Patient Group Directions examples

The use of Patient Group Directions means that designated healthcare professionals may supply (for example, an inhaler or tablets) or administer (for example, an injection) directly to a patient without the need for that patient to first obtain a prescription from a prescriber. Patient Group Directions are intended for shortterm, usually urgent, care it is not intended that they would be used to manage a patient s condition in the long term. 

Figure 3.1 contains a sample template for a Patient Group Direction, Figure 3.2 contains an example of a Patient Group Direction for the administration of fusidic acid cream/ointment 2% by a community pharmacist and Figure 3.3 contains an example of a Patient Group Direction for the administration of trimethoprim 200 mg tablets by community nurses for the management of patients with cystitis. 

Figure 3.2 An example of a Patient Group Direction for the administration of fusidic acid cream/ointment 2% by community pharmacists. (Continued overleaf.)...

Part A of the Patient Group Direction will list the conditions that can be treated by use of this Patient Group Direction (for example, anal fissures, inflammatory bowel disease, management of colostomy/ileostomy patients, etc.). 

Part B lists the medicines in chapter 1 of the British National Formulary that may not be supplied to a patient under this Patient Group Direction (for example, items not intended for repeat use, items only intended for acute use or items not intended for primary care use). This is repeated for each chapter of the British National Formulary. 

The concentrations of licensed medications may be too high, necessitating further manipulation in the form of dilution with an excipient. However, when the concentration is low, the dose volume may be too large for some children. The excipients in many liquid formulations may not be suitable for selected patient groups. For example, the propylene glycol content in amprenavir liquid formulation makes it unsuitable for children under 4 years of age. Severe delayed-onset hypersensitivity reaction was associated with formulation of amoxicillin liquid the reaction may have been caused by the exicipent (Chopra et ai, 1989). Sweeteners, dyes and other excipients may cause adverse reactions and should be identified and restricted in paediatric formulations (Kumar et ai, 1996). Some clinical studies have been directed to ascertain the effect of drug concentration and frequency of... 

Special warnings, precautions or use limitations cited in the product monograph should be included in the body copy. Examples include abuse potential for narcotics or central nervous system agents, or specific directions for use in special patient groups such as elderly people, children, pregnant women, nursing mothers, women of childbearing age. 

In many cases an endpoint directly measures time from the point of randomisation to some well-defined event, for example time to death (survival time) in oncology or time to rash healing in Herpes Zoster. The data from such an endpoint invariably has a special feature, known as censoring. For example, suppose the times to death for a group of patients on a particular treatment in a 24 month oncology study are as follows ... 

---