BACKGROUND: National Medicines Regulatory Authorities like the Pharmacy Board of Sierra Leone are responsible for protecting and promoting public health, implementing regulatory standards, and maintaining a supply chain with an assured supply of medical products that are safe, effective, and of good quality. This retrospective study assesses the identification of substandard and falsified medicines, the changes in the functions and key indicators of assessment, and the quality improvement changes of the Pharmacy Board of Sierra Leone.
METHODS: Data was obtained from 2013 to 2021 records using a data collection tool to collate and review all relevant information to address the different objectives. All data were sourced from the Department of Quality Assurance and the Department of Enforcement and Narcotics at the Pharmacy Board of Sierra Leone. The review also included, identified substandard and falsified medicines, the World Health Organisation Global benchmarking self-assessment tool, and internal and external audit records of the quality management system of all twelve departments of the Pharmacy Board of Sierra Leone.
RESULTS: The study showed marked changes in identifying substandard and falsified medicines by the Pharmacy Board of Sierra Leone during ISO 9001:2015 implementation (2017- 2020) compared to Pre-ISO 9001:2015 implementation (2013- 2016). Critical functions of the Pharmacy Board of Sierra Leone from the assessment of the WHO GBT ML in 2016 and 2021 showed that several indicators had been addressed during ISO 9001:2015 certification with improvement in the level of maturity for the quality management systems and Pharmacovigilance functions. There was also an improvement in identifying non-conformances and a commitment to continuous improvement of processes during ISO 9001:2015 implementation.
CONCLUSIONS: This study revealed that regular checks through standard assessment, internal audits, and standard management review processes that generate follow-up actions, timelines, and a commitment to identifying correction, and corrective actions for non-conformances are essential quality improvement tools for the efficient functioning of an institution (Pharmacy Board of Sierra Leone). Our study revealed that commitment to continuous implementation of proper quality management system could significantly improve institutional efficiency, thereby improving service delivery and customer satisfaction.

In this article the authors offer their perspective on the changes in the Dutch harm reduction field. From the 1970s to the 1990s, the Netherlands emerged as a leader in harm reduction services, driven by grassroots movements like the Medisch-sociale Dienst Heroïne Gebruikers (MDHG) (Medisch-sociale Dienst Heroïne Gebruikers (MDHG) translates to Medical-Social Service Heroin Users in English) in Amsterdam and Junkiebond in Rotterdam. These organisations advocated for health-centred policies, initiated needle exchange programmes, and created safe consumption spaces. Their efforts led to significant public health improvements and policy shifts towards harm reduction, reducing HIV and hepatitis rates among people who use drugs. By the 1980s, harm reduction became institutionalised within local health and social care systems, leading to notable declines in drug-related harm and crime. However, from the 2000s, a shift towards security and crime prevention emerged, influenced by socio-political changes. Increased criminal justice measures and budget cuts for harm reduction services strained the system, making it harder to address emerging drug trends and the complex needs of people who use drugs. Despite challenges, there is renewed momentum for reform, particularly at the local level, advocating for the responsible regulation of psychoactive substances. Amsterdam Mayor Femke Halsema\'s 2024 conference on drug regulation exemplifies this shift, calling for policies that address prohibition failures and centre harm reduction. International bodies like the UN High Commissioner for Human Rights support this approach, emphasising a health and rights-based framework. As the Netherlands navigates these evolving dynamics, there is a pressing need to reinvest in harm reduction infrastructure, ensuring it meets diverse community needs and reaffirms its foundational rights-affirming principles.

OBJECTIVE: The purpose of this study was to determine if controlled substance waste management systems (CSWMS) demonstrate microbial growth, and therefore present a potential infection risk to pediatric hospital patients.
METHODS: Twenty CSWMS, either Smart Sink or Pharma Lock systems, located in patient care areas were sampled. Twelve were located in critical care areas. Cultures were obtained by swabbing the drain grate with a sterile swab. Swabs were then transported to the microbiology lab for culture. Each sample was labeled with the location of the CSWMS and each system was photographed.
RESULTS: Of the CSWMS sampled, 50% demonstrated bacterial or fungal growth with a total of 15 microorganisms isolated, including 3 systems with Micrococcus luteus, 2 with Aspergillus species, and 2 with -Bacillus cereus. Nine of the 15 microorganisms isolated were from systems in the pediatric intensive care unit (PICU) followed by 2 microorganisms in the neonatal intensive care unit (NICU). Of the 12 systems sampled in critical care areas, 8 (66%) had positive cultures. Of the 10 systems which demonstrated growth, 9 were Pharma Lock and 1 was Smart Sink.
CONCLUSIONS: Controlled substance waste management systems harbor potential pathogens and may serve as reservoirs of infectious agents in pediatric hospitals. Microbial growth was identified in more than half of sampled CSWMS located in critical care areas, where the most vulnerable patients are located. Based on this study, a cleaning procedure for CSWMS should be implemented. Further investigation on the relationship between CSWMS and nosocomial infections is warranted.

BACKGROUND: Federal deregulation of opioid agonist therapies are an attractive policy option to improve access to opioid use disorder care and achieve widespread beneficial impacts on growing opioid-related harms. There have been few evaluations of such policy interventions and understanding effects can help policy planning across jurisdictions.
METHODS: Using health administrative data from eight of ten Canadian provinces, this study evaluated the impacts of Health Canada\'s decision in May 2018 to rescind the requirement for Canadian health professionals to obtain an exemption from the Canadian Drugs and Substance Act to prescribe methadone for opioid use disorder. Over the study period of June 2017 to May 2019, we used descriptive statistics to capture overall trends in the number of agonist therapy prescribers across provinces and we used interrupted time series analysis to determine the effect of this decision on the trajectories of the agonist therapy prescribing workforces.
RESULTS: There were important baseline differences in the numbers of agonist therapy prescribers. The province with the highest concentration of prescribers had 7.5 more prescribers per 100,000 residents compared to the province with the lowest. All provinces showed encouraging growth in the number of prescribers through the study period, though the fastest growing province grew 4.5 times more than the slowest. Interrupted time series analyses demonstrated a range of effects of the federal policy intervention on the provinces, from clearly positive changes to possibly negative effects.
CONCLUSIONS: Federal drug regulation policy change interacted in complex ways with provincial health professional regulation and healthcare delivery, kaleidoscoping the effects of federal policy intervention. For Canada and other health systems such as the US, federal policy must account for significant subnational variation in OUD epidemiology and drug regulation to maximize intended beneficial effects and mitigate the risks of negative effects.

BACKGROUND: The African Medicines Regulatory Harmonisation (AMRH) Initiative was formed in 2009 and subsequently, three regional initiatives (East African Community Medicines Regulatory Harmonisation [MRH], Southern African Development Community [SADC]/ZaZiBoNa MRH, and the Economic Community of West Africa States MRH) were established. As these initiatives serve as a foundation for the African Medicines Agency (AMA), the aim of this study was to compare their operating models, successes and challenges to identify opportunities for improvement and alignment.
METHODS: A mixed method approach was used for the data collection using a questionnaire, the Process, Effectiveness and Efficiency Rating (PEER), developed by the authors specifically for this study and semi-structured interview techniques. There were 23 study participants (one from each agency of the member countries of the three regions). It was hoped that data generated from this study would lead to a series of recommendations, which would then be ratified by the regulatory authorities.
RESULTS: Most respondents stated that AMRH contributed to the strengthening of regulatory systems and harmonising regulatory requirements across economic regions of Africa, potentially resulting in improved access to quality-assured medicines. Although established at different times and at the discretion of each region, the marketing authorisation application review processes are largely similar, with a few differences noted in the eligibility and submission requirements, type of procedures employed, the timelines and fees payable. The challenges identified in the three regions are also similar, with the most noteworthy being the lack of a binding legal framework for regional approvals.
CONCLUSIONS: In this study, we compared the process, successes and challenges of these three regional harmonisation initiatives in Africa addressing the areas of legal frameworks, information management systems, the accessibility and affordability of medicines and reliance that will bring greater alignment and efficiency in their operating models, thereby strengthening the foundation of the soon-to-be-operationalised AMA.

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Cannabis, also known as marijuana, is the dried flowers, stems, seeds, and leaves of the Cannabis sativa plant. It contains more than 100 compounds, including tetrahydrocannabinol, which has psychoactive effects. Federal law prohibits the possession, distribution, and use of cannabis outside limited research activities, but most states have legalized cannabis for medical or recreational use. However, research into the potential therapeutic and adverse health effects of cannabis has been limited, in part because of the drug\'s federal legal status. In this position paper, the American College of Physicians (ACP) calls for the decriminalization of possession of small amounts of cannabis for personal use and outlines a public health approach to controlling cannabis in jurisdictions where it is legal. ACP recommends the rigorous evaluation of the health effects and potential therapeutic uses of cannabis and cannabinoids as well as research into the effects of legalization on cannabis use. It also calls for evidence-based medical education related to cannabis and increased resources for treatment of cannabis use disorder.

BACKGROUND: Hemp-based psychoactives comprise a burgeoning legal substance market with rising trends in use across the U.S. and Canada as well as parts of Europe. Currently, scant empirical research on the use of these Novel Psychoactive Substances (NPS) exists. By examining policy, market conditions, consumer uptake, and related risks, this research extends theory on drug trends by describing the regulatory environments that shape the emergence and popularity of psychoactive hemp-based products among young adults.
METHODS: Relying on ethnographic fieldwork of hemp-based markets across 3 U.S. state hemp and cannabis policy contexts as well as in-depth interviews with 40 young adult cannabis consumers recruited across 10 U.S. states, we examined how regulatory conditions shape hemp-based psychoactive markets, trends in their use, and associated risks.
RESULTS: Young adults are motivated to consume hemp-based psychoactives due to the regulatory and market environments that facilitate the production of highly potent products that are inexpensive and easily accessible. States that regulate hemp-based psychoactives as cannabis, do not provide hemp markets with a competitive advantage and as such see minimal uptake. In the absence of hemp specific policies, substantial variations in product potencies, insufficient dosing information, and unscrupulous product packaging practices may increase related risks.
CONCLUSIONS: Trend theory provides insight into the complex relationships that exist between drug policy, markets, and the proliferation of legal highs. Understanding the contextual significance that both market and regulatory conditions have on legal drug production, distribution, and consumption may better inform approaches to reduce the risks commonly associated with novel psychoactive substances like hemp-based psychoactives.

Drug-impaired driving is a growing problem in the U.S. States regulate drug-impaired driving in different ways. Some do not name specific drugs or amounts. Others do identify specific drugs and may regulate cannabis separately. We provide up-to-date information about these state laws.

While the federal government continues to pursue a punitive \"War on Drugs,\" some states have adopted evidence-based, human-focused approaches to reducing drug-related harm. This article discusses recent legal changes in three states that can serve as models for others interested in reducing, rather than increasing, individual and community harm.