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The Journal of Clinical Psychiatry Sep 2015Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate...
Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy or development of drug-related adverse effects if these generics are interchanged in stable patients. In a recent study involving 292 indirect comparisons of generic formulations of 9 different drugs, mathematical modeling showed that in most cases (87.0% for maximum concentration, 90.1% for area under the curve, and 80.5% for both) generic drugs are bioequivalent to each other. These reassuring findings notwithstanding, prudence dictates that, in stable patients, generic drugs should be interchanged only if there is a good reason for it. This is because bioequivalent brands of drugs may differ in their excipient content, and this can result in variations in safety profiles.
Topics: Drugs, Generic; Excipients; Humans; Therapeutic Equivalency
PubMed: 26455677
DOI: 10.4088/JCP.15f10300 -
European Journal of Dermatology : EJD Sep 2022Generic drugs may differ from brand-name drugs in nature and quantity of excipients. Hypersensitivity to generic drugs is a subject of growing importance given their key... (Review)
Review
Generic drugs may differ from brand-name drugs in nature and quantity of excipients. Hypersensitivity to generic drugs is a subject of growing importance given their key role in healthcare spending policies, however, a review of published data highlighted that relevant data is sparse. No scientific rationale has emerged for labelling patients allergic to all generic drugs, and hypersensitivity to generic drugs may rather be explored on a case-by-case basis. In the case of hypersensitivity without any change in medication, it is advisable to check for a switch from a brand-name to a generic drug, and if hypersensitivity to a generic drug is suspected, its composition must be checked.
Topics: Humans; Drugs, Generic; Hypersensitivity; Excipients; Product Labeling
PubMed: 36468717
DOI: 10.1684/ejd.2022.4291 -
Clinical Pharmacokinetics Sep 2020There appears to be a mismatch between the assumed therapeutic equivalence of generic drugs, their interchangeability, and reported clinical discomfort following generic...
There appears to be a mismatch between the assumed therapeutic equivalence of generic drugs, their interchangeability, and reported clinical discomfort following generic drug use and drug switches. In this article, we describe why we are of the opinion that the current regulatory approach to the evaluation of generic drugs based on average bioequivalence is sufficient to expect therapeutic equivalence in the clinical setting. This has often been debated, specifically as adverse drug reactions related to generic drug switches are regularly reported. We agree that clinical discomfort during a bioequivalent drug switch may indeed be caused by different exposures to the active substance. However, this difference in exposure is not a result of the characteristics or quality of generic drugs; it is caused by the pharmacokinetic within-subject variability of the active substance, i.e., the variability on the bioavailability of the active substance, when comparing two occasions of administration of the same drug product, to the same patient. Therefore, reported clinical discomfort following generic drug use and drug switches does not warrant a change in the regulatory approach to the evaluation of the bioequivalence of generic drugs. Switching from a brand-name drug to currently approved generic drugs, or between different generic drugs, will in principle result in comparable exposure, within boundaries determined by the within-subject variability of the pharmacokinetics of the active substance involved.
Topics: Area Under Curve; Biological Availability; Drug Substitution; Drugs, Generic; Government Regulation; Humans; Therapeutic Equivalency
PubMed: 32557345
DOI: 10.1007/s40262-020-00909-8 -
Advanced Drug Delivery Reviews 2020Ideally, inhaled therapy is driven by the needs of specific disease management. Lung biology interfaces with inhaler performance to allow optimal delivery of therapeutic... (Review)
Review
Ideally, inhaled therapy is driven by the needs of specific disease management. Lung biology interfaces with inhaler performance to allow optimal delivery of therapeutic agent for disease treatment. Inhalation aerosol products consist of the therapeutic agent, formulation, and device. The manufacturing specifications on each of the components, and their combination, allow accurate and reproducible control of measures of quality and in-vitro performance. These product variables in combination with patient variables, including co-ordination skill during inhaler use, intrinsic lung biology, disease and consequent pulmonary function, contribute to drug safety and efficacy outcomes. Due to the complexity of pulmonary drug delivery, predicting biological outcomes from first principles has been challenging. Ongoing research appears to offer new insights that may allow accurate prediction of drug behavior in the lungs. Disruptive innovations were characteristic of research and development in inhaled drug delivery at the end of the last century. Although there were relatively few new inhaled products launched in the first decade of the new millennium it was evident that the earlier years of exploration resulted in maturation of commercially successful technologies. A significant increase in new and generic products has occurred in the last decade and technical, regulatory and disease management trends are emerging. Some of these developments can trace their origins to earlier periods of creativity in the field while others are a reflection of advances in other areas of basic and computer, sciences and engineering. Select biological and technical advances are highlighted with reflections on the potential to impact future clinical and regulatory considerations.
Topics: Administration, Inhalation; Aerosols; Drug Delivery Systems; Drugs, Generic; Humans; Lung; Nebulizers and Vaporizers
PubMed: 32663488
DOI: 10.1016/j.addr.2020.07.006 -
PLoS Genetics Aug 2020
Topics: Drug Development; Drug Industry; Drugs, Generic; Genetic Diseases, Inborn; Humans
PubMed: 32817613
DOI: 10.1371/journal.pgen.1008889 -
Applied Health Economics and Health... Aug 2015Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and... (Review)
Review
Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.
Topics: Cross-Cultural Comparison; Developing Countries; Drugs, Generic; Health Policy; Humans; Internationality; Legislation, Drug; Therapeutic Equivalency; World Health Organization
PubMed: 26091708
DOI: 10.1007/s40258-014-0146-1 -
Value in Health : the Journal of the... Oct 2022Substitution of brand-name drugs with less expensive, equally effective interchangeable generics is an important strategy for promoting adherence and controlling...
OBJECTIVES
Substitution of brand-name drugs with less expensive, equally effective interchangeable generics is an important strategy for promoting adherence and controlling prescription drug spending. US state laws govern generic substitution, but there is variability among states in how these laws are designed. We aimed to determine how different features of state laws regulating generic substitution are associated with use of generic drugs.
METHODS
Using national claims databases, we studied individuals with commercial insurance or Medicare Advantage plans who newly initiated one of 34 prescription drugs during the year after new generic competition (2017-2018) to determine any association between generic use and 3 different features of state laws. We used multivariable logistic regression to adjust for demographic and clinical characteristics.
RESULTS
Of 502 763 individuals who initiated one of the drugs, 409 856 (81.6%) received a generic version. Those in states requiring patient consent or notification had lower use of generics (81.1% vs 82.9%; adjusted odds ratio 0.89; 95% confidence interval 0.87-0.91; P < .001). By contrast, mandating versus permitting generic substitution and protecting pharmacists from liability did not appear to have significant effects.
CONCLUSIONS
In this study of commercially insured and Medicare Advantage patients, patients in states requiring consent or notification for pharmacists to substitute Food and Drug Administration-certified interchangeable generics had lower use of generics. Laws in 39 states plus the District of Columbia could be amended to improve use of inexpensive and equally effective generic drugs.
Topics: Aged; Drug Substitution; Drugs, Generic; Humans; Medicare; Pharmacists; Prescription Drugs; United States
PubMed: 35487821
DOI: 10.1016/j.jval.2022.03.012 -
Applied Health Economics and Health... Nov 2023Drug repurposing is the process of identifying a new use for an existing drug or active substance in an indication outside the scope of the original indication. Drug...
Drug repurposing is the process of identifying a new use for an existing drug or active substance in an indication outside the scope of the original indication. Drug repurposing has important advantages including reduced development time and costs, and potentially large societal healthcare cost savings. However, current generic drug repurposing research faces a number of challenges in obtaining research funds. Furthermore, regardless of the success of a repurposing trial, commercial parties often lack interest in pursuing marketing authorisation for financial reasons, and academic researchers lack the knowledge, time and funding. Therefore, the new indication of a repurposed drug often does not make it 'on label'. We propose a large increase in public funding for generic drug repurposing research, including funds for the marketing authorisation process when a trial is successful, and a reduction in the regulatory burden of the marketing authorisation process for repurposed generic drugs.
Topics: Humans; Drug Repositioning; Drugs, Generic; Government; Health Care Costs
PubMed: 37398987
DOI: 10.1007/s40258-023-00816-6 -
Research in Social & Administrative... Jul 2018With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug... (Review)
Review
INTRODUCTION
With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions.
MATERIALS AND METHODS
Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies.
RESULTS
Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors.
CONCLUSION
Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use.
Topics: Cost Control; Drug Substitution; Drug Utilization; Drugs, Generic; Formularies as Topic; Health Education; Humans; Marketing; Practice Patterns, Physicians'; Technology
PubMed: 28814375
DOI: 10.1016/j.sapharm.2017.08.001 -
International Journal of Environmental... Apr 2021Generic drugs were instituted in 1984 in the United States. Since that time, many studies have been conducted in several countries into consumer attitude and behavior...
Generic drugs were instituted in 1984 in the United States. Since that time, many studies have been conducted in several countries into consumer attitude and behavior when purchasing generic drugs. Understanding the factors that can influence attitude and purchasing intention in this segment has been a challenge. Thus, this paper aims to present a mapping of the literature on the attitude toward and intention to purchase generic drugs and capture insights that can help define and improve promotional strategies for the use of these products. To identify articles related to the theme, we selected the Web of Science, Science Direct, Scopus, Lilacs, Pubmed Central, Springer, and Embase databases time limited to June 2020, using the keywords "generic drug", "purchase intention", and "attitude". The results indicate that this topic is relatively new, with publications in the leading journals in the area demonstrating its importance. Analysis revealed five strategic insights and showed that the research theme could be grouped into three clusters: (i) consumer attitude and behavior, (ii) perspective of patients and health professionals, and (iii) assessment of the risks associated with generic medications to determine which factors can influence purchase intention, providing decision makers with a broader view with regard to directing public policy strategies in healthcare.
Topics: Attitude; Consumer Behavior; Drugs, Generic; Humans; Intention; Surveys and Questionnaires
PubMed: 33925923
DOI: 10.3390/ijerph18094579