Preventive Measures of Patient Group Directions

The main preventive measures built into all PGDs are inclusion and exclusion criteria. Each PGD, by MHRA definition must have precisely worded exclusion and inclusion criteria as to protect the more vulnerable in society. An inclusion criteria means groups of patient who have certain attributes such as over 18 or have certain symptoms which can have treatment from a PGD authorised clinician. Conversely, exclusion criteria are the oposite, exclusion criteria specify attributes of patient which cannot be treated under the PGD. 

Inclusion / exclusion occurs in all PGDs, an example of which are heart conditions and Erectile Dysfunction PGDs. Sildenafil (Viagra) was originally created as a heart medicine, it was found during the clinical trials that patients often had an "embarrassing" side effect, prolonged erections. Sildenafil proved extremely useful as a male impotence drug, however if it was given to a patient with High Blood pressure or a patient taking a complicated heart medicine regime it may adversely interact with the patients condition. If Sildenafil were prescribed to a patient with heart complications it would require a specialist who know the exact ins and outs of the patients condition. As authorised clinicians who use PGDs can sometimes be inhibited by lack of patient information and do not have the specialist knowledge needed, patients with heart conditions are usually excluded from access to medicines via PGDs and referrals are made.

Inclusion / exclusion criteria are not infallible. There may be undiscovered categories of patients with certain medical conditions which would have a higher predisposition to side effects and should not take the drug. This is why PGDs are normally restricted to those drugs which have a long history of patient safety.