the Data Protection Commissioner;

(b) incorporate access control mechanisms to minimise the risk of unauthorised or unnecessary access to patient specific data;

(d) provide for the collection, storage and display of patient medication records containing the following as a minimum:

(i) sufficient information about the patient to allow accurate identification;

(ii) the identity of the patient's GP;

(iii) prescription details (quantity supplied, directions, date of dispensing, any balance owed).

6. Repeat medication services

A repeat medication service is a service operated in co-operation with local prescribers, in which pharmacists will provide professional support to assist in the rational, safe, effective and economic use of medicines.

(a) The pharmacy must operate a patient medication record (PMR) system, notified to the Data Protection Commissioner, and ensure that an audit trail exists to identify each request and supply so as to enable the service to be monitored.

(b) The request for the service must come from the patient or their carer and be recorded in writing. Pharmacists may not act as the carer for this purpose.

(c) Unless this information is already available from the prescription form, pharmacists must establish with the prescriber the period for which repeat prescriptions will be issued. Pharmacists must be alert to the possibility of the patient needing earlier review. On dispensing the final repeat the pharmacist must remind the patient or their carer, preferably in writing, of the need to visit the prescriber.

(d) Pharmacists may institute a patient reminder system but may not request a repeat prescription from a surgery before obtaining the patient or carer's consent.

(e) At the time of each request the pharmacist must establish which items the patient or their carer considers are required and ensure that unnecessary supplies are not made. At this stage pharmacists must also use their professional judgment to decide whether concordance or other problems encountered by the patient may require early reference to the prescriber.

(f) Records of all interventions should be kept in order to be able to deal with any queries that may arise and to advise the prescriber.

7. Prescription collection services

Prescription collection services encompass any scheme whereby a pharmacy receives prescriptions other than directly from the patient, their carer or representative.

(a) Prescriptions must be collected by individuals acting in accordance with directions given by the pharmacist.

(b) Pharmacists must ensure that the procedures for the collection of prescriptions safeguard patient confidentiality and the security of prescriptions.

(c) The request for the ongoing service must come from the patient or carer and the pharmacy must ensure that a procedure for recording the initial request, preferably consisting of written authorisation, exists.

(d) All requests to the doctor for repeat prescriptions must be initiated by the patient or carer and be made directly to the surgery unless the pharmacy is offering a repeat medication service in compliance with Service Specification 6.

(e) On receipt of prescriptions pharmacists must ensure that the pharmacy is authorised to receive and dispense them. Any prescriptions received for which the pharmacy does not have the patient's or their carer's consent must be returned to the surgery for collection by the patient or carer or be directed to the pharmacy authorised to receive the prescription.

8. Delivery services

A delivery service is one where medicines are handed over to a patient or their carer other than on the registered pharmacy premises. The provisions detailed in this service specification also apply to rural collection points. On each occasion a service is requested pharmacists must use their professional judgment to assess whether direct face-to-face contact with the patient or their carer is necessary.

In addition to complying with all other professional requirements relating to the sale or supply of medicines pharmacists are responsible for ensuring that the delivery mechanisms used:

(a) are safe and that the medicines will be delivered promptly to the intended recipient with instructions for use. Unless alternative delivery arrangements have been made, medicines must only be handed over to the patient or their carer and before doing so the delivery person must confirm with the patient or their carer that the name and address of the patient is correct;

(b) cater for any special storage requirements of the product;

(c) enable a verifiable audit trail to be kept identifying the initial request for the service and each delivery and attempted delivery so that the service can be monitored. Wherever possible a signature should be obtained indicating safe delivery of the medicines.

9. On-line pharmacy services

The public is entitled to expect the same high quality pharmaceutical care irrespective of whether the service is provided on-line or face-to-face on pharmacy premises. At all times pharmacists must act in the best interests of the patient and seek to provide the best possible health care.

Pharmacy websites must clearly display the name of the owner of the business and the address of the pharmacy at which the business is conducted.

In addition to complying with all other professional requirements relating to the sale or supply of medicines pharmacists must ensure compliance with the following:

(a) Security and confidentiality

(i) Pharmacists must ensure that the confidentiality and integrity of all patient information is protected. All patient data transmissions must be encrypted to prevent the possibility of access by the internet service provider or any other unauthorised party;

(ii) National Health Service patient data must comply with security standards and other requirements determined by the NHS Executive;

(b) Request for supply of medicines

(i) In all cases where a pharmacy medicine is requested or recommended, pharmacists must ensure that sufficient information is available to enable a professional assessment of the request and that they have an opportunity to provide appropriate counselling or advice. Advice must be available to all prospective purchasers of general sale list medicines and vitamin and mineral supplements;

(ii) Pharmacists providing on-line pharmacy services must advise patients to consult a convenient pharmacy whenever a request for a medicine or the symptoms described indicate that the patient's interests would be better served by a face-to-face consultation;

(i) All information related to specific products must comply with the marketing authorisation, the patient information leaflet and the Medicines (Advertising) Regulations;

(ii) Information relating to medicines must include all relevant details of contra-indications and side-effects;

(iii) Non-patient specific health care advice, such as that relating to the treatment of symptoms or specific conditions, first aid, travel precautions, etc, provided on pharmacy web sites must be of a high professional standard and the pharmacist assuming professional responsibility for the provision of that advice must be identified;

(iv) Product recommendations may only be given in respect of individual patients and a record must be kept of the pharmacist assuming professional responsibility for the recommendation;

(v) Before a patient receives a pharmacy or prescription only medicine pharmacists must ensure that the patient receives sufficient information to enable the safe and effective use of the medicine. Procedures for dealing with requests for supplies of medicines and/or delivery arrangements must ensure that this occurs;

(d) Record keeping

(i) The pharmacy must maintain information about supplies of medicines sufficient to guard against risks of abuse or misuse;

(ii) Records must be kept to identify the pharmacist authorising every supply of a P or POM medicine following an e-mail request to purchase.

10. Sales of pharmacy medicines

The public is entitled to expect that medicines purchased over the counter will be safe, effective and appropriate for the condition to be treated and the intended recipient. The following requirements apply to pharmacy medicines intended for human use and pharmacy only veterinary medicines.

All staff whose work regularly includes the sale of pharmacy medicines must be competent and instructed to refer customers to the pharmacist where appropriate. Pharmacists responsible for the provision of professional services in a pharmacy must ensure that the following standards are observed in the sale of pharmacy medicines.

(a) Pharmacists or assistants asked for advice on treatment must obtain sufficient information to allow an assessment to be made that self-medication is appropriate, and to enable a suitable product or products to be recommended. Advice on the use of products must be provided.

(b) Pharmacists must ensure that when a product is requested by name the procedures for sales of medicines provide for professional advice and intervention whenever this can assist in the safe and effective use of pharmacy medicines. Pharmacists or assistants must provide any advice relevant to the product and the intended consumer.

(c) Pharmacists must be personally involved whenever this is necessary to provide an acceptable standard of pharmaceutical care. Assistants must be trained to know when the pharmacist should be consulted.

(d) Procedures must ensure that the particular care needed is provided when supplying products for children, the elderly and other special groups or individuals or where the product is for animal use.

(e) Pharmacists must ensure that they are involved in the decision to supply any medicine, which requires their intervention. Such medicines may include those that have recently become available without prescription, that may be subject to abuse or misuse, or where the marketing authorisation for non-prescription use is restricted to only selected conditions. Pharmacists and their staff must be aware of the abuse potential of certain OTC products and should not supply where there are reasonable grounds for suspecting misuse.

11. The supply of emergency hormonal contraception as a pharmacy medicine

Pharmacists in personal control of a pharmacy must ensure that the following standards are observed in the supply of emergency hormonal contraception as a pharmacy medicine. As with all medicines pharmacists must have sufficient knowledge of the product to enable them to make an informed decision when requests are made.

(a) Pharmacists must deal with the request personally and decide whether to supply the product or make a referral to an appropriate health care professional.

(b) Pharmacists must ensure that all necessary advice and information is provided to enable the patient to assess whether to use the product.

(c) Requests for emergency hormonal contraception must be handled sensitively with due regard being given to the patient's right to privacy.

(d) Only in exceptional circumstances should pharmacists supply the product to a person other than the patient.

(e) Pharmacists should whenever possible take reasonable measures to inform patients of regular methods of contraception, disease prevention and sources of help.

12. Complementary therapies and medicines

The public trusts pharmacists to offer informed advice on treatments and medicines, and the profession expects pharmacists to ensure that they are competent in any area in which such advice is given.

Pharmacists providing homoeopathic or herbal medicines or other complementary therapies have a professional responsibility:

(a) to ensure that stocks of homoeopathic or herbal medicines or other complementary therapies are obtained from a reputable source of supply;

(b) not to recommend any remedy where they have any reason to doubt its safety or quality;

(c) only to offer advice on homoeopathic or herbal medicines or other complementary therapies or medicines if they have undertaken suitable training or have specialised knowledge.

13. Health care information and advice

Pharmacists are encouraged to contribute to the promotion of healthy lifestyles. By increasing public awareness of health promotion issues and participating in disease prevention strategies pharmacists can work actively towards improving the nation's health.

The public and other health care professions are entitled to expect pharmacists and their staff to be able to provide up to date, accurate and reliable advice and information on a wide range of health care issues.

Pharmacists and staff providing information and advice on health related issues must:

(a) have an adequate level of current knowledge and information about relevant subjects;

(b) ensure that all advice is independent and not compromised by commercial considerations;

(d) continually review their knowledge and keep up to date regarding new products and new policies for health promotion;

(e) be aware of local and major national and topical health promotion initiatives;

(f) work in partnership with patients and other health care professionals in seeking to promote healthy lifestyles and respect patients' rights to be involved in decisions about their health.

14. Diagnostic testing and health screening

Pharmacists working in primary care are well placed to provide diagnostic testing and health screening services to the public, who would expect any such service to be safe and accurate.

Pharmacists providing diagnostic testing or health screening services must:

(a) ensure that before providing a service all staff have completed any training required to ensure competency with the equipment and procedures to be used and in the interpretation of results. They must be aware of the limits of the tests provided. The pharmacy must have a designated area, not in the dispensary, with suitable facilities to perform the tests and provide counselling;

(b) institute and operate an appropriate quality assurance programme in order to ensure the reliability of the results produced;

(d) keep up to date with developments in the field and ensure that they are aware of current advice or local guidance on when to refer patients to their general medical practitioner;

(e) before undertaking a test provide an explanation to the patient of the procedure to be adopted and obtain the patient's consent;

(f) communicate test results to the patient in a manner in which they can be understood. Patients should be fully informed about the significance of the results and must be provided with any necessary counselling and available information;

(g) ensure that adequate documentation is maintained to enable the service to be audited.

15. Emergencies

Increasingly the public looks to pharmacists in community practice for help and assistance, sometimes in emergencies.

(a) Pharmacists must consider using their rights to make emergency supplies of medicines whenever a patient has an urgent need for a medicine. They must consider the medical consequences, if any, of not supplying.

(b) Where pharmacists are not able to make an emergency supply of a medicine they should do everything possible to advise the patient how to obtain essential medical care.

(c) Pharmacists must assist persons in need of emergency first aid or medical treatment whether by administering first aid within their competence or by summoning assistance and/or the emergency services. The Society's booklet, “Emergency first aid: guidance for pharmacists”, provides guidance on action in life-threatening situations.

16. Collection and disposal of pharmaceutical waste

These services include the collection and disposal of unwanted medicines returned to the pharmacy by patients and other members of the public, or from wards, clinics or other departments in a hospital, and the disposal of obsolete pharmacy stock.

(a) Within the hospital sector pharmacists must ensure that a standard operating procedure dealing with waste management, including pharmaceutical waste, is in place.

(b) Pharmacists must ensure that a contract has been made with an authorised carrier for the collection and disposal of pharmaceutical waste at regular intervals or on demand.

(d) Pharmacists must ensure that consignment notes and any other requisite documentation are completed and copies kept to comply with legal requirements.

17. Advisory services to nursing and residential homes

This service specification applies to any service intended to facilitate the safe, effective, and appropriate usage of medicines, dressings and appliances, their storage, stock control or disposal, and the associated record keeping in nursing and residential homes and hospices.

Pharmacists providing advisory services must ensure that:

(a) they have undertaken adequate training relevant to the services being provided;

(b) they visit the home regularly by appointment. All staff visiting the home should carry identification;

(c) they have contact, regularly and as frequently as needed, with medical and nursing personnel responsible for the care and medical treatment of residents;

(d) they undertake professional assessments to ensure appropriate usage of medicines in the home;

(e) they assess and advise on procedures to ensure safe and accurate administration of medicines;

(f) all necessary supplementary information, eg, patient information leaflets, is available at the home;

(g) they advise on the safe disposal of unwanted medicines supplied by the pharmacy and of other pharmaceutical and clinical waste, in compliance with legal requirements;

(h) adequate records are maintained to enable them to deal with any queries that may arise and to enable audit of the service;

(i) where they do not supply the medicines to the home they liaise with the pharmacy that does.

18. Domiciliary oxygen services

Domiciliary oxygen services comprise the supply of oxygen and associated equipment to a patient's home and the provision of advice on the use of oxygen in the home.

(a) The pharmacy must operate a patient medication record system, notified to the Data Protection Commissioner.

(b) The pharmacy must have the facilities, as laid down in statute, for the safe storage of oxygen cylinders and oxygen concentrators and display the required statutory warning signs.

(c) Personnel involved in the provision of domiciliary oxygen services must be suitably trained to undertake the tasks required of them and should carry identification.

(d) All patients receiving domiciliary oxygen for the first time must be visited by the pharmacist or a suitably trained and competent member of staff to instruct the patient or their carer on the use of oxygen in the home.

(e) Pharmacists must ensure that all necessary safety information is provided to the patient or their carer.

(f) Sets must be serviced regularly in accordance with the manufacturer's recommendations.

(g) Pharmacists must maintain adequate records of supplies and advice given to enable the regular audit of the service.

19. Services to drug misusers

Services to drug misusers include the dispensing and/or supervision of patient self-administration of methadone and other products dispensed on instalment prescriptions.

(a) The pharmacy must operate a patient medication record system, notified to the Data Protection Commissioner.

(b) Pharmacists must liaise with health care professionals and others involved in the care of the patient having due regard for the patient's confidentiality.

(c) If pharmacists anticipate or experience problems of unacceptable behaviour by a patient they should enter into an agreement with the patient for the future provision of the service. This should detail the services that the pharmacist will provide and also outline the pharmacist's expectations of the patient, the reasons why and any action to be taken if the patient's conduct becomes unacceptable. Pharmacists may decline to provide a service to a patient whose conduct is unacceptable.

(d) The pharmacy must not deviate from the instructions given on the prescription. Sugar- and/or colour-free products have a greater potential for abuse than syrup based and coloured products and must not be dispensed unless specifically prescribed.

(e) Patients must be treated with respect and courtesy and where self-administration occurs due regard must be given to the provision of a quiet area in order to provide some privacy for both the patient and other members of the public.

(f) Only in exceptional circumstances should pharmacists supply clean injecting equipment for drug misusers if the pharmacy has no arrangements for taking back contaminated equipment. Purchasers of injecting equipment should be advised of the availability of disposal facilities at the pharmacy and should always be encouraged to dispose of used syringes and needles safely.

20. Needle and syringe exchange schemes

Needle and syringe exchange schemes involve the provision of clean syringes and needles and the collection of contaminated equipment used by substance and drug misusers.

(a) Pharmacists must be aware of local facilities for drug misusers and have established contacts with other health care professionals involved in the care of drug misusers.

(b) All staff who may be involved in the service must be instructed on procedures to be followed to minimise risks.

(d) Individuals must be encouraged to return used contaminated equipment in approved disposal containers, but a supply of clean equipment must not be refused if they omit to do so.

(e) Used equipment must be disposed of, preferably by the individual, into a properly designed sharps container available in the pharmacy.

(f) Suitable arrangements must be made for the disposal of full sharps containers.

21. Extemporaneous preparation/compounding

This service specification is not intended to cover the reconstitution of dry powders with water or other diluents.

The public is entitled to expect that products extemporaneously prepared in a pharmacy will be prepared accurately, suitable for use and meet the accepted standards for quality assurance.

Pharmacists wishing to be involved in extemporaneous preparation must ensure that they, and any other staff involved, are competent to undertake the tasks to be performed and that the requisite facilities and equipment are available.

(a) A product should only be extemporaneously prepared when there is no product with a marketing authorisation available and where the pharmacist is able to prepare the product in compliance with accepted standards.

(b) Equipment must be maintained in good order to ensure that performance is unimpaired.

(d) Ingredients must be of sourced from recognised pharmaceutical manufacturers and be of a quality accpeted for use in the preparation and manufacture of pharmaceutical products. All calculations and, where possible, measurements should be checked. Pharmacists must pay particular attention to substances which may be hazardous and require special handling techniques.

(e) The product must be labelled with the necessary particulars, including any special requirements for the safe handling or storage of the product, and an expiry date.

(f) Records must be kept for a minimum of two years but if possible for five years. The records must include the formula, the ingredients and the quantities used, their source, batch number and expiry date. Where the preparation is dispensed in response to a prescription the records must also include the patient's and prescription details and the date of dispensing. A record must be kept of personnel involved including the identity of the pharmacist taking overall responsibility.

22. Aseptic dispensing services from non-licensed units

Aseptic dispensing includes manipulations such as reconstitution, dilution and transfer of a sterile preparation avoiding microbiological contamination and maintaining a physicochemical stability, under the supervision of a pharmacist.

(a) The preparation of products intended for administration to humans must be in accordance with the principles of good manufacturing practice throughout the process. This is encompassed in the documents “Quality assurance of aseptic preparation services” and “Aseptic dispensing for NHS patients” and any subsequent revisions.

(b) The decision to prepare a product aseptically should be made in the context of the clinical needs of the patient. The pharmacist must ensure that the product complies with the standards to be expected for that product.

(d) The facilities and the service as a whole must be regularly audited and faults and deficiencies once identified must be promptly rectified.

23. Patient group directions

Pharmacists involved in writing and/or approving patient group directions are accountable for their content and must therefore ensure that:

(a) they only approve directions which comply with legal requirements;

(b) the staff training specified will enable safe operation of the patient group direction;

(d) they have up-to-date knowledge relating to the clinical situation covered by the patient group direction, the medicine and its use for the indications specified in the patient group direction;

(e) they are familiar with their role and responsibilities and the government advice set out in relevant guidance.*

Pharmacists involved in the supply and/or administration of a prescription only medicine under a patient group direction must:

(f) ensure that they have up-to-date knowledge relating to the clinical situation covered by the patient group direction, the medicine and its use for the indications specified;

(g) ensure that they have undertaken any training required for operation of the patient group direction;

(h) be satisfied that the patient group direction is legally valid and that it has been approved by the relevant health authority or other NHS body;

(i) ensure that when supplies are made the agreed protocol is followed and that the information specified in the patient group direction is recorded. These records must include the identity of the pharmacist assuming responsibility for each supply.

* HSC 2000/026 (England only), WHC: (2000) 116 (Wales only) or HDL (2001) 7 (Scotland only)