Why Is Oral Phenylephrine on the Market After Compelling Evidence of Its Ineffectiveness as a Decongestant?

Ineffective over-the-counter (OTC) drugs should be removed from the US market. Despite solid research showing that oral phenylephrine is ineffective as a decongestant, the US Food and Drug Administration has failed to respond to a 2015 citizen's petition to remove it from the OTC nasal decongestant monograph. Other examples of scientifically proven ineffective OTC medications include guaifenesin as an expectorant, dextromethorphan as a cough suppressant, and chlorpheniramine for cold symptoms.

Countries Manufacturing Pharmaceuticals for the US Market: A 10-Year Analysis of Public Data.

Background: Concerns about strategic supplies and quality have increased the scrutiny of the countries where US pharmaceuticals are made.

Objective: To examine the locations of manufacturers of brand name, biological, and generic drugs over 10 years.

Methods: This longitudinal descriptive study used publicly available data from US government Web sites, including the Food and Drug Administration (FDA) Drug Establishments list, FDA National Drug Code Directory, FDA Orange Book, FDA Purple Book, and the National Institutes of Health DailyMed Drug Labels.

Site-Specific and Country-of-Origin Labeling for Pharmaceutical Manufacturing.

There is increasing concern about the quality of pharmaceuticals, especially generics made in Asia. Popular books and news reports have the public questioning the quality of pharmaceuticals. Recalls and import bans shake confidence in medications, particularly for active pharmaceutical ingredients and finished dosage forms made outside the United States.

Meeting report: an exploration into the scientific and regulatory aspects of pharmaceutical drug quality in the United States.

Introduction: The University of Florida College of Pharmacy, Department of Pharmaceutical Outcomes and Policy hosted a seminar 6-7 March 2021, on the quality of pharmaceutical products in the United States. This meeting report summarizes the topics presented at the seminar and highlights the expert opinions offered by the presenters.

Areas Covered: The seminar, held virtually due to the COVID-19 pandemic, included slide presentations and faculty-moderated panel discussions from experts in the field.

Consistency of psychotropic drug-drug interactions listed in drug monographs.

Background: With an increasing prevalence of psychotropic polypharmacy, clinicians depend on drug-drug interaction (DDI) references to ensure safe regimens, but the consistency of such information is frequently questioned.

Objectives: To evaluate the consistency of psychotropic DDIs documented in Clinical Pharmacology (CP), Micromedex (MM), and Lexicomp (LC) and summarize consistent psychotropic DDIs.

Methods: In May 2016, we extracted severe or major psychotropic DDIs for 102 psychotropic drugs, including central nervous system (CNS) stimulants, antidepressants, an antimanic agent (lithium), antipsychotics, anticonvulsants, and anxiolytics-sedatives-hypnotics from CP, MM, and LC.

Emerging roles for pharmacists in clinical implementation of pharmacogenomics.

Pharmacists are uniquely qualified to play essential roles in the clinical implementation of pharmacogenomics. However, specific responsibilities and resources needed for these roles have not been defined. We describe roles for pharmacists that emerged in the clinical implementation of genotype-guided clopidogrel therapy in the University of Florida Health Personalized Medicine Program, summarize preliminary program results, and discuss education, training, and resources needed to support such programs.

Evaluating incorporation of drug restrictions into computerized drug order entries after transition to an electronic health record.

Background: Incorporation of drug restriction policy into electronic drug order entries (DOEs) can promote responsible medication use and resource utilization when implemented systematically.

Objective: To identify drugs that require further incorporation of formulary restriction policy into their DOEs after migration to an electronic health record with computerized prescriber order entry (CPOE).

Methods: After transition to CPOE, test orders for formulary restricted drugs were entered in the CPOE environment.

Complete-block scheduling for advanced pharmacy practice experiences.

Purpose: An innovative approach to meeting increased student demand for advanced pharmacy practice experiences (APPEs) is described, including lessons learned during a two-year pilot project.

Summary: To achieve more efficient allocation of preceptor resources, the University of Florida College of Pharmacy (UFCOP) adopted a new APPE rotation model in which 20 pharmacy students per year complete all required and elective APPEs at one practice site, an affiliated academic medical center. Relative to the prevailing model of experiential training for Pharm.

Factors associated with the publication of scholarly articles by pharmacists.

Purpose: Factors associated with the publication of scholarly articles by pharmacists were evaluated.

Methods: A Web-based survey was distributed to all pharmacists who published at least one scholarly article in selected pharmacy and medical journals in 2008. All scholarly works published in the American Journal of Health-System Pharmacy, Annals of Pharmacotherapy, and Pharmacotherapy during the study period were categorized by study design using a predetermined algorithm.

Evaluation of contraindicated drug-drug interaction alerts in a hospital setting.

Background: Risks associated with contraindicated drug-drug interaction alerts (CDDIAs) should always outweigh benefits. Misclassified CDDIAs should be eliminated.

Objective: To review CDDIAs and determine if they are contraindicated according to Food and Drug Administration-approved product labeling and if there are circumstances in which contraindicated interactions are acceptable.

Pharmacy resident project publication rates and study designs from 1981, 1991, and 2001.

Purpose: The publication rates and characteristics of residency projects presented at the Southeastern Residency Conference (SERC) in 1981, 1991, and 2001 are described.

Methods: SERC abstracts from 1981, 1991, and 2001 were searched in MEDLINE and International Pharmaceutical Abstracts with a time limit of six years after the conference. All potential positive publications were reviewed and validated by a second investigator.

Evaluation of seven i.v. drug compatibility references by using requests from a drug information center.

Purpose: The scope of coverage and clinical performance of i.v. drug compatibility references were evaluated for drug pairs.

Effects of concomitant amiodarone and haloperidol on Q-Tc interval prolongation.

Purpose: The effects of concomitant amiodarone and haloperidol on Q-Tc interval prolongation were studied.

Methods: All adult patients admitted to a 618-bed tertiary referral teaching hospital between January 1, 2005, and December 31, 2006, who received amiodarone and haloperidol concomitantly were included in this retrospective descriptive analysis. Data collected to assess patients' risk of developing Q-T interval prolongation included age, sex, past medical history, and number of days of concomitant exposure.

An evaluation of the effects of gatifloxacin on glucose homeostasis.

Introduction: The United States labeling for gatifloxacin has been updated to include contradictions related to its reported association with dysglycemia. However, adequately controlled studies in acute care settings assessing the magnitude and clinical determinants of dysglycemia are lacking.

Objectives: To compare the hypoglycemic and hyperglycemic effects of gatifloxacin with ceftriaxone in hospitalized patients.

Efficacy and safety of oral phenylephrine: systematic review and meta-analysis.

Background: Oral phenylephrine is used as a decongestant, yet there has been no previously published systematic review supporting its efficacy and safety.

Objective: To assess the efficacy and safety of oral phenylephrine as a nonprescription decongestant.

Methods: MEDLINE, the Cochrane Central Registry of Controlled Trials, EMBASE, International Pharmaceutical Abstracts, and the Federal Register were searched for English and non-English-language studies published through January 2007 that measured the effects of oral phenylephrine on nasal airway resistance (NAR) in patients with nasal congestion.

Automatic replacement of albuterol nebulizer therapy by metered-dose inhaler and valved holding chamber.

Purpose: Evidence supporting the delivery of bronchodilators with a metered-dose inhaler and a valved holding chamber (MDI+VHC) in place of a small-volume nebulizer (SVN) is discussed, and the steps taken to accomplish such a conversion program at one institution are described.

Summary: Double-blind, randomized studies in patients with acute exacerbations of asthma have demonstrated that higher doses of albuterol delivered by MDI+VHC (4-10 puffs per dose) are as effective as 2.5 mg of albuterol sulfate delivered by SVN.