Generic drugs in Brazil: historical overview and legislation

The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.

Use of analgesics in intentional drug overdose presentations to hospital before and after the withdrawal of distalgesic from the Irish market

BACKGROUND: Distalgesic, the prescription-only analgesic compound of paracetamol (325 mg) and dextropropoxyphene (32.5 mg) known as co-proxamol in the UK, was withdrawn from the Irish market as of January 2006. This study aimed to evaluate the impact of the withdrawal of distalgesic in terms of intentional drug overdose (IDO) presentations to hospital emergency departments (EDs) nationally. METHODS: A total of 42,849 IDO presentations to 37 of the 40 hospitals EDs operating in Ireland in 2003-2008 were recorded according to standardised procedures. Data on sales of paracetamol-containing drugs to retail pharmacies for the period 1998-2008 were obtained from IMS Health. RESULTS: The withdrawal of distalgesic from the Irish market resulted in an immediate reduction in sales to retail pharmacies from 40 million tablets in 2005 to 500,000 tablets in 2006 while there was a 48% increase in sales of other prescription compound analgesics. The rate of IDO presentations to hospital involving distalgesic in 2006- 2008 was 84% lower than in the three years before it was withdrawn (10.0 per 100,000). There was a 44% increase in the rate of IDO presentations involving other prescription compound analgesics but the magnitude of this rate increase was five times smaller than the magnitude of the decrease in distalgesic-related IDO presentations. There was a decreasing trend in the rate of presentations involving any paracetamol-containing drug that began in the years before the distalgesic withdrawal. CONCLUSIONS: The withdrawal of distalgesic has had positive benefits in terms of IDO presentations to hospital in Ireland and provides evidence supporting the restriction of availability of means as a prevention strategy for suicidal behaviour.

Legal Protection for Consumer of Pharmaceutical Products

The overall focus of the thesis involves the legal protection for consumers of pharmaceutical products.The work on “Legal Protection for Consumers of Pharmaceutical Products” is undertaken to study the legal framework that is existing for this purpose and the functioning of regulating mechanism that is envisaged under it. The purpose of the study is to analyse how far these measures are effective in adequately protecting various aspects of consumer interest. Methodology adopted for the study is analytical.The present study revealed that the theory of freedom of contract is only an ideal relevant when the parties are assumed to be on equal footing.In a more complicated social and economic society, it ceased to have any relevance. Many countries in the world enacted legislations to protect the consumers of pharmaceutical products.The meaning of ‘consumers of drugs’ provided in the law is inclusive and not exhaustive one. The definition of ‘drug’ as interpreted by the courts is comprehensive enough to take in it not only medicines but also substances. The meaning of the word substances has been widened by the interpretation of the courts so as to include all the things used in treatment.The definition of the word ‘consumer’ has been liberally interpreted by the courts so as to provide protective net to a large section of the public.The studies subsequent to this report also revealed that there is a shortage of essential drugs necessary to cure local diseases like tuberculosis and malaria where as drugs containing vitamins and other combinations which are more profitable for the manufacturers are produced and marketed in abundance.The study of the provisions in this regard revealed that the duty of the drug controlling authorities is confined to scrutinize the data of the clinical test already conducted by the sponsor of the drug.Study of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational productStudy of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational product.the study of the provisions of the Drugs and Cosmetics Act and the rules framed under it revealed that the law in this regard is comprehensive to protect the consumer provided it is sufficiently supported by adequately equipped enforcement machinery.

Transformaciones discursivas en el proceso de securitización del narcotráfico. Un análisis de los actos discursivos oficiales de Colombia y Estados Unidos en la Guerra contra las drogas 1986 - 1990

El tema de las drogas suscita un debate entre quienes defienden la prohibición y la represión, y aquellos que defienden alternativas como la legalización y/o regulación y otras más moderadas como la descriminalización y la despenalización. Aunque ambas posturas muestran datos empíricos que las soportan, desde el ámbito discursivo la visión represiva se ha posicionado como la más aceptada en el continente americano, más específicamente, en Latinoamérica. El presente trabajo, hace un estudio de caso del proceso de securitización del narcotráfico entre los presidentes de Estados Unidos y Colombia durante el período 1986-1990. A lo largo del texto, se analizan discursos oficiales de los presidentes de ambos Estados, resaltando las estrategias retóricas y sus transformaciones que legitimaron acciones represivas de tipo político-militar contra las drogas. Al final se apunta a reivindicar el discurso como un instrumento para reproducir creencias sobre fenómenos, en este caso, la creencia de que las drogas son una amenaza existencial a la seguridad política y militar para los Estados.

Análise dos aspectos legais das prescrições de medicamentos

This article describes a survey of prescriptions dispensed in drugstores and pharmacies in the city of Araraquara in the state of São Paulo, Brazil, in May 2006. Their contents were assessed for compliance with the laws in force on drug prescription and dispensing. A total of 1,335 prescriptions were examined: 40 (3%) were unsigned, 212 (15.9%) did not contain the prescribing physician's stamp, 170 (12.7%) were undated. There were prescriptions containing corrections (4.6%), and written in code (4.4%). Only 58.8% were legible and easy to understand; nevertheless all of them were dispensed. Some did not specify the name of the patient (7.2%). On how to use the medication prescribed, not a single prescription contained all the information required by law. Specifically, 7.6% lacked information on dosage, 54.3% on presentation, 33.6% on how to take the drug, and 51.2% on duration of treatment. The data show a general failure to comply with the laws on drug prescription and dispensing. Incomplete information on the drugs and their correct use could lead to irrational use and errors in medication. The lack of prescribers' signature and stamp, date of emission and name of patient can lead to fraudulent and counterfeit prescriptions. Thus, the data found point to the need for capacitation of prescribing and dispensing professionals and the importance of the role of professional associations in guiding their members.

Avaliação do conhecimento e das condutas dos farmacêuticos, responsáveis técnicos por drogarias

Através deste estudo, avaliou-se o nível de conhecimento e conduta dos farmacêuticos, responsáveis técnicos (RT) em drogarias, quanto a alguns aspectos da legislação farmacêutica e sanitária. Foram entrevistados 45 RT em 2007, sendo que 19 desconheciam a definição dos medicamentos de referência, 21 do genérico e 25 do similar. Todos sabiam da permissão de aplicação de medicamentos injetáveis. Porém, apenas dois sabiam da permissão da aplicação de penicilínicos, metade desconhecia que é permitido fracionar medicamentos fracionáveis em drogaria, 18 não sabiam dispensar corretamente uma prescrição pelo princípio ativo e 37 acreditavam que o farmacêutico pode intercambiar qualquer medicamento de marca pelo genérico. A maioria dos RT apresentou nível regular e insatisfatório de conduta e de conhecimento sobre a legislação profissional e sanitária, o que sinaliza um problema na formação acadêmica e de atualização permanente, podendo comprometer as diretrizes da política nacional de medicamentos. Palavras-chave: Legislação de Medicamentos. Legislação Farmacêutica. Legislação Sanitária, Conhecimentos. Condutas e Prática em Saúde. Atitude do Pessoal de Saúde. ABSTRACT Assessment of knowledge and behavior of pharmacists with technical responsibility for drugstores This paper is a study of the level of knowledge and conduct of the legally responsible pharmacist-in-charge (PIC) at drugstores, regarding certain aspects of pharmaceutical and health legislation. In 2007, 45 PICs were interviewed, of whom 19 did not know the definition of original (innovative) branded drugs, 21 of generic drugs and 25 of similar branded drugs. All PICs knew that it is permitted to administer injectable drugs in the drugstore. However, only two knew that penicillins can be injected, half of them did not know that certain medicines can be fractionated in drugstores, 18 did not know how to dispense correctly a prescription for an active ingredient and 37 believed that the pharmacist can swap any brand name drug with its generic counterpart. Most PICs showed an unsatisfactory level of conduct and knowledge of the professional and health legislation, which points to problems in the undergraduate and in-service training of pharmacists, that could jeopardize the national drug policy guidelines. Keywords: Legislation, Drug. Legislation, Pharmacy. Legislation, Health. Health Knowledge. Attitudes, Practice. Attitude of Health Personnel.

Pure food and drugs in California.

Pt.1. Food and drug legislation.--Pt.2. Experiences in food and drug enforcement.--Bibliography (p.201)

Chromatographic analysis and survey studies to evaluate the emerging drugs of synthetic cannabinoids in Scotland and Saudi Arabia

Synthetic cannabinoid receptor agonists or more commonly known as synthetic cannabinoids (SCs) were originally created to obtain the medicinal value of THC but they are an emerging social problem. SCs are mostly produced coated on herbal materials or in powder form and marketed under a variety of brand names, e.g. “Spice”, “K2”. Despite many SCs becoming controlled under drug legislation, many of them remain legal in some countries around the world. In Scotland, SCs are controlled under the Misuse of Drugs Act 1971 and Psychoactive Substances Act 2016 that only cover a few early SCs. In Saudi Arabia, even fewer are controlled. The picture of the SCs-problem in Scotland is vague due to insufficient prevalence data, particularly that using biological samples. Whilst there is evidence of increasing use of SCs throughout the world, in Saudi Arabia, there is currently no data regarding the use of products containing SCs among Saudi people. Several studies indicate that SCs may cause serious toxicity and impairment to health therefore it is important to understand the scale of use within society. A simple and sensitive method was developed for the simultaneous analysis of 10 parent SCs (JWH-018, JWH-073, JWH-250, JWH-200, AM-1248, UR-144, A-796260, AB-FUBINACA, 5F-AKB-48 and 5F-PB-22) in whole blood and 8 corresponding metabolites (JWH-018 4-OH pentyl, JWH-073 3-OH butyl, JWH-250 4-OH pentyl, AM-2201 4-OH pentyl, JWH-122 5-OH pentyl, JWH-210 5-OH pentyl, 5F-AKB-48 (N-4 OH pentyl), 5F-PB-22 3-carboxyindole)in urine using LLE and LC-MS/MS. The method was validated according to the standard practices for method validation in forensic toxicology (SWGTOX, May 2013). All analytes gave acceptable precision, linearity and recovery for analysing blood and urine samples. The method was applied to 1,496 biological samples, a mixture of whole blood and urine. Blood and/or urine samples were analysed from 114 patients presenting at Accident and Emergency in Glasgow Royal Infirmary, in spring 2014 and JuneDecember 2015. 5F-AKB-48, 5F-PB-22 and MDMB-CHMICA were detected in 9, 7 and 9 cases respectively. 904 urine samples from individuals admitted to/liberated from Scottish prisons over November 2013 were tested for the presence of SCs. 5F-AKB-48 (N-4 OH pentyl) was detected in 10 cases and 5F-PB-22 3-carboxyindole in 3 cases. Blood and urine samples from two post-mortem cases in Scotland with suspected ingestion of SCs were analysed. Both cases were confirmed positive for 5F-AKB-48. A total of 463 urine samples were collected from personnel who presented to the Security Forces Hospital in Ryiadh for workplace drug testing as a requirement for their job during July 2014. The results of the analysis found 2 samples to be positive for 5F-PB-22 3carboxyindole. A further study in Saudi Arabia using a questionnaire was carried out among 3 subpopulations: medical professionals, members of the public in and around smoking cafes and known drug users. With regards to general awareness of Spice products, 16%, 11% and 22% of those participants of medical professionals, members of the public in and around smoking cafes and known drug users, respectively, were aware of the existence of SCs or Spice products. The respondents had an overall average of 4.5% who had a friend who used these Spice products. It is clear from the results obtained in both blood and urine testing and surveys that SCs are being used in both Scotland and Saudi Arabia. The extent of their use is not clear and the data presented here is an initial look into their prevalence. Blood and urine findings suggest changing trends in SC use, moving away from JWH and AM SCs to the newer 5F-AKB-48, 5-F-PB-22 and MDMBCHMICA compounds worldwide. In both countries 5F-PB-22 was detected. These findings clarify how the SCs phenomenon is a worldwide problem and how the information of every country regarding what SCs are seized can help and is not specific for that country. The analytes included in the method were selected due to their apparent availability in both countries, however it is possible that some newer analytes have been used and these would not have been detected. For this reason it is important that methods for testing SCs are updated regularly and evolve with the ever-changing availability of these drugs worldwide. In addition, there is little published literature regarding the concentrations of these drugs found in blood and urine samples and this work goes some way towards understanding these.

Estado de las enfermedades raras que cursan con discapacidad intelectual en Colombia

Las enfermedades raras o huérfano son una problemática que ha tomado mucha importancia en el contexto mundial del presente siglo, estas se han definido como crónicas, de difícil tratamiento de sus síntomas y con baja prevalencia en la población; muchas de estas enfermedades cursan con varios tipos de discapacidad, siendo el objetivo del presente trabajo el enfocarse en aquellas enfermedades raras que cursan con discapacidad intelectual. Para poder profundizar en estas enfermedades se realizó una revisión teórica sobre las enfermedades raras, así como de la discapacidad psíquica y su importancia a nivel mundial y nacional. A partir de estas definiciones, se revisaron en profundidad 3 enfermedades raras que cursan con discapacidad intelectual en el contexto colombiano, como son: el síndrome de Rett, el síndrome de Prader-Willi y el síndrome de X frágil. En cada una de estas enfermedades además se explicaron los tipos de diagnóstico, intervención, prevención, grupos de apoyo y tipos de evaluación que más se usan en el contexto nacional

Legal and health variations in drug litigation injunctions granted in Minas Gerais

OBJECTIVE To investigate the factors related to the granting of preliminary court orders [injunctions] in drug litigations. METHODS A retrospective descriptive study of drug lawsuits in the State of Minas Gerais, Southeastern Brazil, was conducted from October 1999 to 2009. The database consists of 6,112 lawsuits, out of which 6,044 had motions for injunctions and 5,167 included the requisition of drugs. Those with more than one beneficiary were excluded, which totaled 5,072 examined suits. The variables for complete, partial, and suppressed motions were treated as dependent and assessed in relation to those that were independent – lawsuits (year, type, legal representation, defendant, court in which it was filed, adjudication time), drugs (level five of the anatomical therapeutic chemical classification), and diseases (chapter of the International Classification of Diseases). Statistical analyses were performed using the Chi-square test. RESULTS Out of the 5,072 lawsuits with injunctions, 4,184 (82.5%) had the injunctions granted. Granting varied from 95.8% of the total lawsuits in 2004 to 76.9% in 2008. Where there was legal representation, granting exceeded 80.0% and in lawsuits without representation, it did not exceed 66.9%. In public civil actions (89.1%), granting was higher relative to ordinary lawsuits (82.8%) and injunctions (80.1%). Federal courts granted only 68.6% of the injunctions, while the state courts granted 84.8%. Diseases of the digestive system and neoplasms received up to 87.0% in granting, while diseases of the nervous system, mental and behavioral disorders, and diseases of the skin and subcutaneous tissue received granting below 78.6% and showed a high proportion of suspended injunctions (10.9%). Injunctions involving paroxetine, somatropin, and ferrous sulfate drugs were all granted, while less than 54.0% of those involving escitalopram, sodium diclofenac, and nortriptyline were granted. CONCLUSIONS There are significant differences in the granting of injunctions, depending on the procedural and clinical variances. Important trends in the pattern of judicial action were observed, particularly, in the reduced granting [of injunctions] over the period.

A New Partnership in Education: From Consultation to Legislation in the Nineties

"In the nineties, dialogue in the Irish education system has been frenetic and painful at times. But it has gradually led to an extraordinary cohesion and partnership in the system. The book tracks the major consultations - and confrontations - of the nineties and it explores the personalities and policies of the protagonists - ministers, officials, leaders of Church bodies and third-level institutions, representatives of teachers' unions and parents' organisations." "All of the important consultation documents of the decade are here, the various drafts of the Green and White Papers - some benign, some infamous - the Bills, the Acts. The big issues are expertly set forth - intermediate structures and regionalisation, school governance and boards of management, the role of the Churches, higher education and the abolition of tuition fees."-This resource was contributed by The National Documentation Centre on Drug Use.

Multinational drug corporations, intellectual property rights and the Canadian state : a historical and critical analysis

This study critically analyzes the historical role and influence of multinational drug cotpOrations and multinational corporations in general; the u.s. government and the Canadian state in negotiating the global recognition ofIntellectual Property Rights (IPR) under GATT/NAFTA. This process began in 1969 when the Liberal government, in response to high prices for brand-name drugs amended the Patent Act to introduce compulsory licensing by reducing monopoly protection from 20 to seven years. Although the financial position ofthe multinational drug industry was not affected, it campaigned vigorously to change the 1969 legislation. In 1987, the Patent Act was amended to extend protection to 10 years as a condition for free trade talks with the u.s. Nonetheless, the drug industry was not satisfied and accused Canada of providing a bad example to other nations. Therefore, it continued to campaign for global recognition ofIPR laws under GATT. Following the conclusion of the GATTI Trade-Related aspects of Intellectual Property Rights agreement (TRIPS) in 1991, the multinational drug industry and the American government, to the surprise of many, were still not satisfied and sought to implement harsher conditions under NAFTA. The Progressive Conservative government readily agreed without any objections or consideration for the social consequences. As a result, Bill C-91 was introduced. It abandoned compulsory licenses and was made retroactive from December 21, 1991. It is the contention of this thesis that the economic survival of multinational corporations on a global scale depends on the role and functions of the modem state. Similarly, the existence of the state depends on the ideological-political and socioeconomic assistance it gives to multinational corporations on a national and international scale. This dialectical relation of the state and multinational corporations is explored in our theoretical and historical analysis of their role in public policy.

Implementation of Evidence-Based Practices for Treatment of Alcohol and Drug Disorders: The Role of the State Authority

The current climate of increasing performance expectations and diminishing resources, along with innovations in evidence-based practices (EBPs), creates new dilemmas for substance abuse treatment providers, policymakers, funders, and the service delivery system. This paper describes findings from baseline interviews with representatives from 49 state substance abuse authorities (SSAs). Interviews assessed efforts aimed at facilitating EBP adoption in each state and the District of Columbia. Results suggested that SSAs are concentrating more effort on EBP implementation strategies such as education, training, and infrastructure development, and less effort on financial mechanisms, regulations, and accreditation. The majority of SSAs use EBPs as a criterion in their contracts with providers, and just over half reported that EBP use is tied to state funding. To date, Oregon remains the only state with legislation that mandates treatment expenditures for EBPs; North Carolina follows suit with legislation that requires EBP promotion within current resources.

Crack and powder cocaine federal legislation: A sentencing disparity and potential for policy improvement

Since its introduction into the United States in the 1980s, crack cocaine has been a harsh epidemic that has taken its toll on a countless number of people. This highly addictive, cheap and readily available drug of abuse has permeated many demographic sectors, mostly in low income, lesser educated, and urban communities. This epidemic of crack cocaine use in inner city areas across the Unites States has been described as an expression of economic marginality and “social suffering” coupled with the local and international forces of drug market economies (Agar 2003). As crack cocaine is a derivative of cocaine, it utilizes the psychoactive component of the drug, but delivers it in a much stronger, quicker, and more addictive fashion. This, coupled with its ready availability and cheap price has allowed for users to not only become very addicted very quickly, but to be subject to the stringent and sometimes unequal or inconsistent punishments for possession and distribution of crack-cocaine. ^ There are many public health and social ramifications from the abuse of crack-cocaine, and these epidemics appear to target low income and minority groups. Public health issues relating to the physical, mental, and economic strain will be addressed, as well as the direct and indirect effects of the punishments that come as a result of the disparity in penalties for cocaine and crack-cocaine possession and distribution. ^ Three new policies have recently been introduced into the United Stated Congress that actively address the disparity in sentencing for drug and criminal activities. They are, (1) Powder-Crack Cocaine Penalty Equalization Act of 2009, (HR 18, 111th Cong. 2009), (2) The Drug Sentencing Reform and Cocaine Kingpin Trafficking Act of 2009, (HR 265, 111th Cong. 2009) and (3) The Justice Integrity Act of 2009, (111th Cong. 2009). ^ Although they have only been initiated, if passed, they have potential to not only eliminate the crack-cocaine disparity, but to enact laws that help those affected by this epidemic. The final and overarching goal of this paper is to analyze and ultimately choose the ideal policy that would not only eliminate the cocaine and crack disparity regardless of current or future state statutes, but will provide the best method of rehabilitation, prevention, and justice. ^