Prescription Drug Labeling Research Articles

Medication Safety: Effect of Content and Format of Prescription Drug Labels on Readability, Understanding, and Medication Use: A Systematic Review

To evaluate the evidence regarding the optimal content and format of prescription labels that might improve readability, understanding, and medication use. We performed a systematic review of randomized controlled trials, observational studies, and systematic reviews from MEDLINE and the Cochrane Database (1990-June 2005), supplemented by reference mining and reference lists from a technical expert panel. We selected studies that focused on the content of physician-patient communication about medications and the content and format of prescription drug labels. Two reviewers extracted and synthesized information about study design, populations, and outcomes. Of 2009 articles screened, 36 that addressed the content of physician-patient communication about medications and 69 that were related to the content or format of medication labels met review criteria. Findings showed that patients request information about a drug's indication, expected benefits, duration of therapy, and a thorough list of potential adverse effects. The evidence about label format supports the use of larger fonts, lists, headers, and white space, using simple language and logical organization to improve readability and comprehension. Evidence was not sufficient to support the use of pictographic icons. Little evidence linked label design or content to measurable health outcomes, adherence, or safety. Evidence suggests that specific content and format of prescription drug labels facilitate communication with and comprehension by patients. Efforts to improve the labels should be guided by such evidence, although additional study assessing the influence of label design on medication-taking behavior and health outcomes is needed. Several policy options exist to require minimal standards to optimize medical therapy, particularly in light of the new Medicare prescription drug benefit.

Development of an illustrated medication schedule as a low-literacy patient education tool

Objective Patients with low health literacy have difficulty understanding prescription drug labels and other medication instructions. This article describes the development, implementation, and preliminary evaluation of an illustrated medication schedule (a “pill card”) that depicts a patient's daily medication regimen using pill images and icons. Methods Participants in a randomized controlled trial who were assigned to receive the pill card intervention described their use of the card and its perceived effectiveness. Responses were analyzed by level of patient literacy and other characteristics. Results Among the 209 respondents, 173 (83%) reported using the pill card when they initially received it, though use declined to 60% approximately 3 months later. Patients with inadequate or marginal literacy skills, less than high school education, or cognitive impairment were most likely to refer to the card on a regular basis initially and at 3 months ( p < 0.05). Most pill card users (92%) rated the tool as very easy to understand, and 94% found it helpful for remembering important medication information, such as the name, purpose, or time of administration. Conclusion Nearly all patients considered an illustrated medication schedule to be a useful and easily understood tool to assist with medication management. Patients with limited literacy skills, educational attainment, or cognitive function referred to the aid with greater frequency. Practice implications Picture-based instructions promote better understanding of prescription medications, particularly among patients with limited literacy skills or cognitive impairment, and should be used more widely in practice.

Thalidomide- and Lenalidomide-Associated; Thromboembolism; NMS with Delayed Fever Associated with Risperidone Another Interesting Adverse Effect to Risperidone – Priapism; Hyperlactatemia due to Nevirapine; Recurrent Anaphylaxis with Gonadotropin-Releasing Hormone Analogs; Psychotropic Effects of Antiepileptic Drugs; Literacy and Misunderstanding of Prescription Drug Labels

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers. Write to Dr. Shuster at ISMP, 1800 Byberry Road, Suite 810, Huntingdon Valley, PA 19006 (call 215-947-7797; fax 215-914-1492; E-mail: joel.shuster@temple.edu ). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices in cooperation with the FDA's medWatch Program and Temple University School of Pharmacy. ISMP is an FDA medWatch partner.

Literacy and Misunderstanding Prescription Drug Labels

Letters21 August 2007Literacy and Misunderstanding Prescription Drug LabelsDavid Katz, MDDavid Katz, MDFrom CommuniCare Health Centers, Davis, CA 95616.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-147-4-200708210-00017 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:I agree with Dr. Parker, who suggests putting the reason for prescribing a medication on the instruction label on the bottle. However, with the use of standardized, computer-generated instruction labels, I find that my own written instructions for the sig are usually reduced to the number and frequency of pills to take. We need to work with the retail pharmacy industry to make changes in their label-generating software, so that individualized instructions, such as “take 1 daily for high blood pressure,” end up on the label in the same wording that we use on the prescription.David ... Author, Article, and Disclosure InformationAffiliations: From CommuniCare Health Centers, Davis, CA 95616.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoLiteracy and Misunderstanding Prescription Drug Labels Terry C. Davis , Michael S. Wolf , Pat F. Bass III , Jason A. Thompson , Hugh H. Tilson , Marolee Neuberger , and Ruth M. Parker Literacy and Misunderstanding Prescription Drug Labels Ali Jawaid Literacy and Misunderstanding Prescription Drug Labels Munsey S. Wheby Literacy and Misunderstanding Prescription Drug Labels Christopher T. Parker Metrics 21 August 2007Volume 147, Issue 4Page: 281KeywordsComputersConflicts of interestDrugsLiteracyPrimary hypertension ePublished: 21 August 2007 Issue Published: 21 August 2007 CopyrightCopyright © 2007 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...

Acquiring Health Information: Interpreting Terminology and Reported Search Sources

This study examines two main topics concerning the acquisition of health-related information. One was to explore how people interpret some relatively common terms used in the labeling of prescription and non-prescription drugs, specifically focusing on the terms “family history” and “MAOI.” The second is to determine the sources people report they would use to gather health information, or specifically, where they would go to get health-related information associated with an iron supplement. The results show that “family history” evoked an interpretation of older more than the younger blood relatives. Few persons could report what monoamine oxidase inhibitor (MAOI) meant. People report being more likely to consult the Internet or a health professional than any of the other sources listed. Implications for better health-related information acquisition through better-designed warning systems are discussed.

Eye Tracking Study on the Impact of the Manufacturer's Logo and Multilingual Description on Drug Selection Performance

The object of the study was a proposed standardized format for Abbott prescription drug labels as it would be applied to domestic and international cartons. We focused on two label elements which were not investigated in our previous study (Bojko et al., 2005) — an additional logo and multilingual description of the drug carton contents, and their potential effect on drug selection performance. Twenty-two pharmacy practitioners completed a series of tasks that involved locating a particular drug among several others. Eye movement measures (fixation count, mean fixation duration, and pupil diameter) and conventional performance metrics (error rate and time on task) were collected. The results suggested that neither the Abbott “a” nor the additional languages affected participants' accuracy, search and information processing efficiency, or mental workload. We discuss additional factors for consideration in a follow-up study to further investigate the effect of multilingual descriptions on user performance.

Regulators demand leaner, succinct drug labeling

FDA wants pharmaceutical makers to get the clutter out of prescription-drug labeling, officials said on May 9 during an educational webcast about the new labeling rule. The new requirements, announced in January, revise the content and format of prescribing information on drug and biological

FDA resurrects, finalizes labeling rule

New federal regulations governing the labeling of prescription drugs and biological products require a cleaner look for prescribing information but rescind, for now, previously proposed changes to container labeling. After reviewing comments to the December 2000 proposed rule “Requirements on

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FDA Preemption: When Tort Law Meets the Administrative State

Conventional wisdom holds that regulation by the administrative state generally establishes minimum standards for product manufacturers that tort liability may usefully supplement. This account of the relationship between tort law and the administrative state has come under increasing attack in recent decades. This Article focuses on what many regard as among the most controversial settings for such attacks today: contentions that regulatory action by the federal Food and Drug Administration (FDA) operates to preempt product liability suits under state law against the manufacturers of medical devices and prescription drugs. The Article initially explores the debate over FDA preemption as a doctrinal matter, drawing on insights from litigation over medical devices to parse the more difficult preemption issues presented in suits over prescription drug labeling. As to the latter, the Article focuses on recent litigation over an alleged causal link between the leading class of antidepressant drugs and suicide by some drug users. The Article then shifts from doctrine to institutional design, explaining why tort law and the administrative state have come into conflict in recent years and considering how law reform might approach preemption questions based on a richer understanding of the two areas. The challenge for the future involves using the prospect of preemption to bolster the predicates for preemption itself within the regulatory system. Fresh thinking about preemption would challenge the pharmaceutical industry to act on its depictions of tort liability run amok by embracing enhanced information disclosure and policing of fraud in the regulatory process - the logical predicates for the kind of optimal risk regulation by the FDA that should carry preemptive effect. Under this approach, the prospect of preemption would function as a preference-revealing device for regulated industry and thereby position it to settle by way of its revealed behavior the seemingly intractable academic debate about the consequences of pharmaceutical liability. There are implications for tort theory as well. A major trend in tort theory has been to think about tort liability as a form of privatized regulation. The approach offered here seeks to initiate a conversation about how the regulatory sphere might partake of the capacity of tort litigation to update information about the risks posed by pharmaceutical products in the marketplace.

Analysis of drug-induced effect patterns to link structure and side effects of medicines

The high failure rate of experimental medicines in clinical trials accentuates inefficiencies of current drug discovery processes caused by a lack of tools for translating the information exchange between protein and organ system networks. Recently, we reported that biological activity spectra (biospectra), derived from in vitro protein binding assays, provide a mechanism for assessing a molecule's capacity to modulate the function of protein-network components. Herein we describe the translation of adverse effect data derived from 1,045 prescription drug labels into effect spectra and show their utility for diagnosing drug-induced effects of medicines. In addition, notwithstanding the limitation imposed by the quality of drug label information, we show that biospectrum analysis, in concert with effect spectrum analysis, provides an alignment between preclinical and clinical drug-induced effects. The identification of this alignment provides a mechanism for forecasting clinical effect profiles of medicines.

Audible medication vials slowly gain momentum

Although the federal government stated several years ago that recipients of new prescriptions must also receive useful written information from their pharmacist, no law or regulation requires that prescription drug labels be decipherable by blind or visually impaired patients. And without a mandate from the government, there is no compelling reason for health insurers and pharmaceutical firms to improve the use of medications by the blind and visually impaired, one purveyor of audible medical products has learned. “I had the right relationships,” said Barry Scheur, referring to insurance and drug company executives he met over the years as a managed care executive, venture capitalist, lobbyist, and lawyer. But, he said, nothing in his varied career prepared him for the negative reactions to his promotions for a reusable audible prescription-assistance device that his Massachusetts-based company, Talking Rx Inc., sells for about $10 apiece. Scheur said the executives told him they were not interested in the memo-recorder-like product unless Medicare—which covers the health care of the disabled and persons age 65 years or older—would pay or a law forced the firms to pay. Some executives even worried that all health plan enrollees, not just those with poor eyesight, would want the product if its cost were covered, he said.

Review of pregnancy labeling of prescription drugs: Is the current system adequate to inform of risks?

Evidence-based medicine that is designed to guide benefit/risk drug therapy decisions does not exist for pregnant women. The types of studies that do exist are usually conducted in animals, which may not reflect human benefits and risks. The types of studies that do exist in humans are typically limited and, at best, may show an “association” between a particular drug therapy and an undesirable effect. This review outlines the difficulties that are associated with the assessment of the benefits/risks of drug therapy during pregnancy, the history of the Food and Drug Administration regulations for labeling prescription drugs, and the strengths and weaknesses of the current Food and Drug Administration pregnancy labeling system. Proposed changes to the current system are reviewed. (Am J Obstet Gynecol 2002;187:333-9.)

Off-Label Uses of Drugs in Children

As we approach the new millennium, very little has changed regarding the labeling of prescription drugs for use in infants and children. Along with pregnant women, infants and children remain therapeutic orphans. This condition is understandable because there are very few therapeutic indications that are unique to this patient population and the absolute quantities of drugs required by these patients remains relatively small. On an actuarial basis, humans spend only approximately 16 years as children, whereas they spend another 60 to 80 years as adults. As a result, there is very little incentive for pharmaceutics companies to develop drugs and drug dosing guidelines for infants and children. Careful review has revealed that >70% of all the Physicians' Desk Reference (PDR) entries have either no existing dosing information for pediatric patients or explicit statements that the safety and efficacy in children have not been determined. In the best of circumstances, there are age-specific admonitions because of lack of dosing information for infants and children. The resulting conundrum can be illustrated best by a case presentation. A 6-month-old infant, born 29 weeks premature, presents to a physician's office in respiratory distress. His medical history is significant for developing bronchopulmonary dysplasia as well as for prematurity. Vital signs are temperature: 37.7°C; pulse: 180; respiration: 72; blood pressure: 84/56; physical examination: intercostal retractions, increased anteroposterior diameter, bilateral diffuse expiratory wheezing, nasal flaring; treatment: albuterol 2.5 mg in 2 mL normal saline by nebulization. While receiving the aerosol, the patient's pulse rate climbs to 215 beats per minutes and he becomes cyanotic despite theo2 used to nebulize the drug. The physician is called by the nurse and witnesses the patient turn black with eyes rolled back. He then suffers a respiratory arrest. Resuscitation is unsuccessful. When confronted with a similar clinical emergency, most … Address correspondence to Jeffrey L. Blumer, PhD, MD, Pediatric Pharmacology and Critical Care, Rainbow Babies and Children Hospital, 11100 Euclid Ave, Cleveland, OH 44106.

Summary of Recent Proposed Regulation for Assessment of Safety and Effectiveness of Drugs and Biological Products in the Pediatric Population

In the fall of 1997, the US Food and Drug Administration (FDA) proposed to add onto the existing 1994 regulations dealing with the “pediatric use” subsection of prescription drug labels. These new regulations were titled Docket No. 97N-0165 “Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients”1. These new rules will require pharmaceutical companies to collect data for those drugs whose indications may be applicable to usage in children before the compound will be approved (or soon thereafter). In some cases, manufacturers will also have to provide this information (within a length of time determined by both the FDA and the manufacturer) for drugs already marketed. It is proposed that, by including safety and effectiveness information on the label, the pediatric population will be less likely to have serious adverse events or subtherapeutic treatments. This article will cover in detail the 1997 proposed regulations and what it will mean for industry.

Immediate Action Needed to Improve Labeling of Prescription Drugs for Pediatric Patients

Immediate Action Needed to Improve Labeling of Prescription Drugs for Pediatric Patients

An Index of United States Regulations Pertaining to Labeling of Prescription Drugs

An index is provided of the contents of the sections of Title 21, Code of Federal Regulations 201, and other selected sections of Title 21 which cover the content of prescription drug package inserts and other aspects of labeling required of United States drug manufacturers.

New Regulations for Pediatric Labeling of Prescription Drugs

Table 1. Information for New Molecular Entities Approved by the Food and Drug Adrninistration The term patients would include those from birth to 16 years of age. As a guide, the FDA provides age breakdowns as follows: birth-I month, I month-2 years, 2-12 years, and 12-16 years. Although these breakdowns were considered inevitably arbitrary, each of these age groups can be heterogenous. For example, the age range of I month-2 years be too broad. The total body clearance of theophylline increases with age up to 12 months,3 while that of midazolam increases up to 3 months.4 In addition, although the pharmacokinetics of ibuprofen were similar in two age groups of children «I y vs. >5 y), the antipyretic response was not.5 Although the FDA requires a description of risks associated with inactive ingredients in the dosage form, such risks be unknown at the time of drug approval. Finally, it not be possible in some cases to extrapolate data from adults to predict therapeutic outcomes in pediatric patients. Uniform enforcement of the new regulations will be difficult. For example, how will it be decided (1) whether the disease and the drug effects are sufficiently similar in adults and pediatric patients; or (2) whether the drug is widely used, represents a safety hazard, or is therapeutically important in the pediatric population? If the FDA has concluded the latter to be true, the agency may require that the sponsor and/or pediatric information.· If the sponsor fails to provide pediatric information, the FDA consider the drug to be misbranded or falsely labeled and constitute an unapproved or unlicensed product. However, how accurate would be the labeling statements prepared from various studies that had used different designs and methodologies? If previous studies were done with extemporaneous formulations, would the sponsor be required to market a liquid or intravenous formulation suitable for in pediatric patients? Although the rule states, Because this final rule does not impose additional requirements for sponsors to conduct EFFECTIVE JANUARY 12, 1995 the Food and Drug Administration (FDA) implemented revised regulations for labeling of prescription drugs for pediatric patients. Under the previous requirements issued in 1979, pediatric labeling normally required substantial evidence derived from adequate and well-controlled studies in the pediatric population.· Although the creation of a Pediatric use subsection was intended to encourage drug labeling in this population, only 19% of the new molecular entities contained pediatric information in the labeling at the time of approval during 1991-1995 (Table 1). Too often a statement such as, Safety and effectiveness in children have not been established, appears in the labeling for many drugs frequently used in pediatric patients. This either discourage the of important drugs or lead to suboptimal therapy in infants, children, and adolescents. Under the new rule, the sponsors (i.e., the pharmaceutical industry) reexamine existing data to determine whether the subsection of the labeling can be modified based on adequate and well-controlled studies in adults, and other information supporting pediatric use, and if appropriate, a supplemental application to comply with new rule by December 13, 1996.· Furthermore, the sponsor is expected to develop and/or submit data if the drug is widely used, represents a safety hazard, or is therapeutically important in pediatric patients. The new regulations would allow labeling of drugs for pediatric based on adequate and well-controlled studies in adults and additional supporting studies dealing with pharmacokinetics, pharmacodynamics, and safety in pediatric patients, provided that the course of the disease and the drug effects are sufficiently similar in the pediatric and adult populations.· The rule clearly states, Pediatric subsection of the labeling must include any limitations on the pediatric indication, need for specific monitoring, specific hazards of the drug, differences between pediatric and adult responses to the drug, and other information related to the safe and effective of the drug in pediatric patients.· The new regulations appear to be a step in the right direction to encourage labeling of more drugs for pediatric patients. However, certain issues need to be clarified.

Pharmaceutical container labels: enhancing preference perceptions with alternative designs and pictorials

The appropriate use of pharmaceuticals, as well as their hazards, are not commonly known to most people. In fact, the only information available to consumers at the time of consumption is usually the material found on the product label. Unfortunately, people often have difficulty with the labels because the print on the label is too small for them to read. Two alternative (tag and fold-out) designs were developed to increase the available surface area on a fictitious prescription drug label. The alternative label designs, with and without pictorials depicting instructions and warnings, were compared to a standard control label. In Expt. l, 84 undergraduates rated the labels on several preference dimensions, including: ease of reading the labels, likelihood of noticing the warnings, likelihood of reading the warnings, preference for each of the labels, and likelihood that they would recommend each label for use by a friend or family member. Across all dimensions, undergraduates preferred the alternative labels, especially the tag labels, and labels with pictorials. In Expt. 2, the ratings of 58 older adults (mean age = 73 years) showed a similar pattern of results. Implications of these results and recommendations for future research in this area are discussed.

Evaluating Pictograms as an Aid for Counseling Elderly and Low-Literate Patients

ABSTRACTOver 20% of the U.S. population consists of individuals who are functionally illiterate or low literate. Prescription labels are typically written at the sixth-grade level. A significant number of individuals, because they may not be able to read prescription drug labels, may not have a good understanding of their drug therapy and so may not take their drug regimens correctly. The elderly population is at high risk of not being able to understand their prescription instructions. Literacy is positively related to age, and as individuals grow older, visual acuity diminishes. The USP-DI Pictograms® have been designed to help people understand how to take their prescriptions. The purpose of this study is to determine whether these pictograms can be understood by illiterate and elderly individuals. A study of 14 USP-DI Pictograms was conducted using a sample of 45 respondents from 2 nursing homes and 3 adult literacy programs. Understanding of the pictograms was recorded at two separate times during th...