Generic substitution and prescription drug prices : economic effects of state drug product selection laws /

Item 535.

Accès sans prescription aux statines: bénéfique ou délétère. [Over-the-counter statins: benefit or harmful?]

Making statin available over the counter is one of the measures proposed to correct its underuse. Since May 2004, simvastatin 10 mg is sold over the counter in Great Britain. But uncertainties persist concerning the efficacy of statin in primary prevention and at a 10 mg dose. Finally, there is a risk of side effects and drug interactions. Beyond the correction of statin underuse and the hope of coronary heart disease mortality reduction, the British decision highlighted the will to give individuals a sense of responsibility concerning their health and its financial cost. Anyway, the benefit of switching statin from prescription to over the counter should be experimentally evaluated before its introduction.

Quelle adéquation entre les messages publicitaires sur les médicaments avec les évidences basées sur les preuves de l'EBM et les normes législatives

L'objectif de cette étude est d'évaluer l'adéquation des messages publicitaires sur les médicaments parus en 2007 dans quatre journaux destinés aux professionnels de la santé ("Praxis", "Forum médical suisse", "Bulletin des médecins suisses" et "Revue médicale suisse") avec les évidences basées sur les preuves de l'EBM et des normes législatives ainsi que de vérifier s'ils sont supportés par les références bibliographiques mentionnées. Méthode: les messages publicitaires des cinq grands groupes thérapeutiques (à savoir: anti-ostéoporotiques/arthrosiques, antidépresseurs, antihypertenseurs, AINS et hypolipémiants) sont évalués sur [ces] trois critères. [Auteure, p. 5]

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.

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.

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. ^

Process to develop a State Model Law to reduce prescription drug trafficking while protecting pain management

This paper will discuss the intersection of pill mills and the under-treatment of pain, while addressing the unintended consequence that cracking down on pill mills actually has on medical professionals' treatment of legitimate pain in clinical settings. Moreover, the impact each issue has on the spectrum of related policy, regulatory issues and legislation will be analyzed while addressing the national impact on medical care. Lastly, this paper will outline a process to develop a State Model Law on this subject. This process will include suggestions for the future and how we can move forward to adequately address public safety needs and how we can attempt to mitigate the unintended impact prescription drug trafficking has had on a patient's right to appropriate pain management. This balance is achievable and this paper will address ways we can find this elusive balancing point through the development of a State Model Law. ^

Federal food, drug, and cosmetic act; judicial and administrative records 1938-49,

Mode of access: Internet.

Federal food, drug, and cosmetic act, judicial and administrative record, 1938-1949,

Mode of access: Internet.

Federal food, drug, and cosmetic act; judicial and administrative record, 1949-1950,

Mode of access: Internet.