A therapeutic medicine monitoring service is designed to allow adjustment to the dose of a medicine to obtain maximum clinical benefit and avoid unnecessary toxicity. This is achieved by the measurement of plasma concentrations of a medicine in specific conditions coupled with the interpretation of the results obtained. If a therapeutic medicine monitoring service is provided the following standards are applicable:
| (a) |
The role of the pharmacy, the pathology and, if appropriate, the clinical pharmacology departments must be clearly defined locally. It is important to promote good relations and ensure that equipment is not duplicated and that analysis and the taking of samples is carried out by suitably trained people observing health and safety procedures. |
| (b) |
Pharmacists must be involved in the interpretation of results from medicine assays. |
| (c) |
Policies and procedures must include: |
| (i) |
guidance on the types of medicine of which therapeutic medicine monitoring has been shown to be of value and those medicines where plasma level measurements are unnecessary; |
| (ii) |
indications for therapeutic medicine monitoring; |
| (iii) |
detailed guidelines on the application of therapeutic medicine monitoring to all the medicines for which the service is available; and |
| (iv) |
guidelines on sampling. |
| (d) |
A pharmacokinetic profile form/reporting sheet, must be designed and agreed upon by the Pharmacy and Therapeutics Committee. Explanatory notes must be provided on the use of these forms. |
| (e) |
Results from therapeutic medicine monitoring and interpretation of these results must be communicated to the clinician by a pharmacist on the approved form to become part of the patient's permanent records. |
| (f) |
Quality assurance procedures must be introduced to ensure that results are consistent and reproducible. This should involve participation in rational quality control schemes if these are available. |
Special Investigating Units and Special Tribunals Act, 1996
