Earlene Lipowski

Evaluation of FDA safety-related drug label changes in 2010

This study characterizes drug safety‐related label changes by evidence source contribution, time from drug approval to label change, initiator (FDA or sponsor), and drug class.

Developing great research questions

PURPOSE The process for developing a good research question is described. SUMMARY Three steps comprise the formulation of a great research question: (1) ask interesting questions, (2) select the best question for research, and (3) transform the research question into a testable hypothesis. Research is designed to generate information that cannot be gained from any other source. A research question is a narrow, challenging question addressing an issue, problem, or controversy that is answered with a conclusion based on the analysis and interpretation of evidence. A variety of strategies can be applied to stimulate creative thinking and generate new insights into old problems. A good research question challenges researchers to see matters from a new perspective and to learn something new. Practice research questions are evaluated by the probability of achieving their goal, along with the potential impact and feasibility of the project. The proposed research must meet important professional and societal goals, fit with the mission of the organization, garner administrative support, and be accomplished with available resources in a reasonable time frame. The research question should be refined to generate one or more hypotheses that specify the nature of the relationships to be observed and measured. Properly formulated questions yield findings to inform decisions that enhance practice, transfer to other settings, and make efficient use of resources. CONCLUSION Developing a good research question is the most important part of the research process. The question should be narrow and address an important issue that fits within the mission of the organization.

Pharmacy practice-based research networks: Why, what, who, and how

OBJECTIVES To describe practice innovations that can lead to measurable advances in the safety and effectiveness of medication use and to recommend a course of action that is likely to lead to practicable improvements in the medication use system. DATA SOURCES Proceedings of a national conference; review of the medical literature. DATA SYNTHESIS Only those interventions that can be reliably implemented by typical practitioners in a wide range of practice settings can produce lasting benefits for considerable numbers of patients. Teamwork between and among disciplines is needed for new insights and novel approaches to delivering pharmaceutical products and services. Building on the experience of other health disciplines, a cross section of pharmacy practitioners, researchers, educators, and leaders were able to identify the key questions, strategies, and actions needed to form collaborations for devising and testing new ideas and transferring the findings into everyday practice. CONCLUSION Pharmacy practice research that leads to improvements in the medication use process is needed. Practice-based research networks provide a model for building a synergy among pharmacists and other stakeholders to devise improvements that provide sustainable and systemwide improvements in medication use.

Physicians’ intent to comply with the American Medical Association’s guidelines on gifts from the pharmaceutical industry

Objective: To identify factors that predict physicians’ intent to comply with the American Medical Association’s (AMA’s) ethical guidelines on gifts from the pharmaceutical industry. Methods: A survey was designed and mailed in June 2004 to a random sample of 850 physicians in Florida, USA, excluding physicians with inactive licences, incomplete addresses, addresses in other states and pretest participants. Factor analysis extracted six factors: attitude towards following the guidelines, subjective norms (eg, peers, patients, etc), facilitating conditions (eg, knowledge of the guidelines, etc), profession-specific precedents (eg, institution’s policies, etc), individual-specific precedents (physicians’ own discretion, policies, etc) and intent. Multivariate regression modelling was conducted. Results: Surveys were received from 213 physicians representing all specialties, with a net response rate of 25.5%. 62% (n = 133) of respondents were aware of the guidelines; 50% (n = 107) had read them. 48% (n = 102) thought that following the guidelines would increase physicians’ credibility and professional image; 68% (n = 145) agreed that it was important to do so. Intent to comply was positively associated with attitude, subjective norms, facilitators and sponsorship of continuing medical education (CME) events, while individual-specific precedents had a negative relationship with intent to comply. Predictors of intent (R2 = 0.52, p <0) were attitude, subjective norms, the interaction term (attitude and subjective norms), sponsorship of CME events and individual-specific precedents. Conclusions: Physicians are more likely to follow the AMA guidelines if they have positive attitudes towards the guidelines, greater subjective norms, fewer expectations of CME sponsorship and fewer individual-specific precedents. Physicians believing that important individuals or organisations expect them to comply with the guidelines are more likely to express intent, despite having fewer beliefs that positive outcomes would result through compliance.

Considerations for embracing and expanding community engaged scholarship in academic pharmacy: Report of the 2013-2014 research and graduate affairs committee.

The Bylaws of the American Association of Colleges of Pharmacy (AACP) charge the Research and Graduate Affairs committee (RGAC) with the development of the Association’s research, graduate education and scholarship agenda.1 To this end, the RGAC met in Crystal City, VA on October 28 and 29, 2013, to begin deliberating on the charges for 2013-14. The committee subsequently conducted frequent conference calls and electronic communications throughout the year to prepare this report.

Professionalism in Pharmacy

Professionalism. Have you heard that word lately? Pharmacists are greatly concerned about professionalism among pharmacy students and peers. Many in the forefront of the profession are searching for ways to “reprofessionalize” pharmacy or to enable pharmacists to better function as the professionals they are trained to be. The 2003 APhA House of Delegates debated and passed several new policy items that address specific concerns of the pharmacy community, and each of these has a direct impact on professionalism. Learning Professionalism From a Distance How did you learn to be a professional? Was it through face-to-face interaction with faculty, daily contact with practitioners at work, modeling by pharmacist preceptors, or involvement with the activities of the APhA Academy of Students of Pharmacy (APhA –ASP)? Who can say definitely what educational process is optimal for producing high quality professionals? Providing education on professionalism is not solely the responsibility of the academic community or the American Council on Pharmaceutical Education (ACPE). Every pharmacist is a stakeholder in the future of pharmacy, and, in large part, the shape the future takes will depend on what pharmacy students learn during their education. The APhA House expressed this sentiment clearly in passing a policy item related to distance education. Although practitioners have often participated in continuing education programming or other types of postgraduation distance education, few have had experience with undergraduate programs that are entirely or extensively delivered from a distance. Some people do not understand how the programs are intended to work, and being

Achieving recognition as patient-centered care providers: We are our own best advocates

As much as getting involved in the political process is unappealing, every decision that affects our profession is a political decision. Currently, we are battling pharmacy benefit managers in an effort to ne gotiate fair audit practices, Medicaid cuts to pharmacies for medication reimbursement, and overuse and misuse of opiates resulting in cumbersome documentation. Neglecting to closely monitor legislation addressing the practice of pharmacy may result in state laws being passed that have a negative effect on our practices for years to come. Actively educating our legislators regarding the impact on safe patient care and cost effectiveness is in our best interest as professionals.

Academies Bring Forth a Unified Voice During House Proceedings

“In an unprecedented spirit of bipartisanship, the House passed several policies that all parties had agreed upon.” If only that statement could apply to national or state legislators as it did for the House of Delegates at APhA2005, the American Pharmacists Association (APhA) Annual Meeting in Orlando, Fla. Several policies brought before the House were jointly crafted and agreed upon in working groups by members of APhA’s Academy of Pharmacy Practice and Management (APhA–APPM) and Academy of Pharmaceutical Research and Science (APhA–APRS). The positive outcomes achieved when pharmacy science and pharmacy practice unite highlighted House of Delegate activities this year. Three policies were adopted that came to life through this process. The first policy, “Public Access to Clinical Trials Data,” supports access by health professionals and the public to all clinical trial data derived from scientifically valid studies. APhA supports the establishment of a single, independent, publicly accessible clinical trials database that includes, but is not limited to, several components that are delineated in the policy. Although APhA is totally supportive of this concept, whether it will come to fruition is anybody’s bet—and one that I’m not willing to make. Although burdensome to administer, it would be beneficial to have a centralized database for clinical trial data. The second policy, “Compounding with MultiComponent Vehicles,” highlighted APhA’s continuing concern with the safety and efficacy of components pharmacists use in compounding practice. APhA believes it is incumbent on manufacturers of multicomponent vehicles to restrict claims about these vehicles to structure and function of the ingredients unless clinical evidence exists to support more specific claims. The third policy, “Efforts to Limit Methamphetamine Access,” has aspects that some people believe will turn pharmacists into “meth policemen.” I guess to some extent that is the case. However, living in Kentucky, where methamphetamine abuse is Academies Bring Forth a Unified Voice During House Proceedings rampant, I must say that pharmacists are the most logical point in the health care system to try and stem this tide. Pharmacists are educated about drug diversion as well as drug abuse and its prevention. They are readily available for patient education. They routinely provide employee education and are active in community organizations that would be involved in this battle. From my point of view, I am glad APhA has taken a public stand: everyone must understand this monumental problem facing the country and that pharmacists are willing and able to be part of the solution.

Judging a book by its cover: the predicament with Canadian pharmacy advertisements and American consumers.

An increasing proportion of the health care dollar is spent on prescription drugs, these medications are costly, and the elderly are paying proportionally more of their income on prescriptions than the general population, according to recent estimates.1,2 Although drug importation is illegal, Americans are crossing borders in search of price relief by traveling to pharmacies in Canada or Mexico, ordering from non–U.S. Internet pharmacies, or becoming clients of local storefront pharmacies that serve as liaisons with pharmacies in countries other than the United States. In response, organizations and trade groups have offered suggestions for judging the quality Internet pharmacies. These recommendations can be used as benchmarks in assessing pharmacy Web sites. The following examines the extension of the recommendations to Canadian pharmacy newspaper advertisements. The purpose of the analysis is neither to endorse nor condemn importation, but to determine whether consumers have adequate information to make educated decisions about importing.