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BackgroundPatient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk.ObjectiveTo test the effectiveness of a patient-centered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard.DesignTwo-arm, multi-site patient-randomized pragmatic trial.ParticipantsEnglish- and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) ≥30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking ≥2 oral medications.InterventionA patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime).Main MeasuresDemonstrated proper use of a multi-drug regimen; medication adherence measured by self-report and pill count at 3 and 9 months.Key ResultsA total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13–4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63–2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08, 95 % CI 1.15–22.37) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17–6.53).ConclusionsA simple modification to pharmacy-generated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens.Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849

Introduction As part of its mission, the US Food and Drug Administration (FDA) communicates with the public regularly about the benefits and risks of prescription and over-the-counter (OTC) drugs. Effectively communicating risk, however, is a significant public health challenge. Objective To better understand how different populations understand information communicated by the FDA about drug safety, we conducted a randomized experiment to examine comprehension and other measures of effectiveness of drug safety messages that occurred in a post-market surveillance phase. Methods We used an Internet panel survey of 1244 consumers, of whom 58 % used prescription drugs in the past year. Half of the sample panel was randomized to read a previous FDA Drug Safety Communication (DSC) with the drug name changed, and the other half was randomized to read a revised version of the same DSC. We examined how making certain modifications to the way drug risk information is communicated has an impact on comprehension and behavioral intentions, including the user’s likelihood of discontinuing the drug. We also studied how comprehension varied by respondent characteristics, health literacy skills, risk perceptions, and trust in the message. Results Based on a five-item comprehension index, the revised version of the message was associated with significantly greater comprehension of the information relative to the standard version (63 vs 52 % correct, p  < 0.001). Significantly more respondents found the revised version to be clear (82 vs 73 %, p  < 0.000), while fewer in that group reported learning something new (78 % vs 84 %, p  = 0.015). No significant differences emerged between the two groups in terms of the message being informative, convincing, or helpful. We found no significant differences between the two groups in terms of behavioral intentions, risk perception, and trust. Conclusions We found that making plain language changes to the DSC significantly increased consumers’ level of comprehension of its content, providing support for ongoing use and further exploration of these strategies in pharmacovigilance communication research. The study findings have important implications for future drug safety and other communication messages related to prescription drugs.

Background: All licensed medicines in the European Union must be provided with a Patient Information Leaflet that includes a list of all known side effects. Among patients who read the leaflet, the side effects section is the most often read. A UK government regulatory publication recommends providing medicine side effect risk information in a combined format, using verbal descriptors accompanied by numerical information. Objectives: This study, with users of an existing popular patient information website, investigates the effectiveness of presenting medicine side effect risk information in different forms. Design: Participants were randomly allocated to one of the three formats for representing risk information (verbal descriptors, e.g. ‘common’; absolute frequencies , e.g. ‘less than 1 in 10 people’; and a combination of verbal descriptors and frequency bands, e.g. ‘common (affects less than 1 in 10 people)’. Methods: Participants (n= 187) were recruited from users of the Cancer Research UK patient information website. They were asked to imagine that they had to take a cancer treatment (tamoxifen), estimate the risks of four side effects occurring, and complete Likert scales relating to their satisfaction with the information supplied and perceived likelihood of various outcomes. Results: Those in the absolute frequency format demonstrated greater accuracy in estimating the likelihood of having two of four side effects than the other two formats. They were also more accurate at estimating the likelihood of themselves or the average person having any side effect from taking tamoxifen. Participants in the absolute frequency format rated the risk to health from tamoxifen as lower than those in the other two formats, were more satisfied with the information they received than those in the verbal format, and felt there would be less impact of the information on tamoxifen use than those in the combined format. Conclusions: These findings fail to confirm that the recommended use of combined descriptors for medicine side effects is unequivocally superior to absolute frequency alone. They also add weight to the growing body of research highlighting the deficiencies in using verbal descriptors for conveying side effect risk, and the strength of using absolute frequency descriptors.

The counterfeiting of vaccines is an increasing problem globally with the safety of persons vaccinated, the trust in vaccines generally and the associated reputation of vaccine manufacturers and regulatory agencies at risk. This risk is especially critical with the on-going development of COVID-19 vaccines. The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced. In this context of traceability, the global immunization community has recently set the barcoding of the primary packaging of vaccines, specifically vaccine vials and pre-filled syringes, as a top priority. Emerging vaccine manufacturers are already engaged in investigating ways to incorporate barcoding in their labelling and packaging using GS1 international standards. A specific pilot taking place in Indonesia by the national vaccine manufacturer, Bio Farma, shows the innovation of barcoding on primary packaging already underway with a relatively modest level of investment and success at this stage. This article highlights the efforts of industry and governments on the value of traceability and introduction to 2D barcodes. Access to financial resources and support from the international immunization community would accelerate such innovations leading to enhanced security of the vaccine supply chain.

Poor-quality antimalarial drugs lead to drug resistance and inadequate treatment, which pose an urgent threat to vulnerable populations and jeopardise progress and investments in combating malaria. Emergence of artemisinin resistance or tolerance in Plasmodium falciparum on the Thailand–Cambodia border makes protection of the effectiveness of the drug supply imperative. We reviewed published and unpublished studies reporting chemical analyses and assessments of packaging of antimalarial drugs. Of 1437 samples of drugs in five classes from seven countries in southeast Asia, 497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified. In 21 surveys of drugs from six classes from 21 countries in sub-Saharan Africa, 796 (35%) of 2297 failed chemical analysis, 28 (36%) of 77 failed packaging analysis, and 79 (20%) of 389 were classified as falsified. Data were insufficient to identify the frequency of substandard (products resulting from poor manufacturing) antimalarial drugs, and packaging analysis data were scarce. Concurrent interventions and a multifaceted approach are needed to define and eliminate criminal production, distribution, and poor manufacturing of antimalarial drugs. Empowering of national medicine regulatory authorities to protect the global drug supply is more important than ever.

Substandard and falsified antimicrobials threaten public health due to their role in resistance development. Pharmacies, as key access points for antimicrobials, can play a crucial role in detecting these products. In this study, a visual assessment tool which incorporates a novel packaging quality index estimate, was developed and used in pharmacies to evaluate antimicrobial packaging and flag suspicious products. A cross-sectional study was conducted in 23 community pharmacies in the Ho Municipality between November 2023 and February 2024. The developed checklist contains indicators on registration compliance, language & medical information, batch information consistency, and product security of the antimicrobials. The tool was validated, and its use on randomly sampled antimicrobials informed the development of the packaging quality index from regression analysis involving weights determined from principal component analysis of the results. Statistical analyses were performed with SPSS (version 26.0) and OriginPro (version 2022). The packages and labels of the 275 antimicrobials evaluated were antibacterials (41%), antiprotozoals (28%), antifungals (22%) and antivirals (9%). Most products were of foreign origin (58.5%) and labelled in English (98%). Significant variations were observed in the registration compliance and product security indicators by origin and antimicrobial class (p < 0.01). Batch information consistency varied significantly across the antimicrobial classes (p < 0.01), whereas language & medical information quality remained consistent. The packaging quality index scores followed a normal distribution, with majority (95.6%) referred to as moderate quality (Index: 1.81-5.34). High quality packages (2.2%; Index: 5.47-5.53) were mostly observed in antibacterials of local origin (66.7%) whereas the poor-quality packages observed (2.2%; Index: 1.48-1.78) were mostly antibacterials of foreign origin (66.7%). This study identified packaging quality issues among the antimicrobials investigated which may suggest potential risk to falsification. Routine antimicrobials packages assessment with developed tools like the packaging quality index could help pick up early signals of substandard and falsified antimicrobials for further regulatory investigations and action.

Medication error is an important cause of patient morbidity and mortality, yet it can be a confusing and underappreciated concept. This article provides a review for practicing physicians that focuses on medication error (1) terminology and definitions, (2) incidence, (3) risk factors, (4) avoidance strategies, and (5) disclosure and legal consequences. A medication error is any error that occurs at any point in the medication use process. It has been estimated by the Institute of Medicine that medication errors cause 1 of 131 outpatient and 1 of 854 inpatient deaths. Medication factors (eg, similar sounding names, low therapeutic index), patient factors (eg, poor renal or hepatic function, impaired cognition, polypharmacy), and health care professional factors (eg, use of abbreviations in prescriptions and other communications, cognitive biases) can precipitate medication errors. Consequences faced by physicians after medication errors can include loss of patient trust, civil actions, criminal charges, and medical board discipline. Methods to prevent medication errors from occurring (eg, use of information technology, better drug labeling, and medication reconciliation) have been used with varying success. When an error is discovered, patients expect disclosure that is timely, given in person, and accompanied with an apology and communication of efforts to prevent future errors. Learning more about medication errors may enhance health care professionals' ability to provide safe care to their patients.

Excipients, or inactive ingredients, are a frequent cause of medication intolerance and allergy. Patients and clinicians concerned about medication allergies and sensitivities rely on the U.S. National Library of Medicine’s DailyMed for accurate lists of excipients. Based on our anecdotal discovery of several examples of excipient omissions, we wished to examine the accuracy of DailyMed’s listings more systematically in a sample of commonly prescribed medications. The objective of the study is to identify the frequency of inconsistency of excipient reporting within the DailyMed website. We performed a database audit of the Structured Product Labeling XML file provided by the drug manufacturer to the Food and Drug Administration and DailyMed for two randomly selected formulations of each of 50 commonly prescribed medications. For each of the 100 formulations, we compared the excipients listed in the “Description” to those in the “Ingredients and Appearance” sections in DailyMed. The Structured Product Labeling data file provided by the drug manufacturer contained internal inconsistencies of excipients in 39% of the formulations examined. Despite the use of Structured Product Labeling, the drug manufacturer’s medication labels provided to the FDA and reported by DailyMed often contain conflicting information about inactive ingredients. Patients with allergies and excipient sensitivity should be aware of these discrepancies and consult multiple sections of the label to identify potential allergy-inducing inactive ingredients.

Background Most people do not apply sunscreen effectively. The Australian and New Zealand standard for sunscreen specifies labels must provide clear and adequate directions for use but does not prescribe specific wording or positioning. Additionally, water-resistant sunscreens must declare the duration of laboratory-tested water resistance, up to 4 h maximum. Formative research found consumers are confused by reapplication directions and water resistance claims. This study aimed to explore whether enhanced sunscreen labelling information can improve sunscreen reapplication. Methods Adult sunscreen users ( n  = 3,363) were randomised to view one of ten mock sunscreen labels in a 2 × 5 online experiment. Labels differed according to front-of-pack (FOP) water resistance claim (standard: tested for 4 h water resistance vs. alternative: water resistant) and reapplication information (none vs. any; with four message variations: simple text, simple icon, extended text, extended icon). We used multivariate logistic regression to examine the effect of FOP labelling on knowledge and intention to reapply sunscreen every 2 h and after swimming, sweating and towel drying (henceforth: activity), considering: (i) water resistance and reapplication information and (ii) reapplication message type. Results Compared to no information, FOP reapplication information increased knowledge (48% vs. 70%) and intention to reapply within 2 h (41% vs. 54%), but not after activity. Compared to the standard claim, the alternative water resistant claim increased knowledge (60% vs. 72%) and intention to reapply within 2 h (47% vs. 56%), but not after activity. Although there was no clear pattern of effects for reapplication message type, only the extended icon (with directions to reapply every 2 h or after activity) increased knowledge to reapply after activity, irrespective of the water resistance claim (52% standard and 57% alternative). Conclusions Under the current standard, sunscreen labels do not provide clear directions for use, which leaves consumers vulnerable to UV damage. Mandating FOP reapplication directions and adopting an alternative ‘water resistant’ claim could improve consumer understanding of how often to reapply sunscreen. Due to common misperceptions about the limits of water resistance, further user-centred label design and public education is needed to improve reapplication after swimming, sweating and towel drying.

Introduction The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and effective drug use. Postmarketing surveillance plays a pivotal role in identifying previously undetected adverse events (AEs) that emerge when a drug is used in broader and more diverse patient populations. However, traditional methods of updating drug labeling with new AE information have been manual, time consuming, and error prone. This paper introduces the LabelComp tool, an innovative artificial intelligence (AI) tool designed to enhance the efficiency and accuracy of postmarketing drug safety surveillance. Utilizing a combination of text analytics and a trained Bidirectional Encoder Representations from Transformers (BERT) model, the LabelComp tool automatically identifies changes in AE terms from updated drug labeling documents. Objective Our objective was to create and validate an AI tool with high accuracy that could enable researchers and FDA reviewers to efficiently identify safety-related drug labeling changes. Results Our validation study of 87 drug labeling PDF pairs demonstrates the tool's high accuracy, with F1 scores of overall performance ranging from 0.795 to 0.936 across different evaluation tiers and a recall of at least 0.997 with only one missed AE out of 483 total AEs detected, indicating the tool's efficacy in identifying new AEs. Conclusion The LabelComp tool can support drug safety surveillance and inform regulatory decision-making. The publication of this tool also aims to encourage further community-driven enhancements, aligning with broader interests in applying AI to advance regulatory science and public health.