Angela Bussey (left) and Theresa Rutter discuss the use of PGDs, highlight key points for primary care, and list useful online resources and toolkits
Although Patient Group Directions (PGDs) have been in existence for 8 years, questions still arise about the appropriate use of this exemption to the Medicines Act1 to supply and administer medicines. Enquiries received via the PGD website and other networks over the past couple of years imply that PGDs are sometimes being developed without sufficient consideration of the legal and governance issues involved.
Why this article is necessary
There is often a lack of awareness regarding the legal framework for medicines and of the specific legal requirements for PGDs. Practical medicines-related issues such as how the patient will have access to medicines (e.g. by prescription from a medical or non-medical prescriber, direct administration, or supply by an authorised healthcare professional using a PGD) need to be addressed early in the planning stages for a new or redesigned service. Otherwise, delays in the delivery of the service and other problems, including unintentional/inadvertent practice outside of the legal framework, can occur.
This article may sometimes seem to be stating the obvious but the authors believe there is a need to remind clinicians of key messages, particularly with the introduction of practice-based commissioning (PBC), and an increase in the number of services led by non-medical healthcare professionals.
Supply or administration of a medicine under a PGD is not prescribing
Prescribing involves individual assessment; diagnosis; selection of the most appropriate medicine available and its dose, frequency, and length of course; and subsequent monitoring of a condition. The majority of clinical care should be provided on an individual, patient-specific basis.
Prescribing or a ‘Patient Specific Direction’ are the preferred2 and often the only legal route for patients’ access to medicines. A Patient Specific Direction is the ‘traditional written instruction, from a doctor, dentist, nurse, or pharmacist independent prescriber for medicines to be supplied or administered to a named patient. … In primary care, this might be a simple instruction in the patient’s notes. Examples in secondary care include instructions on a patient’s ward drug chart.’2
The definition of a Patient Group Direction is ‘a written instruction for the supply or administration of a licensed medicine (or medicines) in an identified clinical situation, where the patient may not be individually identified before presenting for treatment. This should not be interpreted as indicating that the patient must not be identified; patients may or may not be identified, depending on the circumstances.’2
A PGD is the supply or administration of a specified medicine or medicines, by named authorised healthcare professionals, to a well-defined group of patients who require treatment for the condition described in the PGD.2 Patient Group Directions have a rigid legal and governance framework, which enables certain healthcare professionals to supply and administer medicines according to specific criteria.3,4
When using a PGD, the supply and administration of medicines should only be conducted in the limited situations where there is an advantage for patient care, and also where it is consistent with appropriate professional relationships and accountability.3 Practice under a PGD should be carried out by professionals who are legally authorised and competent to do so. A senior person from each profession is responsible for assuring the competence of those working under a PGD and every professional working under a PGD must sign local documentation.
Is a PGD the most appropriate method of supply or administration?
It is the opinion of the authors that some sources anticipated that the introduction of non-medical prescribing would decrease the use of PGDs. However, PGDs continue to be necessary for the delivery of certain services that aim to achieve accessible, high-quality, comprehensive healthcare. Indeed, the delivery of some services can be dependent on PGDs, for example:
- the administration of vaccines to children in schools
- in nurse-led sexual health clinics
- in walk-in centres where there may be an insufficient cohort of nurse prescribers.
On the other hand, PGDs may not be appropriate for some services and may impede practice. They also take a significant amount of time and a lot of resources to develop and implement.5 It is important to give careful thought and consideration to the most appropriate route for supply or administration of a medicine when starting to re-design a service, in order to save time in the long-run and contribute to safe and timely delivery of patient care.6 Therefore, whenever a new service is being commissioned or an existing service re-designed, the most appropriate route for supply or administration of medicines needs to be considered early in the planning cycle.
Medicines are the most common treatment intervention and almost all care pathways involve their use. As well as PGDs and prescribing, there are other options available for the supply and administration of medicines facilitated by specific exemptions in the Medicines Act. These include medicines supplied or administered in the course of occupational health schemes and administration of certain parenteral medicines by registered chiropodists.7
Other legal and contractual issues may also need to be considered. For example, under the requirements of the Abortion Act 1967, a PGD cannot be used to supply or administer abortifacients because these must be prescribed by the medical practitioner who is responsible for the termination.8
To decide the most appropriate route for administration and/or supply of the medicine, individual organisations must take into account the needs of patients, including safety, and consider how the particular service is being structured and delivered.2 ‘Making the right choice is by no means simple and sometimes it can be difficult to envisage the best way of making medicines available in practice.’6
PGD Website Toolkit
Tools to support decision-making have been developed on the national Patient Group Directions Website (see Box 1) such as a step-by-step guide to clarify the PGD clinical governance processes. The tool entitled ‘Are PGDs the safest route for your service?’ aims to help users understand the various options. Examples of common scenarios are included to demonstrate what works well with PGDs and what does not. These documents reflect developments such as the introduction of independent nurse and pharmacist prescribing, and encourages users to consider key national and local resources. The tools are cross-linked to each other and externally linked to relevant information on the internet such as the PGD legal frameworks on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
Medicines in Commissioning Toolkit
Another toolkit has been produced by a working group from the East and South East England Specialist Pharmacy Services to help commissioners ‘get medicines right’.9 This toolkit includes information on the use of PGDs and could also be useful to service providers in helping them identify and address the issues relating to medicines when deciding on service specifications. The focus of the document is on the practical aspects of managing medicines safely rather than specific prescribing issues, such as high-cost drugs. However, some of the content does relate to prescribing and expenditure (e.g. a funding checklist is included).9 The toolkit is available via the National electronic Library of Medicines (NeLM) website: www.nelm.nhs.uk/en/.
Specific PGD issues for general practice
General practitioners providing an NHS service under the General Medical Services contract can use PGDs developed and approved by their PCT if they are available;3 for example, PGDs for hepatitis vaccines for patients travelling abroad.
There may be some PGDs already in existence that the local PCT is willing to share with the general practice; however, the PCT may not be able to offer the full range of PGDs required or have the resources to support the development of such PGDs, for example those required for travel clinics. The Medicines and Healthcare products Regulatory Agency (MHRA) has stated that PGDs cannot be developed for private services offered by GP practices (e.g. vaccination for yellow fever).
A general practice can develop its own PGDs. The practice would need to contract with a pharmacist who has experience of developing them. This pharmacist, along with a GP from the surgery, would write and approve the clinical content of the PGD on behalf of the practice.3 As general practices are not included in the organisations able to approve PGDs,3 the PCT would need to agree to be responsible for the ‘clinical governance’ authorisation for these PGDs.
It is the practice’s responsibility to ensure that only suitably qualified and fully competent healthcare professionals, employed by the practice, work according to the PCT-approved PGDs, and that records are kept of the individual’s signed authorisation to do so.3
Laws currently in place state that non-dispensing general practices can only supply medicines that are personally administered, such as childhood vaccines, or drugs that are necessary for immediate treatment10 (e.g. salbutamol to be administered in an acute asthma attack). For any other drug treatment requirements, a prescription would normally be written.
The NHS Patient Group Directions website
The NHS Patient Group Directions website, a portal of the NeLM, is the national resource in England for both public and independent sector organisations who use, or intend to use, PGDs.11 It is also widely used by healthcare professionals who work with PGDs or who are involved in their development and review.
A Board supports the development and review of the website content, particularly of the tools and frequently asked questions (FAQs). Members of the Board include experts from a range of backgrounds: Department of Health, MHRA, Healthcare Commission, acute and primary care sector, senior pharmacists with clinical governance responsibilities, and practitioners.
A series of FAQs has been developed in response to enquiries. Examples include:
- Can supply or administration be delegated to another practitioner under a PGD?—Answer: this is not allowed under a PGD12
- Questions and answers relating to the use of PGDs within NHS commissioned services from non-NHS providers.13
There is a selection of local examples of PGDs on the website, which cover a range of medicines and care settings. Any PGD submissions to the website must meet certain selection criteria and all legal requirements. In addition, PGDs are only selected to be posted on the site if there is evidence of a robust clinical governance process and of the relevant organisational approval.
The clinical content of each PGD is not checked in detail by the site editor, and users of the site who download a PGD for local use are warned that they are responsible for checking the details of the PGD and its appropriateness for use in their specific circumstances.14
As part of the ongoing project to rebuild the NeLM, the PGD website will undergo technical development to introduce improved search and navigation features. It is hoped that an updated PGD website will be launched early in 2009.
In summary, the appropriate use of PGDs, and their development, approval, and implementation, requires a multidisciplinary approach and integration into the clinical governance structure for the organisation/practice. The doctor/dentist and pharmacist involved in developing a PGD need to understand the legal framework for medicines as well as understanding the clinical area and how the service is provided. The process of writing, agreeing, and ‘signing off’ a PGD takes time. They cannot be implemented overnight. In the first instance, the authors recommend that GP practices seek advice from their PCT/PBC pharmacist as well as accessing the PGD website resources for help and access to supporting tools and documents.
With the permission of Pharmacy Management Journal, this article is adapted from a contribution by the authors published in January 2009, entitled ‘To PGD or not to PGD? That is not the only question’.
- The Medicines Act. London: HMSO, 1968.
- Department of Health. Medicine matters: A guide to mechanisms for the prescribing, supply and administration of medicines. London: DH, 2006.
- MHRA website: Patient Group Directions in the NHS. www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingand supplyingofmedicines/ExemptionsfromMedicinesActrestrictions/PatientGroupDirectionsintheNHS/index.htm (accessed 10 December 2008).
- MHRA website: Patient Group Directions in the private sector. www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingand supplyingofmedicines/ExemptionsfromMedicinesActrestrictions/ PatientGroupDirectionsintheprivatesector/index.htm (accessed 10 December 2008).
- Onatade R, Mehta R. Tracking the patient group directions development process. Pharmacy Management 2007; 23 (3): 21–24.
- NHS Patient Group Directions website: Option appraisal—are PGDs the safest route for your service? www.portal.nelm.nhs.uk/PGD/toolkit.aspx (accessed 10 December 2008).
- MHRA website: Exemptions from Medicines Act restrictions. www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingand supplyingofmedicines/ExemptionsfromMedicinesActrestrictions/index.htm (accessed 10 December 2008).
- Department of Health. Termination of pregnancy by medical methods: the role of the registered nurse or midwife and others who are not registered medical practitioners. Letter from the Chief Medical Officer and the Chief Nursing Officer, 24 June 1994. PL CMO (94) 8, PL CNO (94) 10. Available at: www.parliament.uk/deposits/depositedpapers/2008/DEP2008-2678.pdf
- East and South East England Specialist Pharmacy Services. Medicines in commissioning: a toolkit to help ensure safe and accessible services for patients. June 2008. Available at: www.nelm.nhs.uk/en/NeLM-Area/Community-Areas/Primary--Community-Care/Community-Health-Services/Medicines-in-Commissioning-Toolkit/ (accessed 10 December 2008).
- National Chlamydia Screening Programme website: Current legal framework for the supply and administration of medicines used by the National Chlamydia Screening Programme. www.chlamydiascreening.nhs.uk/ps/assets/pdfs/LegalFramework.pdf (accessed September 2008).
- NHS Patient Group Directions website: About the PGD website. www.portal.nelm.nhs.uk/PGD/about.aspx (accessed 10 December 2008).
- NHS Patient Group Directions website: Can supply or administration be delegated to another practitioner under a PGD? www.portal.nelm.nhs.uk/PGD/viewRecord.aspx?recordID=1090&referer=http://www.portal.nelm.nhs.uk/PGD/pgdfaq.aspx (accessed 10 December 2008).
- NHS Patient Group Directions website: Answers to FAQs about NHS services commissioned from private or voluntary providers. www.portal.nelm.nhs.uk/PGD/viewRecord.aspx?recordID=961&referer=http://www.portal.nelm.nhs.uk/PGD/pgdfaq.aspx (accessed 10 December 2008).
- NHS Patient Group Directions website: Resource links. www.portal.nelm.nhs.uk/PGD/links.aspx (accessed 10 December 2008).G