GPhC: Prove you have assessed unlicensed medicines risks
Pharmacists should carry out regular audits of their processes for preparing unlicensed medicines, guidance published by the GPhC has urged
Pharmacies preparing unlicensed medicines need to prove they have assessed the risks involved, the General Pharmaceutical Council (GPhC) has said in guidance published last week (May 27).
The guidance, which follows a consultation earlier this year, advises pharmacies to carry out a regular audit of their processes for preparing unlicensed medicines, including methadone. This should include assessing the temperature and moisture controls in the premises, training staff, monitoring hygiene issues and keeping detailed records, the GPhC said.
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The guidance advises pharmacies to carry out regular audits of their processes for preparing unlicensed medicines, such as methadone |
 More on unlicensed medicines
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Pharmacies needed to have a system in place to recall unlicensed medicines if a problem was detected, the GPhC said. Staff should be allowed to raise concerns if they suspected that an unlicensed medicine prepared in the pharmacy was not fit for purpose, the regulator said. |
GPhC calls for higher standards for specials preparation|
The ‘peppermint water case' in 2000, when a child died after being given an undiluted form of the medicine by a pharmacist, showed that preparing an unlicensed medicine could pose a "significant risk to patients" if the processes were not managed properly, the GPhC added. "I hope that our new guidance will assist pharmacy owners and superintendents in ensuring that patients are kept safe and that our standards for registered pharmacies are met," said GPhC chief executive Duncan Rudkin. The guidance on unlicensed medicines is the first supplementary document for the GPhC's standards for registered pharmacies. |
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What is in the guidance?● Risk assessment A regular risk assessment needs to be undertaken to safeguard the health, safety and wellbeing of patients and the public. ● Trained and competent staff All staff must have appropriate training to undertake their duties in preparing unlicensed medicines. ● Contamination and hygiene control Measures should be in place to minimise contamination and records should be kept of steps taken to ensure that the environment, conditions and equipment are clean enough for the preparation of medicines. ● Ingredients and quality assurance Ingredients or starting materials should be obtained from a reputable source and a robust system of quality assurance should be in place that provides the necessary safeguards. ● Patient information Pharmacy staff must communicate with patients to ensure they have all of the information they require about the unlicensed medicine. ● Equipment and facilities Pharmacies must have the appropriate equipment and facilities available to produce a high quality, safe product. |
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What will you have to do to comply with the new guidance?
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