Trust in the approval process of medicines mediates the effect of an educational intervention on the pain relief induced by a generic analgesic

BackgroundGeneric medicines have been associated with less efficacy compared to originator products. Educational videos explaining generic medicines can have a positive effect on perceptions of generic drugs and their pain-relieving effect.The central aim of the current study was to examine whether trust in the governmental approval process of medicines mediates the effect of educational video interventions on the pain-relieving effect induced by a generic medicine and whether trust can be built by improving individuals’ understanding of generic medication.MethodsThis is a secondary analysis of a randomized controlled trial where participants with frequent tension headaches were randomly assigned to either watching a video explaining generic drugs (n = 69) or a video informing about headaches (control group: n = 34). After watching the video, participants took an originator and a generic pain analgesic in a randomized order to treat their next two consecutive headaches. Pain severity was measured before and 1 h after taking the medicine.ResultsA multiple serial mediator model showed that improving individuals' understanding of generic medicines is associated with increased trust in medicines. Both factors together, understanding and trust, significantly mediated the effect of the video education about generic drugs on the generic's pain-relieving effect (total indirect effect: coefficient: 0.20, 95% CI: 0.42, −0.0001).ConclusionResults of this study show that improving individuals’ understanding of generic medication and trust in the process of approving medicines should be considered as important mechanisms of future educational interventions about generic medicines.     

Generic drug approval: A US perspective

Abstract

Objective:

Generic drugs are identical or bioequivalent versions of the brand name drugs. They are the economic alternative of the costlier brand name drugs. This article presents a general overview of the procedure and regulatory aspects relating to generic drug approval in the US.     

Vaccination approval literacy and its effects on intention to receive future COVID-19 immunization

BackgroundBefore the coronavirus disease 2019 (COVID-19) vaccine release, polls showed only 50% of Americans had intention to receive the COVID-19 vaccine. The vaccine hesitancy may result from a lack of confidence in vaccine safety and efficacy. More research is needed to identify whether knowledge of vaccine approval processes relates to vaccination intentions.ObjectivesThe objectives of this study were to (1) evaluate participants’ knowledge regarding COVID-19 and vaccine approval processes, (2) evaluate participants’ intentions to receive the COVID-19 vaccine, and (3) compare participants’ knowledge assessment results with COVID-19 vaccine intentions.MethodsA prospective, cross-sectional questionnaire was administered to patients participating in a pharmacist-led chronic disease state management program. The 22-item questionnaire assessed demographic information and evaluated the participant’s knowledge and vaccine intentions. Data were analyzed with an a priori alpha value of 0.05.ResultsNearly all participants answered correctly on questions pertaining to COVID-19 infection (n = 92, 93%), COVID-19 symptoms (n = 96, 96%), and the Food and Drug Administration’s roles in vaccine approval processes (n = 92, 92%). Participants scored lower on questions involving the differing requirements between clinical trial phases (n = 20, 21%) and vaccine safety in the United States (n = 51, 53%). Most participants (n = 54, 55.1%) did not believe the trials were taking too long to produce a vaccine, but 40.4% of the participants (n = 40) believed the vaccine was approved too quickly. More than half of the participants (n = 55, 56.1%) desired more information on how vaccines get approved in the United States. Participants who scored higher on the knowledge assessment were more likely to have a plan to receive the vaccine (P = 0.008).ConclusionsThe results of this study demonstrate the influence knowledge has on intentions to receive vaccines and may aid health care providers in their attempts to promote vaccinations.     

Consumer perceptions of the OTC Coach: A clinical decision support system aimed at improving the safe use of over-the-counter medications

BackgroundThere are more than 300,000 over-the-counter (OTC) medications on the market making it challenging for consumers to select safe and effective products to treat their minor ailments.ObjectiveWe sought to identify consumer perceptions about the use of a clinical decision support system, OTC Coach, to help them make informed decisions about OTC medications.MethodsWe developed a prototype of the OTC Coach that focused on treating fever in adults. We recruited community members who were 18 years and older via our institutional research website. Participants completed a 30- to 45-minute video interview in which they initially discussed their perceptions and experiences of using OTC medications. We subsequently shared the OTC Coach prototype and sought feedback related to the content and format of the tool. We asked participants to rate their likelihood of using the tool to treat a new symptom (10-point Likert scale, 1 = not at all to 10 = extremely likely) and conducted a qualitative and quantitative analysis of these findings.ResultsAmong 20 participants, 11 (55%) were female, 10 (50%) were white, and the mean age was 47.9 years (range 18-81 years). Participants reported that the tool was easy to understand. The questions reported as being extremely important by most participants were allergies (n = 17, 85%), increased risk of bleeding (n = 15, 75%), temperature (n = 12, 60%), and duration of symptoms (n = 12, 60%). Three-fourths of participants (n = 15) selected a score of 7 or higher when asked about their likelihood of using this tool for a new symptom. Concerns that were raised included ensuring that the tool accounted for their personal health history, data storage, and accessibility.ConclusionConsumers were interested in using an electronic tool to determine if their symptoms can be self-treated and, if so, which medications are appropriate.     

Exploring community pharmacists�� views on generic medicines: a nationwide study from Malaysia

Objective To evaluate the Malaysian community pharmacists?? views on generic medicines. Setting A sample of 1419 Malaysian community pharmacies with resident pharmacists. Method A cross-sectional nationwide survey using a self-completed mailing questionnaire. Main outcome measure Pharmacists?? views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Results Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. Conclusion The Malaysian pharmacists?? have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.     

Evaluating pharmacists’ views, knowledge, and perception regarding generic medicines in New Zealand

Background

Generic medicines are commonly used in New Zealand; however, Pharmaceutical Management Agency of New Zealand (PHARMAC) has indicated a need for better information to the public. Studies on consumers’ perceptions suggest that pharmacists play an important role in consumers’ choice; hence, “quality use of generic medicines” can be promoted with a better understanding of pharmacists’ views, knowledge, and perception.

Objectives

(1)To evaluate pharmacists’ perceptions, views, and knowledge of and willingness to recommend generic medicines. (2) To explore pharmacists perceptions of the safety, quality, and efficacy of generic medicines. (3) To assess pharmacists’ views on current policy with respect to substitution of generic medicines.

Methods

A cross-sectional survey using a postal questionnaire was conducted, and questionnaires were sent to 625 randomly selected pharmacists from a list of 1594 pharmacists who had agreed to release their details for research purposes.

Results

Three-hundred and sixty pharmacists responded to the questionnaire (a response rate of 58%). Seventy percent of pharmacists stated there is no difference in safety between original brand and generic medicines. However, 65% stated that original brand medicines were of higher quality than their generic counterparts, and half stated that generic medicines and original brand medicines are equally effective. A large number of pharmacists reported concerns regarding brand substitution and offered suggestions, such as the need for advertising campaigns, patient pamphlets, updating prescribers’ software, and distinct packaging for generic medicines. It was found that pharmacists’ perceptions of generic medicines are primarily driven by PHARMACs policies and their experiences with consumers.

Conclusions

About one-third of pharmacists correctly defined the term “generic medicines,” suggesting discrepancies in pharmacists’ knowledge and perceptions of generic medicines. Concerns were raised regarding: quality, safety, and effectiveness; however, most of the pharmacists acknowledged the economic benefits to the health care system.     

对上海青浦区基本药物目录中抗高血压药物可负担性的实证研究

目的 评估基本药物制度下上海青浦区口服抗高血压药物的可负担性,为促进社区慢性病基本药物价格合理性提供实证依据。方法 采用WHO/HAI标准化法和贫化法对该地区口服抗高血压药物的可负担性进行评价。结果 用WHO/HAI标准化法评价结果显示,医疗保险患者对原研药和仿制药的可负担性都较好,而自费患者对原研药的可负担性较差。贫化法结果显示,使用同一通用名的5种原研药和仿制药的致贫人口数量差距较小。厄贝沙坦原研药的可负担性高于仿制药。结论 医疗保险对提高基本药物可负担性作用明显,同时要对一些具有明确循证学证据和使用人群广泛的药物给予合理的定价,以提高治疗高血压药物的可负担性。     

A wound care and immunization needs assessment for participants of a mobile syringe services program in Austin,TX

BackgroundPeople who inject drugs (PWID) are subject to injection-related harm, including skin and soft tissue infections. Syringe services programs (SSPs) provide sterile syringes, disposal of used syringes, and other supportive services. Given their contact and credibility with PWID, SSPs could facilitate triage and treatment of wounds and access to immunizations for communicable diseases.ObjectiveThis work aimed to assess wound care and immunization needs among participants accessing mobile SSP services in Austin, TX.MethodsA 21-item mixed-methods survey was created to assess frequency and severity of wounds, wound care approaches, and vaccination status. Participants were included if they reported injection drug use and experienced a related wound in the previous 6 months. Interview sections included screening, demographics, wound care, and immunization status.ResultsA total of 21 participants completed the semistructured interview. A majority identified as male (n = 13, 61.9%), white (n = 12, 57.1%), and were unhoused (n = 12, 57.1%). The primary drug of injection was heroin alone (n = 14, 66.7%). Many avoided seeking wound care from health care providers (n = 16, 76.2%) owing to stigmatization (n = 13, 61.9%) and previous negative experiences (n = 7, 33.3%). Self-treatment of wounds included over-the-counter medications (n = 10, 47.6%), over-the-counter supplies (n = 10, 47.6%), and antibiotics (n = 9, 42.8%). In the past 5 years, few had received vaccination for hepatitis A and B (n = 3, 14.3%) or tetanus (n = 7, 33.3%), and many expressed interest in receiving vaccinations through the SSP. Interest for other expanded services included access to antibiotics, an on-site provider, wound care supplies, and education.ConclusionsPWID may avoid professional health care for wound care or immunizations owing to perceived stigma. Expanding availability of wound care services and immunizations directly through mobile SSPs is desired by participants and could positively affect public health.     

An evaluation of consumers’ knowledge, perceptions and attitudes regarding generic medicines in Auckland

Objectives The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. Methods A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. Results A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers’ willingness to use generics. Conclusion Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.     

A modified large sample approach in the assessment of population bioequivalence

The U.S. Food and Drug Administration (FDA) requires pharmaceutical companies to show bioequivalence between different formulations or generic companies to show bioequivalence between generic drugs and brand drugs before approval. In a recent FDA guidance on bioequivalence, new criteria were proposed for assessment of population and individual bioequivalence. In this article, computer simulation is used to compare a modified large sample (MLS) upper bound for the population bioequivalence ratio with the bootstrap upper bound recommended by the FDA. The comparison criteria are the ability to maintain the stated confidence level and the estimated power of tests based on these bounds.     

Older adults’ perceptions of deprescribing chronic benzodiazepines

ObjectiveThe primary objective of our study was to explore older adults’ willingness to stop or lower the dose or frequency their chronic benzodiazepine with the long-term goal of developing a patient-centered intervention to support older adults during the deprescribing process.MethodsWe conducted semistructured interviews with adults aged 60 years and older who reported taking a benzodiazepine for at least 3 months. We recruited participants using our institutional research recruitment website between September and November 2019. Eligible participants completed an interview which was audio-recorded and subsequently transcribed. We identified themes related to older adults’ willingness to consider deprescribing their benzodiazepine, if recommended by their prescriber in a hypothetical scenario. Secondary outcomes focused on their use and perceptions of taking a benzodiazepine as well as their experiences attempting to stop the medication.ResultsAmong the 21 participants, most were female (n = 14, 66.7%), white (n = 20, 95.2%), and reported good or fair health (n = 17, 81.0%). More than three-fourths of participants who reported data (n = 14 of 18, 77.8%) had taken a benzodiazepine for 6 or more years. Participants generally reported that the medication was very effective (n = 16, 76.2%) and adverse effects were infrequent (n = 5, 23.8%). Participants varied widely in their attitudes toward the hypothetical questions about changing their current benzodiazepine. A total of 7 people were open to stopping the medication, 4 were willing to potentially consider it, and 10 were resistant. However, most of the participants were open to the idea of de-escalation (n = 17, 81.0%).ConclusionMany older adults were willing to consider deprescribing a long-term benzodiazepine if it were recommended by their prescriber. Older adults were more open to consider lowering the dose or frequency of the chronic benzodiazepine than stopping the medication. Further research is needed to design a patient-centered intervention tool to support prescribers and older adults in deprescribing conversations about benzodiazepines.     

Community pharmacists' understanding and perceptions of FDA therapeutic equivalence standards

Background

Pharmacists need to demonstrate knowledge of and have confidence in Food and Drug Administration (FDA) therapeutic equivalence (TE) standards to improve acceptance of generic medicines amongst patients and other healthcare professionals.

Understanding the scientific issues embedded in the generic drug approval process.

OBJECTIVE: To review the major scientific issues embedded in the generic drug approval process. DATA SOURCES: Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. CONCLUSION: Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.