Active safety monitoring of measles-mumps-rubella vaccine in the National Immunisation Programme of Sri Lanka

Objectives: This study was designed to report incidence and characteristics of selected adverse events following immunisation which have consistent causal association (AEFIc) with Measles-Mumps-Rubella (MMR) vaccination given at the age of one year in the National Immunisation Programme of Sri Lanka. Methods: The data presented here were obtained from a cohort event monitoring study. It was carried out in the Jaffna Regional Directorate of Health Services area from November 2012 to December 2014. A representative sample of 3002 infants who received MMR immunisation were actively followed up for adverse events (AE) using over the phone interviews, self-reporting, and home or hospital visits up to 45 days. All AEs were reviewed by two investigators independently in two step-wise processes to detect the AEFIc. Seven AEFIc were detected using standard case definitions and onset time limit criteria. They were subjected to further analysis to describe the incidence rates and characteristics. Results: Of the 2398 (80%) infants who completed follow up of 45 days, 1321 infants experienced 2621 AEFI. Of them 209 were classified as AEFIc. Incidence of AEFIc was 87/ 1000 immunisation. They were mainly nonserious and resolved completely. There were no fatal or life threatening AEFIs. Incidence per 1000 immunisations; allergic reactions 0.83, injection site reactions 4.58, fever100.4° F or lasting more than  3 days 9.59, macular papular rash 2.92, parotitis 2.92 and generalised convulsions 1.25. Conclusions: The MMR vaccine used in NIP of Sri Lanka had low incidence of AEFIc and were mainly non-serious in nature.

Resistance and utilisation pattern of antibacterial agents in outpatient settings in two Teaching Hospitals in Colombo.

OBJECTIVES: Antibacterial resistance (ABR) is a public threat. Sri Lanka is a country with limited surveillance of ABR in the community. The WHO methodology was adapted to identify ABR in outpatient settings (nonhospitalised patients) and its link to consumption of antibiotics. METHODS: It was a cross-sectional descriptive community based study to collect ABR data from Out Patient Department (OPD) of two leading Teaching Hospitals in Colombo district. The indicator organism Escherichia coli (E. coli) was obtained from the urine specimens of patients who were suspected to have urinary tract infections. Antibiotic susceptibility testing was performed for commonly used oral antibiotics using disc diffusion method. The antibiotic consumption aggregate data were collected from the OPD pharmacies of the said hospitals and expressed as Defined Daily Doses (DDD) per 1000 inhabitants per 1000 day. RESULTS: Of the 2183 urine samples, pathogenic E. coli was isolated in 9.3% (204), and 8% (n=16) of them were Extended Spectrum Beta Lactamase (ESBL) producers. E.coli was most resistant to ampicillin (85%), followed by nalidixic acid (58.5%), trimethoprim/sulphamethoxazole (47.1%), ciprofloxacin (46.2%), norfloxacin (43.7%) amoxicillin /clavulanic acid (36.3%) and nitrofurantoin (15%). Multi-drug resistance was seen in 44%. Amoxicillin was the most frequently consumed antibacterial agent (2.65 DDD per 1000 inhabitants per day). CONCLUSIONS: There is an alarmingly high antibiotic resistance in the non-hospitalised patients indicating high prevalence of E. coli resistance in the community.

Safety of live attenuated Japanese encephalitis vaccine given at the age of 9 months in National Immunisation Programme of Sri Lanka.

OBJECTIVES: This study was designed to describe the safety profile of the single dose live attenuated Japanese encephalitis vaccine (LJEV) SA-14-14-2 given at the age of 9 months in the National Immunisation programme of Sri Lanka. METHODS: cohort event monitoring (CEM) was conducted in the Jaffna district during November 2012 to January 2015. A representative sample of 3041 infants who received the LJEV at the age of 9 months was followed up actively over telephone interviews on days 1, 3, 14, 30 and 45 for adverse events (AE). Parents were encouraged to self-report in between these interviews. When an AE is notified, further clinical information was obtained through in-depth interviews and home/hospital visits to determine as an adverse event following immunisation (AEFI). Investigators independently reviewed each AEFI for consistent causal association with LJEV according to WHO causality assessment. RESULTS: Of the 2878 (94%) infants who completed the follow up of 14 days, 911 (32%) experienced 1423 AEFIs. Of them, 376 (26%) were identified as AEFI with consistent causal association to LJEV (AEFIc). Irritability (53/ 1000 doses administered) and fever ≥100.4° F (46/1000 doses administered) accounted for 41% and 35% of AEFIcrespectively. Majority of AEFI (940) were identified as inconsistent as there were alternate causes. Nineteen AEFIc in 14 infants were classified as serious since they led to hospitalisation. Of the 2392 (79%) infants who completed 45 days follow up, 1022 experienced 1804 AEFI during 15-45 days. Only 20 were identified as AEFIc. There were no reported fatal or life threatening AEs. CONCLUSIONS: LJEV administered to infants at 9 months was devoid of any significant safety concerns as most of the AEFIs were non-serious and resolved completely. CEM is a useful method for AEFI surveillance.

Medicines use in hospitalised children: current status and outcome after an intervention.

INTRODUCTION: Challenges in rational use of medicines (RUM) in children are different from that of adults. In Sri Lanka, data on RUM in children are limited. OBJECTIVE: To assess the current status and to investigate effectiveness of an intervention in improving RUM in children. METHODS: Non-randomised controlled before and after study design was employed. Study settings were one paediatric unit in two Teaching Hospitals one for intervention (IU) and the other as a control (CU) unit. After assessing the current status in both units, a combined intervention (one-time training and distribution of a paediatric formulary) was offered to IU and medicine use was re-assessed in both units three months and one year after intervention. Fourteen indicators (7 WHO and 7 developed by investigators) were employed in the assessment. Any improvement was analysed using percentage changes, Chi-square or t tests as appropriate. RESULTS: A total of 1134 charts, 735 (3197 medicines) in IU and 399 (1539 medicines) in CU were subjected to analysis. At base level, of the 14 indicators, 9 were assessed satisfactory in both units. Four could not be assessed without knowing the clinical setting. The remaining indicator, reason for prescribing was recorded for 48% and 76% of medicines respectively in IU and CU. After intervention, only three indicators, medicines that had the reason for prescription recorded in the patient records, children treated without regular medicines, and children received the recommended doses of paracetamol, showed favourable changes in three months and one year. Percentage of medicines written in abbreviation showed an undesirable increase in IU (6.9, 16.2, 29.6) which was higher than what was observed in CU (3.2, 13.5, 18.4). CONCLUSIONS: Passive interventions appear to be ineffective in improving RUM in children. In addition, general medicine use indicators seem to be insensitive to capture the true challenges in paediatric pharmacotherapy.

A national survey of availability of key essential medicines for children in Sri Lanka.

OBJECTIVES: To investigate the availability of key essential medicines for children in Sri Lanka. METHODS: This national survey assessed the availability of 25 key essential medicines for children using the WHO/Health Action International medicine price methodology. Data were collected from a representative sample of 40 public hospitals (Outpatients Department pharmacies), 40 private and 8 'Rajya Osusala' (ROS) pharmacies. The hospitals and pharmacies were selected from 8 provinces using a multistage clustered approach to represent different levels of public hospitals. Descriptive statistics were used for analysis. RESULTS: The mean per cent availability of the basket of survey medicines was 52% in pubic hospitals when compared to 80% in private, and 88% in ROS pharmacies. teaching/general hospitals had better availability (mean per cent availability 62%) than district hospitals (54%), peripheral units (49%) and central dispensaries (45%). Availability of anti-infectives, anti-asthma medicines and oral liquid preparations of carbamazepine, iron, paracetamol, domperidone and ibuprofen was found to be less in public hospitals than private and ROS pharmacies. Availability in public hospitals similar to that of private and ROS pharmacies was only for paracetamol tablet, oral rehydration salt, vitamin C and chlorphenamine syrup. CONCLUSIONS: Key essential medicines for children were less available in public hospitals than in private and ROS pharmacies. This deprives children from access to effective and safe medicines more in the public hospitals than in the private sector or ROS.