For Jonathan
Although 2005 is almost 15 months away, pharmacists are being urged to make a start on writing standard operating procedures (SOPs). This will allow time for using the procedures to become second nature in their pharmacies.
The National Pharmaceutical Association is launching a training pack this month aimed at making sure its members are able to comply with the Royal Pharmaceutical Society’s requirements for SOPs. The pack consists of an introduction to writing SOPs and guidance on applying this to the six areas of the dispensing process set out by the Society. The pack has been developed in conjunction with GlaxoSmithKline’s +Plus programme and details of how to apply for the packs has been sent to NPA members. They can also request packs through a website (
www.npasops.co.uk).
The NPA’s guide to writing SOPs is now available to its members
Why are SOPs being introduced? In its guidance to pharmacists (‘Medicines, Ethics and Practice’, p99), the Royal Pharmaceutical Society says that SOPs form part of clinical governance. In particular, they show that pharmacists are putting in place strategies for risk management and harm minimisation. Reviewing SOPs will allow for a continual improvement in standards of service. Janet Flint was one of the Society’s practice pharmacists involved with working parties on developing SOPs (she is now project manager for support staff regulation). She says that the Society does not want to be prescriptive about how SOPs are written — “There are different ways and formats of doing it.” The main aim is to get pharmacy staff to write down what they do and, at the same time, to have an opportunity to review what they are doing.
The main benefits of SOPs are seen as ensuring that good practice is achieved at all times, clarifying who does what — with opportunities for pharmacists to delegate work and make the best use of support staff — and giving guidance for locums, part-time staff and new recruits.
For the purposes of SOPs, the Society breaks down the dispensing process into six steps, marking the natural flow of work, each of which will need an individual SOP:
• Taking in prescriptions
• Pharmaceutical assessment
• Interventions and problem-solving
• Assembly and labelling
• Accuracy checking
• Transfer to the patient
What should be in an SOP? Each SOP should have two main parts. Firstly, an outline or summary that includes descriptions of the aim or purpose of the SOP, its scope (what is or is not covered), when it should be reviewed and any known risks associated with the task in question. The second part is an accurate step-by-step description of how the task is carried out together with who is responsible for each step. This should also include guidance on what to do in case of changes in circumstance, such as holidays, sickness or computer failure.
The most important thing to note is that each SOP must be written specifically for the pharmacy to which it applies. Although multiples can write approved SOPs for adoption by their branches, there must be a mechanism for taking into account individual circumstances of location, staffing or the physical layout of a pharmacy. For this reason, independent pharmacies have an advantage in writing SOPs since they will be able to take these factors into account from the start.
Writing good SOPs
SOPs in hospitals as well as the community
The Royal Pharmaceutical Society’s requirement for written standard operating procedures for dispensing also applies to hospital pharmacies. However, Chris Barrass, director of pharmacy at King’s College Hospital NHS Trust, London, says that the use of SOPs is already well established in the hospital sector.
“New staff starting at King’s College Hospital are given a pack of around 30 procedures to read on their first day,” he says. These cover a range of subjects, including dispensing, handling Controlled Drugs, providing clinical pharmacy services and medicines information, as well as alarm procedures and other general guidance for staff.
The SOP should be written by the pharmacist in charge of the pharmacy or the superintendent pharmacist. However, it is a good idea to involve pharmacy staff in reading and commenting on SOPs so that they are happy to use them. Getting staff who are involved in specialist tasks to do the first draft of procedures can help, especially if the pharmacist does not have much experience in that area.
Lorraine Treeves-Brown is clinical governance facilitator for Stockport Primary Care Trust. She has been involved with writing SOPs as a pharmacy manager for a national multiple and in reviewing them as part of the PCT’s “Going for gold” pharmacy accreditation scheme (PJ, 31 August 2002, p274).
“Bad SOPs are wordy and complicated,” she says. “Don’t use lots of words if short sentences will do the trick.” Vague SOPs are bad SOPs. “You have to say what is covered by each one. If there are exceptions, say what they are and what to do instead.”
When writing the step-by-step parts of an SOP these can be described as a numbered list or by using flow charts. “Flow charts are good.”
One decision that has to be taken locally is whether to name responsible staff individually in an SOP or whether to use job titles (ie, “dispenser”, “counter assistant”).
“Job descriptions can be used if there is a high turnover of staff but it can be useful for locums to know who people are so I name them in SOPs,” Mrs Treeves-Brown says. However, the downside of this is that SOPs will need to be amended each time a member of staff leaves.
Dr Gill Hawksworth, President of the Society, wrote a large number of SOPs for the pharmacy she formerly owned in Mirfield, West Yorkshire. She says that the SOP has to match the layout and workflow within the pharmacy.
“For example, checking the stock availability of a product when a prescription is handed in, and telling the patient whether they will have to wait or come back later, is good. But whether this check is carried out by a medicines counter assistant, the dispenser or the pharmacist will depend on the layout of the pharmacy,” she advises.
In her pharmacy, Dr Hawksworth kept copies of all the SOPs in a clinical governance folder, together with other information about the running of the store. She also gave copies of relevant SOPs to her staff.
Moss Pharmacy implemented a first wave of SOPs, covering the six dispensing steps, earlier this year following trials in a small number of branches last year. The head office sends out templates representing best practice for each branch to adopt. Branches use the templates to specify, for each pharmacy, how each task is to be done, which member of staff is responsible and what level of training the person performing the task must have. The SOPs make a lot of use of flow charts. They are also available through the company’s intranet.
Nanette Kerr, head of the pharmacy superintendent’s office at Moss, explains that branches can opt out of the recommended SOPs if there is a specific local reason for this. “In order to do this, they have to explain why they want to opt out. Then they have to put together a specific SOP to replace the recommended one and this has to be approved by the area manager and the clinical governance manager at head office.” One area where opting out has been approved is for Moss pharmacies situated in doctors’ surgeries. Normally, a docket system is used when prescriptions are handed in. In surgeries, where most patients wait for their prescriptions to be dispensed rather than return later, the docket system has proved cumbersome and, as a result, some branches have opted out of it.
Mrs Kerr says that the company has received a lot of positive feedback about its SOPs, both from its own staff and from locums. A second wave of SOPs, covering extemporaneous dispensing and specials, returned medicines, dealing with dispensing incidents and customer complaints, and the supply of strychnine, has been issued to branches. They have until November to implement these or request opt-outs.
Help with SOPs
For pharmacies that are not being supplied with templates from head office, there are other sources of advice on writing SOPs.
As mentioned, the Society’s ‘Medicines, Ethics and Practice’ guide contains information on writing SOPs for the six dispensing steps (pp99–104). This is also available on the Society’s website (PDF 40K).
The Centre for Pharmacy Postgraduate Education has a multimedia distance learning pack called SWEEP which covers writing SOPs. (The pack was originally written by the Welsh Centre for Postgraduate Pharmaceutical Education with support from the Welsh Office.) It comes with a training guide, three CD-ROMs and a procedures folder to put the completed SOPs in, and requires access to a personal computer with sound facilities. The training consists of a variety of written exercises supported by video clips, mostly filmed in pharmacies. The SWEEP pack is aimed at helping pharmacists write procedures for a variety of tasks within their pharmacies, not just dispensing (PJ, 5 May 2001, p615).
Other pharmacy groups may also be able to help their members with writing SOPs. Numark says that while it is not issuing specific guidance to its members, most of whom are NPA members, it is carrying out research, using hidden cameras and mystery shoppers, into areas of pharmacy work that may cause concern and for which writing SOPs may help.
“This initial work has helped us begin to better understand the workflow and responsibilities within pharmacy. As a result we are looking to expand this research further and carry out similar trials in other pharmacies within Numark with a view to distilling the elements of good practice into something that can be used by our members in the development of their own SOPs,” the company says.
SOPs and more SOPs
Those who have already been involved in writing SOPs say that the process is not as daunting as it might seem at first. Mrs Treeves-Brown says: “Doing an SOP is about writing down what is done, step-by-step, and who does it.” She adds that pharmacists may then find that they do not actually want to do things in the way they have initially described.
Once an SOP has been drafted, it should be discussed with the staff who are going to have to work with it. Staff should be asked to sign that they have read and understood the SOP and that they will work in the way described. The SOP should then have a trial period of between one and three months after which it should be reviewed to check that it is workable and that it is not creating any new errors.
SOPs should be reviewed at least annually after this and the review date should be stated on the document. SOPs should also be reviewed after any serious dispensing incidents and after any changes in legislation, the Society’s Code of Ethics or internal company policies.
Writing SOPs can be habit forming. Once the basic dispensing process has been covered, most pharmacists will want to go on to write procedures for other areas. As well as the topics covered by Moss Pharmacy in its second wave, these could include dispensing methadone or other items for drug users, providing services to nursing or residential care homes, prescription collection and delivery services or telephone requests for prescriptions, for example. That is why it is best to get started now.
Writing and implementing SOPs can be fun
To the surprise of some participants at a session at the British Pharmaceutical Conference last month, the writing and implementing of standing operating procedures was said to be fun. This admission, by Steve Eastham, head of clinical governance for Boots The Chemists, was supported by other speakers and commentators from the floor.
To many pharmacists, at first glance, SOP writing seems a daunting process. Mr Eastham explained that if the process is broken down into different stages, it makes the writing and implementation a great deal easier. He recommended that one of the first things to do is to define the journey through the pharmacy for patients and their prescriptions.
If this is followed up by a risk assessment of each stage, a management plan can be developed which encompasses ethical and legal issues. Armed with this information it is much easier to write the SOPs.
In Mr Eastham’s experience, before the SOPs can be implemented it is important to have staff training and determine their development needs. It is also important to ensure that good clinical governance precepts are embedded in all the practices of the pharmacy.
