International Journal of Risk & Safety in Medicine - Volume 30, issue 2

Authors: Danborg, P.B. | Valdersdorf, M. | Gøtzsche, P.C.

Article Type: Review Article

Abstract: BACKGROUND: Millions of people are treated with antidepressants like selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This clinical practice is based on short-term trials that have exaggerated the benefits and underestimated the harms. We also know too little about long-term harms. AIM: To assess harms of SSRIs and SNRIs that persist after end of drug intake. METHODS: Systematic review of placebo-controlled randomised trials of any length in patients with a psychiatric diagnosis and a follow-up of at least six months. Our primary outcomes were mortality, functional outcomes, quality of life and core psychiatric …events. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials and checked the references for eligible articles. One researcher extracted data and another checked the data extraction. RESULTS: Our searches returned 9,153 unique records. We included 22 papers for 12 trials on SSRIs. Median intervention and follow-up periods were 15 and 52 weeks, respectively. Median number of randomised participants was 51; only two trials had a drop-out rate below 20%. Outcome reporting was less thorough during follow-up than for the intervention period and only two trials maintained the blind during follow-up. All authors concluded that the drugs were not beneficial in the long term. All trials reported harms outcomes selectively or did not report any. Only two trials reported on any of our primary outcomes (school attendance and number of heavy drinking days). CONCLUSION: The randomised trials currently available cannot be used to investigate persistent harms of antidepressants. Show more

Keywords: SSRI, harms, long-term, antidepressants, SNRI

DOI: 10.3233/JRS-180046

Citation: International Journal of Risk & Safety in Medicine, vol. 30, no. 2, pp. 59-71, 2019

Authors: Sridharan, Kannan | Sivaramakrishnan, Gowri | Kanters, Steve

Article Type: Review Article

Abstract: BACKGROUND: Data regarding the relative safety profile of anti-malarial drugs in pregnancy is sparse mainly limited by the absence of head-to-head clinical trials. The present study is a network meta-analysis of safety of anti-malarial drugs used to treat malaria in pregnant women. METHODS: A thorough literature search using the search strategy “Malaria [tiab] AND (Pregnant [tiab] OR Pregnancy [tiab])” was carried out for either randomized controlled trials or prospective cohort studies in pregnant malarial women prescribed any of the recommended anti-malarial drugs by World Health Organization (WHO) and that have reported adverse pregnancy outcomes such as miscarriage, still …birth, and neonatal deaths. Odds ratio with 95% confidence interval was used as the effect estimate. Random-effects model and Markov Chain Monte Carlo simulation method was used to generate pooled estimates. Sensitivity analysis was performed excluding data from first trimester and GRADE approach was used to categorize the quality of evidence. RESULTS: A total of 1242 papers were obtained with the search strategy, of which seven evaluating 10 treatment arms in a total of 5510 participants were included in the present meta-analysis. The pooled estimates revealed significantly lower risks of abortion with quinine and artemisinin-lumefantrine compared to dihydroartemisinin-piperaquine, artesunate with mefloquine and artesunate with amodiaquine. But when a cohort study that was conducted in the first trimester of pregnancy was excluded, no significant differences were observed in the risk of abortion between the anti-malarial drugs. No significant differences in the risk of either stillbirths or neonatal deaths were observed with any of the drugs. The quality of evidence was found to be very low due to serious limitations in both the precision and indirectness. CONCLUSION: WHO recommended anti-malarials in pregnancy have similar risk profiles with regard to abortion, stillbirth and neonatal deaths. Show more

Keywords: Pregnant malaria, artemisinin, ACT, chloroquine, quinine

DOI: 10.3233/JRS-180022

Citation: International Journal of Risk & Safety in Medicine, vol. 30, no. 2, pp. 73-89, 2019

Authors: Chhabra, Anuj | Nidhi, C. | Jain, Anurag

Article Type: Research Article

Abstract: BACKGROUND: There has been an increasing need to examine undergraduate dental education in prescribing to confirm whether it is establishing the goal of producing safe and rational prescribers. Prescribing by dental doctors after graduation is influenced by a variety of factors: the different teaching approaches of the professors at the clinics and in the pharmacology course, fellow colleagues and even the information provided by the pharmaceutical industry. OBJECTIVE: The aim of this study was to assess the prescription knowledge, attitude, preference and common errors made by junior resident dental doctors in the dental department of two medical colleges …and hospitals in India. METHODS: Dental graduates (n  = 70) who served as junior resident doctors at dental departments and graduated from various dental colleges in India, participated in the study. A survey was conducted among 70 junior resident dental doctors in the dental department, applying a previously validated questionnaire consisting of open-ended questions. The knowledge, attitude and practice preference of resident doctors regarding drug prescription and common errors made by them were analyzed and reviewed. RESULTS: The most frequent response to each question was considered the most significant. The most common reason for prescribing medication was infection (n  = 33, 47.14%) and the most widely prescribed antibiotic was amoxicillin (n  = 29, 41.42%). The most frequent error reported by resident doctors was lack of knowledge about drug posology (n  = 31, 44.28%). Maximum number of junior doctors acquired the information for prescribing drugs from their faculty (n  = 33, 47.14%). Around 45.71% dental doctors had no knowledge about the WHO Guide to Good Prescribing. About 50– 60% doctors had knowledge about the dose, frequency, duration and route of administration of the drug prescribed. While prescribing drugs to the patient, 25.71% doctors explain the disease and treatment properly to the patient; 24.28% doctors do not criticize other doctors, and 10% doctors address the patient by name. CONCLUSION: The results of this study indicate that resident dental doctors’ knowledge, attitudes and behavior about the drug prescription need to be improved. More studies are needed to determine whether this issue affects the quality of patient care and the effectiveness and safety of treatments. Show more

Keywords: Prescription, dental prescription, dental junior residents, doctors, drugs, knowledge

DOI: 10.3233/JRS-180021

Citation: International Journal of Risk & Safety in Medicine, vol. 30, no. 2, pp. 91-100, 2019

Authors: Ambade, Preshit Nemdas | Katragadda, Chinmayee | Sun, Diana | Bootman, J. Lyle | Abraham, Ivo

Article Type: Research Article

Abstract:  This paper argues that health policies should transcend national boundaries yet should not reach the supranational level. Along with multinational global health efforts, such cross-national health policies are essential to leverage joint efforts by countries learning from their peers that experience similar health system challenges. In our analysis, we used World Bank Health, Nutrition, and Population (HNP) data from 1995 to 2014 for East Asia Pacific (EAP) countries to explore health system comparability across member nations. We applied a hierarchical cluster analysis using Ward’s method and a squared Euclidean distance approach to classify 24 EAP countries into four relatively stable …clusters based on their (dis)similarities over nine selected health expenditure and health system performance related indicators. One-way analysis of variance (ANOVA) was used to assess the discreteness of the formed clusters. Each cluster had unique characteristics based on the included indicators and health system performance of the member countries. We present transnational health policy recommendations for the EAP region based on both our use of robust methodology and the resulting comparative clusters. Show more

Keywords: East Asia Pacific countries, EAP, hierarchical cluster analysis, transnational health policies, health system research, world bank health nutrition and population statistics database

DOI: 10.3233/JRS-199001

Citation: International Journal of Risk & Safety in Medicine, vol. 30, no. 2, pp. 101-125, 2019