Professionals have always been required to follow recommendations in the pursuit of their work. These have been self imposed through rules of ethics, through guidelines (Pharmacopoeias) and some from external sources via Laws and Guidelines set up by interested parties outside the profession ie Governments.
Pharmacy is no exception and the more risky the activity the greater are the controls. Aseptic preparation is perhaps the most risky of the pharmacists activities and is therefore controlled the most.
The controls we face come from:
- EU Directives
- EMA (GMP)
- Pharmacopoeia (Pharmaceutical Preparations)
- Specialist Advisory Committees under the Council of Europe (Aseptic Services)
- Individual Country Laws and Recommendations (various)
- Professional Bodies
- Best Practice
All can be adapted and interpreted by ’case law’ following judgement in a Law Court whether that be at a European Level (eg Abcur) or a National level.
Most recommendations are developed from actual or perceived risk/harm caused to patients. History has taught us that they will continue to develop, become more restrictive and thus change the affected practice. The rate of change will increase with time.