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Medicines are essential commodities that form the cornerstone in majority of processes and interventions aimed at assuring optimal healthcare and wellbeing for any population. Apart from being saddled with the responsibility of providing medications for this purpose, the pharmaceutical industry has the potential to catalyse socioeconomic development such as job creation and revenue generation. This study aimed at assessing government's role in driving development in Nigeria's pharmaceutical sector. Questionnaires were administered to healthcare practitioners that participated in an event targeted at developing Nigerian pharmaceutical sector. Data collected were analysed using Statistical Package for Social Sciences. A total of 76 respondents participated in the study. Two-thirds of the study participants (69.7%) were males, slightly above a third of the study participants (38.2%) were aged 51 and above, and close to a quarter of the participants (21.1%) were doctorate degree holders. About half of the study participants (51.4%) indicated that Nigerian pharmaceutical sector was not adequately regulated, whilst almost all (97.4%) indicated that engaging the legislature was critical for the development of the sector. A strong majority of the study participants (87.5%) indicated that existing drug laws should be reviewed so as to protect the pharmaceutical sector. Also, majority of the participants (56.3%) were not satisfied with government's efforts in developing the pharmaceutical industry. Although this study explored a small cohort, its findings have revealed novel insights regarding factors limiting the requisite prioritisation of the Nigerian pharmaceutical sector. The emergent evidence can begin to underpin proactive policy and practice reforms aimed at achieving medicines' security in Nigeria. Further studies can build on these preliminary findings to enable robust and comprehensive sectoral interventions that improve access to healthcare, whilst also catalysing socioeconomic development. [ABSTRACT FROM AUTHOR]

This article provides a review of four books that offer valuable perspectives on the history and current issues surrounding drug use in the United States. "Whiteout" explores the influence of race and capitalism on the opioid crisis, while "The Prescription-to-Prison Pipeline" examines the impact of medicalization and criminalization of pain on mass incarceration. "Quick Fixes" analyzes the cultural and historical significance of psychoactive substances, and "The Long War on Drugs" delves into the history and concept of prohibition. These interdisciplinary books contribute to our understanding of the enduring significance of drugs in America, but could benefit from further exploration of the links between prohibition, labor relations, racialization, and disability studies. [Extracted from the article]

OBJECTIVE: In conjunction with widening legalization, there has been a rapid rise in unintentional cannabis ingestions in young children. We sought to determine if the legal status of recreational cannabis was associated with resource use in young children with cannabis poisoning. METHODS: This retrospective cross-sectional study of the Pediatric Health Information System included emergency department encounters between January 2016 and April 2023 for children <6 years of age with a diagnosis indicating cannabis ingestion. The primary exposure was recreational cannabis legalization status in the state in which the encounter occurred.We used logistic regression models to determine the association of recreational cannabis legality with resource utilization outcomes, adjusting for demographic covariates. RESULTS: We included 3649 children from 47 hospitals; 29% of encounters occurred in places in which recreational cannabis was legal. Compared with environments in which recreational cannabis was illegal, cannabis-legal locations had lower uses of advanced neuroimaging (24% vs 35%; adjusted odds ratio [aOR], 0.65; 95% confidence interval [CI]: 0.55-0.77), lumbar puncture (1.6% vs 3.8%; aOR, 0.42; 95% CI: 0.24-0.70), ICU admission (7.9% vs 11%; aOR, 0.71; 95% CI: 0.54-0.93), and mechanical ventilation (0.8% vs 2.9%; aOR, 0.30; 95% CI: 0.14-0.58). Urine testing was more common in places in which recreational cannabis was legal (71% vs 58%; aOR, 1.87; 95% CI: 1.59-2.20). CONCLUSIONS: State-level legalization of recreational cannabis was associated with a significant decrease in the utilization of advanced medical resources in cases of cannabis intoxication in children. These findings suggest the need for a focus on policies and procedures to minimize invasive testing in cases of cannabis intoxication in children. [ABSTRACT FROM AUTHOR]

The article delves into the ethical complexities surrounding the use of psychedelics in psychiatric care, highlighting issues such as legal status discrepancies, informed consent challenges, and uncertainties regarding clinical responses.

Social media drug markets are likely to present people participating in these spaces with new vulnerabilities to law enforcement. There is currently limited research on how people perceive and manage the risk of exposure to law enforcement in social media drug markets. This is particularly notable considering widespread practices of user data collection and the normalization of surveillance as part of social media engagement. We present a thematic analysis of data from anonymous online interviews with people who buy and sell drugs (N = 33) via social media and messaging apps in New Zealand. We use the concept of "imagined surveillance" to explore how participants adapted existing understandings of online surveillance to online risk management strategies to avoid police. Most participants reported low concern for exposure to law enforcement while using social media and messaging apps for drug trading. Nevertheless, almost all participants took active risk management measures. Examples of strategies used included limiting the accumulation of evidence via self-deleting messages or arranging drug trades using code language. Participants often also reported low concern for their digital trace data to be accessed by police. Navigating law enforcement risk in social media drug markets is likely to be informed and shaped by more general perceptions of digital privacy risk and related management strategies, particularly in more normalized drug market contexts. The potential for broader and unexpected consequences to result from the use of drug-related digital trace data across public and private contexts is discussed. [ABSTRACT FROM AUTHOR]

Context Methods Findings Conclusions Policy Points Opioid treatment agreements (OTAs) are controversial because of the lack of evidence that their use reduces opioid‐related harms and the potential risks they pose of stigmatizing patients and undermining the clinician–patient relationship. Even so, their use is now required in most jurisdictions, and their use is influencing the outcomes of civil and criminal lawsuits. More research is needed to evaluate how OTAs are implemented given existing requirements. If additional research does not resolve the current level of uncertainty regarding OTA benefits, then policymakers in jurisdictions where they are required should consider eliminating OTA mandates or providing flexibility in the legal requirements to make room for clinicians and health care institutions to implement best practices. Opioid treatment agreements (OTAs) are controversial because of the lack of evidence that their use reduces opioid‐related harms and the potential risks they pose of stigmatizing patients and undermining the clinician–patient relationship. Even so, their use is now required in most jurisdictions, and their use is influencing the outcomes of civil and criminal lawsuits. More research is needed to evaluate how OTAs are implemented given existing requirements. If additional research does not resolve the current level of uncertainty regarding OTA benefits, then policymakers in jurisdictions where they are required should consider eliminating OTA mandates or providing flexibility in the legal requirements to make room for clinicians and health care institutions to implement best practices. Opioid treatment agreements (OTAs) are documents that clinicians present to patients when prescribing opioids that describe the risks of opioids and specify requirements that patients must meet to receive their medication. Notwithstanding a lack of evidence that OTAs effectively mitigate opioids’ risks, professional organizations recommend that they be implemented, and jurisdictions increasingly require them. We sought to identify the jurisdictions that require OTAs, how OTAs might affect the outcomes of lawsuits that arise when things go wrong, and instances in which the law permits flexibility for clinicians and health care institutions to adopt best practices.We surveyed the laws and regulations of all 50 states and the District of Columbia to identify which jurisdictions require the use of OTAs, the circumstances in which OTA use is mandatory, and the terms OTAs must include (if any). We also surveyed criminal and civil judicial decisions in which OTAs were discussed as evidence on which a court relied to make its decision to determine how OTA use influences litigation outcomes.Results show that a slight majority (27) of jurisdictions now require OTAs. With one exception, the jurisdictions’ requirements for OTA use are triggered at least in part by long‐term prescribing. There is otherwise substantial variation and flexibility within OTA requirements. Results also show that even in jurisdictions where OTA use is not required by statute or regulation, OTA use can inform courts’ reasoning in lawsuits involving patients or clinicians. Sometimes, but not always, OTA use legally protects clinicians from liability.Our results show that OTA use is entwined with legal obligations in various ways. Clinicians and health care institutions should identify ways for OTAs to enhance clinician–patient relationships and patient care within the bounds of relevant legal requirements and risks. [ABSTRACT FROM AUTHOR]

Ongoing calls for police reform across North America alongside the growing momentum for the removal of criminal sanctions for personal possession of drugs have placed policing agencies in an ambivalent position with respect to drug governance and people who use drugs (PWUD). Meanwhile, in response to the longstanding harms produced by drug law enforcement, calls for harm reduction policing have gained traction in recent years, resulting in collaborations between policing agencies and health services, including naloxone administration by police officers, post-overdose outreach and wellness checks, and integrated public health-public safety response and information sharing frameworks. Using situational analysis method, we consider the range of elements and actors that form these partnerships, and their broader structural, institutional, and policy effects. We detail the actual and potential implications of such forms of institutional coordination on health, equity, and the possibility of meaningful drug law reform. Our analysis reveals that rather than mitigating the harms of drug enforcement, such initiatives stand to undermine access to services and increase health system avoidance by eroding trust in public health and harm reduction among PWUD. We reason that the recasting of police as therapeutic agents and as embedded in medico-therapeutic practices reaffirms the role of punitive enforcement practices in drug governance. [ABSTRACT FROM AUTHOR]

Purpose: State-level prevalence data are used to investigate whether recreational cannabis legalization moderates the mediated pathway from the perception of low risk of harm, to cannabis use, to cannabis use disorder (CUD) treatment admissions, among adolescents (age 12–17) in the US. Methods: Annual state prevalence measures of perception of low risk, cannabis use, and CUD treatment admissions between 2008 and 2019 (N = 542 state-year observations) were collected from the National Survey on Drug Use and Health (NSDUH) and the Treatment Episode Dataset – Admissions (TEDS-A). A two-way fixed effects (state and year) moderated mediation model was used to test whether recreational legalization moderated the indirect effect of perception of low risk on treatment admissions via cannabis use. Results: A positive indirect effect of perceiving cannabis as low risk on CUD treatment admissions via cannabis use was observed prior to legalization but not afterwards. After legalization, the positive association of perceiving cannabis as low risk with cannabis use was strengthened, and the positive association of cannabis use with treatment admissions was suppressed, as compared to before legalization. Discussion: Recreational legalization may alter the social acceptability and medical self-administration of cannabis, potentially leading to CUD treatment utilization decline among adolescents even as risk factors for CUD increase. Linking recreational cannabis legalization to advancing awareness of the health risks associated with adolescent cannabis use and promoting adolescent CUD treatment engagement through mHealth approaches and primary care providers are key to addressing potential adolescent health challenges brought about by expanding cannabis legalization. [ABSTRACT FROM AUTHOR]

Few studies of recreational cannabis legalization (RCL) have assessed adolescents both before and after RCL or considered moderators of RCL effects. The present study tested whether RCL was more strongly associated with cannabis use for girls and among youth whose parents had a history of cannabis use during adolescence. Data were pooled from 940 adolescents from three intergenerational studies that began in Washington (where RCL was enacted in 2012), Oregon (RCL year = 2015), and New York (RCL year = 2021). Youth were assessed repeatedly from ages 13 to 18 years (k = 3,650 person–years) from 1999 to 2020 (prior to RCL in New York). Parent cannabis use at or before age 18 years (yes/no) was assessed prospectively during the parent's adolescence. Multilevel models focused on the between-subjects effects of years of youth exposure to RCL on adolescents' mean cannabis use likelihood, and interactions with child sex and parent use history. Child exposure to RCL was associated with a higher likelihood of cannabis use if their parents had a history of adolescent use, (Estimate [SE] = 0.67 [0.25], p = 0.008), versus no such history (Estimate [SE] = −0.05 [0.28], p = 0.855). RCL effects were not moderated by child sex. The effects of RCL on adolescents' cannabis use may depend on their parents' history of using the drug. Identifying other moderators of RCL effects, and understanding the mechanisms of these risks and the ways that parents and communities can offset them, are prevention priorities. (1) Adolescents' use of cannabis may have intergenerational consequences, making it more likely their future offspring will use cannabis. (2) Whether or not recreational cannabis legalization influences adolescents' cannabis use may depend on their parents' cannabis use history. (3) Parenting in a state with liberalized cannabis policies may present new challenges and require that novel prevention resources be developed. [ABSTRACT FROM AUTHOR]

Background: Delta-8 THC is a federally unregulated psychoactive cannabis product rising in popularity. However, little is known regarding its retail availability. Method: We assessed Delta-8 THC retail by calling locations with alcohol, tobacco, and/or consumable hemp retail licenses in Fort Worth, Texas, before and after Texas announced ongoing litigation surrounding Delta-8 THC legality. We linked census block area deprivation index (ADI) scores (1–10; 10 = most disadvantaged) to locations. Logistic regression models examined associations between license type, ADI, ADI*license type interaction, and Delta-8 availability at each time. Results: Retail availability was 11% at Time 1 (n = 133/1,223) and 9% at Time 2 (n = 94/1,026). Alcohol (aORTime1 = 0.18, 95%CI = 0.12,0.28; aORTime2 = 0.14, 95%CI = 0.08,0.24), tobacco (aORTime1 = 15.13, 95%CI = 6.78,33.74; aORTime2 = 12.39, 95%CI = 4.97,30.91), and consumable hemp licenses (aORTime1 = 21.85, 95%CI = 7.91,60.39; aORTime2 = 22.93, 95%CI = 6.92,75.98) were associated with Delta-8 THC retail availability; ADI scores were borderline but not statistically significant. The multiplicative interaction at Time 2 indicated locations with both high ADI scores and alcohol retail licenses had higher odds of selling Delta-8 THC. Differential associations between ADI and Delta-8 THC availability were observed based on those with (b = 0.007) or without (b = −0.023) alcohol retail licenses. Conclusions: Both timepoints had similar proportions of Delta-8 THC retailers, indicating that despite the uncertain legal landscape in Texas, interest in Delta-8 did not appear to be declining. Geographic socioeconomic disparities were observed among locations with alcohol retail licenses. Future regulations may include minimum distances from specific locations (e.g., schools), particularly in more disadvantaged areas. Increasing the compliance of Texas Delta-8 THC retailers to have the required hemp license is important for surveillance and product safety. [ABSTRACT FROM AUTHOR]

The current regulatory path for new drug registration in East Asian countries has led to significant delay of the new medicines in these countries. A unified regulatory path and allowance of mutual usage of clinical data in East Asian countries would lead to cost saving in drug development and expedite the new drug registration in these countries. The objectives of the present analysis are to compare the approval dates of a selection of products developed by Pfizer in the United States and East Asian countries (China, Japan, Korea) and compare the pharmacokinetics and recommended doses of these products in East Asian countries. Eighteen products (20 drugs, 2 products with 2 combination drugs) with exposure data available in at least 2 of the 3 East Asian countries across different therapeutic areas were included in the analyses. The results showed that most products had delayed approval in East Asian countries (up to 8 years) after US or EU approval. No distinct differences were observed in the drug exposure and recommended doses for the selected products in East Asian countries. These results together with literature data of genetic similarity of the East Asian populations support the mutual usage of the clinical data in the East Asian countries for expedited regulatory submission and approval. [ABSTRACT FROM AUTHOR]

Enhancers are critical for regulating tissue-specific gene expression, and genetic variants within enhancer regions have been suggested to contribute to various cancer-related processes, including therapeutic resistance. However, the precise mechanisms remain elusive. Using a well-defined drug-gene pair, we identified an enhancer region for dihydropyrimidine dehydrogenase (DPD, DPYD gene) expression that is relevant to the metabolism of the anti-cancer drug 5-fluorouracil (5-FU). Using reporter systems, CRISPR genome-edited cell models, and human liver specimens, we demonstrated in vitro and vivo that genotype status for the common germline variant (rs4294451; 27% global minor allele frequency) located within this novel enhancer controls DPYD transcription and alters resistance to 5-FU. The variant genotype increases recruitment of the transcription factor CEBPB to the enhancer and alters the level of direct interactions between the enhancer and DPYD promoter. Our data provide insight into the regulatory mechanisms controlling sensitivity and resistance to 5-FU. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them. Methods: We sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross‐sectional analysis of US FDA oncology drug approvals (2006–2023). We searched for OS data in registration trials and the peer‐reviewed literature. Results: We found 392 oncology drug approvals. Eighty‐seven (22%) drug approvals were based on OS, 147 drug approvals were later tested for OS benefit (38% of all approvals and 48% of drugs approved on a surrogate), and 130 (33%) have yet to be tested for OS benefit. Of the 147 drug approvals later tested for OS, 109 (28% of all approvals and 74% of drugs later tested for OS) have yet to show OS benefit, whereas 38 (10% of all approvals and 26% of drugs later tested for OS benefit) were later shown to have OS benefit. In total, 125 out of 392 (32%) drugs approved for any indication have been shown to improve OS benefit at some point, and 267 (68%) have yet to show approval. Conclusion: About 32% of all oncology drug approvals have evidence for an improvement in OS. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival. [ABSTRACT FROM AUTHOR]

Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act ("FDCA"), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers. Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA's enactment and without any attempted interference by the Food and Drug Administration ("FDA"). But, approximately fifty years after Congress enacted the FDCA, the FDA began to change its tune. The FDA's policy guides first proclaimed such compounding to be illegal under the FDCA in relation to human drugs. Congress pushed back and, in 1997, created the Food and Drug Administration Modernization Act ("FDAMA"), which expressly permits pharmacy compounding from bulk drug substances for human use. Despite this congressional statement, the FDA persisted in its position that using bulk drug substances to compound drugs for companion animals is illegal per se. Its latest 2022 policy guide adheres to this position, stating that the FDA, "in its discretion," will permit such compounding only in limited, delineated circumstances. But in that same year, the Supreme Court officially recognized the "major questions doctrine," which attempts to rein in overzealous agency assertions of power beyond that which Congress likely granted. In West Virginia v. EPA, the Court announced that, when faced with dramatic claims of agency authority that have political or economic significance, are novel or unprecedented, or impact traditionally state-regulated areas, the Court will look for a "clear statement" from Congress that it delegated such authority to the agency. This Note analyzes the legality of the FDA's 2022 policy guide for pharmacy compounding from bulk drug substances for companion, nonfood animals. For several reasons, the "major questions doctrine" should apply to curtail the FDA's claimed authority. The FDA's position ignores centuries of history, several FDCA textual provisions, the FDA's own inconsistent policy positions, and traditional state regulation over pharmacy and medical practices. And, at bottom, the FDA's policy jeopardizes companion animals' medical needs and runs counter to the FDCA's mission. If the FDA's 2022 policy guide is allowed to stand, it will have a substantial and unnecessary negative impact on the health and wellbeing of nonfood companion animals--who, for many of us, are beloved members of our families. [ABSTRACT FROM AUTHOR]

Adenomyosis (AM) is a common gynecological disorder characterized by the presence of endometrial glands and stroma within the uterinemyometrium. It is associated with abnormal uterine bleeding (AUB), dysmenorrhea, and infertility. Although several mechanisms have been proposed to elucidate AM, the exact cause and development of the condition remain unclear. Recent studies have highlighted the significance of macrophage polarization in the microenvironment,which plays a crucial role in AMinitiation and progression. However, a comprehensive review regarding the role and regulatory mechanism of macrophage polarization in AM is currently lacking. Therefore, this review aims to summarize the phenotype and function of macrophage polarization and the phenomenon of the polarization of adenomyosis-associated macrophages (AAMs). It also elaborates on the role and regulatory mechanism ofAAMpolarization in invasion/migration, fibrosis, angiogenesis, dysmenorrhea, and infertility. Furthermore, this review explores the underlying molecular mechanisms of AAM polarization and suggests future research directions. In conclusion, this review provides a new perspective on understanding the pathogenesis of AM and provides a theoretical foundation for developing targeted drugs through the regulation of AAM polarization. [ABSTRACT FROM AUTHOR]

The article discusses research by Arpit Parmar, Radhika Chakraborty, and Yatan P. S. Balhara, reported in the April 2024 issue of the Indian Journal of Psychiatry, focusing on the current status of harm reduction initiatives in India. Topics include the history of harm reduction in India, the Indian status of harm reduction compared to global standards, and the strategies of harm reduction services in the country, highlighting the need for improved support and funding for these services.

Liposomal doxorubicin hydrochloride is an antineoplastic agent widely used against human cancers. The data from in vitro drug release test (IVRT) is essential for quality and/or bioequivalence evaluation in drug approval and post-approval regulation of liposomal drug products. However, most of the currently available IVRT methods for liposomal doxorubicin hydrochloride have experimental deficiencies associated with liposomal rupture during the separation process which is needed for selective quantification of released drug from liposomal-bound drug. In addition, many of the methods are time consuming, requiring bulk quantities of liposomal drug product, and lack of automation. We have developed a selective, sensitive, and automated capillary electrophoresis (CE)-based IVRT method, measuring released doxorubicin without additional sampling and separation steps. This method requires a small volume of sample compared to currently available methods. The IVRT release study with liposomal doxorubicin was conducted at different temperatures and pH conditions. It was observed that the release profiles obtained for five formulations including the reference listed drug were similar at pH 6.50 and 47.0 °C. The drug release increased with the increase of media pH and temperature. Complete doxorubicin release (100 %) was obtained in 7 h at pH 6.50 and 47.0 °C, and in less than 3 h at pH 6.50 and 52.0 °C. This CE-based method can be extended for determination of the IVRT profiling of other liposomal drug products. [Display omitted] • Automated capillary electrophoresis-based method was developed for in vitro drug release profiling of liposomal doxorubicin. • Capillary electrophoresis separated and quantitate released doxorubicin from liposomal bound doxorubicin. • Effect of pH, temperature, and ammonium ion concentration was evaluated. • Drug release profiling of five formulations were compared. [ABSTRACT FROM AUTHOR]

Context: The False Claims Act is the US federal government's primary tool for identifying and penalizing pharmaceutical fraud. The Department of Justice uses the False Claims Act to bring civil cases against drug manufacturers that allegedly obtain improper payment from federal programs. Methods: The authors searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. They then used the World Health Organization's Anatomical Therapeutic Classification index to identify the classes of prescription drugs implicated in fraud actions. Findings: During fiscal years 2006–2022, payments by six manufacturers amounted to more than 28% of total payments made as a result of federal False Claims Act actions. Nervous system and cardiovascular drugs were the classes of medications most commonly implicated in alleged fraud. Federal officials most frequently alleged that companies improperly promoted nervous system drugs and paid kickbacks to increase revenues from cardiovascular, antineoplastic and immunomodulating, and alimentary tract and metabolism drugs. Conclusions: Despite frequent pharmaceutical fraud settlements and penalties, incidence of alleged fraud among drug companies remains high. Alternative methods for preventing and deterring fraud could help safeguard our health systems and promote public health, and policy makers should ensure that effective fraud enforcement complements preventive public health regulation. [ABSTRACT FROM AUTHOR]

The article examines the undeveloped law of maritime drug interdictions and proposes reforms to strengthen interdiction procedural law. Topics discussed include logistical obstacles and rights of interdictees, historical development of the Maritime Drug Law Enforcement Act, modern justifications for extended confinement such as detentions at at-sea arrests, federal presentment rule with presumption requirements, and doctrine of outrageous government conduct doctrine.

In addition to autologous bone grafting, the demand for allogeneic and synthetic KEM is increasing, with the latter requiring further scientific optimization and investigation to date. Thus, allogeneic KEM are of growing importance due to the biologically limited amount of autologous KEM. The processes and logistics in orthopaedic surgery are subject to strict regulations in Germany and are standardized according to §20b of the German Drug Law. In orthopaedic surgery, femoral head donation is becoming increasingly important in the context of elective hip joint arthroplasty. As running an in-house bone bank involves a great deal of organizational, structural and personnel effort, collaborations with external bone banks, which take over the preparation and completion of bone donations, are becoming increasingly attractive. Patients are informed by the surgeon about the possibility of voluntary femoral head donation as early as the initial consultation, and an initial donor screening is performed with the aid of a special medical history form. After the blood sample has been taken for serological screening on the day of surgery, the femoral head is collected and, after appropriate labelling and packaging, stored at approx. 2–8° C until collection at the collection facility. Storage is also subject to strict control during transport for processing and evaluation of the blood results. After collection, the collecting surgeon must complete and sign the collection report and fax it to the bone bank. Subsequently, it is filed in the institute‘s own donor file together with the remaining documents. After receiving the results of the serological screening, the donation can either be released for processing or discarded if positive for infectious disease, which must also be documented in writing. After processing and freezedrying, the finished medical product has now emerged from the living donation. [ABSTRACT FROM AUTHOR]

Drug efflux transporters of the ATP-binding-cassette superfamily play a major role in the availability and concentration of drugs at their site of action. ABCC2 (MRP2) and ABCG2 (BCRP) are among the most important drug transporters that determine the pharmacokinetics of many drugs and whose overexpression is associated with cancer chemoresistance. ABCC2 and ABCG2 expression is frequently altered during treatment, thus influencing efficacy and toxicity. Currently, there are no routine approaches available to closely monitor transporter expression. Here, we developed and validated a UPLC-MS/MS method to quantify ABCC2 and ABCG2 in extracellular vesicles (EVs) from cell culture and plasma. In this way, an association between ABCC2 protein levels and transporter activity in HepG2 cells treated with rifampicin and hypericin and their derived EVs was observed. Although ABCG2 was detected in MCF7 cell-derived EVs, the transporter levels in the vesicles did not reflect the expression in the cells. An analysis of plasma EVs from healthy volunteers confirmed, for the first time at the protein level, the presence of both transporters in more than half of the samples. Our findings support the potential of analyzing ABC transporters, and especially ABCC2, in EVs to estimate the transporter expression in HepG2 cells. [ABSTRACT FROM AUTHOR]

The psychedelic psilocybin has shown promise both as treatment for psychiatric conditions and as a means of improving well-being in healthy individuals. In some jurisdictions (e.g., Oregon, USA), psilocybin use for both purposes is or will soon be allowed and yet, public attitudes toward this shift are understudied. We asked a nationally representative sample of 795 US Americans to evaluate the moral status of psilocybin use in an appropriately licensed setting for either treatment of a psychiatric condition or well-being enhancement. Showing strong bipartisan support, participants rated the individual's decision as morally positive in both contexts. These results can inform effective policy-making decisions around supervised psilocybin use, given robust public attitudes as elicited in the context of an innovative regulatory model. We did not explore attitudes to psilocybin use in unsupervised or non-licensed community or social settings. [ABSTRACT FROM AUTHOR]

The article focuses on the argument for reinstating legitimate disapproval of addiction, suggesting that societal stigma may motivate addicted individuals to overcome their addictions. Topics include the role of free will among addicted people, the failure of guilt as a motivating factor for quitting addiction, and the distinction between stigmatizing addictive behavior versus stigmatizing the condition of being addicted.

This study explores the social organisation of risk among injecting drug users in Norway. Based on qualitative interviews with 80 people who regularly injected drugs, recruited from harm reduction services in five Norwegian cities, the analysis illustrates how users embody various forms of capital in order to mitigate harm. These forms of capital work along three axes that we conceptualise as sociocultural, injecting and structural capital. First, the sociocultural capital highlights how users accounted for a field-specific competence that enabled them to evaluate the trustworthiness of drug dealers, and the quality and purity of the drugs they bought. Second, the injecting capital illustrates the drug-related competence among users, and how they managed their drug use in certain ways to minimise harm. Third, structural capital emphasises how users learned to benefit from various low-threshold agencies and the welfare state. Together, these forms of risk capital illustrate the subtle, and often neglected, forms of capital embedded within marginalised populations and how they 'do' harm reduction in their everyday interactions and drug use. If interventions within this population are to succeed, there is need for a greater awareness of such forms of capital and how these are employed within the social environments in which drug-related risks are organised. [ABSTRACT FROM AUTHOR]

[Display omitted] • Hydrogel containing viologen-based hyperbranched polyamide amines with dual drug loading capacity. • Wearable Patch (Patch-DT) uses hydrogel as the drug-carrying cathode and magnesium flakes as the anode. • Patch-DT enables release of two drugs simultaneously, overcoming the limitations of monotherapy. • Visible drug monitoring through wearable Patch's electrochromic properties. Wearable drug delivery systems (DDS) have made significant advancements in the field of precision medicine, offering precise regulation of drug dosage, location, and timing. The performance qualities that wearable DDS has always strived for are simplicity, efficiency, and intelligence. This paper proposes a wearable dual-drug synergistic release patch. The patch is powered by a built-in magnesium battery and utilizes a hydrogel containing viologen-based hyperbranched polyamidoamine as both a cathode material and an integrated drug reservoir. This design allows for the simultaneous release of both dexamethasone and tannic acid, overcoming the limitations of monotherapy and ensuring effective synergy for on-demand therapy. In a mouse model with praziquimod-induced psoriasis, the patch demonstrated therapeutic efficacy at a low voltage. The inflammatory skin returned to normal after 5 days with the on-demand release of dual drugs. This work provides a promising treatment option considering its straightforward construction and the therapeutic advantages of dual-drug synergy. [ABSTRACT FROM AUTHOR]

Recent data show that African Americans (AAs) experienced a greater increase in overdose deaths involving prescription opioids relative to other racial/ethnic groups. One possible mechanism through which elevated risk for overdose is conferred to AAs could be due to greater exposure to contaminated counterfeit pills. Unfortunately, prescription opioid diversion is understudied among AAs and less is known regarding which sources AAs use to access pharmaceutical opioids. The objective of this study, therefore, was to identify and describe the most commonly used diversion sources for prescription opioids among AAs. Qualitative interview data are also presented to contextualize the most prevalent sources. This study used data from the Florida Minority Health Study, a mixed-methods project that included online surveys (n = 303) and qualitative in-depth interviews (n = 30) of AAs. Data collection was conducted from August 2021 to February 2022 throughout Southwest Florida. Analyses revealed that the most widely used sources for prescription opioids were dealers (33.0%) and friends/relatives (34.7%). Additionally, interview data indicated that dealers are the access point where larger volume acquisitions are made and high potency formulations are accessed. These findings suggest that AAs may utilize nonhealthcare related sources at higher rates than healthcare related sources to acquire prescription opioids. This is concerning because opioid pills acquired through nonhealthcare related sources are especially susceptible to fentanyl adulteration. These findings invite further study using nationally representative data to determine if AAs disproportionately use nonhealthcare related sources compared to persons from other racial/ethnic groups. [ABSTRACT FROM AUTHOR]

New regulatory changes were introduced in January further restricting the prescription of valproate medicines in patients under 55 years of age due to the significant reproductive risks. This article discusses these changes as well as the other issues to consider to ensure valproate prescribing is as safe as possible, including monitoring for adverse effects and avoiding interactions. [ABSTRACT FROM AUTHOR]

In several controversial drug approval decisions in recent years, the Food & Drug Administration ("FDA") has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency's determination whether a drug is "safe" and "effective" does not seem to depend on whether its approval also supports innovation. But FDA'suse of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of its regulation of drugs. In this Article, we investigate the broad set of innovation-related judgments that FDA has been making and argue that there are serious concerns with the major innovation role FDA has been playing, at least as the Agency is currently constituted. We conclude that FDA should not separately weigh innovation in decisions about a product's safety and effectiveness. In other areas, health policymakers could reasonably decide that FDA should have either a larger or a smaller role than it currently does in shaping the development of novel drugs. But policymakers should do so while thoughtfully considering both the opportunities and challenges of FDA actively considering innovation incentives in its decisions; those challenges have been rarely considered in the literature and policy discourse. Further, we argue that whether policymakers aim to bolster or limit the ways that FDA considers innovation in its regulatory decisions, changes are needed to the Agency's structure to support its ability to make reasoned judgments based on relevant expertise. [ABSTRACT FROM AUTHOR]

Since 2011, the misuse or abuse of etomidate has gradually increased when propofol was designated a controlled drug under the Narcotics Control Act in Korea. Accordingly, the Ministry of Food and Drug Safety announced that etomidate would be under the 'Regulation on the designation of drugs that may cause concerns of misuse or abuse' rule in June 2020, which is less stringent than the Narcotics Control Act. Therefore, this review investigates potential misuse or abuse cases of etomidate to consider strengthening its management. A literature search was conducted to compare etomidate with other sedatives in their efficacy and side effects, as well as identify the adverse health outcomes, abuse cases, and analytical methods of etomidate. Etomidate has an equal or higher sedative efficacy and lower risk of adverse cardiopulmonary events than propofol. However, major adverse effects of etomidate include adrenocortical suppression and unproven associated deaths, as well as myoclonus requiring pre-treatment. Although the issue of abuse and misuse of etomidate is emerging in recent years, there are few academic reports on these issues and analytical methods in the forensic field. In order to effectively manage the misuse or abuse of etomidate, it is necessary to continuously monitor related cases with great interest and to be more intensively studied on its abuse potential. [ABSTRACT FROM AUTHOR]

Policy PointsThe Orphan Drug Act (ODA) was the result of patient advocacy and by many measures has been strikingly successful. However, approximately 95% of the more than 7,000 known rare diseases still have no US Food and Drug Administration–approved treatment.The ODA's success led to sustained criticism of high drug prices, often for products that have orphan drug indications. Critics misconstrue the ODA's intent and propose reducing its incentives instead of pursuing policies focused on addressing broader prescription drug price challenges that exist in both the orphan and nonorphan drug market.Patients and their families will continue to defend the purpose and integrity of the ODA and to drive investments into rare disease research and clinical development. [ABSTRACT FROM AUTHOR]

Background: Over the last twenty years of orphan drug regulation in Europe, the regulatory framework has increased its complexity, with different regulatory paths and tools engineered to facilitate the innovation and accelerate approvals. Recently, the proposal of the new Pharmaceutical Legislation for the European Union, which will replace at least three Regulations and one Directive, was released and its new framework is raising many questions. The aim of this study was to present a characterisation of the Orphan Medicinal Products (OMPs) authorised by the European Commission (EC), between 2010 and 2022, looking into eighteen variables, contributing to the ongoing discussion on the proposal and implementation of the new Pharmaceutical Legislation proposed. Methods: Data of the OMPs identified and approved between 2010 and 2022 were extracted from the European Public Assessment Reports (EPARs) produced by the European Medicines Agency. Information regarding legal basis of the application, applicant, protocol assistance received, type of authorization, registration status, type of molecule, ATC code, therapeutic area, target age, disease prevalence, number of pivotal clinical trials supporting the application, clinical trial designs, respective efficacy endpoints and number of patients enrolled in the pivotal clinical trials were extracted. A descriptive statistical analysis was applied. Results: We identified 192 OMPs approved in the period between 2010 and 2022. 89% of the OMPs have legal basis of "full application". 86% of the sponsors received protocol assistance whereas 64% of the MAA benefited from the accelerated assessment. 53% of the active substances are small molecules; about 1 in 5 molecules are repurposed. 40% of the OMPs have oncological therapeutic indications and 56% of the OMPs are intended to treat only adults. 71% of the products were approved based on a single pivotal trial. Conclusions: This analysis of OMPs approved between 2010 and 2022 shows that a shift has occurred in the rare disease medicine development space. Through the period studied we observe an increase of non-small molecules approved, accelerated assessment received and non-standard MA's granted. [ABSTRACT FROM AUTHOR]

BACKGROUND: Antimicrobial use in livestock production is considered a key contributor to growing antimicrobial resistance in bacteria. In 2015, California became the first state to enact restrictions on routine antimicrobial use in livestock production via Senate Bill 27 (SB27). SB27 further required the California Department of Food and Agriculture (CDFA) to collect and disseminate data on antimicrobial use in livestock production. OBJECTIVE: The goal of this report is to assess whether CDFA’s data release allows us to evaluate how antimicrobial use changed after the implementation of SB27. METHODS: We combine the CDFA data with feed drug concentration ranges from the Code of Federal Regulation to evaluate the spread of plausible antimicrobial use trends. We also estimate antimicrobial consumption rates using data from the National Agricultural Statistical Service (NASS) and compare these to changes in medicated feed production reported by the CDFA DISCUSSION: We show that CDFA's reported data are insufficient to reliably estimate whether antimicrobial usage has increased or decreased, most notably because no information is provided about the mass of antimicrobials approved for use or medicated feed drug concentrations. After incorporating additional external data on feed drug concentrations, one can at best provide uninformative bounds on the effect of SB27. We find some evidence that antimicrobial use has decreased by incorporating data on national sales of antimicrobials for food-producing animals, but the weakness of this inference underlines the need for improved data collection and dissemination, especially as other states seek to implement similar policies. We provide recommendations on how to improve reporting and data collection under SB27. [ABSTRACT FROM AUTHOR]

Background: Appropriate interactions between antiretroviral therapies (ART) and drug transporters and metabolizing enzymes at the blood brain barrier (BBB) are critical to ensure adequate dosing of the brain to achieve HIV suppression. These proteins are modulated by demographic and lifestyle factors, including substance use. While understudied, illicit substances share drug transport and metabolism pathways with ART, increasing the potential for adverse drug:drug interactions. This is particularly important when considering the brain as it is relatively undertreated compared to peripheral organs and is vulnerable to substance use-mediated damage. Methods: We used an in vitro model of the human BBB to determine the extravasation of three first-line ART drugs, emtricitabine (FTC), tenofovir (TFV), and dolutegravir (DTG), in the presence and absence of cocaine, which served as our illicit substance model. The impact of cocaine on BBB integrity and permeability, drug transporters, metabolizing enzymes, and their master transcriptional regulators were evaluated to determine the mechanisms by which substance use impacted ART central nervous system (CNS) availability. Results: We determined that cocaine had a selective impact on ART extravasation, where it increased FTC's ability to cross the BBB while decreasing TFV. DTG concentrations that passed the BBB were below quantifiable limits. Interestingly, the potent neuroinflammatory modulator, lipopolysaccharide, had no effect on ART transport, suggesting a specificity for cocaine. Unexpectedly, cocaine did not breach the BBB, as permeability to albumin and 4 kDa FITC-dextran, as well as tight junction proteins and adhesion molecules remained unchanged. Rather, cocaine selectively decreased the pregnane-x receptor (PXR), but not constitutive androstane receptor (CAR). Consequently, drug transporter expression and activity decreased in endothelial cells of the BBB, including p-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and multidrug resistance-associated protein 4 (MRP4). Further, cytochrome P450 3A4 (CYP3A4) enzymatic activity increased following cocaine treatment that coincided with decreased expression. Finally, cocaine modulated adenylate kinases that are required to facilitate biotransformation of ART prodrugs to their phosphorylated, pharmacologically active counterparts. Conclusion: Our findings indicate that additional considerations are needed in CNS HIV treatment strategies for people who use cocaine, as it may limit ART efficacy through regulation of drug transport and metabolizing pathways at the BBB. [ABSTRACT FROM AUTHOR]

Despite self-congratulatory rhetoric, Canada compromised COVID-19 vaccine equity with policies impeding a proposed global waiver of vaccine intellectual property (IP) rules. To learn from Canada’s vaccine nationalism we explore the worldview – a coherent textual picture of the world – in a sample of Government of Canada communications regarding global COVID-19 vaccine sharing. Analysed documents portray risks and disparities as unrelated to the dynamics and power relations of the Canadian and international economies. Against this depoliticised backdrop, economic growth fueled by strict IP rules and free trade is advanced as the solution to inequities. Global vaccine access and distribution are pursued via a charity-focused public-private-partnership approach, with proposals to relax international IP rules dismissed as unhelpful. Rather than a puzzling lapse by a good faith ‘middle power’, Canada’s obstruction of global COVID-19 vaccine equity is a logical and deliberate extension of dominant neoliberal economic policy models. Health sector challenges to such models must prioritise equity in global pandemic governance via politically assertive and less conciliatory stances towards national governments and multilateral organisations. Mobilisation for health equity should transform the overall health-damaging macroeconomic model, complementing efforts based on specific individual health determinants or medical technologies. [ABSTRACT FROM AUTHOR]

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities. This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country’s domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance. [ABSTRACT FROM AUTHOR]

Aims: To describe characteristics of applicant, tool, outcomes, regulatory responses and general learnings from European Medicines Agency (EMA) Qualification Procedures on patient‐reported outcomes (PROs), observer‐reported outcomes (ObsROs) and performance outcomes (PerfOs) finalized between January 2013 and December 2018. Methods: Descriptive analysis, and qualitative review of the regulatory outcomes of the study procedures. Results: Seventeen qualification programmes for PROs, 6 for ObsRO tools and 11 for PerfO tools were submitted by consortia, large and small/medium companies. Gastroenterology and neurology were the most frequent therapeutic areas. There was a high level of regulators' partial agreement (above 70%) with applicant's approaches with constructive input; EMA published Letters of Support for PRO (6), ObsRO (2) and PerfO (4) tools, and Qualification Opinions on PROs (2) and PerfOs (1). General issues related to Qualification Procedures on PROs raised by EU regulatorsincluded: population, appropriate studies to demonstrate ability to detect change, tool validation in interventional trials, anchoring, identification of the minimally important difference, item selection, weighting, and multiple domains. In addition, specific issues for ObsROs and PerfO tools validation are identified. Conclusions: Regulators discussed principles and challenges of validation tailored to specific setting in tool development, providing constructive feedback. Regulatory outputs supportive of further development were published in over one‐third of programs. We encourage applicants intending to use or develop novel PRO, ObsRO and PerfO tools that will generate evidence for regulatory submissions on medicines to consider Qualification procedures for novel methods to seek feedback on the development and validation of these tools. [ABSTRACT FROM AUTHOR]

The article discusses the reasons why the regulation regarding the prescriptive authority of pharmacists should be exclusively given by U.S. states rather than the Food and Drug Administration (FDA). Also cited are how the FDA allegedly encroached on states' rights when it revised its Emergency Use Authorization for Paxlovid granting prescriptive authority to pharmacists and a brief history of the FDA's regulation of drugs and devices.

In 2020 and 2021, 44 states and Washington, D.C. passed laws that limited tort liability related to COVID-19. The most common reforms immunized health care providers from malpractice or similar liability. A second category is limited liability to individuals or businesses for exposing others to the novel coronavirus. And a third category protected manufacturers of supplies used to detect and prevent COVID-19 from products liability suits. The goals of these reforms included protecting health care providers from uncertainty in providing care for a novel disease, limiting the macroeconomic consequences of the pandemic, and encouraging the distribution of critical supplies to avoid shortages. States providing immunity assumed that institutions and individuals alike would react to reforms, as theory predicts, by engaging in more of the immunized activities. In general, the literature supports the assumption that institutions, like hospitals or manufacturers of face masks and COVID-19 tests, change their behavior in response to tort reform. Yet there is little empirical evidence demonstrating how tort law affects risk-taking by individuals. The lack of evidence about the relationship between tort law and individual decision-making is of broad interest, as one of the primary goals of tort law is to incentivize efficient levels of risk-taking. This Article provides novel empirical evidence on the effects of COVID-19 tort reform on public health. The analysis yields three important results. First, it shows that medical liability reforms had counterproductive public health effects. States that immunized health care providers from tort suits arising out of COVID-19 care experienced 20% more COVID-19 cases and 5% more COVID-19 hospitalizations. Second, the results demonstrate that exposure reforms counterintuitively decreased COVID-19 cases by making it easier for businesses and other institutions to require customers to comply with public health guidance. Third, the results reveal that tort law had very little effect, if any, on the precautions individuals chose to avoid contracting or spreading the disease. The third result is broadly interesting, as it indicates that tort law will be a weak incentive to individuals whenever they are choosing a level of care that can protect themselves or others. [ABSTRACT FROM AUTHOR]

Hydrogels have broad application prospects in drug delivery due to their biocompatibility, high water content and three-dimensional structure. However, the regulation of drug release from hydrogels is an important issue in medical applications. At the same time, water also has an important impact on drug release. In this study, a hydrogel with hydrogen bond and ion dipole interaction (PAHDP) was prepared by introducing catechol group into polymer to regulate drug release. Ten model drugs were selected to explore the relationship and mechanism of action among polymer, drug and water. The results showed that PAHDP had excellent adhesion and safety. Drug release test showed that 10 kinds of drugs had different drug release trends, and the release amount was negatively correlated with drug polarizability and LogP. In addition, in vitro transdermal test and pharmacokinetic results showed that the hydrogel based on PAHDP achieved increased or decreased blood drug concentration, and the area under the concentration-time curve (AUC) of >1.5 times showed its potential to regulate drug release. The mechanism study showed that the hydrogen bond and ion dipole interaction between polymer and drug were affected by drug polarizability and LogP, and the distribution of water in different states was changed. Hydrogen bond and ion dipole interactions synergistically control drug release. Therefore, the mussel inspired PAHDP hydrogel has the potential to become a controllable drug delivery system. [Display omitted] [ABSTRACT FROM AUTHOR]

Background On June 1, 2021, Vermont repealed all criminal penalties for possessing 224 milligrams or less of buprenorphine. We examined the potential impact of decriminalization with a survey of Vermont clinicians who prescribed buprenorphine within the past year. Methods All 638 Vermont clinicians with a waiver to prescribe buprenorphine were emailed the survey by Vermont Department of Health; 117 responded. We estimated the prevalence of the following four outcomes, for all responding clinicians and stratified by clinician demographics and practice characteristics: awareness of decriminalization, beliefs about the effects of decriminalization, support for decriminalization, and changes in practice resulting from decriminalization. Results 72 (62%) prescribers correctly stated that Vermont does not have criminal penalties for buprenorphine possession. 107 (91%) support decriminalization. 56 (48%) believe that, because buprenorphine is decriminalized, their patients are more likely to give, sell, or trade the buprenorphine that is prescribed to them to someone else. However, only 5 providers (4%) said they now prescribe to fewer patients. Conclusion The great majority of Vermont clinicians who prescribe buprenorphine support its decriminalization and have not changed their prescribing practices because of decriminalization. Highlights In 2021, Vermont repealed criminal penalties for buprenorphine possession. We surveyed Vermont (n = 117) buprenorphine prescribers about decriminalization. 91% of providers support decriminalization. 48% of providers believe decriminalization will increase diversion of medications. Only 4% of providers prescribe to fewer patients because of decriminalization. [ABSTRACT FROM AUTHOR]

Background: Previous studies examining the cannabis-alcohol substitution effect have found that medical cannabis policies may result in substituting the use of cannabis in place of alcohol use. Objectives: This study adds to the literature on cannabis-alcohol substitution by analyzing the effect of decriminalization, medicinal cannabis, and adult-use legalization cannabis policies (2002-2019) on cannabis and alcohol use and substance substitution for all 50 states and the District of Columbia (N=867). Results: Results support the notion that liberalized cannabis policies can increase the prevalence of cannabis use. An adult-use legalization specific analysis yielded findings suggesting a complex and heterogenous effect of such laws on cannabis-alcohol complementation. Conclusion: Given the lack of clarity and heterogenous effects of cannabis laws, policy makers should carefully take into consideration the benefits of medical cannabis laws, along with the risks of decriminalization and adult-use legalization. [ABSTRACT FROM AUTHOR]

Pharmaceutical manufacturers are obligated by national drug regulations to provide package information leaflets (PIL), which is a patientfriendly form of the Summary Product Characteristics (SmPC). The main objective of this study was to evaluate whether and how these patients in Montenegro read PILs and to get insight into patients' opinions regarding comprehension and usefulness of said leaflets. The survey was conducted on randomly recruited patients at a private pharmacy in Podgorica, Montenegro. The survey was conducted in September 2019 on randomly recruited patients (>18 years of age) at the private pharmacy in Podgorica. Number of patients who read PILs, way and frequency of reading PILs, patients' opinions on clearness and usefulness of PILs. Of the 200 patients asked to participate in this research, 126 (63% response rate) filled out the questionnaire. The majority of the respondents thought that it is important to read the patient information leaflet (76.2%) and most of them (75.4%) reported that they always read the leaflet. Less than half of those who read the PIL read it thoroughly (47.9%). Around half of patients reported that the terms and expressions in leaflets are partially understandable (53.7%). After reading the leaflet, around a third of the patients often feel confused (28.1%) or anxious (32.5%). To improve the quality of the information, PILs need to convey the potential risk information in a language that is less fear-provoking. [ABSTRACT FROM AUTHOR]

Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities. Since drug laws in India do not expressly deal with other forms of access like the 'Compassionate Use' or 'Expanded Access' mechanism, demarcating the scope and describing the strategies for PTA are the need of the hour. We propose possible strategies to address inadequacies in the regulatory regime and establish 'win–win' situations among all stakeholders. We further argue that India is well positioned to provide leadership by developing detailed PTA provisions and may set a potential path for the other clinical trial host countries. [ABSTRACT FROM AUTHOR]