Characteristics of staff authorised to take responsibility for the supply or administration of medicines under Patient Group Direction Up to


Clinical condition, inclusion and exclusion criteria for the treatment of genital candidiasis

Clinical condition - The PGD is applicable to any patient (male or female) who has been diagnosed with genital candidiasis. Genital candidiasis is a fungal infection and is commonly caused by the species Candida albicans. In women the sites of infection may include the vulva, vagina and the urethra, and in men the most common sites include the glans, prepuce and urethra. Signs and symptoms are variable. Women may complain of a thick white vaginal discharge, pruritus, soreness, erythema, dysuria and dyspareunia. Fissuring may be apparent on the vulva. Men may present with a visible rash on the glans and they may also complain of pruritus and dysuria. Diagnosis is confirmed either clinically, microscopically (by wet and dry slide) or by culture media. Inclusion criteria - symptomatic patients who have had Candida diagnosed clinically and/or microscopically, and symptomatic patients who have had Candida diagnosed on culture. Exclusion criteria - this includes female patients who have Candida diagnosed microscopically or on culture but are asymptomatic, female patients who have recurrent vulvovaginal candidiasis (RVVC*) as denoted by 4 or more mycologically proven symptomatic episodes in the previous 12 months, patients who have any known allergy to any constituents found within the medication, women who are pregnant/breastfeeding and who require fluconazole and patients with co-existing renal or hepatic disease who require fluconazole.

*For patients considered to have RVVC they will be referred to a consultant specialist clinic (as per clinic guidelines), and all other patients excluded from treatment will be referred to a doctor within the clinic. The nurse will offer a referral to a doctor - if this is declined the nurse will document the discussion, and the decision made by the patient to decline treatment. Source: Gilmour, C. et al. 2005.

Table 20

Competencies required to undertake treatment of genital candidiasis

For the supply of medication for genital candidiasis it is not only important that the nurse has a full understanding of the physiological disease process of Candida and awareness of differential diagnoses, but is also competent in taking a comprehensive sexual history as well as general medical history, providing clear and current health education, recognising dermatological conditions which can mimic candidiasis and having the ability to diagnose candida clinically and microscopically.

To be able to supply treatment under the PGD - the nurse will be expected to:

• Understand the indications and contra-indications for the use of the medicines specified

• Be aware of the route and method of administration

• Be aware of the potential side-effects and discuss with patient

• Have an understanding of the potential drug interactions

Table 21

Information to be included for audit purposes

An audit tool will be developed ... in order to provide a clear audit trail - the first audit of notes will be done three months after working to the patient group direction for the treatment of genital candidiasis. A sample of notes will be reviewed for documented evidence of:

• Appropriate diagnosis

• Correct inclusion criteria for treatment

• Possible contraindications excluded

• Appropriate treatment given

• Correct documentation of treatment supplied/administered

• Advice given to clients

A sample of notes (at least 20 or 50% of the patients seen) will be audited yearly. A short summary will be written within four weeks of its taking place. This must be clearly signed and dated by the nurse using the PGD and the consultant mentor.

2004 the following qualified professionals were able to use PGDs - nurses, midwives, health visitors, optometrists, pharmacists, chiropodists, radiographers, orthoptists, physiotherapists and ambulance paramedics. Changing legislation from May 2004 now allows other qualified professionals, including dietitians, occupational therapists, prosthetists and orthotists and speech and language therapists to use PGDs.

The required level of specialist knowledge and training and the level of competency expected should be clearly stated within the PGD - not only with regard to the clinical condition, but also to the knowledge of the medicines being used. It is also important to document episodes of supervised practice with a medical mentor and to have a written agreement that the individual using the PGD possesses all the relevant competencies to supply and administer medication effectively without compromising patient care and safety. For reference, a list of individuals deemed competent to use certain PGDs should be held locally within the organisation. The recognised training and qualifications will differ according to local NHS Trust, Health Authority or Primary Care Trust (PCT) policy. It is also important to stress that an individual can only use a PGD to administer and supply medicines as a named individual within the PGD.

• Description of treatment available under the PGD - this section includes the names and the legal status of all medicines that will be used within the PGD.

From The Medicines Act 1968, medicines are allocated into 3 categories as described by the MHRA (2005):

• Prescription Only Medicines (POM) - these medicines can only be sold or supplied at registered pharmacy premises, and in accordance with an appropriate practitioner's prescription.

• Pharmacy Medicines (P) - medicines that can be sold or supplied at a registered pharmacy under the supervision of a pharmacist.

• General Sales List (GSL) - these medicines can be bought from a number of premises, including supermarkets, as long as the medicines are pre-packed and the premises are lockable to the general public.

Other categories of medicines that need to be considered with regard to use within a PGD include unlicensed and controlled medicines.

Unlicensed medicines are currently excluded from PGDs, but recent legislation has allowed the inclusion of Black Triangle Drugs and medicines used outside the terms of the Summary of Product Characteristics (RCN, 2004).The Summary of Product Characteristics (SPC) relates to the data sheets that accompany each drug. Black triangle drugs are recently licensed drugs and vaccines that are being closely monitored for any adverse reactions, and are usually subject to special reporting procedures (usually for a minimum period of two years). Their use within a PGD must be justified within the remit of best clinical practice, and it must be clearly stated within the PGD that a black triangle drug is being used or that a product is being used outside the SPC (RCN, 2004). Initially, controlled drugs were also excluded from PGDs; but in October 2003 the Home Office issued a circular (HOC 49/2003: Home Office 2003) that contained amendments to the Misuse of Drugs Act 1971 and thus allows the supply and administration of certain controlled drugs, for example diamorphine for cardiac pain, which can be administered by Emergency Nurses and those who work in a Coronary Care Unit (CCU).

One of the most important aspects of the use of medicines within a PGD relating to a specific condition or situation is the inclusion of antimicrobials, and involving a local microbiologist for guidance and advice is strongly recommended. This guidance will ensure that the inclusion of an antimicrobial can be justified and that there will be minimal or no risk to any strategies already in place to combat antibiotic resistance (MeReC 2004).

Other factors to consider in the description of treatment are the quantity, pharmaceutical strength and form, route of administration and frequency and range of dosages to be used. The dosage documented should be appropriate for the clinical condition, and the clinical criteria for selected doses should be specified. First-line treatments for first episodes should be included as well as any additional treatments required. The individual using the PGD should record in the patient notes the name, dose, route of administration and duration of treatment of medicine used, as well as signing and printing name and designation.

Advice must be given verbally and/or in written form before and after treatment, and must include the giving of a Patient Information Leaflet - this is in line with the EC Labelling and Leaflet Directive 92/27, which applies to all supplies of medicines (RPSGB 2004).

• Management and monitoring of PGDs - It is important to document within the PGD all those who have been involved in the drawing up and approval process of the PGD. Demonstration of documentation to support an audit trail is also a pre-requisite, which allows information gathered regarding the correct implementation and use of the PGD to be easily accessible. Another important amendment to the original criteria is the arrangement for the security and storage of medicine, including the ability 'to reconcile incoming stock and outgoings on a patient by patient basis' (NHS Executive, 2000: HSC 2000/026, no. 9). The authors use a reconciliation book for each medicine given out to a patient - this involves documentation of patient details, how much medicine was given, the date the medicine was given and the total outstanding medicine left against the original stock number - in principle the documentation is very similar to a Controlled Drug register.

The expiry date of the PGD must be agreed and included in this section of the PGD - current guidance suggests that a PGD should be reviewed every two years, or more frequently in cases involving a particular use of some medicines (NHS Executive, 2000: HSC 2000/026). The PGD must be reviewed and resubmitted for approval to use before its expiry date, otherwise it becomes no longer valid and medicines cannot be administered or supplied under an expired PGD. The NPC (2004) states that all documentation for PGDs should be kept for eight years for adults, and, in the case of children, either until the child has reached its twenty-fifth birthday or until eight years after the child has died.

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