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1
Lofgren, Hans. "Medicines policy and drug company investments: the Irish experience." Australian Health Review 33, no. 2 (2009): 295. http://dx.doi.org/10.1071/ah090295.
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THIS BOOK IS ABOUT MANIFESTATIONS of power in medicines and pharmaceutical industry policy. The main focus is on the Republic of Ireland but there are chapters also on drug regulation in Canada, Britain and Australia. The multinational pharma companies loom larger in Ireland than in most other countries; several chapters detail the implications for this small country of the presence of a major cluster of global drug companies. Globalisation is the hallmark of the drug sector; innovation and production occur within international networks which are mirrored by interaction between regulatory agencies which operate similar systems of control and monitoring. Since the 1990s, many aspects of product safety regulation have been standardised across the developed countries through the International Conference on Harmonization (ICH) process, sponsored by the regulatory agencies and industry associations of the USA, the European Union and Japan. While orchestrating vast scientific, economic and technological resources, the big pharma companies participate as insiders in national policy processes, such as those described in this book. Firms typically affirm a commitment to the health and economic concerns of the local jurisdiction ? however governments cannot help but be sensitive to their global reach and power to choose where to invest.
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Aliyeva, Zamina. "The Law Aspects in Health Management: A Bibliometric Analysis of Issues on the Injury, Damage and Harm in Criminal Law." Marketing and Management of Innovations, no. 3 (2020): 293–305. http://dx.doi.org/10.21272/mmi.2020.3-21.
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The paper presents the analysis of the approaches to define the areas of research on the injury, damage and harm to human health in criminal law. The obtained results proved that crimes, connected to drugs abuse, their legislation become an essential part of the issues. At the same, developing of government control, medical standards, improving quality of medical education balancing the «medical mistake – injury to human’s health – jurisprudence consequences» triangle in the tendency of the injury, damage and harm in criminal laware becoming very important to the healthcare system due to increasing requirements of regulators, customers and shareholders. The paper aimed to analyse the tendency in the literature on the injury, damage and harm in criminal law, which published in books, journals, conference proceedings etc. to identify future research directions. The methodological tools are VOSviewer, Scopus and Web of Science (WoS) software. This study covers 1072 papers from Scopus and WoS database. The time for analysis were 1970-2020. The Scopus and WoS analyse showed that in 2012-2019 the numbers of papers on the injury, damage and harm in criminal law issues began to increase. However, the topics changed from general issues to the problem of decriminalisation of drug trafficking, and the corresponding paradigm shift in the punishment of some crimes, increasing interest in punishing corporations for violating environmental regulations. In 2017 the number of documents dedicated to injury, damage and harm in criminal law was increased by 667% compared to 2012. The main subject areas of analyses of the injury, damage and harm in criminal law were the next: Law, Public environmental, occupational health, Criminology penology, Substance abuse, Psychiatry, Medicine. The biggest amount of investigations of the injury, damage and harm in criminal law was published by the scientists from the USA, United Kingdom, Australia and Canada. In 2019 such journals with high impact factor as International Journal of Drug Policy, International Journal of Law and Psychiatry, The Lancet etc. published the number of issues, which analysed of the injury, damage and harm to human health in criminal law. Such results proved that theme on the injury, damage and harm to human health in criminal law is actually in the ongoing trends of the modern jurisprudence and regulation. The findings from VOSviewer defined 6 clusters of the papers which analysed the injury, damage and harm to human health in criminal law from the different points of views. The first biggest cluster (with the biggest number of connections) merged the keywords as follows: criminal justice, law enforcement, public health, health care policy, harm reduction, drug legislation, drug and narcotic control, substance abuse, homelessness etc. The second significant cluster integrated the keywords as follows: criminal behaviour, crime victim, adolescent, violence, mental health, mental disease, prisoner, young people, rape, police etc. The third biggest cluster concentrated on criminal aspects of jurisprudence, criminal law, human right, legal liability, social control, government regulation etc. The obtained results allow concluding that balancing the triangles «medical mistakes – criminal – education» and «drugs – criminal – justice» and «abortion – criminal – women/children» form an important part of the injury, damage and harm in criminal law issues. Keywords injury, damage, harm, human health, criminal law, management, governance.
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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (August 8, 2016): 290–300. http://dx.doi.org/10.18433/jpps.v19i2.27066.
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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT–Medicines (Observer). Results. Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. Conclusions. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (August 8, 2016): 290. http://dx.doi.org/10.18433/j37g80.
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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT–Medicines (Observer). Results. Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. Conclusions. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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Scanlon, Martin N., and Urmil Chugh. "Exploring Physicians' Comfort Level with Opioids for Chronic Noncancer Pain." Pain Research and Management 9, no. 4 (2004): 195–201. http://dx.doi.org/10.1155/2004/290250.
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OBJECTIVE:To explore the attitudes of family physicians (FPs) toward the use of opioids in the management of chronic noncancer pain (CNCP) in the Calgary Health Region (CHR), Calgary, Alberta.METHODS:From January to February 2003, random samples of 147 FPs (32 were used to pretest the instrument and were therefore excluded from the findings) and 142 specialists practicing in the CHR were invited to participate in a 20 min survey to explore aspects of CNCP management in the CHR. Physicians' comfort in prescribing opioids and nonsteroidal anti-inflammatory drugs for CNCP was measured on a four-point ordinal scale. The specialists' subgroup served as a quasi-control group. In addition, a short version of the survey was provided for those physicians who declined to fully partake in the study. This allowed the researchers to compare important characteristics between respondents and nonrespondents.RESULTS:A total of 125 physicians (63 FPs and 62 specialists) participated in the study. The overall response rate was 48.6% and response rates for FPs and specialists were 54.8% and 43.7%, respectively. Response rates for the long version of the survey were 42.6% for FPs (n=49), 31.6% for other specialists (n=45) and 36.6% for both combined. The majority of FPs and specialists (98% and 71.1%, respectively) reported that 'they can handle' nonsteroidal anti-inflammatory drugs, Tylenol No 3 with Codeine (Janssen-Ortho/McNeil Consumer Healthcare, Canada) (95.9% and 64.4%, respectively), morphine/MS Contin (Purdue Pharma, Canada) (61.2% and 24.4%, respectively) and Percocet (Bristol-Myers Squibb, Canada)/OxyContin (Purdue Pharma, Canada) (61.2% and 33.3%, respectively). Fewer FPs and specialists report that 'they can handle' Dilaudid (Abbott Laboratories, Canada)/Hydromorph Contin (Purdue Pharma, Canada) (36.7% and 13.3%, respectively), fentanyl patch (30.6% and 11.1%, respectively) and methadone (0% and 6.7%, respectively). Male FPs reported a greater degree of comfort than female FPs regarding morphine/MS Contin, Percocet/OxyContin and Dilaudid/Hydromorph Contin (Mann-Whitney U tested at a£0.05). No sex differences were detected among specialists. No relationship was detected between comfort and years of practice or number of chronic pain patients in practice. Among specialists, a weak positive relationship was detected between the degree of comfort with methadone (Spearman's rank correlation coefficient=0.35, a=0.03) and the significance of pain management in the practice. Except for methodone, the FPs reported a higher confidence with the drugs in question compared with specialists (a£0.05).CONCLUSIONS:FPs in the CHR need to increase their comfort level toward opioids in general to adequately manage CNCP. Their lack of comfort may reflect a lack of education or fear of regulatory scrutiny.
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Phypers, Melissa D., Linda Panaro, and Penny Nault. "Tuberculosis drug resistance in Canada, 1998 to 2000." Canadian Journal of Infectious Diseases 12, no. 3 (2001): 141–43. http://dx.doi.org/10.1155/2001/148487.
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The emergence of drug-resistant strains of tuberculosis (TB) is a global threat to TB prevention and control efforts. A recent study conducted by the World Health Organization (WHO) and the International Union Against Tuberculosis and Lung Disease found strains of TB resistant to first-line anti-TB drugs in all countries surveyed (1). The WHO estimates that 50 million people are infected with strains of drug-resistant TB (2).
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Barrett, Damon. "Canada, cannabis and the relationship between UN child rights and drug control treaties." International Journal of Drug Policy 71 (September 2019): 29–35. http://dx.doi.org/10.1016/j.drugpo.2019.02.010.
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Ostry, Aleck S. "International Trade Regulation and Publicly Funded Health Care in Canada." International Journal of Health Services 31, no. 3 (July 2001): 475–80. http://dx.doi.org/10.2190/mt8d-h4ec-jkme-3kd3.
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The World Trade Organization (WTO) creates new challenges for the Canadian health care system, arguably one of the most “socialized” systems in the world today. In particular, the WTO's enhanced trade dispute resolution powers, enforceable with sanctions, may make Canadian health care vulnerable to corporate penetration, particularly in the pharmaceutical and private health services delivery sectors. The Free Trade Agreement and its extension, the North American Free Trade Agreement, gave multinational pharmaceutical companies greater freedom in Canada at the expense of the Canadian generic drug industry. Recent challenges by the WTO have continued this process, which will limit the health care system's ability to control drug costs. And pressure is growing, through WTO's General Agreement on Trade in Services and moves by the Alberta provincial government to privatize health care delivery, to open up the Canadian system to corporate penetration. New WTO agreements will bring increasing pressure to privatize Canada's public health care system and limit government's ability to control pharmaceutical costs.
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Egilman, Alexander C., Amy Kapczynski, Margaret E. McCarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, and Joseph S. Ross. "Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration." Journal of Law, Medicine & Ethics 49, no. 3 (2021): 456–85. http://dx.doi.org/10.1017/jme.2021.67.
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AbstractBased on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.
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Price, Polly J. "Public Health Control Measures in Response to Global Pandemics and Drug Resistance." Journal of Law, Medicine & Ethics 43, S2 (2015): 49–56. http://dx.doi.org/10.1111/jlme.12266.
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These teaching materials explore the specific powers of governments to implement control measures in response to communicable disease, in two different contexts:The first context concerns global pandemic diseases. Relevant legal authority includes international law, World Health Organization governance and the International Health Regulations, and regulatory authority of nations.The second context is centered on U.S. law and concerns control measures for drug-resistant disease, using tuberculosis as an example. In both contexts, international and domestic, the point is to understand legal authority to address public health emergencies.
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Scardaccione, Gilda. "Drug Addiction and Juvenile Justice." Journal of Drug Issues 24, no. 4 (October 1994): 687–96. http://dx.doi.org/10.1177/002204269402400410.
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Drug abuse in juveniles is a complex juridical matter. There is neither specific legislation enacted nor special therapeutic programs for deviant populations of this age. Statistics are limited to drug addicts who have been involved with state agencies, such as administrative, judicial or police departments. In recent years some reforms have been enacted, especially for procedural aspects of the trial. Legislation now in force offers opportunities for alternative dispositions for juvenile drug addicts, including educational programs under the supervision of social service agencies. This situation can be improved further by better coordination between drug abuse legislation and juridical norms concerning the procedural phase of the trial. The problem of juveniles and drug abuse, especially when organized crime is involved, has distinctive characteristics which require different control strategies. Peer group influences seem to be the primary psychological dynamic motivating adolescent drug abuse.
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Golomb, Beatrice Alexandra. "Control Theory: Placebo-Controlled Drug Trials Have Problems. Active-Controlled Drug Trials Are Not Always the Solution." American Journal of Bioethics 9, no. 9 (September 11, 2009): 67–69. http://dx.doi.org/10.1080/15265160903098424.
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Kirilenko, V. P., and D. S. Molokovskii. "International Legal Aspects of Control of Trafficking in New Psychoactive Substances." EURASIAN INTEGRATION: economics, law, politics 16, no. 1 (March 29, 2022): 77–85. http://dx.doi.org/10.22394/2073-2929-2022-01-77-85.
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Aim. To analyze relevant provisions of the main national and international regulatory legal acts in the field of monitoring and control of new potentially dangerous substances.Tasks. To study the current legal regulation of legal and illicit trafficking of new psychoactive substances in the Russian Federation and the EAEU states. To examine new amendments in the legislation of the European Union regulating the substances traffic control and illicit traffic countering. To provide an overview of the procedures of new psychoactive substances scheduling under the International Drug Control Conventions. To formulate proposals for improving the national and international anti-drug legislation.Methods. The methods of logical and comparative legal analysis, as well as the legal prediction method have been used in this article.Results. The legislation of the EAEU countries in the field of the control of the legal and illicit trafficking of new psychoactive substances needs to be improved and harmonized. The substances scheduling procedures under the international drug control conventions in the EU and the UN are very difficult multi-stage and excessively long. The timing of adoption of new regulatory acts certainly does not correspond to the potential danger of uncontrolled trafficking of new potentially dangerous psychoactive substances for public health.Conclusion. The penalties under Art. 234.1 of the Russian Federation Criminal Code “Illicit trafficking of potentially dangerous psychoactive substances” should be toughened. The legal procedure for forming the state Register of new psychoactive substances must be changed. In the EAEU countries, it should be necessary to make agreement at the interstate level about a uniform approach to the introduction and content of criminal justice responses to the illicit trafficking of new psychoactive substances. In the EU countries and in the frame of the UN, the scheduling procedure under international drug control should be changed regarding new psychoactive substance. All such substances of this kind should be included in a Special Annex for which certain agreed control measures would be prescribed, with the possibility of subsequent expert evaluation of the potential danger of the substance to individual and public health. These established control measures in the fut ure might be toughened or reduced based on the WHO Expert Committee on Drug Dependence critical review and the Commission on Narcotic Drugs (CND) position.
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Ichida, Fukiko, Nunzia S. Fatica, John E. O'Loughlin, Arthur A. Klein, Michael S. Snyder, Aaron R. Levin, Kathryn H. Ehlers, Martin L. Lesser, and Mary Allen Engle. "Epidemiologic Aspects of Kawasaki Disease in a Manhattan Hospital." Pediatrics 84, no. 2 (August 1, 1989): 235–41. http://dx.doi.org/10.1542/peds.84.2.235.
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Epidemiologic and clinical features of Kawasaki disease in 106 patients seen between 1980 and 1986 at The New York Hospital in midtown Manhattan were compared with those in large series from the United States, Canada, and Japan. Dissimilarities in our Kawasaki disease experience included ethnic heterogeneity of our patients (50% white, 18% black, 16% Hispanic, and 16% Oriental) and, in comparison with the Japanese experience, an older mean age (3½ vs 1½ years) with fewer children less than 2 years of age (32% vs 50% to 60%). In comparison with the general population of the geographic urban and suburban referral area for our hospital and in comparison with our general pediatric population, Oriental children with Kawasaki disease were overrepresented (16% vs 2%). More families of children with Kawasaki disease were members of the upper and middle class (73%) than were the population seen in general pediatrics (31.7%) at our hospital. Personal interviews with 63 families of children with Kawasaki disease and 63 control families with children paired for ethnic group, sex, and age revealed no epidemiologic differences except for use of rug shampoo within 1 month of onset in 16 episodes in 15 children with Kawasaki disease in 14 families (22% of families) compared with two families of control children (3%) (P < .001).
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Plott, Caroline F., and Joshua M. Sharfstein. "Global Regulatory Agencies and Data Transparency." Journal of Law, Medicine & Ethics 49, no. 3 (2021): 486–88. http://dx.doi.org/10.1017/jme.2021.68.
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AbstractEgilman et al. review the current data sharing practices of three global regulatory agencies — Health Canada, the European Medicines Agency and the Food and Drug Agency. While there has been progress towards increasing transparency over the past decade, progress has been slow.
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Zachary, Rebecca. "Formulary Management from a Health Maintenance Organization (HMO) Perspective." Journal of Pharmacy Practice 7, no. 2 (April 1994): 68–73. http://dx.doi.org/10.1177/089719009400700204.
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With the rise of managed care, formularies are being increasingly employed in the outpatient setting to manage use and control costs of prescription drugs. The formulary management policies of various managed care organizations are widely diverse and are largely dependent on the organizational structure of the managed care program. Although reasons for choosing certain types of formulary systems will be briefly explored, this article primarily focuses on formulary management tools used in the group model HMO setting. Various aspects of the formulary process that require ongoing management are described, including non-formulary drug usage, drug restrictions, drug use review, adverse drug reaction reporting, education of the professional staff, reporting of drug use data to physicians, and visitation by pharmaceutical sales representatives.
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Mahir, Isma Lebbe Mohamed, and Thaseem Mohamed Fathima Wazeema. "Social Aspects of Drug Addiction in Sri Lanka." Journal of Politics and Law 13, no. 2 (May 19, 2020): 54. http://dx.doi.org/10.5539/jpl.v13n2p54.
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Social problems are rapidly increasing in modern societies due to various reasons. One of these is drug addiction, which has become a major issue in the contemporary world, as it is proving to be a serious social problem in both developing and underdeveloped countries. This review article that focuses on the social aspects of drug addiction in Sri Lanka is based on secondary data obtained from the published works of different authors; they provide details about the identity of drugs, drug addiction and the increasing number of addicts in Sri Lanka. Drug addiction has become an important issue due to its severe impact on public health, its tendency to encourage crime, cause diseases, poverty and destruction of family life in Sri Lanka. Heroin and cannabis (marijuana) are found to be the most commonly used drugs in Sri Lanka. Laws and policies designed to control drug abuse and regulations on drug addicts have not brought any major change or desired outcome in the Sri Lankan drug scene. Drug users in Sri Lanka get their supply of drugs from the underground drug market, which has its internal and external sources. Rehabilitation of drug addicts has become an urgent need in the country to protect its valuable citizens who are needed to build a sustainable nation that is free from drugs. Drug addiction is preventable and can be managed successfully if every citizen of the country gives his/ her full support and contribution.
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Cáceres, Mariano, Claudia V. Vassena, M. Dolores Garcerá, and Pablo L. Santo-Orihuela. "Silica Nanoparticles for Insect Pest Control." Current Pharmaceutical Design 25, no. 37 (December 17, 2019): 4030–38. http://dx.doi.org/10.2174/1381612825666191015152855.
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To date, control strategies used against insect pest species are based on synthetic insecticide applications. In addition, the efficacy of these treatments could be decreased due to insecticide resistance in insect populations. Also, the irrational use of chemical control strategies has negative consequences of non-target organisms and threatening human health. Designing nanomaterial for pest insect control is a promising alternative to traditional insecticide formulations. In particular, it has been proven that silica nanoparticles have the potential for molecules delivery, release control improvement and also their toxicity as insecticide alone. In this work, we summarized the state of knowledge on silica nanoparticles (SiNPs) used in pest insect management. Besides, aspects of their synthesis, mode of action, and toxic effects on non-target organisms and environment are reviewed.
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Bavli, Itai, and Daniel Steel. "Inductive Risk and OxyContin: The Ethics of Evidence and Post-Market Surveillance of Pharmaceuticals in Canada." Public Health Ethics 13, no. 3 (September 24, 2020): 300–313. http://dx.doi.org/10.1093/phe/phaa031.
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Abstract The argument from inductive risk claims that judgments about the moral severity of errors are relevant to decisions about what should count as sufficient evidence for accepting claims. While this idea has been explored in connection with evidence required for the approval of pharmaceuticals, the role of inductive risk in the post-approval process has been largely neglected. In this article, we examine the ethics of inductive risk in connection with revisions to the product monograph for OxyContin in Canada, which understates the risks of addiction and abuse associated with this drug. Using the concept of inductive risk, we consider what evidence should have been sufficient for Health Canada (HC) to revise the product monograph for OxyContin. Given the stakes involved, we argue that a less strict standard of evidence would have been appropriate, yet HC in fact took the opposite course, insisting upon a higher standard of evidence than it normally requires. In addition to providing a novel perspective on the opioid crisis in Canada, this article contributes to existing philosophical work by demonstrating that inductive risks in the post-approval stage are important and linked to pre-approval inductive risks.
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Synnott, Patricia, Daniel Enright, Dominic Voehler, Stacey Kowal, and Daniel Ollendorf. "OP67 Considerations Of Treatment Novelty In Health Technology Assessment." International Journal of Technology Assessment in Health Care 38, S1 (December 2022): S25. http://dx.doi.org/10.1017/s0266462322001179.
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IntroductionA recent proliferation of value frameworks, as well as the emergence of innovative approaches to treating disease (e.g., cell/gene therapies) have been accompanied by an increased focus on nontraditional elements of value. We sought to understand whether and how health technology assessment (HTA) agencies consider novel aspects of treatment in value assessments.MethodsWe defined treatment novelty as follows: (i) a new mechanism of action or administration; (ii) addresses an unmet need; or (iii) confers a distinct benefit that transforms clinical practice or that is difficult to quantify. We reviewed technical guidance and peer-reviewed literature to investigate how organizations in eight countries (Australia, Canada, England, France, Norway, the Netherlands, Sweden, and the United States) consider aspects of this definition.ResultsAll (n = 8) organizations give special consideration to interventions that address an unmet need, particularly in cancer, rare diseases, and other severe conditions. Nearly all (n = 5) organizations consider whether an intervention produces benefits that may not be adequately quantified. Organizations in England, Norway, and France sometimes recommend drugs with less favorable cost-effectiveness estimates than traditionally considered if the drug addresses rare or severe conditions, or if its quality-of-life benefit is thought to be inadequately quantified. The Institute for Clinical and Economic Review in the United States models cost-effectiveness in rare diseases using both a modified societal and health care system perspective. Importantly, the benefits of novel treatments are frequently considered uncertain, particularly treatments with a new mechanism of action. When uncertainty is high, organizations in Canada, England, France, the Netherlands, and Sweden sometimes issue conditional recommendations until additional evidence is submitted. England and Australia have used risk sharing agreements for drugs determined to be novel but uncertain.ConclusionsThe most widely considered aspects of treatment novelty in HTA are unmet needs and potential benefits that are not easily measured. The willingness to pay for novel treatments is often greater, despite inherent uncertainties about benefit and cost-effectiveness.
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Novek, Joel. "Clinical or Industrial Pharmacy? Case Studies of Hospital Pharmacy Automation in Canada and France." International Journal of Health Services 28, no. 3 (July 1998): 445–65. http://dx.doi.org/10.2190/w2bt-fgxq-ql0g-ynl9.
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Automated medication dispensing systems for hospital pharmacies, heralded as an important means of reducing drug errors and improving labor productivity, have also been seen as a means of furthering the transformation of the pharmacy profession from its role in dispensing prescriptions to a clinical profession concerned with treatments and patient outcomes. Automation aids this transformation by transferring the responsibility for routine dispensing to technicians performing rationalized and computer-mediated tasks. Not all pharmacists agree with these trends. Some fear a loss of professional status and employment as their knowledge is expropriated and incorporated into machinery operated by those with lesser qualifications. They fear an industrial rather than a clinical future. Their concerns are compounded by health care cutbacks. These issues were studied at two hospitals in Canada and one in France, all mid-sized public hospitals with automated unit dose drug delivery systems installed in the late 1980s and early 1990s. Preliminary results indicated national differences in approaches to hospital pharmacy automation. In Canada, pharmacists have resisted major changes in their control of the dispensing process and in their traditional roles vis à vis doctors and pharmacy technicians. In France, where hospital pharmacy as a profession is less developed than in North America, automation has brought about a far more radical substitution for pharmacists' labor.
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Rand, Leah Z., and Aaron S. Kesselheim. "An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles." Journal of Law, Medicine & Ethics 48, no. 3 (2020): 583–94. http://dx.doi.org/10.1177/1073110520958885.
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In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.
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Suter, Paolo M. "Alcohol, nutrition and health maintenance: selected aspects." Proceedings of the Nutrition Society 63, no. 1 (February 2004): 81–88. http://dx.doi.org/10.1079/pns2003326.
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In view of the developments in health care relating to the increased prevalence and incidence of chronic diseases and the continuing increase in health-care expenditure, more attention should be paid to health maintenance and disease prevention. Any strategy that can influence health maintenance is of interest, especially lifestyle factors such as nutrition, exercise or stress control. Alcohol has an important place in the daily life of many healthy as well as sick individuals. Alcohol has three major characteristics; it is a nutrient (energy source), a psycho-active drug and a toxin. Each consumer has the choice of which of the characteristics of alcohol he/she wants to utilise. Thus, alcohol represents one of the most important self-implemented disease modifiers in our modern society. The major determinants of the health effects of alcohol are the absolute amount consumed, the consumption frequency, associated lifestyle factors (e.g. smoking, nutrient intake, substrate composition, physical activity pattern) and last, but not least, the genetic background. There are few known disease conditions that have not already been associated positively or negatively with alcohol consumption. The list of diseases includes atherosclerosis, dementia, diabetes, obesity and conditions relating to Zn metabolism. Obesity represents the most important disease modifier in the world and the prevalence rates are increasing rapidly. Evidence suggests that alcohol represents a risk factor for overweight and obesity as a result of specific effects on energy metabolism and substrate metabolism. The potential role of alcohol as an important modulator for the postprandial lipidaemia and its role in the pathogenesis of modern diseases will be discussed.
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Packer, Claire, Sue Simpson, and Andrew Stevens. "International diffusion of new health technologies: A ten-country analysis of six health technologies." International Journal of Technology Assessment in Health Care 22, no. 4 (September 19, 2006): 419–28. http://dx.doi.org/10.1017/s0266462306051336.
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Objectives: The objective of this study was to examine and explain the differential international diffusion of six health innovations.Methods: A retrospective diffusion study was undertaken of sildenafil, cyclooxygenase-II (COX II) inhibitors, beta interferon, verteporfin, deep brain stimulators, and drug-eluting coronary stents in ten countries—Australia, Canada, Denmark, France, The Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom. We plotted diffusion curves of daily defined doses per quarter, vials or implants per million population, and examined the association between diffusion and five key variables.Results: Canada, Switzerland, and Sweden are generally high users of new technologies; Spain, Denmark, and particularly the United Kingdom are low users. Almost all countries experienced rapid adoption of sildenafil with diffusion to a similar level; there was variable adoption and diffusion of COX II inhibitors, verteporfin, and interferon beta; drug-eluting stents penetrated the market in a similar way in all but one country; and two countries had very different adoption patterns for deep brain stimulators. Above average health spending and the presence of health technology assessment (HTA) or other guidance reports are consistently associated with increased diffusion. Early warning activity and a national coverage decision being taken are more likely to be associated with a reduced diffusion.Conclusions: The significant differences in diffusion between different countries are not consistent with a neat evidence-based world. The tools available to policy makers to control diffusion (early warning systems, HTA, and a fourth hurdle) play some part in influencing diffusion but need close scrutiny of how successfully they operate.
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Morrison, Alena, Neil J. MacKinnon, Nicole R. Hartnell, and Karen J. McCaffrey. "Impact of Drug Plan Management Policies in Canada: A Systematic Review." Canadian Pharmacists Journal / Revue des Pharmaciens du Canada 141, no. 6 (November 2008): 332–38. http://dx.doi.org/10.3821/1913-701x-141.6.332.
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Background/objective: In Canada, pharmaceutical expenditures require an increasing proportion of total health care dollars. Drug plan managers use various policies to manage medication use and control costs, but these policies can have unintended consequences. The objective of this systematic review is to evaluate the impact of drug policies on economic, clinical and humanistic (quality of life or satisfaction) outcomes. Methods: Articles in which the primary objective was to evaluate the impact of a drug policy tool or technique in Canada and that measured one or more economic, clinical or humanistic outcomes were considered for inclusion. Studies were excluded if they were based in institutions or not published in peer-reviewed journals. The search process included searching 9 electronic databases, searching the reference lists of identified articles and working papers and contacting drug policy researchers. Studies were assessed for quality and suitability for meta-analysis. We performed a qualitative synthesis of the study design, study sample and outcomes. Results: Thirty-five articles satisfied the inclusion criteria. Most ( n= 25, 71%) determined that drug policies reduced the costs, utilization or both of the studied drug therapy. Only 13 studies (37%) measured the impact of the drug policy on the cost or utilization of medical care, and the impact of the policy was favourable in only 4 of these cases. Six studies (17%) evaluated the impact of the policy on clinical outcomes; none reported a favourable impact. No studies evaluated the impact of the drug policy on humanistic outcomes. Discussion: Although the drug policies in most of the studies included in this systematic review did achieve the desired goal of reducing drug costs, utilization or both, the impact on other outcomes was seldom examined. In the 6 studies in which clinical outcomes were included in the evaluation framework, the impact was inconclusive. Humanistic outcomes have been completely excluded from evaluations to date.
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Carmo, Ana Cerúlia Moraes do, Stefânia Schimaneski Piras, Nayrton Flávio Moura Rocha, and Tais Gratieri. "Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)." BioMed Research International 2017 (2017): 1–10. http://dx.doi.org/10.1155/2017/7894937.
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Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company’s administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal.Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015.Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015.Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.
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Vukojevic, Vesna, Zorica Kuburic, and Aleksandar Damjanovic. "The influence of perceived discrimination, sense of control, self-esteem and multiple discrepancies on the mental health and subjective well-being in Serbian immigrants in Canada." Psihologija 49, no. 2 (2016): 105–27. http://dx.doi.org/10.2298/psi1602105v.
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The study focuses on the mental health and subjective well-being (SWB) of Serbian immigrants of the first generation in Canada. We wanted to examine if perceived discrimination, sense of control, self-esteem and perceived multiple discrepancy affect their mental health and SWB. Our results indicate that self-esteem and sense of control have a positive effect on mental health and all aspects of the SWB, while the perceived discrimination and perceived multiple discrepancy negatively affect SWB and mental health. Self-esteem was the most salient predictor of mental health, while the perceived multiple discrepancy was the most salient predictor of life satisfaction of Serbian immigrants.
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Fischer, Benedikt, Michelle Pang, and Mark Tyndall. "Applying principles of injury and infectious disease control to the opioid mortality epidemic in North America: critical intervention gaps." Journal of Public Health 42, no. 4 (December 10, 2019): 848–52. http://dx.doi.org/10.1093/pubmed/fdz162.
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ABSTRACT North America has been experiencing an acute and unprecedented public health crisis involving excessive and increasing levels of opioid-related overdose mortality. In the present commentary, we examine current interventions (as existent mainly in Canada) to date and compare them against established intervention frameworks and practices in other areas of public health, specifically injury and infectious disease control. We observe that current interventions focusing on opioid drug safety or exposure—specifically those that focus on distinctly potent and toxic opioid products driving major increases in overdose mortality—may be considered the equivalent of ‘agent-’ or ‘vector’-based interventions. Such interventions have been largely neglected in favor of ‘host’ (e.g., drug user-oriented) or ‘environmental’ measures among strategies to reduce opioid-related overdose, likely contributing to the limited efficacy of current measures. We explore potential reasons, implications and remedies for these gaps in the overall public health strategy employed towards improved interventions to reduce opioid-related health harms.
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Sanagustin Bosqued, D., M. De Dios Felis, E. Monteagudo Gimeno, S. Pérez Gonzaléz, A. Trabsa Biskri, L. Galindo Guarin, M. Grifell Guardia, P. Quintana Mathe, and M. Torrens Melich. "U-47700: The new emerging opioid drug." European Psychiatry 41, S1 (April 2017): S395. http://dx.doi.org/10.1016/j.eurpsy.2017.02.452.
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IntroductionThe trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl) labelled as U-47700 has a high affinity with the selective receptor, considered to have 7.5 times the binding affinity of morphine; as a result, it is sold as a recreational drug because of its analgesic and euphoric effects. Several toxicity cases and some fatalities have been reported during 2016.ObjectivesTo describe the presence of trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl) in samples delivered to Energy Control during 2016 in Barcelona.MethodsFrom January 2016 to October 2016, 4031 samples were delivered and only those samples containing trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl) were studied, 6 of them were analysed as U-47700 (0.148%). Samples were analysed by energy control, a Spanish harm-reduction NGO that offers users the possibility of analysing the substances they intend to consume. Analysis was done by gas chromatography–mass spectrometry.ResultsFrom the 6 samples that were analysed as trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl), the presentation of 4 of them was white powder and the rest were not described. The procedence of the samples was Canada (2), USA (1), Sweden (1), Holland (1) and the remaining sample was not described. All samples were received during 2016.ConclusionsThe use of trans-3;4-dichloro-N-(2-(dimethylamine)cyclohexyl) is progressively increasing in Barcelona. Its harmful effects are being reported in recent medical literature and consumption represents an emerging issue, gaining popularity among recreational opioid users. It is potentially lethal when mixed with depressants like alcohol or benzodiazepines and overdose risk is higher compared to other opioids. This drug is not being detected by routine in medical test.Disclosure of interestThe authors have not supplied their declaration of competing interest.
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Marchildon, Gregory P., Capri S. Cafaro, and Adalsteinn Brown. "Myths, Misperceptions, and Policy Learning: Comparing Healthcare in the United States and Canada." Journal of Law, Medicine & Ethics 46, no. 4 (2018): 833–37. http://dx.doi.org/10.1177/1073110518821975.
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The U.S. and Canadian health care systems are more similar than is commonly believed. This article debunks some of the powerful myths about these health care systems and opens up the discussion for greater policy learning from both sides of the border. Cross-border comparisons can yield a number of lessons from common policy challenges such as cost control, physician organization and payment, and the organization of health coverage and services for Native Americans and Indigenous Canadians.
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Patel, Yesha, Amit A. Patel, and Ravish J. Patel. "A Comparative Study of Biologic Regulation in US, Canada, Australia, Europe and Singapore." International Journal of Drug Regulatory Affairs 10, no. 2 (June 19, 2022): 28–34. http://dx.doi.org/10.22270/ijdra.v10i2.518.
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Extensive research in chemistry, manufacturing, controls, preclinical science, and clinical trials is required when developing a novel biological medication. Drug reviewers in regulatory bodies throughout the world and all regulatory bodies are entrusted with determining whether research evidence establishes new drug product safety, effectiveness, and quality control in order to protect public health. Among the world every province has its own regulatory organization in charge of enforcing laws and regulations and developing guidelines for drug marketing. There are some particular requirements sets by regulatory authority that must be satisfied when submitting in the particular nation. The world is split into various approval procedures, it is pivotal for manufacturers to carefully assess market interest, expenditures, target zones, and regulatory standards before establishing biologics. Despite the existence and widespread adoption of an ICH-CTD standard format, some limitations are included. This article discusses the comparison considerations used for biological product approval in the United States, Canada, Europe, Australia, and Singapore.
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Ribeiro, Luane Santana, Daniel de Medeiros Gonzaga, Matthijs Pieter van den Burg, and Juan Gérvas. "Drug cartels respond to the pandemic." Revista Brasileira de Medicina de Família e Comunidade 16, no. 43 (December 29, 2021): 2675. http://dx.doi.org/10.5712/rbmfc16(43)2675.
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More than 13.6 million Brazilians live in large poor communities known as favelas. Historically, these territories suffer due to social rights insufficiency and violent conflicts orchestrated by the police and the drug cartels. In this context, the dismantling of the public health care system and denialism of the pandemic by the federal government increases the vulnerability within the favelas during the COVID-19 crisis. Although the federal government failed to take up measures to control the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a criminal organization that dominates the trafficking of drugs in several Brazilian favelas, known as Comando Vermelho, instead dictated those protective actions. This study aimed to discuss the ethical aspects of the relationship between primary health care professionals and the drug cartels in order to promote health care in the favelas.
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Wright, Maria da Gloria Miotto, Catherine Caufield, Genevieve Gray, and Joanne Olson. "International research capacity-building programs for nurses to study the drug phenomenon in Latin America: challenges and perspectives." Revista Latino-Americana de Enfermagem 13, spe2 (December 2005): 1095–101. http://dx.doi.org/10.1590/s0104-11692005000800002.
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The First International Research Capacity-Building Program for Nurses to Study the Drug Phenomenon in the Americas is a result of a partnership between the Inter-American Drug Abuse Control Commission (CICAD) of the Organization of American States (OAS) and the Faculty of Nursing in the University of Alberta, with financial support from the Government of Canada. The program was divided into two parts. The first part of the program was held at the University of Alberta in Edmonton, Alberta, Canada. It involved capacity-building in research methodologies at the Faculty of Nursing, which lead to the preparation of four multi-centric research proposals for drug demand reduction in the home countries of the eleven participants in the program. The second part of the program was related to the implementation of multi-centric research proposals in seven countries in Latin America and in Canada. This program presented expertise in research methodology to members of Latin American Schools of Nursing and introduced Latin American expertise to members of a Canadian Faculty of Nursing. The International Research Capacity-Building Program for Nurses to Study the Drug Phenomenon in the Americas has fostered the kind of inter-cultural respect and mutual appreciation necessary to confront the global health problem of the abuse of both licit and illicit drugs.
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Lexchin, Joel. "Canadian Marketing Codes: How Well are They Controlling Pharmaceutical Promotion?" International Journal of Health Services 24, no. 1 (January 1994): 91–104. http://dx.doi.org/10.2190/ekep-d9je-31a4-kte5.
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Pharmaceutical promotion in Canada is controlled by two codes: a voluntary one developed by the Pharmaceutical Advertising Advisory Board dealing mostly with printed promotional material, and one from the Pharmaceutical Manufacturers Association of Canada covering other forms of promotion. This article looks at enforcement of the provisions of these codes and at areas in which they are deficient. One of the major weaknesses in both codes is their lack of effective sanctions for companies that violate their provisions. Strong codes are necessary because many physicians rely heavily on promotional material for their source of prescribing information. However, voluntary codes or codes developed by the industry are inherently weak and lack effective enforcement mechanisms. Although the U.S. Food and Drug Administration is currently very active in curtailing promotional excesses, government control is not the solution since regulatory action will depend on the ideological position of the head of the regulatory body and/or the party in power. An independent body backed by legislative authority is preferable.
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Ali, Amza. "Global Health: Epilepsy." Seminars in Neurology 38, no. 02 (April 2018): 191–99. http://dx.doi.org/10.1055/s-0038-1646947.
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AbstractEpilepsy is a frequently misunderstood and highly stigmatized condition. Major treatment gaps exist across the world, most so in areas of financial constraint. Classification permits the best approaches to treatment and to ascertaining prognosis. The International League Against Epilepsy's new classification system emphasizes clinical aspects and utilizes all available resources to determine whether it is a focal or generalized epilepsy. The most important tools are a careful history, clinical examination, electroencephalography, and appropriate neuroimaging. Inadequate, delayed, and incomplete evaluation may lead to misdiagnosis and costly mismanagement. Treatment is generally pharmacological, with approximately 20 to 30% of patients eventually proving refractory to medications and thus becoming potential surgical candidates. The type of epilepsy, age, gender, comorbidities, drug interactions, and drug cost are important factors in choosing an antiepileptic drug (AED). The teratogenic potential of some AEDs, weight gain, and menstrual hormone–related issues are important considerations in women. The impact of AEDs on bone health is critical in all age groups, particularly in the elderly. Psychiatric problems, mostly depression and anxiety, can have a great impact on seizure control and overall quality of life. Finally, effective partnerships and collaborations can bring resources, both human and financial, to regions that would otherwise find it impossible to effect change on their own.
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Pyatigorskaya, N. V., M. A. Tulina, Zh I. Aladysheva, and V. V. Beregovykh. "INTERNATIONAL APPROACHES TO THE REGULATION OF CELL THERAPY PRODUCTS." Annals of the Russian academy of medical sciences 68, no. 8 (August 19, 2013): 4–8. http://dx.doi.org/10.15690/vramn.v68i8.715.
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This article is a review of the main methods and approaches used in regulation of cell therapy products in the United States of America, Canada, European Union, Australia, Japan and South Korea. Intensive developments of scientific and technological aspects in stem cell and tissue engineering have led to the wide use of human cells and tissues for the treatment of various diseases and injuries of organs and tissues. Drug regulatory agencies of different countries are working on implementation of a risk-based legal framework with some common features. In many countries there is a multilevel control system that assures quality and safety of used cell products. Competent authorities establish strict requirements both to safety of the products and to the implemented standards of good laboratory, manufacturing, clinical and tissue practices.
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Secor, W. Evan. "Early lessons from schistosomiasis mass drug administration programs." F1000Research 4 (October 28, 2015): 1157. http://dx.doi.org/10.12688/f1000research.6826.1.
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Mass drug administration using praziquantel is the backbone of the current strategy for the control of schistosomiasis. As the theoretical plans have moved into practical application, certain challenges with this approach have surfaced, and it is likely that annual mass drug administration alone may not be sufficient to achieve program goals. However, mass drug administration is still the only available intervention that can be readily used in the wide variety of settings where schistosomiasis is endemic. The task then becomes how to improve this approach and identify what adjuncts to mass drug administration are effective, as programs move from morbidity control to elimination goals. Other aspects worthy of consideration include how best to employ new diagnostic tools to more easily identify where treatment is needed, and new formulations of praziquantel to extend the availability of treatment to all age groups. The aim of this review is to highlight both areas of challenge and of opportunity to improve the public health impact of schistosomiasis control programs.
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Bertagnolio, Silvia, Inge Derdelinckx, Monica Parker, Joseph Fitzgibbon, Herve Fleury, Martin Peeters, Rob Schuurman, et al. "World Health Organization/HIVResNet Drug Resistance Laboratory Strategy." Antiviral Therapy 13, no. 2_suppl (February 2008): 49–57. http://dx.doi.org/10.1177/135965350801302s05.
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With rapidly increasing access to antiretroviral drugs globally, HIV drug resistance (HIVDR) has become a significant public health issue. This requires a coordinated and collaborative response from country level to international level to assess the extent of HIVDR and the establishment of efficient and evidence-based strategies to minimize its appearance and onward transmission. In parallel with the rollout of universal access to HIV treatment, countries are developing protocols based on the recommendations of the World Health Organization (WHO) to measure, at a population level, both transmitted HIVDR and HIVDR emerging during treatment. The WHO in collaboration with international experts (HIVResNet Laboratory Working Group), has developed a laboratory strategy, which has the overall goal of delivering quality-assured HIV genotypic results on specimens derived from the HIVDR surveys. The results will be used to help control the emergence and spread of drug resistance and to guide decision makers on antiretroviral therapy policy at national, regional and global level. The HIVDR Laboratory Strategy developed by the WHO includes several key aspects: the formation of a global network of national, regional and specialized laboratories accredited to perform HIVDR testing using a common set of WHO standard and performance indicators; recommendations of acceptable methods for collection, handling, shipment and storage of specimens in field conditions; and the provision of laboratory technical support, capacity building and quality assurance for network laboratories. The WHO/HIVResNet HIVDR Laboratory Network has been developed along the lines of other successful laboratory networks coordinated by the WHO. As of August 2007, assessment for accreditation has been conducted in 30 laboratories, covering the WHO‘s African, South-East Asia, Western Pacific, and the Caribbean Regions.
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Cheng, Lijuan. "Study on the Influence of Pharmaceutical Management on Rational Drug Use under Chinese Health Strategy." BCP Business & Management 13 (November 16, 2021): 180–85. http://dx.doi.org/10.54691/bcpbm.v13i.93.
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In order to better promote the implementation of the healthy China strategy and the innovation of public hospital system management, we can explore a modern public hospital management system that can meet the needs of the people in the new era from the aspects of medical service supply mode, collaborative governance design of public hospitals and internal management system of public hospitals. In this paper, 300 prescriptions in our hospital before and after May, 2020 were selected as research objects, and were randomly divided into two groups, one group was the control group (300 cases) without pharmaceutical management, and the other group was the observation group (300 cases) with pharmaceutical management. Then, the drug satisfaction, irrational drug use and inappropriate drug use of the two groups were compared. The results showed that the satisfaction of medication in the observation group was significantly better than that in the control group, and the irrational and inappropriate medication was lower than that in the control group, with statistical differences (P <0.05). It shows that the implementation of pharmaceutical management measures under the strategy of Healthy China can effectively improve patients' satisfaction with medication and prevent irrational medication.
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Melillo, Margherita. "The Influence of the Commercial Speech Doctrine on the Development of Tobacco Control Measures." Journal of Law, Medicine & Ethics 50, no. 2 (2022): 233–39. http://dx.doi.org/10.1017/jme.2022.47.
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AbstractAmong the attempts to oppose tobacco control legislation, the tobacco industry has alleged violations of its right to commercial speech. While the disputes that took place in some jurisdictions like the United States (US), Canada, or the European Union (EU) have been already analyzed, much less is known about how, globally, this doctrine has influenced the adoption of tobacco control measures. This article contributes to filling this gap by illustrating how the commercial speech doctrine influenced the negotiations of the Framework Convention on Tobacco Control (FCTC). Moreover, using the Tobacco Control Database of Campaign for Tobacco-Free Kids, it shows that arguments on commercial speech have been used to challenge tobacco control measures in an increasing number of countries.
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Ghayur, Muhammad Nabeel. "Science Across Borders: 5th Annual Natural Health Product Research Conference—March 26–29, 2008, Toronto, Canada." Evidence-Based Complementary and Alternative Medicine 7, no. 3 (2010): 391–95. http://dx.doi.org/10.1093/ecam/nen059.
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Canada is experiencing a growing interest in the use of alternative therapies and products particularly natural health products (NHP). In 1997, Canadians spent around C$ 2 billion on NHP. In an attempt to catch with this popularity of NHP use, Canadian researchers and administrators from academia, industry and government jointly established the Natural Health Product Research Society of Canada (NHPRS). Since its formation, NHPRS has been organizing an annual meeting which brings together world renowned researchers and experts in the area of NHP research. For 2008, the annual NHPRS meeting took place in Toronto from the 26th to 29th of March with a focus on ‘Science Across Borders: Global Natural Health Products Research’. The scientific program was spread into three days of plenary lectures and oral presentations. The different sessions containing these talks were on: ethnobotany around the world; chemical analysis of NHP; product standards and quality control; ethnomedicine; novel analytical approaches; systemic research, nutrisciences and molecular medicine; and drug development from NHP. The meeting proved to be a great success in terms of the speakers that were invited and based on the data that was presented which highlighted recent research taking place in the field of NHP not only in Canada but from many parts of the world.
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Stallings, Shirley. "From Printing Press to Pharmaceutical Representative: A Social History of Drug Advertising and Promotion." Journal of Drug Issues 22, no. 2 (April 1992): 205–19. http://dx.doi.org/10.1177/002204269202200202.
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With only a few years left in the twentieth century, a multiplicity of controversies encompass drug advertising and promotion. Have marketing techniques regarding pharmaceutical drugs, proprietary medicines, alcohol, and tobacco really changed over time and disrupted the value structure of society? Past, present, and future affect people; not one aspect of time, but all aspects, bear upon the present. Drug advertising and promotion has maintained vitality and robustness through time by promoting the public's desire for a continuity of familiar and traditional health values. By using the nature of a perpetually changing environment, advertising has advanced drugs as symbols of health. Such symbolic activity has provided hope to people regarding their own power and control over pain and illness. Through time, drug advertising became institutionalized.
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Almashat, Sammy, and Michael Carome. "Withholding Information on Unapproved Drug Marketing Applications: The Public Has a Right to Know." Journal of Law, Medicine & Ethics 45, S2 (2017): 46–49. http://dx.doi.org/10.1177/1073110517750621.
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The Food and Drug Administration (FDA), as a matter of long-standing policy, does not inform the public of instances whereby applications for new drugs or new indications for existing drugs have been rejected by the agency or withdrawn from consideration, nor does it disclose the agency’s analyses of the data submitted with such applications. This lack of transparency is unjustified and prevents patients, researchers, and healthcare providers from gaining insight into why a drug’s application was not approved. The FDA’s policy is particularly troubling in cases where the agency has found a currently marketed drug to be ineffective or unsafe for a newly proposed indication. Disclosure of the FDA’s findings in such cases would promote public health by encouraging healthcare providers to avoid prescribing drugs for unapproved (off-label) uses that the agency has deemed to be potentially dangerous or ineffective. The FDA’s counterpart agencies in Europe and Canada have demonstrated the feasibility of disclosing information on rejected and withdrawn drug marketing applications. The FDA should follow suit and allow the American public to know when a drug is deemed unsafe or ineffective for a certain use.
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Hussain, Afzal, Sima Singh, Sabya Sachi Das, Keshireddy Anjireddy, Subramanian Karpagam, and Faiyaz Shakeel. "Nanomedicines as Drug Delivery Carriers of Anti-Tubercular Drugs: From Pathogenesis to Infection Control." Current Drug Delivery 16, no. 5 (May 29, 2019): 400–429. http://dx.doi.org/10.2174/1567201816666190201144815.
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In spite of advances in tuberculosis (TB) chemotherapy, TB is still airborne deadly disorder as a major issue of health concern worldwide today. Extensive researches have been focused to develop novel drug delivery systems to shorten the lengthy therapy approaches, prevention of relapses, reducing dose-related toxicities and to rectify technologically related drawbacks of anti-tubercular drugs. Moreover, the rapid emergence of drug resistance, poor patient compliance due to negative therapeutic outcomes and intracellular survival of Mycobacterium highlighted to develop carrier with optimum effectiveness of the anti-tubercular drugs. This could be achieved by targeting and concentrating the drug on the infection reservoir of Mycobacterium. In this article, we briefly compiled the general aspects of Mycobacterium pathogenesis, disease treatment along with progressive updates in novel drug delivery carrier system to enhance therapeutic effects of drug and the high level of patient compliance. Recently developed several vaccines might be shortly available as reported by WHO.
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Shaw, Souradet Y., Laurie Ireland, Leigh M. McClarty, Carla Loeppky, Jared Bullard, Paul Van Caeseele, Yoav Keynan, et al. "Healthcare utilization among persons living with HIV in Manitoba, Canada, prior to HIV diagnosis: A case-control analysis." International Journal of STD & AIDS 33, no. 3 (December 11, 2021): 265–74. http://dx.doi.org/10.1177/09564624211051615.
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Background Understanding care patterns of persons living with HIV prior to diagnosis can inform prevention opportunities, earlier diagnosis, and engagement strategies. We examined healthcare utilization among HIV-positive individuals and compared them to HIV-negative controls. Methods Data were from a retrospective cohort from Manitoba, Canada. Participants included individuals living with HIV presenting to care between 2007 and 2011, and HIV-negative controls, matched (1:5) by age, sex, and region. Data from population-based administrative databases included physician visits, hospitalizations, drug dispensation, and chlamydia and gonorrhea testing. Diagnoses associated with physician visits were classified according to International Classification of Diseases chapters. Conditional logistic regression models were used to compare cases/controls, with adjusted odds ratios (AORs) and their 95% confidence intervals (95% CI) reported. Results A total of 193 cases and 965 controls were included. Physician visits and hospitalizations were higher for cases, compared to controls. In the 2 years prior to case date, cases were more likely to be diagnosed with “blood disorders” (AOR: 4.2, 95% CI: 2.0–9.0), be treated for mood disorders (AOR: 2.4, 95% CI: 1.6–3.4), and to have 1+ visits to a hospital (AOR: 2.2, 95% CI: 1.4–3.6). Conclusion Opportunities exist for prevention, screening, and earlier diagnosis. There is a need for better integration of healthcare services with public health.
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Ng, Victoria, Aamir Fazil, Lisa A. Waddell, Patricia Turgeon, Ainsley Otten, and Nicholas H. Ogden. "Modelling the impact of shutdowns on resurging SARS-CoV-2 transmission in Canada." Royal Society Open Science 8, no. 5 (May 2021): 210233. http://dx.doi.org/10.1098/rsos.210233.
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Background: Shutdowns are enacted when alternative public health measures are insufficient to control the epidemic and the population is largely susceptible. An age-stratified agent-based model was developed to explore the impact of shutdowns to control SARS-CoV-2 transmission in Canada under the assumption that current efforts to control the epidemic remains insufficient and in the absence of a vaccine. Methods: We estimated the current levels of interventions in Canada to generate a baseline scenario from 7 February to 7 September 2020. Four aspects of shutdowns were explored in scenarios that ran from 8 September 2020 to 7 January 2022, these included the impact of how quickly shutdowns are implemented, the duration of shutdowns, the minimum break (delays) between shutdowns and the types of sectors to shutdown. Comparisons among scenarios were made using cases, hospitalizations, deaths and shutdown days during the 700-day model runs. Results: We found a negative relationship between reducing SARS-CoV-2 transmission and the number of shutdown days. However, we also found that for shutdowns to be optimally effective, they need to be implemented fast with minimal delay, initiated when community transmission is low, sustained for an adequate period and be stringent and target multiple sectors, particularly those driving transmission. By applying shutdowns in this manner, the total number of shutdown days could be reduced compared to delaying the shutdowns until further into the epidemic when transmission is higher and/or implementing short insufficient shutdowns that would require frequent re-implementation. This paper contrasts a range of shutdown strategies and trade-offs between health outcomes and economic metrics that need to be considered within the local context. Interpretation: Given the immense socioeconomic impact of shutdowns, they should be avoided where possible and used only when other public health measures are insufficient to control the epidemic. If used, the time it buys to delay the epidemic should be used to enhance other equally effective, but less disruptive, public health measures.
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Kosteniuk, Julie, Beliz Açan Osman, Meric Osman, Jacqueline M. Quail, Naorin Islam, Megan E. O'Connell, Andrew Kirk, Norma J. Stewart, and Debra Morgan. "Health service use before and after dementia diagnosis: a retrospective matched case–control study." BMJ Open 12, no. 11 (November 2022): e067363. http://dx.doi.org/10.1136/bmjopen-2022-067363.
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ObjectivesThis study investigated patterns in health service usage among older adults with dementia and matched controls over a 10-year span from 5 years before until 5 years after diagnosis.DesignPopulation-based retrospective matched case–control study.SettingAdministrative health data of individuals in Saskatchewan, Canada from 1 April 2008 to 31 March 2019.ParticipantsThe study included 2024 adults aged 65 years and older living in the community at the time of dementia diagnosis from 1 April 2013 to 31 March 2014, matched 1:1 to individuals without a dementia diagnosis on age group, sex, rural versus urban residence, geographical region and comorbidity.Outcome measuresFor each 5-year period before and after diagnosis, we examined usage of health services each year including family physician (FP) visits, specialist visits, hospital admissions, all-type prescription drug dispensations and short-term care admissions. We used negative binomial regression to estimate the effect of dementia on yearly average health service utilisation adjusting for sex, age group, rural versus urban residence, geographical region, 1 year prior health service use and comorbidity.ResultsAdjusted findings demonstrated that 5 years before diagnosis, usage of all health services except hospitalisation was lower among persons with dementia than persons without dementia (all p<0.001). After this point, differences in higher health service usage among persons with dementia compared to without dementia were greatest in the year before and year after diagnosis. In the year before diagnosis, specialist visits were 59.7% higher (p<0.001) and hospitalisations 90.5% higher (p<0.001). In the year after diagnosis, FP visits were 70.0% higher (p<0.001) and all-type drug prescriptions 29.1% higher (p<0.001).ConclusionsFindings suggest the year before and year after diagnosis offer multiple opportunities to implement quality supports. FPs are integral to dementia care and require effective resources to properly serve this population.
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Safyer, Steven M., Lynn Richmond, Eran Bellin, and David Fletcher. "Tuberculosis in Correctional Facilities: The Tuberculosis Control Program of the Montefiore Medical Center Rikers Island Health Services." Journal of Law, Medicine & Ethics 21, no. 3-4 (1993): 342–51. http://dx.doi.org/10.1111/j.1748-720x.1993.tb01259.x.
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“Recognizing that prisons disproportionately confine sick people, with mental illness, substance abuse, HIV disease among other illnesses; and that prisoners are subject to further morbidity and mortality in these institutions, due to lack of access and/or resources for health care, overcrowding, violence, emotional deprivation, and suicide.…(APHA) condemns the social practice of mass imprisonment.”After decades of steady decline, tuberculosis has emerged as a significant public health threat in the United States. The rising rates of tuberculosis cases, an increasing proportion of which are resistant to standard chemotherapies, are linked to the many scourges threatening our communities: the explosion of poverty, drug use, violence, the HIV epidemic, and the concomitant rise in congregate housing including homeless shelters, residential drug treatment programs and incarceration facilities. Jails and prisons have disproportionately high rates of tuberculosis infection and have been implicated as points of tuberculosis spread and, as such, are a critical point for tuberculosis control interventions.
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Petrin, Dino, Kiera Delgaty, Renuka Bhatt, and Gary Garber. "Clinical and Microbiological Aspects ofTrichomonas vaginalis." Clinical Microbiology Reviews 11, no. 2 (April 1, 1998): 300–317. http://dx.doi.org/10.1128/cmr.11.2.300.
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SUMMARY Trichomonas vaginalis, a parasitic protozoan, is the etiologic agent of trichomoniasis, a sexually transmitted disease (STD) of worldwide importance. Trichomoniasis is the most common nonviral STD, and it is associated with many perinatal complications, male and female genitourinary tract infections, and an increased incidence of HIV transmission. Diagnosis is difficult, since the symptoms of trichomoniasis mimic those of other STDs and detection methods lack precision. Although current treatment protocols involving nitroimidazoles are curative, metronidazole resistance is on the rise, outlining the need for research into alternative antibiotics. Vaccine development has been limited by a lack of understanding of the role of the host immune response to T. vaginalis infection. The lack of a good animal model has made it difficult to conduct standardized studies in drug and vaccine development and pathogenesis. Current work on pathogenesis has focused on the host-parasite relationship, in particular the initial events required to establish infection. These studies have illustrated that the pathogenesis of T. vaginalis is indeed very complex and involves adhesion, hemolysis, and soluble factors such as cysteine proteinases and cell-detaching factor. T. vaginalis interaction with the members of the resident vaginal flora, an advanced immune evasion strategy, and certain stress responses enable the organism to survive in its changing environment. Clearly, further research and collaboration will help elucidate these pathogenic mechanisms, and with better knowledge will come improved disease control.
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Murray, Glenn F. "Cocaine Use in the Era of Social Reform: The Natural History of a Social Problem in Canada, 1880–1911." Canadian journal of law and society 2 (1987): 29–43. http://dx.doi.org/10.1017/s0829320100001149.
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Current interest in the non-medical use of cocaine in Canada can be gauged by the attention this drug is getting in the various media. Not surprisingly, researchers have now entered the arena in the hope of answering some of the questions posed by this phenomenon. A similar trend occurred in regard to marijuana more than a decade ago when popular concern led to a federal commission that eventually recommended the repeal of the offence of cannabis possession. The wave of concern created considerable scholarly interest in Canada's approach to the control of narcotic drugs, including cannabis, which had been defined as narcotic for legal purposes. Much research followed on various fronts, from studies on the effects of cannabis on health to the social consequences of punishment.Several studies have examined the origins of Canada's legislative response to narcotic drug use. A principal conclusion from these studies is that legislation became possible because of hostility toward minority groups associated with drug use, specifically, the Chinese who were known for their use of opium. In the present paper, however, we see that drug control grew as much out of a “cocaine scare” as out of concern with opium use. Moreover, cocaine attracted attention in part precisely because its use was not confined to despised minorities, but permeated society as a whole, affecting “young people as well as seniors,” “men and women,” those from “poorer classes,” those from “respectable families” and those “who should and do know better.”