Current Disposal Practices of Unused and Expired Medicines Among General Public in Delhi and National Capital Region, India.

BACKGROUND: Stocking unused or expired medicines or donating these to others can lead to accidental or inappropriate ingestion, increasing the risk of adverse drug reaction(s) and even lead to antibiotic resistance. Further improper disposal of expired or unused medicines is associated with environmental pollution, health hazards and damage to ecosystem. Ecopharmacovigilance is an important area in this context. OBJECTIVE: To explore the awareness and disposal practices of unused/expired in the general public. MATERIALS AND METHODS: The current study is an observational, cross-sectional, questionnaire-based study conducted in 956 medicine consumers in New Delhi and National Capital Region, India. The knowledge, attitude, and practice of consumers regarding the disposal of unused medicines were evaluated. RESULTS: The majority (89.9%) of consumers opined that expiry of medicine(s) meant for completion of shelf life, production of toxic chemical and loss of or decreasing of beneficial effects of medicines. Majority (87%) of the consumers stored medicines at home. Almost all (92.6%) of the consumers threw away the expired medicines after storing for few days. Consumers discarded the expired medicines mainly in household trash (73%). The majority (93%) of consumers were in favour of a government program to collect unused or expired medicines from their home. CONCLUSION: The knowledge and practices of consumers towards disposal of unused and expired medicines needs to be improved. Health care professionals, government and policy makers should offer training to educate and guide the general public on safe and proper disposal practices of expired or unused medicines.

An Evaluation of Indian Consumers' Reporting of Suspected Adverse Drug Reactions with a Designated Reporting Form.

BACKGROUND: The Pharmacovigilance Program of India recently initiated a process for direct patient reporting of Adverse Drug Reactions (ADRs) with a designated form. PATIENTS AND METHODS: A survey of 200 patients reporting ADRs filling the form. Forms were analysed for patient data, the suspected medication(s), ADRs and possible causality. RESULTS: 54.3% of respondents provided their contact information; the implicated medicine was mentioned in 60% and the description of ADRs in 80% although 46.2% were not interpretable. The severity of ADRs was mentioned in 73.5%. No responder filled the expiry date component of the implicated modification and a causality assessment from most forms was unclassifiable (57%) or unclassified (26%). Details of concomitant drugs were missing. CONCLUSION: Missing information was a deterrent in analysing the consumer ADR reports for signal detection. It is recommended that the following fields are highlighted in the form: consumer's initials, address, date suspected reaction started, description of event, name, dose, and the reason for the use the medication as well as its expiry date. These should be mandatory in the existing form and new fields added for weight and height, batch number for vaccines and biological products, de challenge and rechallenge results to the suspected medicine and concomitantly used medicines. To improve the quality of information in the consumer reporting form an awareness campaign is also suggested.

Predictive value of symptoms for quality of life in first-episode schizophrenia.

BACKGROUND: Management of the disease symptomatology impacts the long-term functioning and quality of life (QOL) in psychotic patients. AIM: The aim of this research was to study the association between psychiatric symptoms (positive, negative and general psychopathology symptoms) and QOL in first-episode schizophrenia patients. METHODS: Fifty-five first-episode drug-naïve schizophrenia outpatients were recruited from a tertiary care hospital in New Delhi, India. WHOQOL-Bref (World Health Organization Quality of Life) Scale was used to assess multi-dimensional domains of QOL (physical, psychological, social and environmental health). The patients were evaluated clinically using PANSS and followed up for 6 months. Multivariate analyses were carried out to outline the symptoms which are predictive of QOL in these patients. RESULTS: Physical well-being as assessed with WHOQOL-Bref is significantly impacted by the positive, negative and general psychopathology symptoms of the disease. General psychopathology symptoms demonstrated a strong relationship with different facets of QOL. These symptoms are predictive of physical (P=0.025) and psychological health (P=0.026), social relationships (P=0.009) and environmental QOL (P=0.022). CONCLUSIONS: The general psychopathology symptoms significantly impact QOL in a diverse manner. Negative symptoms have a greater influence than positive symptoms on subjective QOL. CLINICAL IMPLICATIONS: The antipsychotics focus on primary positive and negative disease symptoms. There is a need to develop a holistic approach (target non-psychotic symptoms intensively) in the disease management to prevent further long-term impairment of QOL.

Comparison of knowledge, attitude and practices of resident doctors and nurses on adverse drug reaction monitoring and reporting in a tertiary care hospital.

BACKGROUND: Lack of knowledge of pharmacovigilance (PhV) and adverse event (AE) reporting culture among the healthcare providers have been identified as major factors for under reporting of AE in developing countries. Hence, this study was planned to assess and compare the knowledge, attitude, and practices (KAP) of resident doctors and nurses about PhV and AE reporting. MATERIAL AND METHODS: This cross-sectional, questionnaire-based study was conducted to compare KAP of 100 doctors and 100 nurses on PhV and AE reporting. RESULTS: All the respondents felt that AE reporting is necessary and two-thirds were aware of the existing PhV Program of India. Significantly, higher proportion of doctors had correct understanding regarding PhV (P<0.05) and knew what should be reported (P<0.05) but nurses (75%) knew better about where to report (P<0.001). Significantly (P<0.001), more doctors (98%) felt that the patients are benefited by reporting AE. Nurses (96%) felt the need for information on drugs causing AE and their management strategy (P<0.001). Around 60% of all the respondents were in favor of mandatory PhV and feedback on the submitted AE. Doctors (67%) (P<0.05) had a practice of inquiring patients for any untoward outcome of therapy. Higher proportion (P<0.05) of nurses (55%) mentioned that observed AE are recorded in patient's case record, but random screening of 1000 patients' record did not reveal it. Nurses mentioned that they never reported any AE (P<0.05) and witnessed discussions on ADRs during the ward rounds (P<0.001). All the respondents preferred phone as the convenient method for reporting AE followed by drop box kept in the ward/OPD and felt the need of frequent workshops and continuing medical education. CONCLUSION: Resident doctors and nurses had good knowledge and awareness on AE reporting and PhV but their practices need to be improved.

Adverse drug reactions: trends in a tertiary care hospital.

BACKGROUND: Pharmacovigilance (PV) System is an integral part of drug therapy which helps in detection, monitoring and designing strategies to minimize the occurrence of adverse drug reaction (ADRs). Present study was planned to study the patterns of ADRs in a tertiary care government hospital. METHODS: The present study was carried out for a period of one year. Suspected adverse drug reaction reports due to medications submitted to the Department of Pharmacology under the Pharmacovigilance Programme of India were included. The reports were analyzed for their type, severity, organ system involvement, and the causality assessment was performed using Naranjo Probability Scale. RESULTS: A total of 520 ADRs were received. The highest percentage (66.2%) of ADRs was seen in adult patients. Female patients experienced more (57.5%) ADRs. 95% of ADRs occurred in patients receiving 5 or more drugs. Medicine department reported the maximum number (38.46%) of ADRs. Antimicrobial agents (AMA) (35.7%) were the commonest group of drugs causing ADRs. Amongst the organ systems affected, skin constituted a major component (40.4%). Causality assessment revealed that 55% of the ADRs were possible. Majority of the ADRs were non-serious and only 7 cases were serious and required hospitalization. CONCLUSION: The results suggest that healthcare professionals (HCP) at this institution are cognizant of PV. However a closer liaison between the HCPs and the hospital PV centre, periodic reinforcement of the HCPs regarding the need for PV can further improve spontaneous reporting. The data will also help in designing strategies for framing policies towards safer use of drugs in future.

Injection practices of healthcare professionals in a Tertiary Care Hospital.

BACKGROUND: Unsafe injection practices are prevalent worldwide and may result in spread of infection. Thus the present study was planned to observe the injection practices of healthcare professionals (HCP), including aseptic precautions and disposal of used syringes/needle. MATERIALS AND METHODS: Injection practices were observed in the outpatients and inpatients departments. Questionnaire was designed, tested and administered for this purpose. RESULTS: 130 patients receiving injections were observed. Overall injection practices of the HCP were satisfactory. However, unsafe practices with respect to not washing hands (95.4%), not wearing/changing gloves (61.6%), recapping of needles (12.2%), wiping of needle with swab (15.4%) and breaking of ampoule with solid object (44.4%) were observed. CONCLUSION: The problem of unsafe injections can be successfully addressed by organizing continuing medical education/symposium/workshops for improving the knowledge, attitude and practices of the HCP. Periodic monitoring and such interventions may also further improve safe injection practices.