Risk Factors of Suicidal Ideation in Iraqi Crystal Methamphetamine Users.

Crystal methamphetamine, a potent psychostimulant, presents a complex clinical landscape. However, insights into the predisposing factors for suicidal tendencies among Iraqi users remain limited. Our study delves into these risks among 165 patients. Rigorous multivariable analysis was conducted, employing binary logistic regression, drawing from patients from Baghdad Medical City and Ibn-Rushd Teaching Hospital. Most participants were in their third decade (26.62 ± 0.53 years). Regarding suicidal ideation, our model demonstrated robust accuracy, supported by the Hosmer-Lemeshow goodness-of-fit test (NagelKerke's R2 = 0.49, accuracy = 79.4%, p = 0.885). Notably, chronic methamphetamine use exceeding a year (OR = 6.15, p = 0.001), absence of psychological trauma (OR = 4.58, p = 0.006), and incidence of visual hallucinations (OR = 4.52, p = 0.001) rendered users more susceptible to suicidal ideation. Furthermore, our investigation unveiled risk factors tied to psychotic features and withdrawal manifestations. The study underscores pivotal predictors of suicidal ideation, warranting interdisciplinary vigilance from psychiatrists, clinical psychologists, and social workers. By monitoring at-risk individuals, progression toward the intricate spectrum of suicide can be potentially averted. These findings illuminate the urgency of tailored interventions for crystal methamphetamine users, contributing to enhanced holistic care.

Impact of risk communication on patient's safety during the pandemic.

More than 2 years has passed since the pandemic was declared in 2019 due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was later declared to be the pathogen causing coronavirus disease 2019 (COVID-19). During this time, many healthcare systems faced numerous challenges to control the high morbidity and mortality of the disease. Unlike previous pandemics, the actions against this pandemic started quickly on both the global and country levels. These actions were, scientifically, to study the virus as well as transmission process and to develop medications and vaccines against it. Also, we had to protect people from transmission by knowing how best to apply precautionary methods. However, there were some unexpected negative consequences of the pandemic and one of those the World Health Organization (WHO) called 'infodemic'. This term infodemic refers to the manipulation of a population's behavior in the assessment of information (or, more accurately, lack of assessment) related to the use of medications, particularly vaccines. Unfortunately, even with positive development in science, there was limited and often contradictory amount of information on the safety and efficacy profile of drugs and vaccines. Therefore, this made it harder for public health agencies to determine the impact of the incidence of adverse reactions and events associated with interventions such as vaccines. Hence, risk communication needs to be emphasized during any pandemic, as ignoring risk communications to different stakeholders could undermine all well-intended therapeutic interventions. Given this, it is important that the different stakeholders involved (health authorities, societies, healthcare professionals, etc.) assess the different behavioral patterns within their respective populations and propose appropriate strategies to act. Such an approach complement having risk management and communication plans for this and future pandemics. The aim of this article is to explore how information management, risk management, and risk communication during the pandemic can provide valuable lessons for the future. Plain language summary: Impact of risk communication on patient's safety during the pandemic More than 2 years have gone by since the pandemic was declared in 2019 due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Many challenges have been confronted by the healthcare system during this time to control the high impact of this disease. This pandemic, unlike others that humanity has faced, is characterized by a special feature: today, we have an enormous amount of information only a click away. This situation has been of great benefit to humanity and has allowed the development of science; nevertheless, misinformation (infodemics) has been a major problem, which has revealed the behavior of the population regarding the evaluation of information (or better, lack of assessment) related to the use of medications and particularly of vaccines. Given this, it is important that the different people involved (health authorities, societies, healthcare professionals, etc.) assess the behavior and propose appropriate strategies to act and have plans for this and future pandemics. This article intends to explore from the authors' perspective how information management, risk management, and risk communication during the pandemic can provide valuable lessons for the future.

Pharmacovigilance regulatory actions by national pharmacovigilance centers in Arab countries following COVID-19 pandemic.

BACKGROUND: Pharmacovigilance (PV) activities were affected by COVID-19. Therefore, several health authorities around the world have issued guidelines and practices to ensure that PV activities are maintained and continued during the pandemic. This study aimed to assess the impact of COVID-19 on the preparedness and performance of national PV systems in 14 Arab countries. RESEARCH DESIGN AND METHODS: This was a cross-sectional study that was conducted between July and October 2020. National PV centers in 18 Arab countries were invited to participate in this study. Descriptive analysis was used to summarize and present the results of this study. RESULTS: Responses were obtained from 14 (77.8%) countries. Adverse events reporting was the main PV activity that was covered by PV guidelines and practices. National guidelines and practices covered other PV activities in 8 (57.14%) of the participating countries. Performance and practices of national PV centers vary considerably among participating countries during the pandemic. CONCLUSION: The findings highlight the differences in preparedness and performance of different national PV centers in participating Arab countries. Improving digital infrastructure among participating countries could serve as a useful tool to minimize the impact of the pandemic on PV activities.

The whole experience of public hospital physicians from several specialties with biopharmaceutical effectiveness, safety, adverse drug reactions and interchangeability: A qualitative study.

Background: Although there is increasing support for biosimilar medicines by the Iraqi Ministry of Health (MOH), there is scarce information about whether physicians accept these medicines and support movement toward replacing reference medicines with their biosimilar counterparts. Objectives: The study objectives were to 1) explore in-depth the perceptions of Iraqi physicians working in public hospitals about the difference in effectiveness and safety between biosimilar medicines and their reference biological counterparts, 2) evaluate physicians' barriers to prescribing biosimilar medicines, 3) assess the adherence of physicians to the new pharmacovigilance regulations on reporting biopharmaceutical adverse drug reactions (ADRs) and 4) identify any barriers facing physicians to reporting biopharmaceutical- ADRs. Methods: This qualitative study included face-to-face and virtual semi-structured interviews involving physicians from different disciplines who had experience with biological or biosimilar medicines. The interviews were conducted between November 6, 2020, and February 7, 2021. Thematic analyses were used to analyze qualitative data generated from the interviews. Results: The study sample included 36 physicians (6 women and 30 men) from seven different specialties at ten governmental hospitals mainly in Baghdad, and one physician was from Mosul, Iraq. Because most physicians had insufficient experience with biosimilar medications and were not sure about their effectiveness, the majority were hesitant to prescribe them. Most physicians preferred to prescribe reference biological medicines initially. However, the initial prescribing and switching between a reference and counterpart biosimilar relies on its availability. They chose biosimilar medications that have been approved by the U.S. FDA or EMA. Most physicians were unaware about the new pharmacovigilance regulations to report adverse biopharmaceutical reactions. The physicians tended to underreport biopharmaceutical ADRs and believed that inadequate physician-pharmacist collaboration negatively impacts preventing and reporting ADRs. Conclusions: Medicine procurement in healthcare settings should focus on sustainably securing high-quality biopharmaceuticals rather than looking only at costs to enhance physician experience and patient clinical outcomes. Promoting documentation, monitoring, and physician-pharmacist collaboration is pivotal to prevent, monitor, and treat biopharmaceutical ADRs.

Spatiotemporal Mapping of Online Interest in Cannabis and Popular Psychedelics before and during the COVID-19 Pandemic in Poland.

BACKGROUND: Psychedelics represent a unique subset of psychoactive substances that can induce an aberrant state of consciousness principally via the neuronal 5-HT2A receptor. There is limited knowledge concerning the interest in these chemicals in Poland and how they changed during the pandemic. Nonetheless, these interests can be surveyed indirectly via the web. OBJECTIVES: We aim to conduct a spatial-temporal mapping of online information-seeking behavior concerning cannabis and the most popular psychedelics before and during the pandemic. METHODS: We retrieved online information search data via Google Trends concerning twenty of the most popular psychedelics from 1 January 2017 to 1 January 2022 in Poland. We conducted Holt-Winters exponential smoothing for time series analysis to infer potential seasonality. We utilized hierarchical clustering analysis based on Ward's method to find similarities of psychedelics' interest within Poland's voivodships before and during the pandemic. RESULTS: Twelve (60%) psychedelics had significant seasonality; we proved that psilocybin and ayahuasca had annual seasonality (p-value = 0.0120 and p = 0.0003, respectively), and four substances-LSD, AL-LAD, DXM, and DOB-exhibited a half-yearly seasonality, while six psychedelics had a quarterly seasonal pattern, including cannabis, dronabinol, ergine, NBOMe, phencyclidine, and salvinorin A. Further, the pandemic influenced a significant positive change in the trends for three substances, including psilocybin, ergine, and DXM. CONCLUSIONS: Different seasonal patterns exist for psychedelics, and some might correlate with school breaks or holidays in Poland. The pandemic induced some changes in the temporal and spatial trends. The spatial-temporal trends could be valuable information to health authorities and policymakers responsible for monitoring and preventing addictions.

Pharmaceutical regulations in Iraq: from medicine approval to postmarketing.

BACKGROUND: Recent information on regulation of the pharmaceutical sector in Iraq is scarce. AIMS: This report summarizes the regulations governing pharmaceutical products in Iraq, assesses the challenges faced and makes recommendations to tackle these issues. METHODS: The Iraq pharmaceutical country profile 2020, prepared by the Iraqi Ministry of Health in collaboration with the World Health Organization (WHO) in 2020, was the main source of information. RESULTS: Despite all the efforts by the Ministry of Health to provide adequate and safe medicines, the Iraqi pharmaceutical sector has several challenges, including inadequate budget allocated to the ministry, shortages in essential medicines, underutilization of electronic technologies in the management of regulation-related work, a large number of substandard and falsified medications in the private sector and a stagnant national pharmaceutical industry. CONCLUSION: The Ministry of Health needs more financial support from the federal government to fund its activities and technical support from international health organizations to provide training and resources.

The Epidemic of Substandard and Falsified Medications in Iraq: Evaluating the Effectiveness of National Pharmacovigilance Alerts to Community Pharmacies.

BACKGROUND: Assessing Iraqi experience with the impact of substandard and falsified (S/F) medicines can help other countries deal comprehensively with the underlying causes of this multifactorial problem. The tools used in this study to assess strategies to prevent the use of S/F medications can be used in other developing countries. This study investigated the problem of S/F medications at three levels: the Ministry of Health (MOH), pharmaceutical company representatives, and community pharmacists. OBJECTIVES: Study objectives were to evaluate the effectiveness of alerts about S/F medications issued by the national Iraqi Pharmacovigilance Center (IqPhvc) to community pharmacies and to explore the reasons and potential solutions for this problem from the perspective of both pharmaceutical companies and pharmacists. METHODS: This was an exploratory mixed-method study. The qualitative phase comprised seven 1-h semi-structured interviews and one focus group conducted via Zoom. Thematic analysis was used to analyse the qualitative data. The findings of the qualitative phase were then used to develop the survey items. The quantitative phase included an electronic survey distributed among pharmacists via two professional Facebook groups between 23 April and 19 May 2020. The Kruskal-Wallis test was used to measure differences in pharmacists' knowledge of and ability to detect S/F medications according to their years of experience in the private sector. RESULTS: Over the last 5 years (2016-2020), the IqPhvc received 183 reports about S/F medications from representatives of 25 international companies. Only 29 (15.8%) of the reports were about falsified medications; the majority were about substandard (parallel) medicines. We interviewed 12 pharmacists (11 male, 1 female) representing ten large international pharmaceutical companies. We also received surveys from 590 pharmacists, of whom 475 (80.9%) were women. Although 72% of the participants had not received any training in the identification of S/F medications, 59.4% of them easily identified S/F medications. Likewise, approximately three-quarters of the participating pharmacists recognized genuine registered medications through three means: medication price sticker, cost, and packaging features. Although 61% of the pharmacists followed-up alerts about S/F medications, only 25.6% were willing to report S/F medications. CONCLUSIONS: Most reports to the IqPhvc were about substandard medications. Participants of the two study phases agreed on several reasons for the problem of S/F medications, including their low prices, the unavailability of registered medications, the lengthy medicine registration process, and inadequate awareness of S/F medications among healthcare providers and the public. They also agreed that national alerts and price stickers are helpful in the identification of S/F medications. Community pharmacists can increase their efforts to report S/F medicines, but they need training, awareness, and tools. The study highlighted the need for a track-and-trace system to detect S/F medicines in the supply chain. In brief, the problem of S/F medication is multifaceted. Reducing it will require effective collaboration among different entities, including health officials, border agencies, healthcare providers, and registered pharmaceutical companies.

Iraqi regulatory authority current system and experience with biosimilars.

Biological medicines have significantly altered treatment for many patients with chronic diseases such as cancers, autoimmune diseases, and diabetes. However, the high cost of biological medicines has limited patients' access to them. Iraq is one of the countries that have decided to increase access to these medicines through biosimilars, which are copies of originator biological medicines. Prior to 2019, the Iraqi National Regulatory Authority (NRA) had no clear guidelines in place for biosimilars uptake. Therefore, approvals of many biosimilars were delayed. As a response to that, a new pivotal committee was found within this authority, and the first version of Iraqi basis and guidelines for the approval of biosimilars was enacted. With the implementation of the Iraqi biosimilars guidelines and escalating the cooperation within the Iraqi NRA, many benefits have been attained in a short time including the approval of many essential biosimilar products which has resulted in a total cost savings estimated to exceed 50 million USD in just the year 2020. However, there are still some barriers towards making the utmost benefit from biosimilars in Iraq, such as lack of familiarity of these products among the Iraqi health care providers which requires appropriate biosimilars-awareness enhancement strategies.