Social media and access to drugs online: a nationwide study in the United States and Spain among adolescents and young adults / Redes sociales y acceso online a las drogas: un estudio nacional en EE UU y España entre adolescentes y adultos jóvenes

Drugs are sold on both dark web services and on social media, but research investigating these drug purchases online is still emerging. The aim of this study is to analyze risk factors associated with buying drugs online. Utilizing theories of criminology and addiction research, it was hypothesized that social bonds, low levels of self-control, and poor mental health are associated with buying drugs online. Additionally, it was predicted that purchases of drugs online would mediate the relationship between low self-control and regular drug use. Participants of this nationwide study were 15 to 25 years old living in the United States (N = 1,212) and Spain (N = 1,212). Measures of impulsivity, a sense of mastery, social belonging, psychological distress, excessive behaviors (drinking, gambling and internet use) were utilized to predict purchasing drugs online. Two percent of the U.S. and Spanish respondents reported buying drugs online with 77% of them utilizing social media services to buy drugs. Results from multinomial logistic regression, penalized maximum-likelihood logistic regression, and binary mediation regression models indicated that buying drugs online was associated with lower self-control, higher psychological distress, and excessive gambling behavior and excessive Internet use. Having online friends was not a risk factor, but having strong social bonds with offline friends served as a protective factor. Additionally, buying drugs online mediated the relationship between low self-control and regular use of drugs. Results indicate that more focus should be placed on mainstream social media services as sources of drug acquisition as online drug buyers have multiple self-control and mental health problems

Las drogas se venden en páginas web oscuras y en las redes sociales, aunque la investigación de estas adquisiciones online está aún en sus comienzos. Este estudio tiene como objetivo examinar los factores de riesgo vinculados a la compra de drogas online. De acuerdo con las teorías de la criminología y la investigación sobre adicciones, se planteó la hipótesis de que los vínculos sociales, el bajo nivel de autocontrol y los problemas de salud mental están relacionados con la compra online de drogas. Además, se postuló que la adquisición online de drogas estaría mediada por la relación entre el bajo autocontrol y el consumo frecuente de drogas. Participaron en el estudio un total de 2,424 jóvenes residentes en Estados Unidos (N = 1,212) y en España (N = 1,212), que fueron evaluados en impulsividad, sensación de dominio, pertenencia social, malestar psicológico, comportamientos abusivos (bebida, juego y utilización de internet) , con el objetivo de predecir la compra online de drogas. El 2% de los participantes de EE UU y España dijeron que compraban drogas online, de los cuales el 77% utilizaba servicios de redes sociales para tal fin. Los resultados de una regresión logística multinomial, regresión logística de máxima verosimilitud penalizada y modelos de regresión de mediación binaria mostraron que la adquisición online de drogas se relaciona con un menor autocontrol y un mayor malestar emocional y abuso del juego, y del uso de internet. El hecho de tener amigos por internet no constituía un factor de riesgo y tener vínculos sociales estrechos con amigos fuera de internet constituía un factor protector. A su vez, la compra online de drogas es un factor que media la relación entre bajo autocontrol y uso habitual de drogas. Los resultados sugieren que debería prestarse mayor atención a las redes sociales como medio habitual de adquisición de drogas, dado que los compradores online de drogas tienen múltiples problemas de salud mental y autocontrol

Community Pharmacies in Poland-The Journey from a Deregulated to a Strictly Regulated Market.

Community pharmacies are the primary entities providing drugs to individual patients in Poland. The pharmacy market has been changing for many years due to significant changes in market regulations. These changes significantly affect the profitability of pharmacies, which may impact the quality of pharmacotherapy. The small number of pharmacies, which resulted from changes in the law in 2017, can influence the level of patient care. The article presents the community pharmacies market in Poland. Particular attention is paid to the legal regulations affecting community pharmacies and the impact of these regulations on the overall shape of the market. The Polish system's specificity, including the pharmacy market indicators, has been compared with data from other European Union countries.

Nonclinical safety assessment of epigenetic modulatory drugs: Current status and industry perspective.

Pharmaceutic products designed to perturb the function of epigenetic modulators have been approved by regulatory authorities for treatment of advanced cancer. While the predominant effort in epigenetic drug development continues to be in oncology, non-oncology indications are also garnering interest. A survey of pharmaceutical companies was conducted to assess the interest and concerns for developing small molecule direct epigenetic effectors (EEs) as medicines. Survey themes addressed (1) general levels of interest and activity with EEs as therapeutic agents, (2) potential safety concerns, and (3) possible future efforts to develop targeted strategies for nonclinical safety assessment of EEs. Thirteen companies contributed data to the survey. Overall, the survey data indicate the consensus opinion that existing ICH guidelines are effective and appropriate for nonclinical safety assessment activities with EEs. Attention in the framework of study design should, on a case by case basis, be considered for delayed or latent toxicities, carcinogenicity, reproductive toxicity, and the theoretical potential for transgenerational effects. While current guidelines have been appropriate for the nonclinical safety assessments of epigenetic targets, broader experience with a wide range of epigenetic targets will provide information to assess the potential need for new or revised risk assessment strategies for EE drugs.

Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned.

Jane H. Mashingia and colleagues reveal the progress made to date for the East African Community Medicines Regulatory Harmonization initiative.

Optimizing the East African Community's Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future.

Margareth Ndomondo-Sigonda outlines future challenges for the East African Medicines Regulatory Harmonization initiative.

Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative.

Hiiti Sillo and colleagues reveal how the East African Community's Medicines Regulatory Harmonization initiative improves access to important medicines in Africa.

Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?

The scientific community has risen to the coronavirus disease 2019 (COVID-19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate treatments may be frustrated by the absence of comprehensive trial coordination mechanisms. Many small stand-alone trials and observational studies of single-agent interventions are currently running or in planning; many of these will likely not deliver robust results that could support regulatory and patient-level treatment decisions. In this paper, we discuss actions that all stakeholders in the clinical trial ecosystem need to take to ensure that the window of opportunity during this pandemic will not shut, both for patients in need of treatment and for researchers to conduct decision-relevant clinical trials.

Impact of the EMA/FDA alerts on the use of effective contraceptive method in women of childbearing age undergoing valproic acid treatment in a long-stay psychiatric center.

OBJECTIVE: We aimed to evaluate the impact of the European Medicines Agency (EMA) and Food Drug and Administration (FDA) alerts on the use of effective contraceptive method in women of childbearing age undergoing valproic acid treatment in a long-stay psychiatric center. MATERIAL AND METHODS: An interrupted time-series analysis of women of childbearing age admitted in a long-stay psychiatric center (2013-2019), according to the EMA/FDA restrictions dates (October 2014 and February 2018). RESULTS: Of the 82 cases included, 50 (61.0%) had an 'off-label' prescription. The percentage of cases with a contraceptive method before October 2014 (31.6%) increased to 61.5% after October 2014, p = 0.004. Women with an 'off-label' prescription after 2018 were more likely to use a contraceptive method than those before 2014, and there were not statistically significant differences in women with an 'under indication' prescription. CONCLUSIONS: The recent regulatory restrictions on the use of a contraceptive method had a positive effect, mainly in women with an 'off-label' prescription. No effect was seen in women with epilepsy, probably because the intervention had started long before.

Drug Enforcement Agency 2014 Hydrocodone Rescheduling Rule and Opioid Dispensing after Surgery.

BACKGROUND: In 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients. METHODS: The authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling's impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively. RESULTS: The sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, -1.1%; 95% CI, -2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2-56.7 mg; P < 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, -5.5% to -2.7%; P < 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6-54.8 mg; P = 0.008) in opioids dispensed within 30 days. CONCLUSIONS: Among patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery.

Policy impact: When policy fails.

The best policies are evidence-based, providing feasible solutions to healthcare issues to prevent unintended consequences. Nurse researchers need to generate evidence with which to create policy. The obligation to monitor the impact of policies and standards rests on nurse leaders who have the duty to advocate when policies fail. Nurses providing direct care are beholden to report failed policies. Advocacy in the situation of a failed policy often requires moral courage to prevent moral distress amongst the ranks of nurses who enact policies at the intersect of care. In this article, the impact of three healthcare policy issues on nursing end-users will be evaluated: aid in dying, titration of vasoactive medications, and the Center for Medicare and Medicaid Services 30-minute rule.

Appraisal of the entrustable professional activities (EPAs) patient care provider domain by North Dakota pharmacists

BACKGROUND: Entrustable Professional Activities (EPAs) are the latest addition to a list of professional competencies that pharmacy educational organizations support, and accreditation organizations require, for assessment by colleges and schools of pharmacy. OBJECTIVE: The study's objective is to assess the use of Core EPAs in the patient care domain (by practice setting, position, and preceptor status) in contemporary pharmacy practice. METHODS: This survey assessed the EPA activities of pharmacists practicing in North Dakota. The pharmacists were asked "how many times in the past 30 days have you delivered the following services in your practice setting?" Response options were: 0, 1, 2, 3, 4, and 5 or more times. RESULTS: Of 990 potential respondents, 457 pharmacists (46.1%) returned a survey, and 107 (10.8%) answered every survey item in the patient care domain. Respondents reported that the highest rated activity items "Collect information to identify a patient's medication-related problems and health-related needs," and "Analyze information to determine the effects of medication therapy, identify medication-related problems, and prioritize health-related needs" were performed an average of 3.9 times per week (SD=1.8), and 3.8 times per week (SD=2.0), respectively. Both of these items, were reported for 70% of the respondents at 5 or more times per week. For these items, the highest reported practice setting was 'other' practice settings (e. g. , long-term care, community health centers) followed by chains, hospitals, and independent pharmacies. By position, clinical pharmacists and preceptors reported the highest activity levels for most EPAs and supportive example tasks. CONCLUSIONS: This study provides empirical evidence suggesting (but not proving) that EPAs have potential as a means to assess outcomes in pharmacy education and practice. Our study sets the stage for future work that further refines and assesses core EPA activities and supportive example tasks to measure the impact of how this process relates to outcomes of care

No disponible

The Extent of Extemporaneous Preparation and Regulatory Framework of Extemporaneous Compounding in Latvia.

Background and objectives: Extemporaneous preparations are pharmaceutical preparations individually prepared for a specific patient or patient group, but also high-risk products accompanied by doubts regarding their safety and quality. Legislation regulating the compounding of extemporaneous preparations is not harmonized among European countries. This problem is partially resolved by Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. In order to understand the relevance of extemporaneous compounding in Latvia and the fulfillment of the abovementioned resolution's requirements, it is essential to get information about the volume and breakdown of sales of extemporaneous medicinal products in community pharmacies. The purpose of this survey is to identify the sales volume of extemporaneous preparations in community pharmacies in Latvia in 2017 by analyzing unpublished data of the State Agency of Medicines (SAM), as well as comparing Latvian laws with the requirements of the resolution. Materials and Methods: A separate Microsoft Excel spreadsheet was prepared for each statistical region in order to summarize the unpublished information of SAM on the turnover of extemporaneous preparations in 2017 in all Latvian statistical regions. In order to compare the regulatory framework in Latvia with the resolution, the Latvian Pharmaceutical Law and the Cabinet of Ministers Regulations regulating prescription, compounding and control of extemporaneous preparations in community pharmacies were analyzed. Results: Only 280 of 384 pharmacies submitted a report of sales of extemporaneous preparations for 2017 to the SAM. These pharmacies represented all Latvian statistical regions. Extemporaneous preparations were mostly sold in Riga (78.93%). The Latvian regulation does not include all paragraphs of the resolution. Most of the paragraphs of the resolution are described in Latvian regulatory enactments only partially. Conclusions: The total number of compounding pharmacies evidence that the service is needed. Latvian example highlights a necessity for European Union countries to compare their national legislation with the requirements of the resolution's last version and, if necessary, implement relevant amendments.