Background Quality of medicines is necessary to ensure patient safety. Quality failures of medicines could result in patient harm. Many medicine quality problems are detected after they arrive at health facilities. Medicine withholds and recalls are conducted for critically defective medicines that pose health risks to patients. Aims To investigate the withheld and recalled medicines in relation to the types of defects, their frequencies, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer. Methods A retrospective review was done on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website, Sri Lanka between June 2018 and January 2022. Two categories of defective medicine alerts were identified: falsified medicines (FM) and substandard medicines (SM), out of which SM were extracted and included as none of the FM was reported in Sri Lanka. Each record of SM was individually reviewed to determine the type of defect, therapeutic category, pharmaceutical dosage form, manufacturer with respect to his country and respective frequencies. Results Among 163 total defects reported, 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 (API) defects (N = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives (for systemic use) accounted for 42.2%, while parenteral preparations (N = 63, 44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin and seven manufacturers were identified as repeatedly involved with medicine withholds and recalls. Conclusions Substandard medicines are a problem in Sri Lanka and have resulted in an increasing number of withheld and recalled medicines. This study revealed that contaminations were the most frequent cause of defective medicines while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form as well as therapeutic category to be substandard. In addition, some manufacturers were accountable for repetitive withholds and recalls. Therefore, this review highlights the need of investigating the underlying causes and preventive measures to be implemented by manufacturers and regulatory authorities to avoid similar episodes in future.

Purpose of the studyThe 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 designPatients 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.ResultsAmong 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).ConclusionsImplementing 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.

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Background Quality of medicines is necessary to ensure patient safety. Quality failures of medicines could result in patient harm. Many medicine quality problems are detected after they arrive at health facilities. Thus, medicine withholds, and recalls are conducted for critically defective medicines that pose health risks to patients. Aims To investigate the withheld and recalled medicines in relation to the types of defects, their frequencies, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer. Methods A retrospective review was done on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website, Sri Lanka between June 2018 and January 2022. Two categories of defective medicine alerts were identified: falsified medicines (FM) and substandard medicines (SM), out of which SM were extracted and included as none of the FM was reported in Sri Lanka. Each record of SM was individually reviewed to determine the type of defect, therapeutic category, pharmaceutical dosage form, manufacturer with respect to his country and respective frequencies. Results Among 163 total defects reported, 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 (API) defects (N = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives (for systemic use) accounted for 42.2%, while parenteral preparations (N = 63, 44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin and seven manufacturers were identified as repeatedly involved with medicine withholds and recalls. Conclusions Substandard medicines are a problem in Sri Lanka and have resulted in an increasing number of withheld and recalled medicines. This study revealed that contaminations were the most frequent cause of defective medicines while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form as well as therapeutic category to be substandard. In addition, some manufacturers were accountable for repetitive withholds and recalls. Therefore, this review highlights the need of investigating the underlying causes and preventive measures to be implemented by manufacturers and regulatory authorities to avoid similar episodes in future.