Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 11.352
Filtrar
2.
Zhongguo Zhong Yao Za Zhi ; 45(16): 4004-4008, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32893601

RESUMO

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.


Assuntos
Medicamentos de Ervas Chinesas , Preparações Farmacêuticas , China , Legislação de Medicamentos , Medicina Tradicional Chinesa
3.
N Z Med J ; 133(1519): 103-111, 2020 07 31.
Artigo em Inglês | MEDLINE | ID: mdl-32777801

RESUMO

New Zealand will hold a public referendum in 2020 on the possible replacement of current cannabis prohibition with legalisation of use and supply policy. Cannabis legalisation policies have been implemented-albeit with heterogeneous regulatory frameworks-in several (eg, North/South America) jurisdictions, with yet inconclusive evidence on main health and social outcomes. The New Zealand government has recently presented the final draft of its Cannabis Legalisation and Regulation Bill, including main regulatory parameters and provisions of the legalisation framework. As regulation elements are known to determine feasibility and outcomes of legalisation policy, we have undertaken a critical review and assessment of 10 of the Bill's main regulation components, based on evidence from and experiences with cannabis policy elsewhere as well as other substance policy areas. The reviewed components include: "political promises; age of use/access; places of use; penalties for underage use; 'home-growing'; retail distribution; licensed production; products available; new/remaining offenses; research and monitoring". New Zealand's cannabis legalisation plan is embedded within an overall public health-oriented framework. However, multiple essential regulatory provisions appear questionable for feasibility, consistency with public health principles or practice, or may lead to-possibly un-intended-adverse outcomes. These regulatory elements should be re-considered and adjusted, ideally before possible implementation of legalisation if supported by the referendum.


Assuntos
Legislação de Medicamentos , Uso da Maconha/legislação & jurisprudência , Cannabis , Política de Saúde , Humanos , Nova Zelândia , Saúde Pública
6.
S Afr Med J ; 110(3): 192-196, 2020 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-32657695

RESUMO

The South African (SA) Constitutional Court recently decriminalised the private cultivation, possession and use of cannabis by adults. Cannabis contains varying amounts of the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), depending on various cultivation factors. No commercial plant-derived cannabis products are currently registered by the SA Health Products Regulatory Authority (SAHPRA) for medical use. Such products are therefore unregulated, but are freely available in SA, and may be of inadequate quality and unverified composition, and not guaranteed to be safe or effective. SAHPRA has to date approved only one synthetic medical cannabis product, dronabinol. Evidence supporting benefit from medical cannabis exists for two drug-resistant childhood forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Adjuvant therapy with medical cannabis can reduce seizure frequency for Lennox-Gastaut syndrome and Dravet syndrome by 18.8% and 22.8%, respectively, and may be beneficial for other rare forms of epilepsy. There is moderate evidence for chemotherapy-induced nausea and vomiting with the synthetic cannabinoids. Multiple sclerosis-associated spasticity showed a small clinical improvement in self-reported spasticity when a purified form of THC/CBD was added to existing therapy. Currently, low-level or no convincing evidence exists for the use of medical cannabis for chronic pain, sleep and weight disorders, and neuropsychiatric disorders. Cannabis is associated with a greater risk of adverse effects than active and placebo controls, and may be involved in clinically significant drug-drug interactions. The evolving regulatory and legal landscape on the use of medical cannabis will guide prescription and recreational use in the coming years.


Assuntos
Maconha Medicinal/uso terapêutico , Canabinoides/farmacologia , Cannabis , Humanos , Legislação de Medicamentos , Maconha Medicinal/efeitos adversos , Médicos
7.
Pediatrics ; 146(2)2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32661191

RESUMO

Most US states have now legalized medical marijuana (MMJ) use, giving new hope to families dealing with chronic illness, despite only limited data showing efficacy. Access to MMJ has presented several challenges for patients and families, providers, and pediatric hospitals, including the discrepancy between state and federal law, potential patient safety issues, and drug interaction concerns. Colorado was one of the first states to legalize MMJ and has remained at the forefront in addressing these challenges. Children's Hospital Colorado has created and evolved its MMJ inpatient use policy and has developed a unique consultative service consisting of a clinical pharmacist and social worker. This service supports patients and families and primary clinical services in situations in which MMJ is actively being used or considered by a pediatric patient. The first 50 patients seen by this consultative service are reported. Eighty percent of patients seen had an oncologic diagnosis. Symptoms to be ameliorated by active or potential MMJ use included nausea and vomiting, appetite stimulation, seizures, and pain. In 64% of patients, MMJ use was determined to be potentially unsafe, most often because of potential drug-drug interactions. In 68% of patients, a recommendation was made to either avoid MMJ use or adjust its administration schedule. As pediatric hospitals address the topic of MMJ use in their patients, development of institutional policy and clinical support services with specific expertise in MMJ is a recommended step to support patient and families and hospital team members.


Assuntos
Comitês Consultivos , Hospitais Pediátricos , Maconha Medicinal/uso terapêutico , Política Organizacional , Adolescente , Criança , Pré-Escolar , Colorado , Governo Federal , Feminino , Humanos , Lactente , Legislação de Medicamentos , Masculino , Encaminhamento e Consulta , Governo Estadual , Adulto Jovem
8.
Sante Publique ; Vol. 32(1): 97-102, 2020 Jun 18.
Artigo em Francês | MEDLINE | ID: mdl-32706231

RESUMO

This article presents the results of a qualitative research on practices of dispensing antiretroviral medication concerning requests for greater than one month, for departure abroad. In spite of a strict regulation, a cartography shows a heterogeneity of its application leading to a great diversity of dispensing practices. This qualitative research with 22 pharmacies across the territory reveals relational and regulatory logics that contribute to this non-uniformity of practices. The concepts of embarrassment, professional commitment, regulatory concerns and personal relationships with patients largely explain the accommodations and crafts observed in this type of ARV dispensing request.


Assuntos
Antirretrovirais/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Farmácias , França , Humanos , Legislação de Medicamentos , Pesquisa Qualitativa , Viagem
9.
Public Health ; 185: 8-14, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32505041

RESUMO

OBJECTIVES: Opioid overdose death rates have continued to spike exponentially from the start of the 21st century, creating what is known to be one of the worst public health crises in the United States. Simultaneously, as more states began passing medical cannabis laws (MCLs), the idea that marijuana was the solution to the opioid crisis began to spread nationwide. As some states have maintained strict medical marijuana policies, others-such as Colorado-have expanded their statutes to allow recreational marijuana sales within their state. Researchers have been able to provide sense of the public health implications resulting from MCLs, but little is known about the effects of this marijuana policy expansion. This preliminary study will focus on exploring the statewide effects of Colorado's recreational marijuana policy on the state's opioid overdose death rates. STUDY DESIGN: Because Colorado has existing panel data for opioid overdose death rates, we can use statistical software to define and create an optimal control group to adequately resemble Colorado's outcome variable of interest. This process known as the synthetic control method can provide a valid counterfactual for Colorado's opioid overdose outcomes in the absence of this policy-a Colorado that did not expand marijuana policy to the point recreational dispensaries were established. METHODS: Opioid overdose death rate data from the Centers for Disease Control and Prevention's Wide-ranging Online Data for Epidemiologic Research (WONDER) will be used to construct a synthetic control unit composed of a donor pool of states resembling Colorado's regulatory environment pertaining to marijuana before legalization. The synthetic control unit allows for a comparative observation of overdose rate trends in Colorado and its synthetic counterpart for the years 1999-2017, all while including a set of predictor variables for robustness checks. A difference-in-difference estimate will then help us observe the effects of the treatment given to Colorado. Inference tests will be conducted to evaluate the method's predictive power and significance of the results. RESULTS: The results of the synthetic control model and its outcomes showed that the estimated negative 5% drop in overdose death rates was deemed insignificant on conducting a placebo in-space analysis, meaning there is not enough evidence to prove that opening recreational dispensaries as a result of recreational marijuana legislation was instrumental in reducing Colorado's ongoing opioid crisis depicted through opioid overdose deaths. CONCLUSION: Owing to the lack of additional post-treatment data and captured lagged effects, it is too soon to dismiss this policy as inadequate in combating the opioid epidemic. Once additional post-treatment data become available, the study can be reproduced to obtain more robust results and achieve a clearer understanding of the policy implications shown.


Assuntos
Analgésicos Opioides/envenenamento , Overdose de Drogas/epidemiologia , Uso da Maconha/epidemiologia , Uso da Maconha/legislação & jurisprudência , Adulto , Cannabis , Centers for Disease Control and Prevention, U.S. , Colorado/epidemiologia , Humanos , Legislação de Medicamentos , Maconha Medicinal , Pessoa de Meia-Idade , Epidemia de Opioides , Saúde Pública , Política Pública , Análise Espacial , Estados Unidos
10.
Lancet Infect Dis ; 20(10): 1161-1171, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32505232

RESUMO

BACKGROUND: Following the discovery and emergence of the plasmid-mediated colistin resistance gene, mcr-1, the Chinese government formally banned colistin as an animal growth promoter on April 30, 2017. Herein, we report patterns in colistin resistance and mcr-1 abundance in Escherichia coli from animals and humans between 2015 and 2019, to evaluate the effects of the colistin withdrawal. METHODS: We did an epidemiology comparative study to investigate: annual production and sales of colistin in agriculture across mainland China according to data from the China Veterinary Drug Association from 2015 to 2018; the prevalence of colistin-resistant E coli (CREC) in pigs and chickens in 23 Chinese provinces and municipalities as reported in the China Surveillance on Antimicrobial Resistance of Animal Origin database from Jan 1, 2015, to Dec 31, 2016, and Jan 1, 2017, to Dec 31, 2018; the presence of residual colistin and mcr-1 in faeces from 118 animal farms (60 pig, 29 chicken, and 29 cattle) across four provinces over July 1, 2017, to August 31, 2017, and July 1, 2018 to August 31, 2018; the prevalence of mcr-1-positive E coli (MCRPEC) carriage in healthy individuals attending routine hospital examinations across 24 provinces and municipalities from June 1 to July 30, 2019, comparing with equivalent 2016 data (June 1 to September 30) from our previous study in the same hospitals; and the patterns in CREC prevalence among hospital E coli infections across 26 provinces and municipalities from Jan 1, 2015, to Dec 31, 2016, and Jan 1, 2018, to Dec 31, 2019, reported on the China Antimicrobial Surveillance Network. FINDINGS: After the ban on colistin as a growth promoter, marked reductions were observed in the production (27 170 tonnes in 2015 vs 2497 tonnes in 2018) and sale (US$71·5 million in 2015 vs US$8·0 million in 2018) of colistin sulfate premix. Across 118 farms in four provinces, mean colistin residue concentration was 191·1 µg/kg (SD 934·1) in 2017 versus 7·5 µg/kg (50·0) in 2018 (p<0·0001), and the median relative abundance of mcr-1 per 16S RNA was 0·0009 [IQR 0·0001-0·0059] in 2017 versus 0·0002 [0·0000-0·0020] in 2018 (p=0·0001). Across 23 provinces and municipalities, CREC was identified in pig faeces in 1153 (34·0%) of 3396 samples in 2015-16 versus 142 (5·1%) of 2781 in 2017-18 (p<0·0001); and in chickens in 474 (18·1%) of 2614 samples in 2015-16 versus 143 (5·0%) of 2887 in 2017-18 (p<0·0001). In hospitals across 24 provincial capital cities and municipalities, human carriage of MCRPEC was identified in 644 (14·3%) of 4498 samples in 2016 versus 357 (6·3%) of 5657 in 2019 (p<0·0001). Clinical CREC infections in 26 provinces and municipalities comprised 1059 (1·7%) of 62 737 E coli infections in 2015-16 versus 794 (1·3%) of 59 385 in 2018-19 (p<0·0001). INTERPRETATION: The colistin withdrawal policy and the decreasing use of colistin in agriculture have had a significant effect on reducing colistin resistance in both animals and humans in China. However, continuous colistin monitoring is essential, in particular to act as an early warning system for colistin stewardship in Chinese hospitals. FUNDING: National Key Research and Development Program of China, National Natural Science Foundation of China, and UK Medical Research Council.


Assuntos
Colistina/farmacologia , Farmacorresistência Bacteriana/genética , Proteínas de Escherichia coli/genética , Escherichia coli/efeitos dos fármacos , Escherichia coli/genética , Ração Animal/análise , Animais , Antibacterianos/farmacologia , China , Colistina/administração & dosagem , Regulação Bacteriana da Expressão Gênica , Humanos , Legislação de Medicamentos
12.
J Pain Symptom Manage ; 60(2): e48-e51, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32387575

RESUMO

Section 2 of the 2019 World Health Organization Model List of Essential Medicines includes opioid analgesics formulations commonly used for the control of pain and respiratory distress, as well as sedative and anxiolytic substances such as midazolam and diazepam. These medicines, essential to palliative care, are regulated under the international drug control conventions overseen by United Nations specialized agencies and treaty bodies and under national drug control laws. Those national laws and regulations directly affect bedside availability of Internationally Controlled Essential Medicines (ICEMs). The complex interaction between national regulatory systems and global supply chains (now impacted by COVID-19 pandemic) directly affects bedside availability of ICEMs and patient care. Despite decades of global civil society advocacy in the United Nations system, ICEMs have remained chronically unavailable, inaccessible, and unaffordable in low- and-middle-income countries, and there are recent reports of shortages in high-income countries as well. The most prevalent symptoms in COVID-19 are breathlessness, cough, drowsiness, anxiety, agitation, and delirium. Frequently used medicines include opioids such as morphine or fentanyl and midazolam, all of them listed as ICEMs. This paper describes the issues related to the lack of availability and limited access to ICEMs during the COVID-19 pandemic in both intensive and palliative care patients in countries of all income levels and makes recommendations for improving access.


Assuntos
Infecções por Coronavirus , Acesso aos Serviços de Saúde , Pandemias , Pneumonia Viral , Analgésicos/uso terapêutico , Infecções por Coronavirus/terapia , Cuidados Críticos/legislação & jurisprudência , Acesso aos Serviços de Saúde/legislação & jurisprudência , Humanos , Internacionalidade , Legislação de Medicamentos , Cuidados Paliativos/legislação & jurisprudência , Pneumonia Viral/terapia , Nações Unidas
13.
Pediatrics ; 145(Suppl 2): S165-S174, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32358207

RESUMO

Various states have legalized marijuana for medical purposes and/or decriminalized recreational marijuana use. These changes coincide with a decrease in perceived harmfulness of the drug and an increase in its use among youth. This change is of critical concern because of the potential harmful impact of marijuana exposure on adolescents. Marijuana use has been associated with several adverse mental health outcomes, including increased incidence of addiction and comorbid substance use, suicidality, and new-onset psychosis. Negative impacts on cognition and academic performance have also been observed. As the trend toward legalization continues, the pediatric community will be called on to navigate the subsequent challenges that arise with changing policies. Pediatricians are uniquely positioned to provide innovative care and educate youth and families on the ever-evolving issues pertaining to the impact of marijuana legalization on communities. In this article, we present and analyze the most up-to-date data on the effects of legalization on adolescent marijuana use, the effects of adolescent use on mental health and cognitive outcomes, and the current interventions being recommended for use in pediatric office settings.


Assuntos
Legislação de Medicamentos , Uso da Maconha/legislação & jurisprudência , Adolescente , Comorbidade , Estudos Transversais , Humanos , Uso da Maconha/efeitos adversos , Uso da Maconha/epidemiologia , Uso da Maconha/terapia , Maconha Medicinal/efeitos adversos , Maconha Medicinal/uso terapêutico , Transtornos Mentais/epidemiologia , Entrevista Motivacional , Psicoterapia Breve , Estados Unidos , Adulto Jovem
14.
Artigo em Inglês | MEDLINE | ID: mdl-32392702

RESUMO

There have been dynamic changes in prescription opioid use in the US but the state level policy factors contributing to these are incompletely understood. We examined the association between the legalization of recreational marijuana and prescription opioid distribution in Colorado. Utah and Maryland, two states that had not legalized recreational marijuana, were selected for comparison. Prescription data reported to the Drug Enforcement Administration for nine opioids used for pain (e.g., fentanyl, morphine, hydrocodone, hydromorphone, oxycodone, oxymorphone) and two primarily for opioid use disorder (OUD, methadone and buprenorphine) from 2007 to 2017 were evaluated. Analysis of the interval pre (2007-2012) versus post (2013-2017) marijuana legalization revealed statistically significant decreases for Colorado (P < 0.05) and Maryland (P < 0.01), but not Utah, for pain medications. There was a larger reduction from 2012 to 2017 in Colorado (-31.5%) than the other states (-14.2% to -23.5%). Colorado had a significantly greater decrease in codeine and oxymorphone than the comparison states. The most prevalent opioids by morphine equivalents were oxycodone and methadone. Due to rapid and pronounced changes in prescription opioid distribution over the past decade, additional study with more states is needed to determine whether cannabis policy was associated with reductions in opioids used for chronic pain.


Assuntos
Analgésicos Opioides , Cannabis , Legislação de Medicamentos , Padrões de Prática Médica , Analgésicos Opioides/uso terapêutico , Colorado , Humanos , Maryland , Oxicodona , Estados Unidos
16.
BMC Public Health ; 20(1): 557, 2020 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-32404144

RESUMO

BACKGROUND: Choice of minimum legal age (MLA) for cannabis use is a critical and contentious issue in legalization of non-medical cannabis. In Canada where non-medical cannabis was recently legalized in October 2018, the federal government recommended age 18, the medical community argued for 21 or even 25, while public consultations led most Canadian provinces to adopt age 19. However, no research has compared later life outcomes of first using cannabis at these different ages to assess their merits as MLAs. METHODS: We used doubly robust regression techniques and data from nationally representative Canadian surveys to compare educational attainment, cigarette smoking, self-reported general and mental health associated with different ages of first cannabis use. RESULTS: We found different MLAs for different outcomes: 21 for educational attainment, 19 for cigarette smoking and mental health and 18 for general health. Assuming equal weight for these individual outcomes, the 'overall' MLA for cannabis use was estimated to be 19 years. Our results were robust to various robustness checks. CONCLUSION: Our study indicated that there is merit in setting 19 years as MLA for non-medical cannabis.


Assuntos
Legislação de Medicamentos , Fumar Maconha/legislação & jurisprudência , Adolescente , Canadá , Humanos , Fumar Maconha/efeitos adversos , Inquéritos e Questionários , Adulto Jovem
18.
PLoS One ; 15(4): e0232041, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32324781

RESUMO

Most U.S. states that have regulated and taxed cannabis have imposed some form of mandatory safety testing requirements. In California, the country's largest and oldest legal cannabis market, mandatory testing was first enforced by state regulators in July 2018, and additional mandatory tests were introduced at the end of 2018. All cannabis must be tested and labeled as certified by a state-licensed cannabis testing laboratory before it can be legally marketed in California. Every batch that is sold by licensed retailers must be tested for more than 100 contaminants, including 66 pesticides with tolerance levels lower than the levels allowable for any other agricultural product in California. This paper estimates the costs of compliance with mandatory cannabis testing laws and regulations, using California's testing regime as a case study. We use state government data, data collected from testing laboratories, and data collected from lab equipment suppliers to run a set of Monte Carlo simulations and estimate the cost per pound of compliance with California's new cannabis testing regulations. We find that cost per pound is highly sensitive to average batch size and testing failure rates. We present results under a variety of different assumptions about batch size and failure rates. We also find that under realistic assumptions, the loss of cannabis that must be destroyed if a batch fails testing accounts for a larger share of total testing costs than does the cost of the lab tests. Using our best estimates of average batch size (8 pounds) and failure rate (4%) in the 2019 California market, we estimate testing cost at $136 per pound of dried cannabis flower, or about 10 percent of the reported average wholesale price of legal cannabis in the state. Our findings explain effects of the testing standards on the cost of supplying legal licensed cannabis, in California, other U.S. states, and foreign jurisdictions with similar testing regimes.


Assuntos
Cannabis/química , Legislação de Medicamentos/economia , Testes Obrigatórios/legislação & jurisprudência , Fumar Maconha/legislação & jurisprudência , California , Comércio/economia , Fidelidade a Diretrizes , Humanos , Testes Obrigatórios/economia , Método de Monte Carlo
19.
Clin Infect Dis ; 71(15): 703-705, 2020 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-32282038

RESUMO

Since the COVID-19 pandemic first hit Wuhan, China, in December 2019, scientists have been racing to develop and test novel vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The speed of scientific discovery related to COVID-19 is unprecedented. With several vaccine candidates already being tested in clinical trials, we pose the question: what will the vaccine hesitant do in the face of this pandemic?


Assuntos
Betacoronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Programas de Imunização/legislação & jurisprudência , Legislação de Medicamentos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Recusa de Vacinação , Vacinas Virais/farmacologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/psicologia , Humanos , Educação de Pacientes como Assunto/legislação & jurisprudência , Pneumonia Viral/imunologia , Pneumonia Viral/psicologia , Estados Unidos/epidemiologia , Recusa de Vacinação/psicologia
20.
Ars pharm ; 61(1): 39-43, ene.-mar. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-188573

RESUMO

INTRODUCCIÓN: Los medicamentos falsificados son un problema emergente en la sociedad actual. Una de las principales estrategias para poder combatirlos es el empleo del Derecho. Por ello se promulgó, por parte de las instituciones europeas legalmente competentes para ello, el Reglamento Delegado de la Unión Europea 2016/161 de la Comisión de 2 de octubre de 2015, que completa la Directiva 2001/83/CE del Parlamento Europeo y del Consejo estableciendo disposiciones detalladas relativas a los dispositivos de seguridad que figuran en el envase de los medicamentos de uso humano (de fabricación industrial). MÉTODO: Se realizó una revisión bibliográfica de esta nueva normativa, promulgada por diversas instituciones comunitarias, con el objetivo de analizar las novedades existentes en el ámbito del medicamento. RESULTADOS: La norma comunitaria, objeto de nuestro estudio, establece las directrices para verificar aquellos medicamentos con mayor riesgo de falsificación, mediante unos dispositivos de seguridad compuestos de dos partes. Un dispositivo anti-manipulación que permite visualizar que el envase no ha sido alterado y un código identificador único, que será reconocido en todos los países comunitarios y que posee información sobre el medicamento. Desde las oficinas de farmacia se autentifica cada medicamento mediante la verificación y desactivación del código identificador en el momento de la dispensación del mismo. CONCLUSIONES: Esta nueva normativa pretende evitar la posible entrada de medicamentos falsificados en la cadena de suministro legal de medicamentos. Sus principales ventajas son, garantizar al paciente la veracidad del medicamento dispensado en las oficinas de farmacia y mejorar la trazabilidad de los mismos


INTRODUCTION: Falsified medicines are an emerging problem in today's society. One of the main strategies to combat them is the use of law. That is why the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 was enacted by the relevant European institutions, which supplements Directive 2001/83/ EC of the European Parliament and of the Council by laying down detailed provisions relating to safety features appearing on the external packaging of medicinal products for human use (industrial manufacturing). METHOD: A literature review of this new legislation enacted by various Community institutions has been carried out with the aim of analyzing developments in the scope of the medicinal product. RESULTS: The Community regulation sets out the guidelines for verifying those medicinal products which have an increased risk of been falsified, using safety features consist of two parts: an anti-tampering device that allows to view that the packaging has not been altered, and a unique identifier code, which will be recognized in all Community countries and it has information on the medicinal product. Each drug is authenticated from the Pharmacies by verifying and deactivating the identifier code at the time of dispensing it. CONCLUSIONS: This new regulation aims to avoid the possible entry of falsified medicines into the legal supply chain of medicinal products. Its main advantages are ensuring to the patient the veracity of the drugs dispensed in the Pharmacy and improving the traceability of them


Assuntos
Humanos , Medicamentos Falsificados , Legislação de Medicamentos/normas , Retirada de Medicamento Baseada em Segurança/legislação & jurisprudência , Qualidade de Produtos para o Consumidor/legislação & jurisprudência , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA