Search

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]

Overdose Good Samaritan laws (GSLs) aim to reduce mortality by providing limited legal protections when a bystander to a possible drug overdose summons help. Most research into the impact of these laws is dated or potentially confounded by coenacted naloxone access laws. Lack of awareness and trust in GSL protections, as well as fear of police involvement and legal repercussions, remain key deterrents to help-seeking. These barriers may be unequally distributed by race/ethnicity due to racist policing and drug policies, potentially producing racial/ethnic disparities in the effectiveness of GSLs for reducing overdose mortality. We used 2015–2019 vital statistics data to estimate the effect of recent GSLs on overdose mortality, overall (8 states) and by Black/White race/ethnicity (4 states). Given GSLs' near ubiquity, few unexposed states were available for comparison. Therefore, we generated an "inverted" synthetic control method (SCM) to compare overdose mortality in new-GSL states with that in states that had GSLs throughout the analytical period. The estimated relationships between GSLs and overdose mortality, both overall and stratified by Black/White race/ethnicity, were consistent with chance. An absence of effect could result from insufficient protection provided by the laws, insufficient awareness of them, and/or reticence to summon help not addressable by legal protections. The inverted SCM may be useful for evaluating other widespread policies. [ABSTRACT FROM AUTHOR]

The article offers information on the development of a model for Medicaid Managed Care (MMC) enacted by Kentucky in 2021 designed to avoid a complete reversal of the Medicaid drug benefit from an MMC model to a purely Medicaid fee-for-service (FFS) model. Topics covered include how the pharmacy benefit manager (PBM) reform legislation disrupted the vertically aligned PBM industry, a summary of the PBM reform elements, and the goal of the model to preserve the intent of the 340B program.

Recently, many studies have shown that lncRNA can mediate the regulation of TF-gene in drug sensitivity. However, there is still a lack of systematic identification of lncRNA-TF-gene regulatory triplets for drug sensitivity. In this study, we propose a novel analytic approach to systematically identify the lncRNA-TF-gene regulatory triplets related to the drug sensitivity by integrating transcriptome data and drug sensitivity data. Totally, 1570 drug sensitivity-related lncRNA-TF-gene triplets were identified, and 16 307 relationships were formed between drugs and triplets. Then, a comprehensive characterization was performed. Drug sensitivity-related triplets affect a variety of biological functions including drug response-related pathways. Phenotypic similarity analysis showed that the drugs with many shared triplets had high similarity in their two-dimensional structures and indications. In addition, Network analysis revealed the diverse regulation mechanism of lncRNAs in different drugs. Also, survival analysis indicated that lncRNA-TF-gene triplets related to the drug sensitivity could be candidate prognostic biomarkers for clinical applications. Next, using the random walk algorithm, the results of which we screen therapeutic drugs for patients across three cancer types showed high accuracy in the drug-cell line heterogeneity network based on the identified triplets. Besides, we developed a user-friendly web interface-DrugSETs (http://bio-bigdata.hrbmu.edu.cn/DrugSETs/) available to explore 1570 lncRNA-TF-gene triplets relevant with 282 drugs. It can also submit a patient's expression profile to predict therapeutic drugs conveniently. In summary, our research may promote the study of lncRNAs in the drug resistance mechanism and improve the effectiveness of treatment. [ABSTRACT FROM AUTHOR]

The article discusses the implementation of legislation by Nevada and the growing number of states that protects hospitals and other participants in the 340B Drug Pricing Program against discriminatory practices initiated by pharmacy benefit managers (PBMs). Topics include key provisions in the law, support of the Nevada Society of Health-System Pharmacists (NVSHP) to the bill, and comments from Adam Porath, legislative director for NVSHP.

The article focuses on the role of the U.S. Department of Veterans Affairs (VA) pharmacists in treating opioid use disorder (OUD). Topics include number of clinical pharmacist practitioners (CPPs) with the VA who are registered with the Drug Enforcement Administration (DEA) to prescribe controlled substances, characteristics of VA CPPs providing OUD care, and factors that drove the passage of the Mainstreaming Addiction Treatment (MAT) Act.

Combination therapy has shown an obvious curative effect on complex diseases, whereas the search space of drug combinations is too large to be validated experimentally even with high-throughput screens. With the increase of the number of drugs, artificial intelligence techniques, especially machine learning methods, have become applicable for the discovery of synergistic drug combinations to significantly reduce the experimental workload. In this study, in order to predict novel synergistic drug combinations in various cancer cell lines, the cell line-specific drug-induced gene expression profile (GP) is added as a new feature type to capture the cellular response of drugs and reveal the biological mechanism of synergistic effect. Then, an enhanced cascade-based deep forest regressor (EC-DFR) is innovatively presented to apply the new small-scale drug combination dataset involving chemical, physical and biological (GP) properties of drugs and cells. Verified by the dataset, EC-DFR outperforms two state-of-the-art deep neural network-based methods and several advanced classical machine learning algorithms. Biological experimental validation performed subsequently on a set of previously untested drug combinations further confirms the performance of EC-DFR. What is more prominent is that EC-DFR can distinguish the most important features, making it more interpretable. By evaluating the contribution of each feature type, GP feature contributes 82.40%, showing the cellular responses of drugs may play crucial roles in synergism prediction. The analysis based on the top contributing genes in GP further demonstrates some potential relationships between the transcriptomic levels of key genes under drug regulation and the synergism of drug combinations. [ABSTRACT FROM AUTHOR]

Purpose To provide health-system pharmacists with published examples of strategies utilized to offer buprenorphine to inpatients with opioid use disorder (OUD) along with information on challenges and legal considerations. Summary Hospitals and emergency departments (EDs) are a constant source of healthcare for patients with OUD. As a result, hospital practitioners can screen, diagnose, begin treatment, and facilitate transfer of care to the outpatient setting. Offering sublingual buprenorphine in the hospital can bridge the gap before outpatient care is established. Multiple studies have shown that initiating treatment in the ED or during inpatient hospitalization results in 47% to 74% of patients utilizing medication-assisted treatment at day 30 of follow-up, statistically superior to the rates achieved with brief interventions or referral alone. Moreover, initiating buprenorphine treatment in the ED has been shown to decrease healthcare costs. Despite the benefits of offering buprenorphine in the inpatient setting, several challenges must be solved by hospital administration, such as achieving clinician readiness to prescribe buprenorphine, developing relationships with outpatient providers of buprenorphine, and creating an efficient workflow. Treatment of OUD with buprenorphine is heavily regulated on the federal level. Pharmacists can participate in the development of these programs and ensure compliance with applicable laws. Conclusion As health systems continue to care for patients with OUD, starting buprenorphine in the inpatient setting can improve the transition to outpatient treatment. Several institutions have developed programs with positive results. With an understanding of the typical barriers and relevant laws when initiating buprenorphine in the hospital setting, health-system pharmacists can assist in the development and operation of these initiatives. [ABSTRACT FROM AUTHOR]

Background: Drug counterfeiting is a rising problem due to difficulties with identifying counterfeit drugs and the lack of regulations and legislation in developing countries. Objective: This study aims to develop a robust and economic reversed phase high performance liquid chromatography (LC) method for simultaneously determining metformin HCl, vildagliptin, saxagliptin, alogliptin benzoate, sitagliptin phosphate monohydrate, and linagliptin to target counterfeiting. Methods: Plackett-Burman (PB) and Box-Behnken (BB) designs were used to screen and optimize the mobile phase composition. Chromatographic separation was carried out on an Inertsil® ODS-3 C18 column with isocratic elution mode and the mobile phase was a mixture of acetonitrile-methanol-ammonium formate buffer, pH 3.5 (25:10:65, v/v/v). This method was applied to analyze synthetic drugs in three traditional Chinese and Indian herbal medicines. To identify the adulterants, thin-layer chromatography (TLC), nuclear magnetic resonance (NMR), and mass spectrometry (MS) were used on counterfeit herbal medicines. Results: The developed method is sensitive, simple, rapid, economical, accurate, and highly robust. Student's t-test and variance ratio (F-test at P < 0.05) were used to compare the results statistically with the reference methods. Conclusion: The study found that the analyzed herbal medicines were adulterated with metformin and the quantification of anti-diabetic counterfeits was therefore applied. Highlights: This study determined counterfeited anti-diabetic drugs in Indian and Chinese traditional herbal medicines(THMs). Design-of-experiment, PB, and BB designs were used. Method validation was also performed in accordance with the International Conference on Harmonization guidelines. [ABSTRACT FROM AUTHOR]

Objective To assess the impact of Florida's 3-day opioid prescription supply law, effective July 2018, on opioids dispensed for acute pain patients. Methods Pharmacy claims from a health plan serving a large Florida employer from January 2015 through March 2019 were analyzed. We used an interrupted time series study design accounting for autocorrelation of trends before and after policy change. Acute pain patients met inclusion criteria if they had not received any opioid containing medications in the past 180 days. Patients could contribute to additional new use time if subsequent opioid claims occurred ≥180 days since the previous claim. Outcomes included mean number of units dispensed of the initial opioid prescription, mean morphine milligram equivalents (MMEs) per day of initial prescription by month, and mean total MMEs per initial prescription by month. Results A total of 8,375 enrollees had 10,583 unique opioid starts in the given timeframe. Following the policy, there was an immediate significant decrease in the units dispensed per prescription of 4.9 (95% confidence interval [CI] −8.95, −.82 units). Additionally, there was a significant immediate reduction in total MMEs dispensed per prescription of 25.6 (95% CI −44.76, −6.44 MMEs). Conclusions Among a group of privately-insured plan enrollees in Florida, and as a result of the law, there were significant decreases in the number of units dispensed, and total MMEs of opioid prescriptions. The immediate reduction in new opioid utilization following policy implementation suggests effective policy; however, impacts on chronic pain patients were not assessed. [ABSTRACT FROM AUTHOR]

Background Respiratory Syncytial Virus is the leading cause of hospitalization for lower respiratory tract infection in young children. The only preventive intervention is an anti-Respiratory Syncytial Virus (RSV) monoclonal antibody (palivizumab, Synagis) administered as monthly intramuscular injections during the winter. Recommendations for palivizumab use have been published by the Canadian Paediatric Society (CPS) and other agencies. We sought to determine if there was interjurisdictional variation in eligibility for palivizumab across provinces and territories and in comparison to CPS recommendations, as well as the nature of this variation. Methods Eligibility criteria were obtained from personnel coordinating provincial and territorial programs and from public governmental websites. Results All 13 jurisdictions provided information about their palivizumab eligibility policies. No province or territory (PT) follows CPS guidelines exactly and substantial heterogeneity exists among jurisdictions. All PT jurisdictions provide prophylaxis in the first year of life to infants with hemodynamically significant congenital heart disease or chronic lung disease on ongoing therapy for those conditions, and to premature children in remote areas. In general, PTs had more liberal policies than the CPS, offering palivizumab to a wide range of children with conditions such as cystic fibrosis, Down syndrome or to moderately premature children with risk factors. Conclusions Substantial variation in PT criteria for RSV prevention exists in Canada, and no jurisdiction follows CPS criteria exactly. Variability in subnational policy may reflect access to human or material resources, varying interpretation of evidence for efficacy, variation in epidemiology, the effect of local pressures, or advocacy. [ABSTRACT FROM AUTHOR]

The article presents commentary on the regulatory level of evidence and practicality in antifungal use decisions for less common fungal diseases. Topics include Invasive candidiasis remains the most prevalent healthcare-related fungal infection; and encompassing catheter related biofilm infections, intraabdominal infections, and multi-organ disseminated infections.

Background To address the growing threat of multidrug-resistant organisms, policymakers are seeking ideas to promote development of novel antibiotics. In 2018, the REVAMP Act was proposed in Congress to reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers. Methods We estimated the economic impact of this proposal by identifying antimicrobial drugs approved by the FDA from 2007–2016 that would likely have qualified for an exclusivity voucher and matching each drug to the highest-revenue fast-track drug facing generic entry within 4 years after the antibiotic was approved. Assuming a spending decrease of 75% after generic entry, we calculated the per-drug and total societal costs of these transferrable market exclusivity extensions over a decade. Results We identified 10 antimicrobials that would have qualified for an exclusivity voucher, each of which was matched with 1 of 17 fast-track drugs facing generic entry through July 2019. These 10 drugs had a median annual revenue before generic entry of $249 million (range, $26 million–$2.7 billion). Accounting for a 75% spending reduction after generic entry, the median excess spending associated with 12 months of extended exclusivity was $187 million, for a total of $4.5 billion over 10 years. Conclusions While market exclusivity extensions are a politically appealing mechanism to encourage novel antibiotic development, this approach would cost public and private payers billions of dollars over the next decade. [ABSTRACT FROM AUTHOR]

Opioid overdose mortality has been increasing in the United States, and other types of mortality, such as motor vehicle crash deaths, may also be linked to opioid use. In this issue of the Journal , Feder et al. (Am J Epidemiol. 2020;189(9):885–893) examine the association between Florida's opioid crackdown laws, implemented in 2010–2011, and opioid-related mortality. They found a decrease in numbers of opioid-overdose and car-crash deaths compared with what would have been expected in the absence of such policies. They also found no evidence of any unintended increase in suicides due to poor pain management. The results were robust to alternative methodological approaches. Florida's opioid policy reforms coincided with the state's convergence towards national unemployment rates, as well as a new state law prohibiting texting while driving. Because opioid overdose mortality is often associated with economic conditions and because car crashes and suicides may also be linked to the macroeconomic environment, future research should take such factors into account when studying the outcomes of opioid prescribing laws. Another data-related aspect to consider is the misclassification of suicides as car crashes or opioid overdoses. Overall, the findings by Feder et al. are encouraging and can inform policy in other countries facing increasing numbers of opioid overdose deaths. [ABSTRACT FROM AUTHOR]

In 2011, Florida established a prescription drug monitoring program and adopted new regulations for independent pain-management clinics. We examined the association of those reforms with drug overdose deaths and other injury fatalities. Florida's postreform monthly mortality rates—for drug-involved deaths, motor vehicle crashes, and suicide by means other than poisoning—were compared with a counterfactual estimate of what those rates would have been absent reform. The counterfactual was estimated using a Bayesian structural time-series model based on mortality trends in similar states. By December 2013, drug overdose deaths were down 17% (95% credible interval: −21, −12), motor vehicle crash deaths were down 9% (95% credible interval: −14, −4), and suicide deaths were unchanged compared with what would be expected in the absence of reform. Florida's opioid prescribing reform substantially reduced drug overdose deaths. Reforms may also have reduced motor vehicle crash deaths but were not associated with a change in suicides. More research is needed to understand these patterns. Bayesian structural time-series modeling is a promising new approach to interrupted time-series studies. [ABSTRACT FROM AUTHOR]

We propose a method that yields a probability distribution for the net weight of drug powder resulting from a seizure of stamp bags. The technique involves the posterior predictive distribution of a beta distribution under a conjugate prior. The convolution of two distributions is computed for two visually distinct groups of stamp bags from the same seizure. [ABSTRACT FROM AUTHOR]

This study explores the penal character of diversion programmes through the subjective experiences of young drug-law offenders. Specifically, punishment experiences are investigated through qualitative interviews with 24 offenders who were arrested between the ages of 15 and 17. The diverted adolescents described four experiences of punishment attending the programmes: (1) deprivation of time; (2) deprivation of social bonds; (3) deprivation of dignity and (4) deprivation of self. These subjective experiences of punishment, which all reflect the supervisory character of alternative penal sanctioning, differed in severity across programmes, individuals and abstraction levels. Punishment is largely an unspoken aspect of diversionary practices, emphasizing the importance of a subjectivist approach to assessments of penal character. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration's accelerated approval and later withdrawal of bevacizumab in patients with metastatic breast cancer (mBC) is a seminal case for ongoing debates about the validity of using progression-free survival (PFS) as a surrogate measure for overall survival (OS) in cancer drug approvals. We systematically reviewed and meta-analyzed the evidence around bevacizumab's regulatory approval and withdrawal in mBC.Methods: We searched for all published phase II or III clinical trials testing bevacizumab as a first-line therapy for patients with mBC. Data were extracted on trial demographics, interventions, and outcomes. Descriptive analysis was stratified by whether the trial was initiated before, during, or after the accelerated approval. We used a cumulative random-effects meta-analysis to assess the evolution of evidence of the effect of bevacizumab on PFS and OS. We estimated the association between the trial-level PFS and OS effect using a nonlinear mixed-regression model.Results: Fifty-two studies were included. Trial activity dramatically dropped after the accelerated approval was withdrawn. Eight clinical trials reported hazard ratios (hazard ratios) and were meta-analyzed. The cumulative hazard ratio for PFS was 0.72 (95% CI = 0.65 to 0.79), and the cumulative hazard ratio for OS was 0.90 (95% CI = 0.80 to 1.01). The regression model showed a statistically nonsignificant association between PFS benefit and OS benefit (β = 0.43, SE = 0.81).Conclusion: The US Food and Drug Administration's decision-making in this case was consistent with the evolving state of evidence. However, the fact that seven clinical trials are insufficient to conclude validity (or lack thereof) for a trial-level surrogate suggests that it would be more efficient to conduct trials using the more clinically meaningful endpoints. [ABSTRACT FROM AUTHOR]

The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017 to authorize the US Food and Drug Administration (FDA) to require pediatric studies for new cancer drugs that have a molecular target relevant to the growth or progression of a pediatric cancer. To assess the possible scope of this new policy, we examined all 78 adult cancer drugs approved by the FDA from 2007 to 2017. Only 17 (21.8%) drugs received any pediatric labeling information. Based on the FDA's Pediatric Molecular Target List, we found that the RACE Act could have increased the proportion of cancer drugs potentially subject to pediatric study requirements from 0% to 78.2%. However, the actual effect of the legislation will depend on how often regulators require pediatric trials and on timely completion of such trials. [ABSTRACT FROM AUTHOR]

The article reports that several states in the U.S. have enacted laws in 2019 to address the growing cost of prescription medications in pharmacy benefit programs. Topics mentioned include the number of bills that were signed into law by early July 2019 that affect the practices of pharmacy benefit managers (PBMs), thoughts from American Society of Health-System Pharmacists official Nicholas Gentile on increase in transparency of PBM practices, and the use of gag clauses in pharmacy programs.

The article discusses the evidence and rationale for the original approval of cefiderocol presented by the U.S. Food and Drug Administration (FDA) within the issue. Topics include the scientific evidence on the efficacy of the drug, the regulatory basis for approval, and how those factors influence incentives for sponsors to provide evidence needed by patients and clinicians to justify clinical use and payment.

Objective. To assess postoperative opioid prescribing in response to state and organizational policy changes. Methods. We used an observational study design at an academic medical center in the Northeast United States over a time during which there were two important influences: 1) implementation of state rules regarding opioid prescribing and 2) changes in organization policies reflecting evolving standards of care. Results were summarized at the surgical specialty and procedure level and compared between baseline (July–December 2016) and postrule (July– December 2017) periods. Results. We analyzed data from 17,937 procedures from July 2016 to December 2017, twothirds of which were outpatient. Schedule II opioids were prescribed in 61% of cases and no opioids at all in 28%. The median morphine milligram equivalent (MME) prescribed at discharge decreased 40%, from 113 MME in the baseline period to 68 MME in the postrule period. Decreases were seen across all the surgical specialties. Conclusions. Postoperative opioid prescribing at the time of hospital discharge decreased between 2016 and 2017 in the setting of targeted and replicable state and health care organizational policies. Policy Implications. Policies governing the use of opioids are an effective and adoptable approach to reducing opioid prescribing following surgery. [ABSTRACT FROM AUTHOR]

Purpose Leveraging pharmacy technicians to take on advanced roles can enable pharmacists to practice at the highest level of their license. Technicians trained through traditional venues may not have the necessary knowledge and skills to adequately take on these roles. To meet this need, a technician residency program was developed and implemented in a health-system pharmacy. Summary The technician residency program was designed to develop competency in the medication use process as assessed through achievement of 30 objectives based on successful completion of rotations, projects, and didactic examination. The program duration was 50 weeks with rotations which included compounding, technician-check-technician cart fill and floor stock replenishment, investigational drug services, regulatory compliance, and other functions. The resident also completed several projects to improve data analytics, communication, and leadership skills. By the end of the program, the residency program director and preceptors determined that the resident achieved 83% (25/30) of objectives and had developed competency in the medication use process superior to technicians with several years of experience. The resident was ultimately hired in a specialty technician position and was found to perform effectively in that role. Conclusion The program allowed the technician resident to gain a comprehensive understanding of health-system pharmacy practice and continue to develop skills and abilities that would typically take several years of work experience to be achieved. [ABSTRACT FROM AUTHOR]

The article discusses the prevalence of cost-related medication underuse (CRMU) or cost-related nonadherence (CRN) in the U.S., as well as the recommended strategies to bolster medication adherence at care transitions. Topics include CRMU prevalence in other countries like Canada, Norway and Sweden, healthcare-associated costs like out-of-pocket cost (OOPC), and the factors resulting in increased drug prices in the U.S. like research and development costs.

Clinical laboratories act at the frontline of identification of infections caused by multidrug-resistant organisms, and yet the tools they apply are often woefully out of date. Incomplete adoption of current testing standards, updated breakpoints, and tests for new drugs across laboratories has been exacerbated by lack of coordination between standards development organizations (SDOs), pharmaceutical companies, susceptibility test manufacturers, and the US Food and Drug Administration. The 21st Century Cures Act includes provisions to enable alignment between these groups by (1) allowing recognition of breakpoints set by qualified SDOs; (2) publicly posting recognized breakpoints; and (3) reviewing breakpoints for necessary updates, every 6 months. Combined, these provisions will ensure more rapid recognition of current breakpoints, improving detection and management of resistant infections. Although several limitations remain, this will ultimately allow susceptibility test manufacturers to more readily update to current breakpoints. [ABSTRACT FROM AUTHOR]

Purpose. Results of a study to estimate the prevalence of look-alike/sound-alike (LASA) medication errors through analysis of Veterans Affairs (VA) administrative data are reported. Methods. Veterans with at least 2 filled prescriptions for 1 medication in 20 LASA drug pairs during the period April 2014--March 2015 and no history of use of both medications in the preceding 6 months were identified. First occurrences of potential LASA errors were identified by analyzing dispensing patterns and documented diagnoses. For 7 LASA drug pairs, potential errors were evaluated via chart review to determine if an actual error occurred. Results. Among LASA drug pairs with overlapping indications, the pairs associated with the highest potential-error rates, by percentage of treated patients, were tamsulosin and terazosin (3.05%), glipizide and glyburide (2.91%), extended- and sustained-release formulations of bupropion (1.53%), and metoprolol tartrate and metoprolol succinate (1.48%). Among pairs with distinct indications, the pairs associated with the highest potential-error rates were tramadol and trazodone (2.20%) and bupropion and buspirone (1.31%). For LASA drug pairs found to be associated with actual errors, the estimated error rates were as follows: lamivudine and lamotrigine, 0.003% (95% confidence interval [CI], 0--0.01%); carbamazepine and oxcarbazepine, 0.03% (95% CI, 0--0.09%); and morphine and hydromorphone, 0.02% (95% CI, 0--0.05%). Conclusion. Through the use of administrative databases, potential LASA errors that could be reviewed for an actual error via chart review were identified. While a high rate of potential LASA errors was detected, the number of actual errors identified was low. [ABSTRACT FROM AUTHOR]

Background In May 2012, the New Hampshire (NH) Division of Public Health Services (DPHS) was notified of 4 persons with newly diagnosed hepatitis C virus (HCV) infection at hospital X. Initial investigation suggested a common link to the hospital cardiac catheterization laboratory (CCL) because the infected persons included 3 CCL patients and a CCL technician. NH DPHS initiated an investigation to determine the source and control the outbreak. Methods NH DPHS conducted site visits, case patient and employee interviews, medical record and medication use review, and employee and patient HCV testing using enzyme immunoassay for anti-HCV, reverse-transcription polymerase chain reaction for HCV RNA, nonstructural 5B (NS5B) and hypervariable region 1 (HVR1) sequencing, and quasispecies analysis. Results HCV HVR1 analysis of the first 4 cases confirmed a common source of infection. HCV testing identified 32 of 1074 CCL patients infected with the outbreak strain, including 3 patients coinfected with >1 HCV strain. The epidemiologic investigation revealed evidence of drug diversion by the HCV-infected technician, evidenced by gaps in controlled medication control, higher fentanyl use during procedures for confirmed cases, and building card key access records documenting the presence of the technician during days when transmission occurred. The employee’s status as a traveling technician led to a multistate investigation, which identified additional cases at prior employment sites. Conclusions This is the largest laboratory-confirmed drug diversion–associated HCV outbreak published to date. Recommendations to reduce drug diversion risk and to conduct outbreak investigations are provided. [ABSTRACT FROM AUTHOR]

The article presents a speech by outgoing American Society of Health System Pharmacists (ASHP) president Paul W. Bush delivered at the ASHP Summer Meetings held in Denver, Colorado on June 5, 2018. Topics of the speech included the ASHP's promotion of resilience, pharmacy leadership and technician training during his term, and his call for all to build on the progress made during the year by continuing support for the pharmacy workforce and frontline staff.

The article presents summaries of changes to the safety labeling of drugs and therapeutic biologicals that were approved by the U.S. Food and Drug Administration (FDA) from January to March 2023. It presents revisions to warnings on the use of Capastat sulfate (capreomycin sulfate) to treat patients with multidrug-resistant tuberculosis and the adverse reactions of Vasanoid (tretinoin) including embryo-fetal loss and malformation during pregnancy and differentiation syndrome.

The article offers information on the use of pet antibiotics to self-treat infections, circumventing the prescription process. It mentions about an abundance of antibiotics that remains available for purchase without a prescription through a subset of pet antibiotics and also introduced the legislation during the 115th U.S. Congress to prevent inappropriate antibiotic use in animals, the Preventing Antibiotic Resistance Act.

Objectives: To explore the trends of antibiotic consumption in public healthcare institutions through analysing the provincial centralized bidding procurement (CBP) data in Shandong, China.Methods: The Shandong CBP system has been established since 2011, covering public healthcare institutions of 500 secondary and tertiary hospitals, 600 urban primary healthcare centres (PHCs) and 1600 rural PHCs. We collected all the antibiotic procurement records from the CBP system between 2012 and 2016. Antibiotic consumption data were calculated using Anatomical Therapeutic Chemical (ATC)/DDD methodology and normalized using DDD per 1000 inhabitants per day (DID).Results: Overall antibiotic consumption increased from 12.859 DID in 2012 to 15.802 DID in 2014, then decreased to 13.802 DID in 2016. The top three antibiotics consumed in 2016 were penicillins (4.251 DID), quinolones (2.957 DID) and macrolides (2.057 DID). PHCs consumed 80% of the total antibiotics, of which rural PHCs accounted for 88%. Antibiotic consumption peaked in 2014 for rural PHCs and in 2015 for hospitals, and declined thereafter. In urban PHCs, the consumption steadily increased from 2012 to 2016.Conclusions: Zero mark-up drug policies and national policies to improve rational use of antibiotic were associated with the reduction of antibiotic consumption in public healthcare institutions in Shandong Province. Regulations for antibiotic use in PHCs should be strengthened. [ABSTRACT FROM AUTHOR]

In international relations, globalization transfers the location of governance from nation-states laterally to such private actors as nongovernmental organizations (NGOs) and multinational firms, as well as vertically to local governments and supranational organizations. The purpose of this article is to clarify how the competitions among firms affect the problem of global issues by examining the case of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and public health. This study shows why most of least developed countries implemented the TRIPS despite the warning of NGOs not to implement earlier for the sake of access to medicines. In order to understand the positive attitude of least developed countries toward the TRIPS, we have to examine how the distribution of pharmaceutical firms capacities in developing countries affect the implementation of the TRIPS Agreement. The existence and different capacities of generic pharmaceutical companies in developing companies are important elements of state policy toward the TRIPS. [ABSTRACT FROM AUTHOR]

Background: In May 2016, the UK Government enacted the Psychoactive Substances Act which made it an offense to produce or supply many drugs including new psychoactive substances (NPS). Aim: We aimed to assess the impact of the Act on the availability of the synthetic cannabinoid receptor agonist methyl 2-[[1-(cyclohexylmethyl)indole-3-carbonyl]amino]-3,3-dimethylbutanoate (MDMB-CHMICA) from internet-based suppliers. Design: Internet snapshot availability study. Methods: We conducted two snapshot availability surveys looking at the number of websites offering to sell MDMB-CHMICA: the first in March prior to implementation of the Act and the second in June, 1 month post-implementation. Results: In March and June 2016, we identified 47 and 38 websites, respectively, which offered to sell MDMB-CHMICA. There were no significant differences in the price of the drug nor the forms available for purchase. In the June survey there was a significant decrease in the number of websites which openly stated they were based in the UK (from 14 down to 2), three websites stated that they did not supply customers based in the UK and two websites stated they had ceased sales of MDMB-CHMICA due to the Act. Conclusions: This study showed a small but limited reduction in the availability of MDMB-CHMICA from internet-based suppliers following implementation of the Act. [ABSTRACT FROM AUTHOR]

Drawing from data obtained in a comparative study of US district courts' criminal justice practices, this paper examines adjudication processing responses at the intersection of immigration and drug offences in a Southwestern federal district court, where the logic of immigration enforcement subsumes more traditional federal drug law enforcement. I demonstrate how characteristics of 'drug cases' are constructed at this intersection in such a manner that they stand apart from the prototypical federal drug case, and more closely resemble criminal immigration cases. I argue that in this border jurisdiction, the prevailing adjudicatory logic is concerned with defendants' status as unauthorized outsiders such that these defendants are barely distinguishable from immigration defendants in how their sentences are calculated and rhetorically justified. [ABSTRACT FROM AUTHOR]

The Orphan Drug Act (ODA) was an historic attempt to stimulate the development of drugs for rare diseases, intended to help bring to the market drugs for diseases that the pharmaceutical industry might otherwise not have had the financial incentives to pursue. While the intended effects of this regulatory stimulus on innovation are widely analyzed, the unintended ones remain unexplored. Thus, the objective of this paper is to analyze and conceptualize the impact of a relevant regulatory stimulus, such as the ODA, on the adoption of the open innovation paradigm in the pharmaceutical industry. Results show that the ODA made the adoption of this paradigm by large pharmaceutical companies possible, even if it partially inhibited its implementation. Finally, this study develops a framework characterizing the orphan drug development process in terms of drivers, activities, and actors. Future avenues for research are also suggested. [ABSTRACT FROM AUTHOR]

Objectives. Clinician communication with patients regarding worrisome findings in Prescription Drug Monitoring Programs (PDMPs) may influence patient responses and subsequent care. The authors studied the range of approaches clinicians report when communicating with patients in this situation and how practice policies and procedures may influence this communication. Design. Qualitative interviews of clinician PDMP users. Setting: Oregon registrants in the state's PDMP. Subjects. Thirty-three clinicians practicing in pain management, emergency medicine, primary care, psychiatry, dentistry, and surgery. Methods. The authors conducted semi-structured interviews via telephone with clinicians who routinely used the PDMP. A multidisciplinary team used a grounded theory approach to identify ways clinicians reported using information from the PDMP when communicating with patients, and policies that influenced that communication. Results. Clinicians reported using a range of approaches for communicating about PDMP results, from openly sharing, to questioning patients without disclosing access to the PDMP, to avoiding the conversation. Clinicians also reported practice policies and procedures that influenced communication with their patients about prescribing and ongoing care, including policies that normalized use of the PDMP with all patients and those that facilitated difficult conversations by providing a rationale not to prescribe in certain circumstances. Conclusion. Clinicians' self-reported approaches to sharing PDMP findings and communicating prescribing decisions with patients vary and may be facilitated by appropriate practice policies. Such communication may have implications for patient engagement and alliance building. More research is needed to identify best practices and potential guidelines for effectively communicating about PDMP findings, as this may enhance health outcomes. [ABSTRACT FROM AUTHOR]

Background: In developing countries such as Pakistan, poor training of mid-level cadres of health providers, combined with unregulated availability of labour-inducing medication can carry considerable risk for mother and child during labour. Here, we describe the exposure to labour-inducing medication and its possible risks in a vulnerable population in a conflict-affected region of Pakistan. Methods: A retrospective cohort study using programme data, compared the outcomes of obstetric risk groups of women treated with unregulated oxytocin, with those of women with regulated treatment. Results: Of the 6379 women included in the study, 607 (9.5%) received labour-inducing medication prior to reaching the hospital; of these, 528 (87.0%) received unregulated medication. Out of 528 labour-inducing medication administrators, 197 (37.3%) traditional birth attendants (also known as dai) and 157 (29.7%) lady health workers provided unregulated treatment most frequently. Women given unregulated medication whowere diagnosed with obstructed/prolonged labour were at risk for uterine rupture (RR 4.1, 95% CI 1.7-9.9) and severe birth asphyxia (RR 3.9, 95% CI 2.5-6.1), and those with antepartum haemorrhage were at risk for stillbirth (RR 1.8, 95% CI 1.0-3.1). Conclusions: In a conflict-affected region of Pakistan, exposure to unregulated treatment with labour-inducing medication is common, and carries great risk for mother and child. Tighter regulatory control of labour-inducing drugs is needed, and enhanced training of the mid-level cadres of healthcare workers is required. [ABSTRACT FROM AUTHOR]

Due to the lack of certified reference material, a reliable quantification in complex postmortem matrices can only be performed either by the addition of isotope-labelled standards or by the standard addition method. Although standard addition is a basic quantification procedure, its practical implementation is challenging, and a highly reproducible extraction method is essential. Therefore, an automated solid-phase extraction screening procedure was validated in respect to the specific requirements in postmortem analyses, using pig brain fortified with nine compounds to represent a realistic postmortem setting. The validation parameters linearity, repeatability, reproducibility and recovery were selected to test the method's 'fitness for purpose'. All obtained results were satisfying, although the method was not optimized for the selected compounds. Therefore, this validated method could be used for further standard addition experiments to evaluate the importance of the initial estimated concentration for the calculation of concentrations to set up the calibration curve. We could show that the best results were obtained when the estimated concentration was close to the real concentration. In case of a deviation, an underestimation is more favorable than an overestimation. [ABSTRACT FROM AUTHOR]

Objectives To investigate the incidence of spinal abscess and substance abuse in a tertiary care hospital after state legislation titled 'House Bill 1' (HB1) mandated stricter regulation of prescription drugs of abuse in Kentucky in 2012. Design A retrospective case series study design was used to review the incidence of spinal abscess and drug abuse diagnoses admissions from 2010 to 2014. Variances in the incidence of spinal abscess and substance abuse were plotted across this time frame. Results The incidence of intraspinal abscess increased 1.56-fold in 2011 ( n = 26) and 2012 ( n = 25) relative to 2010 ( n = 16). However, in 2013, the year following implementation of HB1 legislation, the incidence of intraspinal abscess increased 2.38-fold ( n = 38) and then 4.19-fold ( n = 67) in 2014. The incidence of intraspinal abscess in subjects with drug abuse diagnosis remained constant between 2010 ( n = 3) and 2012 ( n = 3). However, it increased twofold ( n = 7) in 2013 and then ninefold ( n = 27) in 2014. A correlation coefficient (rSAD) of 0.775 revealed a strong association between the increase incidence of intraspinal abscess and diagnosis of drug abuse. Conclusions The results of this retrospective study demonstrate an increased incidence of intraspinal abscess associated with drug abuse after passage of HB1 legislation regulating prescriptions of controlled medications in Kentucky. This increased incidence may be related to individuals relying on nonprescription drugs of abuse due to more highly regulated access to controlled prescription medications. However, additional factors unrelated to HB1 legislation must be taken into account. [ABSTRACT FROM AUTHOR]

The article highlights the evolution of dosage thresholds, their potential for unintended outcomes and advocates for evaluation of the models and adoption of mandatory education-based alternatives that will provide balance approach to the treatment of pain. Topics discussed include efforts of the state of Washington to reduce overdose by experimenting with the use of total daily dosage in their state prescribing guidelines to trigger recommendation for further action by health care provider.

Background: There is little research on how GPs experience the demands of maintaining standards of medical practice in developing countries and what strategies might improve their capability to provide high-quality primary health care (PHC).Objective: This study aims to explore the underlying factors, which shape GPs' experience within the Indonesian PHC system and impact on their experience of professional practice.Methods: A grounded theory approach was applied using semi-structured interviews of 25 purposively selected GPs in West Sumatra, Indonesia. The interviews were analysed inductively through an iterative process of the interplay between empirical data, emerging analysis and theory development.Results: Three major health care systems attribute shaped GPs' experiences of professional practice, including (i) a restricted concept of the PHC system, (ii) lack of regulation of private primary care practice conducted by GPs, midwives, nurses and specialists and (iii) low coverage and inappropriate policy of the health insurance system.Conclusion: The findings indicate that a major revision of current health care system is required with a focus on promoting the concept of PHC services to the population, redefining the role of the GP to deliver recognised best practice within available resources, changing the way GPs are remunerated by the public health system and the health insurance industry, policing of the regulations related to the scope of practice of other health care professionals, particularly midwives and nurses, and regulation of prescribing. GPs can be the champions of the PHC service that Indonesia needs, but it requires sustained systematic change. [ABSTRACT FROM AUTHOR]

The authors present a study related to changes regarding labeling of testosterone products made by regulatory agencies in Europe as of August 2015. They states a consensus made by a regulatory body of European Member States, regarding lack of evidence for adverse effect of testosterone drug on men with hypogonadism (HG) and cites recommendation of the U.S. Food and Drug Administration concerning testosterone prescription. They highlight usefulness of testosterone in HG treatment.

The article discusses a report from the National Academies of Sciences, Engineering, and Medicine which calls for the U.S. government's action on high drug prices. The report provides recommendations to increase transparency within the drug supply chain, to reform federal reimbursement policies for medications, and to expand the government's ability to negotiate drug prices. The American Society of Health-System Pharmacists (ASHP) commended the organization for addressing the issue.

The authors offer a response to a commentary made on their study which noted that the threat of antimicrobial resistance is pressing and that a vibrant antibiotic pipeline is an important social goal. Topics include flaws in a government-sponsored report to estimate the societal value of 8 antibiotics in the study, concerns on transferrable exclusivity vouchers, and the challenge in adding market incentives to make the drugs profitable.

The authors discuss a study by B. N. Rome and A. S. Kesselheim which claimed that rewarding developers of novel antibiotics with transferable exclusivity vouchers is an expensive approach to promoting antibiotic development. Topics include the incompleteness of the analysis, the inability of antibiotic developers to earn a sufficient return on investment, and number of people in the U.S. that suffer from antibiotic-resistant infections every year.

The article reports on the summaries of safety labeling changes on drugs and therapeutic biologicals approved by the U.S. Food and Drug Administration (FDA) under its MedWatch program in October-December 2020. Also cited are the use of boxed warnings to highlight serious adverse reactions and restrictions of use, as well as the drugs like Elestrin (estradiol gel), Pexeva (paroxetine mesylate), and Entereg (alvimopan).

The article offers information on the guidance issued by the U.S. Food and Drug Administration (FDA) on January 12, 2017 on repackaging drug products. Topics discussed include guidelines on the beyond-use-date (BUD) for tablets taken from a manufacturer's large container and repackaged into smaller containers, explanation given by the FDA on BUDs for pharmacy-repackaged drug products, and the biggest challenge to pharmacists, according to Eric Kastango of consulting company Clinical IQ LLC.