Impact of Brand or Generic Labeling on Medication Effectiveness and Side Effects (original) (raw)

The Effect of an Apparent Change to a Branded or Generic Medication on Drug Effectiveness and Side Effects

Psychosomatic Medicine, 2013

Objective: Generic medications are associated with reduced perceived effectiveness, increased perceived adverse effects, and increased rates of nonadherence compared with brand-name medications. This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects. Methods: Sixtytwo university students participated in a study purportedly testing the effectiveness of fast-acting A-blocker medications in reducing preexamination anxiety. All tablets were placebos. In session 1, all participants received a yellow tablet (''Betaprol''). In session 2, participants were randomly allocated to receive Betaprol (no change condition) or a white tablet labeled either as ''Novaprol'' (branded change condition) or ''Generic'' (generic change condition). Blood pressure and state anxiety were measured before and after tablet ingestion. Side effects attributed to medication were assessed. Results: The no change group showed significantly greater decreases in systolic blood pressure (mean [M] [standard deviation] = j7.72 mm Hg, standard error [SE] = 1.45) than the branded change (M = j2.75 mm Hg, SE = 1.44, p = .02) and generic change (M = j3.26 mm Hg, SE = 1.45, p = .03) groups. The no-change group showed significantly greater decreases in state anxiety (M = j1.53, SE = 0.33) than the branded change (M = j0.50, SE = 0.33, p = .03) and generic change (M = j0.52, SE = 0.33, p = .04) groups. Significantly more side effects were attributed to the medication in the generic change (M = 1.83, SE = 0.23) (but not the branded change) condition when compared with the no change condition (M = 0.87, SE = 0.31, p = .03). Conclusions: Medication formulation change, particularly to generic medication, seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects.

Lay views about medicines: The influence of the illness label for the use of genericversusbrand

Psychology & Health, 2010

The aim of this cross-sectional study was to investigate how different types of prescriptions using different illness labels may influence lay views about the use of generic or brand medicines. The participants were 882 Portuguese (both sexes) recruited from the general population, who completed a self-administered questionnaire. A vignette methodology was used in which different prescriptions (generic versus brand) were given for the same label (flu, hypertension, asthma and angina pectoris). The dependent variables were for each illness label: (a) the level of agreement with the prescription, (b) beliefs about the efficacy of a medicine and (c) beliefs about the relief of symptoms. There were main effects of the label and the type of prescription upon beliefs about the use of medicines. There were interactions between illness label and type of medicines. Labels which were perceived as more serious were associated with a lower belief in generic medicines. These results raise important questions concerning the need to consider illness perceptions of lay people (including perceived severity) and its relationship with perceptions of treatment for different conditions. Furthermore, these results may have implications for healthrelated behaviour in general, and in particular for communication between lay people and health professionals, prescribing behaviour, health costs and adherence to treatment.

BEYOND PERCEPTION: BRAND NAMES ACT LIKE PLACEBOS

The commercial reputation that is embodied in brand names is known to alter expectations, preferences, and even the subjective efficacy of products-the very same cola may be expected to be better, be preferred, and even taste better if it is labeled Coke, for example. This paper illustrates that branding can also influence objective product efficacy. For example, study participants facing a glaring light were asked to read printed words as accurately and as quickly as they could, receiving compensation proportional to their performance. Those wearing Ray-Ban labeled sunglasses read more quickly and with fewer errors than those wearing the same sunglasses labeled Mango (a less reputable brand).

Over-the-Counter Analgesics: A Survey of the Public's Knowledge, Attitudes and Beliefs Regarding Current Labeling Practices

Proceedings of the Human Factors and Ergonomics Society, 2002

A wide variety of over-the-counter (OTC) medications are currently available to the general public without a prescription. Among the most popular of these are medicines termed analgesics that have pain-relieving effects. Unfortunately, many people are not aware of the significant health risks associated with their use. The main purpose of this study was to determine whether people want to be informed of these risks and whether such knowledge would influence self-reported precautionary behavior. The results showed that 92% of the 330 people surveyed wanted to be informed of the risks of OTC analgesics and nearly 95% percent agreed that this information should appear on the product label or in the materials that accompany these products. When asked about the likely actions they would take if provided with organ-specific risk information, a large majority of the respondents indicated they would take one or more precautionary behaviors to reduce the risks (e.g., take smaller dosages). A majority of respondents admitted having placed themselves at risk by taking more than the recommended dose of an OTC analgesic at one time. These results have implications for improving the quality and effectiveness of risk communications.

Off-Brand: A Six-Year Study of Medication Brand and Generic Name Usage in a Multi-Facility Academic Healthcare System

Background: Usage of medication brand names in electronic health records may introduce conflicts of interest, perpetuate false perceptions of brand superiority, alter prescribing practices, and cause confusion leading to errors. We sought to identify the frequency of brand name medication usage in clinical documentation, as well as factors associated with increased usage. Methods: We conducted a descriptive analysis to identify generic and brand names for 518 medications in all clinical notes written at our healthcare system between 2015 and 2020. We used string-matching and regular expressions to identify medication mentions. We conducted bivariate analyses to identify associations between brand name usage and author-, note-, and medication-level factors, and a multivariate logistic regression to clarify independent associations between individual factors and brand usage. Results: A total of 104,456,653 notes from 37,285 unique authors were included in our analysis. 162,906,009 med...

Design and test of preference for a new prescription medication label

International Journal of Clinical Pharmacy, 2011

Objective This study measured preference for newly designed prescription labels in comparison with two existing labels from the perspective of patients, pharmacists and physicians, based on three parameters: content, convenience and cosmetic appearance. Setting Participants were interviewed at pharmacies (patients) and at professional meetings (physicians and pharmacists) regarding their preference for the labels. Method Two new labels (A and B) were designed using Publisher Ò Software version 2007 based on literature and results from our previous study. New features focusing on content, convenience and cosmetic appearance (3Cs) included a time table for medication administration, indication of medication and warnings, on a redesigned label. These labels were initially tested on a small sample and then revised. A survey instrument was developed to compare currently used labels and modified labels A and B, on the 3Cs. Main outcome measure The preference of three groups of stakeholders (patients, pharmacists and physicians) were measured for newly designed labels in comparison with two existing labels. Results Complete data obtained with 444 patients, 115 pharmacists and 69 physicians indicated that the median age range of participants was between 51 and 64 years. The patient and physician samples consisted of a higher percentage of women. Pharmacists working in chain pharmacies and family practitioners comprised majority of our sample in professional groups. Mean years of experience in pharmacy and physician groups was 18.2 and 26.8 years, respectively. Most patients (94.4%) in the sample had at least high school education. Majority of patients (82.8%) preferred new labels over existing ones and 55.2% preferred label B on all three parameters. Close to two thirds of pharmacists (76.4%) and physicians (75.3%) preferred new labels with 55.3 and 57.9% preferring label B, respectively. Participants cited all the added modifications as reasons for their preference. Conclusion New prescription labels were favored over existing labels by all stakeholders, for content, convenience and cosmetic appearance. The results may help in making labels more user-friendly and addressing problem areas in labels.

Discrepancies Between the Labels of Originator and Generic Pharmaceutical Products: Implications for Patient Safety

Drugs - Real World Outcomes, 2020

Background All drug marketing authorization holders have the legal obligation to collect data on the use of the products they market and to keep the labels of those products updated. As demonstrated by previous studies, many generic products have labels that are discrepant from the labels of their reference (originator) products. This fact may cause inconsistent messages to be disseminated to healthcare professionals and patients for the same active ingredient. Objective These potential label discrepancies led us to investigate the degree of difference between labels for generic and originator products, the possible consequences of this discrepancy for patients, and its implications for risk minimization. Products and Methods Drugs from different Anatomical Therapeutic Chemical classes were randomly selected from the Electronic Medicines Compendium. For each drug, the consistency and discrepancies between the summaries of product characteristics (SmPCs) for originator and generic products were analyzed for each safety-relevant section of the SmPC separately as well as across all of its sections. The percentile distribution of discrepancy classifications was calculated. The same method was applied when determining the potential impact of label discrepencies on patients. Results Among the 50 drugs selected initially, 31 were eligible for the study and were analyzed further. Of those 31 drugs, 13 (41.9%) presented critical label differences between originator and generic products, 6 (19.4%) showed major label differences, 7 (22.6%) exhibited minor label differences, and 5 (16.1%) showed very minor label differences. Over 60% of the selected drugs (19, 61.3%) presented important (critical, major) label differences between originator and generic products. None of the selected drugs had fully aligned labels of originator and generic products. Label misalignments that could potentially have a fatal or life-threatening impact on the patient were observed for 4 (12.9%) of the selected drugs. Label misalignments that could have a severe patient outcome were noted for 11 (35.5%) of the selected drugs, and label misalignments that could have a medium impact on the patient were seen for 6 (19.35%) of the selected drugs. The label misalignments observed for 10 (32.25%) of the selected drugs would potentially lead to only a minor or no effect on the patient. Almost half (15, 48.4%) of the selected drugs presented label misalignments that could have a critical (fatal, lifethreatening, severe) influence on the patient. Conclusions In this sample, SmPC alignment between generic and originator medicinal products was found to be inefficient for established drugs, and could lead to the diffusion of discrepant messages to healthcare professionals and patients. In order to address this SmPC alignment problem, health authorities such as the EMA and the FDA must conduct retrospective analyses of all drugs on the market as a first step towards realigning labels. These analyses could be performed during the evaluation of aggregate reports.

A PHYSICIAN SURVEY OF THE EFFECT OF RELEVENCE OF DRUG'S BRAND NAME ON PHYSICIAN'S BEHAVIOUR

This research aims to assess the effect of relevance of drug's brand name, on physician's prescribing behaviour. Two brands were selected based on their representative markets' competitiveness and relevance of their names. 214physicians practicing under ambulatory care setting were surveyed to know their preference towards these brands and whether they would use these brands instead of their preferred brands, keeping other factors constant. Research findings indicate that, brand names related to their molecule names are perceived more memorable and meaningful. Such brands get higher share of prescriptions, keeping other factors constant.