Burden of drug induced allergic reactions: a 3-year experience in a tertiary care hospital

Background: DIARs includes a wide spectrum of immunologically-mediated hypersensitivity reactions with varied mechanisms and clinical manifestations. Besides affecting a patient’s quality of life, it may also lead to increased treatment cost and length of hospitalization. The present study aims to provide an overview of drug induced allergic reactions experienced in a tertiary care set-up.Methods: A prospective observational outcome research was conducted over a 3-year period on patients encountering drug induced allergic reactions, who has been analysed for their spectrum of presentation, clinical outcomes (including severity, management and outcome of reaction), economic outcomes (including cost of treatment) and humanistic outcomes (including assessment of quality of life).Results: Drug induced allergic reactions accounts for 2.71% of total hospitalization in this study period. While majority reactions were moderate in severity grading, most were preventable. Direct cost of treating such preventable reactions were much higher along with increased indirect cost (due to prolonged hospitalization) adding to economic burden. Quality of life in patients encountering such reactions was also compromised as assessed using EQ-VAS.Conclusions: Prompt identification, consultation, cessation of culprit drug, management and patient counselling can act as strategies to minimize the burden of these reactions on society and healthcare system at large

Selective serotonin reuptake inhibitor associated suicidal ideation: a case report

This report describes a patient suffering from somatoform disorder that developed suicidal ideation specifically due to the treatment with sertraline. After 6-7 months on the regimen, she presented slight suicidal ideations. However, with gradual progress of time and continuation of the therapy, the ideation became intense. She complained of intense restlessness and anxiety. She presented with fresh cuts and bruises on her left arm and neck. On reporting the problem, the drug was withdrawn. Patient experienced gradual improvement in her state. The case report underlines the importance of onset of suicide risk in panic disorders due to specific antidepressants, selective serotonin reuptake inhibitors (SSRIs). The exact neurobiological basis of depression though being uncertain, the role of serotonin has been mostly implicated. Hypothetically, biological alterations in the serotonergic system might have contributed to the suicidal ideation/attempt in the presence of an SSRI. The present case attempts to highlight an incidence of development of suicidal ideation in a patient who is on chronic SSRI therapy

Monitoring adverse drug reactions in patients on TDF+3TC+EFV in a tertiary care hospital in Eastern India: a prospective observational study

Background: Recently, the National Aids Control Organisation (NACO) in India advocated and recommended the use of tenofovir, lamivudine and efavirenz as a fixed-dose combination in initiating ART in all future treatment-naïve patients. The present study was thus undertaken to assess the nature and extent of safety concerns with this regime.Methods: A prospective observational study was carried out in the outpatient setting of nodal ART centre of Eastern India. A total of 242 patients on various ART regimens were studied for suspected ADRs over one year. Adverse event history, medication history and other relevant details were captured. Causality and severity of each reported ADR were duly assessed.Results: Out of 242 PLHIV put on this regimen, 75 patients did not encounter any adverse reactions during the entire study period. Out of remaining 167 patients who presented with a total of 451 ADRs, maximum ADRs were attributed to various psychiatric disorders which included insomnia, dizziness, drowsiness etc, which were followed by gastrointestinal disorders including anorexia, flatulence, nausea, vomiting etc. Dermatological complications included rashes, itching, SJS, pigmentation of nails, skin hyper pigmentation respectively.Conclusions: The study enables to obtain information on the pattern of adverse drug reactions associated with treatment naïve PLHIV put on first line antiretroviral regimen comprising of once daily dosing of tenofovir, lamivudine, efavirenz. Need of intensive monitoring for ADRs in ARTs followed with proper patient counselling regarding its nature can lead to better compliance to the therapy

Monitoring cutaneous adverse drug reactions in patients on TDF+3TC+EFV: a single centre experience

Background: HIV-infected patients initiating antiretroviral therapy may manifest a wide variety of ADRs ranging from trivial manifestation, such as rashes, pigmentation, to severe life‑threatening reactions, such as Steven–Johnson syndrome, toxic epidermal necrolysis. The present study thus monitored cutaneous adverse drug reactions in patients on first line antiretroviral regimen comprising of tenofovir disoproxil fumerate, lamivudine and efavirenz as a three drug-combination.Methods: A prospective observational clinical study was carried out for a period of one year among PLHIV receiving TDF+3TC+EFV as first line regimen in the outpatient setting of a nodal ART centre of eastern India.Results: The major regimen induced dermatological complications presenting in our study set up included rashes, itching, SJS, pigmentation of nails, skin Hyperpigmentation. The morbilliform eruption, often referred to as a maculopapular rash, is the most common type of reaction occurring after treatment initiation.Conclusions: Adverse drug reactions are one of the most common public health concerns, which influence patients' treatment options along with health care costs

Assessment of drug use practices among dermatology out-patients using WHO core drug use indicators

Background: Considering the economic burden the skin diseases cause owing to its high prevalence, it is of interest to periodically monitor the drug use pattern so as to increase the therapeutic efficacy, decrease adverse effects and provide feedback to prescribers. The present study thus assessed the drug use practices among dermatology outpatients in a tertiary care teaching unit in Eastern India.Methods: The study assessed drug use practices for all prescriptions of patients attending the concerned OPD using WHO core drug use indicators which consist of mainly three domains, prescribing indicators, patient care indicators and healthcare indicators.Results: Total number of drugs in 471 prescriptions was found to be 1050. Number of drugs per prescription varied from 1 to 6 with average of 2.22. The most commonly prescribed drugs were antibiotics, followed by steroids and steroidal combinations. Prescribing indicators revealed that 2.09% drugs were generic prescribing, with about 18.78% of the drugs being prescribed from the WHO essential drug list. The proportion of encounters with at least one antibiotic prescribed was 34.82%. 13.9% drugs actually dispensed from hospital supply, of which all were adequately labelled.Conclusions: Increasing dermatological prescribing has necessitated assessment of their rational usage. Promoting rational drug use policy is recommended for effective healthcare management

Cutaneous Complications in Macrolide Prescribing in Pediatrics

Cutaneous adverse reactions are very common adverse effect of post antibiotic therapy. Cutaneous adverse reactions include skin lesions in the form of rashes urticaria, maculopapular rashes, eythema multiforme, stevens-johnson syndrome and toxic epidermal necrolysis. However macrolides, generally considered safer in this regard, are frequently used to treat both adult and childhood infections, with favorable outcomes. Cutaneous manifestations of this class of antibiotic are scarce. The present case series focuses on conglomeration of few cases of cutaneous reactions due to macrolide therapy in both children and adult population

Cutaneous Complications in Macrolide Prescribing in Pediatrics

Cutaneous adverse reactions are very common adverse effect of post antibiotic therapy. Cutaneous adverse reactions include skin lesions in the form of rashes urticaria, maculopapular rashes, eythema multiforme, stevens-johnson syndrome and toxic epidermal necrolysis. However macrolides, generally considered safer in this regard, are frequently used to treat both adult and childhood infections, with favorable outcomes. Cutaneous manifestations of this class of antibiotic are scarce. The present case series focuses on conglomeration of few cases of cutaneous reactions due to macrolide therapy in both children and adult population

AN OPD BASED PROSPECTIVE EXPLORATORY STUDY OF DERMATOPHYTOSIS - FOCUS ON TREATMENT OUTCOMES, MEDICATION ADHERENCE, AND QUALITY OF LIFE

Objective: The study was planned primarily to judge the effectiveness, safety, and adherence of the prescribed treatments in dermatophytosis along with the effect on the Quality of Life (QoL) of the affected individuals. Methods: In this prospective observational study, spanning over 5 months, participants (dermatophytosis patients) were assessed at baseline and 6 week-follow-up at study site. Information about their clinical presentation, QoL (Quality of Life) parameters, medication adherence, and adverse drug reaction (ADR) were entered in the Case Report Form (CRF) prepared by utilizing global standard tools such as 5D-itch scale, Dermatology Life Quality Index (DLQI), Medication Adherence Rating Scale (MARS), and WHO-ADR reporting form respectively. Results: Total 60 subjects (33 males and 27 females) had completed the study. Overall, tinea cruris (40%) was the most common variety followed by combination of tinea corporis and cruris (35%), tinea corporis (20%), and tinea incognito (3%). Pruritus was the predominant symptom. There was a significant (p<0.001) improvement of both 5D-itch & DLQI scores from baseline to follow-up stage (after 6 weeks). Treatment regimens were well tolerated (only eight subjects reported any adverse event such as gastric irritation and sedation). Medication adherence to the prescribed treatment was good; (mean MARS score 7.588±1.82). Mostly prescribed regimen was a combination of antifungal (oral plus topical) and antihistamine tablet (58/60, 96.66%). The most common drug combination was capsule itraconazole, luliconazole cream, and cetirizine or levocetirizine tablet with or without ketoconazole soap (35/60, 58.33%). Conclusion: Prescribed treatment regimen for dermatophytosis was effective, tolerable, acceptable with high medication adherence and also improved the QoL of the study subjects

Prescribing trends of anti glaucoma medication usage in treatment naive patients of primary open angle glaucoma in a tertiary care hospital in Eastern India

Background: Primary open angle glaucoma remains a high magnitude healthcare problem due to its prevalence and chronicity. The real world scenario of anti glaucoma medical therapy needs periodical auditing as far as drug prescriptions are concerned for formulation of treatment guidelines. Few studies from India have taken a longitudinal approach in this respect. This study was undertaken to identify such lacunae.Methods: This was an open label, prospective, observational study. Each treatment naive patient was followed up for a period of 6 months, where their prescriptions were scanned for the type of the anti glaucoma medications, total number of medications, route of administration, their duration of use and their frequency of dosage and change in medications if any, in each visits.Results: A gradual shift from monotherapy towards combination therapy was observed. Overall averages for prescriptions were topped by monotherapy at 44.25 followed by fixed dose combinations at 38.25, and then combination-polytherapy at 36 and the least number of prescriptions were for concurrent polytherapy at 17.5. Amongst all monotherapy agents, beta blockers were the most frequently prescribed drugs at baseline but their share of prescriptions was almost halved at the end of our study. The prostaglandin analogs on the other hand saw an upsurge in prescriptions from their baseline to the end of this study. Prostaglandin analogs andbeta blockers as fixed dose combination was a popular prescription over the entire study duration.Conclusions: Prescribing trends were remarkable for the shift from primary monotherapy towards fixed dose combinations as the study concluded. The decline in the number of beta blocker prescriptions and a rise in prostaglandin analog prescriptions is a testament to their better effectiveness and tolerability. The future of open angle glaucoma pharmacotherapy lies in prescribing more efficacious drugs either in monotherapy or in fixed combinations

NSAIDS induced cutaneous adverse drug reaction – a case series

Nonsteroidal anti-inflammatory drugs (NSAIDs) are common cause of cutaneous adverse reactions (CADR’s). Though there are fairly high numbers of agents which commonly cause CADR, NSAID’s holds no exception. NSAIDs can cause multiple cutaneous complications like urticaria, angioedema, acneiform eruption, stevens johnson syndrome (SJS), toxic epidermal necrolysis (TEN), vasculitis, fixed drug eruption (FDE) etc. NSAIDs are very frequently prescribed drugs and even one of the frequent over the counter sold medications, thus making it more important to have a more detailed knowledge of the vast cutaneous complications it can cause. The present case series focuses on the conglomeration of the few cases of cutaneous complications experienced by the patients on NSAID’s therapy.   Keywords: NSAIDs, severe cutaneous adverse reactions (SCARs), cutaneous adverse drug reactions (CADRs), stevens johnson syndrome (SJS), fixed drug eruptions (FDEs), fixed dose combination (FDC), over the counter (OTC