The Pharmaceutical Journal
Vol 278 No 7435 p82-83
20 January 2007

Society summary

Society consults on expanded professional guidance

The Royal Pharmaceutical Society has begun consulting pharmacists, pharmacy technicians and others on draft guidance setting out revised and expanded professional standards relating to aspects of pharmacy practice, along with brand new guidance covering patient consent.

The guidance is contained in five consultation documents setting out detailed standards to support the proposed revised Code of Ethics for Pharmacists and Pharmacy Technicians (PJ, 11 November 2006, centre pull-out), which is itself still out for consultation until the end of next week.

The draft new code is much more concise than the existing codes for pharmacists and for pharmacy technicians. It is based on seven principles that will inform the conduct, performance and practice of all registered pharmacy professionals (see Panel).

Each principle is supported in the new code by a series of statements to explain the types of actions and behaviours expected when pharmacists and pharmacy technicians apply the principles in practice. But the revised code does not contain detailed standards. Where more detailed guidance is required for a specific area of practice or professional activity, it is to be provided in separate supporting guidance documents, such as the five now published for consultation with the approval of the Society’s Law and Ethics Committee.

The five documents relate to:

• Sale and supply of medicines
• Patient consent
• Patient confidentiality
• Standards for registered pharmacists and pharmacy technicians in positions of authority
• Professional standards and guidance for pharmacist prescribers

Two more guidance documents are in preparation. One covers internet pharmacy and the other is concerned with advertising. Guidance on further aspects of practice may be produced as and when the need arises.

Lynsey Balmer, head of professional ethics at the Society, says: “In moving to a principle-based Code of Ethics the Society recognises that certain areas of practice or professional responsibilities will still require more detailed standards or guidance than is provided in the actual code itself. This consultation gives the profession and the public the opportunity to have early input into these standards and guidance documents and, therefore, a real input into the shaping of the performance measures that pharmacists and pharmacy technicians will work towards in the future.”

Comments on the consultation documents are to be invited from national pharmacy organisations and health care professional bodies as well as from pharmacists, pharmacy technicians and other individuals.

Each of the guidance documents expands on the new code’s seven principles and supporting explanations to set out professional responsibilities and requirements for pharmacists and pharmacy technicians involved in the activities covered. Each document also concludes by listing supporting guidance and other sources of information and advice.

The content of the five documents is summarised below.

Sale and supply of medicines

The draft “Sale and supply of medicines” document expands on the principles in the new Code of Ethics to set out the mandatory professional responsibilities for pharmacists and pharmacy technicians involved in the sale and supply of medicines. It sets out standards relating to 10 aspects of sale and supply:

• Pharmaceutical stock
• Supply of over-the-counter medicines
• Supply of prescribed medicine
• Extemporaneous preparation/ compounding
• Repeat medication services
• Delivery services
• Prescription collection services
• Complementary therapies and medicines
• Emergencies
• Patient group directions

These 10 sections contain standards that are much the same as guidance found in service specifications 2, 10, 4, 21, 6, 8, 7, 12, 15 and 10, respectively, in Part 3 of the current Code of Ethics and Standards.

Patient consent

The draft “Patient consent” document contains new guidance, drawn up because of the increasing provision by pharmacists of new professional services, treatment and care.

The document sets out mandatory requirements that expand on the principles of the new code, particularly the third principle, “Show respect for others”, and the associated requirements to “Treat others politely and considerately” and to “Obtain consent for the professional services, treatment or care you provide and the patient information you use”.

The document has six main sections:

• The first section states that patients have a right to be involved in decisions about their health care and that obtaining consent is fundamental for patient autonomy. It points out that for consent to be valid the patient must be capable of making that particular decision, must be acting voluntarily, with no pressure to make a particular decision, and must be provided with sufficient information to make an informed decision.

• Section 2 covers the process of obtaining consent. It begins by looking at the amount and type of information needed to allow informed consent in different circumstances. It then considers the way in which the information should be presented to the patient, taking into account factors such as disabilities (eg, poor sight or hearing) and language barriers. It sets out the need for open and honest answers to the patient’s questions and the need to confirm that the patient has understood the information. This section also says that pharmacists should use their professional judgement to decide whether it is appropriate to delegate the task of obtaining consent to another member of staff, who must be suitably trained and competent. It points out that patients are entitled to change their minds — because a patient has consented to a treatment or service in the past the pharmacist should not assume that the patient will consent to it again. Obtaining patient consent must be covered in standard operating procedures, which should cover the process of obtaining patient consent. They should cover issues such as what activities within the pharmacy require patient consent, which activities require the pharmacist to obtain consent, which members of staff may obtain consent on the pharmacist’s behalf, what information should be provided and what type of consent is required (eg, written, verbal). Finally, this section covers the need to obtain a patient’s consent if the pharmacist wishes a third person to be present during a consultation. The patient should be informed who that third person is, in what capacity he or she will be working and what activities her or she will be undertaking (eg, observing or taking notes).

• Section 3 is concerned with forms of consent, which it describes as either explicit consent, given either verbally or in writing, or implied consent, indicated by action other than writing or speaking. An example of implied consent is the act of handing over a prescription for dispensing.

• Section 4 looks in detail at assessing patients’ competence to give consent. It says that, as part of an assessment, the pharmacist should consider whether the patient is able to retain the information provided, has understood the information, has understood the implications of his or her decision and is able to communicate that decision to the pharmacist. Pharmacists should use their professional judgement, taking into account relevant legislation, when determining whether a patient is considered to be competent to provide consent. On children, this section says that children aged 16 or over are considered to be adults with respect to the ability to provide consent. For younger children there is no set age at which a person becomes competent to provide consent. Such children must be assessed to determine whether they are competent to give informed consent. The document suggests that it is good practice to encourage children to involve their parents in the decisions they make about their health care.

• Refusal of consent is considered in Section 5, which says that a competent adult may refuse treatment even if that refusal may result in harm or death to himself or herself. A decision to refuse treatment must be respected, but a record of the refusal should be made, together with the discussions that have taken place. If an incompetent patient has clearly indicated in the past, while competent, that he or she would refuse treatment in certain circumstances, and those circumstances arise, the pharmacist must abide by that “advance refusal”.

• Section 6 looks at emergencies. It says that treatment may be provided without consent in an emergency where necessary to save life — eg, the administration of an Epipen to a person suffering from anaphylaxis. Hospital pharmacists are advised to read any relevant policy regarding patient consent in emergency situations.

Patient confidentiality

The draft document on patient confidentiality expands on the confidentiality requirements found in Part 2C of both current codes. It does so to make the guidance more comprehensive, to clarify some of its content and to ensure that it remains appropriate into the future.

In a section on keeping information confidential, the guidance says that robust procedures must be in place to protect the confidentiality of information received by, stored in, sent by or destroyed by the pharmacy. Records, registers, prescriptions and other sources of confidential information should be kept out of sight of persons who should not have access to them.

The guidance goes on to say that pharmacies must have standard operating procedures to cover the way in which confidential information is handled. It says that SOPs should address issues such as: procedures for processing, using and storing confidential information; procedures for disclosing information; appropriate records of requests for disclosures and details of information disclosed; and who has access to confidential information and in what circumstances.

In a section on disclosure of information, the guidance says that although patients may expect personal information about them to be shared with other health professionals in their own interest, a pharmacist should still ensure that patients are aware of the extent to which such information may need to be shared and check that they do not object. If a patient refuses to consent to personal information being shared with another health professionals, the patient’s decision must be respected, but the patient must be advised of the possible implications of not consenting to disclosure.

In a section on releasing information without consent, the guidance says that confidential information should be disclosed only in exceptional circumstances or when permitted or required by law. It lists and explains the circumstances in which disclosure without consent may be required. It also says that details must be kept of any disclosure made without consent and the relevant circumstances.

Pharmacists and technicians in authority

The draft document on “Standards for pharmacists and pharmacy technicians in positions of authority” is a replacement for the guidance on “Pharmacists who own a pharmacy, superintendent pharmacists and pharmacist managers in hospitals and trusts or other fields of practice”, which forms Part 2A.2 of the current Code of Ethics and Standards. It also replaces the guidance on “Pharmacy technicians who own a pharmacy and pharmacy technician managers in hospitals, trusts or other fields of practice”, which forms Part 2A.2 of the Code of Ethic for Pharmacy Technicians.

The draft new mandatory guidance extends the existing documents to cover the responsibilities of pharmacists and technicians in positions of authority at any level, in any practice setting. It also sets out the requirements for those in authority in much greater detail.

The guidance begins by stating that one should not accept a position of authority unless one has the required skills and competence to perform the tasks. It goes on to list a broad range of responsibilities in the following areas: policies and procedures; pharmacy premises and facilities; responsibilities to those employed, managed or led; responsibilities in employing others; training and development; enabling others to raise concerns; handling complaints; and indemnity arrangements. Two final sections set out requirements specific to registered community pharmacies

Pharmacist prescribers

The draft document on “Professional standards and guidance for pharmacist prescribers” is a substantial document setting out mandatory professional requirements that all pharmacist prescribers must adhere to. It supersedes the 10 brief obligations listed in Service Standard 24 in the current Code of Ethics and Standards.

After a section setting out background information and general requirements, the draft new guidance sets out between two and 12 professional standards relating to each of the seven principles of the new code. For most of the principles it also sets out two or three points of good practice guidance.

In a section headed “Additional information”, the document goes on to give further guidance on writing prescriptions, on prescribing Controlled Drugs, on prescribing unlicensed medicines, on prescribing a medicine for use outside the terms of its licence, on repeat prescribing, on remote prescribing (by telephone, e-mail, fax, video link or website), on reporting adverse reactions and on clinical management plans.

Questionnaires

Each consultation document is accompanied by a questionnaire form designed to determine whether respondents consider the draft standards and guidance to be relevant, appropriate and sufficiently robust to protect the public and the profession adequately.

Each questionnaire asks for comments on:

• Whether the document is clear and easy to understand
• Whether anything needs to be added to or removed from the document
• Whether any areas of the document require further clarification
• Whether the document is useful

In addition, the “Sale and supply” questionnaire asks for views on whether the standards in the “Repeat medication supplies” section of the “Sale and supply” guidance are relevant to current practice.

The Society says that the questionnaires are designed to determine whether respondents see the draft standards and guidance as relevant, appropriate and sufficiently robust to protect the public and the profession.