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Resumen Desde la epidemia de poliomielitis de Copenhague en 1952, los cuidados intensivos no habían enfrentado un desafío tan importante desde el punto de vista médico y mediático como la pandemia por COVID-19, la cual ha tenido consecuencias devastadoras; una de ellas es el desborde en la capacidad de las Unidades de Cuidados Intensivos y, como resultado, la posibilidad de ofrecer ventilación mecánica ha sido insuficiente; además, las características avasallantes y rápidamente cambiantes de la información médica y no médica, al igual que la mortalidad relacionada a la enfermedad, han desarrollado una narrativa deletérea al tratamiento de estos pacientes con apoyo ventilatorio invasivo, lo que ha hecho resurgir viejas cuestiones sobre ésta como lesiones inducidas por ventilación mecánica invasiva. Todo esto ha promovido la revivificación del apoyo ventilatorio no invasivo como medida salvadora; sin embargo, como veremos en esta aproximación a la luz de la evidencia, es errónea y puede resultar deletérea no sólo para el paciente, sino también para el personal de salud que cuida de éstos.
Abstract Since the Copenhagen polio epidemic in 1952, intensive care has not faced as important a challenge from a medical and media point of view as the COVID-19 pandemic, which has had devastating consequences, one of which is the overflow in the capacity of Intensive Care Units, and as a result of the capacity to offer mechanical ventilation has been insufficient, in addition to the overwhelming and rapidly changing characteristics of medical and non-medical information, also of disease-related mortality, has developed a deleterious narrative to the treatment of these patients with invasive ventilatory support and raising old questions about this as injuries induced by invasive mechanical ventilation. All this has promoted the rise of non-invasive ventilatory support as a saving lifes strategy, however, as we will see, this approach, in scope of the evidence, is erroneous and can be hazardous not only for the patient but also for health personnel who care for them.
Resumo Desde a epidemia de poliomielite em Copenhague em 1952, a terapia intensiva não enfrenta um desafio tão importante do ponto de vista médico e midiático como a pandemia de COVID-19, que teve consequências devastadoras, sendo uma delas o transbordamento da capacidade de terapia intensiva unidades, e com isso a possibilidade de oferta de ventilação mecânica tem sido insuficiente, além das características avassaladoras e em rápida mudança das informações médicas e não médicas, bem como a mortalidade relacionada à doença, desenvolveu uma narrativa deletéria ao tratamento da esses pacientes com suporte ventilatório invasivo e ressurgiu antigas questões sobre o mesmo, como as lesões induzidas pela ventilação mecânica invasiva. Tudo isso tem promovido o renascimento do suporte ventilatório não invasivo como medida de economia, porém, como veremos, essa abordagem, à luz das evidências, é errônea e pode ser deletéria não só para o paciente, mas também para o pessoal de saúde quem cuida deles.
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Background: Fixed dose combinations are widely used in India, they are either irrational or prescribed irrationally. Moreover, the government has recently banned over 300 fixed dose combinations (FDCs) because of a lack of therapeutic justification. This study was conducted to study the prescribing pattern of FDCs in a tertiary care teaching hospital and to highlight the rationality of FDCs, and adverse drug reactions (ADRs) associated with them.Methods: In the present prospective observational study, a total of 500 inpatients were evaluated for prescribing pattern, cost analysis, and adverse drug reactions (ADRs) of FDCs. The FDCs were assessed for their rationality. The ADRs and severity were assessed using the WHO causality scale, Hartwig severity scale respectively.Results: Out of total 103 FDCs, 58 were approved, 86 were rational and 17 were irrational. 5 FDCs were banned and irrational. 48.54% of rational FDCs had rationality score from 7 to 9. The most commonly prescribed FDCs belonged to the anatomic therapeutic and chemical class of respiratory system, followed by anti-infectives in younger age group and cardiovascular FDCs in the elderly. The 886 ADRs occurred in 500 patients with a mean of 1.81�9. Banned FDCs contributed to 76 ADRs. According to causality and severity assessment, most of the ADRs were possible (62.53%) and mild (70.77%) respectively.Conclusions: Although FDCs were rational in most cases but banned FDCs were also prescribed. As these FDCs were associated with ADRs, monitoring of patients is necessary. Knowledge and attitude of healthcare professionals can be assessed through awareness programs.
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Organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1/3) as important uptake transporters play a fundamental role in the transportation of exogenous drugs and endogenous substances into cells. Rat OATP1B2, encoded by the gene, is homologous to human OATP1B1/3. Although OATP1B1/3 is very important, few animal models can be used to study its properties. In this report, we successfully constructed the S knockout (KO) rat model using the CRISPR/Cas9 technology for the first time. The novel rat model showed the absence of OATP1B2 protein expression, with no off-target effects as well as compensatory regulation of other transporters. Further pharmacokinetic study of pitavastatin, a typical substrate of OATP1B2, confirmed the OATP1B2 function was absent. Since bilirubin and bile acids are the substrates of OATP1B2, the contents of total bilirubin, direct bilirubin, indirect bilirubin, and total bile acids in serum are significantly higher in KO rats than the data of wild-type rats. These results are consistent with the symptoms caused by the absence of OATP1B1/3 in Rotor syndrome. Therefore, this rat model is not only a powerful tool for the study of OATP1B2-mediated drug transportation, but also a good disease model to study hyperbilirubinemia-related diseases.
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Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probability. The severity was assessed by modified Hartwig and Siegel scale, and preventability of ADRs was assessed by Schumock and Thornton scale.Results: Out of the total forty-one ADRs recorded, 40 (97.56%) were mild and 1 (2.44%) was reported as severe on the Hartwig and Siegel severity scale. Hematuria (68.29%) was the most common ADR followed by hemoptysis (14.63%). Among all anticoagulants, low molecular weight heparin was associated with the majority of ADRs (85.37%). The WHO causality and Naranjo Scale revealed that maximum of the ADRs (~80%) were possible. All ADRs reported was Type 揂� reactions according to Wills and Brown classification of ADRs. Majority of ADRs (97.56%) were probably preventable.Conclusions: In the present study, hematuria was the most common ADR reported. Among all anticoagulants, Low molecular weight heparin accounted for the majority of ADRs followed by acenocoumarol and heparin. Intensive monitoring and frequent reporting need to be done in cardiac units to improve patient safety.
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Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reported ADRs. Demography of patients, causative drugs, reactions, outcome, and severity are recorded. Data were analysed and expressed in numbers, percentages.Results: A total of 180 ADRs were spontaneously reported. Dermatology (42.8%), psychiatry (23.9%) and general medicine (18.3%) are the major departments reporting ADRs in our hospital. 60.6% reports were in males. The body system with maximum reactions is dermatological (51.1%). Drug class most commonly affected is anti-microbials (36.1%). Paracetamol (8.9%) is the most common drug with reactions. Causality assessment stated that 41.7% ADRs are probable and 58.3% were possible. Severity assessment showed 86.7% as mild and 13.3% as moderate. Preventability assessment stated that 93.3% ADRs not preventable, 5.6% probably preventable and 1.1% definitely preventable.Conclusions: The study provides a valuable insight with regards to the pattern of ADRs in our hospital. This will be useful in initiating a reporting culture, increase awareness, reducing under-reporting of ADR in our set up.
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Drugs are designed to treat medical conditions for the general population. Idiosyncratic reactions to drugs are determined by the individual’s respective genetic variations that direct effectiveness and side effects. Adverse drug reactions rank within the top ten leading causes of death in the developed world. The field of pharmacogenomics has advanced in the last fifty years, picking up significant momentum with recent biotechnological developments that allowscientists to investigate the human genome and provide individualized drug therapy that will increase the efficacy of drugs and decrease the incidence of adverse drug reactions. Pharmacogenomics has reached a milestone in making personalized medicine accessible and effective. The medical community shares this responsibility for the emerging focus on pharmacogenomics with regulatory agencies and bioinformatics specialists as they struggle to streamline vast libraries of information and reconcile public and regulatory approval on this critical path to the next level of health care.
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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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In the absence of effective vector control measures and vaccines against leishmaniasis, effective chemotherapy remains the mainstay of treatment. Identification of post-kala-azar dermal leishmaniasis (PKDL) is important due to the long and toxic treatment and the fact that PKDL patients may serve as a reservoir for visceral leishmaniasis (VL). This retrospective study was done to assess the outcome of pharmacotherapy in post-kala-azar dermal leishmaniasis (PKDL) patients in a specialty public hospital in Kolkata. Methods: The hospital records of all consecutive PKDL patients admitted at Calcutta School of Tropical Medicine (CSTM), Kolkata during the last five years - 2010-2014, were reviewed and the relevant information inputs as documented studied to realize the noted objectives. Clinical presentation on admission including presence of co-infections (particularly HIV), trends and patterns of treatment regimens and rationale thereof, if available; treatment (anti-leishmaniasis) outcomes in reference to efficacy, safety and tolerability, fatality like serious complications and mortality and adverse drug reactions (for anti-leishmaninal drugs primarily), if any was noted. Results: PKDL cases presented with insidious onset skin lesions of different types without much systemic illness. 2 out of 19 cases presented with fever and 2 other cases had mild anemia. PKDL cases presented with 4 types of skin lesions. Multiple macular or hyppigmented macular lesions were commonest, 8 out of 19 cases (42.10%). In PKDL cases treatment outcome was difficult to say unless parasitologically declared negative, though clinically regression of the lesions were visible in all cases. Tolerability was least with AmB followed by SSG and best with miltefosine. Conclusion: So, it can be concluded from this study that in this institute PKDL were treated with conventional and liposomal AmB as well as with SSG, miltefosine and combination therapy. Among the regimens short course L-AmB was found to be the most efficacious and tolerable in respect to ADRs and hospital stay.
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Abstract Depression can occur at all ages; however, when it begins early in life, prognosis is less favorable. Early identification and treatment provision need valid and reliable tools to assess depression in children and adolescents. The present study aimed at analyzing, in a Colombian community sample, the psychometric properties of two brief depression scales, using Classical Test Theory methods: The Adolescent Depression Rating Scale (ADRS) self-report version and the Revised Child Anxiety and Depression Scale (RCADS) - Major Depression Subscale. Analyses of both scales showed most item-scale and item-item correlations to be moderate and significant. Internal consistency was significant and adequate for both, ADRS (.67) and RCADS- Major Depression (.71). For ADRS, a two-factor solution explained 37.39% of variance while a one-single factor explained 25.99%. For RCADS-Major Depression, a two-factor solution explained 41.81% of variance while a one-single factor explained 29.14%. Construct validity was satisfactory, as both scales showed moderate and significant correlations with the convergent (RCADS-Generalized Anxiety) and the discriminant (KADS-11) criteria; yet, correlations with the former were stronger. Results provide further evidence in favor of the ADRS and the RCADS-Major Depression as effective tools to assess depressive symptoms in children and adolescents.
Resumen La depresión puede presentarse a cualquier edad; sin embargo, cuando ocurre en etapas tempranas de la vida el pronóstico es menos favorable. La identificación y el tratamiento tempranos necesitan herramientas válidas y confiables para evaluar la depresión en niños y adolescentes. El presente estudio analizó, en una muestra comunitaria colombiana, las propiedades psicométricas de dos escalas breves de depresión, utilizando métodos de la Teoría Clásica de los Test: Escala de Valoración de Depresión Adolescente (ADRS) versión de auto-reporte y la Escala de Ansiedad y Depresión Infantil Revisada (RCADS)- Subescala de Depresión Mayor. El análisis de las dos escalas mostró correlaciones ítem-ítem e ítemescala, moderadas y significativas. La consistencia interna fue significativa y adecuada para ambas escalas, ADRS (0.67) y RCADS-Depresión Mayor (0.71). Para ADRS, dos factores explicaron 37.39% de la varianza, mientras que la solución de un solo factor explicó 25.99% de la varianza. Para RCADS-Depresión Mayor, dos factores explicaron el 41.81% de varianza y un factor único explicó 29.14%. La validez de constructo fue satisfactoria, ambas escalas mostraron correlaciones moderadas y significativas con el criterio convergente (KADS-11) y el criterio discriminante (RCADS-Ansiedad Generalizada); aunque más fuertes en el primer caso. Los resultados evidencian que ADRS y RCADS-Depresión Mayor son herramientas efectivas para la valoración de síntomas depresivos en niños y adolescentes.
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Psychometrics , Adolescent Behavior , Depression/prevention & control , Depression/rehabilitation , Anxiety , Adjustment Disorders , Expressed Emotion , Multidimensional Scaling AnalysisABSTRACT
Background: To analyse adverse drug reactions (ADRs) reported in patients prescribed psychiatric medications at tertiary care hospital.Methods: ADRs reported in psychiatric patients between January 2011 to June 2017 were analyzed for demographic details, causal drugs, system organ classification, causality assessment (WHO-UMC criteria and Naranjo’s scale), preventability (Modified Schumock and Thorton’s criteria) and severity (Hartwing scale).Results: A total 4368 ADRs were reported during study period, out of which 658 (15.06%) were in psychiatric patients. The mean age of patients was 38±13.34 years and men (57.3%) were most commonly affected than women (42.7%). The most common causal drug groups were antidepressants (29.48%) followed by antipsychotics (23.12%) which include drug fluoxetine (33.9%) and olanzapine (34.3%) respectively. The most common system involved were central nervous system (32.8%) followed by gastrointestinal system (22.8%). Most of ADRs (42.7%) were observed after one month of therapy and showed possible (77%) causal relation with drug therapy. Majority of ADRs (77.4%) were not preventable and mild in nature (83.3%).Conclusions: ADRs are commonly seen in psychiatric patients. Hence, their monitoring and assessment in these patients who require multidrug and long-term therapy may help improve patient management.
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Background: Diabetes mellitus is an emerging non communicable, life style disease & the use of anti-diabetics has been increasing. Adverse drug reactions (ADRs) are well known to occur with any class of drugs when used in normal doses for the management of diseases. Anti-diabetic agents are no exception to this. The study of ADRs is the concern of the field known as pharmacovigilance. The objective of the present study was to analyze and describe the patterns of adverse events associated with the use of oral Anti-diabetic agentsMethods: A hospital based prospective observational study at Hi-Tech Medical College and Hospital, Bhubaneswar, Orissa. Convenience samples of 266 adult patients, prescribed with oral anti-diabetic agents from October 2016 to November 2018 were selected, out of which 74 patients developed ADRs. Data collected from available prescriptions. The severity assessment is done using the Hartwig and Siegal scale and preventability assessment using modified Schumock and Thornton is done.Results: Study suggests that female predominance in 41 (55.40%) patients with maximum cases of 43.24% in age group of 61-70 years age group. Maximum ADRs reported related to endocrine system seen in 36 (48.67%) patient population. Sulfonylureas 38 (51.35%) shows the largest numbers of ADR. The maximum ADRs reported were probable (56.73%). The severity assessment using the Hartwig and Siegal scale indicated that the majority of the ADRs were 63 (81.63%) as mild cases respectively.Conclusions: This study has provided evidence of monitoring and detecting ADRs and their management through therapeutic interventions which is beneficial in the better patient outcome.
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Background: Diclofenac and Tramadol are well established analgesics for post-operative pain management, yet some adverse effects are associated with their use which govern their tolerability. The objective of the study was to evaluate the comparative efficacy of the two drugs and to assess the causality and severity of documented Adverse Drug Reactions (ADRs).Methods: An open labelled, prospective, interventional, simple randomized clinical study to compare efficacy and safety of diclofenac and tramadol was conducted by the Department of Pharmacology in collaboration with the Department of Surgery. Post-operative pain intensity was measured on Visual Analogue Scale (VAS). Causality and severity assessment of the recorded ADRs was done using WHO-UMC scale and modified Hartwig and Seigel Scale respectively.Results: A total of 211 patients underwent different surgeries. The most common surgery performed was mesh hernioplasty 78 (36.96%). VAS score was used as data to determine the analgesic efficacy of two drugs. Wilcoxon Signed Rank test showed significant reduction in pain on all days for each group individually while Mann Whitney U test compared both the groups and revealed that both the drugs i.e. diclofenac and tramadol were equally efficacious in reducing post-operative pain. Causality assessment showed that all the documented ADRs fall in POSSIBLE category while severity assessment revealed that all the ADRs were MILD in nature.Conclusions: Diclofenac and tramadol proved to be equi-effective in reducing post-operative pain . The study also emphasized that active surveillance of ADRs can lead to timely intervention and provide maximum benefit to the patient.
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Background: Comparative studies are quite useful in evaluating the current practices in self medication among a similar subset of population. Since, self medication is one of the major causes of promoting irrational use of drugs its burden needs to be estimated more so in students with medical background.Methods: The study was conducted in a tertiary care teaching medical college among MBBS and BDS students. A questionnaire was selected based on outcome of small surveys done prior to this current study was among the MBBS and BDS students to assess their Knowledge, attitude and practice (KAP) towards self medication. Data was analyzed and expressed as numbers and percentage.Results: Total 180 students participated in the study voluntarily (100 MBBS and 80 BDS). Knowledge regarding self medication was more seen in MBBS students as compared to dental students. Only five of MBBS students encountered ADR’s(Adverse drug reactions) due to self medication. Analgesic group of drugs was the most common medication used by both the groups and pain was the chief component for which drug therapy was used.Conclusions: This study showed that students had fair knowledge about self medication but it appeared to be more among MBBS students as compared to BDS, although knowledge about ADR’s was not up to the mark. The attitude and practice of self medication was similar in both the groups. Thus, it is important to impart proper knowledge about self medication among medical students and encouragement regarding ADR teaching should be promoted.
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Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.
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Background: Monitoring and reporting of adverse drug reactions (ADRs) is very important to minimize or prevent drug caused harm. Thus, pharmacovigilance deals with it and ensures the patient safety. However, most of pharmacovigilance centers are concentrated in the urban tertiary care hospitals and contributes the maximum reports of ADRs. Participation of the rural health workers is equally important towards the success of pharmacovigilance.Methods: The study was conducted using a pre-validated questionnaire among forty doctors in rural Sub district hospital Akhnoor, Jammu after approval of the institutional ethical committee of Government Medical Jammu. The questionnaire consisted of 16 questions (7 related to knowledge, 4 related to attitude, and 4 related to practice and one question pertained to under reporting). The responses were recorded, and data obtained was analysed and presented as number and percentage.Results: Total 66.6% doctors gave correct response regarding the definition of pharmacovigilance and purpose of pharmacovigilance was given by 76.6% of doctors. 70% agreed that ADR reporting is a professional obligation for them. 80% responded that health care professionals are responsible for reporting ADRs. 63.3% of them were aware of a pharmacovigilance programme of India. A total of 96.6% doctors agreed that reporting of ADR is necessary and 93.3% were of the view that pharmacovigilance should be taught in detail. Majority of doctors have experienced ADRs in patients and 36.6% have seen the ADR reporting form. However, only 10% have ever reported ADR to a pharmacovigilance center. No remuneration (50%), lack of time to report ADR (30%), belief that a single unreported case may not affect ADR database (10%), and difficulty to decide whether ADR has occurred or not (10%) were important causes for under reporting of ADRs.Conclusions: Current study has shown that majority of the doctors have good knowledge and attitude about pharmacovigilance. However, under reporting is still a major concern among rural doctors and efforts are needed to address this problem of under reporting by conducting CMEs on regular basis.
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Background: Approximately 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. There are currently more than 25 drugs in the market for the treatment of epilepsy, many of which have similar efficacy but differ in their tolerability profile. Besides unmatched beneficial potential of antiepileptic drugs, it is associated with many adverse reactions too. This study aims to identify the serious adverse reactions caused by prescribed antiepileptics, reported at the pharmacovigilance centre of government tertiary care centre.Methods: This is a retrospective, pharmacovigilance study of the antiepileptic drugs adverse reactions reported over a period of 1 year at a tertiary care centre.Results: A total of 120 ADRs of antiepileptic drugs were reported and collected at the pharmacovigilance centre. According to the WHO-ART system organ classification of ADRs, 78% of ADRs belonged to skin and appendages disorder. Based on the modified Hartwig and Siegel scale of severity, 60.8% ADRs were mild, 18.5% were moderate and 20.8 % were severe ADRs. The severe ADRs included: Steven-Johnson syndrome, Toxic epidermal necrolysis, Erythroderma, DRESS syndrome and Acute pancreatitis. Phenytoin has been found to be the antiepileptic drug causing the most number of severe ADRs amongst the prescribed antiepileptics. According to the modified Schumock and Thornton criteria most of the severe ADRs were not preventable.Conclusions: This study analyses the ADRs associated with antiepileptics reported at the pharmacovigilance centre. 20.8% ADRS were severe, this indicates that the epileptic patients should be closely monitored for ADRs, to avoid clinically significant harmful consequences. The awareness of ADRs would help physicians to identify patients with greater risk of ADRs and therefore, might benefit from ADRs monitoring and reporting programmes.
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Background: Pharmacovigilance knowledge and training in post graduate student doctors is key factor for proper implementation of PvPI. Often the dentists and physiotherapists who are also one of the main stakeholders for ADR reporting are neglected for training and knowledge regarding pharmacovigilance. This study was planned to evaluate the knowledge and awareness of pharmacovigilance in post graduate students in tertiary care centre in Indore.Methods: It was a single point cross sectional questionnaire-based study conducted in a tertiary care Institute MGM Medical College and M.Y. Hospital in the state of Madhya Pradesh at Indore. It was conducted among post graduate student doctors from dentistry and physiotherapy. Total of 55 questionnaires were distributed, 50 of them were returned back and were analysed.Results: Overall knowledge level was average. 90% knew about ADR while 80% were aware about PVPI. 10% knew about local AMC at Indore while only 04% knew global centre for Pharmacovigilance is at Sweden Uppsala. 88% thought Med watch as global database for ADR against only 12% knew its Vigibase. 90% thought ADR reporting is necessary. 96% thought it should be included in UG curriculum. 98% had not reported any ADR till date while 84% had not seen an ADR form.Conclusions: Post graduate doctors are the prime candidates to impart the importance of pharmacovigilance. The study strongly suggested that there was a great need to create awareness and impart training among the post graduate doctors to improve the reporting of ADRs.
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Background: Epilepsy is a challenging medical problem in India with an annual incidence of 27.27 per 100,000 population and prevalence of 572.8 per 100,000. People with epilepsy require prolonged treatment and monitoring. The main goal in the treatment of epilepsy should be adequate control of seizures, without causing any life-threatening reactions due to the medications. This study was done to get an insight into the prescription pattern of anti-epileptic drugs (AEDs) in different types of epilepsy.Methods: A prospective study was carried out for six months (Feb to June 2016) in admitted patients in super speciality ward (Lala Shyam Lal) in neurology department of PGIMS, Rohtak, Haryana. The prescription data of 100 patients of seizures was analysed.Results: Idiopathic generalised epilepsy was commonest type of epilepsy (42%) and sodium valproate was the commonest drug prescribed for its treatment (66.66%) followed by phenytoin (23.33%) Symptomatic epilepsy was second commonest seizure (30%) and phenytoin (60%) was the commonest drug prescribed for it followed by sodium valproate (30%). Common adverse effects associated with anti-epileptic drugs (AEDs) were nausea, drowsiness, weight gain, diplopia and ataxia.Conclusions: Idiopathic generalized epilepsy was the commonest type of epilepsy recorded and sodium valproate was the commonest prescribed drug.
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Background: To study cutaneous adverse drug reactions with regard to their clinical pattern. etiology, causality and severity.Methods: It was a prospective study undertaken in a 300 bedded tertiary care hospital. Patients with cutaneous ADRs presenting in Dermatology OPD were studied. Causality and severity of the adverse drug reactions were analysed and other parameters such as gender wise distribution of the ADRs and types of ADR were studied.Results: 35 cases of ADRs were enrolled for the study in the duration of Sept.2016 to May 2017. The majority of the patients were in the age group of 21-30 years (37.14%). The most common CADRs were Acne vulgaris (22.86%), followed by Fixed Drug eruption (11.43%) and Tinea cruris (8.57%). The most common class of drugs causing ADRs were topical steroids (64%), followed by non-steroidal anti-inflammatory drugs (14.29%).Conclusions: Female preponderance was seen. Topical steroids were the most offending drug followed by Diclofenac Sodium, the analgesic. Causality assessment showed a high score of Certain category. These variations may be explained by variations in drug usage patterns. The knowledge of the adverse drug reactions and the drugs causing them is essential for the clinician so that the choice of drug therapy can be made keeping these adverse drug reactions in mind.
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Background: The biggest threat to mankind from the health perspective is probably the virus Human Immunodeficiency Virus (HIV) responsible for a serious disease known as Acquired Immune Deficiency Syndrome (AIDS). To compare the adverse effect profile of two antiretroviral regimens i.e, Zidovudine (ZDV) + Lamivudine (3TC) + Nevirapine (NVP) [regimen A] Vs Tenofovir (TDF) + Lamivudine (3TC) + Atazanavir(ATV) + Ritonavir (RTV) [regimen B] by clinical and biochemical methods.Methods: This prospective, observational study was carried out in 200 HIV positive patients receiving first line and second-line antiretroviral therapy (ART) at ART centre, GGH, Vijayawada. Out of 200 patients, 100 patients received regimen A [(ZDV) + (3TC) + (NVP)] and 100 patients were treated with regimen B [(TDF) + (3TC) + (ATV) + (RTV)]. The collected data has been analysed and presented.Results: Out of 200 patients, 110 patients developed ADRs. In this 110, 38 patients received regimen A and 18 patients received regimen B and had CD4 + count <250 cells/mm3. In the remaining 54 patients, 20 patients received regimen A and 34 patients received regimen B who had CD4+ count >250 cells/ mm3.Conclusions: The ADRs were most common in those patients whose CD4+ count is less than 250cells/cu mm. Though the patients on second line showed significant increase in CD4+count, number of patients with ADRs were also more with regimen B. Though atazanavir containing regimen is more efficacious than zidovudine containing regimen, but regimen B produces more serious adverse effects. So, second line drugs are reserved for treatment failures to first line, drug resistance and for those not tolerating first line drugs.