scholarly journals A study of clinical spectrum of patterns of cutaneous adverse drug reactions in a tertiary care hospital

2019 ◽  
Vol 6 (1) ◽  
pp. 14
Author(s):  
Narendra Gangaiah ◽  
Veena Thimmappa ◽  
Harish Kumar Gajam ◽  
Naveen Kumar
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Past History ◽  
Clinical Spectrum ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Eruptions ◽  
Wide Range ◽  
Mucosal Involvement ◽  
History Of

<p class="abstract"><strong>Background:</strong> Adverse drug reactions are unwanted pharmacodynamic effects following administration of a drug. With an increase in number of newer drugs adverse drug reactions have become very common in recent times. Among them cutaneous reactions have been steadily gaining importance and constitute a major proportion of all the adverse drug reactions.</p><p class="abstract"><strong>Methods:</strong> This observational study was conducted at Sri Siddhartha Medical College and Hospital Tumkur, Karnataka, India, involving 73 patients with cutaneous adverse drug reaction (CADR) during November 2016 to May 2018. The aim of the study is to identify the causal drug and categorised into definite/probable/possible Naranjo Algorithm scale was used.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age of study participants was 35 years. Majority of cases observed had fixed drug eruptions (FDE: 37%), followed by maculo papular drug reaction (MPDR: 26%). Antimicrobials (42%), non-steroidal anti-inflammatory drugs (NSAIDs: 26%), anticonvulsants (9.5%) were commonly implicated drugs causing CADR. Among those with FDE, definite causality was highest for NSAIDs (9.6%) predominantly paracetamol whereas in MPDR definite causality was noted with anti-tubercular drugs (rifampicin 1.4%) and probable causality was highest for cephalosporins (5.5%) predominantly cefpodoxime. In present study it was observed female patient aged ≥35 years showed statistically significant mucosal involvement and past history of CADRs.</p><p class="abstract"><strong>Conclusions:</strong> A wide range of clinical spectrum of CADRs ranging from FDE to serious toxic epidermal necrolysis was observed. Most of these drug eruptions were caused by antimicrobials. Eliciting past history of CADRs with causal association will help to prevent and manage cases in a better way.</p>

The role of electronic records in reporting adverse drug reactions.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 309-309
Author(s):  
Alanna M. Poirier ◽  
Paul Nachowicz ◽  
Subhasis Misra
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Record ◽  
Adverse Drug Reactions ◽  
Improve Patient Safety ◽  
Cancer Center ◽  
Health Record ◽  
Drug Reactions ◽  
History Of ◽  
Electronic Health

309 Background: The Pharmacy and Therapeutics committee at a regional cancer center is responsible to report and trend existing adverse drug reactions. The electronic health record did not have an option to document the history of an event or have an alert function if a medication was re-ordered. The frequency of documented adverse drug reactions did not correlate to what was being observed on the units with the use of a paper document. Methods: InAugust 2010 a Lean Six Sigma project was initiated to improve adverse drug reaction reporting. An adverse drug reaction document along with standard work instructions was completed by March 2011. A report was built in the electronic health record and a computer based learning module was created and rolled out to clinical staff by October 2011. Results: The turn-around time in days to document an adverse drug reaction in the patients chart decreased from 6.8 days to 0.7 days. The documented adverse drug reactions increased by 37%; verified by the use of supportive medications. Conclusions: The root cause for under-reporting was attributed to lack of knowledge, process, and automation. The history of an adverse drug reaction can now be viewed and an automatic alert is produced requiring physician acknowledgement decreasing the chance of repeated discomfort or harm to the patient. Adverse drug reaction documentation can be retrieved within 24 hours, analyzed, trended, and used for educational purposes to improve patient safety. [Table: see text]

scholarly journals Reporting Adverse Drug Reactions Among Hospitalized Medical Patients: A Prospective Study From Tertiary Care Hospital in Western Nepal

2014 ◽  
Vol 4 (1) ◽  
pp. 330-336 ◽  
Author(s):  
Kadir Alam ◽  
R Shakya ◽  
P Ojha
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Uppsala Monitoring Centre ◽  
Care Hospital ◽  
Medical Patients ◽  
Drug Reactions ◽  
Online Data ◽  
General Medical Ward

Background    The risk of adverse drug reaction ranges nearly from zero to high level depending upon the drug itself and the patient factor. The process of detection, assessment, monitoring and reporting of adverse drug reaction is necessary to prevent its occurrence in future. Materials and Methods Information related to suspected Adverse Drug Reactions(ADRs) were collected by pharmacists from general medical ward using ADRs reporting form from Manipal Teaching Hospital (MTH)during ward rounds. The details of suspected drug, drug reaction and all related data were documented. Naranjo Algorithm, modified Hartwig and Siegel and modified Shumock and Thornton scale were used for assessment of causality, severity and preventability respectively. All suspected ADRs were reported to National Pharmacovigilance Center and then to Uppsala Monitoring centre through the electronic online data base named Vigiflow.  Results Among 1,105 patients, 51 patients experienced ADR (4.61%). Incidents of ADRs were higher with antibiotics (47.06%) and Ceftriaxone was at top of list (15.69 %). Dermatological system (25.49%) and gastrointestinal system (19.61%) were affected more. About 33.33% of suspected drugs were discontinued. About 41.18% of ADRs required medical treatment where antihistaminic (24.32%) and antipruritic (21.62%) were most commonly used to treat ADRs. To sum up, 64.71% of ADRs were probable, 62.75% were mild in nature and 60.78% were probably preventable. Conclusion Finding of the study suggests that ADRs still pose serious health threat among hospitalized patients and as a matter of fact over 60% of them are preventable. Reporting of ADR scan provide effective measures to prevent the occurrence in the future in which the role of pharmacist is vital.DOI: http://dx.doi.org/10.3126/nje.v4i1.10135 Nepal Journal of Epidemiology 2014;4 (1): 330-336

scholarly journals Prevalence and pattern of adverse cutaneous drug reactions presenting to a tertiary care hospital

2017 ◽  
Vol 3 (1) ◽  
pp. 74
Author(s):  
B. Janardhan ◽  
D. Shailendra
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Clinical Manifestations ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Female Ratio ◽  
The Mean ◽  
Cutaneous Drug Reactions

<p class="abstract"><strong>Background:</strong> An adverse cutaneous drug reaction (ACDR) is defined as an undesirable clinical manifestation resulting from administration of a particular drug. With an ever increasing number of drugs and varied formulations being continuously made available it is important that a close watch on the risks of adverse drug reactions is looked for, to ensure safe use of medicines in the interest of the patient. In the present study our aim is to study the prevalence &amp; pattern of cutaneous adverse drug reactions reported to department of dermatology at MediCiti Institute of Medical Sciences, Hyderabad, India<span lang="EN-IN">.</span></p><p class="abstract"><strong>Methods:</strong> All suspected cutaneous adverse drug reactions reported to the department of dermatology at MediCiti Institute of Medical Sciences during the two year period from January 2013 to December 2014 were included in this study. A thorough clinical examination of all these cases &amp; details related to the drug use and clinical manifestations of the cutaneous adverse drug reaction were documented using a structured proforma. Naranjo scale was used to assess causality in all the causes of cutaneous adverse drug reactions.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age of the patients was 42 years (age range: 1-64 years). Most of them were in the age group of 30-39 years. The male to female ratio was 1.78:1. The most common type of skin eruptions observed were maculopapular rash (35.55%), urticaria (26.19%) and fixed drug eruption (17.87%). The mean duration between drug intake and appearance of rash was 4 days (range: 1-120 days)<span lang="EN-IN">. </span></p><p class="abstract"><strong>Conclusions:</strong> The pattern of ACDRs and the drugs causing them in this study were similar to that reported in other studies both in terms of disease burden and clinical pattern. Knowledge of adverse cutaneous drug reactions will help to identify common medications contributing to dermatological reactions, so as to anticipate, prevent and limit their undue consequences<span lang="EN-IN">.</span></p>

scholarly journals Psychotic Disorders, Definition, Sign and Symptoms, Antipsychotic Drugs, Mechanism of Action, Pharmacokinetics & Pharmacodynamics with Side Effects & Adverse Drug Reactions: Updated Systematic Review Article

2020 ◽  
Vol 10 (1) ◽  
pp. 163-172
Author(s):  
Rohit Bangwal ◽  
Shivam Bisht ◽  
Saurabh Saklani ◽  
Shobit Garg ◽  
Mohan Dhayani
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Side Effects ◽  
Adverse Drug Reactions ◽  
Common Property ◽  
Antipsychotic Drugs ◽  
Psychotic Disorders ◽  
World Health ◽  
Drug Reactions ◽  
Wide Range

Psychosis is a mental disorder characterized by a disconnection from reality. Psychosis is a group of disorder characterized by thought disorder, abnormal behaviour, defective cognition, delusion and hallucination. Adverse drug reaction is defined as any undesired or unintended effects of drugs treatment. According to the World Health Organization (WHO)- “adverse drug reaction (ADRs) has been defined one which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or modification of physiological function”. Adverse drug reactions are the most important causes of the mortality and morbidity. Antipsychotics are the most effective drugs which are used in the psychiatry in the maintenance therapy of mania, psychoses and schizophrenia. The antipsychotics drugs are chemically disparate but have the common property of alleviating the symptoms of organic as well as functional psychosis. But they also have a capacity to cause a wide range of potential adverse drug reactions that can lead to non-compliance that can impair quality of life, may cause the extra pyramidal symptoms which can lead to discontinuation of therapy and in extreme cases it may be fatal. Knowledge of assessment of ADRs due to different antipsychotics is necessary. It helps to choose to safe treatment and reduce the risk of occurrence of ADRs by the clinicians. ADR are often poorly identified and reported in day to day medical practice. As we collect more and more information about ADRs, we need an active surveillance system regarding identification and reporting of ADRs with antipsychotic drugs.  On many review articles are read & ward round participation experiences we find that antipsychotic drugs can have shown a various kind of ADRs. Psychiatrist and clinical pharmacist are need to be made aware of these potentially fatal adverse effects associated with antipsychotic drugs via conduction of patients counseling regarding (drugs, disease, doses & side effects), quality-based seminars, published medical literature, conferences, learning programs and health care camps. Keywords: Antipsychotic Drugs, WHO, Adverse Drug Reactions, Pharmacovigilance, Psychiatrist.

Cutaneous Drug Reactions in Children Attending a Tertiary Care Hospital

2020 ◽  
Vol 33 (2) ◽  
pp. 56-62
Author(s):  
Md Mostafizur Rahman ◽  
Md Azraf Hossain Khan ◽  
Pampa Chandra ◽  
Laila Shamima Sharmin ◽  
Fazlur Rahman ◽  
...  
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Stevens Johnson Syndrome ◽  
Care Hospital ◽  
Drug Reactions ◽  
Johnson Syndrome ◽  
Cutaneous Drug Reactions ◽  
Cutaneous Drug Reaction

Background: Cutaneous drug reaction (CDR) is a growing health hazard in the world. Adverse drug reactions are common complications in drug therapy. About 3-8% of all hospital admissions are the results of adverse drug reactions, among them 2-3% are children and these can cause significant disability to patients. Early identification and management of adverse cutaneous drug reaction has both short term and long term prognostic significance.  Objective: To know the cutaneous reaction to drugs in children in a tertiary care hospital.  Study design: Hospital based descriptive, observational study. Subjects: 50 children with cutaneous drug reactions were studied in the department of Dermatology and Pediatric respectively in Rajshahi Medical College Hospital, Rajshahi. Methods: Data were collected by detailed history taking, physical examination and laboratory investigations in a prefixed data collection sheet and with the help of GOLD guideline after taken informed consent of the patient. Results: This study showed a significant male predominance. Male: female ratio was 1.08:1 .In this study prevalence was highest among 1-5 years age group. Cotrimoxazole, NSAIDs, anticonvulsant and quinolone were most offending medications. Maculopapular eruption, Stevens Johnson Syndrome, fixed drug eruption and urticaria were most common morphological types. Majority of CDRs were noted with oral route of administration. It was observed that almost all the CDRs that were reported involved mainly the skin. Majority of adverse cutaneous drug reactions reported were moderate in severity. Conclusion: Frequency distribution of the offending drugs and the adverse reactions revealed that adverse cutaneous drug reactions occurred mostly by cotrimoxazole, NSAIDs and quinolones. Maculopapular rash and Stevens Johnson Syndrome were the most common morphological types. A better understanding of the mechanisms underlying CRDs is important in drug development and in patient care. TAJ 2020; 33(2): 56-62

scholarly journals Cutaneous adverse drug reactions in a tertiary care hospital: An observational study

2020 ◽  
Vol 1 (1) ◽  
pp. 6-9 ◽  
Author(s):  
Baijayanti Rath ◽  
Manas Ranjan Naik ◽  
Bhabagrahi Rath ◽  
Renuka Bhoi ◽  
Jai Prakash
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Developed Countries ◽  
Care Hospital ◽  
Severity Assessment ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Antitubercular Drugs ◽  
Drug Eruptions ◽  
Fixed Drug

Introduction: Cutaneous adverse drug reactions (CADRs) are one of the most common ADRs caused by drugs causing a lot of morbidity and mortality. The overall incidence of CADRs in developed countries is 1-3 %, while that in the developing countries is reported to be higher between 2 % and 5 %. Changes in drug metabolism drug interactions, oxidative stress, and various cytokines are the various factors that cause cutaneous adverse drug reactions. Aim and objective: This study aims to evaluate the patterns of CADRs, the causative drugs along with causality and severity assessment. Methods: A total of 50 Patients with cutaneous adverse drug reactions who were included in our last study attended skin OPD, VIMSAR Burla, from June 2018 to September 2018 and were analyzed for causality assessment using the WHO-UMC scale and severity assessment using  Hartwig and Siegel's scale. Results: Out of 50 patients, 48 % belong to the age group 21-40 years. Around 44 % of CADRs were fixed drug eruptions. NSAID was found to be the most offending drug and it contributed to a maximum of 32 % of ADRs. 16 % of ADRs were found to be caused by antitubercular drugs. Paracetamol was the key NSAID, contributing 87.5 % of ADRs. Causality was certain, probable, and possible for 8 %, 24 %, and 60 % of ADRs respectively. Severity was mild for 64 % and moderate for 34 % of ADRs. Conclusions: NSAID and antitubercular drugs are the commonest drugs causing CADRs. Fixed drug eruption is the most common CADRs and the commonest drug was paracetamol. Causality grade was possible and the severity grade was mild.

scholarly journals Prescribing pattern and adverse drug effects monitoring of anti-rheumatoid drugs in rheumatoid arthritis patients in a tertiary care hospital

2019 ◽  
Vol 8 (3) ◽  
pp. 462
Author(s):  
M. Venkateswaran ◽  
M. Dhanasekaran ◽  
S. Rajavelu
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Common Disease ◽  
Care Hospital ◽  
Drug Reactions ◽  
Prescribing Pattern ◽  
Elevated Liver Enzymes

Background: Rheumatoid arthritis (RA) is a common disease that causes substantial morbidity in most patients and premature mortality in many. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is important to monitor the drugs for adverse drug reaction. This study will estimate the prescribing pattern and bring out the possible adverse drug reactions in patients with rheumatoid arthritis.Methods: This study included 200 patients with rheumatoid arthritis who fulfilled the study criteria were observed for three months. Their prescriptions were collected and analysed. The symptoms of adverse drug reaction were documented through questionnaire. The causality assessment was done by WHO-UMC assessment scale and severity by using modified Hartwig-Seigel severity assessment scale.Results: This study showed most of the patients were female (86%). Majority of them were in age group of 51-60 years. Average number of drugs per prescription was 10.57. Out of 200 patients, 2% were on single DMARD and 50.5% were on two DMARDs. 40% and 7.5% were taking three and four DMARDs respectively. A total of 450 adverse drug reactions were reported, out of which 68.4% due to steroid,12.5% due to DMARDs and 19.1 due to use of NSAIDs, DMARDs and glucocortisteroids. Chloroquine maculopathy occurred in 3 patients and elevated liver enzymes due to methotrexate in 3 patients, which necessitated DMARD withdrawal. Most patients had 1-3 ADRs. 6% of ADRs were severe and 54% belongs to probable category of causality assessment.Conclusions: Treatment of rheumatoid arthritis is mainly based on DMARDs, glucocorticosteroids and NSAIDs. So, occurrence of ADR is much common. Proper monitoring of therapy and timely modification of drugs and lifestyle can reduce the ADR occurrence.

Clinical pattern and causative agents of adverse cutaneous drug reactions in a tertiary care hospital SKIMS Soura Srinagar.

JMS SKIMS ◽  
2017 ◽  
Vol 20 (2) ◽  
pp. 73-76 ◽  
Author(s):  
Surjeet Singh ◽  
Zahoor A Wafai ◽  
Ajaz Koul
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
Pharmacovigilance Center ◽  
Causative Agents ◽  
Cutaneous Drug Reactions

Background: Adverse drug reactions are the most frequent side effects of drugs. Most of them being benign but can prove fatal sometimes. Aim: To study the different clinical spectrum of cutaneous adverse drug reactions and to determine causative drugs. Methods: It was a prospective hospital based study carried out for a period of 3 years. It was part of continuous adverse drug reaction monitoring carried out by our pharmacovigilance center at SKIMS. Results: Out of 1225 total adverse drug reactions 685 were enrolled as cutaneous ADR’s. Most common types observed were maculopapular rash (43.9%), fixed drug eruptions (36.2%) and urticaria (15.1%). The drugs most incriminated for various cutaneous ADR’s were antimicrobials (48.7%), anticonvulsants (22%), and NSAIDS (17.9%). Antimicrobials were also responsible for maximum of (58.3%) of severe cutaneous ADR’s like TEN and SJS. Conclusion: Pattern of cutaneous ADR’s and their causative drugs are similar to those observed in other regions with small variations, as reported by similar studies. However, due to emergence of newer drugs and differing trends in use of drugs, both pattern of cutaneous ADR’s as well as drugs causing them are changing every year. Further studies of similar nature with more expertise are required for safe use of drugs in future. JMS 2017;20(2):73-76  

Surveillance of adverse drug reactions and drug–drug interactions with pediatric oncology patients in a south Indian tertiary care hospital

2019 ◽  
Vol 26 (5) ◽  
pp. 1103-1109
Author(s):  
Bency Joseph ◽  
Julius X Scott ◽  
M G Rajanandh
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Interaction ◽  
Adverse Drug Reactions ◽  
Pediatric Oncology ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Drug Interaction

Objective The present study was conducted to evaluate the pattern of occurrence of adverse drug reactions and drug–drug interaction in a pediatric oncology unit of a tertiary care hospital. Methods A prospective, observational study was conducted in the Department of Pediatric Oncology, Sri Ramachandra Medical College and Hospital, India. Patients were monitored actively for the occurrences of any adverse drug reaction during the study period. Patient's demographic details, clinical, and treatment data were collected for drug–drug interaction analysis. The detected adverse drug reaction was assessed for causality, severity, and preventability. Drug–drug interaction identified was rated based on their level of urgency and the nature of actions necessary to respond to an interaction. Results Of 176 patients, 118 were detected for the occurrence of various adverse drug reaction. The majority of the cases were suffering with acute lymphocytic leukemia (67.9%). Vincristine was noted for a maximum number of adverse drug reaction in cytotoxic drugs. Rash is the most frequently occurred reaction. Assessment of causality showed that the majority of cases are “probable” (60.16%). In evaluating the severity of adverse drug reactions, 57.6% reactions were moderately severe and 74.5% of the reactions were preventable. Upon assessing the drug–drug interaction, 38.13% of the prescription needs to be monitored and 10 drug–drug interactions were under the risk category of “X.” The majority of the adverse drug reaction was moderately severe in nature and those were preventable. Conclusion Since pediatrics are vulnerable population, they must have a thorough surveillance system for adverse drug reaction and drug–drug interaction; thereby, a positive impact on the medication-use system and improved patient care can be achieved.

scholarly journals A study on pattern of adverse drug reaction in an adverse drug reaction monitoring centre of a tertiary care hospital in South Kerala, India

2019 ◽  
Vol 8 (8) ◽  
pp. 1813
Author(s):  
Ajay Rajan ◽  
Ramani P. T. ◽  
Sabitha Raj
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Care Hospital ◽  
Reaction Monitoring ◽  
Government Medical College ◽  
Drug Reactions ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Monitoring Centre

Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. Under reporting of ADR from healthcare professional is considered as the contributing factor for increased morbidity and mortality. India has taken well appreciated step to launch Pharmacovigilance Programme of India (PvPI) to safeguard heath care of Indian population. This study looks into the detailed analysis of ADR reported to adverse drug reaction monitoring centre (AMC), Government Medical College, Trivandrum to assess its pattern, causality, severity and seriousness of ADR. Primary objectives of this study are the pattern of adverse drug reactions reported to ADR monitoring centre (AMC) and secondary objective is to assess causality, severity.Methods: A record based descriptive study was conducted in the ADR monitoring centre of government medical college, Trivandrum, Kerala from September 1st  2016 to February 2017(6 months). The data were collected from the all reported case records/ ADR report form of CDSCO. The details of the various adverse drug reactions were identified and analysed to find the pattern of adverse drug reactions including distribution of age, gender, causal drug group, system organ class. Also, an attempt is made to do causality assessment using WHO UMC scale and severity by using Heart wig Seigel Scale.Results: Out of 320 ADR cases, majority of reports were due to cutaneous manifestations. Most common ADRs were erythema, induration, and rash, itching. Females were 56% and males were 44%. Majority cases were of adult age group. Causality 91.88% were probably related, 75.6% were mild reaction. 25% of cases were serious. 77.5% were recovered. Antibacterial implicated 25(7.8%) followed by anti-epileptics 24 (7.5%) ADR.Conclusions: The pattern of adverse drug reactions reported to this AMC is comparable to the studies done in other parts of country. A strong need for streamlining of ADR monitoring system and reporting reemphasized by this study, which will promote the ADR reporting in healthcare professionals.

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