News home implementation models were in He said that military pharmacy pays a bit of money in the long term, when place for primary care settings in the attention to approaches that have proved we re not treating beneficiaries for the flu Army, Navy, and Air Force by 2011. beneficial elsewhere or complications of flu, " he said. According to a Government Account What we try to do is follow the best The population health focus fits in ibility Office report issued last year, commercial practices, when possible, with the military's quadruple aim of im DoD expects its investment in medi- he said proved health for service members, an en cal homes to total about $570 million McGinnis pointed to the increased use hanced experience of care, and lower per hrough fiscal year 2016 and to reap of pharmacist-vaccinators in community capita costs, all in support of readiness about $40 million in savings for the pharmacies as a positive practice change " Our highest priority is our troops, military health system by that time. that DoD pharmacy has embraced McGinnis said. Keeping them ready McGinnis said DoD pharmacists have Since December 2009, he said, phar- go to war is our highest priority. Keeping only recently been working in medical macists in DoD's community pharmacy their family members in good health is homes, but that work will expand network have administered more than important, too, so the active duty [per This is extremely important to 1 million vaccine doses of all types to son] doesn't have to worry about the the medical personnel in the medical military families. He expects to break the 2 family members homes, "McGinnis said. He explained million mark by the end of this flu season. -Kate Traynor that adding pharmacists to these teams McGinnis said 40,000 pharmacists in should reduce unnecessary and costly all 50 states are involved in this effort. DOI10.2146/ newsl30082 medication-related hospital visits and The goal is to get our vaccination rate as high as possible. This will save us quite Informed consent remains a work in progress That's one approach taken for a study St. Jude Children's Research Hospi Ithough patients who participate But Grady said that the research thats tal in Memphis, Tennessee, where the in research have been providing been done on the consent process shows pharmacist-led research team has created informed consent for decades, the issue wide variation in what patients under- an educational video for potentiaL t:OR of how to define consent and properly stand about their participation in clinical ticipants in the Clinical Implementat obtain it remains murky. studies of Pharmacogenetics(PG4KDS )study Informed consent is certainly not She cited reports showing that 28- The video is publicly available on the perfect in medical practice, "said Christine 100% of patients in different studies hospital's website and features discus Grady, chief of the bioethics department were able to name adverse events re- sions among the study investigators and at the National Institutes of Health Clini- lated to their experimental therapy, and family members of patients cal Center, during an October 30 presen- 21-42% correctly answered questions Led by Pharmaceutical Sciences Chair tation for a course on ethics and clinical about randomization. In other studies, Mary Relling, PG4KDS is a study in which research the percentage of patients who knew that genotyping of patients is done prospec- a We need new ways to present infor- they could quit their study ranged from tively to test for gene variations that may ation and help people understand what 44% to 90% response to drug studies are about before they enroll, "she Grady encouraged researchers to "PG4KDS is a protocol where we ask develop new ways to help patients un- the patients to participate in the study so For research involving FDA-regulated derstand what study participation means that we can use their pharmacogenetic drugs, informed consent entails provid- for them. profile to determine if there are certain ing patients with all of the information "There are many ways to present in- medications that they they need to decide whether to enroll formation besides written information, should not receive, be- in a study or continue participating in and we need to be creative with these," cause they might be at it. Federal regulations require that pa- she said increased risk of hav- tients understand the potential risks and Limited evidence suggests that audio- ing toxicity or not ben- benefits of participating in research and visual interventions may improve the efiting because of their also that they can decide to drop out of a informed-consent process, according to a genetic profile," said study at any time. 2008 Cochrane review Cyrine-Eliana Haidar,Cyrine-Eliana Haidar Am J Health-Syst Pharm--Vol 70 Dec 15,20132173
News Am J Health-Syst Pharm—Vol 70 Dec 15, 2013 2173 home implementation models were in place for primary care settings in the Army, Navy, and Air Force by 2011. According to a Government Accountability Office report issued last year, DoD expects its investment in medical homes to total about $570 million through fiscal year 2016 and to reap about $40 million in savings for the military health system by that time. McGinnis said DoD pharmacists have only recently been working in medical homes, but that work will expand. “This is extremely important to the medical personnel in the medical homes,” McGinnis said. He explained that adding pharmacists to these teams should reduce unnecessary and costly medication-related hospital visits and readmissions. He said that military pharmacy pays attention to approaches that have proved beneficial elsewhere. “What we try to do is follow the best commercial practices, when possible,” he said. McGinnis pointed to the increased use of pharmacist–vaccinators in community pharmacies as a positive practice change that DoD pharmacy has embraced. Since December 2009, he said, pharmacists in DoD’s community pharmacy network have administered more than 1 million vaccine doses of all types to military families. He expects to break the 2 million mark by the end of this flu season. McGinnis said 40,000 pharmacists in all 50 states are involved in this effort. “The goal is to get our vaccination rate as high as possible. This will save us quite a bit of money in the long term, when we’re not treating beneficiaries for the flu or complications of flu,” he said. The population health focus fits in with the military’s quadruple aim of improved health for service members, an enhanced experience of care, and lower per capita costs, all in support of readiness. “Our highest priority is our troops,” McGinnis said. “Keeping them ready to go to war is our highest priority. Keeping their family members in good health is important, too, so the active duty [person] doesn’t have to worry about the family members.” —Kate Traynor DOI 10.2146/news130082 Informed consent remains a work in progress Although patients who participate in research have been providing informed consent for decades, the issue of how to define consent and properly obtain it remains murky. “Informed consent is certainly not perfect in medical practice,” said Christine Grady, chief of the bioethics department at the National Institutes of Health Clinical Center, during an October 30 presentation for a course on ethics and clinical research. “We need new ways to present information and help people understand what studies are about before they enroll,” she said. For research involving FDA-regulated drugs, informed consent entails providing patients with all of the information they need to decide whether to enroll in a study or continue participating in it. Federal regulations require that patients understand the potential risks and benefits of participating in research and also that they can decide to drop out of a study at any time. But Grady said that the research that’s been done on the consent process shows wide variation in what patients understand about their participation in clinical studies. She cited reports showing that 28– 100% of patients in different studies were able to name adverse events related to their experimental therapy, and 21–42% correctly answered questions about randomization. In other studies, the percentage of patients who knew that they could quit their study ranged from 44% to 90%. Grady encouraged researchers to develop new ways to help patients understand what study participation means for them. “There are many ways to present information besides written information, and we need to be creative with these,” she said. Limited evidence suggests that audiovisual interventions may improve the informed-consent process, according to a 2008 Cochrane Review. That’s one approach taken for a study at St. Jude Children’s Research Hospital in Memphis, Tennessee, where the pharmacist-led research team has created an educational video for potential participants in the Clinical Implementation of Pharmacogenetics (PG4KDS) study. The video is publicly available on the hospital’s website and features discussions among the study investigators and family members of patients. Led by Pharmaceutical Sciences Chair Mary Relling, PG4KDS is a study in which genotyping of patients is done prospectively to test for gene variations that may affect the response to drug therapy. “PG4KDS is a protocol where we ask the patients to participate in the study so that we can use their pharmacogenetic profile to determine if there are certain medications that they should not receive, because they might be at increased risk of having toxicity or not benefiting because of their genetic profile,” said Cyrine-Eliana Haidar, Cyrine-Eliana Haidar Photo courtesy of Peter Barta, St. Jude Children's Research Hospital
News clinical pharmacogenetics coordinator Informed consent is required in some products. This issue was also discussed a for St. Jude. states for patients to receive collaborative decade ago in AJHP News Study data are kept behind a research drug therapy management services from At presstime, federal legislation that is firewall unless it's determined that in- a pharmacist. Pharmacists'direct in- meant to improve the safety and quality corporating specific genetic information volvement in this process varies by state. of compounded medications had passed into patients'medical records may help The Institute for Safe Medication PI the house and Senate. The legislation to guide current or future therapy. So far, tices last year raised the issue of whether does not mention informed consent. four genes affecting 12 drugs have made informed consent should be required be -Kate Traynor the move from the research lab to the fore patients receive compounded sterile DOI10.2146/news130083 clinical care setting Relling, in the video, said that although no adverse consequences are expected to result from having the information in the nedical record, once it's there, it stays there, and patients need to know that. video were presented in nontechnical L terms as much as possible to help viewers understand the inherently complex topic of pharmacogenetics. News briefs Pharmacy Forecast 2014-2018 trategic Planning Advice for Pharmacy "We think about consent here as more Departments in Hospitals and Health than them signing the piece of paper, Revision of the Basel Statements Systems becomes available in December. Haidar said from the Global Conference on the This report, from the ASHP Foundation Haidar serves on the institutional re- Future of Hospital Pharmacy in 2008 is Center for Health-System Pharmacy view board at St Jude, which ensures that underway. The Hospital Pharmacy Sec- Leadership, presents the results of a sur the content of consent forms is clear and tion of the International Pharmaceutical vey of trend watchers in health-system complete and matches the study protocol. Federation(FIP) has launched an online pharmacy(see figure for an excerpt), ForPg4Kds,sheeducatesthestudy'ssurveyatwww.surveymonkey.com/s/analyzestheirpredictionsandpresents nurses about pharmacogenetics so that FIPBaselStatementSurvey, to collect strategic recommendations to pharmacy they can accurately describe the study input from any individual interested in practice leaders. The intent of the report protocol to patients during enrollment. global pharmacy Section leaders will use is to help pharmacy practice leaders as Haidar said that although pharmacists that information to propose changes to sess the external environment in their don't typically participate in obtaining the Basel Statements and then conduct strategic planning for the next five years. informedconsentfrompatientstheycandiscussionsonthoseproposedchangesTheentirereportisavailableatwww.ashp help make the process better The plan is to finish revising the state- foundation. org/pharmacy forecast. A lot of times we get called in during ments at the 2014 FIP World Congress of when patients are be- Pharmacy and Pharmaceutical Sciences Quality of Care: In at least 75%of hos- ing enrolled on a study, because the par- in Bangkok, Thailand. ents or the teenager asks a question abou accountable for contributing measur now the medicine works, or what the ma- ASHP Chief Executive officer ably to improvement of institutional performance on externally reported jor side effects of the medicine are,"she Paul w. Abramowitz, Pharm. D,"core"indicators of quality and safety aid. "So I definitely think there's a role Sc D.(Hon), FASHP for the pharmacist to be available dur- attended the Virginia ing the consent process and help explain Society of Health- to the patients the adverse effects of the System Pharmacists medicines that they're going to receive. "(VSHP)Fall Meeting In addition to clinical research, in n Norfolk on October formed consent is also a key element in 18. He delivered the certain FDA-mandated risk evaluation keynote presentation,"Transform and mitigation strategies(REMS). Nearly ing Patient Care: Paramount Issues all informed-consent elements found in and Opportunities in Pharmacy REMS deal with teratogenicity, and the Practice," and met with VSHP prescriber must obtain the informed leadership 2174 Am J Health-Syst Pharm--Vol 70 Dec 15, 2013
News 2174 Am J Health-Syst Pharm—Vol 70 Dec 15, 2013 News Briefs clinical pharmacogenetics coordinator for St. Jude. Study data are kept behind a research firewall unless it’s determined that incorporating specific genetic information into patients’ medical records may help to guide current or future therapy. So far, four genes affecting 12 drugs have made the move from the research lab to the clinical care setting. Relling, in the video, said that although no adverse consequences are expected to result from having the information in the medical record, once it’s there, it stays there, and patients need to know that. Haidar said the discussions in the video were presented in nontechnical terms as much as possible to help viewers understand the inherently complex topic of pharmacogenetics. “We think about consent here as more than them signing the piece of paper,” Haidar said. Haidar serves on the institutional review board at St. Jude, which ensures that the content of consent forms is clear and complete and matches the study protocol. For PG4KDS, she educates the study’s nurses about pharmacogenetics so that they can accurately describe the study protocol to patients during enrollment. Haidar said that although pharmacists don’t typically participate in obtaining informed consent from patients, they can help make the process better. “A lot of times we get called in during the consent process when patients are being enrolled on a study, because the parents or the teenager asks a question about how the medicine works, or what the major side effects of the medicine are,” she said. “So I definitely think there’s a role for the pharmacist to be available during the consent process and help explain to the patients the adverse effects of the medicines that they’re going to receive.” In addition to clinical research, informed consent is also a key element in certain FDA-mandated risk evaluation and mitigation strategies (REMS). Nearly all informed-consent elements found in REMS deal with teratogenicity, and the prescriber must obtain the informed consent. Informed consent is required in some states for patients to receive collaborative drug therapy management services from a pharmacist. Pharmacists’ direct involvement in this process varies by state. The Institute for Safe Medication Practices last year raised the issue of whether informed consent should be required before patients receive compounded sterile products. This issue was also discussed a decade ago in AJHP News. At presstime, federal legislation that is meant to improve the safety and quality of compounded medications had passed the House and Senate. The legislation does not mention informed consent. —Kate Traynor DOI 10.2146/news130083 • Revision of the Basel Statements from the Global Conference on the Future of Hospital Pharmacy in 2008 is underway. The Hospital Pharmacy Section of the International Pharmaceutical Federation (FIP) has launched an online survey, at www.surveymonkey.com/s/ FIPBaselStatementSurvey, to collect input from any individual interested in global pharmacy. Section leaders will use that information to propose changes to the Basel Statements and then conduct discussions on those proposed changes. The plan is to finish revising the statements at the 2014 FIP World Congress of Pharmacy and Pharmaceutical Sciences in Bangkok, Thailand. • Pharmacy Forecast 2014-2018: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems becomes available in December. This report, from the ASHP Foundation Center for Health-System Pharmacy Leadership, presents the results of a survey of trend watchers in health-system pharmacy (see figure for an excerpt), analyzes their predictions, and presents strategic recommendations to pharmacy practice leaders. The intent of the report is to help pharmacy practice leaders assess the external environment in their strategic planning for the next five years. The entire report is available at www.ashp foundation.org/pharmacyforecast. Quality of Care: In at least 75% of hospitals, pharmacy departments will be accountable for contributing measurably to improvement of institutional performance on externally reported “core” indicators of quality and safety. ASHP Chief Executive Officer Paul W. Abramowitz, Pharm.D., Sc.D. (Hon), FASHP, attended the Virginia Society of HealthSystem Pharmacists (VSHP) Fall Meeting in Norfolk on October 18. He delivered the keynote presentation, “Transforming Patient Care: Paramount Issues and Opportunities in Pharmacy Practice,” and met with VSHP leadership. 68% 28% 3% 1% 0% 20% 40% 60% 80% Very Likely Somewhat Likely Somewhat Unlikely Very Unlikely
