Generic Substitution Research Articles

Testing the unintended cost effects of health policies for generic substitutions: the case of China's National Volume-Based Procurement (NVBP) policy.

Generic substitutions are globally considered to contain health expenditures. Yet it is uncertain whether the costs would spill over to other medicines or health services. Contextualizing China's National Volume-Based Procurement (NVBP) policy, which promoted generic substitution, this study tests the changes in patients' utilisation of generic medicines and whether the costs shift to other pharmaceutics or health services post-policy. This population-based, matched, cohort study uses claims data from Tianjin, China in 2018-2020. We focus on Amlodipine, the most commonly used calcium channel blocker with the largest volume. We build comparable post-policy cohorts: Non-switchers who kept using originator Amlodipine, Pure-switchers who loyally switched to generic Amlodipine, and Back-switchers who switched back-and-forth; and compare between each matched pair, respectively, of their annual healthcare costs and that broken down by components, and patients' use of and adherence to Amlodipine post-policy. 1185 Pure-switchers, 1398 Back-switchers, and 2330 Non-switchers are identified (mean age: 63.0 years; 58.5% men). For the matched pairs, Pure-switchers (N=772) incurred an annual total medical costs of CNY 9213.5, 12.2% lower than Non-switchers (N=1544, absolute difference CNY -1309.3, 95%CI: [-2645.8, -19.6]). The cost reduction only results from Amlodipine prescriptions in outpatient encounters, and are equally born on health plans and the enrolees. Pure-switchers and Non-switchers are not different in costs from other medicines, nor from other items including tests, surgeries, beds, and medical consumables for hypertension-related encounters/admissions. Pure-switchers had higher daily dosage and better adherence to Amlodipine than Non-switchers as well. The differences between Back-switchers and Non-switchers show similar trends but are less profound. China's NVBP policy is effective to control pharmaceutical costs. No unintended cost effects have yet been identified in the short run. Other countries may learn from China on the comprehensive sets of auxiliary policies, including listing, bidding, purchasing, and reimbursing, to better promote generic substitutions.

THE IMPACT OF DRUG COST ON MEDICATION ADHERENCE IN NIGERIA: A PERCEPTION AMONG PHARMACISTS

Background: Given Nigeria's huge economic instability, medication expenses may significantly impact medication adherence, creating a barrier to the treatment of various ailments. The study aimed to assess pharmacists' perceptions about the impact of drug costs on medication adherence in Nigeria. Methods: The study was cross-sectional among practicing pharmacists across Nigeria. The 25 items semi-structured questionnaire was administered online using simple random sampling with the snowballing technique to recruit the pharmacists for the study. The collected data was coded into Microsoft Excel 2016 and subsequently analyzed using IBM SPSS Statistics for Windows, Version 21.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were utilized to summarize the data, providing an overview of the demographic characteristics and key findings. Inferential statistics, specifically Pearson’s Chi-square test, were employed where applicable to determine the relationships between variables. Results: Total 161 pharmacists responded to the survey, giving an 80.5% response rate. The respondent rate was mainly young pharmacists (20–30 years old; 82.6%) and predominantly male (51.6%). Almost all the respondents possess only a bachelor of pharmacy degree (91.9%). Total 90% have practiced for 5 years or less, mostly in community settings (60.9%). Generic substitution has been cited as the most important technique to manage drug costs. Non-adherence due to cost was associated with practice settings, whereas adherence counseling was correlated with gender and setting of practice. All differences were not statistically significant at p<0.05. Conclusions: Most participants believe that the cost of medication is a major barrier to accessing quality healthcare and drives massive non-adherence among those who can barely afford the medicines. Implementing a comprehensive national strategy to enhance the healthcare system, expand the reach of the national health insurance program, and promote cooperation among healthcare practitioners will result in improved clinical outcomes for patients. Peer Review History: Received 22 May 2024; Revised 11 July 2024; Accepted 26 August; Available online 15 September 2024 Academic Editor: Dr. A.A. Mgbahurike, University of Port Harcourt, Nigeria, amaka_mgbahurike@yahoo.com Average Peer review marks at initial stage: 5.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Prof. Hassan A.H. Al-Shamahy, Sana'a University, Yemen, shmahe@yemen.net.ye Dr. George Zhu, Tehran University of Medical Sciences, Tehran, Iran, sansan4240732@163.com

Libyan Pharmacy Professionals' Knowledge, Attitudes and Practices Regarding Generic Substitution for Prescribed Brand Medications

Libyan Pharmacy Professionals' Knowledge, Attitudes and Practices Regarding Generic Substitution for Prescribed Brand Medications

Patient preferences for generic substitution policies: a discrete choice experiment in China.

Background: Generic substitution policies have been widely implemented worldwide to enhance the accessibility of medications. Nevertheless, certain patients have voiced discontent with these policies. This study aimed to evaluate the patient preferences for generic substitution policies and explore the potential for optimization to enhance patient acceptance. Methods: A discrete choice experiment (DCE) was conducted to estimate the relative importance (RI) of five attributes, including generic consistency evaluation (GCE), reimbursement rate, medication use control, information disclosure, and post-marketing surveillance. Respondents were recruited among inpatients and outpatients in three cities and surveys were conducted face-to-face. Preference coefficients, RI of attributes, and the uptake rate of various policies were computed using a mixed logit model. The interaction effects were also included to examine preference heterogeneity. Results: A total of 302 patients completed the survey. All five attributes significantly impacted policy acceptance. GCE held the highest RI value at 56.64%, followed by reimbursement rate (RI = 12.62%), information disclosure (RI = 12.41%), post-marketing surveillance (RI = 9.54%), and medication use control (RI = 8.80%). Patient preferences varied depending on their gender and income. The patient uptake rate of China's current policy was only 68.56%. If all generics were to pass GCE without altering the other attributes, the uptake rate of policies would rise to 82.63%. Similarly, implementing information disclosure without changing other attributes would result in a 78.67% uptake rate, which is comparable to the effect of a 10% increase in reimbursement rate for generics (78.81%). Combining these policies could mitigate the adverse effects of mandatory substitution on patient. Conclusion: Chinese patient preferences for generic substitution policies were mainly influenced by GCE. China's current generic substitution policy has room for further optimization to enhance patient acceptance.

Delivery problems and switch of the manufacturer of antiseizure medications – An update of an online survey of patient’s experiences in Germany and other German-speaking countries

In the last decade there is an increasing frequency of sudden generic switches of antiseizure medications (ASMs) due to delivery problems. We here explored the patient’s views toward generic substitution of ASMs and their experiences with delivery problems and switches of the manufacturer. A questionnaire already used in 2011 was updateded and published on the website of a patient’s organisation from March 2022 until November 2022. 54.4 % of the responders reported delivery problems. Delivery problems were reported from Germany by a higher number of responders than from Switzerland. To 83.7 % of the responders the delivery problems were communicated by the pharmacists. In 41.9 % of these the delivery problems were coped by generic substitution. In 33 % of the latter breakthrough seizures occurred. 26 % of the respondents with experience of a change of the manufacturer not due to a delivery problem reported breakthrough seizures after being substituted. The majority of patients denied having been well informed about the possible consequences of a switch of the manufacturer. A thorough counselling on the low risks caused by change of the manufacturer and the need for good adherence to further reduce the risks should be part of the general information about their treatment with ASMs for people with epilepsy.

Explaining why increases in generic use outpace decreases in brand name medicine use in multisource markets and the role of regulation.

Healthcare systems worldwide face escalating pharmaceutical expenditures despite interventions targeting pricing and generic substitution. Existing studies often overlook unwarranted volume increases in multisource markets due to differential physician perceptions of brand name and generics. This study aims to explain the outpacing of generic medicine use over brand name use in multisource markets and assess the regulatory role, specifically examining the impact of reference pricing on volume and intensity increases. Analyzing German multisource prescription medicine markets from 2011 to 2014, we evaluate regulatory mechanisms and explore whether brand name and generic medicines constitute separate market segments. Using an Oaxaca-Blinder decomposition approach, we divide the differential in brand name versus generic medicine use rates into market structure and unobserved segment effects. Generic use rates surpass same-market brand name substitution by 3.87 prescriptions per physician and medicine, on average. Reference pricing mitigated volume increase, treatment intensity and expenditure. Disparities in quantity and expenditure dynamics between brand name and generic segments are partially explained by market structure and segment effects. Generic medicine use effectively reduces expenditures but contributes to increased net prescription rates. Reference pricing may control medicine use, but divergent physician perceptions of brand name and generics, revealed by identified segment effects, call for nuanced policy interventions.

Determination of linearized pDNA template in mRNA production process using HPLC.

The recent clinical success of messenger RNA (mRNA) technology in managing the Covid pandemic has triggered an unprecedented innovation in production and analytical technologies for this therapeutic modality. mRNA is produced by enzymatic transcription of plasmid DNA (pDNA) using polymerase in a cell-free process of in vitro transcription. After transcription, the pDNA is considered a process-related impurity and is removed from the mRNA product enzymatically, chromatographically, or by precipitation. Regulatory requirements are currently set at 10 ng of template pDNA per single human dose, which typically ranges between 30 and 100 µg. Here, we report the development of a generic procedure based on enzymatic digestion and chromatographic separation for the determination of residual pDNA in mRNA samples, with a limit of quantification of 2.3 ng and a limit of detection of less than 0.1 ng. The procedure is based on enzymatic degradation of mRNA and anion exchange HPLC separation, followed by quantification of residual pDNA with a chromatographic method that is already widely adopted for pDNA quality analytics. The procedure has been successfully applied for in-process monitoring of three model mRNAs and a self-amplifying RNA (saRNA) and can be considered a generic substitution for qPCR in mRNA in-process control analytical strategy, with added benefits that it is more cost-efficient, faster, and sequence agnostic.

Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia.

WHO estimates that 15.8% of substandard or falsified medical products are used to treat non-communicable diseases which account for 80% of the global burden including diabetes. The increased level of use of metformin hydrochloride tablets in clinical practice creates the need to monitor and ascertain the quality of the various brands available in the drug market for quality control assessment and generic substitution. This study aims to assess the pharmaceutical quality of seven brands of metformin tablets circulating in pharmacy outlets in Gondar City, North West Ethiopia. Official Pharmacopoeia tests such as uniformity of weight, disintegration, assay, and dissolution tests were used to assess the physicochemical quality control parameters of metformin hydrochloride tablet brands. The unofficial tests conducted included crushing strength/hardness and friability. In all seven tests, the tested brands passed the BP official tests for uniformity of weight, friability, disintegration, and dissolution. Each product had a friability of less than 1% with a maximum of 0.385%. In contrast, none of the brands passed the non-official hardness test. Each product disintegrated in seven to twelve minutes, meeting the USP standards. Drug release rates in 45 min ranged from 78.9 to 92.6%, and drug content results were within the USP guidelines (96.55-102.76%). The current study demonstrated that all seven brands of metformin hydrochloride 500 mg tablets adhered to the quality control parameters specified in the pharmacopeia, except for the hardness test across all brands.

Chirurgie bariatrique et médicaments : revue de la littérature et analyse des effets indésirables dans la banque nationale de pharmacovigilance

Bariatric surgery is the only treatment for severe obesity (BMI>35kg/m2) currently recognized as effective both in achieving tangible and lasting weight loss, and in improving obesity-related comorbidities such as type 2 diabetes, hypertension, and cardiovascular complications. Bariatric surgery, like any other surgery of the digestive tract, can have an impact on nutrient absorption, as well as on drug absorption. The literature on drug management in bariatric surgery patients concerned mainly of case reports and retrospective studies involving a small number of patients. No official guidelines are available. We conducted a literature search on the consequences of bariatric surgery in terms of drug bioavailability and/or effect. The Medline® (PubMed) database was searched using the following keywords: "bariatric surgery", "bioavailability", "gastric bypass", and "obesity". We completed this review with an analysis of reports of adverse drug reactions (ADRs) in post-bariatric surgery patients for obesity registered in the National pharmacovigilance database (PVDB). We selected all cases with the mention of "bariatric surgery and/or gastrectomy" as "medical history". After reading the cases, we excluded those in which the patient had undergone surgery for an indication other than obesity, where the route of administration was other than oral, and cases in which ADRs resulted from voluntary overdose, attempted suicide, allergy, switch to Levothyrox® new formulation, meningioma under progestative drugs, inefficacy related to generic substitution and medication error. The literature search identified mainly "case report" about the impact of bariatric surgery on so-called "narrow therapeutic window" drugs. We identified 66 informative cases out of a total of 565 cases selected (11%) in the PVDB. Nevertheless, the information does not allow a clear relationship between the occurrence of the ADR and the influence of bariatric surgery. There is a lack of official information and/or recommendations on medication use in subjects who have undergone bariatric surgery. Apart from under-reporting, ADRs reports remain largely uninformative. Health professional and patients would be awareness for improving, quantitatively and qualitatively the reporting of ADRs in this population.

Adverse drug reactions attributed to generic substitution of antiretroviral medications among HIV treatment and pre-exposure prophylaxis clients in British Columbia, Canada.

In British Columbia, antiretrovirals (ARVs) for HIV treatment (HIV-Tx) and pre-exposure prophylaxis (PrEP) are free-of-charge through publicly-funded Drug Treatment Programs (DTPs). When available, less costly generics are substituted for brand-name ARVs. We describe the incidence and type of product substitution issue (PSI) adverse drug reactions (ADRs) attributed to generic ARVs. Cohorts included DTP clients ≥19years who received generic ARVs for HIV-Tx (abacavir-lamivudine, emtricitabine-tenofovir DF, efavirenz-emtricitabine-tenofovir DF, atazanavir or darunavir between 01 Jun 2017 and 30 Jun 2022) or PrEP (emtricitabine-tenofovir DF, 01 Apr 2018 to 30 Jun 2022). Demographic, ARV and ADR data were extracted from DTP databases and summarized by descriptive statistics. PSI incidence was calculated for each product during the year following brand-to-generic and generic-to-generic transitions (first-year-post-rollout), and compared between generic versions using generalized estimating equations. For context, incidence of any ARV product-related ADR was calculated in the same 1-year periods. During first-year-post-rollout periods, 5339 HIV-Tx (83% male, median age 52years) and 8095 PrEP (99% male, median 33years) clients received generic ARVs, and reported 78 and 23 generic PSIs, respectively. PSI incidence was <1% for most generic ARVs, with mild-moderate symptoms including gastrointestinal upset, headache, dizziness, fatigue/malaise and skin rash. In HIV-Tx clients, the efavirenz-containing product had higher PSI incidence than other ARVs (2.2%, p = .004), due to more neuropsychiatric adverse reactions. Any ADR incidence was stable across measurement periods, and generic PSIs represented less than one third of all product-related ADRs. Generic substitution of antiretrovirals for HIV-Tx and PrEP was well tolerated, with ≤2% incidence of mild-moderate PSI ADRs.

Generic orphan drug substitution: a critical analysis of global practices and Saudi Arabia's perspective.

In an era of cost pressure, substituting generic drugs represents one of the main cost-containment strategies of healthcare systems. Despite the obvious financial benefits, in a minority of cases, substitution may require caution or even be contraindicated. In most jurisdictions, to obtain approval, the bioequivalence of generic products with the brand-name equivalent needs to be shown via bioavailability studies in healthy subjects. Rare diseases, defined as medical conditions with a low prevalence, are a group of heterogenous diseases that are typically severe, disabling, progressive, degenerative, and life-threatening or chronically debilitating, and disproportionally affect the very young and elderly. Despite these unique features of rare diseases, generic bioequivalence studies are typically carried out with single doses and exclude children or the elderly. Furthermore, the excipients and manufacturing processes for generic/biosimilar products can differ from the brand products which may affect the shelf-life of the product, its appearance, smell, taste, bioavailability, safety and potency. This may result in approval of generics/biosimilars which are not bioequivalent/comparable in their target population or that meet bioequivalence but not therapeutic equivalence criteria. Another concern relates to the interchangeability of generics and biosimilars which cannot be guaranteed due to the phenomenon of biocreep. This review summarizes potential concerns with generic substitution of orphan drugs and discusses potentially problematic cases including narrow therapeutic index drugs or critical conditions where therapeutic failure could lead to serious complications or even death. Finally, we put forward the need for refining regulatory frameworks, with emphasis on Saudi Arabia, for generic substitution and recent efforts toward this direction.

Pregled lista i preporuka za zamenljivost lekova u izabranim evropskim zemljama

Generic substitution has been introduced in the healthcare systems of many countries to reduce the costs and ensure the continuity of drug market supply. Common and country-specific strategies on this topic have been presented for several European countries, as well as for the Republic of Serbia. The factors that need to be considered when assessing the interchangeability of medicines may be related to the medicine or the individual patient. Particular caution is required with narrow therapeutic index drugs, drugs with non-linear pharmacokinetics, antiepileptic drugs, medicines with prolonged release formulations, medicines administered in a specific way or with a medical device. Factors such as the different appearance of the medicines, excipients, packaging, indications, but also the patient's condition, age, concomitant diseases, pregnancy, hand function, vision, ability to swallow, and the patient's attitude towards the alternative medicines should also be taken into account. When substituting two generic medicines, it should be noted that those medicines may not be bioequivalent, since bioequivalence is confirmed between a generic medicine and a reference (usually original) medicine, and thus pose an additional risk to the patient's safety. Some countries have opted to form lists of interchangeable medicines and/or detailed guidelines regarding interchangeability to assist healthcare professionals in making decisions on drug substitution.

Therapeutic Substitution in Response to Patent Expiry? Statins in Australia*

This study aims to investigate the effects of generic entry on the market share of different statins. We use administrative records from a representative sample of Australians between 2003 and 2014 and analyse over 21 million prescriptions to quantify the change in the total market share of each statin after experiencing generic entry for the first time. With detailed information on patients' benefits and prices, we also estimate potential savings from increasing the use of statins where generics became available. Our results indicate that despite the price decrease, the market share of the molecule experiencing generic entry does not significantly increase, and there is some evidence of substitution away from statins with generic availability. For the most commonly used molecules, this association is stronger in patients receiving higher government subsidies. We calculate potential savings of A\$17 million if patients had initiated treatment with the most prescribed off‐patent statin rather than a patent‐protected statin. Generic entry after patent expiry presents an opportunity for a significant reduction in pharmaceutical expenditure if these are preferred. This study highlights the importance of improving prescription systems that help doctors recommend lower cost, clinically appropriate alternatives and enhance the effectiveness of policies promoting generic substitution.

Therapeutic monitoring of pediatric transplant patients with conversion to generic tacrolimus

ObjectiveTherapeutic monitoring during interchange of tacrolimus commercial formulations is essential to ensure similar exposure in transplant patients. However, there are limited data in the pediatric transplant population. This study aims to evaluate exposure, safety and efficacy in maintenance pediatric transplant patients under generic tacrolimus substitution. MethodPediatric patients who underwent interchange of tacrolimus formulations were detected by the Service of Pharmacy and included in this study. Tacrolimus trough levels (C0), laboratory parameters and clinical characteristics were recorded before and after the switch. Statistical analysis was performed using Wilcoxon matched pair t-test. ResultsIn total, 10 patients with kidney, liver, heart and hematopoietic stem cell transplantation received the innovator and switched to the generic product. The median (range) of the C0 normalized by the dose before and after switch was 74.8 [(ng/ml)/(mg/kg)] (13.8-518.4) and 65.1 [(ng/ml)/(mg/kg)] (13.5-723.5), respectively (p>0.05). Tacrolimus dose was 0.070(mg/kg) (0.024-0.461) and 0.069(mg/kg) (0.017-0.571) for the innovator and generic formulation, respectively, with no difference when comparing both values (p>0.05). Laboratory parameters did not change after conversion (p>0.05). Adverse events, acute rejection, death and graft loss were not observed. ConclusionsIn our study population, no significant differences in terms of laboratory parameters, drug exposure and dose were observed. We emphasize the need of close monitoring to ensure a safe interchange, especially in vulnerable populations such as the pediatric.

Opinion of Polish Patients with Epilepsy on Generic Medications.

The majority of medicines used in Poland are generic drugs and substitutions of the originals. The objective of this study was to obtain information on the current knowledge about generic medicines among Polish patients with epilepsy. The conducted study was based on a self-developed questionnaire. The questionnaire consisted of 26 questions, including the questions regarding the respondents' knowledge about generics, their previous experience, and the factors behind these choices. Overall, 1220 questionnaires were analyzed. Among all patients, 66.4% reportedly had heard about generics. Of these, 61.5% of patients had used generic drugs in the past. A significant proportion of participants had never been recommended to switch to a generic medicine by their healthcare professional (23% physicians and 13.9% pharmacists). Statistically, relevant differences were observed regarding the respondents' kind and level of education, place of residence, and net income per household. Significant gaps were identified in the knowledge and perceptions among patients regarding generic medicines, especially in relation to their efficacy and safety. Efforts must be directed towards increasing public awareness of generic medicines and there should also be a focus on educating patients about generic medicines.

A comprehensive review addressing the factors influencing generic drug substitution

Generic drug substitution is a common practice in healthcare systems worldwide to promote cost-saving treatments while maintaining therapeutic effectiveness. Several factors influence this substitution, including regulatory policies, safety and efficacy considerations, patient and physician preferences, and market dynamics. This review comprehensively analyzes how these factors interact and influence generic drug substitution in healthcare settings and across various therapeutic classes and highlight the importance of balancing cost-saving measures with maintaining patient safety and therapeutic efficacy. Policies and guidelines established by health authorities in each country influence the approval, interchangeability, and substitution of generic drugs. Bioequivalence and therapeutic equivalence are critical factors, particularly in drugs with narrow therapeutic indexes. Moreover, physicians’ acceptance and willingness to prescribe generic drugs, as well as patient acceptance and compliance with generic drug use, play a vital role in promoting generic substitution.

Impact of China's National Volume-Based Procurement on Drug Procurement Price, Volume, and Expenditure: An Interrupted Time Series Analysis in Tianjin.

National Volume-Based Procurement (NVBP) program has been carried out in China to lower drug prices and reduce patients' medication burden. This study aims to evaluate its impact on drug purchasing in Tianjin city, one of the first 11 cities piloting NVBP in China. Using monthly drug procurement data from Tianjin Medical Purchasing Center between 2018 and 2020, this study identified bid-winning drugs and their alternative drugs in the pilot NVBP, and evaluated the policy impacts on their procurement price (cost of defined daily dose, DDDc), volume (the number of defined daily dose, DDDs), and expenditure, during the first (initiated at April 1, 2019) and second (initiated at April 25, 2020) procurement cycles of pilot NVBP, applying interrupted time series (ITS) analysis. Included drugs were classified into 12 pharmacological subgroups for further analysis. Decrease in DDDc of NVBP-covered drugs (bid-winning and non-winning drugs) were observed in the first (level change: -CNY 3.878/DDD, P<.001; trend change: -CNY 0.068/DDD, P=.001; relative change: -61.55%) and second (level change: -CNY 0.356/DDD, P=.049) procurement cycles of pilot NVBP, while no significant change was observed for the DDDc of alternative drugs, except for the increase in antidiarrheic and anti-inflammatory/antirheumatic subgroups as more expensive drugs were purchased from new suppliers in the second procurement cycle. The DDDs of bid-winning drugs significantly increased, while decreased for the non-winning original and generic drugs. Procurement expenditure was saved for NVBP-covered drugs (level change: -CNY 7.29×107, P<.001; trend change: -CNY 5.62×106, P<.001; relative change: -62.60%). However, during the second procurement cycle, procurement volume and expenditure of alternative drugs increased significantly in 7 out of 12 subgroups. The pilot NVBP policy in China reduced procurement price, promoted generic substitution, and saved procurement expenditure. However, the increase in procurement price, volume and expenditure of alternative drugs may reveal the significance of regulating healthcare institutions' drug purchasing behavior.

Overcoming Barriers to Generic Drug Adoption: Insights from Global Studies

Objective: This review paper aims to provide insights into the awareness of generic drugs among consumers, challenges in the adoption of generic drugs identified in various studies conducted in different countries, and proposed remedies to make generic drugs more available, accessible, and affordable to consumers. Generic drugs, produced and marketed by entities other than the original innovators, are often priced significantly lower than branded drugs. However, patients sometimes exhibit reluctance towards generic versions. This article reviews findings, challenges, and potential solutions recorded in past research from sources like PubMed and Google Scholar. Data: Generic drugs are a vital component of healthcare affordability and accessibility, aligning with the United Nations' Sustainable Development Goals. We explore historical and evolving concepts of generic drugs, challenges posed by patenting, and the overarching issue of catastrophic medical expenditures. Study Selection: This review compiles information from diverse online sources, research articles, and review papers related to generic drugs. Conclusion: While generic drugs are equally effective and more affordable, consumers' awareness and perceptions often present barriers to adoption. Factors such as age, education level, health literacy, income, and trust in prescribers influence willingness to accept generic drugs. Country-specific healthcare policies, prescription regulatory frameworks, and reimbursement mechanisms also affect adoption. Addressing the perception of generic drugs, increasing knowledge, and improving educational interventions can enhance adoption. Making the prescription guidelines more binding and updating legal frameworks for generic substitution are essential steps. Generic drugs are a powerful tool for making healthcare more accessible and affordable, but these challenges must be overcome to realize their full potential.

Generic substitution of epinephrine autoinjectors: Patient and caregiver perceptions and attitudes

It is important to understand and address patient and caregiver perceptions about and attitudes toward generic substitution of drug-device combination products. The goal of this study was to explore how differences in design and usability features of epinephrine autoinjectors (EAIs) affect patients' and caregivers' views of product quality, efficacy, and device usability in an emergency setting and to better understand attitudes about and perceptions of EAI substitution. This qualitative, enhanced focus group study was conducted in the United States among adult and adolescent EAI users. Ajourney mapping exercise was used to explore patient and caregiver perceptions of and barriers to switching to a generic EAI. Discussion topics also focused on questions participants would ask, challenges they would face, and actions they would take if they were switched to a generic EAI. While patients and caregivers were interested in the potential cost savings and increased access to treatment offered by generic EAIs, they wanted to be informed by their prescriber or pharmacist about generic substitution before or when it occurs. In terms of design differences, participant feedback most often related to differences in look and feel (eg, size, force to execute user tasks, hand grip) or functionality and design differences (eg, the generic version has a twist-off cap at the needle end, and the brand-name EpiPen does not). Outcomes from these focus groups suggest opportunities for the US Food and Drug Administration, health care professional organizations, and patient advocacy organizations to improve generic drug literacy among adults, adolescents, and health care providers.

Lebanese pharmacists’ knowledge of generic drugs and factors affecting their use and selection following the pandemic and the economic crisis: A pilot cross-sectional study

Background Pharmacists are crucial in lowering pharmaceutical expenditures by substituting brand-name drugs for generic drugs. They are expected to understand the principles and practices of generic drug substitution for high-quality patient care. Some key areas of knowledge include bioequivalence and therapeutic equivalence, regulatory requirements, drug interchangeability, and adequate patient counseling. Objectives This study aims to assess the knowledge, perception, and practice of generic drug substitution among pharmacists in Lebanon following the crises and the factors affecting the prescription and selection of generic drugs. Methods A pilot descriptive cross-sectional study targeting 80 Lebanese pharmacists was conducted over 2 months (September-October 2022), in which data were collected using a uniform survey. Results Overall, pharmacists had a good knowledge of generic drugs in terms of active ingredients (97.5%), pharmaceutical form (85.0%), lower cost (88.7%), bioequivalence to the brand before (95.0%), and therapeutic equivalence. Nevertheless, 22.5% reported that generic drugs are less safe than brands, and 22.5% said they cause side effects or did not know. Among the possible factors that influence the prescription of generic drugs, 35.0% of pharmacists reported that the financial situation of the patient is among the least important factors, while the lack of possible alternatives (45.0%) and the difference in prices (40.0%) were the most important ones. The price of different generics on the market was among the most important factors (36.3%) affecting the selection of generic drugs, followed by the patient’s. preference (26.3%). Only 11.2% considered the information given by pharmaceutical firms could affect their choice, and 10.0% considered the presence or not of excipients with known effects in the formulation. Conclusion Most pharmacists in Lebanon were familiar with generic drugs and supported generic drug substitution. Factors affecting generic drug use and prescription should be further explored to clarify misconceptions and reduce possible adverse events.