Guidance document

Consultation on SOPs for dispensing

In February, 1999, the Council of the Royal Pharmaceutical Society considered a report on skill mix in pharmacies and approved the introduction of a new policy that from January 1, 2005, pharmacists would be required to put in place and operate written standard operating procedures (SOPs) covering the dispensing process. This was to be part of a process to support clinical governance in the pharmacy setting and would apply to both the hospital and community sectors.

The Society has subsequently worked closely with representatives of major pharmacy bodies on preparing guidance for pharmacists on developing and implementing SOPs for dispensing. The document has been developed through the Science, Technology and Mathematics National Training Organisation's pharmacy sector committee, on which the major employers of pharmacists and support staff throughout Britain are represented.

The Society is now seeking views on the guidance document, which is reproduced in full below. While inviting comment on all sections of the document, the Council wishes to draw particular attention to Section 5(v) which covers the checking procedure following the assembly and labelling of prescriptions. The section relates only to procedures for accuracy checking by trained and competent staff and not to the professional check undertaken by pharmacists. The text of Section 5(v) reflects the Council's current policy that self-checking by non-pharmacists is not recommended. However, the Council believes that this policy needs to change to recognise the fact that a technician who has been trained and accredited for the accuracy checking task would be as competent as the pharmacist. Such a change in policy, the Council suggests, would allow the profession to move forward by permitting increased use of appropriately trained staff.

Copies of the document have already been sent to other national pharmacy organisations, major employers in pharmacy, the Society's branch and regional secretaries and local pharmaceutical committee secretaries (and their Welsh equivalents).

Comments should be addressed to Janet Flint, Practice Division, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (fax 020 7582 3401; e-mail jflint@rpsgb.org.uk), and should arrive by Monday July 2, at the latest.

Developing and implementing standard operating procedures for dispensing
Content of an SOP
Outline for preparing SOPs
Guidance on writing SOPs
Areas of the dispensing process to be covered by SOPs
Conclusion
Further sources of information on writing SOPs

Developing and implementing standard operating procedures for dispensing

From January 1, 2005, the Royal Pharmaceutical Society is to introduce a requirement for pharmacists to put in place and operate written standard operating procedures (SOPs) within individual pharmacies covering the dispensing process and the transfer of prescribed items to patients. The requirement will apply to both the hospital sector and the community sector and will cover all of the activities that 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.

This document sets out the areas of the dispensing process for which SOPs will be required and provides guidance on how to write them.

Why the requirement is being introduced To comply with clinical governance requirements, health care professions are being required to put in place strategies for risk management and risk minimisation. The Society's requirement is part of a process of assuring clinical governance in the pharmacy setting. Pharmacists will continue to be accountable for the dispensing process, but in developing and working to SOPs they will be able to examine/benchmark current practice and ensure that systems of practice operating within pharmacies are safe. SOPs should allow for the continual improvement of standards of service and provide evidence of commitment to protecting patients. In addition, changes in legislation arising from the Health Act 1999 may lead to the establishment of procedures for regulating those working in support of a profession and SOPs will go some way to address this.

For all of the reasons outlined above, it is recommended that pharmacists write and implement SOPs ahead of the requirement to do so in 2005.

What is a standard operating procedure? Although most hospital and industrial pharmacists, and some community pharmacists, particularly those who work for multiples, will be familiar with SOPs, for many the concept will be new. Quite simply, a standard operating procedure specifies in writing what should be done, when, where and by whom.

Benefits of SOPs

• SOPs help to assure the quality of the service
• SOPs help to ensure that good practice is achieved at all times
• SOPs enable pharmacists to delegate and may free up time for other activities
• SOPs help to avoid confusion over who does what (role clarification)
• SOPs provide advice and guidance to locums and part-time staff
• SOPs are useful tools for training new members of staff
• SOPs provide a contribution to the audit process

Delegation of tasks While the pharmacist in charge of a pharmacy will always be accountable for the dispensing process, it is current practice in the majority of pharmacies for pharmacists to delegate parts of the process to others. The extent to which tasks are delegated will depend on sector of practice, the workload, nature of the pharmacy and, most importantly, the qualifications and capabilities of the staff.

In future, pharmacists will be required to document within their SOPs those tasks that can be delegated and to which staff. This process will provide an opportunity to clarify roles within the pharmacy. Staff will be clearer as to when they should refer to the pharmacist, and be more aware of the limits of their own competence.

Those pharmacists who employ competent support staff will be able to use SOPs to safely delegate the technical aspects of the dispensing process, potentially freeing up time for the development and provision of additional services as envisaged in “Pharmacy in the future”*.

* Pharmacy in the future: implementing the NHS plan. A programme for pharmacy in the National Health Service. Department of Health, September, 2000.

NB. Additional training for responsibilities which extend beyond core training and competencies must be considered.

Other related initiatives It is Council policy that from January 1, 2005, all staff within a pharmacy who are involved in dispensing activities (ie, in the assembly of a prescription, including the generation of labels) will need to be competent to a minimum standard (or be undertaking training in this respect). This is additional to the requirement for SOPs. A new qualification for dispensing assistants in community and hospital pharmacies (assistant technical officers in hospital pharmacies) is being developed. The new qualification is of a different standard to existing higher-level qualifications for pharmacy technicians.

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Content of an SOP

All pharmacies operate differently, and SOPs will need to reflect this. However, some general principles will apply. SOPs should be:

• Pharmacy specific
• Dependent on the competence of the staff working in that pharmacy
• Applicable at all times, ie, not dependent on the presence of the pharmacist under whose authority the procedure was prepared

The Society has not produced example SOPs to accompany this guidance since there is no single template that can be applied to all pharmacies.

SOPs should cover all aspects of the dispensing process, including the delivery of the medicine or product to the patient, and must comply with professional requirements applying to the dispensing process as set out in the Code of Ethics. The added value of the pharmaceutical service, ie, the pharmacist's professional input into the assessment of the safety and appropriateness of a prescription and in the provision of information and counselling when completed prescriptions are transferred to patients, should be explicit. SOPs should define the process and specify which activities must carried out personally by a pharmacist, including the pharmaceutical assessment*, which activities can be delegated to identified competent support staff and how the checks for accuracy are to be carried out. It is good practice for SOPs to incorporate an audit trail so that the pharmacist can determine who is responsible for each aspect of the process.

* The pharmaceutical assessment has been defined as the point at which pharmacists apply their knowledge to establish the safety, quality, efficacy and perhaps cost-effective use of drug treatments specified by a prescriber

The professional judgment of the pharmacist in charge must remain paramount. SOPs should help to ensure that procedures recommended by the pharmacist are followed at all times. Their introduction provides an opportunity for pharmacists to define and assess their own practice, to communicate this to staff and help to improve team-working within the pharmacy.

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Outline for preparing SOPs

For each procedure, the pharmacist should think about the following:

Objectives What is the procedure trying to achieve?

Scope What areas of work are to be covered by the procedure?

Stages of the process Describe how the task is to be carried out.

Responsibility Who is responsible for carrying out each stage of the process: (1) under normal operating conditions? (2) in different circumstances, eg, when staff are sick/on holiday, etc?

Other useful information Is there any other information you think could usefully be included in the procedure? Does the SOP incorporate mechanisms for audit?

Review How are you going to ensure that the procedure continues to be useful, relevant and up to date?

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Guidance on writing SOPs

For convenience, the guidance is set out under seven headings:

• Receipt of the prescription
• Assessment of the prescription for validity, safety and clinical appropriateness
• Making interventions and problem solving
• Assembly and labelling of required medicine or product
• Checking procedure
• Transfer of the medicine or product to the patient
• Record keeping and completion of documentation

It is suggested that, as a minimum, SOPs are drafted to cover all of these areas. Where appropriate, the seven areas can be broken down further. All SOPs should specify an order of events applicable under normal operating conditions (recognising that, within the province of the pharmacist, these may change). Processes may be grouped under different headings if it is believed that this will better reflect the circumstances operating within a particular pharmacy. Account should be taken of variables, such as sickness, holidays, volume of work and resources available.

Who should write them? While accountability for a SOP will always rest with the pharmacist, it is good practice to involve staff in drafting them. Large organisations may have a central function in this.

Layout SOPs can be drafted in many different formats e.g. algorithm-based, bulleted points or as detailed information. It may be useful to incorporate references to other material such as “in-house” documents, manuals, reference books or computer based information, within the SOP. A reference numbering system may be used.

Keeping SOPs up to date SOPs should be clearly marked with the date of preparation and/or date of review/amendment. They should be kept up to date and relevant at all times and should be regularly reviewed to allow for changes in practice or circumstances, for example, legislative changes or changes of staff. In the absence of any obvious changes, reviews should be undertaken at least once a year.

When SOPs are first drafted, or when new members of staff are appointed, it is good practice to ask staff to sign to say they have read and understood them. As well as clarifying staff roles, this can also offer an opportunity for staff training and development. Pharmacists should ensure that any changes to SOPs are brought to the attention of relevant staff.

Guidance to locums and other pharmacists on following SOPs prepared under the authority of another pharmacist The pharmacist should specify within each SOP an appropriate level of responsibility for each member of staff involved in the dispensing process. This should be based on an assessment of each person's competence and level of qualification. In the absence of the pharmacist under whose authority the SOP has been prepared, pharmacists should not increase the responsibility of a member of staff they are not familiar with. For example, it would not be appropriate to ask someone to prepare labels if this is not something that they normally do. It would, however, be appropriate to decrease the responsibility of an unfamiliar member of staff if this is considered necessary and appropriate. It is good practice to report any concerns arising when following a procedure authorised by another pharmacist.

Monitoring incidents Monitoring incidents occurring during the dispensing process, ie, all errors identified, not just those that reach the patient, is a useful means of reviewing procedures and identifying any that may need modifying. It is also a useful way of monitoring individual capabilities and identifying training requirements. Pharmacists should consider implementing a separate procedure for incident monitoring. Audit packs on monitoring and evaluating dispensing errors are available from the Society's audit development fellow or from the audit website www.rpsgb.org.uk/audhome.htm.

Non-conformance There may be exceptional circumstances where it is necessary or appropriate to work outside a SOP, eg, in the event of computer breakdown. Incidences of non-conformance with a SOP should always be documented. In some cases it may be possible to anticipate situations where changed circumstances will apply. These should be reflected within the SOPs.

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Areas of the dispensing process to be covered by SOPs

This part of the document is set out in a conventional order. The order of events within a SOP should reflect the operating practices within the pharmacy.

The following principles apply to all stages of the dispensing process and should be taken into consideration when drafting SOPs:

• Patient confidentiality must be maintained at all times
• Appropriate information must be provided to the patient or the patient's representative and, where possible, understanding of this information should be checked
• When necessary applicable reference sources should be used, eg, Drug Tariff on contractual issues, “Medicines, ethics and practice” for legal or ethical queries

5(i) Receipt of the prescription

The SOP should ensure that when prescriptions are received:

• Patient details are checked and confirmed
• Prescription charges are collected promptly and correctly or patient exemptions are checked, as applicable
• The prescription is passed on for pharmaceutical assessment and assembly

Notes

1. The conventional method of receiving prescriptions is where a patient or representative brings a prescription to the pharmacy, but this will not always apply. Prescriptions may be telephoned through by a GP or the pharmacy may offer a prescription collection service. Any member of the multidisciplinary team might be involved, particularly in the hospital sector where prescriptions may be forwarded to the pharmacy electronically or by fax. Electronic transfer of prescriptions within the community sector is likely to occur in the future. Regardless of the way in which a prescription it is presented, the principles for processing remain the same. The SOP should specify how each method of receipt should be dealt with.

5(ii) Assessment of the prescription for validity, safety and clinical appropriateness

The SOP should ensure that when prescriptions are assessed for safety and clinical appropriateness the following areas are covered, if known:

• Assessment of whether the prescription is legally valid
• Assessment of whether the prescription includes an appropriate dosage form and appropriate route of administration
• Where parts of the assessment have been delegated to competent dispensary staff, relevant information should be brought to the attention of the pharmacist
• Appropriateness according to patient's condition
• Dosage within therapeutic range
• Appropriateness according to patient's parameters (age, weight, etc) and previous medication. This is particularly important for treatments with a narrow therapeutic index, oncology preparations, or for babies and young children
• Compatibility with other medication
• Consistency with formularies, clinical guidelines and protocols (including shared care protocols, patient group directions)
• Possible side effects
• Risk of adverse drug reactions
• Potential for non-concordance, inappropriate use and misuse by patient
• Contra-indications

Notes

1. It is recognised that, in different environments, different levels of information are available.

2. In a hospital setting, the pharmaceutical assessment of the prescription may occur at the point of receipt by the pharmacist before the prescription is assembled by dispensing staff. In the community, dispensing staff or counter assistants may receive the prescription and undertake an initial assessment before the prescription is passed on for assembly with the remaining assessment undertaken by the pharmacist.

3. Information from various sources may enable the pharmacist to assess the prescription, for example, information obtained from ward rounds, the patient, the patient medication record (PMR).

5(iii) Interventions and problem solving

A procedure for dealing with interventions should be specified, as should circumstances in which other members of staff may perform certain tasks, for example, to clarify details with a prescriber, and at what stage this should occur, ie, before or after discussion with the pharmacist. SOPs should also include procedures for liaison with other health professionals and/or patients as appropriate.

Notes

1. Recording details of interventions on a PMR system is recommended wherever possible and practical.

5(iv) Assembly and labelling of required medicine or product

The SOP should ensure that when prescriptions are assembled:

• The medicine or product matches the prescription and is in date
• It is assembled using correct equipment and processes
• It is packed and labelled appropriately
• Appropriate records are made
• Health, hygiene and safety procedures are followed at all times

Notes

1. Relabelling or additional labelling of existing supplies, eg, at ward level in hospital requires specific training and a separate SOP.

2. The SOP should enable pharmacists to review the actual processing of prescriptions, to ensure that there is a logical workflow appropriate to the staff and premises. By tackling each element in isolation, pharmacists can ensure safe systems of working. Consideration should be given within the SOP to error minimisation, for example, not dispensing from labels, and to the level of competence of those staff permitted to produce labels.

Other issues Other issues which pharmacists may wish to address within the SOP include:

• Label generation
• The use of child resistant containers
• Appropriate packaging, for example, re-packaging of parallel import packs
• Inclusion of the appropriate patient information leaflet
• Recording interventions
• Queries from other health care professionals
• Expiry dates

Extemporaneous dispensing The SOP should ensure that the requirements of the Society's Code of Ethics in relation to extemporaneous dispensing are met and that, in addition:

• A risk assessment is carried out before the commencement of any extemporaneous process. This should include consideration of the time elapsed since the person making the preparation last performed this operation
• The intended method of preparation is correct
• Wherever possible, ingredients and quantities should be checked by another person
• A visual check of the ingredients and the final product is undertaken as part of the process

Notes

1. Organisations may decide to have a separate SOP covering extemporaneous dispensing.

2. If the final product requires the extemporaneous preparation to be made in various stages, then each of these stages should be recorded.

5(v) Checking procedure

• There should be an accuracy check within the procedure
• Additional training and competence assessment is required to assure appropriate checking
• The SOP should be clear about which persons are competent and authorised to check
• Wherever possible the check should be undertaken by a second person
• Self-checking by non-pharmacists is not recommended

Notes

1. Accuracy checking is covered within the preregistration competencies and performance standards, but the current Business and Technician Education Council and Scottish/National Vocational Qualifications Level 3 qualifications for pharmacy technicians do not cover this task.

5(vi) Transfer of the medicine or product to the patient

The SOP should ensure that when completed prescriptions are transferred to the patient:

• Completed prescriptions are received by the correct person
• Appropriate information is provided to the patient or the patient's representative and, where possible, understanding of this information is checked
• Compliance aids (eg, spoons and syringes) are provided where appropriate
• The Society's standards for delivery of medicines are maintained
• Provision is made for transfer of dispensed items to patients' representatives

Notes

1. The SOP may stipulate which members of staff are able to give dispensed products and medicines to patients, in circumstances where this is deemed to be appropriate. The SOP should specify circumstances in which the pharmacist should be personally involved.

2. Pharmacists may wish to consider outlining within the SOP, circumstances under which it is not always necessary to discuss the medication or product with the person to whom it is transferred, eg, where the person collecting the prescription is not the patient.

3. If a patient has been taking the medication/using the product for a number of years provision of information may not be necessary but the patient should always be given the opportunity to ask questions. The use of open questions (eg, “Is there anything you would like to know about your medicines?”) should be advocated.

5(vii) Record keeping and completion of documentation

The SOP should ensure that:

• Necessary documentation is completed
• Legal and professional requirements for record keeping and records management are upheld

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Conclusion

The introduction of SOPs will bring many benefits. The process of preparing SOPs is not onerous and will help pharmacists to assess their current ways of working and make better use of support staff. SOPs provide an opportunity to demonstrate professionalism, professional accountability and responsibility to Government, and go some way to tackling the issue of clinical governance within the pharmacy setting.

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Further sources of information on writing SOPs

The following is not an exhaustive list and will be added to as further sources of information become available.

• Continuing education packages such as the Welsh Centre for Postgraduate Pharmaceutical Education SWEEP package* offer guidance on writing and implementing SOPs.
• International quality management standards (eg, BS EN ISO 9000:2000: Quality management systems. Fundamentals and vocabulary)

*The SWEEP programme was commissioned and funded by the then Welsh Office and prepared by Sheila Phillips, senior research associate, Welsh Centre for Postgraduate Pharmaeutical Education

Specific reading

1. Phillips S, Temple DJ. Writing a protocol. Pharm J 1994;253:570.
2. Phillips S, Temple DJ. Quality assurance and professional audit in community pharmacy. Pharm J 1992;251:208.

Acknowledgments
The guidance on how to write and implement standard operating procedures was overseen by the ST&M NTO pharmacy sector committee. It incorporates intellectual material from the WCPPE SWEEP package (see section 7 above). The following individuals were also involved in the development of the guidance: Ailsa Benson (head of training, National Pharmaceutical Association); Helen Baker (marketing and operations development manager, dispensing, Boots Co); Peter Curphey (member of the Society's Council; Chris Barrass (chief pharmacist, King's College Hospital, London); Kay Buttars (chief technician/pharmacy operations manager, Addenbrookes Hospital, Cambridge); Helen Darracott (head of ethics, Professional Standards Directorate, the Society; Dale McVeigh (area manager, Weldricks Pharmacy); Jo Martin (community pharmacist, Lloyds Pharmacy); Sheila Phillips (senior research associate, Welsh Centre for Postgraduate Pharmacy Education); Michelle Styles (head of information, NPA); Barbara Wensworth (Bradford Community College). Secretariat: Janet Flint and Jane Lapon (practice division, the Society).

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