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, 2013News 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