Frank J. Ascione

Exploring the iceberg: Common symptoms and how people care for them

Despite the importance of daily symptoms for peoples quality of living, they are seldom studied (thus, the “iceberg of morbidity”). We begin by reviewing United States and British studies that have information on daily symptoms experienced by adults. The most common ones are respiratory (largely from colds) and musculoskeletal (largely from arthritis, injury, overexertion). Using health diaries kept for 6 weeks by a population-based sample of adults, we report the frequency of respiratory and musculoskeletal symptoms, their specific types and causes, and what factors urge people to take therapeutic actions for them. The most popular action for both is prescription or nonprescription drugs, followed by lay consultation, then restricted activity, and lastly seeking medical care. On Respiratory Days, how miserable a person feels is the main stimulus to action; other morbidity aspects of the day also rank high. Sociodemographic groups scarcely differ in their responses to respiratory symptoms. The situation is similar for Musculoskeletal Nondisease Days (injury/overexertion). But for Musculoskeletal Disease Days (arthritis), sociodemographic characteristics figure more strongly in care, and the days degree of morbidity less. These results signal basic differences in how people approach chronic and acute health problems: For chronic ones, they devise strategies of care (determined partly by their roles, attitudes, and resources) over months and years, and apply them during flare-ups. For acute problems, decisions about care are made in the short run and hinge mostly on symptoms. Our analysis also considers how actions complement or substitute for each other: Self-care actions (nonprescription drug use and restricted activity) tend to co-occur, and so do actions based on medical care (prescription drug use and medical contact). The two domains substitute in one way (nonprescription drug use greatly reduces chances of prescription drug use) and join in another (restricted activity increases chances of medical contact).

The Effectiveness of Four Education Strategies in the Elderly

A study was designed for practitioners wishing to provide comprehensive educational services to the elderly. The effectiveness of four methods (i.e., oral instructions alone or in combination with written information, a medication reminder calendar, or a medication reminder package) of changing patient attitudes, drug knowledge, and compliance behavior was measured in 158 ambulatory cardiovascular patients using a randomized, controlled, single-blind design. The results indicate that drug knowledge will most likely be improved by a strategy that provides small amounts of specific information, thereby reducing the possibility of overwhelming the patient. Noncompliance behavior caused by forgetfulness can be best improved by combining a reminder aid with oral reinforcement. The high levels of motivation present in these patients indicate that improving patient attitudes toward medication taking may be unnecessary.

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.

Potential Medication-Related Problems in Noninstitutionalized Elderly

The extent of potential medication-related problems was examined using a thorough review of drug therapy for 53 elderly patients who averaged five chronic illnesses and who used a mean of 11 drugs. An average of 11 specific potential medication-related problems was identified for each patient. These problems fell into three broad categories: Drug toxicity, physician prescribing, and patient medication behaviors. The strongest predictor of the total number of potential problems was the number of prescription medications. The type of drug therapy review used in this study can help health professionals identify and prevent the types of medication-related problems occurring in multiple medication users.

A systematic approach to educating elderly patients about their medications

The purpose of this study was to evaluate a pharmacist-initiated, total package, patient education program based on the concepts described in the PRECEDE model. This program was directed towards 94 therapeutically complex elderly patients and consisted of a medication history, therapeutic evaluation, patient education needs assessment, patient education session, and a patient feedback/satisfaction telephone interview. Pharmacists identified on average 5.6 medication-related problems and provided an average of 6.2 recommendations. Problems commonly identified involved inadequate drug knowledge (25.5%), noncompliance (22.7%), and inappropriate drug use (17.4%). Typical recommendations included altering drug use (35.9%), improving compliance behavior (18.1%), and improving communication with health professionals (18.1%). Patient satisfaction with the education session was overwhelmingly positive. Based on the findings of this study, it is apparent that a patient education program based on the PRECEDE model can be used successfully by pharmacists to prepare education plans that would benefit the therapeutically complex elderly patient.

An assessment of different components of patient medication knowledge

Different components of drug knowledge (i.e., knowledge of the drug purpose, regimen, action if a dose is missed, and common side effects) were examined in 187 ambulatory cardiovascular patients in order to determine whether the components were similar enough to be considered interchangeable in representing drug knowledge. Patients and physicians were interviewed in a family practice setting and their responses compared for each cardiovascular drug the patient was taking. Scores were highest for knowledge of the drug regimen and purpose, fewer patients were correct about the appropriate action if a dose were missed, and only a small number could accurately identify common side effects associated with their drug therapy. The comparison of patient responses to each of the knowledge measures indicated that there was little consistency in response across the various types of knowledge. The differences in the measures were supported further by regression equations that showed different relationships between a set of independent variables and knowledge of drug purpose and regimen, respectively. The study findings suggest that a partial explanation for inconsistencies of research about drug knowledge may be the way this concept is measured.

Antihypertensive Prescribing Patterns for Adolescents With Primary Hypertension

Background: Hypertension is an increasingly common problem in adolescents yet current medical management of primary hypertension in adolescents has not been well-described. Methods: We identified adolescents with primary hypertension by International Classification of Diseases, Ninth Revision codes and looked at prescription patterns chronologically for antihypertensive drug class prescribed and the specialty of prescribing physician. We also examined patient demographics and presence of obesity-related comorbidities. Results: During 2003–2008, there were 4296 adolescents with primary hypertension (HTN); 66% were boys; 73% were aged 11 to 14 years; 53% were black, 41% white, and 4% Hispanic; and 48% had obesity-related comorbidity. Twenty-three percent (977) received antihypertensive prescription. White subjects (odds ratio [OR]: 1.61; confidence interval [CI]: 1.39–1.88), older adolescents (≥15 years, OR: 2.11; CI: 1.79–2.48), and those with comorbidity (OR: 1.57; CI: 1.36–1.82) were more likely to receive antihypertensive prescriptions controlling for gender and years of Medicaid eligibility in logistic regression. Angiotensin converting enzyme inhibitors were the most frequently prescribed monotherapy. Nearly two-thirds of adolescents received prescriptions from adult primary care physicians (PCPs) only. More than one-quarter of adolescents who received a prescription received combination therapy, which was most often prescribed by adult PCPs. Conclusions: Adult PCPs were the leading prescribers of antihypertensives for adolescents with primary HTN. Race differences exist in physicians’ prescribing of antihypertensives to adolescents with primary HTN. The choice of antihypertensives by physicians of different specialties warrants additional study to understand the underlying rationale for treatment decisions and to determine treatment effectiveness.

A cross-media content analysis of motivational themes in direct-to-consumer prescription drug advertising.

BACKGROUND Direct-to-consumer (DTC) advertising of prescription drugs is a widely discussed issue in health care. However, little is known about the characteristics of the motivational themes used in this type of advertising. OBJECTIVES The aim of this study was to investigate the concurrent presentation of motivational themes in DTC print and television advertisements. METHODS The content analyses focused on advertisements of 2 targeted drug classes (cyclooxygenase-2 enzyme inhibitors and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) in magazines and on television. Targeted print advertisements (for celecoxib, rofecoxib, atorvastatin, pravastatin, and simvastatin) from September to December 2001 and targeted television advertisements (for celecoxib, rofecoxib, and simvastatin) from November 2001 were investigated. The motivational themes were assessed using a theoretical framework based on self-regulatory focus theory and cultural orientation. Self-regulatory focus was examined in terms of goal orientation (promotion vs prevention) and emotional aspects, (e.g., cheerfulness, dejection, quiescence, agitation). The cultural orientation was examined in terms of individualism versus collectivism. The visual-verbal match was categorized as direct if the audio and visual information was semantically redundant, as partial if it was partially related, and as no match at all if it was different or conflicting. RESULTS Twelve print advertisements in 10 magazines and 4 television advertisements on 4 television networks were examined; the interrater reliability scores from 3 independent, trained judges ranged from 0.93 to 0.99. The score was low (0.57) in the visual-verbal match measurement for television advertisements. Products in the same category appeared to be promoted using different self-regulatory foci. For example, celecoxib and atorvastatin advertisements tended to be promotion oriented, whereas pravastatin advertisements tended to be prevention oriented. Motivational themes were found throughout the print advertisements (e.g., pictures, headlines, main text). Only a few advertisements illustrated factual information about a product in a pictorial format. The cultural orientation of the advertisements was similar across brands, with individualistic appeals being common. On television, visual-verbal matches (either direct or partial matches) were generally found, except in the section where risk information was presented. CONCLUSION In this content analysis, prescription drugs in the same class appeared to be promoted using different self-regulatory foci, but individualistic appeals were found more often than collectivistic appeals across brands.

Evaluation of a medication refill reminder system for a community pharmacy

The problem of maintaining compliance in patients taking chronic medications is well established. One recommended approach to reducing this problem is to develop a system which identifies non-compliers in order that interventions can be devised to improve that behavior. A medication refill reminder system is an example of this approach. The refill behavior was observed for 102 cardiovascular patients who were patrons of one community pharmacy in order to assess the effects of a postcard/telephone reminder system. Patients who failed to refill their prescriptions on time were sent a postcard reminding them to have them refilled. A telephone call would follow if the patient failed to visit the pharmacy after the postcard. The study results showed that the average day s late for patients who failed to refill their prescription as expected decreased from 19.15 to 6.6 days after the reminder system was used (P less than 0.005). In addition, the percent of late refills of these patients was 13% less than controls. These findings provide strong evidence that a refill reminder system can be used successfully in a community pharmacy as part of a program to identify non-compliant patients and improve their compliance with chronic medication therapy.

Economics and structure of the generic pharmaceutical industry.

OBJECTIVE To review key economic trends of the generic medication market and analyze the changing structure of the generic medication industry. DATA SOURCES Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. STUDY SELECTION Performed by the authors. DATA EXTRACTION Not applicable. DATA SYNTHESIS The generic pharmaceutical market has the potential to play an important role in containing drug costs, although the amount that could be saved through the use of generic medications is not easy to measure. If estimates for the future growth in the use of generic products prove correct, the proportion of pharmaceutical sales attributable to generic products will remain in the 9% to 10% range through the first decade of the 21st century. The generic pharmaceutical industry includes several categories of companies based on business strategies. Further consolidation is expected as more resources are needed to address patent challenges stimulated by the Drug Price Competition and Patent Restoration Act. Companies are also entering into partnerships with research manufacturers to share profits from proprietary products. Future growth of the generic market will require more than increased use of generic products. Therapeutic interchange, involving switching from single-source, patent-protected products to products within the therapeutic class for which there are generic equivalents, represents a major growth opportunity for generic drug manufacturers because the savings potential is more significant than that for straightforward substitution of generic for brandname products. CONCLUSION As it responds to challenges and opportunities, the generic pharmaceutical industry will continue to be a major force shaping the economics of medication use.