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Cover -- Introduction -- 1. Club Drugs Can Be Harmful -- 2. New Synthetic Club Drugs Pose Serious Challenges to Drug Enforcement -- 3. Legislation Is Needed to Ban Synthetic Club Drugs -- 4. Club Drugs Can Be Used to Facilitate Rape -- 5. Ecstasy Use by Pregnant Women Can Affect Infant Development -- 6. Recreational Use of the Club Drug Ketamine Can Lead to Bladder Disease -- 7. Ketamine: A Fast-Acting Antidepressant? -- 8. The Use of Methamphetamine Can Devastate Lives -- 9. The Drug "Spice" May Be Harmful and Should Be Regulated -- 10. Use of the Drug "Spice" Is Causing Concern in the Military -- 11. Taking Drugs Known as Bath Salts Can Cause Serious Health Consequences -- 12. Community Coalitions Can Help Reduce Access to Synthetic Drugs -- Organizations to Contact -- Bibliography -- Index

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'

This report discusses the Office of National Drug Control Policy Reauthorization Act of 2005 , which would reauthorize ONDCP for five years, through FY2010, and authorize funding in specific annual amounts for the High Intensity Drug Trafficking Area (HIDTA) Program, the media campaign, a Southwest Border violence study, and several anti-methamphetamine initiatives.

Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia

Background: Drugs have become an essential necessity in public health, people and the government has become willingly to spend more money on the country's healthcare system to restore health, save lives, preventing disease and epidemics. Drugs should be properly regulated throughout development, production, importation and subsequent distribution to ensure it is prescribed with safe, effective and of good quality standards. The structure of drug regulations today has evolved over time. During the process, the scope of legislative and regulatory power expanded in result of a series of disastrous events related to pharmaceutical products, the adoption of more restrictive legislative were put in place for stronger safeguard to the public. In comparison to Singapore, Taiwan, US and EU where the drug regulatory system is highly structured, flexible and innovative, Hong Kong (HK) has a relatively simple and stubborn drug regulatory system and drug approval is greatly dependent on the approval status of the advance countries. According to the current registration system in HK, a new drug usually takes about 18-24 months to obtain an approval, and this figure is far behind the standard of Singapore in which medicine could be registered in 60 days. It is vital to have speedy approval process with high standards in safety, efficacy and quality on all approved drugs. If drugs are approved in a rush manner, it will lead to serious adverse drug reactions (ADR), or even deaths in consumption of unsafe, and ineffective drugs. On the other hand, slow approval will make patients suffer and increase the mortality rate to due inaccessibility of appropriate medicines to sustain life and combat diseases. With reference to the initiatives and innovative regulatory frameworks in the abovementioned countries, the modification of the local drug regulatory system is strongly recommended. Aim: 1. To examine the regulatory frameworks between Singapore, Taiwan, US and EU which affect the evaluation timeline required for new drugs approval. 2. As the first study to examine the drug regulations in HK, the regulatory barriers for new drugs submission will be explored and whether the regulatory initiatives from the abovementioned countries may result in an improvement in the overall drug regulation system HK. Method: This dissertation is a literature review and it will employ concentration in the drug regulation systems in Singapore, Taiwan, US and EU with varying levels of pharmaceutical regulation capacities. Search engines including Google, MedLine, PubMed (database up to 2012) with key words search of "Department of Health (DoH), Food and Drug Administration (FDA), European Union (EU), Taiwan FDA, Health Sciences Authority, evaluation routes, drug registration requirement, review timeline, Centre for Drug Evaluation, Pharmaceutical Evaluation Reports, risk management systems, pharmacovigilance, drug legislation". Results: With an in-depth evaluation of the HK's guideline and supporting document required for new drug submission, it is highly recommended that unnecessary documents at new drug submission (NDA) should be elimination to facilitate the new drugs approval process. The regulatory frameworks between all studied countries vary significantly in which implementation of initiatives (e.g. multiple evaluation routes, in-house evaluation system) from individual country affects the standards of new drugs approval and the evaluation timeline required to grant approvals. Conclusion: The regulatory frameworks in HK shall be revised with reference to numerous initiatives developed in the regulatory systems in Singapore, Taiwan, Us and EU. The possible key regulatory barriers which leads to the delays in new drugs approvals in HK includes duplication of certificates, limited number of Pharmacy and Poison Board meetings, the requirement of endorsement of new drugs approvals at the legislative council , absence of in-house evaluation system which allows full assessment of submission dossier, deficiency of clinical trials with the inclusion of local population, absence of electronic submission, multiple evaluation routes and rigorous post-marketing pharmacovigilance monitoring system. If the Department of Health (DoH) in Hong Kong could scrutinize the current regulatory frameworks with referenced to these countries, it will improve the overall drug regulatory system and reduce drug lag due to unnecessary barriers. ; published_or_final_version ; Public Health ; Master ; Master of Public Health

6 The Case for Dynamic Interpretation of the International Drug Control Conventions7 Moving the 'thumb on the scales' -- Towards a Dynamic Human Rights-based Interpretation of International Drug Control Law; 8 The Future for a 'Fifth Stage' of Drug Control; Bibliography; Index

This paper uses California's first opium law in 1875 to examine the process of early drug legislation, specifically the political and economic conditions leading up to the passage of the law. We explore the possibility that initial opium prohibition was simply a component of a larger process of social control aimed at securing the isolation of the Chinese in the lower rungs of the labor market. It is suggested that analyses of social control must take into account the interrelationship between economic, political and ideological motivations behind any quest for prohibitive legislation.

Tracing the international and Australian history of both licit and illicit drug use, this investigation combines the topic of drug use with analyses of political power, the rise of the market, and social issues. It examines the way in which drug consumption is regulated in the era of global free trade by first looking at the start of the opium-growing industry and the racist origins of drug laws. Providing a social history of drug use through the lens of international politics, market forces, medicine, and race, this discussion also considers the paradox o

The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.

Globally, millions of people suffer health and socio-economic related problems due to the unavailability of controlled essential medicines such as morphine for pain treatment, which leaves them in disabling and sometimes degrading situations. Controlled essential medicines are medicines included in the World Health Organization's List of Essential Medicines, and whose active substance is listed under the international drug-control treaties. Their availability and accessibility therefore fall within the remit of both human rights and international drug-control law. Even though the unavailability of controlled essential medicines is generally caused by a multifaceted and complex interplay of factors, the current international drug-control framework paradoxically hinders rather than fosters the access to medicines. Human Rights and Drug Control analyses a human rights interpretation of the international drug-control framework with an emphasis on advancing the access to controlled essential medicines in resource-constrained countries. Its approach goes beyond the more conventional legal analysis and includes an ethical analysis as well as two case studies in Uganda and Latvia. It first aims to identify a human rights foundation of drug control by examining how human rights norms would balance the underlying tension: some controlled substances have a clear, evidence-based medical benefit, yet also have the potential to be misused, which may lead to dependency disorders. This makes it evident that States should regulate this delicate equilibrium, the challenge being how they can do so legitimately in light of human rights norms. Having explored this premise in the context of human rights law and theory, this book then applies these findings to Uganda and Latvia, - two 'best practice' countries - when it comes to improving the accessibility of morphine for pain treatment. Relying on qualitative research methods, the study explores whether the human rights basis of drug-control regulation may be adequately integrated into the structures of the present international drug-control system. It specifically deals with various technical, administrative and procedural obligations relating to the import/export and retail trade of controlled medicines. The book concludes with a proposal on how a human rights approach to drug-control may be advanced, specifically highlighting the importance of reconciling international obligations with the local reality in which these ...