Medicines are traditionally supplied and/or administered according to a prescription for a named individual written by a prescriber. However, there are instances of administering medicines, according to a written direction from a doctor, for groups of patients in the absence of a prescription for each named patient. Such a direction is not entirely consistent with the Medicines Act 1968 and raises the question of whether or not it is legal.
As a consequence, and as a result of other anomalous circumstances relating to the prescribing, supply and administration of medicines, the Minister for Health convened a group to review the situation in the UK. A requirement of the brief was to produce and submit to ministers an interim report making recommendations on the use of group protocols for the supply and administration of medicines.
The interim report1 was published in March 1998, subsequent to which health authorities in England were requested to implement the findings of the report in respect of Group Protocols HSC 1998/051.2
The report defined a group protocol as a specific written instruction for the supply or administration of named medicines in an identified clinical .ituation. It is drawn up locally by doctors, pharmacists and other appropriate professionals, and approved by the employer (e.g. hospital trust, PCG/T), advised by the relevant advisory committee (e.g. drugs & therapeutics/medicines management).
It applies to groups of patients or other service users who may not be individually identified before presenting for treatment.
This project was established at Hope Hospital, Salford, in order to provide a central resource of information and expertise to support the successful development and implementation of group protocols following the Crown Report guidelines.1
The purpose of the project was to establish and deliver a programme that would:
- Develop multidisciplinary working to determine treatment pathways as specified in patient group directions (PGDs) formerly known as group prescribing protocols and renamed patient group directions by the Medicines Control Agency
- Ensure an evidence-based approach to PGDs
- Ensure that supply and administration of medicines by practitioners occurred in an appropriate legal framework
- Ensure that the above were done in the best interests of patient care and in support of the clinical governance agenda.
These objectives were to be achieved by:
- Developing a multidisciplinary steering group to plan the introduction of PGDs on behalf of the Salford Royal Hospitals advisory group, i.e. Medicines Management Advisory Group (MMAG)
- Providing professional support to practitioners in both primary and secondary care
- Establishing an interactive database comprising a broad range of PGDs
- Providing internet access to this database to promote quality and efficiency and provide a national lead.
A multidisciplinary steering group including pharmacists, nurses, midwives and radiographers was convened to plan the approach to PGDs and advise the MMAG.
The group adopted the following approach:
- Publication of a PGD template comprising all the clinical and organisational recommendations of the Crown Report
- Promote prescriptions for named individuals as the norm and PGDs as the exception
- Identify areas where patients would benefit the most from a PGD and develop a team of doctor, pharmacist and other health professional to produce the PGD
- Publish the PGDs on the hospital intranet as models of good practice.
- Develop an interactive database on the internet to publish PGDs from the NW Region, enabling people to search for, submit and retrieve approved PGDs.
Numerous meetings of health professionals were organised to discuss the need and appropriate use of PGDs to benefit patients in podiatry, diabetes, dermatology and emergency medicine. These developed to include endoscopy clinics, genitourinary medicine, occupational health, laser clinics and obstetrics.
Specific problems addressed by the steering group related to the Crown Review Team statement that certain classes of drugs should not normally be included in a group protocol.
Current practice already included the use of 'black triangle' drugs for which the MCA requires reporting of all adverse drug reactions. The dilemma faced by the steering group was whether to cease using such a drug in the absence of a prescription for a named individual, or to allow the drug to be included in the protocol.
Group members felt that it was impractical to provide the same level of service to the patient if an individual prescription had to be obtained, and were mindful of the Crown Report recommendation that good service developments should not be compromised, albeit in a different context. It was considered wise to include every drug used within a broad treatment plan in the protocol to ensure consistency.
In addition, this would enable practitioners who might subsequently seek independent or dependent prescriber status to gain the experience of working to PGDs that embraced the total treatment plan as a training experience.
Legal advice was sought on the inclusion of drugs that the Crown Report stated 'should not normally be included'. The advice given was that there would have to be an extremely good reason, e.g. significant advantages for patient care, for including such a drug and as much authoritative support for doing so as possible. The protocol would have to be drafted extremely tightly giving the absolute minimum of discretion in the supply of the drug. It would not be possible to fall back on the Crown Report if challenged.
The steering group also considered the need for controlled drugs (CDs) to be included in PGDs and acknowledged that it would be difficult to comply with the requirements of the Misuse of Drugs Regulations 1985. However, there was an overwhelming consensus that benefits to patient care would be lost in certain circumstances if CDs had to be administered on every occasion in response to a prescription for a named patient.
In particular, nurses working within a pain control team need to be able to adjust doses of opioid analgesia or change routes of administration in accordance with a broad treatment plan or PGD to maintain control of analgesia.
A review of the Misuse of Drugs Act 1985 is now needed to bring the benefits to patients that the Crown Review of Prescribing Supply and Administration of the Medicines Act 1968 is currently achieving.
The MMAG at Hope Hospital, Salford, requires each PGD to be submitted with supporting statements specifying:
- It was not possible to obtain a prescription for a named individual
- Whether the PGD represented current practice, extension to current practice or a new practice
- Benefits to patients, e.g. improved access to treatment, reduced waiting times, speedier discharge from hospital.
This information emphasises that the PGD is not a substitute for a prescription where one could be obtained, identifies the reasons for adopting the PGD and the rate at which it is being adopted, and ensures that benefits for patients are identified.
Before a PGD is approved, the MMAG requires:
- Approval by the clinical director, executive or head nurse, and director of pharmacy
- Approval by a consultant in the same specialty for peer review
- If the drug is an antibiotic, approval by the consultant microbiologist, accompanied by a medical management plan.
On approval, the Group specifies that an audit of practice utilising PGDs should be conducted at 6 months and thereafter at 12-monthly intervals, and the results presented to the MMAG. The purpose of this is to ensure that PGDs are not only introduced for the correct reasons but also deliver the intended benefits to patients.
The local secondary care trusts and primary care groups (PCGs) were contacted to raise awareness of the project. Publicity identified ways in which support could be provided and was followed up with a series of formal lectures and short presentations, which generated a great deal of interest locally, regionally and nationally.
Practitioners were encouraged to audit practice and identify instances of medicines being administered without a prescription for a named individual.
If it was not possible to obtain a prescription, multidisciplinary discussions were proposed to determine the need for a protocol, facilitated by the provision of information on the criteria for PGDs, the necessary benefits to patients, and the clinical and organisational components of a PGD. Relevant approved PGDs in use elsewhere were reviewed to assess the feasibility of adapting them for local use.
An audit within one PCG showed that while many practitioners in individual practices felt isolated and had neither the time nor expertise to produce protocols, they all had a need for PGDs. This suggested that an interactive centralised database could be beneficial.
Following publication of the Crown Report,1 chief pharmaceutical officers, directors of pharmacy and pharmaceutical advisers had been given the task of raising awareness of the importance of group protocols by the NHS(E) North West. This involved:
- Identification and review of all protocols currently in operation in each secondary care trust and primary care setting
- Identification of all areas where protocols are necessary but do not exist
- Development of a protocol template for new PGDs
- Establishing an approval mechanism for PGDs.
Chief pharmacists and HA pharmaceutical advisers were asked to submit PGDs. These were then compiled into a database, and a report was circulated showing the areas for which PGDs had been developed.
The establishment of the database demonstrated that the utilisation of PGDs varied tremendously from one locality to another. The majority of PGDs were from secondary care, highlighting the need for input and support of primary care. Many PGDs submitted from primary care failed to meet the Crown standard. The exercise did, however, suggest that there were many possibilities for the extension of professional roles through the group protocol route.
These findings plus those from the later project demonstrated the need for an interactive database to identify a quality standard and to help reduce duplication of effort nationwide.
The motivating factors behind the decision to develop the interactive database were as follows:
- Continuous improvement in quality standards
- Improvement in quality of service to patients
- Educational support for those producing PGDs
- Efficiency in the utilisation of the time of healthcare professionals
- The appropriate breaking down of barriers to enable practitioners to work as a team for the benefit of patients
- Attention to the clinical governance agenda.
The internet was chosen as the best medium as it provides (relatively) easy access, and has more potential users than NHSnet. The website (www.groupprotocols.org.uk) was established to provide access to the PGDs. The site also provides advice on how to produce PGDs and a mechanism that enables users to submit their protocols to the site.
The site was launched in January 2000 and publicised via the professional journals and related health professionals' websites, such as the Pharmaceutical Journal website,3 Pharmweb,4 and the UK Health Centre.5
Since then the number of PGDs has risen to 166, covering 221 drugs. Priority has been given to ensuring breadth of quality and coverage, rather than a multitude of similar protocols. The site was visited more than 3000 times in the first 3 months, and a recent addition is the ability to monitor the number of times a protocol is viewed.
The site is open to anyone to view, but submission or amendment is restricted to authorised users. The database contains information about the PGDs including its title, the drugs involved, who it is for, when and where to use it, as well as contact details of the 'owner' of the protocol.
To ensure that the PGDs are up to date, they are tracked by the date of submission and the review dates, with simple flags being set to ensure that no protocols are displayed if they have not been reviewed.
The submission of protocols can be divided into information about the protocol and the protocol itself.
Information about the protocol is qubmitted by use of an on-line form (see Figure 1,below), and the protocol itself can be submitted in one of four ways:
- Posting it on a floppy disk
- Uploading a Word document file to the website
- Via an electronic template
- Providing a reference (URL) to the protocol which is already on a website.
|Figure 1: Protocol submission page (in part)|
The submitted PGD does not appear on the site until the date entered is checked by the site administrator, who does this on a daily basis. Should there be a reason for not posting the PGD the person submitting it is contacted to resolve the matter.
Searching is straightforward and very user friendly via the 'Search for Protocols' link (see Figure 2, below) which offers a number of options. These options return a simple select list, except for the 'complex searches' option, which enables the user to perform free text searches. Users may choose from one or more of the fields using the complex search option, but it is usually more successful to do a simple search.
|Figure 2: Protocols search options page|
The options 'Recent Submissions', 'Full list of all group protocols ordered by title', 'By primary care/ secondary care/both', 'Protocols by "popularity"' will produce a list of titles. Users choose a title and click on it to view a summary of key fields and an option to view or download.
Searching by 'Clinical area', 'Drug', 'Disease/situation' or 'Profession' will lead to a list of variables under those headings, each of which is followed by a number in brackets indicating the number of PGDs that contain that variable. Users choose a variable and click on it to display a list of titles, then click on a title to view the PGD.
In response to increasing pressure within the health service for both primary and secondary care to develop PGDs for the benefits of patients and protection of staff, this project presents an exciting new opportunity to share expertise and save resources.
The group protocol website provides access to a database of up-to-date information, which is currently maintained centrally. This database is a valuable resource, pulling together approved PGDs for a comprehensive range of drugs and situations, and information on how to develop them. It gives healthcare professionals quick and easy access to the relevant protocol, regardless of their IT capability.
The project also incorporates a targeted training and awareness programme for users, providing a reliable, rapid and cost-effective system of disseminating information about PGDs.
We believe that the system demonstrates very well how world wide web technology can provide low-cost services of national interest. Centres of expertise can easily make their knowledge available nationally, avoiding duplication of effort and investment. The savings obtained by providing support for the production of individually tailored PGDs will release scarce NHS resources for other purposes. We would encourage anyone with a local database that might be of national interest to consider publishing it using the low-tech, low-cost techniques described above.
- This project wishes to acknowledge the initiative and support of the Director of Pharmacy (Stephen Freeborn) and the Clinical Services Manager (Sarah Smith) at Hope Hospital, Helen McKnight who managed the initial collation of group protocols in the NW Region, and the Greater Manchester West Education and Training Consortium who funded the project.
- Department of Health. Review of Prescribing, Supply and Administration of Medicines (Crown Report). London:, DoH, 1999.
- Report on the Supply and Administration of Medicines under Group Protocols: review of prescribing, supply and administration of medicines. HSC 1998/051.
- The Pharmaceutical Journal, the official journal of the Royal Pharmaceutical Society of Great Britain - http://www.pharmj.com/
- PharmWeb - http://www.pharmweb.net/
- UK Health Centre, Internet health resources library http://www.healthcentre.org.uk/