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
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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
News Continued from page 2100
NABP announced this past summer that it had reviewed nearly 11,000 Internet sites that sell medications and found that 97% appeared to be out of compliance with U.S. laws and pharmacy practice standards. Catizone said applicants for dotpharmacy domain names will be screened to ensure that they abide by all laws and regulations in the jurisdictions where they do business. He said NABP will make that determination for U.S. applicants, but pharmacies in other countries may also apply for the new domain designator. “If it’s outside the U.S., then we will have memoranda of understanding or agreements with regulators of countries around the world. And they will vet, for us, the legitimate pharmacies,” Catizone said. He said NABP will also work with FIP and LegitScripts, an Internet pharmacy monitoring and verification service, to verify the legitimacy of non-U.S. pharmacies that apply for a dot-pharmacy domain name. Catizone noted that familiar, existing websites won’t need to be scrapped or duplicated when they acquire a dot-pharmacy domain name. “It will simply be a site that will then redirect to a primary website,” he said. Several entities submitted formal objections to ICANN about NABP’s proposed policies for registering nonU.S. applicants. A common theme was that appropriately licensed and regulated pharmacies outside the United States would be prohibited from obtaining a dot-pharmacy domain name for the purpose of selling drugs to U.S. customers. According to the comments, excluding these pharmacies from the dot-pharmacy community would be anticompetitive and could decrease Americans’ access to low-cost medications from pharmacies operating outside of the United States. NABP’s response is that applicants must adhere to laws in their home countries and the jurisdictions where their medications are sold—and U.S. law prohibits the importation of prescription
2104
drug formulations that have not been approved by FDA. “If a pharmacy in Canada wanted a dotpharmacy [domain name], but they plan to ship [Canadian products] to the United States—which would be illegal—they wouldn’t be able to be issued a dotpharmacy” name, Catizone confirmed. Most U.S. states require all pharmacies that do business within the state, including Internet pharmacies, to be licensed in that state. This represents an additional hurdle for non-U.S. pharmacies that want to operate a “.pharmacy”designated website to sell medications to U.S. customers. NABP doesn’t regulate Internet pharmacies, but it does accredit them through a voluntary program established in 1999. Nearly 50 pharmacy websites are currently accredited through NABP’s Verified Internet Pharmacy Practice Sites program. Catizone said these pharmacies already meet the criteria for a dot-pharmacy domain name and would be able to obtain one without paying the usual fees. He said a tiered structure will be used to set fees for purchasing a dot-pharmacy domain name. In general, he said, a pharmacy would pay a $750 fee to the domain name registrar and $2000 to NABP to
evaluate the site and ensure that it qualifies for the domain. He noted that pharmacy-related websites would have exclusive rights to a dotpharmacy designation that corresponds to their registered trademarks. If these organizations choose not to apply for a dot-pharmacy domain name for their trademarks, NABP will not release the name to anyone else. “That’s an important difference compared to what some of the other domains have done,” Catizone said. He said generic domain designations like “diabetes.pharmacy” or “immunization.pharmacy” will also be available, and fees for such designations “will range anywhere from a few hundred dollars to upwards of $50,000.” NABP and its supporters hope that such sites would become trusted information portals for consumers. “Now, when you type in ‘diabetes,’ you can’t separate the commercial from the illegitimate from the really good sources,” he said. He said potential purchasers of generic dot-pharmacy domain names include drug manufacturers and nonprofit organizations. —Kate Traynor DOI 10.2146/news140086
Early clinical leader Lawrence Borgsdorf dies at 67
L
awrence R. Borgsdorf, Pharm.D., FCSHP, who started his decadeslong clinical pharmacy career as a fulltime practitioner–educator in a school of medicine, died on October 14 in Bakersfield, California. He was 67 years old. The unusual employment arrangement in the 1970s made the residencytrained Borgsdorf a clinical pharmacist independent of a pharmacy department and a pharmacy school.
Am J Health-Syst Pharm—Vol 71 Dec 15, 2014
Years later, as an ambulatory care pharmacist for the Kaiser Permanente Medical Program in his native California, he provided innovative services that caught the attention of the HMO’s physicians.
Lawrence R. Borgsdorf, circa 1990s
Continued on page 2106
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.
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
News Continued from page 2100
NABP announced this past summer that it had reviewed nearly 11,000 Internet sites that sell medications and found that 97% appeared to be out of compliance with U.S. laws and pharmacy practice standards. Catizone said applicants for dotpharmacy domain names will be screened to ensure that they abide by all laws and regulations in the jurisdictions where they do business. He said NABP will make that determination for U.S. applicants, but pharmacies in other countries may also apply for the new domain designator. “If it’s outside the U.S., then we will have memoranda of understanding or agreements with regulators of countries around the world. And they will vet, for us, the legitimate pharmacies,” Catizone said. He said NABP will also work with FIP and LegitScripts, an Internet pharmacy monitoring and verification service, to verify the legitimacy of non-U.S. pharmacies that apply for a dot-pharmacy domain name. Catizone noted that familiar, existing websites won’t need to be scrapped or duplicated when they acquire a dot-pharmacy domain name. “It will simply be a site that will then redirect to a primary website,” he said. Several entities submitted formal objections to ICANN about NABP’s proposed policies for registering nonU.S. applicants. A common theme was that appropriately licensed and regulated pharmacies outside the United States would be prohibited from obtaining a dot-pharmacy domain name for the purpose of selling drugs to U.S. customers. According to the comments, excluding these pharmacies from the dot-pharmacy community would be anticompetitive and could decrease Americans’ access to low-cost medications from pharmacies operating outside of the United States. NABP’s response is that applicants must adhere to laws in their home countries and the jurisdictions where their medications are sold—and U.S. law prohibits the importation of prescription
2104
drug formulations that have not been approved by FDA. “If a pharmacy in Canada wanted a dotpharmacy [domain name], but they plan to ship [Canadian products] to the United States—which would be illegal—they wouldn’t be able to be issued a dotpharmacy” name, Catizone confirmed. Most U.S. states require all pharmacies that do business within the state, including Internet pharmacies, to be licensed in that state. This represents an additional hurdle for non-U.S. pharmacies that want to operate a “.pharmacy”designated website to sell medications to U.S. customers. NABP doesn’t regulate Internet pharmacies, but it does accredit them through a voluntary program established in 1999. Nearly 50 pharmacy websites are currently accredited through NABP’s Verified Internet Pharmacy Practice Sites program. Catizone said these pharmacies already meet the criteria for a dot-pharmacy domain name and would be able to obtain one without paying the usual fees. He said a tiered structure will be used to set fees for purchasing a dot-pharmacy domain name. In general, he said, a pharmacy would pay a $750 fee to the domain name registrar and $2000 to NABP to
evaluate the site and ensure that it qualifies for the domain. He noted that pharmacy-related websites would have exclusive rights to a dotpharmacy designation that corresponds to their registered trademarks. If these organizations choose not to apply for a dot-pharmacy domain name for their trademarks, NABP will not release the name to anyone else. “That’s an important difference compared to what some of the other domains have done,” Catizone said. He said generic domain designations like “diabetes.pharmacy” or “immunization.pharmacy” will also be available, and fees for such designations “will range anywhere from a few hundred dollars to upwards of $50,000.” NABP and its supporters hope that such sites would become trusted information portals for consumers. “Now, when you type in ‘diabetes,’ you can’t separate the commercial from the illegitimate from the really good sources,” he said. He said potential purchasers of generic dot-pharmacy domain names include drug manufacturers and nonprofit organizations. —Kate Traynor DOI 10.2146/news140086
Early clinical leader Lawrence Borgsdorf dies at 67
L
awrence R. Borgsdorf, Pharm.D., FCSHP, who started his decadeslong clinical pharmacy career as a fulltime practitioner–educator in a school of medicine, died on October 14 in Bakersfield, California. He was 67 years old. The unusual employment arrangement in the 1970s made the residencytrained Borgsdorf a clinical pharmacist independent of a pharmacy department and a pharmacy school.
Am J Health-Syst Pharm—Vol 71 Dec 15, 2014
Years later, as an ambulatory care pharmacist for the Kaiser Permanente Medical Program in his native California, he provided innovative services that caught the attention of the HMO’s physicians.
Lawrence R. Borgsdorf, circa 1990s
Continued on page 2106
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.
