Knowledge, attitude and practice among consumers about adverse drug reaction reporting

Background: Background: Adverse Drug Reaction (ADR) reporting by consumers is quite low in India. Assessing knowledge and attitude of consumers regarding ADR reporting and observing practice of ADR reporting among them can help explore probable causes for underreporting of ADRs by consumers.Methods: This was a cross-sectional study conducted in a tertiary care teaching hospital using investigator-administered questionnaire and interviewing indoor patients of Surgery, Medicine, Obstetrics & Gynaecology and Dermatology departments. The questionnaire was prepared to assess knowledge, attitude and practice of consumers about ADR reporting. Data was analysed using mean, standard deviation and percentages.Result: A total of 820 consumers of medicines were included. It was found that 32.2% consumers were not aware that a drug can produce adverse effects. After being explained about adverse drug reactions, 94.6% consumers felt that adverse drug reactions should be reported. However, 98.8% consumers were not aware of Pharmacovigilance Programme of India. After consulting about consumer reporting programme, majority of respondents (96.1%) felt that the direct consumer reporting programme helps reporting of ADRs. Moreover, 93.7% of consumers were willing to use it to report ADRs in future. Consumers preferred the Telephonic method with a Toll free number for ADR reporting followed by informing a health care professional.Conclusion: Poor knowledge and awareness about ADR reporting is the major factor for low to nearly absent ADR reporting by consumers in India.

Pattern of adverse drug reactions into psychiatric patients

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.

An evaluation of Metered-Dose Inhaler Administration Technique in Patients of Asthma and Chronic Obstructive Pulmonary Disease.

Objectives: To evaluate the technique of use of metered dose inhaler (MDI) in patients of asthma or chronic obstructive pulmonary disease (COPD) patients at a tertiary health care hospital. Materials and methods: This was a cross-sectional observational study conducted in the patients of bronchial asthma and COPD who were prescribed MDI. The method to use MDI was assessed by using checklist made by WHO Guide to Good Prescribing. Results: A total of 193 patients (128 COPD, 65 asthma) were included. Majority of patients (95%) were educated by the treating physician for the use of inhalational technique of MDI. Majority of patients (98.4%) followed the step to place the lips tightly around the mouthpiece. While the least followed steps were coughing up as much sputum as possible (14.5%), breathing out through nose (15%) and rinsing the mouth after use (22.8%). Conclusion: Few steps of MDI use were missed in majority of the patients. This can be improved by demonstration and by providing awareness by the health care worker.

Evaluation of efficacy, safety and cost of oral and parenteral iron preparations in patients with iron deficiency anemia.

Objective: To compare the efficacy and safety of different oral and parenteral iron preparations in patients with anemia. Methods: An observational, prospective study in patients of anemia in pregnancy and chronic kidney disease (CKD) receiving iron sucrose, oral ferrous ascorbate and ferrous sulfate were included. Demographic details, clinical history, baseline hemoglobin, anemia indices data were recorded in a case record form. The patients were followed up monthly for 12 weeks and observed for clinical and haematological improvement and adverse drug reactions (ADRs). The data was analyzed using paired t-test, unpaired t-test and Fisher`s exact test. Results: Out of 232 patients, 84 received iron sucrose, 62 ferrous ascorbate and 86 ferrous sulfate. Oral and parenteral iron preparations significantly (P<0.0001) improved mean hemoglobin, anemia indices and serum ferritin at the end of study. However, mean increase in hemoglobin and anemia indices were significant (P<0.0001) with iron sucrose (4.42 ± 0.17gms/dL) as compared to ferrous ascorbate (3.45 ± 0.1) and sulfate (3.3 ± 0.4). Increase in serum ferritin was more and rapid (at 4 weeks) with iron sucrose as compared to ferrous ascorbate in CKD patients. Surprisingly, ADRs were more in patients treated with oral ferrous sulfate (86%) and ascorbate (71%) compared to iron sucrose (63%). Conclusion: Parenteral iron sucrose improves hemoglobin. anemia indices and replenish iron stores rapidly and is well tolerated than oral iron preparations.

Availability of pediatric medicines and their perception among prescribers at a Tertiary Care Teaching Hospital.

The pediatric population is heterogeneous group with markedly different pharmacokinetics from that in adults. However, conventionally adult dosage forms are fragmented to treat pediatric patients due to the poor availability of child friendly formulations in public health facilities. An observational, cross-sectional study was undertaken at pharmacy store and pediatric department at a tertiary care hospital. Each medicine with dosage form and strength was listed separately and compared with WHO Model List of Essential Medicines for Children (EMLc), Key tracer and Priority medicines for children. Prescribers were also interviewed using a validated structured questionnaire. Out of 27 drug groups listed in WHO EMLc, a large deficiency was observed in chemotherapeutics (47%), gastrointestinal (50%) and ophthalmic preparations (100%). Out of total 258 paediatric medicines, 55.8% were available. A gross deficiency of child specific dosage formulations was also observed. Majority (91%) of the prescriber confessed of using fragmented adult formulations and experienced drug administration problem. The availability of paediatric medicines in appropriate dosage formulations and strength is not satisfactory at public health facilities. Pharmacologically, children are separate group and their need should be addressed by including child friendly formulations in EML or having separate EMLc.