Quality of medicines in Sri Lanka: a retrospective review of safety alerts.

BACKGROUND: Many medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to be withheld or recalled. AIMS: To investigate the withheld and recalled medicines in relation to the types of defects, their total numbers, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer during the study period. METHODS: A retrospective review was performed on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website in Sri Lanka between June 2018 and August 2021. Details on substandard medicines (SM) were extracted and documented. Each record of SM was individually reviewed to determine the type of defect, subsequent action taken by NMRA, therapeutic category, pharmaceutical dosage form, and country of manufacturer. RESULTS: A total of 163 defects were identified in 143 defective medicines, among which the most common types of defects were contamination (n = 59, 36.2%), stability defects (n = 41, 25.2%), packaging and labelling defects (n = 27, 16.6%) and active pharmaceutical ingredient defects (n = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives accounted for 41.9%, while parenteral preparations (44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin, and some manufacturers were identified to be repeatedly involved. CONCLUSIONS: This study revealed that contamination was the most frequent cause of defective medicines, while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form and therapeutic category found to be substandard, respectively. In addition, the findings show that some manufacturers were accountable for repetitive withholdings and recalls, which reflects the ignorance of quality control measures and weak regulatory inspections as a violation of Good Manufacturing Practice (GMP).

Impact of selected clinical pharmacy services on medication safety and prescription cost of patients attending a selected primary healthcare setting: a translational experience from a resource-limited country.

PURPOSE OF THE STUDY: The impact of clinical pharmacy (CP) services on primary healthcare (PH) is less well studied in resource-limited countries. We aimed to evaluate the effect of selected CP services on medication safety and prescription cost at a PH setting in Sri Lanka. STUDY DESIGN: Patients attending a PH medical clinic with medications prescribed at the same visit were selected using systematic random sampling. A medication history was obtained and medications were reconciled and reviewed using four standard references. Drug-related problems (DRPs) were identified and categorised, and severities were assessed using the National Coordinating Council Medication Error Reporting and Prevention Index. Acceptance of DRPs by prescribers was assessed. Prescription cost reduction due to CP interventions was assessed using Wilcoxon signed-rank test at 5% significance. RESULTS: Among 150 patients approached, 51 were recruited. Nearly half (58.8%) reported financial difficulties in purchasing medications. DRPs identified were 86. Of them, 13.9% (12 of 86) DRPs were identified when taking a medication history (administration errors (7 of 12); self-prescribing errors (5 of 12)), 2.3% (2 of 86) during reconciliation, and 83.7% (72 of 86) during medication reviewing (wrong indication (18 of 72), wrong strength (14 of 72), wrong frequency (19 of 72), wrong route of administration (2 of 72), duplication (3 of 72), other (16 of 72)). Most DRPs (55.8%) reached the patient, but did not cause harm. Prescribers accepted 65.8% (56 of 86) DRPs identified by researchers. The individual prescription cost reduced significantly due to CP interventions (p<0.001). CONCLUSIONS: Implementing CP services could potentially improve medication safety at a PH level even in resource-limited settings. Prescription cost could be significantly reduced for patients with financial difficulties in consultation with prescribers.

Impact of selected clinical pharmacy services on medication safety and prescription cost of patients attending a selected primary healthcare setting: a translational experience from a resource-limited country.

PURPOSE OF THE STUDY: The impact of clinical pharmacy (CP) services on primary healthcare (PH) is less well studied in resource-limited countries. We aimed to evaluate the effect of selected CP services on medication safety and prescription cost at a PH setting in Sri Lanka. STUDY DESIGN: Patients attending a PH medical clinic with medications prescribed at the same visit were selected using systematic random sampling. A medication history was obtained and medications were reconciled and reviewed using four standard references. Drug-related problems (DRPs) were identified and categorised, and severities were assessed using the National Coordinating Council Medication Error Reporting and Prevention Index. Acceptance of DRPs by prescribers was assessed. Prescription cost reduction due to CP interventions was assessed using Wilcoxon signed-rank test at 5% significance. RESULTS: Among 150 patients approached, 51 were recruited. Nearly half (58.8%) reported financial difficulties in purchasing medications. DRPs identified were 86. Of them, 13.9% (12 of 86) DRPs were identified when taking a medication history (administration errors (7 of 12); self-prescribing errors (5 of 12)), 2.3% (2 of 86) during reconciliation, and 83.7% (72 of 86) during medication reviewing (wrong indication (18 of 72), wrong strength (14 of 72), wrong frequency (19 of 72), wrong route of administration (2 of 72), duplication (3 of 72), other (16 of 72)). Most DRPs (55.8%) reached the patient, but did not cause harm. Prescribers accepted 65.8% (56 of 86) DRPs identified by researchers. The individual prescription cost reduced significantly due to CP interventions (p<0.001). CONCLUSIONS: Implementing CP services could potentially improve medication safety at a PH level even in resource-limited settings. Prescription cost could be significantly reduced for patients with financial difficulties in consultation with prescribers.