The Pharmaceutical Journal
Vol 276 No 7404 p701-702
10 June 2006

Society summary

The Legal and Ethical Advisory Service

The Royal Pharmaceutical Society's Legal and Ethical Advisory Service provides advice on the Codes of Ethics and the Society's interpretation of medicines legislation. This article, produced within the advisory service, describes the services available

The Royal Pharmaceutical Society’s Legal and Ethical Advisory Service has existed in some form since the early 1960s — albeit referred to by different titles at different times. Established to deal with written and telephoned enquiries, it now also provides published guidance in ‘Medicines, ethics and practice: a guide for pharmacists’, in Law and Ethics Bulletin items in The Pharmaceutical Journal and in a range of fact sheets available from its own page in the “Fitness to practise” section of the Society’s website.

The advisory service team has recently been expanded from four experienced pharmacists to five. They are based within the Fitness to Practise and Legal Affairs Directorate at the Society’s London headquarters, but they also work closely with other units within the Society — particularly the Technical Information Service and the Practice and Quality Improvement Directorate — to ensure that all information given is consistent with the Society’s guidance and policies.

New team member Daniella Murphy says: “Having recently rejoined the advisory service I feel that this is an exciting time for pharmacy with all the new changes to the regulations. I am greatly looking forward to assisting pharmacists in making the necessary adjustments to comply with these amendments and advising them when in difficult situations.”

Who is the service aimed at?

The service is aimed mainly at those registered with the Society — pharmacists and pharmacy technicians — who have queries about legal and ethical aspects of their work. In addition, other health professions and regulatory bodies may telephone for advice in relation to the practice of pharmacy. Enquiries are also received from trading standards officers, police officers, staff of the Veterinary Medicines Directorate, the Home Office and other health care regulators, and members of the public.

The service can answer queries about a wide range of subjects, including topics such as Controlled Drugs, collection and delivery services, and supplies by pharmacists to midwives or paramedics.

Routes of enquiry and types of enquirer

The service is accessible by telephone, letter and e-mail. Most enquiries are received by telephone, but an increasing number of questions are raised by e-mail.

The e-mail culture has added the odd problem for the service. Carole Green, the longest serving member of the current team, says: “Having worked in the advisory service for some time, I have seen the transition from queries being mainly telephone calls and letters, to telephone calls and e-mails. Some pharmacists appear to expect a quicker response by e-mail and are therefore surprised if they have not received a reply by the next day. But this is not possible because of the number of e-mails received and the need to research each query, in liaison with other departments where necessary.”

Last year the service dealt with more than 14,000 enquiries, of which 86 per cent were made by telephone, 11 per cent by e-mail and 3 per cent by letter. Half of all the enquiries taken by telephone came from community pharmacists, with a further 12 per cent from hospital pharmacists and 8 per cent from primary care organisations. Academia and industry were responsible for a further 2 per cent, and prisons, care homes and pharmacy technicians each accounted for 1 per cent. Members of the public made 5 per cent of the enquiries. The remaining 20 per cent were from a variety of other sources, including other health care professions and other health care regulators. This category also includes queries that were not within the service’s remit.

Types of query received

The enquiries received are many and varied. Those submitted by e-mail or letter tend to be more complex than telephoned enquiries and may require extensive research if the question is to be answered fully.

Answers to questions may be found by referring to ‘Medicines, ethics and practice’, fact sheets, Regulations and Acts of Parliament. In more obscure queries the answer may be found in an old Act of Parliament. Some queries combine legislation with best practice guidance and policies, and it is important that responses are researched thoroughly to ensure that all aspects of the question are addressed.

Pharmacists often ask for guidance on ethical dilemmas that arise in the course of their practice. Where possible, enquirers will be advised on relevant legislation and will be referred to the Code of Ethics or best practice guidance to allow them to make a decision on the most appropriate course of action. However, it is up to the individual pharmacist to decide on the appropriate course of action after considering the information available because pharmacists must be able to justify their decisions to their peers and to any person or organisation affected by their actions.

When new legislation is implemented or new guidance is issued, the advisory service usually receives a number of enquiries. A recent example was the new Misuse of Drugs Regulations amendments, concerning Controlled Drugs, that came into force in the middle of November 2005. Many pharmacists had questions initially, and many still do. Guidance was produced and published in The Pharmaceutical Journal (PJ, 12 November 2005, p617). However, it has been found that when pharmacists read information such as this they may wish to talk through and clarify their understanding of the changes when they receive a prescription after the new legislation has come into effect. The service welcomes the opportunity to assist pharmacists who require further information.

Examples of queries

The advisory service is able to answer most of the questions it receives. However, it declines to answer some questions because it is more appropriate for them to be addressed by other information sources. When it is not possible to provide advice, every endeavour is made to direct the enquirer to the appropriate source of assistance.

Some examples of questions that the service has answered recently are given in Panel 1 and examples of recent queries that could not be answered appear in Panel 2. A recent Law and Ethics Bulletin gave a list of contact details for a range of organisations that pharmacists may find useful when researching queries for which the Society’s advisory service is not an appropriate source of information (PJ, 3 June, p664).

Occasionally the service is asked about subjects that do not fall within the Society’s remit. The service is unable to advise other health care professionals about what is best practice within their own sphere of activity and in these situations the health professional will be directed to his or her own professional body or appropriate authority for advice.

The advisory service is also asked about the actions of others who are not involved in health provision. For instance, enquirers often ask about the legality of sales of general sale list (GSL) medicines from petrol stations, market stalls and other non-pharmacy locations. Many people (including pharmacists) are unaware that the Medicines and Healthcare products Regulatory Agency is responsible for regulation of the supply of such medicines from non-pharmacy locations — and also the supply of prescription-only medicines from non-pharmacy locations by methods such as personal distribution, mail order and the internet. Where a query falls outside the remit of the advisory service, the enquirer will, wherever possible, be directed to the appropriate agency.

Regardless of which sector of practice they work in, pharmacists and registered pharmacy technicians are encouraged to use the advisory service. There is no charge for contacting the service.

Fact sheets

Before contacting the advisory services, enquirers may wish to see whether their query is answered in one of the fact sheets produced by the service. All the fact sheets can be downloaded as PDF files from the Legal and Ethical Advisory Service page of the Society’s website. There are currently 13 fact sheets, with two more expected shortly.

The fact sheets are written with a view to providing comprehensive information about various topics based on new legislation and guidance as well as queries received from members. When amendments to current legislation come into force, the fact sheets are updated to ensure they include accurate information. This is why the “Controlled Drugs and community pharmacy” and “Controlled Drugs and hospital pharmacy” fact sheets have been withdrawn temporarily. The advisory service is awaiting further clarification from the Home Office and the Department for Environment, Food and Rural Affairs following the implementation of the new waste regulations and amendments to the Misuse of Drugs legislation.

Team member Ambrose Paschalides said: “It is important that all our fact sheets are updated regularly, so that pharmacists have current information that they can rely on. It is a great responsibility to be the person who must ensure that a fact sheet accurately reflects any changes that have been made to legislation. Pharmacists refer to fact sheets and use the information contained within them to make decisions on the course of action to take in a particular situation. The information will often be needed in difficult situations and pharmacists must be able to trust that the information is accurate, considering the source. This is the reason why fact sheets may be withdrawn for revision when legislation changes mean that they would contain out-of-date information.”

The recently added “Employing a locum / working as a locum” fact sheet (number 13), was written in response to queries from locums and employers about what was required from them, in addition to the personal responsibilities contained in the Code of Ethics.

The most recent fact sheet, added in March, is on the sale of non-medicinal poisons from pharmacies (PJ, 1 April, p402).

MEP updates

Each July, ‘Medicines, ethics and practice: a guide for pharmacists’ is updated. The advisory service is responsible for updating its “legal” content. This challenging task involves adhering to a deadline while trying to incorporate last minute changes to legislation. As new legislation comes into force, the relevant parts of MEP are amended and kept on file to be included in the list to be sent to the editor. Currently, only the alphabetical list of medicines for human use is updated more frequently, because it is also accessible online.

On some occasions whole sections of the MEP guide may need to be rewritten. On other occasions just certain parts may require attention, eg, the advanced electronic signature as part of the prescription only medicines section.

Recent changes to the Misuse of Drugs Regulations 2001 mean that the MEP’s handwriting exemptions section, the requirements for Controlled Drug prescriptions and the Controlled Drugs register section will all need to be amended for this year’s 30th edition. A section on extended formulary nurse prescribers and Controlled Drugs will have to be amended, following changes to the Misuse of Drugs Regulations and the Prescription Only Medicines (Human Use) Order 1997. Additionally, the section on supply of Controlled Drugs to misusers will have to be changed to include the addition of ascorbic acid to the list of drug paraphernalia that specified persons (including pharmacists) can supply to illicit drug users for the purpose of administering or preparing Controlled Drugs. In the interim, a Law and Ethics Bulletin has been published in The Pharmaceutical Journal giving guidance on these changes (PJ, 12 November 2005, p617).

Commenting on the updating of the MEP, team member Priya Sejpal says: “Before I started working here I never fully appreciated how much time it took for the MEP to be written. The cycle begins towards the end of February and lasts right up until the beginning of July. It’s a lot of hard work but great fun at the same time — although I probably wouldn’t say that by the time we are proof reading the fifth draft!”

Law and Ethics Bulletins

Most of the Law and Ethics bulletins that appear in The Pharmaceutical Journal are written by the pharmacist advisers. As with the Controlled Drug example given above, some of the topics relate to recently enacted legislation. Others reflect the types of queries being received. On occasion they may be drafted as a result of one of the Society’s disciplinary hearings.

Team member Joanne Anokwuru says: “Law and Ethics Bulletins may advise on recent changes in legislation or serve as reminders to pharmacists about good practice issues that may have been highlighted by a complaint to the Society. When writing an LEB, the accuracy and accessibility of information is essential. They are featured in The Pharmaceutical Journal to provide guidance to pharmacists. Past LEBs can provide a good learning tool and resource. Those published since 2001 can be easily accessed at PJ Online (www.pjonline.com/lawandethics).”