Annex A2: Ethical And Legal Considerations
1. Code of Ethics of the Royal Pharmaceutical Society of Great Britain
General and specific references relevant to counselling and advice on medicines and appliances in community pharmacy are to be found in the Code of Ethics of the RPSGB. It follows therefore that, whatever the contractual arrangements in existence to reimburse community pharmacists for this professional service, the provision of appropriate counselling and advice places an ongoing professional responsibility on the pharmacist which cannot be abdicated. The reference figures given below refer to sections in the Code and its Appendix which should be referred to for a further explanation.
As with all other professional activities, the pharmacist's approach to counselling and advice is governed by Principle 1 of the Code that a pharmacist's prime concern must be for the welfare of both the patient and other members of the public, and specifically (obligation 1.14), a pharmacist must conform to the obligations in the Standards of Good Professional Practice and with other guidelines or codes of practice appropriate to the relevant field of work.
Principle 4 of the Code requires a pharmacist to respect the confidentiality of information acquired in the course of professional practice relating to a patient and the patient's family. Such information must not be disclosed to anyone without the consent of the patient or appropriate guardian unless the interest of the patient or public requires such disclosure. Information includes that retained through memory as well as that held in records. Any disclosure of information relating to a patient and the patient's family (obligation 4.3), should be limited to the minimum necessary for the specific purpose involved. It should be noted that information can be shared with others who participate in, or assume a responsibility for, the care or treatment of the patient and who would be unable to provide that care or treatment without the necessary information; this is the "need-to--know" concept.
In relation to Principle 4 on confidentiality, the Code gives specific guidance relating to contraceptive advice or pregnancy testing for a girl under the age of 16.
In the Appendix to the Code of Ethics, the Guidance notes under Section 5 (Standards for dispensing procedures) state that "it is beneficial to maintain pharmacy records of medicines dispensed for and purchased by patients". To such records may be added information on counselling and advice given. The Guidance notes continue: "Where these records are kept on a computer, the pharmacy must register with the Data Protection Registrar" ... "Whatever method of keeping patient medication records is used, a pharmacist must ensure that the information held remains confidential and full regard is paid both to Principle 4 of the Code of Ethics and the Data Protection Act 1984".
As in contractual terms, provision of counselling and advice is a professional service, pharmacists are reminded that any reference to this service in publicity material should comply with Principle 7 of the Code. Thus any pharmacist or pharmacy owner must not claim or imply in publicity any superiority over the professional services provided by other pharmacists or pharmacies. Publicity must be dignified, and must not bring the profession into disrepute.
In the Code of Ethics Appendix, the thrust of the guidance concerns the provision of information and advice required for the safe and effective use of medicines, taking care to assess both the wishes of the prescriber and the information and counselling needs of the individual patient. The Appendix directs that the pharmacist should ensure that the patient is given and understands sufficient written and oral information to enable him/her to obtain maximum benefit from the medicine.
2. The Scottish Office Department of Health
The Scottish Office Department of Health (SODoH) Code of Practice on "Confidentiality of Personal Health Information'' gives further guidance to all those employed by or contracted to the Scottish Health Service. Particular guidance is given on "Disclosure by Implied Consent" and "Disclosures Without Consent". The Code of Practice advises that disclosure without consent always raises extremely difficult questions involving moral, ethical and medical issues and such cases must be considered with great care. It points out that the Chief Administrative Medical Officer/Director of Public Health or his/her nominated deputy has responsibility for confidentiality, security and access to personal health information held by a Health Board and should be regarded as a source of advice on all aspects of disclosure. All disclosures and their extent should be recorded on the patient's record.
3. Patient Information Leaflets
When a medicine is prescribed for an indication which is not covered by the PIL for the product, pharmacists may wish to discuss the advice to be given to the patient with the prescriber.
The pharmacist is strongly urged to consult the ethical principles, obligations, and guidance of the Society, as outlined above in conjunction with the SODoH Code of Practice, the Data Protection Act 1984 and the information given in these practice guidelines. The Society's Cede of Ethics, and the Appendix relating to Standards of Good Professional Practice are found for example in the publication "Medicines, Ethics & Practice" sent to all practising pharmacists. As well as a professional requirement to observe the Society's Code of Ethics pharmacists who fail to perform to an acceptable professional level could find themselves in a position of legal liability.