The Pharmaceutical Journal
Vol 273 No 7319 p460-461
2 October 2004

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Standard operating procedures: time to knuckle down and get writing

The deadline of 1 January 2005 for having mandatory standard operating procedures for dispensing in place in individual pharmacies is looming. Should pharmacists be worried if they have not got their act together yet? Zoë Gross investigates

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With only three months to go before the Royal Pharmaceutical Society introduces its requirement for pharmacists to implement, within individual pharmacies, written standard operating procedures (SOPs) covering the dispensing process, pharmacists are being advised to knuckle down.

In its guidance to pharmacists (see “Medicines, ethics and practice”, no 28, p99), the Society recommends that pharmacists should develop and implement SOPs ahead of the requirement to do so in 2005. It also states that the requirement will apply to both hospital and community sectors and that the SOPs that pharmacists should be putting in place and operating “will cover all of the activities which occur from the time that prescriptions are received in the pharmacy, or by a pharmacist, until medicines or other prescribed items have been collected or transferred to the patient”.

There are a number of different sources where pharmacists can get assistance with writing their SOPs, if they have not done so already. Even if they do have them in place, pharmacists are advised to review their SOPs regularly.

Start thinking now

“Everyone should have by now thought about SOPs,” says Gill Hawksworth, the Society’s Immediate Past President. She says that “2005 is going to be a busy year with SOPs, continuing professional development and staff training issues all being introduced by the Society. So it is best to start thinking now if pharmacists have not done so already.”

Ross Groves, community pharmacy consultant, is in the process of looking into what stage pharmacists have reached in terms of having SOPs in place. This work is being carried out on behalf of the Society. Mr Groves comments that even if we know how many pharmacists have put SOPs in place, we still need to know of what standard the SOPs are.

He advises pharmacists not to be frightened of implementing SOPs and says that three months is long enough to develop SOPs, particularly if a template is used. However, Mr Groves says: “There appears to be a degree of misconception and confusion about SOPs. Individual pharmacists seem to be unsure about their direct relevance to day-to-day pharmaceutical practice. This may be because large companies have produced SOPs from head office.” He adds that whether or not these SOPs are being adapted for individual practices is unclear.

He also raises the question of whether locum pharmacists should in fact have their own SOPs, so as to prove that they have considered how to fit their professionalism into the running of any community pharmacy where they provide cover.

Paula Hayes, pharmacy technician development co-ordinator, Centre for Pharmacy Postgraduate Education, says that “many pharmacists and their staff have already taken the steps necessary to have well written SOPs in their pharmacy and all team members should work to these standards at all times”. However, there are others who have not yet made this move forward. Reasons for this will vary and may include lack of awareness, knowledge or understanding of the processes and insufficient time, she says.

The CPPEs offer the SWEEP open learning programme for pharmacists — originally developed by the Welsh Centre for Postgraduate Pharmaceutical Education (PJ, 1 May 2001, p615). The CPPE is now in the process of piloting a learning programme that covers SOPs for pharmacy technicians working in all areas of pharmacy. The programme is expected to be rolled out nationally later this year and is aimed at pharmacists and technicians working together to produce SOPs.

Matthew Shaw, assistant director, CPPE, comments on the technicians’ programme: “Our intention is to support the development of the pharmacy-based team. One of the most rewarding outcomes from the first pilot session, held in Norfolk, was to see how the confidence of pharmacy technicians grew as they worked with their pharmacists in designing a SOP that would be useful for everyone back in practice.”

Last year, the National Pharmaceutical Association produced a guide to SOPs (PJ, 4 October 2003, p443). Michelle Styles, head of information services at the NPA, says that the pack has been extremely popular. Five and a half thousand packs have been sent out and a further 2,000 copies have now been ordered. She comments: “We have made it as easy as possible. If you work through the pack it will not take that long. We have divided it into six steps along the Society’s guidelines and we reckon it would probably take about a maximum of half a day per step, probably less, to write an SOP.” The NPA advises that after members have written their SOPs they should get someone to follow what they have written to check that it has worked. “Nine times out of 10 you will have missed out a step or put something in the wrong order or it will not be quite right,” Mrs Styles says.

The NPA also advises that, although there is still time to put SOPs in place, pharmacists should do so as soon as they possibly can. Mrs Styles says: “I do not think you need to be worried yet if you do not have [SOPs] in place, but I do think you need to be taking steps to put them in place.” She adds that in addition to meeting the Society’s requirements, one of the requirements of the new pharmacy contract is likely to be to have SOPs in place.

The NPA is in the process of producing draft SOPs, along the lines of the ones in the current pack, for other services such as instalment dispensing, consumption of methadone, needle exchange, collection and delivery services and repeat dispensing. These are expected to be made available later this year and early next year.

Earlier this year, UniChem launched a template on CD-ROM to help pharmacists develop their own SOPs. The template has been sent to more than 3,000 customers. Alistair Marsh, head of pharmacy retail services at UniChem, says: “Feedback received to date from UniChem’s independent pharmacy consultative boards has been positive. A large proportion of pharmacists have expressed their support and relief at having a tool like UniChem’s template to help with the complicated, but essential, task of SOPs.” UniChem advises those pharmacists who have still to implement SOPs to ensure that they do so within the deadline. Mr Marsh adds: “UniChem is working with its pharmacy customers to ensure they implement these SOPs in time and the CD-ROM is an excellent tool to help them do so quickly and easily. UniChem continues to work with the pharmacy consultative boards to develop additional SOP templates for 2005.”

Nanette Kerr, head of the superintendent pharmacist’s office at Moss Pharmacy, comments on the implementation of SOPs at Moss: “At present, our regional practice pharmacists are using their annual audits of all branches to check implementation and compliance with SOPs. This is the important thing: SOPs are no use if they are just another folder on the dispensary shelf.” Ms Kerr adds: “We are constantly reviewing our SOPs in the light of suggestions from branches and changes in professional practice. SOPs have to be living documents, not set in stone.”

Moss Pharmacy tested its first SOPs in 14 of its branches during 2002. The SOPs were then released the following year in the form of templates to create SOPs from for the basic dispensing process and were made available for all branches to use. At the same time, a training pack was made available for pharmacists, accredited by the College of Pharmacy Practice for eight hours of continuing professional development. Ms Kerr says that the company has 40 more templates in development or on trial, covering all professional activities and services.

Focus on the task

Stephen Eastham, head of professional governance at Boots The Chemists, says that “producing SOPs can easily become a chore and a bureaucratic exercise” and “pharmacists should bear this in mind as they develop their own”. He advises: “To avoid generating large, unwieldy documents, pharmacists should ensure that the SOP focuses on the task and not on other information which may be good to know but which may not be essential for completion of the task.”

However, he comments: “While SOPs may be a new professional requirement, they are not necessarily new to all pharmacists. They are a useful means to improve quality and consistency of service and efficiency in the pharmacy. At Boots we have taken the opportunity to review our operating procedures and associated documentation with a view to improving the support they give to staff who have to use them. We have developed and tested a format that is simple to understand and use. We plan to replace our existing supporting documents with this new simpler version in the next few weeks.”

Do community pharmacists think three months is sufficient time for them to get their act together? According to community pharmacist Bob Rihal, three months should be adequate. However, pharmacists are going to have to “knuckle down”, he says. He adds that although pharmacists may have thought about SOPs and probably have ideas in terms of what to do to put them in place, there are probably still pharmacists who have not yet put them in place.

Mr Rihal comments: “Once you get started it is actually quite easy. The difficulty is getting started.” He suggests that pharmacists should speak to their local pharmaceutical committee or primary care trust if they are having difficulty getting started, or need help or support with SOPs.

Mr Rihal explains that, as an independent contractor, he has been involved in implementing SOPs in his pharmacies. “What we have used is the templates that were produced by Lambeth, Southwark and Lewisham LPC,” he says. The templates have been used as a flow chart and the pharmacist has filled in the gaps in the flow chart and then sent it back to the LPC for ratification.

So what advice does the Society have for its members? Sue Kilby, head of practice at the Society, advises that pharmacists who do not yet have SOPs in place covering the dispensing process, should “sit down and write them”. She says that the Society is, however, aware that although large multiples have been providing training for their staff on SOPs, “there is still a certain degree of confusion out in practice about how to produce them and what pharmacists need to be doing”.

When writing SOPs, pharmacists need to make sure that the SOP reflects what is happening in the pharmacy itself, she says. SOPs need to be in place to help effectively safeguard pharmacists so that they can be confident that practice is being delivered appropriately and effectively. Thus, SOPs, she says, should be “relevant to practice, realistic and not too complicated, and written in a way that people understand”.

She adds that once SOPs have been written, pharmacy managers need to inform staff that they are in place and check that staff are following them. Managers also need to make sure that SOPs are available to locums. Equally, locums need to make sure that they are aware of what SOPs are in place within the pharmacy they are working in.

Accommodate changes in practice

Mrs Kilby also advises that even if SOPs are already in place, as may be the case in the hospital pharmacy sector, they need to be reviewed to accommodate changes in practice. “The problem is that SOPs are not something you just write once. Most hospitals have got SOPs in place but they may need to be reviewed.” She adds that community pharmacists should also be aware that SOPs need to be reviewed periodically to check that they are still appropriate and that they do not need any modification.

So will the Society be sending the inspector round? Jackie Giltrow, the Society’s chief inspector, says: “From 1 January 2005 inspectors will carry out their routine visits as they normally do and, during the course of those visits, they will look to see whether there are SOPs in existence for the dispensing process.” If inspectors find that SOPs are not in place, they will try to help pharmacists by pointing them in the right direction for getting assistance with SOPs. For example, if the inspector is aware that the pharmacist is an NPA member, then he or she may direct the pharmacist to the NPA for help, she says.

The Society has not yet set a specific grace period following an inspection during which pharmacists will be required to put SOPs covering the dispensing process in place if they have not done so already. However, Mrs Giltrow says that routine visits are normally carried out every 18 to 24 months. She says that the Society would expect pharmacists to respond to the advice of the inspector for any mandatory requirement within a reasonable time period. She adds: “I expect if we receive any complaints of dispensing errors from pharmacies, then during the course of an investigation one of the things that an inspector would no doubt want to look for would be the dispensing SOP to see what the SOP says in relation to dispensing.”

In terms of advice for pharmacists implementing SOPs over the next three months, Mrs Giltrow says that the Society’s fitness to practise advisory service can give broad information on the content of SOPs. She comments: “If someone rings our fitness to practise advisory service and says they have not got a SOP in place, we would probably advise them to get cracking and point them in the right direction for assistance.”