Duane M. Kirking

Compliance from Self-Reported versus Pharmacy Claims Data with Metered-Dose Inhalers

OBJECTIVE: To determine how well self-reported compliance with metered-dose inhalers (MDIs) agrees with compliance determined from pharmacy claims data. Additional analyses were conducted to establish psychometric properties of the questionnaire. METHODS: A cross-sectional survey was performed of all adult enrollees with asthma of a managed care organization. The overall return rate was 63.4% (696/1098). Patients with persistent asthma and at least one prescription claim for a controller MDI during the four months preceding the survey were included. Pharmacy claims data were used to calculate a compliance ratio. Self-reported compliance was based on a four-item questionnaire. The primary end points were the percent-agreement and the overall correlation between the two measures. The questionnaires internal reliability and construct validity were assessed using Cronbachs α and Pearsons correlations, respectively. Mean item response scores for compliant patients were compared with scores of noncompliant patients using the Students t-test. RESULTS: One hundred questionnaire respondents met the study criteria. The mean ± SD compliance ratio was 0.52 ± 0.27, the mean ± SD self-reported compliance score was 4.07 ± 1.0. The overall percent agreement and correlation between self-reported compliance score and the compliance ratio were 75.5% and r = 0.348 (p = 0.01), respectively. The percent agreement was highest (85%) when noncompliant patients (by compliance ratio <0.8) reported being noncompliant (questionnaire score <5). Cronbachs α was 0.86. CONCLUSIONS: This study demonstrated a moderate correlation between self-reported asthma compliance and the compliance ratio determined using claims data. The questionnaire may be useful as a screening tool to detect noncompliant behavior in populations or individual patients with asthma.

Influence of sociodemographics on the health-related Quality of Life of pediatric patients with Asthma and their caregivers

The relationship between socioeconomic variables and the health-related quality of life (HQL) of children with asthma and their caregivers was examined. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and Pediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ) were administered to 99 pediatric asthmatic patients and caregivers in two specialty clinics. Sociodemographic data was obtained from medical records and additional questions. The relationship between sociodemographic variables and HQL was determined using multiple linear regression. The mean patient age was 12.6 ± 2.1 years; more were male and from a minority race. The mean age of caregivers was 41.2 ± 8.5 years; most were female and were from a minority race. Patients tended to rate their asthma severity as mild to moderate, while caregivers tended to rate patients in the moderate to severe category. Based on prescribed medications, most patients had mild to moderate asthma. Household income was consistently associated with patient-perceived HQL. Less consistent associations were seen with other variables. Household income and the caregivers perception of asthma severity were associated with all caregiver HQL domains. It was concluded that household income was most consistently associated with the HQL of asthmatic pediatric patients and their caregivers.

Self-Reported Adherence in Patients with Asthma

Background: Not all patients with asthma adhere to their prescribed drug regimens. The Behavioral Model of Health Services Utilization, organized as predisposing, enabling, and need variables, may be useful in identifying variables related to adherent medication-taking behavior. Objective: To examine the relationship between predisposing, enabling, and need variables and self-reported adherence with asthma controller drugs. Methods: A secondary analysis was conducted from a cross-sectional study using survey and claims data obtained from adults with asthma enrolled in a managed care organization. Independent variables included predisposing (age, gender, race, years with asthma, number of comorbidities, health beliefs), enabling (income, number of metered-dose inhaler [MDI] instructors, inhaler technique, perceived physician access), and need (patient-perceived severity, symptom-derived severity, health-related quality of life). Adherence was measured using a 4 item questionnaire scored as the mean of the responses, with 5 denoting highest adherence. Multivariate regression analysis was used to identify variables with statistically significant relationships to self-reported adherence. Stepwise backward elimination was used, with the final model consisting of variables considered significant at p less than 0.05. Results: The 573 respondents (1270 packets sent; 45% response rate) were primarily white (89.5%) and female (71.0%), with an average age of 40.5 ± 12.4 years (mean ± SD) and average asthma duration of 18.3 ± 14.2 years. The mean adherence scale score was 3.7 ± 1.1, with 84.6% indicating some level of nonadherence (score < 5). The final model had an adjusted R2 of 0.26 and Included 6 independent variables. Better adherence was associated with stronger beliefs in the benefits of treatment and trigger avoidance, greater perceived asthma severity, longer asthma duration, more MDI Instructors, and higher scores on the Short-Form 36 mental component summary. Conclusions: Complex beliefs, perceptions, and experiences constitute the variables associated with adherent medication-taking behavior. Future longitudinal studies should include these variables to determine the predictive strength of the model.

Assessing the Quality of Pharmaceutical Care II. Application of Concepts of Quality Assessment from Medical Care

Objective To present a framework that facilitates quality assessment of pharmaceutical care (PC) so that the profession and the public may identify pharmacists in ambulatory settings who provide quality care in all aspects of their practices. Data Sources A MEDLINE search augmented by a review of International Pharmacy Abstracts was used to identify pertinent quality assessment and pharmacy practice literature; indexing terms included quality assurance, healthcare, pharmacists, community pharmacy services, ambulatory, pharmacy, and process and outcome assessment. Study Selection All identified quality assessments of community pharmacy practice were considered. Studies that documented the effectiveness of specific pharmacist activities and patient satisfaction were also included. Data Extraction The literature was independently reviewed by the primary author. Data Synthesis The structure–process–outcome paradigm is presented as a framework for quality assessment of PC. Structure should be assessed at periodic intervals because it identifies the potential for the provision of quality care. Process, the care that pharmacists provide, must be documented and linked to outcomes before either structure or process can be used to make inferences about the quality of PC. Technical and interpersonal processes should be examined. Outcomes require an interdisciplinary approach that not only considers other medical care inputs but also recognizes the psychologic, economic, and social factors that affect health status and quality of life. Process and outcome must both be assessed to distinguish the contribution of pharmacists from that of other healthcare providers. Examples of criteria are provided and a model to integrate PC within the healthcare system is discussed. Conclusions It is pharmacists’ duty to ensure that patients receive an acceptable level of PC. The structure-process-outcome paradigm provides a framework to identify and link pharmacists’ processes with patients’ outcomes.

Understanding the scientific issues embedded in the generic drug approval process.

OBJECTIVE To review the major scientific issues embedded in the generic drug approval process. DATA SOURCES Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. STUDY SELECTION Performed by the authors. DATA EXTRACTION Not applicable. DATA SYNTHESIS Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. CONCLUSION Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.

Assessing Metered-Dose Inhaler Technique: Comparison of Observation vs. Patient Self-Report

The purpose of this study was to develop and determine the validity of a patient-completed questionnaire that assesses metered-dose inhaler (MDI) technique. Self-reported MDI technique was compared to observed technique. The questionnaire included nine steps for MDI use, with two to three response choices for each step. A total of 159 patients were studied. Direct observation revealed that greater than 82% of patients exhibited inadequate technique (more than two out of nine steps incorrect). The mean percentage agreement between the questionnaire and observation was 77.4%. Questionnaire results where in higher agreement with observation when patients performed correct MDI technique.

Evaluation of a pharmacist-managed anticoagulation clinic.

Medical records were retrospectively analyzed to evaluate the success of a pharmacist‐managed Anticoagulation Surveillance Clinic (ASC). The 78 patients in group I were followed by the ASC. The 17 patients in Group II were followed by other Veterans Administration Medical Center clinics.

Impact of consumer fees on drug utilisation.

SummaryA review of research on consumer fees for drugs and drug utilisation suggests that the demand for drugs tends to be quite insensitive to consumer fees. Although higher consumer fees are associated with slightly reduced rates of drug utilisation, use of most other medical services is not meaningfully affected and health status has not been shown to be adversely affected. The larger impact of consumer fees demonstrated in the published literature is to shift drug costs from third parties to consumers. Since much of the literature is limited to insurance programmes with quite small consumer fees, the generalisability of results may be limited. Ability-to-pay and health needs may also be important considerations in the relationship between use and fees for particular drugs.

Research Experiences and Research-Related Coursework in the Education of Doctors of Pharmacy

A study assessed coursework and experiential activities of students to determine the role of research in Doctor of Pharmacy education. Questionnaires were sent to all 78 (at that time) colleges and schools of pharmacy in the United States. Responses were received from 60 (76.9%), of which 57 were used, representing 139 Pharm.D. program types (entry‐level, post‐B.S., track‐in, nontraditional). Most programs required coursework in research methodology, statistics, and drug information and literature evaluation, with research methodology required least. Although 41.0% of programs provided students the opportunity to conduct research as an elective, only 12.9% required an extensive project with data collection, analysis, and write‐up. Another 6.5% required a project proposal only. Most colleges of pharmacy now offer the Pharm.D. degree, and the role of the pharmacist has also changed. Pharmacists must be able to disseminate evidence‐based knowledge about drug products and drug therapy and use scientific knowledge and scholarly principles to solve problems.

Patient-Reported Underuse of Prescription Medications: A Comparison of Nine Surveys

Nine national surveys documenting patient underuse of prescription medications were examined to describe the variation and trends in that underuse and identify possible reasons for the substantially different rates that were reported. Underuse includes unfilled prescriptions, delayed therapy, reduced frequency, and lowered dosage. Rates of cost-related patient underuse in the studies ranged from 1.6 to 22 percent. Insurance coverage, level of wealth, age, and health status were the sociodemographic variables most strongly related to underuse. Seven additional factors in the design and administration of the surveys were identified as providing plausible explanations for the variance across surveys. The most conspicuous variation was between three government-sponsored periodic surveys and six generally one-time assessments, with the latter yielding higher rates and greater variance in underuse. Understanding the factors contributing to the variation in reported rates of underuse of medications is an important prerequisite for the design of effective prescription-drug benefit programs.