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1.
Health Policy ; 142: 105027, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38452575

RESUMO

BACKGROUND: The appropriate use of medicines has long been recognized as a fundamental component of medicine policies. We aimed to extract lessons from published research on how policy contexts and mechanisms can affect the outcomes of national- or health-system level interventions to promote appropriate medicine use (defined as an increase in underutilized medications or decrease in inappropriate medication use). METHODS: We conducted a rapid realist review of published evidence concerning system-level policies to promote the appropriate use of medicines in high-income countries with universal prescription drug coverage. We searched MEDLINE and Embase to identify relevant publications. We used a realist evaluation framework to identify contexts, mechanisms, and outcomes for each intervention and to hypothesize which policy contexts and mechanisms supported successful outcomes in terms of relative changes in the prevalence of use of the specific medication classes targeted. RESULTS: From 1,318 identified studies, 18 met our inclusion criteria. 13 distinct policies were identified. Three main policy-related factors underpinned successful interventions: involving providers and patients through program interventions; central coordination through national agencies dedicated to medicine policies; and the establishment of an explicit and integrated national medicine policy strategy. CONCLUSION: Policymakers can improve coordination of national pharmaceutical policies to reduce harms from inappropriate medicines use, thus improving health outcomes through cost-effective programs.


Assuntos
Controle de Medicamentos e Entorpecentes , Políticas , Humanos , Países Desenvolvidos
2.
BMC Health Serv Res ; 24(1): 111, 2024 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-38245720

RESUMO

INTRODUCTION: The COVID-19 pandemic highlighted an urgent need for harmonised requirements for the regulation of medicines. To fully implement harmonised medicines regulations across Africa, common technical standards of medicine regulations are needed. One such technical standard is the labelling of medicines on outer packaging. In this study, we compared outer packaging labelling requirements and transition terms for harmonization for countries in the Southern African Development Community (SADC) region. METHODS: Data on legislation and/or regulatory guidelines for medicine outer packaging labelling from National Medicines Regulatory Authorities (NMRAs) were obtained for countries in the SADC region (n = 16) by February 2023. A detailed comparative content analysis was conducted to determine alignment with the requirements of the Southern African Development Community (SADC) harmonised labelling guidelines to assess readiness levels of each country to transition to the SADC harmonised labelling guideline for outer packaging of medicines. RESULTS: Content analysis showed at least 11 out of 16 countries require national legal reform to transition to the SADC harmonised labelling guideline. In all cases where countries specified labelling requirements for outer packaging of medicines, these were stipulated in national medicines legislation. CONCLUSION: Even though there is a high level of alignment across the countries in terms of national labelling requirements, most countries in the SADC region would still require national legislative reform to transition to regional harmonised labelling requirements and then ultimately to continental requirements of the African Medicines Agency (AMA).


Assuntos
Embalagem de Medicamentos , Pandemias , Humanos , África Subsaariana , Controle de Medicamentos e Entorpecentes
3.
JAMA Health Forum ; 5(1): e234819, 2024 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-38214918

RESUMO

This Viewpoint discusses the importance of the Drug Supply Chain Security Act and the need for pharmaceutical supply chain safeguards.


Assuntos
Comércio , Preparações Farmacêuticas , Preparações Farmacêuticas/provisão & distribuição , Controle de Medicamentos e Entorpecentes
4.
Artigo em Alemão | MEDLINE | ID: mdl-38214723

RESUMO

Drug regulation is a system to support and protect public health. Drugs with market access must be effective, safe and of high quality. Therefore, drug regulatory decision-making by the competent authorities is made on a scientific basis. Real-world evidence (RWE) from real-world data (RWD) has so far predominantly been taken into account in a supportive manner in drug regulatory decision-making with regard to drug safety after marketing authorisation. The extensive potential of RWE for regulatory decision-making processes along the entire product life cycle has been increasingly used and further examined in recent years.This article provides an overview of current applications of RWE in drug regulatory decision-making processes. The potentials of RWE along with the hurdles to be addressed are described and examples of current projects on RWE research for drug regulation are given. The work is based on current international literature as well as examples from international and European initiatives and regulatory practice, which aim to support an increased use of RWD/RWE in regulatory decision-making processes. In order to be able to utilise the potential of RWE even more in the future, it is important to make relevant RWD sources more readily available through research projects and initiatives, to further develop evaluative methods and to establish the significance of RWE.


Assuntos
Tomada de Decisões , Controle de Medicamentos e Entorpecentes , Alemanha
5.
Clin Transl Sci ; 17(1): e13683, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37957894

RESUMO

Drug regulatory institutions, infrastructures, and systems are becoming increasingly interconnected across national boundaries and increasingly global in outlook. This process is reflected in the broadening and deepening application of the principles and practice of Regulatory Reliance, and parallel initiatives to strengthen the capacities of regulatory institutions in low- and middle-income countries (LMICs). Although these developments are important and constructive, they have tended to be framed in terms of the transfer of systems, knowledge, and skills from relatively "mature" regulatory agencies in high-income countries (HICs) to less-well-resourced regulatory agencies in LMICs. This framing recognizes and foregrounds the considerable practical challenges that many LMIC regulatory agencies face, but in doing so, also backgrounds and underestimates the significance of the different contextual insights that LMIC health researchers and regulators can bring to the regulatory deliberations of their HIC counterparts. This position paper argues that the systematic pursuit, identification, and sharing of these different contextual insights-a dimension of regulatory science that we term "Regulatory Complementarity"-can augment the current practice and goals of Regulatory Reliance, and further invigorate the emerging global regulatory ecosystem.


Assuntos
Países em Desenvolvimento , Controle de Medicamentos e Entorpecentes , Humanos
6.
Pharmacol Res ; 199: 107045, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38157999

RESUMO

Since the 1980s, medical specialists in Clinical Pharmacology have been playing a crucial role in the development of drug regulation in Spain. In this article we report on the activities carried out and the prospects for development in three very relevant areas from the regulatory perspective: 1) the development of stable public infrastructures to facilitate non-commercial clinical research with medicines, 2) the regulatory aspects of individual access to medicines in special situations, beyond their regular access after marketing approval and funding by the National Health System, and 3) the challenges of development and access to advanced therapies, with special reference to the figure of the hospital exemption.


Assuntos
Controle de Medicamentos e Entorpecentes , Farmacologia Clínica , Aprovação de Drogas
7.
BMJ Open ; 13(12): e075333, 2023 12 10.
Artigo em Inglês | MEDLINE | ID: mdl-38072481

RESUMO

BACKGROUND: Benefit-risk assessment (BRA) is used in multiple phases along the health technology's life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA's application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA. METHODS AND ANALYSIS: This scoping review protocol was developed following the framework proposed by Arksey and O'Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts. ETHICS AND DISSEMINATION: This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops. TRIAL REGISTRATION NUMBER: Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).


Assuntos
Controle de Medicamentos e Entorpecentes , Projetos de Pesquisa , Humanos , Medição de Risco , Literatura de Revisão como Assunto
8.
J Law Med Ethics ; 51(S1): 6-16, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38156348

RESUMO

The demographic and epidemiological transitions are driving pharmaceutical expenditures up in Latin American and the Caribbean, with much of the cost falling on households. The domestic development and manufacturing of bio-similars could make medicines more affordable.


Assuntos
Controle de Medicamentos e Entorpecentes , Humanos , América Latina , Região do Caribe
9.
Lancet ; 402(10416): 1941, 2023 11 25.
Artigo em Inglês | MEDLINE | ID: mdl-38007253
10.
Regul Toxicol Pharmacol ; 145: 105497, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37778434

RESUMO

BACKGROUND: Key regulatory entities can serve as building blocks for the African Medicines Agency (AMA). The aim of this study is to demonstrate how the regional medicines regulatory harmonisation programmes could contribute to AMA's effectiveness and efficiency. METHODS: A literature search was conducted using key words to identify publications about the AMA, African Medicines Regulatory Harmonisation (AMRH) and East African Community Medicines Regulatory Harmonisation programmes (EAC-MRH) from 2009 to 2023. The EAC-MRH programme experience was used to highlight the benefits and challenges of African regulatory harmonisation. RESULTS: As the foundation for the AMA, the AMRH has established structures and workstreams to support its operationalisation, including 10 Technical Committees (TCs) and 5 Regional Economic Committees (RECs). Lessons learned from the EAC-MRH 10-year experience are being used to scale up regulatory harmonisation and could be of value to AMA harmonisation experience. CONCLUSIONS: As of June 2023, 35 of 55 countries have either signed and/or ratified the AMA Treaty, whilst 20 have neither signed nor ratified it. An effective AMA will need strong National Medicines Regulatory Authorities as well as Regional programmes and it is imperative for more well-resourced countries to ratify the treaty to ensure access to essential medical products and technologies for the African people.


Assuntos
Controle de Medicamentos e Entorpecentes , África
12.
Clin Ther ; 45(11): 1142-1147, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37704457

RESUMO

The medicines regulatory network of the European Economic Area comprises 30 countries, their National Competent Authorities (NCA), and the European Medicines Agency (EMA). The NCAs and EMA are involved at different stages of the medicine life cycle; not all are engaged in a particular medicine's development discussions. As a result, knowledge management (ie, acquisition and transfer between medicine developer and the NCAs) is fragmented and inefficient. Dynamic regulatory assessment (DRA), a regulatory science concept developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), could drive increased connectedness supporting more continuous knowledge building. DRA works via iterative release and assessment of discrete data packets (DDPs) at mutually agreed milestones during development, culminating in more efficient development and faster authorization. This commentary seeks to build on an earlier article by unpacking the DRA concept, with a particular focus on DDPs. Its aim is to show how DDPs can support efficient and predictable release of data to encourage development and assessment of promising medicines, and it makes the case for piloting the DRA concept with European regulators now.


Assuntos
Indústria Farmacêutica , Controle de Medicamentos e Entorpecentes , Humanos , Europa (Continente)
13.
Expert Rev Pharmacoecon Outcomes Res ; 23(10): 1169-1176, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37747325

RESUMO

INTRODUCTION: The aim of this study was to analyze existing research on the involvement of community pharmacists in the planning and execution of pharmaceutical policies and economic strategies. METHODS: The researcher searched five scholarly databases: Medline, BioMed Central (BMC), Excerpta Medica Database (EMBASE), ProQuest, and PubMed for the reviewed articles. The search and selection of the articles involved searching each of the databases using specific keywords and a combination of them to form phrases and the Boolean search string. The researcher adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in developing this study. RESULTS: From the original search, a total of 537 articles emerged from which 17 articles remained upon screening. Findings show that the community pharmacy role has expanded over the past years to enable pharmacists serve diverse roles, but there is a high lack of involvement of these stakeholders in the planning and execution of policies. The pharmaceutical and health-care sectors operate in a way that does not recognize nor engage community pharmacists sufficiently in the policy planning and execution. CONCLUSIONS: Relevant stakeholders need to create an enabling and supportive environment for utilizing the abilities, knowledge, and skills of community pharmacists in policy planning and execution.


Assuntos
Serviços Comunitários de Farmácia , Farmacêuticos , Humanos , Controle de Medicamentos e Entorpecentes , Cuidados Paliativos , Setor de Assistência à Saúde , Papel Profissional
14.
Healthc Policy ; 19(1): 54-64, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37695707

RESUMO

Children deserve the same high standards for drug safety, efficacy and access as adults. Unfortunately, Canada lags behind leading international regulators in implementing reforms to ensure access to paediatric medications. Paediatric regulations, also known as paediatric rules in the US, include a mandate to submit paediatric data in all new drug applications when paediatric use can be anticipated. Absent paediatric regulations, many medications with paediatric-specific indications in other countries remain "off-label" for Canadian children. In addition to concerns related to off-label drug safety, the absence of paediatric indications prohibits appropriate paediatric-specific health technology assessments and limits the evidence-based listing of paediatric medications on public and private formularies.


Assuntos
Controle de Medicamentos e Entorpecentes , Uso Off-Label , Adulto , Humanos , Criança , Canadá
16.
J Manag Care Spec Pharm ; 29(6): 607-613, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37276044

RESUMO

BACKGROUND: In an effort to control drug spending, health plans are increasingly shifting specialty drugs from their medical benefit to the pharmacy benefit. One consequence of this trend is that some health plans have both a medical and a pharmacy coverage policy for the same drug. OBJECTIVE: To examine how frequently health plans issue medical and pharmacy benefit policies for the same specialty drug and to evaluate the concordance between plans' medical and pharmacy policies when plans issue both policy types. METHODS: We identified specialty drug coverage policies from the Tufts Medical Center Specialty Drug Evidence and Coverage Database, which includes policies issued by 17 of the largest US commercial health plans. Policies were current as of August 2020. We determined plans that issued both medical and pharmacy policies. Next, we identified drugs with "medical-pharmacy policy pairs," ie, drugs for which a plan issued both a medical and a pharmacy policy. For these pairs, we compared the plan's policies while accounting for the following coverage criteria: patient subgroups (patients must meet certain clinical criteria), prescriber requirements (a specialist must prescribe the drug), and step therapy protocols (patients must first fail alternative treatments). We considered medical-pharmacy policy pairs to be discordant if coverage criteria differed, eg, the medical policy included a prescriber requirement but the pharmacy policy did not. RESULTS: Eight plans issued separate medical and pharmacy benefit coverage policies for the same specialty drug and indication. Among these 8 plans, we identified 1,619 medical-pharmacy policy pairs. Eighty-six percent of pairs were concordant (1,386/1,619), and 14% were discordant (233/1,619). Discordance was most often due to differences in plans' application of step therapy protocols (184/233), followed by prescriber requirements (52/233) and patient subgroups (25/233). Forty pairs were discordant in multiple ways. Of discordant pairs, medical policies were more restrictive 41% (96/233) of the time; pharmacy policies were more restrictive 54% (125/233) of the time; 5% of the time (12/233), the medical policy was more restrictive in some ways, but the pharmacy policy was more restrictive in others. Overall, plans imposed coverage restrictions in their medical and pharmacy policies with similar frequencies. CONCLUSIONS: Commercial health plans' medical and pharmacy coverage policies for the same specialty drugs tended to be concordant, although we found coverage criteria to be discordant 14% of the time. Medical and pharmacy policies that are inconsistent in their coverage criteria and restrictions complicate, and potentially hinder, patients' access to specialty drugs. DISCLOSURES: Drs Kauf, O'Sullivan, and Strand were employees of Alkermes, Inc., when the study was conducted and may own stock in the company. Mx Levine, Mr Panzer, and Dr Chambers have no conflicts of interest to disclose. This research study was supported by Alkermes, Inc.


Assuntos
Controle de Medicamentos e Entorpecentes , Farmácia , Humanos , Estados Unidos , Políticas
17.
ACS Synth Biol ; 12(7): 1924-1934, 2023 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-37315218

RESUMO

Protein-based switches that respond to different inputs to regulate cellular outputs, such as gene expression, are central to synthetic biology. For increased controllability, multi-input switches that integrate several cooperating and competing signals for the regulation of a shared output are of particular interest. The nuclear hormone receptor (NHR) superfamily offers promising starting points for engineering multi-input-controlled responses to clinically approved drugs. Starting from the VgEcR/RXR pair, we demonstrate that novel (multi)drug regulation can be achieved by exchange of the ecdysone receptor (EcR) ligand binding domain (LBD) for other human NHR-derived LBDs. For responses activated to saturation by an agonist for the first LBD, we show that outputs can be boosted by an agonist targeting the second LBD. In combination with an antagonist, output levels are tunable by up to three simultaneously present small-molecule drugs. Such high-level control validates NHRs as a versatile, engineerable platform for programming multidrug-controlled responses.


Assuntos
Expressão Gênica , Receptores Citoplasmáticos e Nucleares/agonistas , Receptores Citoplasmáticos e Nucleares/genética , Receptores Citoplasmáticos e Nucleares/metabolismo , Controle de Medicamentos e Entorpecentes , Humanos , Genes Reporter , Ligantes , Sítios de Ligação
18.
Drug Alcohol Depend ; 249: 109911, 2023 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-37301067

RESUMO

BACKGROUND: In the U.S., "War on Drugs" policies have led to large and unequal increases in arrests among particularly of Black/African American men. The change in the legal status of cannabis may reduce the racial disparity in arrests. We examined the impact of changing legal status on arrest disparities. METHODS: We obtained publicly available deidentified cannabis arrest data from the District of Columbia (D.C.) Metropolitan Police Department (2012-2019) and Los Angeles (L.A.) Police Department (2010-2019). We examined the differences in average monthly cannabis arrest rates for each city and each outcome (possession, possession with intent to distribute, distribution, and public consumption) across racial groups. RESULTS: For both D.C. and L.A. following changes in the legal status of cannabis, we saw a decrease of the absolute disparity in possession-related arrests. There was also a reduction in D.C. for the relative disparity, but there was an increase in the relative disparity in L.A. In both cities, there was an emergence of public consumption-arrests. In D.C., there was an absolute increase of 4.0 (SD=2.5) more arrests per-month for Black people than white people and a relative increase of 9.1 (SD=1.5). In L.A., absolute disparity of 0.6(SD=1.3) and a relative disparity of 6.7 (SD=2.0). CONCLUSIONS: There was a reduction in the absolute arrest disparity for cannabis-related possession arrests following decriminalization and legalization in both D.C and L.A. However, we saw the emergence of arrests for public consumption. This emergence of possession arrests towards public consumptions arrests, underscores the need to examine arrests beyond possession.


Assuntos
Cannabis , Masculino , Humanos , Cidades , Aplicação da Lei , Controle de Medicamentos e Entorpecentes , Polícia , Legislação de Medicamentos
19.
Int J Drug Policy ; 117: 104050, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37267739

RESUMO

As the world's second largest coca producer, Peru has a flourishing market for coca for non-narcotic uses. With more than 20,000 hectares and approximately 35,000 officially registered farmers in the Peruvian legal scheme for coca cultivation and commercialization, this market is formally under the monopoly of the National Enterprise of Coca (ENACO). Nonetheless, ENACO only captures 2% of all coca produced nationally and has experienced a sustained reduction of farmers' participation and coca purchases within the legal trade. At different times, these problems have opened the way to demands from left-wing political parties, subnational governments, coca growers' organizations and even Peru's central drug control institutions to reform the legal coca market in Peru. However, none of these attempts have succeeded. Based on a policy analysis of the legal coca trade and analysis of official data, together with a case study of Peru's main legal coca valley (La Convención) this article seeks to understand the current crisis of the legal coca trade as well as the repeated failures of reform. Peru's political centralism and the historical marginalization of Andean culture help to explain the successful blocking of reform attempts to the legal coca trade.


Assuntos
Coca , Cocaína , Humanos , Peru , Controle de Medicamentos e Entorpecentes , Governo
20.
Cochrane Database Syst Rev ; 6: CD013780, 2023 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-37288951

RESUMO

BACKGROUND: The costs of developing new treatments and bringing them to the market are substantial. The pharmaceutical industry uses drug promotion to gain a competitive market share, and drive sale volumes and industry profitability. This involves disseminating information about new treatments to relevant targets. However, conflicts of interest can arise when profits are prioritised over patient care and its benefits. Drug promotion regulations are complex interventions that aim to prevent potential harm associated with these activities. OBJECTIVES: To assess the effects of policies that regulate drug promotion on drug utilisation, coverage or access, healthcare utilisation, patient outcomes, adverse events and costs. SEARCH METHODS: We searched Epistemonikos for related reviews and their included studies. To find primary studies we searched MEDLINE, CENTRAL, Embase, EconLit, Global Index Medicus, Virtual Health Library, INRUD Bibliography, two trial registries and two sources of grey literature. All databases and sources were searched in January 2023. SELECTION CRITERIA: We planned to include studies that assessed policies regulating drug promotion to consumers, healthcare professionals or regulators and third-party payers, or any combination of these groups.In this review we defined policies as laws, rules, guidelines, codes of practice, and financial or administrative orders made by governments, non-government organisations or private insurers. One of the following outcomes had to be reported: drug utilisation, coverage or access, healthcare utilisation, patient health outcomes, any adverse effects (unintended consequences), and costs. The study had to be a randomised or non-randomised trial, an interrupted time series analysis (ITS), a repeated measures (RM) study or a controlled before-after (CBA) study. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed eligibility for inclusion of studies. When consensus was not reached, any disagreements were discussed with a third review author.  We planned to use the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials, and CBA studies, we planned to estimate relative effects, with 95% confidence intervals (CI). For dichotomous outcomes, we planned to report the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For ITS and RM, we planned to compute changes along two dimensions: change in level and change in slope. We planned to undertake a structured synthesis following EPOC guidance.  MAIN RESULTS: The search yielded 4593 citations, and 13 studies were selected for full-text review. No study met the inclusion criteria. AUTHORS' CONCLUSIONS: We sought to assess the effects of policies that regulate drug promotion on drug use, coverage or access, use of health services, patient outcomes, adverse events, and costs, however we did not find studies that met the review's inclusion criteria. As pharmaceutical policies that regulate drug promotion have untested effects, their impact, as well as their positive and negative influences, is currently only a matter of opinion, debate, informal or descriptive reporting. There is an urgent need to assess the effects of pharmaceutical policies that regulate drug promotion using well-conducted studies with high methodological rigour.


Assuntos
Controle de Medicamentos e Entorpecentes , Serviços de Saúde , Humanos , Gastos em Saúde , Pessoal de Saúde , Marketing
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