Quality improvement in medicines regulation: a retrospective analysis of the Pharmacy Board of Sierra Leone before and during quality management system implementation.

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.

Essential/precursor chemical control research: Giommoni's review, understanding multi-replication interrupted time series analysis, and next steps.

Controls on essential/precursor chemicals from commercial companies have been associated with many large downturns in illicit drug markets and attendant problems. My colleagues and I brought this to light in the studies that are the subject of Giommoni's review. McKetin et al. in an earlier review considered several of our studies on chemical controls for methamphetamine, all centered in North America. Giommoni discusses not only those studies but also our later work on chemical controls for cocaine and heroin. This later work evaluates US essential/precursor chemical policies targeting illicit drug producers outside of North America, and it examines impacts on illicit drug availability and use (the studies reviewed by McKetin et al. predominantly focused on outcomes such as drug-related hospitalizations, arrests, and treatment). Giommoni's review is a new resource that will help make the varied topics in essential/precursor chemical control research more accessible to many readers. After noting this, I discuss some common methodological misconceptions about our studies. For example, our studies generally used multi-replication interrupted time series analysis, a research design among the most powerful of all quasi-experimental designs. Authors, however, typically discuss the studies as if they used single-intervention interrupted time series analysis, a less powerful design. Multi-replication and single-intervention interrupted time series analyses also differ regarding likely confounders; awareness of this is critical to accurately assessing our findings and critiquing alternative explanations. Finally, I note that commercial chemical companies function as the silent, albeit usually unwitting, partners in the large-scale production of several illicit drugs, including fentanyl. And many governments are implementing essential/precursor chemical controls to help stymie this partnership. But they are doing so largely without evaluation and study-a poor policy practice. To remedy this, I suggest establishing multi-disciplinary applied research teams to help assess, guide and improve essential/precursor chemical control efforts.

Federal opioid agonist therapy policy: interrupted time series analysis of the impact of the methadone exemption removal across eight provinces in Canada.

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.

Comparison of Three Regional Medicines Regulatory Harmonisation Initiatives in Africa: Opportunities for Improvement and Alignment.

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. CONCLUSION: 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.

Reframing Dutch drug policies: a new era for harm reduction.

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.

Regulatory Framework for Cannabis: A Position Paper From the American College of Physicians.

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.

Hemp-based psychoactive use and risk among young adults: Trend theory, policy, and regulation beyond legality.

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. CONCLUSION: 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.

Breaking Free From the "War on Drugs": Examples From Three Leader States.

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.

State Driving Under the Influence of Drugs Laws.

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.

How Should the Use of Opioids Be Regulated to Motivate Better Clinical Practice?

This article describes historical and political reasons for-and devastating consequences of-US opioid prescribing policy since the 1990s, which has restricted opioid prescribing for pain less than for treating opioid use disorder (OUD) treatment. This article considers merits and drawbacks of a new diagnostic category and proposes a regulatory and clinical framework for prescribing long-term opioid therapy for pain and for prescribing opioids to treat OUD.

"In Sweden you are worthless. In Denmark you get an identity again" - on being perceived and received as a person who uses drugs in different drug policy settings.

BACKGROUND: Policies to address substance use differ greatly between settings, where goals may range from zero-tolerance to harm reduction. Different approaches impact formats of care, policing, and even interpersonal interactions, and may play a role in the labelling and stigmatization of people who use drugs (PWUD). Where Sweden has a more restrictive policy, aiming to have a society free from drugs, Denmark has embraced harm reduction principles. The aim of this study was to explore PWUDs' experiences of interpersonal interactions, policing, and service formats in the two countries. METHODS: The data consists of 17 qualitative semi-structured interviews with Swedish PWUD who have been in both Sweden and Denmark. Recruitment took place at harm reduction sites in both countries, and through snowball sampling. RESULTS: Participants reflected on how they were perceived by those in public spaces, and received by care systems and personnel. In public settings in Sweden, participants felt they were ignored, rendered invisible, and lost their humanity. In Denmark, they were perceived and acknowledged, valued as people. This was simultaneously linked to being embodied by the availability of differing service offerings and policing practices, which solidified their "right to be out" in public. Reflecting on their reception in the treatment system, strict formatting in Sweden caused participants to feel that an identity was projected upon them, limiting their opportunities or growth of new facets of identity. Care relations in Denmark fostered more opportunity for autonomy and trust. CONCLUSION: A zero-tolerance policy and associated public discourses could solidify and universalize stigmatizing categorizations as a central feature of PWUD identity and reception from those around them, exacerbating social exclusion. Conversely, harm reduction-centered policies fostered positive interactions between individuals with care providers, public, and police, which may promote inclusion, empowerment, and wellbeing.

A content analysis of legal policy responses to xylazine in the illicit drug supply in the United States.

BACKGROUND: Xylazine is a veterinary sedative that is quickly spreading in the U.S. illicit drug supply and is increasingly associated with fatal overdoses and severe wounds. In response, xylazine has been deemed an emerging public health threat and several policy initiatives have been introduced to combat its spread and negative broad health impact. We aimed to synthesize trends in all-time U.S. policy responses to xylazine in the drug supply. METHODS: In April 2024, we systematically identified and categorized proposed and enacted policy initiatives that related to human xylazine consumption by searching LexisNexis and Thomas Reuters Westlaw legal databases. RESULTS: Of 58 unique policy initiatives, most were introduced in 2023 (n = 37/58, 64 %) and concentrated in Northeastern states. Penalties for xylazine possession, often tied to state drug scheduling changes, were the most common provision (n = 34/58; 59 %) and Schedule III was the most frequently proposed scheduling level (n = 17/30; 57 %). Other provisions included proposals to enhance: test strip access (n = 11/58; 19 %), public awareness and education (n = 3/58; 5 %), xylazine-specific research (n = 4/58; 7 %), and surveillance (n = 8/58; 14 %). CONCLUSION: U.S. state and federal policy responses to xylazine grew rapidly in 2023, were most concentrated in states affected most by xylazine, and scheduling was the most commonly proposed policy approach. Research measuring policy effects should be prioritized as policies are implemented.

Comparing methadone policy and practice in France and the US: Implications for US policy reform.

Despite being among the most effective treatments for opioid use disorder, methadone is largely unavailable in the United States, due primarily to federal and other policies that limit its availability and regulate clinical decisions about doses, visit frequency, and drug testing. There is unprecedented momentum to change decades-old US methadone policies. Yet uncertainty remains as to whether reforms will be adopted and how policies will be implemented. France has among the best methadone access and lowest overdose death rates worldwide. 87 % of French people with opioid use disorder receive methadone or buprenorphine, versus an estimated 13-20 % in the US. France's opioid-related overdose rates are far lower than the US. This article compares French and US systems, including current and proposed US policies, and underscores potential implications for US policymakers. In France, methadone can be initiated in specialty addiction settings and hospitals, with subsequent handoff to primary care. Methadone can be dispensed in community pharmacies and filled like other opioids, without requirements for supervised dosing. Decisions about visit frequency, medication doses, and drug testing are governed by clinical best practices and patient-clinician shared decision-making. In the US, methadone for opioid use disorder is regulated unlike any other medication (including methadone for pain) and is governed by strict federal controls, including from law enforcement and healthcare. With few exceptions, methadone for opioid use disorder is only available in Opioid Treatment Programs. US clinicians cannot prescribe methadone for opioid use disorder. Federal rules determine minimum visit frequency, initial dose limits, and other conditions of treatment, which states may further limit. Policies assert strong influence on patient experience, treatment access, and health outcomes. Despite being less restrictive than the US, the French model includes limits designed to avoid or minimize potential harms. French policies have important implications for potential US reforms.

Decriminalization or police mission creep? Critical appraisal of law enforcement involvement in British Columbia, Canada's decriminalization framework.

The unregulated drug toxicity crisis in British Columbia (BC), Canada, has claimed over 14,000 lives since 2016. The crisis is shaped by prohibitionist policies that has led to the contamination of the unregulated drug supply, resulting in a surge of fatal and non-fatal overdose events. The criminalization of drug users exacerbates this situation, pushing individuals into carceral systems for the possession of and/or social practices related to drug use. This commentary examines the involvement of policing in the development, and throughout the first 15 months of its implementation, of BC's decriminalization framework. We highlight concerns regarding police discretion, the expansion of scope, and the interweaving of carceral logics into policies that purport to be public health-oriented.

Navigating the nexus between British Columbia's public consumption and decriminalization policies of illegal drugs.

In January 2023, the province of British Columbia (BC) decriminalized the possession of certain illegal drugs for personal use. The province's primary intent was to reduce the stigma associated with drug use, as well as barriers for people who use drugs (PWUD) to access treatment and supports. However, less than ten months into the decriminalization policy, due to growing concerns about public safety voiced by municipal governments and communities, the provincial government made amendments to the policy to ban the public consumption of illicit drugs in additional locations, and subsequently introduced additional legislation, Bill 34, aimed at regulating public consumption of drugs in public spaces. Some communities have also implemented local bylaws similarly regulating public drug use. Bill 34 and local bylaws may serve as tools to promote community health and safety and minimize direct and indirect harms associated with public drug use. However, such legislation may re-criminalize PWUD and reinforce negative perceptions surrounding drug use, especially if these policies are not paired with strategies to expand the availability and accessibility of critical harm reduction and housing services. Without ample access to these services, limitations on public drug use can potentially displace individuals to areas where they are more likely to use alone, further exposing them to substance use-related harms, and undermining the goals of decriminalization. The potential effects of these restrictions may also disproportionately impact marginalized populations. As of April 2024, Bill 34 remains on hold. Moving forward, it will be important to monitor this bill, as well as other public consumption bylaws and legislation, and their impact on BC's overall decriminalization initiative. Decision-makers are urged to increase engagement with PWUD and relevant stakeholders in the design and implementation of policies pertaining to public consumption to ensure that they effectively address the evolving needs and realities of PWUD, and align with decriminalization goals.