scholarly journals Adverse Drug Reactions, Power, Harm Reduction, Regulation and the ADRe Profiles

Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 102 ◽  
Author(s):  
Sue Jordan ◽  
Patricia Logan ◽  
Gerwyn Panes ◽  
Mojtaba Vaismoradi ◽  
David Hughes

The power and influence of healthcare systems comes largely from the ability to prescribe efficacious medicine. However, medicine can sometimes cause harm rather than bring benefits. Systematically checking patients for the adverse effects of medicines, as listed in manufacturers’ literature, would protect patients from iatrogenic harm, but this is rarely undertaken. We argue for the benefits of this approach using the example of the prescription of antipsychotics to older adults. Prescribing antipsychotics to control challenging behaviours associated with dementia is a controversial matter, and regulatory intervention is under discussion. Improved regulatory systems could protect against iatrogenic harm, such as over-sedation, falls, tremor, or drug-induced Parkinsonism. However, measuring the impact and outcomes of regulatory interventions has proved difficult, not least because there are rarely systematic records of all adverse effects of medicines. We indicate how regulatory initiatives to reduce antipsychotic prescribing can be supported by systematic monitoring and documentation of patients’ signs and symptoms of putative adverse drug reactions. Monitoring documentation then provides the rationale and support for professionals’ responses to identified problems. Longitudinal monitoring records would improve understanding of the impact and outcomes of adverse drug reactions (ADRs) on health and wellbeing, and the many costs of ADRs.

Author(s):  
Amy L. Ball ◽  
Katarzyna M. Bloch ◽  
Lucille Rainbow ◽  
Xuan Liu ◽  
John Kenny ◽  
...  

AbstractMitochondrial DNA (mtDNA) is highly polymorphic and encodes 13 proteins which are critical to the production of ATP via oxidative phosphorylation. As mtDNA is maternally inherited and undergoes negligible recombination, acquired mutations have subdivided the human population into several discrete haplogroups. Mitochondrial haplogroup has been found to significantly alter mitochondrial function and impact susceptibility to adverse drug reactions. Despite these findings, there are currently limited models to assess the effect of mtDNA variation upon susceptibility to adverse drug reactions. Platelets offer a potential personalised model of this variation, as their anucleate nature offers a source of mtDNA without interference from the nuclear genome. This study, therefore, aimed to determine the effect of mtDNA variation upon mitochondrial function and drug-induced mitochondrial dysfunction in a platelet model. The mtDNA haplogroup of 383 healthy volunteers was determined using next-generation mtDNA sequencing (Illumina MiSeq). Subsequently, 30 of these volunteers from mitochondrial haplogroups H, J, T and U were recalled to donate fresh, whole blood from which platelets were isolated. Platelet mitochondrial function was tested at basal state and upon treatment with compounds associated with both mitochondrial dysfunction and adverse drug reactions, flutamide, 2-hydroxyflutamide and tolcapone (10–250 μM) using extracellular flux analysis. This study has demonstrated that freshly-isolated platelets are a practical, primary cell model, which is amenable to the study of drug-induced mitochondrial dysfunction. Specifically, platelets from donors of haplogroup J have been found to have increased susceptibility to the inhibition of complex I-driven respiration by 2-hydroxyflutamide. At a time when individual susceptibility to adverse drug reactions is not fully understood, this study provides evidence that inter-individual variation in mitochondrial genotype could be a factor in determining sensitivity to mitochondrial toxicants associated with costly adverse drug reactions.


Author(s):  
Robin Ferner ◽  
Anthony Cox

An adverse drug reaction is defined as ‘an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product; adverse effects usually predict hazard from future administration and warrant prevention, or specific treatment, or alteration of the dosage regimen, or withdrawal of the product’ (p. 1255, Edwards IR and Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet 2000; 356: 1255–9). Adverse drug reactions can cause or contribute to central and peripheral nervous system disorders, including traumatic, infective, neoplastic, demyelinating, and vascular diseases.


2012 ◽  
Vol 4 (2) ◽  
pp. 61-76
Author(s):  
Lidija Kandolf-Sekulović ◽  
Tatjana Radević

Abstract Adverse drug reactions may be defined as undesirable clinical manifestations resulting from administration of a particular drug; this includes reactions due to overdose, predictable side effects, and unanticipated adverse manifestations. Adverse drug effects on the skin are among the most frequent reactions and, according to a study, account for approximately 14% of all adverse drug reactions. However, the incidence of cutaneous adverse effects in general population is unknown. Systemic drug administration results in various cutaneous adverse reactions, and medications used in the treatment of skin diseases themselves have their own adverse effects. Adverse drug reactions include a wide range of effects, from harmless exanthema of short duration, urticaria to systemic cutaneous reactions such as drug rash with eosinophilia and systemic symptoms (DRESS) or toxic epidermal necrolysis. Exanthematous eruptions and urticaria are the two most common forms of cutaneous drug reactions. Less common include fixed eruptions, lichenoid, pustular, bullous and vasculitis reactions. The most severe cutaneous and mucosal adverse drug reactions are epidermal necrolysis, which is usually drug-induced, DRESS syndrome, and acute generalized exanthematous pustulosis. Therefore, the diagnostic of adverse drug reactions requires a detailed history of drug intake and development of skin disorders, excellent knowledge of clinical presentations for a wide range of drug-induced skin reactions as well as of the very medications being taken by patients. In addition to details on drug intake, it is necessary to learn about taking herbal and alternative preparations, which may also cause adverse reactions. A drug started within 6 weeks of the development of disorders is considered the most common cause of adverse reaction, as well as drugs taken periodically but regularly. Once a reaction has occurred, it is important to prevent future similar reactions with the same drug or a cross-reacting medication. Early withdrawal of all potentially responsible drugs is essential, particularly in case of severe drug reactions.


Author(s):  
Bartłomiej Juszczak ◽  
Jerzy Sułko

AbstractTo evaluate patient-reported effectiveness, safety and social influence of Pamidronate in the therapy of NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis in children. Authors reviewed self-created questionnaires, which asked patients for symptoms alleviation, adverse drug reactions frequency and degree of severity and daily activities self-reliance. Only surveys with complete answers, which were returned to authors by an e-mail from juvenile patients treated for NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at the University Children’s Hospital of Cracow were analyzed. Between 2010 and 2019, 61 children were diagnosed with NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at our department. Out of 61 requests sent, 42 complete replies (33 females, 9 males) were gathered and analyzed. All patients included in this research were administered with at least one set of Pamidronate intravenously in the dose of 1 mg/kg/day for 3 consecutive days. Our analysis shows remarkable in terms of patient’s impressions decrease of pain intensity after 2.5 series of Pamidronate on average, and total pain resolution after 5.9 series on average. Overall number of adverse drug reaction events reported by responders was 105. One patient developed drug-dependent renal insufficiency in the course of therapy. Outcome assessment indicates that nearly 50% of the studied population was more eager to participate in social life just after the first infusion of the drug. 95% of the surveyed unanimously agreed to recommend Pamidronate therapy to cure NSAIDs-refractory CRMO. 39 out of 42 (93%) patients considered Pamidronate effective at the end of the treatment. Onset of Pamidronate’s action is gradual and differs in terms of symptoms alleviation between sexes. The therapy can induce considerable number of adverse drug reactions (2.5 per patient). Only 3 out of 42 (7%) patients were free from any ADRs. To demonstrate the impact of the use of Pamidronate on daily activities more precisely, further research with quantification of the quality of life is warranted.


2021 ◽  
Vol 22 (12) ◽  
pp. 6480
Author(s):  
Céline K. Stäuble ◽  
Markus L. Lampert ◽  
Thorsten Mikoteit ◽  
Martin Hatzinger ◽  
Kurt E. Hersberger ◽  
...  

We report two cases of patients who developed severe adverse drug reactions including persistent movement disorders, nausea, and vertigo during treatment with quetiapine at maximum daily doses ranging between 300 and 400 mg. The extensive hepatic metabolism of quetiapine is mainly attributed to cytochrome P450 3A4 (CYP3A4). However, there is recent evidence supporting the idea of CYP2D6 playing a role in the clearance of the quetiapine active metabolite norquetiapine. Interestingly, both patients we are reporting of are carriers of the CYP2D6*4 variant, predicting an intermediate metabolizer phenotype. Additionally, co-medication with a known CYP2D6 inhibitor and renal impairment might have further affected quetiapine pharmacokinetics. The herein reported cases could spark a discussion on the potential impact of a patient’s pharmacogenetic predisposition in the treatment with quetiapine. However, further studies are warranted to promote the adoption of pharmacogenetic testing for the prevention of drug-induced toxicities associated with quetiapine.


2013 ◽  
Vol 14 (12) ◽  
pp. 920-925 ◽  
Author(s):  
Carolien G.M. Sino ◽  
Marcel L. Bouvy ◽  
Paul A.F. Jansen ◽  
Ilona M.B. Schop ◽  
Toine C.G. Egberts ◽  
...  

Author(s):  
SANTA TREASA CYRIAC ◽  
DIVYA SARA IYPE

Anti-bacterial are agents that inhibit bacterial growth or kills bacteria and are a sub-type of antimicrobials. These are drugs used to treat infections, but they sometimes pose a threat of adverse events. Some of these adverse events are neuropsychiatric, which are generally hard to diagnose and is often paid less attention. They account for about 30% of total Adverse drug reactions (ADRs) caused by drugs in patients without mental abnormalities. The spectrum ranges from episodes of seizure to acute psychosis. The article emphasizes the frequency of such adverse events and means to raise awareness among medical practitioners regarding the same. The various neuropsychiatric adverse effects and the agents responsible have been reviewed, along with their possible mechanisms and general management. The information for writing this review was selected by searching for keywords such as Neurotoxicity, GABA, Psychosis, Naranjo scale, and Antibiomania in databases such as Google Scholar, PubMed, Elsevier, etc. After searching the articles in the above-mentioned databases, the articles were screened concerning their importance with our work and according to their title and abstract. Additional articles were discovered by checking the references in the current study's citations. Using this method, the various neuropsychiatric adverse effects of Antibacterial agents were summarized in this review.


2002 ◽  
Vol 37 (10) ◽  
pp. 1040-1042 ◽  
Author(s):  
Joel Shuster

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.


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