Purpose A survey of guidelines and current practices was conducted to examine the safe handling procedures for antineoplastic and other hazardous drugs that are used in 24 countries including the Americas, Europe, the Mideast, Far East, and Australia. Methods Subject experts were asked to complete a brief survey regarding safe handling guidelines and practices for hazardous drugs in their countries. Questions addressed practices for handling monoclonal antibodies, the use of closed-system transfer devices, medical surveillance practices, and measurements of compliance with existing guidelines. Results Responses from 37 subject experts representing 24 countries revealed considerable variation in the content and scope of safe handling guidelines and pharmacy practices among the participating countries. Guidelines in the majority of countries used the term "cytotoxics," while others referred to "hazardous" or "antineoplastic" drugs. The International Society of Oncology Pharmacy Practice standard was cited by six countries, and five cited the National Institute for Occupational Safety and Health Alert. Others cited international guidelines other than International Society of Oncology Pharmacy Practice, or they have created their own guidelines. Approximately half reported that their guidelines were mandatory under federal, state, or provincial legislation. Only 11 countries reported that monoclonal antibodies were covered in their guidelines. Closed-system drug-transfer devices are widely used, but were not specifically recommended in four countries, while one country required their use. Medical surveillance programs are in place in 20 countries, but only in The Netherlands is surveillance mandatory. Nine countries reported that they have completed recent updates or revisions of guidelines, and the measures for their adoption have been initiated. Conclusions Although the overall goals in the participating countries were similar, the approaches taken to assure safe handling of hazardous drugs varied considerably in some cases.

Due to concerns about exposure of health care workers to hazardous drugs, The National Institute for Occupational Safety and Health (NIOSH) convened a Hazardous Drug Working Group in 2000 in Washington, DC. The primary output of the group, which disbanded in 2007, was the 2004 publication of the NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings. This alert included a definition of hazardous drugs that was modified from a definition proposed by the American Society of Hospital Pharmacists (currently the American Society of Health-System Pharmacists). The 2004 alert included a sample, non-all-inclusive list of 136 drugs that should be handled as hazardous. It comprised lists being used at that time by four institutions: The National Institutes of Health, Johns Hopkins University, University of Michigan, and Northside Hospital in Atlanta. It also included a list generated by the Pharmaceutical Research and Manufacturers of America (PhRMA). At the time the 2004 Alert was published, NIOSH acknowledged that it would update the hazardous drug list as needed. After deciding on an approach and a mechanism to perform these updates, NIOSH reviewed all new drugs approved by the FDA and all new warnings on existing drugs from 2004 to 2007, to determine whether they qualified as hazardous under the NIOSH definition. This resulted in the official update that was published in 2010, which contained 31 additions to the original list. The list was updated a second time in 2012 with 33 additions and 15 removals. The Latest Update: The process of updating the hazardous drug list includes a number of steps and takes about two years to complete; therefore, the list is about two to three years out of date when it is published. Currently, the expert review panel is made up of at least 10 members representing pharmacy and nursing organizations (ASHP, Hematology/Oncology Pharmacy Association, Oncology Nursing Society, American Nurses Association), government (Food and Drug Administration, Department of Veterans Affairs, Occupational Safety and Health Administration), industry (Biological Industry Organization, drug manufacturers), and academia.

We read with interest the article by Traynor1 that appeared in the September 1 issue of AJHP and would like to clarify a potential misconception—that the National Institute for Occupational Safety and Health (NIOSH) recommends all hazardous drugs be handled in the same manner, regardless of dosage form. The 2004 NIOSH alert on this topic recommends a “universal” or “standard” precautions approach to safe handling but does not recommend that all formulations be handled in the same manner.2 | The NIOSH alert reflects an understanding that many factors affect the determination of handling procedures for hazardous drugs. The purpose of the list of hazardous drugs provided in the alert, updated in 2010 and 2012, is to identify hazardous drugs and assist health care facilities in developing their own risk management procedures based on the drugs and formulations used in their facility. The most recent update to the hazardous-drugs list states the following3: | Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (for example, coated tablets or capsules—solid, intact medications that are administered to patients without modifying the formulation). Uncoated tablets may present a risk of exposure from dust by skin contact and/or inhalation when the tablets are counted and if solid drug formulations are altered, such as by crushing tablets or making solutions from them.

An enzyme-linked immunosorbent assay (ELISA) kit made for determination of polycyclic aromatic compounds (PACs) in water was adapted for measuring PACs and their metabolites in urine. This method was then applied to a pilot asphalt worker PAC exposure study. Currently, liquid-liquid extraction with gas chromatography/isotope dilution high-resolution mass spectrometry (GC/HRMS) is the preferred method to determine urinary PAC metabolites. Although sensitive and specific, GC/HRMS is time consuming and costly. The ELISA method had a range from 14-720 ng/ml 1-hydroxypyrene equivalents with a lower limit of detection (LOD) of 14 ng/ml urine. ELISA and GC/HRMS PAC metabolite measurements had a statistically significant correlation and the PAC ELISA results were indicative of potential asphalt exposure. PAC ELISA is promising as a more rapid and less costly routine method for determining worker exposure to PACs in asphalt emissions.

Residual methamphetamine contamination in clandestine laboratories represents a hazard to emergency response personnel, remediation workers and the general public. To address this threat, two rapid, sensitive surface sampling techniques to assess the location and level of methamphetamine contamination were developed. Both methods employ established industrial hygiene surface sampling materials (wipes and swabs) but differ in their sensitivity and detection technology. One method, based on colorimetric disclosure, detects and confirms a collected sample or visible residues. The second method uses a lateral flow immunochemical assay (LFIA) for semi-quantitative detection of trace contamination. The National Institute for Occupational Safety and Health (NIOSH) partnered with public health agencies to develop applications of the methods for assessment of methamphetamine contamination of suspected properties. These applications focused on safe strategies for site assessment, hazard characterization, and remediation effectiveness. To conduct the field studies, NIOSH researchers and their partners visited more than a dozen suspected laboratories including mobile labs, abandoned properties, occupied residences, and motel rooms. NIOSH found greater than 95% agreement between positive identification of the presence of methamphetamine by LFIA and laboratory-based, liquid chromatography mass spectroscopy (LC- MS) methods. Test results were used to develop site assessments and make personal protective equipment recommendations. Results were also used to conduct process-based decontamination of properties and to make health-based decisions on remediation, re-occupancy of residences, as well as determine the degree of contamination of personal property in an inactive clandestine laboratory. By partnering with stakeholders, NIOSH was able to achieve two primary goals: (1) to develop a level of awareness in health department sanitarians, law enforcement personnel and other first responders that methamphetamine surface contamination was a potentially significant route of exposure; (2) to validate our methods in the field and to develop protocols for proper use and interpretation of the results.

BACKGROUND: Cigarette smoking is the major cause of chronic obstructive pulmonary disease, but studies on the contribution of other smoking techniques are sparse. OBJECTIVE: To determine whether pipe and cigar smoking was associated with elevated cotinine levels, decrements in lung function, and increased odds of airflow obstruction. DESIGN: Cross-sectional study. SETTING: Population-based sample from 6 U.S. communities. PARTICIPANTS: Men and women aged 48 to 90 years without clinical cardiovascular disease at enrollment who were part of MESA (Multi-Ethnic Study of Atherosclerosis). MEASUREMENTS: The MESA Lung Study measured spirometry according to American Thoracic Society guidelines and urine cotinine levels by immunoassay on a subsample of MESA. Pipe-years and cigar-years were calculated as years from self-reported age of starting to age of quitting (or to current age in current users) multiplied by pipe-bowls or cigars per day. RESULTS: Of 3528 participants, 9% reported pipe smoking (median, 15 pipe-years), 11% reported cigar smoking (median, 6 cigar-years), and 52% reported cigarette smoking (median, 18 pack-years). Self-reported current pipe and cigar smokers had elevated urine cotinine levels compared with never-smokers. Pipe-years were associated with decrements in FEV(1), and cigar-years were associated with decrements in the FEV(1)-FVC ratio. Participants who smoked pipes or cigars had increased odds of airflow obstruction whether they had also smoked cigarettes (odds ratio, 3.43 [95% CI, 1.75 to 6.71]; P < 0.001) or not (odds ratio, 2.31 [CI, 1.04 to 5.11]; P = 0.039) compared with participants with no smoking history. Limitation: Cross-sectional design. CONCLUSION: Pipe and cigar smoking increased urine cotinine levels and was associated with decreased lung function and increased odds of airflow obstruction, even in participants who had never smoked cigarettes. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute, National Institutes of Health.

BACKGROUND: Recent surveys suggest nail technicians, particularly artificial nail applicators, have increased respiratory symptoms and asthma risk. METHODS: We examined lung function (n = 62) and a marker of airway inflammation, i.e., exhaled nitric oxide (ENO) (n = 43), in a subset of nail technician and control participants in a pilot health assessment. RESULTS: Bivariate analysis of technicians demonstrated that job latency was inversely correlated with FEV1 percent predicted (FEV1PP) (r = -0.34, P = 0.03) and FVCPP (r = -0.32, P = 0.05). Acrylic gel contact hours were inversely correlated with FEV1PP (r = -0.38, P = 0.02) and FVCPP (r = -0.47, P = 0.003). Current smoking was inversely and significantly (P ≤ 0.05) associated with ENO in bivariate analysis. Log 10 ENO levels were directly correlated with job latency (P = 0.012) and gel nail application (P = 0.026) in multivariable analyses. CONCLUSIONS: These positive pilot respiratory test results warrant additional future investigation. Am. J. Ind. Med. (c) 2009 Wiley-Liss, Inc.