scholarly journals Viewpoint: The New Zealand Centre for Adverse Reactions Monitoring: a source of practice-based evidence

2013 ◽  
Vol 5 (2) ◽  
pp. 170 ◽  
Author(s):  
Ruth Savage
Keyword(s):  
New Zealand ◽  
Observational Studies ◽  
Adverse Reactions ◽  
Case Reports ◽  
Case Series ◽  
Sufficient Evidence ◽  
Drug Reactions ◽  
Prescribing Practices ◽  
Valuable Contribution ◽  
Primary Health

The database of the New Zealand Centre for Adverse Reactions Monitoring (CARM) is an example of the practice-based evidence discussed in the June issue of the Journal of Primary Health Care. Databases of reported adverse drug reactions (ADRs) were established to generate hypotheses to be tested about previously unrecognised adverse reactions and interactions. Occasionally they are sufficient evidence in themselves. They can also identify prescribing practices that might increase the potential for ADRs to occur and provide feedback into guidelines in terms of the consequences of their use or non-use. Well-documented ADR reports can also highlight risk factors, thus providing a valuable contribution to risk benefit assessments in individual patients. Examples are discussed that support the use of ADRs as practice-based evidence in a non-hierarchical system in which case reports and case series, observational studies and randomised clinical trials contribute in a flexible relationship depending on the issue under investigation.

scholarly journals Zolpidem for Insomnia: A Double-Edged Sword. A Systematic Literature Review on Zolpidem-Induced Complex Sleep Behaviors

2021 ◽  
pp. 025371762199237
Author(s):  
Niti Mittal ◽  
Rakesh Mittal ◽  
M. C. Gupta
Keyword(s):  
Adverse Reactions ◽  
Case Reports ◽  
Case Series ◽  
Eligibility Criteria ◽  
Study Objective ◽  
Spontaneous Reports ◽  
Cochrane Database ◽  
Sleep Behaviors ◽  
Therapeutic Doses ◽  
Favorable Side Effect Profile

Background: Being a nonbenzodiazepine, zolpidem is believed to have a favorable side-effect profile and is widely prescribed for insomnia. However, in the past few years, numerous neuropsychiatric adverse reactions, particularly complex sleep behaviors (CSBs), have been reported with zolpidem. Objective: To conduct a systematic review of zolpidem-associated CSBs. Data Sources: An electronic search was conducted using MEDLINE, Embase, PubMed, and Cochrane database of systematic reviews to extract relevant articles till July 2020. Study Eligibility Criteria: Any type of literature article (case report, case series, and observational or interventional study) reporting CSBs associated with zolpidem. Results: In this review, we present aggregate summarized data from 148 patients presenting with zolpidem-induced CSBs (79 patients from 23 case reports and 5 case series; 69 patients out of 1454 taking zolpidem [4.7%] from three observational clinical studies). Various types of CSBs associated with zolpidem were reported, most common being sleepwalking/somnambulism and sleep-related eating disorder. On causality assessment, around 88% of cases were found to have a probable association with zolpidem. Limitations: Extraction of data from observational studies and spontaneous reports, due to nonavailability of any randomized controlled trials relevant to the study objective. Conclusion and Implication of Key Findings: Zolpidem-induced CSBs, although not very common, may develop when the drug is used at therapeutic doses for insomnia. Doctors need to be alert to monitor such adverse effects of zolpidem and exercise caution while prescribing it.

scholarly journals Ayahuasca, dimethyltryptamine, and psychosis: a systematic review of human studies

2017 ◽  
Vol 7 (4) ◽  
pp. 141-157 ◽  
Author(s):  
Rafael G. dos Santos ◽  
José Carlos Bouso ◽  
Jaime E. C. Hallak
Keyword(s):  
Systematic Review ◽  
Family History ◽  
Adverse Reactions ◽  
Population Studies ◽  
Case Reports ◽  
Case Series ◽  
Lysergic Acid ◽  
Psychotic Illness ◽  
History Of ◽  
Low Incidence

Ayahuasca is a hallucinogen brew traditionally used for ritual and therapeutic purposes in Northwestern Amazon. It is rich in the tryptamine hallucinogens dimethyltryptamine (DMT), which acts as a serotonin 5-HT2A agonist. This mechanism of action is similar to other compounds such as lysergic acid diethylamide (LSD) and psilocybin. The controlled use of LSD and psilocybin in experimental settings is associated with a low incidence of psychotic episodes, and population studies corroborate these findings. Both the controlled use of DMT in experimental settings and the use of ayahuasca in experimental and ritual settings are not usually associated with psychotic episodes, but little is known regarding ayahuasca or DMT use outside these controlled contexts. Thus, we performed a systematic review of the published case reports describing psychotic episodes associated with ayahuasca and DMT intake. We found three case series and two case reports describing psychotic episodes associated with ayahuasca intake, and three case reports describing psychotic episodes associated with DMT. Several reports describe subjects with a personal and possibly a family history of psychosis (including schizophrenia, schizophreniform disorders, psychotic mania, psychotic depression), nonpsychotic mania, or concomitant use of other drugs. However, some cases also described psychotic episodes in subjects without these previous characteristics. Overall, the incidence of such episodes appears to be rare in both the ritual and the recreational/noncontrolled settings. Performance of a psychiatric screening before administration of these drugs, and other hallucinogens, in controlled settings seems to significantly reduce the possibility of adverse reactions with psychotic symptomatology. Individuals with a personal or family history of any psychotic illness or nonpsychotic mania should avoid hallucinogen intake.

scholarly journals Bibliometric analysis of adverse drug reactions and pharmacovigilance research activities in Nepal

2020 ◽  
Vol 11 ◽  
pp. 204209862092248
Author(s):  
Sunil Shrestha ◽  
Krisha Danekhu ◽  
Bhuvan KC ◽  
Subish Palaian ◽  
Mohamed Izham Mohamed Ibrahim
Keyword(s):  
Bibliometric Analysis ◽  
Adverse Drug Reactions ◽  
Case Reports ◽  
Research Performance ◽  
Case Series ◽  
Original Research ◽  
Drug Reactions ◽  
Drug Induced ◽  
Scientific Publications ◽  
Research Activities

Background: Bibliometric analyses have been used previously to study the measures of quality and impact of research performed in several health-related areas such as adverse drug reactions (ADRs) and pharmacovigilance (PV), etc. This method can assess the research performance of publications quantitatively and statistically. There is no evidence of bibilometric studies analyzing ADRs and PV from Nepal. Therefore, the present study aimed to assess scientific output on ADRs and PV-related research activities in Nepal using a bibliometric analysis of publications from 2004 January to December 2018, that is, 15 years. Methods: A systematic search was conducted in PubMed, Web of Science, Google Scholar, Scopus and Nepal Journal Online (NepJOL) databases. ‘Adverse Drug Reactions‘ or ‘ADRs‘ or ‘ADR‘ or ‘Adverse drug reaction‘ or ‘AE‘ or ‘Adverse Event‘ or ‘Drug-Induced Reaction‘ or ‘Pharmacovigilance‘ or ‘PV‘ and ‘Nepal‘. The search covered 15 years (January 2004 to December 2018) of study on ADRs and PV in Nepal. Only articles retrieved from databases were included, whereas published/unpublished drug bulletins, pharmacy newsletters and thesis were excluded. The articles thus retrieved were recorded, and thereafter analyzed. Word count code was used for the analysis of keywords used in the retrieved articles. Results: A total of 124 articles were retrieved, with the highest rate of publications in 2006 and 2007, with 16 papers each. Among the articles, 10 (8.1%) were published in Kathmandu University Medical Journal (KUMJ). Single papers were published in 38 different journals. Brief reports (1.6%), case reports (31.2%), case series (0.8%), education forums (0.8%), letters to the editor (5.6%), original research articles (41.9%), review articles (9.7%), short communications and short reports (8.1%) on ADRs and PV were recorded. Out of 124 papers, 52 (41.9%) were original research publications. The majority (74.1%) of research was done in the category of ADR incidence, types, prevention, and management, followed by policy and suggestions for strengthening national and regional pharmacovigilance centers of Nepal (14.5%). Conclusions: During the study years, there was an increase in scientific publications on drug safety. A total of 124 published articles were found during bibliometric analysis of ADRs and PV research activities in Nepal.

scholarly journals Implications of COVID-19 in high burden countries for HIV/TB: A systematic review of evidence

2020 ◽  
Author(s):  
Jacques L Tamuzi ◽  
Ayele T Birhanu ◽  
Constance S Shumba ◽  
Olatunji Adetokunboh ◽  
Jeannine Uwimana-Nico ◽  
...  
Keyword(s):  
Clinical Management ◽  
Observational Studies ◽  
Case Reports ◽  
Case Series ◽  
People Living With Hiv ◽  
Related Field ◽  
High Burden ◽  
Screening Algorithm ◽  
Clinical Trials Registry ◽  
Living With Hiv

Abstract Background The triple burden of COVID-19, tuberculosis and human immunodeficiency virus is one of the major global health challenges of the 21 st century. In high burden HIV/TB countries, the spread of COVID-19 among people living with HIV is a well-founded concern. A thorough understanding of HIV/TB and COVID-19 pandemics is important as the three diseases interact. This may clarify HIV/TB/COVID-19 as a newly related field and play an important role in the present and future management of the co-infections. However, several gaps are remaining in the knowledge of the burden of COVID-19 on patients with TB and HIV, the diagnosis, and management of these patients. Objectives The study was conducted to review different studies on SARS-CoV, MERS-CoV or COVID-19 associated with HIV/TB co-infection or only TB and to understand the interactions between HIV, TB and COVID-19 and its implications on the burden of the COVID-19 among HIV/TB co-infected or TB patients, screening algorithm and clinical management. Methods We conducted electronic search of potential eligible studies published in English in the Cochrane Controlled Register of Trials, PubMed, Medrxiv, Google scholar and Clinical Trials Registry databases. We included case studies, case series and observational studies published between January, 2002 and March, 2020 in which SARS-CoV, MERS-CoV and COVID-19 co-infected to HIV/TB or TB were managed in adult patients. We screened titles, abstracts and full articles for eligibility. As we anticipated heterogeneity in the literature, results were reported narratively. Main results After removing 69 duplicates, 24 out of 246 articles were assessed for eligibility, of which 9 studies were included for qualitative analysis. Among them, we included two case reports, four case series, one case-control and two retrospective observational studies. The studies have shown that TB may occur during or after SARS-CoV. In terms of severity, the proportion of severe/critical SARS, MERS and COVID cases with TB co-infection was higher than in patients with mild/moderate stages (P= 0.0008). Conclusion SARS/MERS-CoV/COVID-19 associated to HIV/TB or TB subjects had a higher risk of developing severe/critical than mild/moderate SARS/MERS-CoV/COVID-19. Diagnostic algorithms and clinical management were suggested for efficiently improving COVID-19/HIV/TB co-infections outcomes.

scholarly journals Treatment of Tinnitus in Children—A Systematic Review

2021 ◽  
Vol 12 ◽  
Author(s):  
Max J. Dullaart ◽  
Marijn Kip ◽  
Adriana L. Smit ◽  
Inge Stegeman
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Case Reports ◽  
Case Series ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Subjective Tinnitus ◽  
Randomized Controlled

Objectives: To systematically review studies on the effect of treatment of subjective tinnitus in children.Data Sources: We searched for studies in MEDLINE and EMBASE databases, after which additional studies were hand searched using Scopus databases. The methods are described in the study protocol, which has been registered in the PROSPERO register. PRISMA guidelines were followed in the reporting of this study.Eligibility Criteria: We considered for inclusion randomized controlled trials (RCTs), observational studies, case reports, and case series, with tinnitus as primary outcome in children (0–18 years old) with acute or chronic subjective tinnitus. We excluded studies in which both children and adults participated but outcomes were not specifically reported for children, as well as animal studies, studies with a non-original study design and studies about children with pulsatile or objective tinnitus.Data Selection: Two reviewers independently assessed studies for eligibility and quality, collected and extracted data. Statistical analyses were performed in case of homogeneous outcomes.Results: The search yielded a total of 4,447 studies. Of these, 147 eligible studies were selected. One case report and five observational studies met the eligibility criteria. Three studies applied counseling and (simplified-)TRT and reported improvement in tinnitus outcome in 68 out of 82 children after 3–6 months of treatment. Two studies used pharmacological treatments and reported improvement in 74 out of 86 patients after 10 days to 3 months of treatment. One study reported the outcome of biofeedback therapy, describing an improvement in tinnitus loudness and annoyance after 2 months of treatment.Conclusion: Due to the high risk of bias of the included studies, we cannot determine the effectiveness of the treatment of subjective tinnitus in children. Also, owing to brief follow-up periods, it is not possible to draw conclusions regarding long-term effects. Randomized controlled trials with longer follow-up periods are necessary to provide substantial evidence of the effects of therapies for children affected by tinnitus. https://www.crd.york.ac.uk/prospero/Systematic Review Registration:https://www.crd.york.ac.uk/prospero/, identifier [CRD42020178134].

Association between antipsychotic medication and venous thromboembolism

2010 ◽  
Vol 27 (1) ◽  
pp. 22-26
Author(s):  
Santhana Gunasekaran
Keyword(s):  
Venous Thromboembolism ◽  
Observational Studies ◽  
Case Reports ◽  
Case Series ◽  
Case Control ◽  
Case Control Studies ◽  
Antipsychotic Medications ◽  
Strength Of Evidence ◽  
Increased Risk ◽  
Strength Of Association

AbstractObjective: This study aims to identify and review available evidence in the literature to determine the strength of association between antipsychotic medications and thromboembolism as an adverse effect.Method: Electronic databases were searched for evidence.Results: A total of 15 case reports, 14 case series, two observational studies and three case-control studies were found in the literature. Two case control studies found significantly increased risk of venous thromboembolism (OR 13.3 and 7.1 respectively). The risk was high for low potency antipsychotics. Studies were critically appraised to determine the strength of evidence.Conclusion: The studies reviewed indicate a significant association between antipsychotics and venous thromboembolism. Patients using the antipsychotics and those who prescribe them should be aware of this association.

scholarly journals Ovarian inguinal hernia

2020 ◽  
Vol 102 (2) ◽  
pp. 75-83
Author(s):  
A Prodromidou ◽  
N Machairas ◽  
Z Garoufalia ◽  
ID Kostakis ◽  
AV Kyriakidis ◽  
...  
Keyword(s):  
Inguinal Hernia ◽  
Observational Studies ◽  
Case Reports ◽  
Case Series ◽  
Reproductive Age ◽  
Preoperative Imaging ◽  
Fallopian Tubes ◽  
Mesh Placement ◽  
Inguinal Hernias ◽  
Groin Hernias

Introduction Gynaecological structures such as the ovaries, fallopian tubes, ligaments and uterus are rarely encountered inside a hernial sac. The prevalence of groin hernias containing parts of female genitalia remains unknown. The aim of this review was to summarise the existing evidence on inguinal hernias containing ovaries with or without the other female adnexa. Methods A systematic search was conducted for literature published up to February 2018 using the MEDLINE®, Scopus® and Google Scholar™ databases along with the references of the full-text articles retrieved. Papers on observational studies and case reports concerning women who were diagnosed with an ovarian inguinal hernia (pre or intraoperatively) were considered eligible for inclusion in the review. Results Fifteen papers (13 case reports, 2 case series) comprising seventeen patients (mean age 47.9 years) were evaluated. A left-sided hernia was noted in 13 cases (77%) whereas 4 patients had a right-sided hernia. Eight patients underwent preoperative imaging with computed tomography, ultrasonography or both. This was diagnostic in five cases. In 11 patients, hernia contents were repositioned, 2 had a salpingo-oophorectomy and 2 an oophorectomy. Eight patients underwent hernia repair with mesh placement while three had a herniorrhaphy. Conclusions Ovarian inguinal hernias should be considered among the differential diagnoses of a groin mass or swelling. In women of reproductive age, repair of the hernia with the intent to preserve fertility is of critical importance.

A review of neuropsychiatric adverse events from topical ophthalmic brimonidine

2020 ◽  
Vol 39 (10) ◽  
pp. 1279-1290
Author(s):  
N Cimolai
Keyword(s):  
Dose Response ◽  
Adverse Reactions ◽  
Case Reports ◽  
Age Groups ◽  
Case Series ◽  
First Line ◽  
Double Blind ◽  
Topical Medication ◽  
At Risk Populations ◽  
Neuropsychiatric Side Effects

Brimonidine is a first-line topical medication for increased intraocular pressure and glaucoma which may be used alone or in conjunction with other topical therapies. Its structural and pharmacological comparabilities to clonidine give way to the hypothesis that it may cause neuropsychiatric side effects. The majority of case reports citing brimonidine toxicity, either for topical or peripheral exposure, include pediatric age groups but especially infants. Among the latter, a dose-response phenomenon is evident. Dose-response correlates have also been shown among adults. Case series and prospective double-blind treatment studies also give evidence for the occurrence of several central nervous system adverse reactions. Topical ophthalmic brimonidine use should be followed for the occurrence of neuropsychiatric disturbances generally, and enhanced vigilance should be maintained for at-risk populations.

scholarly journals Real-World Safety of CFTR Modulators in the Treatment of Cystic Fibrosis: A Systematic Review

2020 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Renée V. E. Dagenais ◽  
Victoria C. Su ◽  
Bradley S. Quon
Keyword(s):  
Systematic Review ◽  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Real World ◽  
Observational Studies ◽  
Case Reports ◽  
Case Series ◽  
Patient Characteristics ◽  
Online Databases ◽  
Cftr Modulators

Cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies target the underlying cause of cystic fibrosis (CF), and are generally well-tolerated; however, real-world studies indicate the frequency of discontinuation and adverse events (AEs) may be higher than what was observed in clinical trials. The objectives of this systematic review were to summarize real-world AEs reported for market-available CFTR modulators (i.e., ivacaftor (IVA), lumacaftor/ivacaftor (LUM/IVA), tezacaftor/ivacaftor (TEZ/IVA), and elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA)), and to identify ways in which the pharmacist on CF healthcare teams may contribute to mitigating and managing these AEs. The MEDLINE, EMBASE, CINAHL, and Web of Science Core Collection online databases were searched from 2012 to 1 Aug 2020. Full manuscripts or conference abstracts of observational studies, case series, and case reports were eligible for inclusion. The included full manuscripts and conference abstracts comprised of 54 observational studies, 5 case series, and 9 case reports. The types of AEs reported generally aligned with what have been observed in clinical trials. LUM/IVA was associated with a higher frequency of respiratory-related AE and discontinuation in real-world studies. A signal for mental health and neurocognitive AEs was identified with all 4 CFTR modulators. A systematic approach to monitoring for AEs in people with CF on CFTR modulators in the real-world setting is necessary to help better understand potential AEs, as well as patient characteristics that may be associated with higher risk of certain AEs. Pharmacists play a key role in the safe initiation and monitoring of people with CF on CFTR modulator therapies.

scholarly journals Adverse effects and Drug Interactions Associated with Inhaled Recreational and Medical Marijuana

2016 ◽  
Vol 7 (2) ◽  
Author(s):  
Maisha Kelly Freeman ◽  
Pilar Z Murphy
Keyword(s):  
Adverse Effects ◽  
Drug Interactions ◽  
Adverse Reactions ◽  
Case Reports ◽  
Medical Marijuana ◽  
Marijuana Use ◽  
Drug Reactions ◽  
Search Terms ◽  
Pubmed Search ◽  
Recreational Marijuana

Objectives: To provide an overview of the addiction potential; adverse effects (e.g., cardiovascular, immune dysfunction, respiratory system, mental health disorders); drug interactions; effects of accidental exposure; crime statistics; and pharmacist’s considerations for the use of inhaled medical marijuana. Methods: A PubMed search was conducted from 1966 to March 2016 to identify articles in which the safety of inhaled medical marijuana was assessed. Key MeSH search terms included medical marijuana with a subheading for adverse effect. Only articles in adult patients were considered. In addition, medical marijuana or cannabis plus one of the following search terms were searched: drug interactions, herb-drug interactions, drug-related side effects and adverse drug reactions, substance-related disorders, addiction, and abuse. A free-text search was also conducted to identify articles not included in the MeSH term search. A bibliographic search was also conducted. Articles were included if they addressed adverse effects of medical marijuana for the treatment of a condition. Meta-analyses, randomized controlled clinical trials, and case reports were included in the review if the primary focus of the article related to the adverse effect profile of inhaled medical marijuana. Medical marijuana efficacy studies were not assessed. In the absence of this information, case reports or reports of inhaled recreational marijuana use was used. Studies were excluded if published in languages other than English. In addition, studies highlighting mechanisms of action, studies of pharmacodynamics or pharmacokinetic effects were excluded, unless these effects were due to drug-drug interactions. Prescription products containing marijuana or derivatives were excluded from evaluation. An Internet search was conducted to locate the most up-to-date information on the laws concerning medical marijuana. Key findings: A PubMed search revealed 58 articles and 28 of those studies were included in this review. Several studies were located that evaluated the safety of medical marijuana; however, much of the review focused on inhaled, recreational marijuana use due to the paucity of information on inhaled medical marijuana. Since marijuana is a Schedule1 product, few clinical studies have been conducted to determine the adverse event profile of the product. As a result, several articles that characterized recreational inhaled marijuana were included. Recreational inhaled marijuana use may be associated with an increase in cardiovascular (CV)/ cerebrovascular effects (CVA); however, conflicting information exists in the literature. Recreational marijuana use may also increase risky behaviors that increase the transmission of infectious diseases and respiratory diseases. Many of the studies were retrospective in nature; therefore, it was difficult to determine a cause and effect relationship between inhaled marijuana use and the development of adverse reactions or drug-drug interactions. Conclusions: There is a paucity of information related to the use of inhaled medical marijuana. Recreational marijuana use is associated with several adverse events including CV/CVA, respiratory, and transmission of infectious diseases. Theoretical literature indicates that medical marijuana may be associated with significant drug-drug interactions and adverse drug reactions. Legalization of medical marijuana may be associated with an increase in abuse/dependence and accidental exposures in children. Pharmacists need to be educated regarding the appropriate use of medical marijuana to avoid adverse reactions and potential drug-drug interactions between medical marijuana and other products.   Type: Original Research

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