News
Also at the hearing were advisory group chair Katelyn Dervay of Tampa General Hospital and former advisory group member Suprat S. Wilson of Detroit Receiving Hospital. Prince said New York ACEP’s members strongly believe that “having 24-hour-
a-day pharmacists in our emergency departments is a good safety practice.” But that safety practice, she added, can be “very expensive.” A policy statement by ACEP in support of clinical pharmacy services in the ED may encourage hospital systems to
NIOSH revamps hazardous drugs update
T
he National Institute for Occupational Safety and Health (NIOSH), in its latest revision to the list of hazardous drugs in healthcare facilities, has adopted an approach that takes into account workers’ exposure risks and categorizes hazardous drugs by type. “This is a huge step forward in presenting the information,” said Annie Lambert, pharmacy manager for oncology and ambulatory infusion services at MultiCare Health System in Tacoma, Washington. Unlike the 2012 version, Annie Lambert the 2014 edition of the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings divides hazardous drugs into three groups, with some overlap: antineoplastic drugs, nonantineoplastic drugs, and drugs whose hazards primarily pose reproductive risks to certain men or women. Exposure to drugs in the latter category may not pose a serious risk to some workers, according to NIOSH. But the agency noted that it has not attempted to define exposure limits or perform risk assessments for any hazardous drug. The 2014 document states that some dosage formulations of hazardous drugs, such as capsules and coated tablets, may not pose a “significant” exposure risk to healthcare workers who handle the medications without altering them. But crushing tablets or preparing solutions
of hazardous drugs may increase the exposure risk. NIOSH stated that all hazardous drugs, regardless of their formulation, should be labeled as hazardous to prevent improper handling. To help healthcare facilities manage exposure risks, the 2014 update contains recommendations for the use of personal protective equipment (PPE) in specific situations. According to NIOSH, a single set of gloves may be all the PPE necessary for a healthcare worker to administer an intact tablet or capsule from unit dose packaging. But preparing an i.v. solution of a hazardous drug may require double gloves, a protective gown, eye and respiratory protection, and the use of a biological safety cabinet and closed-system drugtransfer device. ASHP, in its official comments to NIOSH about the proposed 2014 update, generally supported the agency’s approach to revising the document and providing recommendations for the use of PPE. The list and PPE recommendations are particularly relevant to Lambert in her work on a subcommittee to implement a 2011 Washington state law that protects healthcare workers against exposure to hazardous drugs. That law requires employers in healthcare facilities where workplace exposures may occur to implement a
consider paying for those services for safety purposes, Prince said. —Cheryl A. Thompson DOI 10.2146/news140084
hazardous drugs control program by January 2015 that is consistent with the NIOSH recommendations. “Here in Washington state . . . we must adopt the NIOSH list,” Lambert said. “We can always add things to it, but we have to take the NIOSH list for what it is.” But she said healthcare facilities in the state have “a lot of leeway” to craft policies for the use of PPE to protect workers in settings and situations with different exposure risks. At her hospital, she said, “everyone agrees that we’re going to gown up and glove up and do everything we can to protect our workers during the highestrisk activities, such as i.v. chemotherapy compounding and administration.” But in the health system’s community pharmacies and standard nursing units, she said, elaborate gowning and masking is probably “excessive,” and she expects policies for those areas to reflect that. California and North Carolina in 2013 enacted laws that require healthcare facilities to develop policies and procedures to protect workers from hazardous drugs. But the regulations apply only to NIOSH-designated antineoplastic drugs, not all drugs deemed hazardous by NIOSH. The United States Pharmacopeial Convention (USP) is developing a general chapter (chapter 800) on the handling of hazardous drugs in the workplace. A proposed version of the chapter that was released for comment this past March required healthcare settings to designate as hazardous all drugs on the NIOSH list.
Am J Health-Syst Pharm—Vol 71 Dec 15, 2014
2099
News
USP in October announced that it is revising the proposed chapter in response to public comments, and a new version is expected to be available for review by April of 2015. Once finalized, general chapters may be adopted for enforcement by federal, state, and local regulatory bodies. For 2014, the NIOSH list contains 27 drugs that weren’t on the previous list and eliminates one drug—tetracycline— in response to comments from stakeholders, according to the agency. Bruce Chaffee, strategic project coordinator and adjunct clinical associate professor at the University of Michigan Health System and College of Pharmacy Bruce Chaffee in Ann Arbor, said his institution reviews each NIOSH hazardous
drugs list when it comes out. But he said that the health system doesn’t wait for NIOSH before making changes. “Any time we add something to the formulary, we review it for its hazardous potential,” Chaffee said. “The challenge that we have is to correlate what NIOSH has done with what we have ruled and try to understand why there may be similarities or differences in the lists.” Chaffee said his hospital generally excludes monoclonal antibody products from its hazardous drugs list even though NIOSH typically designates some of these products as hazardous. But he said that because these products are prepared in an “oncology area” using closed–system techniques to maintain sterility, they are essentially handled as if they are hazardous anyway.
New Internet domain launched for pharmacy community
W
ith its launch of a new family of Internet domain names, the National Association of Boards of Pharmacy (NABP) hopes to establish a safe place within cyberspace for consumers to purchase and get facts about medications. NABP plans a phased rollout of the “.pharmacy” domain name starting in mid-December, with most registrations occurring in 2015, according to the organization’s website. NABP member boards of pharmacy will be the first entities eligible to register a domain, followed by holders of pharmacy-related trademarks. Next, NABP-accredited Internet pharmacies, other pharmacies, and other purveyors of pharmacy-related products, services, and information will be eligible to register a dot-pharmacy domain. According to NABP, the dot-pharmacy domain project is meant to serve the
2100
needs of Internet, community, and veterinary pharmacies; pharmacy schools and other providers of pharmacy education; drug manufacturers and distributers; patient advocacy organizations; drug information groups; healthcare providers; and other medication-related entities. The Internet Corporation for Assigned Names and Numbers (ICANN)—the worldwide regulator of naming systems for the Internet—calls the character sets that make up the domain names “strings.” The organization released the “pharmacy” string to NABP on September 5 as part of a major expansion of so-called generic top-level domains. ICANN stated that the expansion could lead to the release of more than 1300 strings for generic top-level domains within a few years, joining the better-known strings com, org, gov, and edu. Strings that have been released this
Am J Health-Syst Pharm—Vol 71 Dec 15, 2014
Chaffee said every drug has “some potential for toxicity,” and protecting workers from all occupational exposures would be ideal. “The challenge we all have—we have it, manufacturers have it—is that there’s really not a lot of research in this area,” Chaffee said. For example, he said, it’s usually not possible to be certain that a particular brand of glove will protect workers from exposure to specific drugs because permeability testing hasn’t been done on all drug–glove combinations. “There needs to be more funding for evaluating the impact of hazardous drugs in the workplace,” Chaffee said. —Kate Traynor DOI 10.2146/news140085
year include healthcare, fitness, college, and pizza. In its application to ICANN, NABP stated that it represents a coalition of U.S. and international pharmacy groups and associations whose goals include providing a trusted Internet space for consumers and preventing the dot-pharmacy domain from being associated with fraudulent activity. Specific partners named by NABP in the domain initiative include the International Pharmaceutical Federation (FIP), the Alliance for Safe Online Pharmacies, Eli Lilly and Company, the European Alliance for Access to Safe Medicines, Gilead Sciences, Janssen Pharmaceuticals, and state boards of pharmacy. “We were approached by various stakeholders in the pharmacy community that saw a problem with rogue [Internet] pharmacies and counterfeit drugs,” explained NABP Executive Director Carmen A. Catizone in an interview. Continued on page 2104
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Also at the hearing were advisory group chair Katelyn Dervay of Tampa General Hospital and former advisory group member Suprat S. Wilson of Detroit Receiving Hospital. Prince said New York ACEP’s members strongly believe that “having 24-hour-
a-day pharmacists in our emergency departments is a good safety practice.” But that safety practice, she added, can be “very expensive.” A policy statement by ACEP in support of clinical pharmacy services in the ED may encourage hospital systems to
NIOSH revamps hazardous drugs update
T
he National Institute for Occupational Safety and Health (NIOSH), in its latest revision to the list of hazardous drugs in healthcare facilities, has adopted an approach that takes into account workers’ exposure risks and categorizes hazardous drugs by type. “This is a huge step forward in presenting the information,” said Annie Lambert, pharmacy manager for oncology and ambulatory infusion services at MultiCare Health System in Tacoma, Washington. Unlike the 2012 version, Annie Lambert the 2014 edition of the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings divides hazardous drugs into three groups, with some overlap: antineoplastic drugs, nonantineoplastic drugs, and drugs whose hazards primarily pose reproductive risks to certain men or women. Exposure to drugs in the latter category may not pose a serious risk to some workers, according to NIOSH. But the agency noted that it has not attempted to define exposure limits or perform risk assessments for any hazardous drug. The 2014 document states that some dosage formulations of hazardous drugs, such as capsules and coated tablets, may not pose a “significant” exposure risk to healthcare workers who handle the medications without altering them. But crushing tablets or preparing solutions
of hazardous drugs may increase the exposure risk. NIOSH stated that all hazardous drugs, regardless of their formulation, should be labeled as hazardous to prevent improper handling. To help healthcare facilities manage exposure risks, the 2014 update contains recommendations for the use of personal protective equipment (PPE) in specific situations. According to NIOSH, a single set of gloves may be all the PPE necessary for a healthcare worker to administer an intact tablet or capsule from unit dose packaging. But preparing an i.v. solution of a hazardous drug may require double gloves, a protective gown, eye and respiratory protection, and the use of a biological safety cabinet and closed-system drugtransfer device. ASHP, in its official comments to NIOSH about the proposed 2014 update, generally supported the agency’s approach to revising the document and providing recommendations for the use of PPE. The list and PPE recommendations are particularly relevant to Lambert in her work on a subcommittee to implement a 2011 Washington state law that protects healthcare workers against exposure to hazardous drugs. That law requires employers in healthcare facilities where workplace exposures may occur to implement a
consider paying for those services for safety purposes, Prince said. —Cheryl A. Thompson DOI 10.2146/news140084
hazardous drugs control program by January 2015 that is consistent with the NIOSH recommendations. “Here in Washington state . . . we must adopt the NIOSH list,” Lambert said. “We can always add things to it, but we have to take the NIOSH list for what it is.” But she said healthcare facilities in the state have “a lot of leeway” to craft policies for the use of PPE to protect workers in settings and situations with different exposure risks. At her hospital, she said, “everyone agrees that we’re going to gown up and glove up and do everything we can to protect our workers during the highestrisk activities, such as i.v. chemotherapy compounding and administration.” But in the health system’s community pharmacies and standard nursing units, she said, elaborate gowning and masking is probably “excessive,” and she expects policies for those areas to reflect that. California and North Carolina in 2013 enacted laws that require healthcare facilities to develop policies and procedures to protect workers from hazardous drugs. But the regulations apply only to NIOSH-designated antineoplastic drugs, not all drugs deemed hazardous by NIOSH. The United States Pharmacopeial Convention (USP) is developing a general chapter (chapter 800) on the handling of hazardous drugs in the workplace. A proposed version of the chapter that was released for comment this past March required healthcare settings to designate as hazardous all drugs on the NIOSH list.
Am J Health-Syst Pharm—Vol 71 Dec 15, 2014
2099
News
USP in October announced that it is revising the proposed chapter in response to public comments, and a new version is expected to be available for review by April of 2015. Once finalized, general chapters may be adopted for enforcement by federal, state, and local regulatory bodies. For 2014, the NIOSH list contains 27 drugs that weren’t on the previous list and eliminates one drug—tetracycline— in response to comments from stakeholders, according to the agency. Bruce Chaffee, strategic project coordinator and adjunct clinical associate professor at the University of Michigan Health System and College of Pharmacy Bruce Chaffee in Ann Arbor, said his institution reviews each NIOSH hazardous
drugs list when it comes out. But he said that the health system doesn’t wait for NIOSH before making changes. “Any time we add something to the formulary, we review it for its hazardous potential,” Chaffee said. “The challenge that we have is to correlate what NIOSH has done with what we have ruled and try to understand why there may be similarities or differences in the lists.” Chaffee said his hospital generally excludes monoclonal antibody products from its hazardous drugs list even though NIOSH typically designates some of these products as hazardous. But he said that because these products are prepared in an “oncology area” using closed–system techniques to maintain sterility, they are essentially handled as if they are hazardous anyway.
New Internet domain launched for pharmacy community
W
ith its launch of a new family of Internet domain names, the National Association of Boards of Pharmacy (NABP) hopes to establish a safe place within cyberspace for consumers to purchase and get facts about medications. NABP plans a phased rollout of the “.pharmacy” domain name starting in mid-December, with most registrations occurring in 2015, according to the organization’s website. NABP member boards of pharmacy will be the first entities eligible to register a domain, followed by holders of pharmacy-related trademarks. Next, NABP-accredited Internet pharmacies, other pharmacies, and other purveyors of pharmacy-related products, services, and information will be eligible to register a dot-pharmacy domain. According to NABP, the dot-pharmacy domain project is meant to serve the
2100
needs of Internet, community, and veterinary pharmacies; pharmacy schools and other providers of pharmacy education; drug manufacturers and distributers; patient advocacy organizations; drug information groups; healthcare providers; and other medication-related entities. The Internet Corporation for Assigned Names and Numbers (ICANN)—the worldwide regulator of naming systems for the Internet—calls the character sets that make up the domain names “strings.” The organization released the “pharmacy” string to NABP on September 5 as part of a major expansion of so-called generic top-level domains. ICANN stated that the expansion could lead to the release of more than 1300 strings for generic top-level domains within a few years, joining the better-known strings com, org, gov, and edu. Strings that have been released this
Am J Health-Syst Pharm—Vol 71 Dec 15, 2014
Chaffee said every drug has “some potential for toxicity,” and protecting workers from all occupational exposures would be ideal. “The challenge we all have—we have it, manufacturers have it—is that there’s really not a lot of research in this area,” Chaffee said. For example, he said, it’s usually not possible to be certain that a particular brand of glove will protect workers from exposure to specific drugs because permeability testing hasn’t been done on all drug–glove combinations. “There needs to be more funding for evaluating the impact of hazardous drugs in the workplace,” Chaffee said. —Kate Traynor DOI 10.2146/news140085
year include healthcare, fitness, college, and pizza. In its application to ICANN, NABP stated that it represents a coalition of U.S. and international pharmacy groups and associations whose goals include providing a trusted Internet space for consumers and preventing the dot-pharmacy domain from being associated with fraudulent activity. Specific partners named by NABP in the domain initiative include the International Pharmaceutical Federation (FIP), the Alliance for Safe Online Pharmacies, Eli Lilly and Company, the European Alliance for Access to Safe Medicines, Gilead Sciences, Janssen Pharmaceuticals, and state boards of pharmacy. “We were approached by various stakeholders in the pharmacy community that saw a problem with rogue [Internet] pharmacies and counterfeit drugs,” explained NABP Executive Director Carmen A. Catizone in an interview. Continued on page 2104
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
