The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
DEVELOP A PROTOCOL TO PREPARE MAGISTRAL FORMULAS WHICH INCLUDE HAZARDOUS SUBSTANCES (submitted in 2019)
European Statement
Production and Compounding
Author(s)
Lucía Rubio , Mónica Montero
Why was it done?
Hospital Pharmacy Services staff may be exposed to hazardous substances, involving a risk to health. For this reason, is important to identify these substances and measures must be taken to ensure maximum safety for the staff at work. We decided to review the topic when we saw in the Technical Document on Prevention Measures for the Preparation and Administration of Dangerous Drugs, published by the National Institute for Safety and Hygiene at Work (INSHT) there are no specific recommendations for protection of raw materials used in magistral formulas; it only refers to dangerous drugs.
What was done?
Identify health problems involved in handling raw materials that we use in the preparation of magistral formulations. Define personal protective equipment and installations necessary for handling.
Improve work safety of area’s staff.
How was it done?
We have to update raw materials discharged in 2018 in the Pharmacy Service.
The safety data sheets were reviewed in the National Institute for Occupational Safety and Health, paying special attention to dangerous identification and exposure controls/individual protection sections. In this database there is not all the information, so we have to use data sheets of our supplier.
We studied Regulation (EU) Nº 1272/2008 on classification, labelling and packaging of substances and mixtures to determined 3 variables: health dangerous, using hazard class like REPR B, MUTA 2 and STORE RE 1; personal protective equipment and installations must be used in handling of our raw materials.
What has been achieved?
We obtained a list of 20 raw materials. 40% of raw materials aren´t considered hazardous.
Of 60% that are classified as hazardous, they were divided into 2 levels: the first, with categories such as serious eye injuries, skin disorders, respiratory tract irritation or toxicity if swallowed; it includes 75% of raw materials. The second level, which includes the rest of products considered hazardous (25%), is associated with 3 categories: REPR B or possible carcinogenicity, that influence the fertility and development of the fetus; MUTA 2 or genetic defects, that are associated with germ cell or mutations; and STORE RE 1 that can cause damage to organs after prolonged or repeated exposure. For 40% of raw materials there are no specific recommendations about using personal protective equipment. With 60% it is recommended to use self-filtering masks for particles, protective gloves and glasses. For 16% of materials, protective clothing against chemicals is required too. In 65% of raw materials, no specific installation is required to handle them. However, for 25% it is recommended to have well-ventilated areas and with 10% a chemical smoke cabin.
What next?
Most of raw materials we use to make magistral formulations are considered hazardous according to Regulation (EU) nª1272/2008. For this reason, we developed a protocol that included individual protection measures and laboratory equipment necessary to handle such raw materials. So it is possible to normalise the preparation of magistral formulations guaranteeing the safety of the area’s staff. We have devised a plan for review and update of the protocol, following current regulations.