Immune-mediated inflammatory disease patients' preferences in adverse drug reaction information regarding biologics.

Expert Opin Drug Saf. 2020 Aug;19(8):1049-1054

Authors: Kosse LJ, Weits G, Vonkeman HE, Spuls PI, Van Den Bemt BJF, Tas SW, Hoentjen F, Nurmohamed MT, Van Doorn MBA, Van Puijenbroek EP, Jessurun NT

Abstract
OBJECTIVES: Patient-reported outcomes (PROs) are increasingly used in studies and medical practice to obtain information on patients' perspectives toward their treatment or disease. However, most study outcomes are primarily directed at healthcare professionals. It was aimed to obtain insight in which type of information immune-mediated inflammatory disease (IMID) patients prefer to receive after participating in the Dutch Biologic Monitor (DBM), a PRO-based prospective cohort event monitoring system focused on adverse drug reactions (ADRs).
METHODS: A survey was conducted among DBM participants that wanted information about the results. Patients' preferences were identified using twelve statements and rated with five-point Likert-type scales. Subgroup analyses and differences between statements were performed using Mann-Whitney U Tests.
RESULTS: The survey was completed by 591 patients (response rate 67.6%). Most respondents had inflammatory rheumatic diseases (76.8%) and used adalimumab (37.2%) or etanercept (33.2%). Respondents preferred results per IMID over aggregated results (p = <0.001). Information on whether patients with similar IMIDs experience ADRs (average 4.5), which biologics are most likely to cause ADRs (4.4) and whether ADRs disappear (4.4) were most interesting.
CONCLUSION: DBM participants prefer to receive disease-specific information on ADRs that is tailored to their own biologic and IMID, including the outcome of ADRs.

PMID: 32524887 [PubMed - indexed for MEDLINE]

Utilizing drug-target-event relationships to unveil safety patterns in pharmacovigilance.

Expert Opin Drug Saf. 2020 Aug;19(8):961-968

Authors: Hauser AS, Kooistra AJ, Sverrisdóttir E, Sessa M

Abstract
INTRODUCTION: Signal detection is the most pivotal activity of signal management to guarantee that drugs maintain a positive risk-benefit ratio during their lifetime on the market. Signal detection is based on the systematic evaluation of available data sources, which have recently been extended in order to improve timely and comprehensive signal detection of drug safety problems.
AREAS COVERED: In recent years, attempts have been made to incorporate pharmacological data for the prediction of safety signals. Previous studies have shown that data on the pharmacological targets of drugs are predictive of post-marketing adverse events. However, current approaches limit such predictions to adverse events expected from the interaction of a drug with the main pharmacological target and do not take off-target interactions into consideration.
EXPERT OPINION: The authors propose the application of predictive modeling techniques utilizing pharmacological data from public databases for predicting drug-target-event relationships deriving from main- and off-target binding and from which potential safety signals can be deduced. Additionally, they provide an operative procedure for the identification of clinically relevant subgroups for predicted safety signals.

PMID: 32510245 [PubMed - indexed for MEDLINE]

Adverse drug reactions in adolescents: a review of reporting to a national pharmacovigilance system.

Expert Opin Drug Saf. 2020 Jul;19(7):915-922

Authors: Rebelo Gomes E, Ribeiro-Vaz I, Santos CC, Herdeiro MT

Abstract
OBJECTIVE: Adverse drug reactions (ADR) cause significant morbidity, mortality and health costs and have an important prevalence in all ages. Few studies focus on ADR in adolescents. The goal of this study was to characterize a case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) of the National Authority of Medicines and Health Products (INFARMED, I.P.) during an eleven-year period (from 2006 to 2016) concerning this specific population.
METHODS: Retrospective analysis of reports concerning patients from 10 to 18 years received by the PPS between 2006 and 2016. The authors evaluated patients' demographics (age and sex). The characteristics and seriousness of the reactions, the type of reaction reported, and the drugs involved were assessed.
RESULTS: The authors found 782 reports (59% females). Most reports came from physicians (61%). Overall 80% of the reports described serious ADR. A greater proportion of serious events was found among males. Most reactions referred to general disorders and administration site conditions (38%), followed by skin and subcutaneous tissue reactions (33%). In 3rd and 4th were gastrointestinal disorders (24%) and the nervous system disorders (23%), the former more frequent among females. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (19%).
CONCLUSION: Major findings considering drugs involved and the reported reactions varied according to age and sex.

PMID: 32422079 [PubMed - indexed for MEDLINE]

Drug-induced retroperitoneal fibrosis: a case/non-case study in the French PharmacoVigilance Database.

Expert Opin Drug Saf. 2020 Jul;19(7):903-914

Authors: Brasselet D, Chouchana L, Vial T, Damin-Pernik M, Lebrun-Vignes B

Abstract
OBJECTIVES: The potential role of drugs in the onset of retroperitoneal fibrosis (RPF) is poorly understood. The aim of this study was to identify drugs that may cause RPF.
METHODS: The authors used case/non-case method in the French PharmacoVigilance Database (FPVD).
RESULTS: Among the 722992 reports recorded, 73 cases of RPF were identified. 67% were men and the median age was 60 years (range 26-87). In these 73 cases, 176 drugs were 'suspect.' Derivatives of ergot alkaloids (DEA) presented the most significant association with RPF. To a lesser extent, significant associations were found with many drugs used in cardiology, e.g. beta-blockers, platelet antiaggregant, statins, and antihypertensive drugs, drugs used in neuropsychiatry, e.g. hypnotics, antiepileptic drugs, anxiolytics, antipsychotics, and antidepressants, and with other pharmacological classes, e.g. TNF-alpha antagonists.
CONCLUSION: This study confirmed an association between RPF and derivatives of ergot alkaloids. These data represent a pharmacovigilance signal despite the limits of non/non-case method (underreporting, confounding factors, etc.). Indeed, a significant signal was found with drugs less known (TNF-α antagonists) or not known (some hypnotics, antiepileptic drugs, antipsychotics, anxiolytics, and antidepressants) to induce such an adverse drug reaction (ADR). Finally, these data could contribute to realize prospective studies to confirm these signals.

PMID: 32374194 [PubMed - indexed for MEDLINE]

Adverse Reactions Induced by Minocycline: A Review of Literature.

Curr Drug Saf. 2021 Jan 19;:

Authors: Dominic MR

Abstract
BACKGROUND: Minocycline is a tetracycline antibiotic that is widely used to treat infections, and is a first-line oral antibiotic in the treatment of moderate to severe inflammatory acne. Although it has high efficacy, several adverse reactions, including life-threatening ones have been reported in association with its use.
OBJECTIVE: To identify all the potential adverse reactions due to minocycline and analyze them in terms of the number of cases reported so far, salient features, severity and clinical outcome.
METHODS: Comprehensive PubMed search of English and non-English literature for case reports of adverse reactions to minocycline.
RESULTS: A total of 550 cases were identified from over 200 publications. The major reported adverse events caused by minocycline are drug reaction with eosinophilia and systemic symptoms syndrome, autoimmune syndromes like hepatitis, lupus and vasculitis, acute eosinophilic pneumonia, pseudotumor cerebri, hyperpigmentation, serum sickness like reaction, Sweet's syndrome and drug fever. Several other reactions involving multiple organ systems have also been reported. All of these show an overlap of clinical features and may be associated with multiple events causing considerable morbidity. Eight of these cases resulted in the death of the patients.
CONCLUSION: In view of the evident potential of minocycline to cause long-lasting and severe adverse effects, significant morbidity and even mortality, it should be prescribed with caution in the first-line treatment for moderate to severe acne.

PMID: 33494681 [PubMed - as supplied by publisher]

Checkpoint Inhibitors and Hepatotoxicity.

Biomedicines. 2021 Jan 21;9(2):

Authors: Malnick SDH, Abdullah A, Neuman MG

Abstract
Uncontrolled immune response to a pathogen or any protein can lead to tissue damage and autoimmune diseases, that represent aberrant immune responses of the individual to its own cells and/or proteins. The immune checkpoint system is the regulatory mechanism that controls immune responses. Tumor cells escape the immune surveillance mechanism, avoiding immune detection and elimination by activating these checkpoints and suppressing the anti-tumor response, thus allowing formation of tumors. Antigenic modulation facilitates masking and contributes to the escape of tumor cells. In addition, there are growing cell promoters, like transforming growth factor β (TGF-β), contributing to escape mechanisms. Targeting the immunological escape of malignant cells is the basis of immune oncology. Checkpoint inhibitors, cytokines and their antibodies may enhance the immune system's response to tumors. Currently, immunomodulatory agents have been designed, evaluated in clinical trials and have been approved by both European and United States Drug Agencies. The present review is a reflection of the increasingly important role of the checkpoint inhibitors. Our aim is to review the side effects with the emphasis on hepatic adverse reactions of these novel biological drug interventions.

PMID: 33494227 [PubMed]

Adverse drug reactions reported to a provincial public health sector pharmacovigilance programme in South Africa.

S Afr Med J. 2020 Nov 27;110(12):1226-1230

Authors: Jones J, Swart A, Tommy E, Cohen K, Stewart A, Voget J, Blockman M

Abstract
BACKGROUND: There are limited data in South Africa (SA) on adverse drug reaction (ADR) patterns and common causative medicines, outside of HIV and tuberculosis treatment programmes. In SA, Western Cape Province has a pharmacovigilance programme that collects spontaneous reports of suspected ADRs from public sector healthcare facilities.
OBJECTIVES: To describe reports received by the pharmacovigilance programme over a 4-year period (excluding those ascribed to medicines used to treat HIV and tuberculosis), as well as challenges faced in the implementation of such a system.
METHODS: Reports of suspected ADRs and deaths possibly related to ADRs received between January 2015 and December 2018 were reviewed. Causality was assessed by a pharmacist, with multidisciplinary team involvement for all deaths and complicated cases. Causality was categorised according to the World Health Organization-Uppsala Monitoring Centre system. Preventability was assessed using Schumock and Thornton criteria. Observations on preventability and challenges faced in the operation of a spontaneous reporting system were also noted.
RESULTS: We received 5 346 reports containing 6 023 suspected ADRs. There were 5 486 ADRs confirmed after causality assessment, in 5 103 reports. Cough, angio-oedema, movement disorders and uterine bleeding disorders were the most common ADRs. Enalapril, etonogestrel, amlodipine and hydrochlorothiazide were the most commonly implicated drugs. Seven deaths were reported; 3 of these reports of deaths had confirmed ADRs, and these ADRs were assessed as contributing to the deaths. Approximately 3.8% of commonly reported ADRs were preventable.
CONCLUSIONS: Enalapril and etonogestrel were responsible for a significant proportion of ADRs reported to this provincial programme. Future work should include quantification of preventability aspects to better inform gaps in healthcare worker knowledge that can be addressed in order to improve patient care.

PMID: 33403970 [PubMed - indexed for MEDLINE]

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.

Clin Dermatol. 2020 Nov - Dec;38(6):702-711

Authors: Cardones AR

Abstract
Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a severe cutaneous drug reaction characterized by fever, lymphadenopathy, hematologic abnormalities, multisystem involvement, and viral reactivation. Although most patients with DRESS syndrome are able to fully recover, a subset of patients go on to have a prolonged course with recurrence, and/or autoimmune complications. Severe systemic involvement is associated with significant morbidity and mortality. Viral reactivation, especially of human herpes virus 6, Epstein-Barr virus, and cytomegalovirus, is a common feature of DRESS, with a high viral load and antibody titers being associated with poor outcomes. Aside from prompt discontinuation of the offending drug, treatment for patients with significant disease consists of systemic therapy with corticosteroids.

PMID: 33341203 [PubMed - indexed for MEDLINE]

Neutrophilic drug reactions.

Clin Dermatol. 2020 Nov - Dec;38(6):648-659

Authors: Coromilas AJ, Gallitano SM

Abstract
Neutrophilic drug reactions are unique eruptions that can affect hospitalized patients and share a common pathophysiology with neutrophils as the key mediators of inflammation. They range in clinical presentation from papules and plaques to bullae and erosions to pustules. Although there is some overlap in presentation, each has distinguishing features that aid the clinician in differentiation from one another and from other drug hypersensitivity reactions. Much of the data on these reactions are from case reports and series or retrospective review studies. There are limited prospective observational studies dedicated to these adverse drug reactions. We review the more common and life-threatening neutrophilic drug reactions, their proposed mechanism of action, and their management.

PMID: 33341199 [PubMed - indexed for MEDLINE]

Thinking outside the box: Is there a role for extracorporeal blood purification in DRESS syndrome complicated by acute kidney injury?

Clin Dermatol. 2020 Sep - Oct;38(5):580-583

Authors: Waldman RA, Grant-Kels JM

Abstract
Drug reaction with eosinophilia and systemic clinical manifestations (DRESS syndrome) is a potentially fatal drug reaction that is hallmarked by a hypercytokinemic state that results in organ dysfunction. For this reason, plasmapheresis and therapeutic plasma exchange are being increasingly utilized in DRESS syndrome refractory to systemic corticosteroids to remove the pathogenic cytokines that cause end-organ damage. This contribution proposes a novel approach to DRESS syndrome complicated by acute kidney injury. Specifically, the authors argue that patients with DRESS syndrome complicated by acute kidney injury may benefit from utilization of specific forms of renal replacement therapy that also provide plasmapheresis. This is relevant acute kidney injury that develops in more than one-third of cases of DRESS syndrome with at least 10% of cases progressing to acute renal failure requiring renal replacement therapy. Renal replacement therapy can include intermittent hemodialysis or continuous renal replacement therapy.

PMID: 33280807 [PubMed - indexed for MEDLINE]

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ACG Case Rep J. 2021 Jan 19;8(1):e00530. doi: 10.14309/crj.0000000000000530. eCollection 2021 Jan.

ABSTRACT

Empagliflozin belongs to a class of sodium-glucose cotransporter-2 inhibitors, a medication approved by the US Food and Drug Administration in 2014 for the treatment of type 2 diabetes mellitus. Well-known side effects of this medication include symptomatic hypotension, hypoglycemia, and urinary tract infections among others. We present a case of severe epigastric abdominal pain consistent with acute pancreatitis in the setting of empagliflozin use, suggesting a possible drug-induced acute pancreatitis.

PMID:33490300 | PMC:PMC7813547 | DOI:10.14309/crj.0000000000000530

A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.

J Hepatol. 2021 Jan 20;:

Authors: Schattenberg JM, Pares A, Kowdley KV, Heneghan MA, Caldwell S, Pratt D, Bonder A, Hirschfield GM, Levy C, Vierling J, Jones D, Tailleux A, Staels B, Megnien S, Hanf R, Magrez D, Birman P, Luketic V

Abstract
BACKGROUND AND AIM: Patients with primary biliary cholangitis (PBC) who have an incomplete response to ursodeoxycholic acid remain at risk of disease progression. We investigated the safety and efficacy of elafibranor, a dual PPARα/δ agonist, in patients with PBC.
METHODS: This 12-week, double blind phase 2 trial enrolled 45 adults with PBC who had incomplete response to ursodeoxycholic acid (alkaline phosphatase levels ≥1.67-fold the upper limit of normal (ULN). Patients were randomly assigned to elafibranor-80 mg, elafibranor-120 mg or placebo. The primary end-point was the relative change of ALP at 12 weeks (NCT03124108).
RESULTS: Reductions of ALP at 12 weeks were -48.3±14.8% for elafibranor-80 mg (p<0.001 vs placebo), -40.6±17.4% for elafibranor-120 mg (p<0.001) and +3.2±14.8% in the placebo group. The composite endpoint of ALP≤1.67-fold the ULN, decrease of ALP >15% and total bilirubin below the ULN was achieved in 67% patients in the elafibranor-80 mg group and 79% patients in the elafibranor-120 mg group, versus 6.7% patients in the placebo group. Levels of gamma glutamyl transferase decreased by 37.0±25.5% in the elafibranor-80mg group (p<0.001), 40.0±24.1% in the elafibranor-120mg group (p<0.01) compared with no change (+0.2±26.0%) in the placebo group. Levels of disease markers such as IgM, 5'-nucleotidase or hsCRP were likewise reduced from elafibranor. Pruritus was not induced or exacerbated from elafibranor and patients with pruritus at baseline reported less pruritic symptoms at the end of treatment. All possibly drug related non-serious adverse events were mild to moderate.
CONCLUSION: In this randomized phase 2 trial, elafibranor was generally safe and well tolerated and significantly reduced levels of ALP, composite endpoints of bilirubin and ALP, as well as other markers of disease activity in patients with PBC and incomplete response to ursodeoxycholic acid. Data is available from the Study Sponsor Genfit SA.
CLINICAL TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT03124108.

PMID: 33484775 [PubMed - as supplied by publisher]

Variation in statin prescribing across England.

Drug Ther Bull. 2021 Jan 22;:

Authors:

Abstract
Every month, DTB scans sources of information on treatments, disease management and other healthcare topics for key items to bring to our readers' attention and help them keep up to date. To do this, we produce succinct, contextualised summaries of the information concerned.

PMID: 33483339 [PubMed - as supplied by publisher]

Risk of acute kidney injury by initiation of non-steroidal anti-inflammatory drugs in hospitalised patients treated with diuretics and renin-angiotensin-aldosterone system inhibitors.

Eur J Hosp Pharm. 2021 Jan 21;:

Authors: Bories M, Bacle A, Gilardi H, Le Corre P

Abstract
OBJECTIVES: Concurrent use of non-steroidal anti-inflammatory drugs (NSAIDs) with diuretics and renin-angiotensin-aldosterone system inhibitors (RAASI) has been associated with an increased risk of developing acute kidney injury (AKI) in the ambulatory setting. There is currently no information on AKI prevalence in hospitalised patients where initiation of NSAID prescription is quite frequent. The aim of our study was to assess the prevalence of AKI in patients treated with diuretics and/or RAASI in the hospital setting when NSAIDs are initiated.
METHODS: This was a retrospective single centre study on inpatients receiving triple or dual association treatment. AKI was established according to evidence-based clinical practice guidelines in kidney disease (Kidney Disease Improving Global Outcome, KDIGO) using the following criteria : increase in serum creatinine (SCr) by ≥0.3 mg/dL (or ≥26.5 µmol/L) within 48 hours, or increase in SCr to ≥1.5 times baseline occurring within the last 7 days.
RESULTS: AKI was identified in 5 of 151 patients (3.3%) treated with both diuretics and RAASI in whom NSAIDs were initiated, with a 49 µM average increase in SCr within 48 hours compared with baseline. AKI was identified in 2 of 117 (1.7%) patients treated with diuretics and NSAIDs, and in 1 of 427 (0.23%) patients treated with RAASI and NSAIDs. The average increase in SCr within 2 days was 29 µM. No AKI was identified in a control group of 1886 patients treated with diuretics and RAASI but with no initiation of NSAIDs during their hospitalisation.
CONCLUSION: Initiation of NSAID therapy in hospitalised patients already being treated with diuretics and RAASI is a risk factor for AKI. The risk of AKI with the triple association appeared higher than with the dual association treatment.

PMID: 33478983 [PubMed - as supplied by publisher]

Self-Reported Allergy to Thyroid Replacement Therapy: A Multicenter Retrospective Chart Review.

Endocr Pract. 2020 Jul;26(7):761-767

Authors: Chamorro-Pareja N, Carrillo-Martin I, Haehn DA, Westphal SA, Park MA, Bernet VJ, Gonzalez-Estrada A

Abstract
OBJECTIVE: To determine patterns of adverse drug reactions (ADRs), including immediate drug hypersensitivity reactions (DHRs) and predictable ADRs, to thyroid replacement therapy (TRT). TRT is the treatment of choice for hypothyroidism. Levothyroxine (LT4) is among the most commonly prescribed medications in the United States, with over 70 million prescriptions annually. Documented immediate DHRs to TRT are rare, with only a few case reports.
METHODS: An 11-year (2008-2018) retrospective medical chart review of identified patients with self-reported allergy to TRT. ADRs to TRT were divided into immediate DHRs and predictable ADRs.
RESULTS: A total of 466 patients were included in our study. We found an overall incidence of ADRs to TRT of 0.3%. Median age was 61.2 years; 85.8% were women, and 94.4% were Caucasian. The principal indication for TRT was autoimmune hypothyroidism (73.6%), followed by postsurgical hypothyroidism (17.4%) and subclinical hypothyroidism (6.7%). Predictable ADR manifestations to TRT were reported more commonly than DHR manifestations (57.5% vs. 42.5%, respectively). The most frequently reported of the former were palpitations (16.4%), nausea/vomiting (9.3%), and tremor (6.3%), while rash (23.8%), hives (9.5%), and pruritus (7.1%) were the most common regarding the latter. Fifty-six percent of the patients with an ADR to TRT tolerated an alternative TRT presentation.
CONCLUSION: In our cohort, the majority of self-reported allergies to TRT were due to predictable ADRs rather than an immediate DHR.
ABBREVIATIONS: ADR = adverse drug reaction; DHR = drug hypersensitivity reaction; FDA = Food and Drug Administration; LT3 = liothyronine; LT4 = levothyroxine; SCAR = severe cutaneous adverse drug reaction; TRT = thyroid replacement therapy.

PMID: 33471645 [PubMed - indexed for MEDLINE]

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment.

J Vis Exp. 2020 12 03;(166):

Authors: Marin TM, Indolfo NC, Rocco SA, de Carvalho M, Dias MM, Vasconcelos Bento GI, Bortot LO, Schuck DC, Lorencini M, Pagani E

Abstract
The recently introduced microphysiological systems (MPS) cultivating human organoids are expected to perform better than animals in the preclinical tests phase of drug developing process because they are genetically human and recapitulate the interplay among tissues. In this study, the human intestinal barrier (emulated by a co-culture of Caco-2 and HT-29 cells) and the liver equivalent (emulated by spheroids made of differentiated HepaRG cells and human hepatic stellate cells) were integrated into a two-organ chip (2-OC) microfluidic device to assess some acetaminophen (APAP) pharmacokinetic (PK) and toxicological properties. The MPS had three assemblies: Intestine only 2-OC, Liver only 2-OC, and Intestine/Liver 2-OC with the same media perfusing both organoids. For PK assessments, we dosed the APAP in the media at preset timepoints after administering it either over the intestinal barrier (emulating the oral route) or in the media (emulating the intravenous route), at 12 µM and 2 µM respectively. The media samples were analyzed by reversed-phase high-pressure liquid chromatography (HPLC). Organoids were analyzed for gene expression, for TEER values, for protein expression and activity, and then collected, fixed, and submitted to a set of morphological evaluations. The MTT technique performed well in assessing the organoid viability, but the high content analyses (HCA) were able to detect very early toxic events in response to APAP treatment. We verified that the media flow does not significantly affect the APAP absorption whereas it significantly improves the liver equivalent functionality. The APAP human intestinal absorption and hepatic metabolism could be emulated in the MPS. The association between MPS data and in silico modeling has great potential to improve the predictability of the in vitro methods and provide better accuracy than animal models in pharmacokinetic and toxicological studies.

PMID: 33346185 [PubMed - indexed for MEDLINE]

eHealth technologies assisting in identifying potential adverse interactions with complementary and alternative medicine (CAM) or standalone CAM adverse events or side effects: a scoping review.

BMC Complement Med Ther. 2020 Jul 29;20(1):239

Authors: Ng JY, Mooghali M, Munford V

Abstract
BACKGROUND: While there are several existing eHealth technologies for drug-drug interactions and stand-alone drug adverse effects, it appears that considerably less attention is focussed on that of complementary and alternative medicine (CAM). Despite poor knowledge of their potential interactions and side effects, many patients use CAM. This justifies the need to identify what eHealth technologies are assisting in identifying potential 1) adverse drug interactions with CAM, 2) adverse CAM-CAM interactions or 3) standalone CAM adverse events or side effects.
METHODS: A scoping review was conducted to identify eHealth technologies assisting in identifying potential adverse interactions with CAM or standalone CAM adverse events or side effects, following Arksey and O'Malley's five-stage scoping review framework. MEDLINE, EMBASE, and AMED databases and the Canadian Agency for Drugs and Technologies in Health website were systematically searched. Eligible articles had to have assessed or referenced an eHealth technology assisting in identifying potential one or more of the three aforementioned items. We placed no eligibility restrictions on type of eHealth technology.
RESULTS: Searches identified 3467 items, of which 2763 were unique, and 2674 titles and abstracts were eliminated, leaving 89 full-text articles to be considered. Of those, 48 were not eligible, leaving a total of 41 articles eligible for review. From these 41 articles, 69 unique eHealth technologies meeting our eligibility criteria were identified. Themes which emerged from our analysis included the following: the lack of recent reviews of CAM-related healthcare information; a large number of databases; and the presence of government adverse drug/event surveillance.
CONCLUSIONS: The present scoping review is the first, to our knowledge, to provide a descriptive map of the literature and eHealth technologies relating to our research question. We highlight that while an ample number of resources are available to healthcare providers, researchers, and patients, we caution that the quality and update frequency for many of these resources vary widely, and until formally assessed, remain unknown. We identify that a need exists to conduct an updated and systematically-searched review of CAM-related healthcare or research resources, as well as develop guidance documents associated with the development and evaluation of CAM-related eHealth technologies.

PMID: 32727531 [PubMed - indexed for MEDLINE]

[Biotherapies in elderly patients].

Rev Med Interne. 2020 Sep;41(9):591-597

Authors: Michaut A, Varin S

Abstract
The ageing of the population leads health professionals to question the tolerance and the effectiveness of the different biotherapies used in autoimmune diseases. Due to the exponential increase of biotherapies and their indications, several studies have been carried out to evaluate their impact on elderly patients suffering from autoimmune disease. However, these studies are still too few to take into account all the different specificities of elderly patients and their comorbidities; prescribers are therefore hesitant with their introduction after 75 years or even 65. More than the age of patients, it is necessary to evaluate the comorbidities before introducing this kind of treatments. Every biotherapy has different indications and contraindications, which must be known to adapt each treatment to each patient. This focus aims to remind of the adaptations and contraindications of the different biological disease-modifying anti-rheumatic drugs for geriatric population, and improve their uses since the treatments for these patients are sometimes not enough. Here we resume the methods allowing supervisors to identify errors of clinical reasoning in medical students and interns and we explain remediation techniques adapted to the types of error identified. Access to short illustrative videos of a MOOC (Massive Open On line Course) devoted to the supervision of clinical reasoning constitutes practical help for supervisors who are not expert in the complexity of medical pedagogy at the bedside.

PMID: 32674900 [PubMed - indexed for MEDLINE]

Quality evaluation of the Japanese Adverse Drug Event Report database (JADER).

Pharmacoepidemiol Drug Saf. 2020 02;29(2):173-181

Authors: Tsuchiya M, Obara T, Sakai T, Nomura K, Takamura C, Mano N

Abstract
INTRODUCTION: The spontaneous adverse drug reaction (ADR) reporting system plays an important role in pharmacovigilance by providing information from clinical settings in the postmarketing environment. The Japanese Adverse Drug Event Report (JADER) database contains a portion of Japanese ADR reports, and no previous study has described the quality or characteristics of ADR reports in the JADER.
OBJECTIVE: The aim of this study was to identify the characteristics of the JADER database and to evaluate the quality of ADR reports contained in the JADER using the documentation-grading scheme developed by the World Health Organization.
METHODS: Of 478 508 ADR reports in the JADER, the analysis set consisted of 395 091 reports meeting inclusion criteria. An analysis was carried out to evaluate the quality of the reports according to the type of report, the type of sender, and the qualification of the reporter. Annual changes in the number of reports from medical institutions submitted by pharmacists were compared with changes in the number submitted by physicians.
RESULTS: The distribution of documentation grade differed according to the type of report, the type of sender, and the qualification of the reporter. Regarding "medical institution reports", the quality of reports was similar among qualification types, while the quality of reports submitted by physicians was higher for "company reports" and "study reports" (P < .0001, respectively).
CONCLUSION: Our study showed that the quality of the ADR reports in the JADER differed among the type of report, the sender of the report, and the qualification of the reporter.

PMID: 31823506 [PubMed - indexed for MEDLINE]