Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India

Background: Adverse drug reactions (ADRs) are among the leading cause of morbidity and mortality in hospital setup. This study was conducted with the aim of understanding the pattern and occurrence of ADRs to minimize their risk and safeguard public health.Methods: This study is a retrospective analysis of pattern of ADRs reported at ADR monitoring centre (AMC) in a tertiary care hospital. A total of 207 spontaneous ADR reports collected over a period of 18 months were analysed for pattern and type of reactions, demographic profile of patients, organ system affected by ADRs, causative drugs, route of drug administration, severity of reaction, their outcome, management and causality assessment.Results: Most common age group affected by ADRs was 41-50 years with almost equal involvement of male and female gender. Cutaneous reactions involving skin like rashes and itching were most common ADRs. The most common causative drug for ADRs were antimicrobials agents like Penicillin and Cephalosporin group of antibiotics. Orally administered drugs were most commonly involved in causing ADRs. Most of the ADRs belonged to Type A category, were non-serious and moderate in severity. Most of the patients recovered from the ADRs on stopping the suspected drug. On assessing the causality, most of the ADRs were probable with the suspected drugs.Conclusions: Most of the patients recover from ADRs with appropriate and timely intervention, but it is important to understand the pattern and occurrence of ADRs for patient safety and this is possible only with an effective and robust pharmacovigilance system.

Study of prescribing pattern of drugs used in the treatment of bronchial asthma at tertiary care hospital of northern India

Background: Asthma is a chronic inflammatory disease requiring long term treatment. For an effective control of asthma symptoms background knowledge of the prescribing pattern of anti-asthmatic drugs is a must.Methods: A prospective, observational study was conducted in the Department of Respiratory Medicine OPD, King George's Medical University, Lucknow. 114 patients of asthma were recruited for the study. A case report form was filled from patient’s prescription containing the demographic details of the patients, presenting complaints, investigations and drugs prescribed along with their dose, duration, frequency, route of administration.Results: 114 patients’ prescriptions were assessed which showed average number of drugs per prescription - 3.22. 42.8% and 50% of the drugs were prescribed in accordance with World Health Organization model list of essential medicines and National list of essential medicines. Short acting ?2 agonist (salbutamol), 61.4% was the most commonly and frequently prescribed single anti asthmatic drug. Combination of inhaled corticosteroid and long acting ?2 agonist, 86.8% was the most commonly prescribed fixed dose combination anti asthmatic drug. Inhalational route (75%) was the most preferred one over oral route (25%).Conclusions: Asthma being a chronic disease requires prolonged treatment which imposes economic burden on the patients. Judicious prescription of drugs not only improves the patient clinically but also removes the unnecessary burden. Data obtained from these studies can be used as a guide to make future decisions regarding standard prescription.

An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India

Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.

An observational study to find out incidence and pattern of adverse drug reactions among multidrug resistant tuberculosis patients treated under revised national TB control program of India

Background: Between 2006 and 2015, the prevalence of MDR-TB has been found to be as high as 39.9% in some states. Approximately 35.8% of all previously treated patients developed MDR-TB. The objective of the present study was to identify demographic and health characteristics of patients as well as incidence and pattern of the adverse drug reactions caused by antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This 12 months study of observational study was conducted at a DOTS centre. MDR-TB diagnosed patients treated with DOTS Plus regimen were enrolled after getting informed consent. Patient information was recorded. Patient follow-up was conducted to identify the incidence and pattern of ADRs.Results: A total of 115 patients were enrolled. Maximum number of cases were in the 31-40 age group (25.21%) followed by the 41-50 age group (20.86%). 76 (66.08%) were males and 39 (33.91%) were females. 52 patients (45.21%) had concomitant diseases, out of which 15 (13.04%) were HIV positive and 21 (18.26%) were diabetic. 70 patients (60.86%) developed ADRs. The adverse drug reaction that were seen are -38 (38.76%) cases of gastrointestinal adverse drug reactions, 8 (8.16%) jaundice/hepatitis, 7 (7.14%) impaired hearing/vertigo, 21 (21.24%) central nervous system adverse drug reaction, 6 (6.12%) peripheral neuropathy, 6 (6.12%) rash and itching, 5 (5.10%) arthralgia, 3 (3.06%) renal impairment, 2 (2.04%) hypothyroidism and 2 (2.04%) blurred vision.Conclusions: Determining which population groups are affected most by ADRs can help physicians to better monitor and make an early diagnosis to reduce ADR-related morbidity and mortality.

Assessment of awareness towards pharmacovigilance programme of india and reporting of adverse drug reactions among nurses in a tertiary care hospital

Background: The success of PvPI depends upon spontaneous reporting of ADRs by health care professionals especially nurses as they are usually first contact persons for patients in case of ADRs after use of medicines. Underreporting of ADRs due to inadequate reporting culture among health care professionals is the main hindrance in the path of this programme. So, to assess the awareness, attitude and practices of nurses regarding PvPI and ADR reporting this study was undertaken.Methods: It was a cross-sectional, questionnaire-based study in which 130 nurses responded. The 12-items questionnaire feedback form provided by Indian Pharmacopoeia Commission (IPC) was used to assess the awareness of nurses towards pharmacovigilance programme and Adverse Drug Reaction (ADR) reporting practices.Results: After analysing the questionnaire, it was observed that, despite satisfactory level of awareness and interest of the nurses to participate in this programme, still there is meagre ADR reporting practices among the nurses.Conclusions: Lack of reporting culture and improper communication is the root of problem which should be overcome in future by proper training for patient safety.

Primary tubercular submandibular abscess: a rare presentation in two years old girl

Retroperitoneal Lymphangiomas are rare and account for only 1% of lymphangiomas. They usually present in infancy, rarely they may present symptomatically in adulthood. We present a case of a 19-year old female with a symptomatic retroperitoneal lymphangioma. It was treated with complete surgical excision. Retroperitoneal lymphangiomas are rare. Imaging alone cannot differentiate them from other retroperitoneal cystic masses. Surgical excision is the treatment of choice and required for final diagnosis.

Adhesive Meckel’s Diverticulitis Causing Intestinal Obstruction in a Nine Months Old Child.

Meckel’s diverticulum is often detected incidentally in children with recurrent pain abdomen or bleeding per rectum. Meckel’s diverticulum can also be the leading point in intussuception. We present a case of nine months old male child who presented with adhesive meckel’s diverticulitis.

Effect of ondansetron on sensory level produced by intrathecal bupivacaine.

Background: For spinal anesthesia there are drugs which can increase the level and quality of analgesia. Any drug which decreases sensory block level in spinal anesthesia is of great concern as it may need analgesic, sedative, supplement or even conversion to general anesthesia. Ondansetron is one such drug which has been reported to decrease the height of sensory block achieved after subarachnoid administration of bupivacaine. In this prospective observational study, we studied the effect of administration of ondansetron on the level of the sensory block achieved after subarachnoid blockade. Methods: In Group II, 4 mg ondansetron was given and 15 mins before giving spinal anesthesia Group II against control group receiving 2 ml saline intravenous (Group I). 15 mins before giving spinal anesthesia. Both groups received 3.5 ml of bupivacaine heavy was given intrathecally. Sensory and motor block was assessed 5, 15, and 30 mins. We analyzed both highest spinal block level achieved and time to regress to L1 level. Results: We found that in Group II both highest level of sensory block (T6 by median method) duration to regress to L1 level (1.43±0.22 hrs) was lesser as compared to group I and Group III T4 by median method and time to regress from T6 to L1 Group I 2.03±0.06 hrs Group III 1.84±0.27 hrs. Motor block did not differ between groups. Conclusions: We concluded that probably ondansetron was responsible for lower spinal block level and early recovery from spinal anesthesia after intrathecal bupivacaine and should not be given empirically for nausea and vomiting.

Role of ‘Gokshuradi Yog’ in Early Symptomatic Relief in Urinary Tract Infection in Children.

Background: Gokshuradi Yog used from for strengthening and functioning of genitourinary tract. The study aims to study the role of this Ayurvedic medicine along with antibiotic in early response to treatment of urinary tract infection in children. Methods: This study was conducted on 52 children (32 girls and 20 boys). They had symptomatic and culture proven urinary tract infection. They were randomly allotted the treatment group and control group. Patents in control were given the antibiotics for seven days and were evaluated every alternate day for symptomatic relief. Similarly the patients in treatment group were started the antibiotics along with preparation of ‘Gokshuradi Yog’ for seven days and were evaluated every alternate days. Repeat culture was performed on seventh day of treatment and the final result was evaluated. Results: The most common organism grown on culture was Escherichia coli in 39 patients (22 girls and 17 boys). Of the 28 children in treatment group 26 were asymptomatic in 2 days however they continued to be on therapy for seven days. Two patients were symptomatic even after four days, one of whom was culture positive even after 7 days of treatment and was put on intravenous antibiotics. Six out of 24 patients in control group were asymptomatic in two days; the 18 remaining patients were symptomatic even till day seven of treatment out of which two patients were culture positive. Conclusion: Patients when treated with ‘Gokshuradi Yog’ along with the antibiotics brings early symptomatic relief in children suffering from culture proven UTI.

A comparative study to evaluate the role of inhaled steroid versus lowdose oral steroid in patients of chronic obstructive pulmonary disease.

Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of death and disability worldwide. Its prevalence is increasing globally, especially in countries with high frequencies of smoking combined with signifi cant environmental exposures to pollutants and biomass smoke. Currently COPD is the third leading cause of death worldwide, after ischemic heart disease and stroke. Efforts have been made to design a standard protocol for treatment of the disease, and these efforts are still in the process. Methods: The study was done on 100 subjects to assess whether steroid (inhaled or oral) actually have any role in decreasing the decline in forced expiratory volume in 1 sec and to compare the effect of both to fi nd out which one is superior. Patients were divided into two arms, inhaled steroids group (according to GOLD guidelines), and the other group was oral prednisolone 10 mg in addition to standard treatment except inhaled steroid. The effects were studied with appropriate statistical tests. Results: Our study data showed that oral steroids are more effective on symptom control as compared to inhaled steroids. Symptoms such as cough (64% vs. 82%) and breathlessness (76% vs. 94%) signifi cantly improved in the oral corticosteroids group. The rate of exacerbation also improved (22% vs. 12%) in the test group. Conclusion: The use of steroids has ever been a subject of divergence of views ever since its role in the treatment of COPD was fi rst described. Although, overall steroid in any form is benefi cial in symptomatic/subjective and objective improvements in COPD, oral steroids stand a better chance as compared to inhaled steroids.

A comparison of toxicity profi le of gemcitabine monotherapy versus etoposide/cisplatin in the treatment of locally advanced or metastatic non-small cell lung cancer.

Background: Lung cancer is the leading cause of cancer deaths globally in which about 40% patients reporting in advanced stage disease. Both platinum and non platinum combinations have been shown to be equally effi cacious as initial fi rst-line treatment of advanced non-small cell lung cancer (NSCLC), however because of the toxicity of cisplatin, combination treatment can only be administered to a minority of patients in good general health. Gemcitabine could be combined with one of the other new agents to create novel non-platinum-doublet combinations with effi cacy and/or toxicity profi le superior to that of standard platinum based combinations. Hence, this study was conducted to compare the toxicity profi les of gemcitabine monotherapy and the cisplatin/etoposide combination therapy. Methods: This was a randomized prospective study, which included 96 patients selected on the basis of histologically or cytologically confi rmed Stage III B or IV of NSCLC. Study was divided into two arms-Arm A received gemcitabine monotherapy in a dose of 1000 mg/m2 on day 1 and 5 of the cycle and repeated after every 3 weeks while Arm B received cisplatin (25 mg/m2 on day 1, 2 and 3) + etoposide (100 mg/m2). Patient were evaluated for adverse events by following World Health Organization grading of toxicity. Results: Out of the 96 patients enrolled in the study, 74 (77.0%) patients were eligible and were analyzed. Of these, 36 (37.5%) patients belonged to Arm A and 38 (39.5%) to Arm B. Transient vomiting (45.8% vs. 37.5%), leukopenia (33.3% vs. 8.3%) were seen more in Arm A, while thrombocytopenia (33.3% vs. 12.5%), patchy hair loss (68.4% vs. 16.6%) was seen more in Arm B. Nephrotoxicity was seen almost similarly in both the groups. Conclusions: Single-agent gemcitabine appears to have a safer toxicity profi le than the combination cisplatin-etoposide in the fi rst-line chemotherapy of advanced NSCLC. With less toxic anticancer drugs like gemcitabine, the physician now has greater choice in choosing treatment, which can have better effect on the patients concerned.

Cervical tuberculosis masquerading as cancer cervix: A report of three cases.

Summary: Tuberculosis is still frequently observed in third world countries like Africa and Asia. Here we report three cases of genital tuberculosis with variable presentations. First case was a lady of reproductive age group who presented with polymenorrhea and post-coital bleeding with unhealthy cervix. Histopathology of cervical tissue revealed tubercular cervicitis. Second and third cases presented with different complaints like discharge per vaginum, post-coital bleeding and pain in lower abdomen with growth over the cervix. Cervical biopsy was inconclusive of tuberculosis but endometrial tissue sampling for TB PCR was positive. This shows that newer diagnostic marker test can help us to detect secondary genital tuberculosis.