Stephen W. Schondelmeyer

Prescribing problems and pharmacist interventions in community practice.

Interventions performed by 89 community pharmacists in 5 states to correct the prescribing problems they identified on new prescription orders were documented by trained observers. Pharmacists intervened to resolve a prescribingrelated problem in 623 (1.9%) of 33,011 new prescription orders that were screened and dispensed during the study period. A panel of three expert evaluators concluded that 28.3% of the prescribing problems identified during the study could have caused patient harm if the pharmacist had not intervened to correct the problem. The rate at which pharmacists identified prescribing problems was negatively related to the number of prescriptions they dispensed per hour, suggesting that in pursuing distributive efficiency, some pharmacists may be exceeding their safe dispensing threshold. The authors recommend that the interprofessional system of oversight and verification (i.e., “checks and balances”) in the delivery of pharmaceutical care in the community setting should be maintained and strengthened.

Economic analysis of health care technology: A report on principles

Preamble Although economic outcomes research is an evolving field in health services research, there are correct and incorrect ways to conduct and report on economic outcomes studies. Research practices that help to minimize real or perceived bias will increase the quality and usefulness of such studies for those who sponsor, publish, and use them. Because of public concerns about the potential for bias in the design, analysis, and reporting of economic analyses of health care technology, we formed a task force to develop principles to enhance the credibility of these studies. The Task Force on Principles for Economic Analysis of Health Care Technology included participants from academia, the pharmaceutical industry, the public sector, and private research organizations. As health care resources become increasingly constrained, the information used to make resource allocation decisions must be as reliable, valid, and free of bias as possible. Getting it right at the level at which economic results are produced will help to protect consumers and will advance the health of the public. Bias stems from two broad categories: lack of appropriate independence for researchers and lack of consensus about methods. We focused heavily on the first of these categories for two major reasons. First, few have yet considered the unique issues of researcher independence in economic outcomes research [1, 2]. Second, other investigators have begun to consider and define proper methods for economic outcomes work (an area of considerable controversy) [3-5]. We also looked closely at the requirements for the reporting of economic analyses, which are intended to ensure methodologic transparency and accountability. The Need for Voluntary Guidelines Widespread use of economic analysis as part of the development of pharmaceutical, biotechnologic, and medical devices is relatively new. To date, many economic analyses of health care have focused on pharmaceutical agents, and many such studies have been funded by pharmaceutical companies. Results of these economic outcomes studies are used by medical technology firms to support the pricing and marketing of new interventions and to influence national health care systems and third-party payers in their development of coverage and payment decisions. Managed care organizations, hospitals, and government-subsidized health care programs rely on economic analysis of medical technology to help make formulary purchasing and utilization decisions. Physicians may use the results of these analyses to help guide treatment and prescription decisions. Health care economic outcomes projects are sponsored and conducted by pharmaceutical, biotechnologic, and medical device companies; government agencies; nonprofit foundations; academic investigators; and private research and consulting firms. The standards and methods used to evaluate the safety and efficacy of pharmaceutical products in randomized, controlled trials have evolved over 50 years of collaboration among researchers in private, public, and academic settings. Compared with those established to ensure the safety and efficacy of clinical trials, the principles and methods for the conduct of economic studies of health care technology are far less developed. Problems of conduct, reporting, and bias exist in all types of research [6-14]. In response, codes of conduct, such as those developed by the American Federation for Clinical Research and the Institute of Medicine, have been developed for many scientific disciplines [15-24]. These are good models on which to base principles of conduct for economic outcomes analysis. Although many published principles apply to economic studies, others should be modified and new ones should be developed to guide the conduct and reporting of economic outcomes analyses. Economic outcomes research requires unique guidelines for the following reasons: 1) As a field, it continues to evolve and is often misunderstood by end users; 2) peer review of it requires special expertise that often exceeds the capabilities of reviewers and scientific journals; 3) it often uses secondary data and requires that many assumptions be made [for example, attribution of a dollar cost to a unit of resource use]; 4) it offers unique methodologic choices, such as which types of costs to include (direct, indirect, intangible, induced), which perspective to apply (that of society, payer, provider, patient), which design to adopt (cost-identification, costbenefit, cost-effectiveness, costutility), from where to obtain costs [indemnity database, managed care or capitated database, hospital cost systems, Medicare, Medicaid], and whether to collect resource consumption data prospectively or retrospectively through various modeling techniques; and 5) economic studies play an increasingly important role in health care decision making because of increasing financial constraints throughout the health care industry. The financial and medical implications of decision making done on the basis of these studies, coupled with the lack of widely accepted guidelines about the conduct and reporting of economic analyses, undermine the credibility of this research. A major issue is that the primary source of funding for this research is often the primary financial beneficiary of positive study results. Unfortunately, even valid studies done under the best of circumstances may be suspect [25-29]. This has led at least one major journal to conclude that these analyses should be viewed much like editorials or review articles are viewed in terms of potential for conflicts of interest [30]. We developed the guidelines reported here after extensive consultation with experts from the public, private, and academic sectors. We recommend that researchers and sponsors adhere to these guidelines, and we suggest they state publicly within their manuscripts that they have done so. End users, including journal editors and readers, consumers, and social decision makers, may then feel more secure in accepting the results of the research, while recognizing that intensive critique of the research will always be necessary. Operations of the Task Force The Task Force on Principles for Economic Analysis of Health Care Technology was initiated and organized by faculty from the Leonard Davis Institute (LDI) Center for Health Policy of the University of Pennsylvania. However, because not all LDI faculty were involved, this paper does not represent an official LDI position statement. The Task Force was funded by a coalition of pharmaceutical companies (Appendix A). Funding was also requested (but not obtained) from various government and private foundations. All funding was provided in the form of unrestricted research grants or gifts to the University of Pennsylvania. Guidelines derive their credibility in part from the composition of the panel that creates them and the process by which they are developed. Candidates for participation in the Task Force from the private sector and the academic research community were identified by the frequency with which they were cited in the health economics literature, which was obtained using a MEDLINE search of literature related to economic analyses of medical technology published between 1983 and 1992. Approximately 15 members attended each meeting. Minutes were distributed after each meeting and approved by all members present. Members from the sponsoring pharmaceutical companies and the academic organizers rotated so that they numbered three and one, respectively, at the table for each formal Task Force meeting. Several professional and governmental organizations, including the Institute of Medicine, the Agency for Health Care Policy and Research, the Food and Drug Administration (FDA), the Health Care Financing Administration, the Centers for Disease Control and Prevention, and a managed care organization, were asked to suggest persons who might participate. In addition, other organizations with a stake in economic analyses were each asked to suggest a person who, because of his or her professional background, had extensive knowledge of or experience with economic analyses. An academic pharmacist, an academic researcher, a private researcher, an ethicist and patient advocate, and an attorney specializing in medical ethics rounded out the Task Force (Appendix B). Two members withdrew from participation. A small audience consisting of industry sponsors, academic organizers, staff, and a few other interested parties were invited to each meeting and allowed to comment. Four formal meetings of the Task Force were held in Philadelphia during 1993 and 1994, and the most substantial work was done by various subcommittees between these meetings. The three main subcommittees were titled Ethical Conduct, Responsibility and Control (the findings of these two subcommittees were later merged into one report), and Reporting Requirements for Economic Evaluations (Appendix C). The Task Force was assisted by a professional facilitator. Although Task Force members sought consensus wherever possible on the key issues, consensus was not forced and recommendations were issued only when substantial agreement existed among the members. Task Force members were not asked to formally represent any organization. Formal endorsement of the final document was not sought. Copies of this report will be distributed to all organizations that were asked to suggest a participant and to other parties who responded to announcements placed in The New England Journal of Medicine, Scrip, and the Pink Sheet. The Task Force findings will also be reported at academic conferences, medical profession meetings, and appropriate trade conventions. Findings and Recommendations Valid approaches to economic analyses can be defined; acceptable methods can be differentiated from unacceptable ones. Bias in economic research stems from two major sources: lack of appropriate independence for researc

A thematic analysis for how patients, prescribers, experts, and patient advocates view the prescription choice process.

BACKGROUND Typically, patients are unaware of the cost consequences regarding prescribing decisions during their clinical encounter and rarely talk with their physicians about costs of prescription drugs. Prescription medications that are deemed by patients to be too costly when the costs become known after purchase are discontinued or used at suboptimal doses compared to prescription medications that are deemed to be worth the cost. OBJECTIVES To learn more about the prescription choice process from several viewpoints, the purpose of this study was to uncover and describe how patients, prescribers, experts, and patient advocates view the prescription choice process. METHODS Data were collected via 9 focus group interviews held between April 24 and July 31, 2007 (3 with patients, 3 with prescribers, 2 with experts, and 1 with patient advocates). The interviews were audiotaped and transcribed. The resulting text was analyzed in a descriptive and interpretive manner. Theme extraction was based on convergence and external divergence; that is, identified themes were internally consistent but distinct from one and another. To ensure quality and credibility of analysis, multiple analysts and multiple methods were used to provide a quality check on selective perception and blind interpretive bias that could occur through a single person doing all of the analysis or through employment of a single method. RESULTS The findings revealed 5 overall themes related to the prescription choice process: (1) information, (2) relationship, (3) patient variation, (4) practitioner variation, and (5) role expectations. The results showed that patients, prescribers, experts, and patient advocates viewed the themes within differing contexts. CONCLUSIONS It appears that the prescription choice process entails an interplay among information, relationship, patient variation, practitioner variation, and role expectations, with each viewed within different contexts by individuals engaged in such decision making.

Pharmaceutical Expenditures as a Correlate of Population Health in Industrialized Nations

Background: In recent years, healthcare spending has outpaced economic growth in developed countries, with pharmaceutical expenditures being a key driver of this trend. While a significant number of studies investigating the effect of healthcare resource productivity on health status have been done, only a few have disaggregated pharmaceutical expenditures from total healthcare expenditures. Objective: To assess the independent association between pharmaceutical expenditures and health outcomes in 14 industrialized countries. Methods: We used data from the Organisation for Economic Co-operation and Development to construct a panel data set covering the years from 1985 to 2001. These data contain information on pharmaceutical expenditures, other healthcare expenditures, environmental health determinants, lifestyle health determinants, potential years of life lost, and life expectancy at ages 65 and 80 years across 14 industrialized nations. We estimated the relationship between pharmaceutical expenditures and potential years of life lost and life expectancy at ages 65 and 80 years for both males and females, using nonlinear fixed-effects regression models that corrected for serial correlation. All explanatory variables were lagged by 5 years to account for their cumulative effect on population health outcomes. Results: Pharmaceutical expenditures proved to be a robust correlate of health outcomes from 1985 to 2001 in this sample of nations, when controlling for the effects of other variables likely to impact population health outcomes. Our estimates imply that a 10% increase in pharmaceutical expenditures during these years was associated with a 0.3% (95% CI 0.1% to 0.5%; ~21 days) increase in female life expectancy at age 65 years (p < 0.05), while a similar increase was associated with a 0.4% (95% CI 0.1 to 0.7; ~24 days) increase in male life expectancy at age 65 years (p < 0.05) and a 0.5% increase (95% CI 0.03 to 1.0; ~14 days) at age 80 years (p < 0.05). Conclusions: Our results suggest that significant, but small, marginal gains in population health outcomes were associated with increased pharmaceutical expenditures in developed nations during the period studied.

PDP or MA-PD? Medicare part D enrollment decisions in CMS Region 25

BACKGROUND The Medicare Prescription Drug Improvement and Modernization Act of 2003 provides outpatient prescription drug coverage for Medicare beneficiaries through private insurers. This coverage is available through 2 primary venues: stand-alone prescription drug plans (PDPs) and integrated managed care (or Medicare Advantage) plans that also provide prescription drug coverage (MA-PDs). OBJECTIVES The first objective was to describe factors associated with Medicare beneficiaries choosing to enroll in any Medicare part D PDP. The second objective was to describe factors associated with the choice of an MA-PD, given enrollment in the part D program. METHODS The study used a cross-sectional, survey design. Data were collected from a stratified random sample of 5000 community-dwelling adults, aged 65 years and older in the Center for Medicaid and Medicare Services Region 25. Data were collected by means of a mailed questionnaire. Data analyses included univariate and bivariate descriptive statistics and multivariate probit modeling. RESULTS The overall adjusted response rate was 50.2% (2309 of 4603). Data from 1490 respondents (32.4% of those attempted) were analyzed in this study. Nearly 75% of sample members elected to enroll in one of the Medicare part D coverage options in 2007, with more than 3 times as many choosing a PDP compared with a MA-PD option (57.2% vs 17.8%). A variety of variables including rurality, plan price, perceived future need for medications, and preferences emerged as important predictors of choosing to enroll in any Medicare part D drug plan, whereas rurality, state of residence, and number of diagnosed medical conditions were associated with the decision to enroll in a MA-PD. CONCLUSIONS Models of health insurance demand and plan choice applied in this context appear to be modestly effective. Rurality and state of residence were particularly important contributors to both of these decisions, as were a variety of individual characteristics.

Comparison of consumer-oriented books on medications

Consumers increasingly want to be informed about the processes involved in their own health care. Health professionals may be called upon to recommend appropriate consumer-oriented sources of information. To assist the health professional in making a rational recommendation, 15 currently available consumer-oriented books on prescription medications were compared with respect to readability, number of drugs covered, completeness of drug monograph information, price, and other factors. Mean readability scores, reported as a reading grade level, ranged from 9.2 to 14.3. The number of drugs covered by these books ranged from 135 to 1,200. Monograph completeness scores were assigned by determining the percentage of information from a standard references drug monograph covered in each book. The lowest percentage completeness score was 21.4%, while the highest was 76.7%. Prices for the books ranged from

Perspectives on medical specialization.

2.50 to

Medical marijuana: Policy topic for 2015 APhA House of Delegates

19.95. Regardless of the relative priorities placed on these factors, a consumer or health professional may use the objective and descriptive assessments of this study to make an informed decision when choosing among consumer-oriented sources of medication information.

Pharmacists, pharmaceuticals, and drug information in the 21st century.

The role of specialization in pharmacy practice is an important issue confronting the profession today. The historical evolution of specialization in American medicine is presented. Medicine, while not a complete model of specialization, probably has the most mature structure of any profession. Pharmacy, in directing its own specialization process, can learn from medicines experience.Emergence of specialties is a function of both social and technological change. An increase in the knowledge base and an expanding technology stimulated physicians to specialize. The narrowing technical interests of the medical specialist led to the formation of elite specialty societies. While these organizations initially moved to develop specialty education and training programs, later they came to have a significant impact on the entire medical profession. A major decision for medicine was the requirement that all physicians receive the same general medical education — the M.D. degree — prior to entering specialty traini...

Clinical and economic outcomes of medication therapy management services: The Minnesota experience

The use of medical marijuana is an emerging health care trend for the medical community nationwide. While marijuana has been used for centuries, its potential medicinal benefits have only recently been acknowledged. In 2013, the State of Connecticut adopted medical marijuana legislation for patients with the specific diseases outlined in the law. Throughout the controversial legislative debate, the Connecticut Pharmacists Association (CPA) was a strong advocate for bringing medical marijuana, through a regulated process, to patients in need. CPA’s position stated that if we were going to treat marijuana as a medicine, the State of Connecticut should move marijuana from a Schedule I controlled substance to a Schedule II controlled substance and mirror the current distribution system being used for any Schedule II drug. Unlike models in other states, Connecticut has integrated pharmacists into the drug selection and dispensing process. Patients have the benefit of a pharmacist in the key roles of providing a patient evaluation, including an evaluation review of all medicines the patient is currently taking, reviewing dosing recommendations, evaluating the potential of adverse events, and selecting and dispensing the appropriate medication. Pharmacists believe their clinical knowledge will be critical in the documentation and evaluation components of any research initiative. It’s also exciting to see team-based care in action in the health care system: A physician authorizes the patient to be eligible to try medical marijuana and a pharmacist then selects the appropriate product based on the physician’s diagnosis. Connecticut law also requires that pharmacists input information into the Prescription Monitoring Program run by the State of ConMedical marijuana: Policy topic for 2015 APhA House of Delegates