Adr In Journals: Are They Translated Into Regulatory Frameworks?

Introduction: An adverse drug reaction case report refers to a scientific publication that is written by a health care professional who suspects a causal relationship between a drug and an adverse drug reaction (ADR). ADR case reports help to identify potential risks associated with the use of the drug. Most of the case reports do not mention reporting the ADR to regulatory authorities. With this objective, the aim of this study was to analyze the number of Adverse Drug Reaction (ADR) published as case reports (PubMed indexed journals) from January 2018 to June 2019 and observe if they are translated into a regulatory framework like Vigibase and package inserts. Materials And Methods: 321 ADRs were obtained with the keywords “Adverse Drug Reaction.” Out of those, 158 were independently extracted by two investigators, observed and categorized according to classes of the drugs, geographic location, severity, hospitalization, completeness of ADR, and whether they were reported to the regulatory authority (VigiBase) or listed in the package insert. Literature review articles were excluded. Results: Out of the 158 ADRs, antibiotics accounted for 12.65%, CNS drugs and monoclonal antibodies accounted for 11.39%, anticancer drugs for 9.49%, CVS drugs for 4.43%, anti-virals for 3.79%, and the others for 45.56%. According to geographic region, 26 ADRs published were from USA, 4 from Australia, 3 from Italy, 17 from India, 9 from Turkey, 1 from Singapore and the UK, 20 from China, 2 from Denmark and Canada, 10 from Japan, 9 from France, 1 from Austria, 5 from Korea, 3 from South America, and 2 from Switzerland. Depending upon the severity, causality assessment was performed for 45 ADRs only; it was not performed for 113 ADRs. 41.13% of patients (from 65 case reports) were hospitalized. Among the 158 ADRs, 14 ADRs were not found in VigiBase. 32 ADRs were not mentioned in the drug package inserts. When categorized according to the completeness of case reports, weight accounted for 1.89%, lab values and procedure for diagnosis accounted for 96.8%, risk factors for 95.56%, prior exposure for 88.60%, post ADR status for 60.12%, and the start-stop medication, route of administration, first dose, last dose, and the duration of illness accounted for 100%. Conclusion: Depending upon our observation, we have noticed that there is a deficiency in reporting of suspected ADR to the regulatory authorities. Reporting can be included as mandatory criteria for ADR case reports. Also, there is an increased need for various healthcare workers to be aware about reporting ADR.

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Gendered Experiences of Living with HIV in Australia

Sexes ◽

10.3390/sexes2030020 ◽

2021 ◽

Vol 2 (3) ◽

pp. 244-255

Author(s):

Vicki Hutton

Keyword(s):

Mental Health ◽

Lived Experience ◽

Case Reports ◽

Economic Status ◽

Geographic Location ◽

Geographic Region ◽

Gender And Sexuality ◽

Economic Consequences ◽

People Living With Hiv ◽

Living With Hiv

Globally, women represent more than half the people living with HIV. This proportion varies by country, with an over-representation of HIV among men who have sex with men (MSM) in some regions. For example, in Australia, MSM account for over 60% of transmissions, with heterosexual sex accounting for almost a quarter of transmissions. Irrespective of geographic region, there is evidence that women can have a different lived experience of HIV due to their unequal social and economic status in society, while MSM can have a different lived experience depending on the laws and customs of their geographic location. Gender differences related to risk factors, stigma, access to services, mental health, health-related quality of life and economic consequences have been consistently reported globally. This paper explores the subjective lived experience of gender and sexuality disparities among three individuals living with HIV in Australia: a male who identified as gay, and a male and female who each identified as heterosexual. Analysis of themes from these three case reports indicated discernible differences by gender and sexuality in four areas: access to medical services, social support, stigma and mental health. It is argued that knowledge and understanding of potential gender and sexuality disparities must be factored into supportive interventions for people living with HIV in Australia.

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Amoxicillin Induced Steven Johnson’s Syndrome: A Case Report

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v10i4-s.4205 ◽

2020 ◽

Vol 10 (4-s) ◽

pp. 220-222

Author(s):

R Mahendra Kumar ◽

Sanatkumar Nyamagoud ◽

Krishna Deshpande ◽

Ankitha Kotian

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Case Reports ◽

The Body ◽

Stevens Johnson Syndrome ◽

Hypersensitivity Reactions ◽

Johnson Syndrome ◽

Oral Consumption ◽

Life Threatening

Stevens-Johnson syndrome (SJS) is a very rare, potentially fatal skin reaction that is typically the result of reaction to the drug. In particular, SJS is characterized by extensive skin and mucous membrane lesions (i.e. mouth, nose, esophagus, anus, and genitalia), epidermis detachment, and acute skin blisters. In 95 % of case reports, drugs were found to be an important cause for the development of SJS. This story is a case of A 42 year old male hospitalized with rashes all over the body and fever, after oral consumption of Amoxicillin drug for sore throat. This case study discusses the possibility that serious hypersensitivity reactions with Amoxicillin can rarely occur and can be extremely harmful and life-threatening Menacing. Keywords: Toxic Epidermal Necrolysis, Stevens Johnson Syndrome, Adverse drug reaction, Nikolsky’s sign

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Capecitabine-induced myopericarditis – A case report and review of literature

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155218774871 ◽

2018 ◽

Vol 25 (4) ◽

pp. 1006-1010 ◽

Cited By ~ 2

Author(s):

Sydney Saunders ◽

Maria Anwar

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Case Report ◽

Literature Search ◽

Case Reports ◽

Locally Advanced ◽

Rectal Adenocarcinoma ◽

Review Of Literature ◽

Medication Discontinuation ◽

Laboratory Investigations

Objective To describe a possible case of capecitabine-induced myopericarditis in a patient at the Cardio-Oncology Clinic in Calgary, AB. Design A literature search and adverse drug reaction assessment with the Naranjo tool was conducted. Results A 39-year-old male with recurrent locally advanced rectal adenocarcinoma presented two days after adjuvant treatment with capecitabine and oxaliplatin complaining of intermittent, severe interscapular pain. Based on symptoms, laboratory investigations, and imaging, the patient was diagnosed with acute myopericarditis. Management included aspirin, colchicine, and discontinuing adjuvant chemotherapy. A literature review revealed one case report of capecitabine-induced myopericarditis; however, more data were found regarding the cardiotoxicity of fluorouracil, for which capecitabine is a pro-drug. No case reports were found for oxaliplatin. Conclusion Due to the timeline of capecitabine administration, symptom onset, and improvement upon medication discontinuation, capecitabine is the probable cause of the myopericarditis. Although rare, it is important to consider the possibility of myopericarditis in patients receiving a fluoropyrimidine who present with cardiovascular symptoms.

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SELF-REPORTED ALLERGY TO THYROID REPLACEMENT THERAPY: A MULTICENTER RETROSPECTIVE CHART REVIEW

Endocrine Practice ◽

10.4158/ep-2019-0488 ◽

2020 ◽

Vol 26 (7) ◽

pp. 761-767

Author(s):

Natalia Chamorro-Pareja ◽

Ismael Carrillo-Martin ◽

Daniela A. Haehn ◽

Sydney A. Westphal ◽

Miguel A. Park ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Replacement Therapy ◽

Chart Review ◽

Case Reports ◽

Drug Hypersensitivity ◽

Retrospective Chart Review ◽

The United States ◽

Autoimmune Hypothyroidism ◽

Drug Hypersensitivity Reaction

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

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SPONTANEOUS ADVERSE DRUG REACTION REPORTS FOR NEONATES AND INFANTS IN THE UK 2001–2010

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-310148.48 ◽

2015 ◽

Vol 101 (1) ◽

pp. e1.43-e1

Author(s):

Dan Hawcutt ◽

Hannah Maqsood ◽

Simon Gomberg ◽

Andrew Riordan ◽

Mark Turner

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Gestational Age ◽

Spontaneous Reporting ◽

Swine Flu ◽

Yellow Card ◽

Neisseria Meningitides ◽

Spontaneous Adverse Drug Reaction ◽

The Uk ◽

Neonates And Infants

AimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme [YCS]) to collect ‘suspected' adverse drug reaction (ADR) data. We aim to describe the Yellow card reports received for patients aged ≤1 year for a 10 year period and assess their utility.MethodsData on all ADRs reported via the YCS in Infants aged ≤1 years from the years 2001–10 were supplied by the MHRA.ResultsIn total, 3217 suspected ADRs were reported to the YCS between 2001–10 for infants age ≤1 year (Neonates n=97, vaccinations n=2673, infant [neither neonate nor vaccine] n=477). Overall only 0.88 YC per day were received by the MHRA with a male preponderance (Male 50.3%, Female 45.7%); only 25 (0.8%) YC reports stated a gestational age for the affected infant. The medications most frequently reported as suspected of causing an ADR were Swine Flu Vaccine (neonates n=8), Neisseria meningitides (vaccinations n=693) and oseltamivir (infants n=37). Reports associated with vaccinations followed the expected trends. ADRs highlighted by regulators for neonatal and infant populations are not represented in the YCs received by the regulator.Conclusions The frequency of YCS reports for those ≤1 year is low, with less than 1 per day overall. Neonates are poorly represented, and recording of gestational age is very limited. The YCS appears to be more effective for spontaneous reporting of vaccination-related ADRs in infants than for other medications. Action is required to improve reporting of suspected ADRs that affect neonates and infants.

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