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.

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.

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.

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.