Pharmaceutical Dust Exposure at Pharmacies Using Automatic Dispensing Machines: A Preliminary Study
ABSTRACT ABSTRACT Automatic dispensing machines (ADMs) used in pharmacies concentrate and dispense large volumes of pharmaceuticals, including uncoated tablets that can shed dust. We evaluated 43 employees' exposures to pharmaceutical dust at three pharmacies where ADMs were used. We used an optical particle counter to identify tasks that generated pharmaceutical dust. We collected 72 inhalable dust air samples in or near the employees' breathing zones. In addition to gravimetric analysis, our contract laboratory used internal methods involving liquid chromatography to analyze these samples for active pharmaceutical ingredients (APIs) and/or lactose, an inactive filler in tablets. We had to choose samples for these additional analyses because many methods used different extraction solvents. We selected 57 samples for analysis of lactose. We used real-time particle monitoring results, observations, and information from employees on the dustiness of pharmaceuticals to select 28 samples (including 13 samples that were analyzed for lactose) for analysis of specific APIs. Pharmaceutical dust was generated during a variety of tasks like emptying and refilling of ADM canisters. Using compressed air to clean canisters and manual count machines produced the overall highest peak number concentrations (19,000-580,000 particles/L) of smallest particles (count median aerodynamic diameter ≤ 2 μm). Employees who refilled, cleaned, or repaired ADM canisters, or hand filled prescriptions were exposed to higher median air concentrations of lactose (5.0-12 μg/m(3)) than employees who did other jobs (0.04-1.3 μg/m(3)), such as administrative/office work, labeling/packaging, and verifying prescriptions. We detected 10 APIs in air, including lisinopril, a drug prescribed for high blood pressure, levothyroxine, a drug prescribed for hypothyroidism, and methotrexate, a hazardous drug prescribed for cancer and other disorders. Three air concentrations of lisinopril (1.8-2.7 μg/m(3)) exceeded the lower bound of the manufacturer's hazard control band (1-10 μg/m(3)). All other API air concentrations were below applicable occupational exposure limits. Our findings indicate that some pharmacy employees are exposed to multiple APIs and that measures are needed to control those exposures.
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ABSTRACT: The active ingredients used in the pharmaceutical industry's products are designed to modify biological processes; thus, if not adequately controlled, they can place employees at risk. This chapter provides an historical look at the need for occupational exposure limits, as well as an overview of the limit-setting process.Occupational medicine (Philadelphia, Pa.) 01/1997; 12(1):67-80.
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ABSTRACT: The presence of IgE-mediated occupational respiratory sensitization to microbial enzymes has been well documented in a variety of industries. Aspergillus oryzae -derived lactase is used as a dietary aid for patients with lactose intolerance. In 1993, a cross-sectional survey of 94 pharmaceutical workers exposed to lactase for a mean duration of 23 months and 24 nonexposed recently hired employees was initiated to identify lactase-sensitized workers and potential risk factors that could be used in making recommendations for preventing future cases of lactase sensitization. The survey included a physician-administered questionnaire, skin prick testing to lactase enzyme and a panel of common aeroallergens, and spirometry. Twenty-seven of 94 lactase-exposed workers (29%) had positive skin test responses to lactase. These workers were 9 times more likely to have upper or lower respiratory symptoms compared with workers with negative skin test responses. Atopic workers were 4 times more likely to have lactase skin sensitivity than nonatopic workers. However, atopy was not a risk factor for the development of upper and/or lower respiratory symptoms. Lactase skin reactivity was not observed in the 24 nonexposed employees. This cross-sectional survey revealed that atopic workers were more likely to have lactase sensitization and that lactase-sensitized workers were more likely to have upper and/or lower respiratory symptoms, but atopy was not a risk factor for upper or lower respiratory symptoms. In spite of these findings, the company allowed only nonatopic, nonlactase-sensitized workers to continue working in high lactase-exposure areas with careful symptom monitoring and use of protective clothing. Although this strategy was successful in total prevention of new cases of occupational respiratory disease after 5 years, the results of this cross-sectional survey do not support exclusion of atopic workers from working with industrial enzymes.Journal of Allergy and Clinical Immunology 07/1999; 103(6):1153-7. DOI:10.1016/S0091-6749(99)70192-2 · 11.25 Impact Factor
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ABSTRACT: Pharmaceutical workers may be at risk for the development of respiratory problems as a result of their work environment. This study investigated 163 female and 35 male workers, employed in a pharmaceutical plant processing different types of medication, primarily antibiotics, in order to characterize the risk of this environment. Chronic respiratory symptoms were recorded by using the British Medical Research Council questionnaire. Acute symptoms, which developed during the work shift, were also recorded. Ventilatory capacity was measured by recording maximum expiratory flow-volume (MEFV) curves on which FVC, FEV1, FEF50, and FEF25 were measured. Controls (113) were selected from a food packing facility. A significantly higher prevalence of chronic respiratory symptoms was recorded among workers (compared to controls), the highest being for sinusitis, nasal catarrh, and dyspnea. There was also a high prevalence of acute symptoms recorded during the workshift. Odds ratio showed that the most significant risk factors for these respiratory findings were smoking and length of time worked in the pharmaceutical industry, particularly in men. Pulmonary function testing demonstrated significantly decreased measured values in comparison to predicted European pulmonary function measurements (P < 0.01). This was particularly pronounced for FEF50 and FEF25, suggesting obstructive changes in smaller airways. Our data suggest that workers employed in the pharmaceutical industry may develop respiratory symptoms accompanied by ventilatory impairment.American Journal of Industrial Medicine 11/2004; 46(5):472-9. DOI:10.1002/ajim.20085 · 1.59 Impact Factor