Patient group directions were formerly known as 'group protocols', and were derived from recommendations contained within the first Crown Report (DH,
Advanced Clinical Skills for GU Nurses. Edited by Matthew Grundy-Bowers and Jonathan Davies © 2007 John Wiley & Sons Ltd
1989). Primarily this Crown Report focused upon recommendations and criteria for the authorisation of nurses working in the community (who held District Nurse and/or Health Visiting qualifications) to be able to prescribe medicines from a limited Nurse Prescribers' Formulary (NPF). However, the view was also advocated that doctors and nurses, in collaboration, could produce group protocols using local guidance in the administering and supplying of medicines (McHale, 2003). As more and more emphasis was being applied to 'patient-centred care', group protocols were seen as a potential benefit to the development of hospital services by providing quicker access to treatment, reducing waiting times and, most importantly, efficiently utilising and enhancing existing resources and professional skills (DH, 1998). Examples of where group protocols were initially used included travel and flu vaccination services (NPC, 2004).
Over time, though, concerns became raised around the actual legalities of using group protocols for the supply and administration of medicines, and whether patient safety was being compromised. Some of these concerns included the legal acceptability of nurses administering medication to patients who had not been seen by a medical practitioner, and working under group protocols that related to groups of patients rather than being patient-specific (McHale, 2003). In response, the Department of Health (DH) commissioned a review of supplying and administering medicines under group protocols which was led by June Crown in 1998, and resulted in the publication of the second Crown Report Part 1 (DH, 1998). The Crown Report defines a group protocol as:
... a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn up locally by doctors, pharmacists and other appropriate professionals, and approved by the employer, advised by the relevant professional advisory committees. It applies to groups of patients or other service users who may not be individually identified before presentation for treatment (Crown Report 1998 Appendix E: DH, 1998).
The Advisory Group found, on reviewing existing group protocols, many anomalies regarding the written interpretation and implementation of group protocols within clinical practice. Inconsistencies were evident with regard to the monitoring, authorisation, responsibility and accountability of group protocols, and importantly there appeared a lack of clarity surrounding the actual requirements needed for the clinical criteria and types of medicines being used (DH, 1998).
In order to aid the process of clarification, the Advisory team produced criteria to support the development of group protocols and gave current and future recommendations for the conformity and standardisation of all current and future group protocols within established and legal criteria. In particular, the Advisory team recommended that 'the majority of patients should continue to receive medicines on an individual basis. However, there is likely to be a continuing need for supply and administration under group protocols in certain limited situations as part of a comprehensive health service and most importantly 'the law should be clarified to ensure that health professionals who supply or administer medicines under approved protocols are acting within the law' (NHS Executive, 1998: HSC 1998/051, P. 4).
Following this in-depth review and subsequent recommendations outlined in the Crown Report Part 1 (DH, 1998), a consultation document (referred to as MLX 260) was issued in March 2000 by the Medicines and Healthcare Products Regulatory Agency (MHRA), entitled Sale, supply and administration of medicines by health professionals under patient group directions (MHRA, 2000). Within this document, the terminology changed, and 'group protocol' was now referred to as 'patient group direction'. Proposed amendments were outlined with regard to the Medicines Act 1968 and other medicine regulations, which would then in turn allow nurses and other healthcare professionals specifically to use patient group directions (PGDs) within agreed legal criteria. Other proposals for consideration included suggested mechanisms for approving PGDs, the use or exemption of certain controlled and unlicensed medicines within PGDs and identification of areas within the NHS and private sector where PGDs could be implemented (MHRA, 2000).
A definition of a PGD was also given in the document issued by the MHRA that was very similar to the existing definition of a group protocol, and read:
... a specific written instruction for the supply and administration, or administration of a named medicine in an identified clinical situation. This definition applies to presenting for groups of patients who may not be individually identified before presenting for treatment. Patient group directions are drawn up locally by doctors, pharmacists and other health professionals, signed by a doctor or a dentist, as appropriate and approved by an appropriate healthcare body' (MHRA, 2000, p. 2)
It may be prudent here to mention the term 'patient specific direction' - this is where a prescriber (doctor, dentist or nurse) directs another healthcare worker to administer or supply medicines to a named patient(s) (NPC, 2004). It is important to have an understanding of both of these terms in order to allay any confusion and potential misunderstanding surrounding the legal requirements for the administration and supply of medicines.
In considering the proposed amendments to satisfy legal requirements, the consultation document (MLX 260: MHRA, 2000) included a regulatory appraisal that listed four possible options, and outcomes (Table 17) that could potentially impact upon the future use of patient group directions.
Following consultation, Option 3 was the most favoured, as it was deemed appropriate enough to allow current effective practice to continue without compromising patient safety and also it would maximise the efficient use of resources and clinical skills in practice. It was also suggested that this option would not greatly impact upon costing in terms of producing new PGDs to satisfy the new legal requirements.
ADVANCED CLINICAL SKILLS FOR GU NURSES Table 17
Options put forward by MHRA consultation document mlx 260 (MHRA, 2000)
Option 2 - Voluntary agreement by appropriate healthcare sectors to ensure directions meet the standards recommended in the Crown report, supplemented by centrally issued guidance.
Option 3 - Amend the law as proposed to remove uncertainty about the legality of the operation of group directions and set out legal criteria that they will need to meet. This option would interpret the law more widely and allow for directions to apply to unnamed groups of patients with a particular clinical condition.
Option 4 - Amend the law to confirm existing views on the meaning of 'directions'. This option would result in a narrower interpretation of the existing law, as group directions that did not apply to named patients would be illegal.
In context then, from the initial recommendations of the Crown Report Part 1 (DH, 1998) and the response to the MHRA consultation document (MLX 260), a Health Circular was issued in 2000 to all chief executives, which contained amended legislative requirements and guidance pertaining to the use of PGDs (NHS Executive, 2000: HSC 2000/026). Changes were made accordingly to The Prescription Only Medicines (Human Use) Amendment Order 2000, the Medicine (Pharmacy and General Sale - Exemption) Amendment Order 2000 and the Medicines (Sale and Supply) (Miscellaneous provisions) Amendment (No. 2) - these amendments are legally defined within the Statutory Instruments 2000 Nos. 1917,1919 and 1918 respectively.
To further clarify the appropriate use of PGDs the NHS Executive stated that:
The majority of clinical care should be provided on an individual, patient specific basis. The supply and administration of medicines under patient group directions should be reserved for those limited situations where this offers an advantage for patient care (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability (NHS Executive, 2000: 2000/026 p. 2).
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