Assessment of Comorbidity and Use of Prescription and Nonprescription Drugs in Patients Above 65 Years Attending Family Medicine Outpatient Clinics

Background and aim: Aging is often accompanied by chronic diseases, comorbidity, and polypharmacy. Use of prescription/nonprescription drugs, and over-the-counter (OTC) drugs seen frequently in the elderly. The aim of this study was to assess the comorbidity and multimorbidity status and to evaluate the use of prescription and nonprescription drugs in patients aged 65 years. Materials and Methods: In this cross-sectional and descriptive study, statistical analyses were performed using SPSS Version 22.0. Kolmogorov–Smirnov tests were applied based on meeting the assumption of a normal distribution of the data. Other statistical tests used were one-way analysis of variance tests, t tests, Pearson correlation analysis, Chi-square tests, Mann–Whitney U tests, and Spearman correlation analysis. Results: A total of 244 people participated in the study. The multimorbidity rate was 85%. Participants used an average of 4.26 drugs daily. The polypharmacy ratio was 42%. The nonprescription drug usage rate was 20%. Participants used nonprescription drugs most often with the pharmacist’s advice. Conclusion: Multimorbidity, comorbidity, prescription, and nonprescription drug use were very high among elderly patients. Because older people are more susceptible to adverse drug reactions and drug interactions, physicians who provide care to older people should take a comprehensive drug history.

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

Despite providing a consistent and comprehensible format for over-the-counter (OTC) drug communication, research suggests important limitations in the communication effectiveness of the Drug Facts Label required on OTC drugs in the United States. This literature is reviewed and some of these critical limitations of the Drug Facts Label (DFL) highlighted. These include difficulty communicating complex information that requires integration of multiple pieces of label information and limited adaptability to serve the unique needs of individual populations (e.g., low literacy or older consumers). Potential ways to improve the DFL’s communication effectiveness are identified along with complementary opportunities to improve OTC drug communication by leveraging the role of pharmacists and use of adjunctive technologies.

Dietary Supplement Adverse Event Report Data From the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2004-2013

Background: The Food and Drug Administration (FDA)’s Center for Food Safety and Applied Nutrition (CFSAN) oversees the safety of the nation’s foods, dietary supplements, and cosmetic products. Objective: To present a descriptive analysis of the 2004-2013 dietary supplement adverse event report (AER) data from CAERS and evaluate the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act as pertaining to dietary supplements adverse events reporting. Methods: We queried CAERS for data from the 2004-2013 AERs specifying at least 1 suspected dietary supplement product. We extracted the product name(s), the symptom(s) reported, age, sex, and serious adverse event outcomes. We examined time trends for mandatory and voluntary reporting and performed analysis using SAS v9.4 and R v3.3.0 software. Results: Of the total AERs (n = 15 430) received from January 1, 2004, through December 31, 2013, indicating at least 1 suspected dietary supplement product, 66.9% were mandatory, 32.2% were voluntary, and 0.9% were both mandatory and voluntary. Reported serious outcomes included death, life-threatening conditions, hospitalizations, congenital anomalies/birth defects and events requiring interventions to prevent permanent impairments (5.1%). The dietary supplement adverse event reporting rate in the United States was estimated at ~2% based on CAERS data. Conclusions: This study characterizes CAERS dietary supplement adverse event data for the 2004-2013 period and estimates a reporting rate of 2% for dietary supplement adverse events based on CAERS data. The findings show that the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act had a substantial impact on the reporting of adverse events.

Community Pharmacists’ Classification of Prescription Drugs into an Expanded Class of Nonprescription Drugs under the FDA's Proposed NSURE Initiative

Objectives: There has been considerable debate over the last few decades about creating a third class of drugs that would not require a prescription or not be available freely over the counter, but require a pharmacist’s consultation upon purchase. These debates reignited again in 2012, when the Food and Drug Administration (FDA) held a hearing about a third class of drugs positioned as an expanded nonprescription drug class under the FDAs Nonprescription Safe-Use Regulatory Expansion (NSURE) Initiative. The objective of this study was to determine which prescription drugs community pharmacists believe are acceptable additions to an expanded definition of nonprescription drugs that would be available pending pharmacists’ consultation with a patient. Methods: This cross-sectional study was conducted using a self-report, web-based survey administered to a national panel of community pharmacists. The survey contained a list of 24 current “prescription-only” drugs which may be potential candidates for an expanded nonprescription drug class, based on criteria outlined by the FDA, and questions related to respondent demographic and practice characteristics. The respondents were asked to indicate whether a particular drug should be marketed as a prescription drug, nonprescription drug or as part of an expanded non-prescription drug class. Descriptive analyses were conducted to determine the drugs that community pharmacists believed would be suitable additions to an expanded non-prescription drug class under the NSURE initiative. Results: 462 completed surveys were received. Most respondents indicated that clopidogrel bisulfate (85.3%) and zolpidem (86.6%) should continue to be dispensed as prescription drugs. Atorvastatin, metformin, and sildenafil (among others) were considered appropriate to be marketed as an expanded nonprescription drug, in other words, dispensed without a prescription but upon pharmacist consultation. Desloratadine (64.6%) and pre-natal vitamins (50.2%) were considered appropriate for nonprescription status (over-the-counter, without pharmacist intervention). Conclusions: Respondents suggested that 18 out of 24 drugs (75%) on the list provided could be categorized into an expanded class of nonprescription drugs. Adding more drugs to an expanded nonprescription drug class has the potential to expand pharmacists’ provision of patient care under the FDA’s proposed NSURE program. Type: Student Project