Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use-A Cross-Sectional Study in Sri Lanka.

BACKGROUND: Look-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which could create confusion among users and challenge the safe use of medicines. The availability of foreign products in local markets aggravates the situation. This study was designed to examine the registered medicine proprietary names in Sri Lanka to discern the presence of similar medicine names in the industry. METHODS: A cross-sectional study was conducted on the registered drug proprietary names in Sri Lanka. Using the RAND and RANK functions in Microsoft® excel® 365, a random sample of 385 proprietary names was selected. Two evaluators independently evaluated each proprietary name in the sample against the other registered proprietary names following a stepwise text filtering method. After each filter, the resulting proprietary names were manually examined for identical, similar-looking, and similar-sounding proprietary names to the name under evaluation. The observations were matched, categorized, and collated into ten groups. RESULTS: Among the 385 names evaluated, 138 (35.84%) proprietary names had no similarity to existing other registered proprietary names. The rest of the names (n = 247, 64.15%) were found to be either identical (n = 03 pairs), look-alike (n = 91 pairs), or sound-alike (n = 80 pairs) to the registered proprietary names. CONCLUSION: The findings revealed the presence of equal and similar proprietary names in the system. A multifactorial strategy led by the National Medicine Regulatory Authority (NMRA) is recommended to minimize the confusing names entering the system. Primarily the NMRA's call for action should include adequate industry guidance with specific guidelines, a significant pre-submission assessment process, and denying approval of LASA proprietary names.

Age-dependent assessment thresholds to optimize patient care in a resource-limited setting: an analysis based on the Sri Lankan FRAX model.

Age-dependent upper and lower assessment thresholds help categorizing women aged 40 years or more according to their fracture risk, independent of BMD information. INTRODUCTION: Age-dependent assessment thresholds of the FRAX algorithm help stratifying men and women aged 40 years or more according to their fracture risk. This allows clinicians to decide on those who require interventions without BMD assessment and those who require BMD input for further assessment. METHODS: Intervention thresholds were defined by 10-year probabilities of a major osteoporotic fracture (MOF) and hip fracture (HF) considering a woman with a BMI of 25.0 kg/m2 having a prior fragility fracture but no other clinical risk factors. The lower assessment thresholds (LAT) were set at 0.8 times the 10-year probabilities of a MOF and HF in a woman with a BMI of 25.0 kg/m2, without previous fracture or other clinical risk factors. The upper assessment thresholds (UAT) were set at 1.2 times the intervention thresholds of MOF and HF. Fracture probabilities were estimated for the age range of 40-80 years, without BMD input. These values were applied to a group of women who underwent DXA for clinical reasons in a single center. RESULTS: The LATs of MOF and HF varied from 0.7 to 8.8% and 0.1 to 3.7%, from 40 to 80 years, respectively. The corresponding values for UATs were 2.5 to 21.6% and 0.3 to 8.4%. ITs of MOF and HF varied from 2.1 to 18% and 0.2 to 7%, respectively. When applied to a group of 315 postmenopausal women who underwent DXA for clinical indications, 22.9% of women were above the UATs (high-risk category) while 8.6% were below the LATs (low-risk category). The proportion of women in the intermediate category who require BMD for further assessment was 68.6% (95% CI 59.7 to 77.5%). CONCLUSIONS: In nearly one-third of women aged 40 years or more, the decision to treat or not to treat can be achieved without BMD estimation. The remaining two-thirds will require a BMD assessment for further evaluation.

Regulatory requirements and labeling of commercially available prescription (oral) medicines in Sri Lanka: there is room for improvement.

BACKGROUND: The consistency and the quality of medicine labels are sought through the regulatory frameworks. This study aims at investigating the secondary labels of medicines based on the labeling regulations and guidelines issued by the National Medicines Regulatory Authority (NMRA), Sri Lanka. METHODS: A descriptive cross-sectional study was conducted on 53 commonly used prescription-only oral medicines selected using the price regulations published for most commonly used drugs. High-resolution images of 216 brands/branded generics/generic products' secondary labels were collected in April 2021 from six community pharmacies in six districts chosen as a convenience sample. Each label was manually assessed using a checklist prepared based on the regulatory requirements by four trained investigators. The status of registration of each product was assessed using the NMRA website. Descriptive statistics were performed. RESULTS: There was a variation observed in labeling regulations and information present on packages. Among the 216 products evaluated, only 148 (68%) products appeared as registered medicines on the NMRA website, and 2.3% of medicines fulfilled all stipulated labeling parameters set out by the NMRA, 3% of products abided by the general labeling requirements, and 76% of the products complied with labeling requirements for API. Major deficiencies were observed in the presentation of registration numbers and the details of the local agent, which were unaccounted for in 210 (97%) and 131 (61%) products, respectively. The highest consistency (100%) of information was noted with the dosage form, date of manufacture, date of expiry, and batch numbers. Among the restricted information, attractive pictures (2%), web addresses (6%), and over-stickers (34%) were found. CONCLUSIONS: The results highlighted a gap between regulatory requirements and practice in medicine labeling information. Regular post-market examination of medicinal labels is highly advised in a country that relies largely on imports. Similarly, careful adherence to the labeling regulations is required. Furthermore, suppliers and local agents should be held accountable for ensuring accurate medicine labeling through increased awareness, education, and sanctions.

Ability of FRAX Sri Lanka adjusted for trabecular bone score to discriminate between postmenopausal women with a recent fracture and without a fracture.

OBJECTIVES: We evaluated the ability of fracture risk assessment tool (FRAX) Sri Lanka to discriminate between women with a recent fracture and without a fracture, when trabecular bone score (TBS) is added to the calculation. METHODS: We studied 394 women without previous fractures and 87 women who underwent dual energy X-ray absorptiometry within 3 months after the first fragility fracture. Fracture probabilities (FP) were estimated with and without TBS using Sri Lankan FRAX model and their ability to discriminate those with and without fracture was tested. RESULTS: Women without fractures had higher bone mineral densities (BMDs) and lower FPs, compared to those with a recent fracture. Area under curves of receiver operating characteristic for FPs unadjusted were not different from those adjusted for TBS. The odd ratios of FPs unadjusted were not different from those of adjusted. The FPs estimated with TBS were higher, hence the intervention thresholds (ITs) were higher compared to FPs estimated without TBS. Thirty-two percent of women without previous fracture were above the ITs and the inclusion of TBS increased this to 36%. The integrated discriminatory index analysis showed a 8% increase in the discriminatory slope. CONCLUSIONS: The inclusion of TBS to Sri Lankan FRAX did not show an added advantage in discriminating between postmenopausal women with a recent fracture and without a fracture. TBS inclusion in fracture risk calculation among those without previous fractures, however, showed a marginal increase in the number of women above ITs.

Revised FRAX®-based intervention thresholds for the management of osteoporosis among postmenopausal women in Sri Lanka.

This paper revised the fixed intervention thresholds (ITs) based on the Sri Lankan fracture risk assessment tool (FRAX) published in 2013 and introduced new ITs, hybrid and two-tier, aiming to help clinicians in the management of postmenopausal osteoporosis. The hybrid and two-tier ITs have a better discriminatory power than age-dependent and revised fixed ITs. INTRODUCTION: This study revised the Sri Lankan FRAX®-based intervention thresholds (ITs) previously published in 2013. METHOD: Age-dependent ITs were estimated, from 50-80 years with 5-year intervals, using a Sri Lankan FRAX® algorithm for a woman with a BMI of 24.8 kg/m2 and history of prior fragility fracture without other clinical risk factors. Data of 653 postmenopausal women were used in estimating fixed, hybrid, and two-tier ITs. ITs were determined using the ROC curve and partial Youden index. New ITs were validated using data of 356 postmenopausal women who underwent DXA and 62 women who had a recent fragility fracture. Women in the two groups (n = 653 and n = 356) came from the Southern Province and had undergone DXA in our state-owned tertiary care hospital as a part of their routine clinical assessment. RESULTS: The mean (SD) age and BMI of the subjects (n = 653) were 62 (8) years and 24.8 (1.2) kg/m2, respectively. Age-dependent ITs of major osteoporotic fracture risk (MOFR) and hip fracture risk (HFR) ranged from 2.7 to 18% and from 0.4 to 7.1%. The best fixed ITs for women aged 50-80 years were 9% for MOFR and 3% for HFR. In the hybrid method, MOFR of 6% and HFR of 2% were found appropriate for women aged < 70 years. These were combined with age-dependent ITs for women aged 70 years and above. In the two-tier system, two sets of ITs were calculated (ITs of MOFR/HFR for women aged < 70 years and ≥ 70 years were 6%/2% and 12%/5%, respectively). When age-dependent ITs were considered the reference standard, sensitivities of the fixed, hybrid, and two-tier ITs were 0.63, 0.73, and 0.74, respectively. The specificities were 0.76, 0.86, and 0.80 in the same order. Sensitivities of the age-dependent, fixed, hybrid, and two-tier ITs in identifying a woman with an incident fracture were 26%, 48%, 61%, and 61%, respectively. CONCLUSIONS: The new fixed MOFR is slightly lower than the previous value and hybrid and two-tier ITs perform better than age-dependent and fixed ITs.