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3PC-040 Health hazards of raw materials used in the compounding of pharmaceuticals formulations
  1. EA Álvaro Alonso,
  2. P Tejedor Prado,
  3. E Izquierdo Garcia,
  4. A Such Diaz,
  5. A Lazaro Cebas,
  6. S Esteban Casado,
  7. I Cañamares Orbis,
  8. C Esteban Alba,
  9. A Santiago Perez,
  10. I Escobar Rodriguez
  1. Hospital Universitario Infanta Leonor, Pharmacy, Madrid, Spain


Background The National Institute for Occupational Safety and Health (NIOSH) has studied only the hazards of marketed drugs, excluding raw materials (RM). For this reason, it is necessary to study the hazards of RM used in the compounding of pharmaceuticals formulations.

Purpose Analyse and establish the hazards of RM used in our pharmacy department. Also, classify the type of health hazards of RM in order to establish protective measures (PM) when handling them.

Material and methods Descriptive study carried out in June to September 2018. All safety data sheets (SDS) of RM (provided by Fagron) used in our hospital were reviewed. Regulation No 1272/2008 of the Classification, Labelling and Packaging of substances and mixtures (CLP) establishes a system for identifying chemical risk. Health hazards are found in the range H300–H373. We subdivided RM with health hazards into four groups depending on toxicity properties: Group 1 (G1): carcinogenic (H350–H351); Group 2 (G2): mutagenic/teratogenic (H340–H341); Group 3 (G3): reproduction/breastfeeding toxicity (H360–H361); and Group 4 (G4): others (ocular, cutaneous, gastrointestinal or respiratory toxicity). Finally, we established PM to prevent hazards when handling RM.

Results Eighty-one RM were analysed. Thirty-three (40.7%) were not classified according to CLP regulations, so they were excluded. Twenty-three RM (28.4%) had no health hazards. Finally, 25 RM (30.9%) were found with any health hazards, of which 13 belonged to any of the groups G1–G3. G1: six RM (7.4%): atenolol, budesonide, diltiazem, spironolactone, phenobarbital and furosemide; G2: one RM (1.2%): phenol; and G3: seven RM (8.6%): boric acid, dexamethasone, disodium tetraborate, triamcinolone acetonide, clobetasol, captoril and phenobarbital. The other 12 RM were in G4. Regarding PM, we established the use of Biological Safety Cabinet Class I to handle G1–G3 RM and the use of personal protective equipment including gloves, protective gown and respiratory protection. It is worth stressing that marketed drugs containing the following active pharmaceutical ingredients analysed atenolol, budesonide, diltiazem, phenobarbital, furosemide, dexamethasone, triamcinolone acetonide, clobetasol and captoril are not included in the NIOSH list.

Conclusion Approximately one-third of RM analysed have any health hazards. It is necessary to review the hazards of RM used in pharmacy departments to prevent workers’ occupational exposure. Despite CLP regulation, there are plenty of RM that remain unclassified. Further studies related to harzardous RM are necessary.

References and/or acknowledgements–161/pdfs/2016–161.pdf

No conflict of interest.

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