Communicating benefits and risks of generic drugs to consumers: Patient and caregiver opinions of two FDA-developed educational materials

BackgroundIncreasing prescribing and dispensing of generic drugs, compared to brand drugs, may increase patient access to affordable medications. However, little is known about patients' and caregivers' needs and receptiveness regarding the design of educational materials about generic drugs.MethodsThe research used focus groups of patients and caregivers who were students or employees of one university in the Southeastern U.S. to gather input on the optimal content, format and design, delivery channel, and level of satisfaction for two existing, FDA-developed educational materials about generic drugs (infographic and brochure).ResultsParticipants stated a need for the materials to modernize their graphics, emphasize generic drug cost-savings for consumers, reduce scare tactics when discussing adverse events, and be disseminated directly from physician's offices and pharmacies. Despite an overall positive impression of the materials, participants wanted more consumer-oriented materials that were tailored to fit the needs of different types of patients/caregivers, including older adults.ConclusionsThis paper discusses how these findings relate to theories of multimedia learning and guidelines for designing health educational materials, as well as implications for the development of tailored generic drug educational materials for use in public health campaigns to improve access to medication therapy.     

Medication-related problems encountered in the Program of All-Inclusive Care for the Elderly: An observational study

ObjectiveTo evaluate pharmacist-encountered medication-related problems (MRPs) among the participants of the Program of All-Inclusive Care for the Elderly (PACE).DesignThis was a retrospective analysis of proprietary pharmacy records detailing pharmacist encounters with PACE clinical staff.Setting and participantsA national provider of pharmacy services to more than 75 PACE organizations. In total, 1057 PACE participants at 69 PACE sites across the United States with documented pharmacist encounters between March and May 2018.Outcome measuresMRPs were classified using the Hepler-Strand taxonomy, and pharmacists’ recommendations made to prescribers to resolve these MRPs were classified using a modified Hoth taxonomy. In addition, pharmacists’ communication methods and prescribers’ responses were analyzed.ResultsOverall, 2004 MRPs were encountered. The most frequent MRPs identified were related to medication safety concerns, including drug interactions (720, 35.9%), adverse drug reactions (ADRs, 356, 17.8%), high doses (270, 13.5%), and unindicated drugs (252, 12.6%). Drug interactions frequently involved competitive inhibition, 3 or more drugs, opioids, anticoagulants, antiplatelets, and antidepressants. Deprescribe medication (561, 24.8%), start alternative therapy (553, 24.4%), change doses (457, 20.2%), and monitor (243, 10.7%) were the top 4 types of recommendations made by pharmacists. Among 1730 responses obtained from PACE prescribers, 78.1% (n = 1351) of pharmacists’ recommendations were accepted. Compared with electronic communication, telephonic communication was associated with more acceptance and less prescriber nonresponse (χ² = 78.5, P < 0.001).ConclusionPharmacists identified a substantial number of MRPs in PACE, especially those related to medication safety such as drug interactions and ADRs. In this practice setting, significant collaboration occured between pharmacists and PACE prescribers, as evidenced by the rate of prescribers’ acceptance of pharmacists’ recommendations. Further research is needed to fully evaluate the economic, clinical, and humanistic outcomes associated with pharmacists’ encounters in PACE.     

Drug newsletters and quality assurance of drug usage.

The use of a drug newsletter publishing results of drug usage review studies, as a quality assurance measure aimed at improving drug prescribing in an Australian acute care hospital, is described. Drug usage review studies focus primarily on newly registered drugs, drugs with potential for misuse or adverse reactions, and expensive drugs. Data are collected on comprehensive data sheets by clinical pharmacists. Information is supplemented from relevant sources, including laboratory test results. Feedback to prescribers, through the hospital's drug newsletter, presents review results, evaluated by comparison with predetermined standards for appropriateness, together with recommendations for improvement, where indicated. The reviews have highlighted areas in which prescribing could be improved. Studies have shown that the drug newsletter has a significant, but possibly transient, impact on modifying prescribing patterns. Newsletter messages are therefore reinforced by personalized clinical pharmacist interaction with prescribers.     

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.

A prospective,multisite implementation-efficacy trial of a collaborative prescriber-pharmacist model of care for Medication Assisted Treatment for Opioid Dependence: Protocol for the EPIC-MATOD study

BackgroundMedication Assisted Treatment for Opioid Dependence (MATOD) is clinically effective and cost effective, yet a lack of MATOD prescribers in the community limits access to this treatment in Australia. These shortages are often greatest in regional and rural areas.Objective(s)The Enhancing Pharmacist Involvement in Care (EPIC)-MATOD study will evaluate clinical and implementation outcomes among people with opioid dependence receiving MATOD through a collaborative pharmacist-prescriber model of care across multiple sites in a regional location (encompassing a mix of metropolitan and non-metropolitan areas) of Victoria, Australia.Methods and analysisThe EPIC-MATOD study is a prospective, multisite, implementation trial of collaborative MATOD care. Pharmacists and prescribers will be recruited through the local network of opioid pharmacotherapy providers. Patients will be recruited through participating healthcare providers. After induction into the collaborative care model, patients and healthcare professionals will be followed up over 6- (patients) and 12-months (pharmacists and prescribers) in a hybrid implementation-efficacy study, with outcomes mapped to the RE-AIM framework. The primary clinical efficacy endpoint is patient retention in treatment at 26 weeks. The primary implementation outcome is treatment capacity, based on prescriber time required to provide treatment through collaborative care compared with traditional care. Secondary clinical endpoints include attendance for dosing and clinical reviews, substance use, mental and physical health and overall well-being. Implementation costs, acceptability, and provider engagement in collaborative care will be used as secondary implementation outcome indicators. Time and costs associated with collaborative care, and health service utilisation, will also be estimated.Project impactThe study will provide important information on outcomes and acceptability of collaborative care for MATOD, as well as the cost and key considerations in delivering a collaborative model of care in Australia and other countries where similar treatment barriers exist.     

I don&#x27;t even want to go to the doctor when I get sick now: Healthcare experiences and discrimination reported by people who use drugs,Arizona 2019

BackgroundPeople who use drugs experience severe health inequities created by structural and social barriers related to healthcare access. This includes stigma.ObjectiveTo characterize the experience of healthcare access among people who use drugs in Maricopa County, Arizona USA.MethodsA 20-item guided survey with quantitative and qualitative items was fielded between October 23-November 5, 2019 among people who use drugs in community locations (public spaces, trap houses, drug copping areas). Surveys were administered face-to-face by community researchers with lived experiences. Survey recruitment included convenience sampling and social referral among respondents. Quantitative items were described and qualitative data were independently coded using an a priori coding scheme including reasons for healthcare seeking and healthcare-related stigma (anticipated, experienced, enacted).ResultsOver one-third (39.5%) of the185 person sample did not seek medical care in the past year. Of this group, 34.2% reported that they did not seek needed healthcare because they were afraid of being treated badly by medical providers for using drugs. The three major experiences reported by those seeking healthcare in the past year included 1) medical mistreatment (not addressing the primary medical complaint, providing wrong or inadequate treatment), 2) social mistreatment (disapproval, embarrassment, shaming) and 3) abusive behavior (verbal and physical) by healthcare providers.ConclusionsEfforts should create healthcare social and practice environments that assure appropriate and competent medical care and prohibit healthcare provider mistreatment of people who use drugs. Structural incentives such as healthcare finance, hospital accreditation and medical complaint registration should be considered.     

Risk evaluation and mitigation strategies (REMS): educating the prescriber

The US FDA Amendments Act of 2007 was signed into law on 27 September 2007. A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question exists as to whether the benefits of a drug outweigh its risks. REMS constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients. This applies to existing drugs on the market, new drug applications (NDAs), abbreviated NDAs (generics) and biologics licence applications. REMS represent an 'upgrade' from previously required risk minimization action plans, based on the strengthening of FDA powers of authority and enforceability to incur monetary penalties against individuals representing the pharmaceutical industry who fail to comply. For illustrative purposes, we chose the drug romiplostim (Nplate?) to present an REMS, as all components were utilized to help assuage risks associated with the drug. Romiplostim is an FDA-approved drug used to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura that has a significant adverse safety profile based on the risk of changes in bone marrow reticulin formation and bone marrow fibroses, and other associated risks. This review of current REMS policy is intended to provide the prescriber with a better understanding of current modalities in FDA-mandated drug safety programmes, which will impact day-to-day healthcare provider practices.     

Utilization of drug information resources among community pharmacists in Jordan: A cross-sectional study

BackgroundPharmacists are considered to be important sources of drug information (DI) for patients and other healthcare providers. This study aims to examine the characteristics of DI utilization for practicing pharmacists in Jordan and identify the main barriers that impede their ability to utilize them.MethodA cross-sectional study using an online survey was conducted in Jordan between the 27th of November 2020 and 18th of January 2021. Our questionnaire was constructed to explore pharmacists’ utilization patterns of DI resources, the types of DI resources they use and barriers impeding them.ResultsA total of 1875 pharmacists participated in this study. Only one-fifth of the participating pharmacists reported that they referred to DI databases. The most commonly reported databases/websites were Drugs.com, Jordan FDA, and Medscape. The most commonly reported paper-based resources were Drugs in Jordan, Step up pharmacy, and British Pharmacopeia. The most commonly used mobile applications were Drugs.com, Medscape and Lexicomp. 44% of the pharmacists reported that they use DI resources fewer than five times per week and more than half of them (60.7%, n = 1138) reported that the day-shift was the shift that allowed them more time to use DI resources. Lack of time was the most common barrier (53.2%) that restricted the ability of pharmacists to use DI resources.ConclusionUsing electronic resources is still deficient and far from optimum and interventions to improve the pharmacists’ utilization of electronic drug databases are required. Universities and various pharmaceutical bodies are advised to train pharmacists on using DI databases.     

Texas pharmacists’ opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study

Objective Pharmacists in the United States (U.S.) are encouraged to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA) through MedWatch. The aim of this study is to investigate the beliefs and opinions of Texas pharmacists toward reporting ADEs to the FDA. Methods The comments made by pharmacists in state-wide mail survey about reporting serious ADEs to the FDA were independently content analyzed and categorized into themes by two raters. Some comments contained more than one idea and these were categorized into different themes. Main outcome Beliefs and opinions of Texas pharmacists toward ADE reporting. Results A total of 86 pharmacists provided comments on ADE reporting. Texas pharmacists had positive opinions about reporting ADEs to the FDA (e.g., important, valuable and positive). Respondents cited many constraints that impeded the reporting of ADEs: lack of time, failure to know which ADEs to report, difficulty in linking ADEs to a specific drug, lack of patient history, lack of compensation, fear of malpractice suits, limited support from employers and mistrust of the FDA. Pharmacists recommended continuing education and training to raise awareness on ADE reporting and streamlining the reporting process to enhance pharmacists’ reporting behavior. Conclusions Despite pharmacists having positive opinions about reporting ADEs to the FDA, actual reporting may be impeded by a myriad of challenges involved in reporting ADEs. ADE reporting can be improved through addressing these challenges. Continuing education and on-the-job training on ADE reporting are imperative.     

Shedding the light on Pharmacists’ roles during COVID-19 global pandemic

Introduction(Background)The role of pharmacists revolves around providing the highest levels of care to society and ensuring the provision of medicine to all patients. However, with the spread of coronavirus disease 2019 (COVID ?19), pharmacists as a very important part of healthcare professionals’ team are responsible for fighting against the disease regardless of their setting of practice. The role of pharmacists will undergo a little change to extend and include other roles in order to ensure the safety of the community and limit the virus spread. Also, they will be required to obtain information from reliable sources, and to be up to date, so they can be reliable advisors to the community and raise their awareness.ObjectivesThe purpose of this review is to highlight community and hospital pharmacists’ roles during (COVID-19) global pandemic, and to clearly illustrate how they are contributing to maintain pharmacy services continuity, supporting other healthcare professionals, and facilitating the patient’s education.SummaryClinical pharmacists provide direct patient care through monitoring adverse drug reactions, ensuring individualized treatment, performing evidence-based practice, and evaluating drugs in clinical trials. On the other hand, community pharmacists which are the most accessible healthcare providers by the community increase their awareness regarding the preventive measures, balance medicines supply and demand, provide drive-thru and home delivery services, offer telehealth counselling, psychological support, refer suspected COVID-19 patients, and provide vaccination when available.ConclusionInnovative pharmacists’ roles have emerged to adapt to changes during COVID-19 pandemic, however, they may be needed in the post COVID-19 world as well.     

临床药师参与1例小儿烫伤后感染治疗方案的制定

目的 探讨临床药师在重症感染病例救治中的作用。方法 临床药师通过参与1例小儿烫伤后感染治疗方案的会诊工作, 对抗感染药物的选择提出具体意见, 为患儿制定个体化的给药方案。结果 重症感染的患儿得到及时控制和治疗。结论 临床药师参与临床治疗, 有利于提高临床治疗水平, 促进合理用药。