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- 27. The Role of the Pharmacy Technician in Purchasing, A.M.N.C.H. Yvonne Sheehan Senior Pharmacy Technician I.I.P.M.M 27 March 2010
Editor's Notes
- The Declaration of Helsinki , developed by the World Medical Association , is a set of ethical principles for the medical community regarding human experimentation . It was originally adopted in June 1964 in Helsinki , Finland , and has since been amended multiple times. Nazi human experimentation trials in WW2 Like the Nuremberg Code , the Declaration made informed consent a central requirement for ethical research while allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor. . The Declaration is important in the history of research ethics as the first significant effort of the medical community to regulate itself. In principle, this document set the stage for the implementation of the Institutional Review Board /independent ethics committee (IRB/IEC) process (Shamoo & Irving, 1993) in USA and ethics committee, ethical review board or Human Research Ethics Committees (HREC) in some other countries.
- For many years there were numerous sets of GCP guidelines in operation e.g. European, Nordic, Japanese as well as the US code of federal regulations. In May 1996, a harmonised set of GCP guidelines (the ICH GCP guidelines) was finalised and approved by the regulatory authorities & by pharmaceutical industry representatives in Europe, Japan and the USA. These ICH GCP guidelines are now accepted as the required global standard for the conduct of clinical trials. Whilst these were all similar, there was some notable differences in the requirements they contained. This made it difficult to perform a study in one country that was acceptable in all the others.
- Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. This Directive aims at facilitating the internal market in medicinal products within the European Union , while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonize the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure. The Member States had to apply these provisions at the latest with effect from 1 May 2004. GMP principles and guidelines: GMP will mean the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. Authorization of manufacture/ importing/ labelling of medical products Application format for an ethics committee opinion and competent authorities. GCP principles and inspections European data base of SUSAR (Eudravigilence)
- Clinical trials in Ireland are governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004. The Regulations transposed into Irish law the provision of Council Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The regulations supersede the Control of Clinical Trials Acts 1987 – 1990 for clinical trials using medicinal products.
- As you can see a lot of the roles overlap.
- IMPs must be stored separately from normal pharmacy stock in an area with restricted access. IMPs that are returned by patients or which have expired should be stored separately from unused IMPs. Regular temp monitoring of IMP storage facilities must be undertaken and these records archived. Suitable archiving must be available for pharmacy files and should allow for prompt retrieval of any pharmacy file or other non-trial specific documentation, temp logs etc
- Good clear, complete documentation is vital
- Insert a food note if required
- Results can not be attributed to a test product unless there is evidence that the subject actually took the medication. Hence estimating compliance is important. Clear instructions must be given to the patient to return the whole pack of medication. The returned subject packs should be retained by the pharmacist. The sponsor will collect unused and returned trial product. This should be documented accurately in the Pharmacy file Occasionally the same drug will be used for different trials. Care must be taken to select the correct trial stock.
- Trial drugs have to be manufactured in accordance with GMP(Good manufacturing Practice). Important that any details on the label ARE NOT OBSCURED. Any additional labels must be approved by the CRA. They are produced to high quality standards. It is important that trial materials are stored at the correct temperatures & that other environmental conditions are controlled as appropriate. A regular temperature check must be undertaken and the results recorded and signed off by the person undertaking the measurement. Sometimes trials take much longer than expected and retesting of the product and extension of the expiry date or replacement of the stock may be required.