Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, HETA 2010-0026-3150, 2011 Dec; :1-45
NIOSH investigators conducted an health hazard evaluation (HHE) at a mail order pharmacy to determine whether employees were exposed to pharmaceutical dust and noise and were experiencing health effects related to these exposures. We observed work processes, practices, and workplace conditions. We collected air samples to characterize employees' exposures. We measured employees' noise exposures and sound levels in the production areas. We held confidential interviews with 45 employees to learn about their health and workplace concerns. Using real-time particle meters, we identified releases of dust during the cleaning, repairing, and refilling of cells and canisters. We sampled the air for different sizes of dust particles and analyzed the samples for active pharmaceutical ingredient (APIs) and lactose, a common ingredient of pharmaceuticals. Most of these air samples contained lactose and one or more APIs, suggesting that some of the airborne dust came from pharmaceuticals. We quantified two APIs on these air samples, warfarin and lisinopril; the air concentrations were well below applicable OELs. Most employees wore protective gloves but did not wear protective clothing when handling pharmaceuticals. Consequently, personal clothing could become contaminated with APIs and become a source of secondary exposure to employees or their family members. Many employees washed hands before eating or smoking, which should minimize the ingestion of APIs. Some employees voluntarily wore N95 filtering facepiece respirators. However, these respirators were not always worn or maintained correctly. Shortly before our second visit, pharmacy managers developed standard operating procedures for the handling of hazardous drugs. These procedures required hazardous drug prescriptions to be filled and verified in a separate area by dedicated personnel. Gloves were the only control measure required for this process. The most likely health effects from exposure to APIs are allergic reactions and upper respiratory irritation. Nearly half the employees reported eye and upper respiratory irritation, which could be related to their exposures to APIs. However, these symptoms could also be caused by general dust exposures or non-occupational factors, such as weather conditions and seasonal allergies. We were unable to quantify employees' exposures to all APIs. Given the uncertainty of our exposure assessment, the potential for surface and personal clothing contamination, and the lack of knowledge regarding the toxicity of low-level exposures to multiple APIs, exposures to pharmaceutical dust should be reduced as much as feasible. We recommend installing ventilation booths and movable capture hoods that can be used when hand filling hazardous drug prescriptions and cleaning, repairing, and refilling cells and canisters. All hazardous drugs should be identified and labeled. All employees who handle drugs should wear lab coats or other protective clothing to minimize contamination of their personal clothing. We found that full-shift TWA noise exposures for employees working near the Baker machines could exceed the OSHA AL and NIOSH REL of 85 dBA. Employees' noise exposures in other production areas were below these exposure limits. Some employees wore hearing protection, but the noise reduction rating was more than what was needed. We recommend providing hearing protectors with a noise reduction rating of 15-20 dB. We noted that many employees wore an earphone from a personal music player in one of their ears. Because this can increase the risk of hearing loss if the sound level from the earphone is higher than the background noise in the facility, we recommend that personal music players not be used in the workplace. One-third octave band noise level measurements at several different work areas or around pharmacy equipment indicated that the highest noise levels occurred at high frequencies (greater than 8,000 Hz). To reduce noise levels and noise exposures, we recommend installing mufflers on the exhaust port of solenoid valves and actuators throughout the facility and constructing a better enclosure at the capper machine, located near the Baker machine.
Region-5; Pharmacy-workers; Pharmaceutical-industry; Pharmaceuticals; Dusts; Dust-exposure; Noise; Work-practices; Protective-clothing; Personal-protective-equipment; Respiratory-protective-equipment; Respiratory-protection; Respirators; Respirable-dust; Respiratory-system-disorders; Respiratory-irritants; Pulmonary-system-disorders; Eye-irritants; Ventilation; Ventilation-systems; Ventilation-hoods; Hearing-conservation; Hearing-protection; Drugs;
Author Keywords: Pharmacies and Drug Stores; drugs; pills; pill dust; active pharmaceutical ingredients; APIs; tablets; pharmaceuticals; mail order pharmacy; automatic pill dispensing machine; robotic pill dispenser; Hispanic; Spanish-speaking