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PURPOSE To compare the predictive ability of mapping algorithms derived using cross-sectional and longitudinal data. METHODS This methodological assessment used data from a randomized controlled noninferiority trial of patients with low-risk prostate cancer, conducted by NRG Oncology (ClinicalTrials.gov identifier: NCT00331773 ), which examined the efficacy of conventional schedule versus hypofractionated radiation therapy (three-dimensional conformal external beam radiation therapy/IMRT). Health-related quality-of-life data were collected using the Expanded Prostate Cancer Index Composite (EPIC), and health utilities were obtained using EuroQOL-5D-3L (EQ-5D) at baseline and 6, 12, 24, and 60 months postintervention. Mapping algorithms were estimated using ordinary least squares regression models through five-fold cross-validation in baseline cross-sectional data and combined longitudinal data from all assessment periods; random effects specifications were also estimated in longitudinal data. Predictive performance was compared using root mean square error. Longitudinal predictive ability of models obtained using baseline data was examined using mean absolute differences in the reported and predicted utilities. RESULTS A total of 267 (and 199) patients in the estimation sample had complete EQ-5D and EPIC domain (and subdomain) data at baseline and at all subsequent assessments. Ordinary least squares models using combined data showed better predictive ability (lowest root mean square error) in the validation phase for algorithms with EPIC domain/subdomain data alone, whereas models using baseline data outperformed other specifications in the validation phase when patient covariates were also modeled. The mean absolute differences were lower for models using EPIC subdomain data compared with EPIC domain data and generally decreased as the time of assessment increased. CONCLUSION Overall, mapping algorithms obtained using baseline cross-sectional data showed the best predictive performance. Furthermore, these models demonstrated satisfactory longitudinal predictive ability.

OBJECTIVE: To estimate the impact of implementing prescription drug monitoring program (PDMP) best practices on prescription opioid use. DATA SOURCES: 2007–2012 Medicare claims for noncancer pain patients, and PDMP attributes from the Prescription Drug Abuse Policy System. STUDY DESIGN: We derived PDMP composite scores using the number of best practices adopted by states (range: 0‐14), classifying states as either no PDMP, low strength (0

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug (IND) application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation.

Background and aims Prescription Drug Monitoring Programs (PDMPs) are a principal strategy used in the United States to address prescription drug abuse. We (1) compared opioid use pre- and post-PDMP implementation and (2) estimated differences of PDMP impact by reason for Medicare eligibility and plan type. Design Analysis of opioid prescription claims in US states that implemented PDMPs relative to non-PDMP states during 2007-12. Setting Florida, Louisiana, Nebraska, New Jersey, Vermont, Georgia, Wisconsin, Maryland, New Hampshire and Arkansas, USA. Participants A total of 310 105 disabled and older adult Medicare enrolees. Measurements Primary outcomes were monthly total opioid volume, mean daily morphine milligram equivalent (MME) dose per prescription and number of opioid prescriptions dispensed. The key predictors were PDMP status and time. Tests for moderation examined PDMP impact by Medicare eligibility (disability versus age) and drug plan [privately provided Medicare Advantage (MAPD) versus fee-for-service (PDP)]. Findings Overall, PDMP implementation was associated with reduced opioid volume [-2.36 kg/month, 95% confidence interval (CI) = -3.44, -1.28] and no changes in mean MMEs or opioid prescriptions 12 months after implementation compared with non-PDMP states. We found evidence of strong moderation effects. In PDMP states, estimated monthly opioid volumes decreased 1.67 kg (95% CI = -2.38, -0.96) and 0.75 kg (95% CI = -1.32, -0.18) among disabled and older adults, respectively, and 1.2 kg, regardless of plan type. MME reductions were 3.73 mg/prescription (95% CI = -6.22, -1.24) in disabled and 3.02 mg/prescription (95% CI = -3.86, -2.18) in MAPD beneficiaries, but there were no changes in older adults and PDP beneficiaries. Dispensed prescriptions increased 259/month (95% CI = 39, 479) among the disabled and decreased 610/month (95% CI = -953, -257) among MAPD beneficiaries. Conclusions Prescription drug monitoring programs (PDMPs) are associated with reductions in opioid use, measured by volume, among disabled and older adult Medicare beneficiaries in the United States compared with states that do not have PDMPs. PDMP impact on daily doses and daily prescriptions varied by reason for eligibility and plan type. These findings cannot be generalized beyond the 10 US states studied.

The advent of fecal microbiota transplantation (FMT) and the prospect of other types of microbiota transplants (MT), e.g. vaginal, skin, oral and nasal, are challenging regulatory agencies. Although FDA is regulating FMT (as a biologic), there is currently no widely accepted or agreed upon scientific or legal definition of FMT or MT. The authors report on discussions regarding a definition of MT that took place among a working group of stakeholders convened under a National Institutes for Allergies and Infectious Diseases grant to address the regulation of MT. In arriving at a definition, the group considered the 1) nature of the material being transplanted; 2) degree of manipulation of the transferred materials prior to implantation; 3) ability to characterize the transplanted product using external techniques; and 4) origin of the stool product (single vs multiple donors).

The integrity of unbiased clinical data is essential to the future of the health care system by facilitating the discovery of lifesaving medicines and ensuring investigational drugs are safe and effective. Since 2002, the US pharmaceutical industry has invested over $500 billion, which is the largest research and development investment of any sector of the US economy. As a consequence of this significant investment, pharmacy compounders and other stakeholders must be acutely aware of the consequences of noncompliance. Pharmacy compounders are required to navigate through a complex and ever-changing regulatory landscape governed by US federal and state authorities competing for oversight and enforcement authority. In particular, pharmacy compounders participating in clinical investigation are faced with inconsistent federal and state drug labeling regulations, which can lead to enforcement for violating acceptable standards for clinical investigation and informed consent. As FDA registrants, Outsourcing Facilities are able to produce large volumes of clinical supplies without the need for prescriptions for individually named patients. Some states, however, may have prescription drug labeling laws that could thwart the ability to provide these clinical supplies. Accordingly, researchers should be aware of the implications of federal and state laws, including any inconsistencies, prior to engaging in clinical investigation.

The Human Microbiome Project and similar research has generated great interest in potential health benefits of microbiota transplantations (MTs). The use of fecal microbiota transplantation (FMT), the transfer of stool from a human donor to a human recipient, for recurrent Clostridium difficile infection (CDI) is considered by many to be standard-of-care therapy, and data on its safety and effectiveness are accumulating ( 1 – 3 ). Yet, although some physicians are practicing FMT using stool from donors known to the physician or patient, stool is inconsistently screened for infectious pathogens. The use of prescreened stool obtained from a stool bank and shipped to the physician is increasing, but the stool banks are not regulated. Patients who self-administer FMT using unscreened stool sourced from family or friends is also widely described. In consideration of these and other particular characteristics and challenges of MT, and the nascent regulatory landscape, we convened human microbiome researchers, legal experts, and others to explore regulatory pathways for MT ( 4 ). We believe our proposed approach is an improvement on the U.S. Food and Drug Administration's (FDA) current and proposed scheme and could provide a model for other countries that are contemplating regulatory frameworks for FMT.

Background: Social media offer a novel avenue to engage with and recruit research participants. Facebook in particular is a promising option given its popularity and widespread use. Objective: To explore the feasibility of using Facebook to recruit physicians and patients to participate in a survey to assess their perceptions about generic venlafaxine extended release (ER) tablet indicated for depression. Methods: Web-based surveys were developed to gauge physicians’ prescribing experiences with and patients’ perceptions of generic venlafaxine ER tablet. The surveys included questions specific to venlafaxine ER tablets, such as perceived safety and efficacy of the drug and overall comfort level with either prescribing or taking the drug. Survey links were then posted and advertised on Facebook to recruit physicians and patients. Results: Advertisement for physicians reached 1898 Facebook users and advertisement for patients reached 1144 users during a 10-day advertising period. However, only 14 and 35 users clicked on the survey for physicians and patients, respectively. No physician completed the physician survey while 3 patients completed the patient survey. Conclusions: The findings of this study suggest that Facebook may not be an effective method to recruit physicians. Facebook holds promise to recruit patients, but additional recruitment efforts, such as incentives, are needed.

Objectives Use of patient provider agreements (PPAs) is increasing, yet there is limited evidence on the effectiveness of PPAs to prevent prescription opioid misuse and diversion, and few guidelines for providers. We conducted eight focus groups to understand patient and prescriber perceptions of PPAs. Methods We recruited 40 patients who had been asked to sign a PPA and 40 prescribers who had administered at least one PPA. We developed topic guides for the two groups based on prior literature. Focus groups were audio-recorded and transcribed verbatim. Two investigators independently performed the content analysis of the transcripts and reached consensus on recurring themes. Key findings PPA use varied according to physician specialty. General practitioners used PPAs the least but reported increasing pressure from liability insurers to use them. Many patients reported signing a PPA in the emergency room of a hospital. Prescribers and patients reported a lack of understanding among patients concerning the purpose and content of the PPA. Prescribers questioned the legal status of the PPA, while patients believed that the PPA was a legal document intended to protect prescribers. Patients and prescribers valued PPA content items differently, although both groups agreed that signing a PPA would not prevent opioid misuse. Conclusions We identified several themes concerning the administration, content, effectiveness and utility of PPAs that highlight areas of research to improve PPAs. We also describe trends requiring further investigation. Understanding content of importance to patients will facilitate the development of a patient-centred PPA.

As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 – Introduction; 2 – Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 – Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 – Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 – Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 – Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 – Patient Centricity and Patient Engagement new addition, with explanation and guidance ; 8 – Publication and Dissemination ; and 9 – Conclusion and Limitations .

Objectives Antipsychotic polypharmacy is increasingly prescribed despite little documented evidence of a therapeutic benefit. There is also a limited understanding of the role that health insurance plays on the prevalence of antipsychotic polypharmacy. This study was undertaken to investigate the relationship between antipsychotic polypharmacy and individuals' intended source of payment in a US national sample of ambulatory care patients. Methods The study combined 2002, 2003 and 2004 data from the National Ambulatory Medical Care Survey (NAMCS) among adults seeking outpatient-based physician medical care services in the USA. We investigated characteristic differences among patients who were prescribed multiple antipsychotics versus individuals receiving only a single antipsychotic medication. Multivariable logistic regression examined the association between antipsychotic polypharmacy and patients' primary payment type classified as private insurance, Medicaid, Medicare or other (primarily out-of-pocket) payment type. Key findings Use of more than one antipsychotic agent was recorded in 68 of 830 (8.2%) outpatient physician visits in the 3-year period 2002–2004. Among the payer types studied, Medicaid payment status was correlated with increased risk of antipsychotic polypharmacy (odds ratio 2.7, 95% confidence interval 1.1–6.7). Conclusions Insurance status was associated with antipsychotic polypharmacy among non-institutionalized US residents prescribed antipsychotic medications. Patients reporting Medicaid as their primary payer were nearly three times as likely to be prescribed multiple antipsychotic drugs, potentially increasing their risk of adverse side effects as well as greater taxpayer burden. Future research should determine whether these trends continued after 2004 and to determine the costs of treating patients in the public sector with multiple antipsychotic drugs, a common scenario despite financial pressures and uncertain medical benefit.

Objective The purpose of this paper is to review the US policies that either restrict or provide medication access, with a particular focus on access in the aftermath of Medicare Part D implementation. In this commentary, access is defined as getting the right drug to the right patient for the right condition at the right time and at the right dose. The potential implications for patient outcomes and total healthcare costs will be discussed. Key findings In an effort to expand access to healthcare in the USA, Congress and the Administration are heavily involved in healthcare reform efforts. For those who currently qualify for government-sponsored access to prescription drugs, Medicare Part D represents a major step forward for the nation's elderly and disabled. In 2009, over 26 million Medicare beneficiaries were enrolled in this program. However, 44.8 million Americans not eligible for government programs such as Medicare still lack medical and/or drug insurance coverage. There are many barriers to medication access. Cost and lack of adequate insurance are the most visible. Individuals who do have medical and/or drug coverage may be impeded from obtaining full access to medications due to rules and policies affecting drug prescribing and dispensing and may be considered underinsured. Summary Once a basic level of access is in place, attention should then be turned to the effect of restrictions on access and how they impact the health of patients and their utilization of other costly services. As the USA moves toward improved access, now is the time to consider both the positive and negative long-term effects of restricting access to medications.

Background: Importation of prescription drugs into the United States has been a major health policy issue for some time. The original objective of personal importation was to allow patients to have access to drugs that were not available to them in the United States either for continuation of therapy begun in another country or when all US Food and Drug Administration (FDA)-approved drug options for their condition had been exhausted. An increasing proportion of personally imported drugs are currently marketed in the United States, but imported drugs are presumably available at a lower cost to the consumer. As US consumers opt for importation through Internet sites and other means of purchase from other countries, potential risks of exposure to counterfeit products have increased, presenting challenges to both the US regulatory system and pharmaceutical companies. Objective: This commentary summarizes the current state of importation of prescription drugs into the United States. Conclusions: Regulators and policymakers are under increasing pressure to address the high cost of branded drugs in the United States and the desires of many US patients to purchase less expensive formulations of these products through importation. In many cases, the historical policies surrounding personal importation of prescription drugs that are not sold in the United States have been blatantly ignored, leaving the FDA in a quandary. While current legislative proposals would allow for greater access to drugs directly to consumers from other countries, they do not address the fact that the FDA has no ability to monitor the safety and efficacy of imported products. As such, the possibility of the entry of counterfeit medications and the related potential harm remain concerns.

Specialty pharmaceuticals are a unique group of drug agents used to treat complex clinical conditions. Many specialty pharmaceuticals are biological in nature and administered through injection or infusion. Tracking spending on these pharmaceuticals is complex, because these products may be processed as either medical or pharmacy claims. This benchmarking study of ten Blue Cross Blue Shield plans, representing almost eighteen million covered lives, documents large expenditures on select specialty pharmaceutical categories and much variation in spending across plans, age groups, and time. Our results underscore the need for insurers to scrutinize trends in specialty pharmaceutical spending and identify appropriate management strategies.

To examine 1) the effect of prior antiparkinson drug (APD) nonadherence on subsequent APD regimen modifications; and 2) the influence of modifications on healthcare utilization and costs by patients with Parkinson's disease (PD).This retrospective cohort study included 7052 PD patients with ≥2 APD prescriptions who initiated a modification of APD regimens in 2007. Modification was assessed as changing from one APD to another and/or adding a new APD to an existing regimen. Nonadherence was measured using Medication Possession Ratio0.8. Discrete-time survival analyses were used to estimate the effect of prior nonadherent behavior on initiating APD modifications. Generalized linear models were used to estimate the effect of initiating medication modifications on subsequent 3-month medical use and costs.Initiation of APD modifications in any given month was higher among patients who were nonadherent to APDs in the preceding month (adjusted hazard ratio [HR] = 1.23), compared to their adherent counterparts. Modifications significantly predicted higher risk of all-cause and PD-related hospitalizations (adjusted relative risk [RR] = 1.22 and 1.83, respectively), home health agency utilization (RR = 1.18 and 1.52), and use of physician services (RR = 1.14 and 1.41), as well as higher total all-cause healthcare expenditures (mean = $1064) in any given 3-month interval.Prior nonadherence to APDs might influence initiation of APD modification. APD modifications were associated with increased health care utilization and expenditures, with the caveats that indications of modifications and disease severity may still play roles. Prescribers should consider patients' medication adherence when changing APD regimens to lower the costs of medical services.

A national mail survey was designed to study how pharmacoeconomic (PE) data were applied to formulary decisions in teaching hospitals in the United States. The study objectives were to determine the criteria for using PE data for formulary decisions, to describe PE data sources that were used, and to assess the opinions of pharmacy directors regarding the quality of available PE data. One hundred and sixty-six (39.6%) pharmacy directors responded to the survey from April to July 1999. There were no significant differences between respondents and non-respondents with regard to hospital demographics. One hundred and thirty eight hospitals (83.1%) reported using PE data. The two most important criteria leading to a PE analysis were the impact that a new medication may have on institutional cost, and the anticipated annual pharmacy budget for a new medication (the threshold of potential cost was concentrated between $25,000 and $100,000 per medication). Classes of drugs that frequently “ranked first” in requiring PE data were antiplatelets, systemic anti-infective drugs, and antineoplastics. Drugs that required PE data were those which were recently approved by the Food and Drug Administration (FDA) and that were relatively expensive (eg, Glycoprotein IIb/IIIa inhibitor; Cox-II inhibitor; Low molecular weight heparin). The most important sources of PE data were published literature, pharmaceutical companies, and in-house PE assessments. Hospitals that could identify greater cost-savings used more in-house PE data. Seventy-six percent of pharmacy directors had a moderate to high level of skepticism of PE data derived from PE modeling and 79% of them felt that the use of PE data might expand if the FDA review process incorporated approval of such data.

This review discusses the approaches to prescription drug payment practices taken by managed care to influence drug use and costs, and presents the research evidence supporting these interventions. In the US, drugs were infrequently covered as an ambulatory benefit under fee-for-service indemnity insurance; however, health maintenance organisations almost always provide outpatient drugs and consequently have developed approaches to influence drug use and manage its costs. Managed care as a set of tools and as an organisational form is moving toward more restrictions on direct access to pharmaceuticals as a covered benefit. Options for influencing drug use and cost may address access, ingredient costs, dispensing fees and cost sharing. The formulary process is the foundation for a managed pharmacy benefit and integrates these options. The limited empirical evidence for an effect of managed care on drug costs and use is reviewed. A proposed research agenda includes evaluation of the effects of restrictive formularies, capitation, disease management and other programmes to influence the cost and use of pharmaceuticals.

To test the hypotheses that African American patients and older patients with stage IV colorectal cancer were less likely to receive newer chemotherapy agents.Retrospective cohort design.Among 5068 Surveillance, Epidemiology, and End Results-Medicare patients diagnosed as having stage IV colorectal cancer between 2000 and 2002, a total of 2466 received chemotherapy and were included in the analysis. Irinotecan hydrochloride was the first of the "newer" chemotherapy agents and was marketed in 2000 as a first-line add-on agent. Descriptive statistics were generated, and a multivariable logistic regression was run to estimate the odds of receiving irinotecan among African American patients and older patients and within 2 months of chemotherapy initiation.African American patients had lower odds of initiating treatment with a newer chemotherapy than white patients (adjusted odds ratio, 0.641; 95% confidence interval, 0.453-0.907). An age disparity was also found, with all older age groups being significantly less likely to initiate treatment with a newer chemotherapy than the youngest age group: the adjusted odds of receiving newer chemotherapy agents (relative to patients aged 66-70 years) were lower and significant among patients aged 71 to 75, 76 to 80, and older than 80 years (odds ratios, 0.708, 0.527, and 0.213, respectively).Disparities in chemotherapy selection exist among patients receiving chemotherapy for stage IV colorectal cancer. On initiating chemotherapy, African American patients and older patients were less likely to receive a newer agent.

For several years, the American Society of Hospital Pharmacists (ASHP) has voiced concern about the impact of federally mandated changes on the pharmaceutical products marketplace. Since this marketplace is relatively inelastic, manipulating one segment in the interest of cost efficiencies is likely to result in price increases in other segments. That manipulation could come through such decisions as a "one-price" policy for pharmaceuticals, mandatory rebates for certain segments of the marketplace, or the elimination of discounts. The issue of cost-effective purchasing of prescription drugs and related supplies has recently come under increased scrutiny from the U.S. Congress, the Department of Health and Human Services, the General Accounting Office, and the Federal Trade Commission. In light of these and future activities, ASHP determined that there was a need to collect credible data on the potential impact of the termination of the Robinson-Patman Act's nonprofit institutional exemption, other discounts, or both on pharmaceutical expenditures in institutional health-care settings. The authors of this paper report the results and analysis of a 1990 mail survey conducted by ASHP and Concepts in Healthcare, Inc., to collect information on pharmaceutical purchasing and discounting procedures in community hospitals and selected nonhospital settings in the United States. Survey respondents reported that they would expect substantial increases in pharmaceutical expenditures if volume and nonprofit discounts were eliminated. Nonprofit hospitals expected a 24.4% increase in pharmaceutical expenditures in the wake of discount elimination, while for-profit institutions projected an 11.9% increase. Pharmaceutical expenditures of the study hospitals averaged $1.69 million per year; respondents estimated that this sum would increase by $390,000 (23.1%) if volume and nonprofit discounts were eliminated.

To examine the relative preferred placement of commonly dispensed prescription drugs and to assess variations in drug coverage across a convenience sample of 12 health insurance plans.A cross-sectional analysis of the plans focused on all 67 patented brand-name prescription drugs from among the top 200 prescribed drugs in 2004.For each plan, we created a preferred placement index representing the percentages of drugs that were positioned on the formulary with preferred placement, defined as tier 2 without restricted access. A separate cardiovascular index was also created. Sensitivity analyses determined the effect of limiting the sample to the top 25 patented branded drugs and examined the robustness of our index when prior authorization restrictions were allowed.Across 67 drugs and 12 insurance plans, drugs were rated as having preferred placement 59.1% of the time. The preferred placement index ranged from 31.3% to 88.1% across the plans for the full sample of 67 drugs; for the sample of cardiovascular drugs, the range was 25.0% to 100.0%. Results were robust across sensitivity analyses.Based on this convenience sample of 12 formularies, there is a wide variation in preferred placement of the most commonly prescribed branded medicines across insurers. The wide range implies that the specific insurance coverage a patient selects may have an effect on whether his or her prescribed drugs have preferred formulary placement and on his or her out-of-pocket drug expenditures.

Objective To address the value of Board of Pharmaceutical Specialties (BPS) certification, particularly as perceived by different stakeholders (pharmacists, employers, government, and academia), and to draw a parallel between specialization and certification in pharmacy and in medicine. Data Sources Electronic databases (Medline, International Pharmaceutical Abstracts, Sociological Abstracts), associations/health care organizations Web sites, outside reports, and clinical pharmacists involved in certification processes. Study Selection Studies and reports that addressed the value of specialty certification were selected by the authors. Data Extraction By the authors. Data Synthesis Pharmacists with specialty certification report enhanced feelings of self-worth, improved competence, and greater marketability. Other values of certification include increased acceptance by health care professionals, salary increases, and job promotions. Employers have acknowledged board-certified pharmacists through public recognition, increase in responsibility, and some types of monetary compensation. In some governmental organizations, certified pharmacists receive salary raises and are granted prescribing authority. However, the overall value of specialty certification in pharmacy as perceived by the public or payers lags behind when compared with the status of specialty certification in medicine. Conclusion Board-certified pharmacists appreciate the value of pharmacy specialty certification, and in a number of organizations and practice settings, board-certified pharmacists are perceived as valuable. Still, unlike board-certified physicians, board-certified pharmacists are not widely recognized outside or even within the pharmacy profession. To address this challenge, board-certified pharmacists ought to market their services to assure that other stakeholders recognize their value.

In 2001, ISPOR convened a Task Force on Code of Ethics for Researchers (The Task Force). This Task Force was to build on the previous work of ISPOR Health Science Policy Task Forces and develop a code of ethics that would be applicable to all ISPOR members and to ISPOR itself. The Task Force developed a code of ethics that was subsequently adopted by the ISPOR Board of Directors. The Code of Ethics is appended to this article and can be found on ISPOR's Web page at http://www.ispor.org/workpaper/code_ethic.htm. This article provides supportive information and justification for the ISPOR Code of Ethics for Researchers and includes a discussion of the stakeholders as well as ethical considerations for the researcher on research practices, research sponsorship, research publication and dissemination, and relationships with others. It also includes a discussion of the ethical considerations for the Society.

Objective. To measure the prevalence, incidence, types, and certain characteristics of antibiotics prescribed in nursing homes. Design and Setting. Periodic survey over 1 year of patient charts in 53 stratified, randomly selected nursing homes in the state of Maryland. Patients. All patients 65 years of age or more residing in these nursing homes on the first day of study. Results. Of 4,165 patients in 53 nursing homes, records over the year were satisfactory in 3,899 patients in 52 nursing homes. The prevalence of antibiotic use on the first day of the study was 8%. Over the next 12 months, observations of more than one million patient-days revealed an incidence of 0.46 antibiotic courses/100 patient-days; 54% of the 3,899 patients received at least one antibiotic course. For presumed active infections, beta lactam antibiotics were the most commonly used, 54% of antibiotic orders. For all antibiotics, urinary tract infection was the most common indication, eliciting 36% of orders including 9% for asymptomatic bacteriuria. Skin, lower respiratory, and upper respiratory infections comprised 14%–17% each. Physicians prescribed 94% of courses but documented examinations of only 44% of patients at the outset of these courses. Consensus criteria for minimal diagnostic evaluation of four selected infections were met in only 11% of episodes of infection. Although the most serious infections tended to be better evaluated than others, 31% of the former were not noted to have been examined by a physician. Three percent of orders were for prophylaxis and two-thirds of these antibiotics were administered for more than 2 days. Conclusions. Antibiotics are frequently prescribed for aged nursing home patients, often in the absence of a physician's examination and other features commonly performed in evaluation of specific infectious diseases. More than one-fifth of antibiotics prescribed by presumed active infections were for two infections usually thought not to require antibiotic therapy, “viral” upper respiratory infection (13%) and asymptomatic bacteriuria (9%). To optimize antibiotic use in nursing homes, greater attention should be directed to appropriate durations of prophylaxis for urologic, dental, and minor surgical procedures; to standards for diagnostic evaluations of common infections; and to the roles of antibiotics in upper respiratory infections and in asymptomatic bacteriuria.

A major activity occupying the U.S. Food and Drug Administration for several years has been a rewrite of the FDA's IND and NDA regulations which govern the clinical testing of investigational new drugs and the process for subsequent market approval for those drug entities. In March of 1987, the FDA "reproposed" that portion of the 1983 IND rewrite dealing with the "treatment use" of investigational new drugs during the clinical testing phases of new drug development or during the period between the completion of clinical testing and NDA approval. The Treatment IND reproposal resulted in substantial controversy immediately following its publication in the Federal Register. This article compares the key features of the Treatment IND regulations as reproposed with those of the Final Rule and summarizes the major points of contention among the various interest groups affected. With its new Treatment IND regulations, the FDA appears to have placed itself squarely between competing interests and public policy considerations. The essential purpose and role of the FDA is to determine the inherent safety and effectiveness of new therapeutic medications. Debate on the Treatment IND regulations has raised a number of questions as to the regulations' own safety and efficacy in achieving that objective. It is likely the Treatment IND implementation will engender as much controversy as the regulations as originally reproposed.

We report the successful recruitment of a stratified random sample of nursing homes in the state of Maryland into three research studies funded by the National Institute on Aging. These studies examine the prevalence of infections and urinary tract instrumentation and the incidence of antimicrobial use in nursing home residents. Following selection of a facility, the administrator was telephoned and a meeting at the home was requested. At this meeting, the project was explained in detail using a packet of promotional information which included a project summary, a listing of project staff and their qualifications, and letters of support from influential organizations. A total of 61 eligible facilities were contacted in order to achieve a group of 53 participating homes with approximately 5000 beds. One hundred percent cooperation was achieved from all strata except small (less than or equal to 50 beds) proprietary comprehensive care facilities, and homes with both comprehensive and domiciliary beds. A direct, personal approach, backed by a carefully prepared study information and the support of medical and nursing home organizations resulted in successful recruitment of 53 (87%) of 61 homes sampled.

A retrospective drug usage review was performed on 1,033 randomly sampled prescription orders from the outpatient pharmacy of a hospital and clinic system. Prescription orders were screened in accordance with criteria based on daily dosage, length of therapy or quantity dispenced, diagnosis, and labeling. The results of the study point to a number of potential prescribing problems. In addition, the study demonstrates the feasibility of collecting and analyzing drug usage data on a retrospective basis.

This paper describes an operational computer-based system for conducting Drug Prescribing Review (DPR). The system was designed to: arrive at specific judgements about the potential problems of drug orders taking into account the characteristics of the patient and their medical conditions; be relatively independent of the structure of the data base; and be capable of expressing and evaluating any DPR criteria. This was accomplished by developing a hierarchical, rule-based system for expressing and evaluating DPR criteria. This system was then linked with a specific patient data base for implementation. Drug orders for 65 patients have been evaluated and the results agree with expert judgement. The rule-based DPR system appears to be a feasible method of evaluation of drug orders.