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ILAPHAR | Revista de la OFIL

ILAPHAR | Revista de la OFIL

Revista de la Organización de Farmacéuticos | Ibero-latinoamericanos | Ibero Latin American Journal of Health System Pharmacy

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Health hazards of raw materials and protective measures for occupational exposure during the compounding of pharmaceutical formulations

Rev. OFIL 2018, 28;1:62-76

Fecha de recepción: 11/01/2018 –  Fecha de aceptación: 18/01/2018

Fuentes Irigoyen R, Tornero Torres O, Tejada González P

Hospital Central de la Cruz Roja. Madrid (España)

Los autores declaramos que los datos fueron presentados parciamente en el 62 Congreso de Sociedad Española deFarmacia Hospitalaria en forma de comunicación póster

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SUMMARY

Objective: The Spanish National Occupational Safety and Health Institute (INSHT) establish recommendations about the manipulation of drugs classified as hazardous. It doesn’t gather information about raw materials used in the compounding of pharmaceuticals formulations. The objective is to identify the norms regulating the occupational exposure to raw materials and describe the health hazards and the needed protective measures in the manipulation of raw materials used in our hospital.

Methods: The legislation that regulates the protection of workers exposed to chemical agents was revised. Material Safety Data Sheets (MSDS) of those used in our hospital were also analyzed.

Results: Raw materials are regulated by RD 374/2001 on Workers’ Health and Safety Protection; CE/1907/2006 (REACH); CE/1272/2008 (CLP); and RD 665/1997 on Workers’ Protection against Risk of Exposure to Carcinogenic or Mutagenic Agents. MSDS show the different risks and conditions for handling substances. 65 raw materials were evaluated, 5 of them had carcinogenic, teratogen or reproductive toxicity properties in different categories: triamcinolone acetonide, sodium borate, captopril, enalapril maleate and crystallized phenol; 60 required personal protective equipment (PPE) (respiratory, cutaneous and/or ocular) and 21 required mechanical air extraction systems.

Conclusions: Prevention of occupational hazards in the raw materials handling is regulated by the applicable legislation about chemical agents. The majority of the raw materials analyzed require the use of PPE to be manipulated.

Key Words: Hazardous substances, drug compounding, occupational exposure.

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Descargar artículo en PDF: Peligros para la salud de las materias primas y medidas de protección ante la exposición laboral en la elaboración de fórmulas magistrales y preparados oficinales

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ISSN Edición impresa: 1131-9429
ISSN Edición electrónica: 1699-714X

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