A national survey on registered products, availability, prices, and affordability of 100 essential medicines in community pharmacies across Sri Lanka.

INTRODUCTION: Availability of essential medicines that meet the expected quality standards, in appropriate dosage forms at affordable prices is a fundamental prerequisite to fulfill healthcare needs of given a population. This study assessed available products, prices and affordability of essential medicines (EM) in community pharmacies in Sri Lanka with comparison of registration status from the National Medicines Regulatory Authority(NMRA). METHODS: A cross-sectional island-wide survey of 80 pharmacies was conducted according to World Health Organization and Health Action International Manual (WHO/HAI). Hundred medicines were selected from the global core list(n = 14), regional core list(n = 16) and the Sri Lanka Essential Medicine List (SL-EML) (n = 70) based on healthcare needs. Number of registered products in 2015 and 2021 were compared. FINDINGS: Average availability was 85.4%(± 12.31) and availability was lowest in the Northern province (69.38 ± 21.18%)(p = 0.008). Availability between the state owned, franchise and privately owned pharmacies was not significantly different (p > 0.05). 89.4% medicines were affordable except for amiodarone, hydroxychloroquine, sitagliptin, soluble insulin, isophane insulin, losartan, levodopa carbidopa combination, clonazepam and ceftriaxone. The median price ratio (MPR) of 33.7% of medicines was less than 1 and MPR of 37.1% originator brands (OB) was over 3. Median number of generic brands in the market was 8(range 2-44), 9% of medicines had 20 or more products in the market and 72.7% medicines had more products available than the number registered in 2015. The average number of registered products were similar in 2015 (8.27) and 2021(7.59) (p = 0.15). CONCLUSION: The overall availability of EMs in Sri Lanka was high in all categories of community pharmacies. Medicines were largely affordable and reasonably priced in 2015, although OBs were generally more expensive. Majority of medicines had more products in the market than the number of registered products.

Pharmacokinetics and Bioequivalence of Two Amoxicillin 500 mg Products: Effect of Food on Absorption and Supporting Scientific Justification for Biowaiver.

PURPOSE: Aims of this study were to compare the bioequivalence of two formulations of amoxicillin 500 mg capsules under fasted and fed conditions in the same set of healthy volunteers, compare pharmacokinetics of amoxicillin under the two conditions and to assess the possibility of predicting in vivo bioequivalence of the two formulations using in vitro dissolution data. METHOD: The innovator product of amoxicillin was used as the reference formulation and a test product, which showed in vitro equivalence after a biowaiver study with the same reference product was used in the bioequivalence study. Altogether 16 subjects were randomized to the reference and test products in the fasted study and 12 of them participated in the fed study. Plasma concentration of amoxicillin was analyzed by a validated Liquid chromatography coupled with two mass spectrometry (LC-MS/MS) method. Noncompartmental analysis was used to determine the pharmacokinetic parameters. Average bioequivalence method was used to evaluate the bioequivalence of the two formulations and statistical significance of the pharmacokinetic parameters were tested to study the effect of food on amoxicillin absorption. RESULTS: The Geometric Mean Ratio (GMR) for the test/reference product for the maximum drug concentrations (Cmax) was 102.77% and 97.38% in fasted and fed conditions respectively which was within 80.00-125.00% range required to demonstrate bioequivalence. The GMR for test/reference products for the area under the curve (AUC0-8,) was 100.05% and 96.91% in fasted and fed conditions respectively meeting the bioequivalence criteria. For the reference product, the Cmax was 9.38 and 7.61 µg x mL-1(p =0.0224), time to reach maximum concentration (Tmax) was 1.73 and 3.02 h (p=0.0005) and AUC0-8 was 26.02 and 25.54 µg/h-1 mL-1p = 0.672) under fasted and fed conditions respectively. CONCLUSION: The test and the reference formulations were bioequivalent under both fasted and fed conditions. Although the Cmax was significantly lower and Tmax was significantly delayed under fed conditions, it did not affect the AUC. Therefore, being a time dependent antibiotic, clinically significant effect of food on efficacy of amoxicillin is unlikely. As the selected products were equivalent in vitro, these findings support scientific justification for conducting in vitro dissolution studies for solid oral amoxicillin products as a surrogate for in vivo bioequivalence studies.

Core Prescribing Indicators and the Most Commonly Prescribed Medicines in a Tertiary Health Care Setting in a Developing Country.

Irrational prescribing is common, especially in developing countries. It is important to identify the magnitude of irrational use, to take necessary steps to promote rational prescribing. We identified core prescribing indicators and commonly prescribed medicines at ward settings (IW) and outpatients' clinics (OPC) in a tertiary care hospital in Sri Lanka. A descriptive cross-sectional study was carried out at IW and OPC settings. Prescriptions were obtained from 5 major specialties (Clinical Medicine (CM), Gynaecology and Obstetrics (GO), Paediatrics, Psychiatry, and Surgery). The WHO core prescribing indicators were used to describe the pattern of prescribing, and the most commonly prescribed medicines were identified. A total of 1,318 prescriptions were analyzed. The five most commonly prescribed medicines were paracetamol (31.0%), omeprazole (20.6%), folic acid (18.3%), atorvastatin (16.2%), and salbutamol (15.3%). The average number of medicines per encounter was 4.8 ± 3.6 (IW: 5.7 ± 4; OPC: 3.8 ± 2.8; p < 0.001), with the highest IW (7.8 ± 4.2) and OPC (7.8 ± 2.7) values were from CM, being significantly higher than all other disciplines (p < 0.05). Percentage encounters with an antibiotic or an injection was 26.4% and 30.1%, respectively, with IW being significantly higher than OPC (p < 0.001). Percentage of medicines prescribed by generic name and from the essential medicine list (EML) was 90.1% and 91.1%, respectively, with no significant IW and OPC difference. In conclusion, a high degree of polypharmacy was noted. The use of injectable medicines, prescribing from the EML, and generic name prescribing was satisfactory; however, overall rational prescribing needs further improvement. Further investigation into the degree of rational prescribing associating it with clinical information will be important.

Sex Difference in Risk Factors, GRACE Scores, and Management among Post-Acute Coronary Syndrome Patients in Sri Lanka.

OBJECTIVE: To assess sex-based differences in the prevalence of risk factor, their management, and differences in the prognosis among acute coronary syndrome (ACS) in Sri Lanka. METHODS: Patients diagnosed with ACS were recruited from hospitals throughout the island. The Joint European Societies guidelines were used to assess recommended targets for coronary heart disease risk factors, and the GRACE score was used to assess the post-ACS prognosis. Age-adjusted regression was performed to calculate odds ratios for men versus women in risk factor control. RESULTS: A total of 2116 patients, of whom 1242 (58.7%) were men, were included. Significant proportion of women were nonsmokers; OR = 0.11 (95% CI 0.09 to 0.13). The prevalence of hypertension (p < 0.001), diabetes (p < 0.001), and dyslipidemia (p=0.004) was higher in women. The LDL-C target was achieved in a significantly higher percentage of women (12.6%); OR = 0.33 (95% CI 0.10 to 1.05). When stratified by age, no significant differences were observed in achieving the risk factor targets or management strategies used except for fasting blood sugar (p < 0.05) where more men achieved control target in both age categories. Majority of the ACS patients had either high or intermediate risk for one-year mortality as per the GRACE score. In-hospital and 1-year mean mortality risk was significantly higher among men of less than 65 years of age (p < 0.05). CONCLUSIONS: Smoking is significantly lower among Sri Lankan women diagnosed with ACS. However, hypertension, diabetes, and dyslipidemia were more prevalent among them. There was no difference in primary and secondary preventive strategies and management in both sexes but could be further improved in both groups.

Safety monitoring of treatment in bipolar disorder in a tertiary care setting in Sri Lanka and recommendations for improved monitoring in resource limited settings.

BACKGROUND: Safety monitoring of medicines is essential during therapy for bipolar disorder (BD). We determined the extent of safety monitoring performed according to the International Society for Bipolar Disorders (ISBD) guidelines in patients with BD attending the main tertiary care psychiatry clinics in Sri Lanka to give realistic recommendations for safety monitoring in resource limited settings. METHODS: Patients diagnosed with BD on mood stabilizer medications for more than 1 year were recruited. Data were collected retrospectively from clinic and patient held records and compared with the standards of care recommended by ISBD guidelines for safety monitoring of medicines. RESULTS: Out of 256 patients diagnosed with BD, 164 (64.1%) were on lithium. Only 75 (45.7%) had serum lithium measurements done in the past 6 months and 96 (58.5%) had concentrations recorded at least once in the past year. Blood urea or creatinine was measured in the last 6 months only in 30 (18.3%). Serum electrolytes and thyroid-stimulating hormone (TSH) concentrations were measured in the last year only in 34 (20.7%) and 30 (18.3%) respectively. Calcium concentrations were not recorded in any patient. None of the patients on sodium valproate (n = 119) or carbamazepine (n = 6) had blood levels recorded to establish therapeutic concentrations. Atypical antipsychotics were prescribed for 151 (59%), but only 13 (8.6%) had lipid profiles and only 31 (20.5%) had blood glucose concentration measured annually. Comorbidities experienced by patients influenced monitoring more than the medicines used. Patients with diabetes, hypothyroidism and hypercholesterolemia were more likely to get monitored for fasting blood glucose and (p < 0.001), TSH (p < 0.001) and lipid profiles (p < 0.001). Lithium therapy was associated with TSH monitoring (p < 0.05). Therapy with atypical antipsychotics was not associated with fasting blood glucose or lipid profile monitoring (p > 0.05). A limitation of the study is that although some tests were performed, the results may not have been recorded. CONCLUSIONS: Safety monitoring in BD was suboptimal compared to the ISBD guidelines. ISBD standards are difficult to achieve in resource limited settings due to a multitude of reasons. Realistic monitoring benchmarks and recommendations are proposed for methods to improve monitoring in resource limited settings based on our experience.

Obstetric outcomes and effects on babies born to women treated for epilepsy during pregnancy in a resource limited setting: a comparative cohort study.

BACKGROUND: Management of epilepsy during pregnancy in a resource-limited setting (RLS) is challenging. This study aimed to assess obstetric outcomes and effects on babies of women with epilepsy (WWE) exposed to Anti-epileptic drugs (AEDs) compared to non-exposed controls in a RLS. METHODS: Pregnant WWE were recruited from antenatal and neurology clinics of a tertiary care hospitals in Sri Lanka. Patients were reviewed in each trimester and post-partum. Medication adherence, adverse effects, seizure control and carbamazepine blood levels were monitored. Post-partum, measurements for anthropometric and dysmorphic features of the babies and congenital abnormalities were recorded. Age and sex matched babies not exposed to AED recruited as controls were also examined. RESULTS: Ninety-six pregnant WWE were recruited (mean period of gestation 22.9 weeks). Mean age was 28 years and 48(50%) were primigravidae. Fifty percent (48) were on monotherapy, while 23.8, 15.9 and 4.1% were on two, three and four AEDs respectively. AEDs in first trimester (TM1) were carbamazepine (71%), valproate (25.8%) clobazam (29.5%), lamotrigine (7%) topiramate (5%) and others (3.4%). Sodium valproate use reduced significantly from T1 to T2(p < 0.05). Sub-therapeutic carbamazepine levels correlated positively (r = 0.547) with poor medication adherence (p = 0.009) and negatively (r = 0.306) with adverse effects (p = 0.002). Seventy-six WWE completed follow-up reporting w 75 (98.6%) live births and one T1 miscarriage (1.3%). Three (4.3%) were preterm. Majority (73.33%) were normal vaginal deliveries. Cesarean sections were not increased in WWE. Fifty-nine (61.45%) babies were examined. For those examined during infancy, 53 age and sex matched controls were recruited and examined.. Congenital abnormalities occurred in 5 (9.43%) babies of WWE [atrio-ventricular septal defect (2), renal hypoplasia (1), cryptorchidism (1), microcephaly (1)] compared to 2 (3.77%) in controls (2 microcephaly; p = 0.24). Fetal exposure to AEDs increased a risk of low birth weight (RR 2.8; p = 0.049). Anthropometric parameters of AED exposed babies were lower at birth but not statistically significant between the two groups (weight p = 0.263, length p = 0.363, occipito-frontal circumference (OFC) p = 0.307). However, weight (p = 0.009), length (p = 0.016) and OFC (p = 0.002) were significantly lower compared to controls at an average of 3.52 months. CONCLUSION: Most pregnancies are unplanned in the RLS studied, and AEDs were altered during pregnancy. Congenital anomalies occurred at rates comparable to previous reports. Fetal exposure to AED had growth retardation in infancy compared to non-exposed babies.

Management, characteristics and outcomes of patients with acute coronary syndrome in Sri Lanka.

BACKGROUND: Ischaemic heart disease is the leading cause of in-hospital mortality in Sri Lanka. Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP) is the first national clinical-audit project that evaluated patient characteristics, clinical outcomes and care provided by state-sector hospitals. METHODS: ACSSLAP prospectively evaluated acute care, in-hospital care and discharge plans provided by all state-sector hospitals managing patients with ACS. Data were collected from 30 consecutive patients from each hospital during 2-4 weeks window. Local and international recommendations were used as audit standards. RESULTS: Data from 87/98 (88.7%) hospitals recruited 2177 patients, with 2116 confirmed as having ACS. Mean age was 61.4±11.8 years (range 20-95) and 58.7% (n=1242) were males. There were 813 (38.4%) patients with unstable angina, 695 (32.8%) with non-ST-elevation myocardial infarction (NSTEMI) and 608 (28.7%) with ST-elevation myocardial infarction (STEMI). Both STEMI (69.9%) and NSTEMI (61.4%) were more in males (P<0.001). Aspirin, clopidogrel and statins were given to over 90% in acute setting and on discharge. In STEMI, 407 (66.9%) were reperfused; 384 (63.2%) were given fibrinolytics and only 23 (3.8%) underwent primary percutaneous coronary intervention (PCI). Only 42.3 % had thrombolysis in <30 min and 62.5% had PCI in <90 min. On discharge, beta-blockers and ACE inhibitors/angiotensin II receptor blockers were given to only 50.7% and 69.2%, respectively and only 17.6% had coronary interventions planned. CONCLUSIONS: In patients with ACS, aspirin, clopidogrel and statin use met audit standards in acute setting and on discharge. Vast majority of patients with STEMI underwent fibrinolyisis than PCI, due to limited resources. Primary PCI, planned coronary interventions and timely thrombolysis need improvement in Sri Lanka.

Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial.

BACKGROUND: This study evaluated the effects of zinc supplementation on glycemic control, other cardiometabolic and anthropometric parameters, and disease progression in prediabetes. METHODS: A randomized double-blind placebo-controlled Phase 2 clinical trial was conducted over a 12-month period in 200 subjects (43% male; mean [± SD] age 51.8 ± 7.3 years), randomly assigned (1: 1) to the treatment or control group. The treatment group received zinc (20 mg daily). Subjects were evaluated at baseline and at 1, 3, 6, and 12 months. The primary outcome was the change in glycemic control from baseline. Multiple regression analyses were performed, with change in outcome variables after intervention from baseline used as continuous dependent variables. RESULTS: In both groups, mean serum zinc concentrations prior to the trial were below normal (15.29-21.41 µmol/L). During the 12-month follow-up, a significantly higher percentage of participants developed type 2 diabetes in the control compared with zinc-treated group (25.0% vs 11.0% respectively; P = 0.016). Fasting plasma glucose (FPG), 2-h glucose levels in the oral glucose tolerance test (OGTT), homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) were significantly lower in the treated group, with significant improvement in ß-cell function. In all four regression models, the best predictor of the dependent variables (i.e. change in FPG, 2-h glucose in the OGTT, HOMA-IR, and homeostatic model assessment of ß-cell function) was zinc treatment. CONCLUSIONS: Zinc supplementation reduced blood glucose and insulin resistance while improving ß-cell function. Furthermore, supplementation reduced disease progression to diabetes and had beneficial effects on TC and LDL-C.

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate.

Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release solid oral dosage forms containing amoxicillin trihydrate are reviewed. Solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), therapeutic uses, therapeutic index, excipient interactions, as well as dissolution and BE and bioavailability studies were taken into consideration. Solubility and permeability studies indicate that amoxicillin doses up to 875 mg belong to BCS class I, whereas 1000 mg belongs to BCS class II and doses of more than 1000 mg belong to BCS class IV. Considering all aspects, the biowaiver procedure can be recommended for solid oral products of amoxicillin trihydrate immediate-release preparations containing amoxicillin as the single active pharmaceutical ingredient at dose strengths of 875 mg or less, provided (a) only the excipients listed in this monograph are used, and only in their usual amounts, (b) the biowaiver study is performed according to the World Health Organization-, U.S. Food and Drug Administration-, or European Medicines Agency-recommended method using the innovator as the comparator, and (c) results comply with criteria for "very rapidly dissolving" or "similarly rapidly dissolving." Products containing other excipients and those containing more than 875 mg amoxicillin per unit should be subjected to an in vivo BE study.

Pregnancy outcomes and contraceptive use in patients with systemic lupus Erythematosus, rheumatoid arthritis and women without a chronic illness: a comparative study.

OBJECTIVES: To compare the pregnancy outcomes and contraceptive practices in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and women with no chronic illness (WNCI) in a tertiary care referral center in Colombo, Sri Lanka. METHODS: Patients with SLE satisfying American College of Rheumatology criteria for diagnosis and history of pregnancies were recruited from university lupus clinic, National Hospital of Sri Lanka (NHSL). Age-matched women with history of pregnancy and RA were recruited from the rheumatology clinic, NHSL and WNCI from a surgical clinic. RESULTS: In 71 patients with SLE, 79 pregnancies occurred in 38 patients. The number of total pregnancies in SLE, RA and WNCI (79, 80 and 85 respectively) were not significantly different (P > 0.05), but most occurred before diagnosis of SLE and RA. Pregnancies occurring after diagnosis were significantly higher in SLE compared to RA (P = 0.013, χ2 = 6.169). Mean age at diagnosis was higher (P < 0.01) in RA (35 years) than in SLE (26 years). Percentage live births after diagnosis was significantly lower (P < 0.01) in SLE (9/20; 45%) compared to RA (6/8; 75%) and WNCI (77/85; 91%). Adverse fetal outcomes (fetal loss, pre-maturity, low birth weight) and assisted deliveries were significantly more (P < 0.001) in SLE than in WNCI. Unplanned pregnancies were significantly higher (P < 0.01) in SLE (80%) compared to RA (25%) and in WNCI (9.4%). Contraceptive usage was lower in patients with SLE (25.6%) and RA (33%) compared to WNCI (56.4%). Disease exacerbations occurred in 20% of SLE patients during pregnancy. CONCLUSIONS: More pregnancies occur in SLE than in RA after diagnosis of illness. Unplanned pregnancies and adverse pregnancy outcomes need to be addressed more in SLE than in RA or in WNCI.

Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial.

BACKGROUND: Leg edema is a common adverse effect of dihydropyridine Calcium Channel Blockers (CCB) that may need dose reduction or drug withdrawal, adversely affecting the antihypertensive efficacy. Leg edema is reported to occur less often with (S)-amlodipine compared to conventional racemic amlodipine. We aimed to find the incidence of leg edema as a primary outcome and antihypertensive efficacy with (S)-amlodipine compared to conventional amlodipine. METHODS: This prospective, double-blind, controlled clinical trial randomized 172 hypertensive patients, not controlled on beta-blockers (BB) and angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB), to either conventional amlodipine (5-10 mg; n = 86) or (S)-amlodipine (2.5-5 mg; n = 86), while continuing their previous anti-hypertensive medications. Sample was sufficient to find a difference in edema between the interventions with 80 % power at 5 % significance level. Intension to treat analysis (ITT) for safety data and per protocol analysis for efficacy data was performed. Fischer's exact test was applied to observe difference between responder rates and proportions of subjects having peripheral edema in the two groups. Pitting edema test scores were compared using Mann-Whitney test. RESULTS: Altogether 146 patients (amlodipine, n = 76 and (S)-amlodipine, n = 70) completed 120 days treatment. Demographic variables and treatment adherence were comparable in the two groups. Incidence of new edema after randomization was 31.40 % in test group and 46.51 % in control group [p = 0.03; absolute risk reduction (ARR) = 15.1 %; Number Needed to Treat (NNT) = 7, ITT analysis]. Pitting edema score and patient rated edema score increased significantly in the control compared to test group (p = 0.038 and 0.036 respectively) after treatment period. Edema scores increased significantly in the control group from baseline (p < 0.0001). Responders in blood pressure were 98.57 % in test and 98.68 % in control group. Most common adverse events (AE) were pitting edema and increased urinary frequency. Incidence of all AEs other than edema was similar in both groups. Two serious AEs occurred unrelated to therapy. Biochemical and ECG parameters in the two groups were comparable. CONCLUSIONS: In hypertensive patients not controlled on prior BB and ACEI/ARB therapy, addition of (S)-amlodipine besylate at half the dose of conventional amlodipine provides better tolerability with reduced incidence of peripheral edema, and equal antihypertensive efficacy compared to amlodipine given at usual doses. TRIAL REGISTRATION: Sri Lanka Clinical Trials registry: www.slctr.lk, SLCTR/2013/006.

Zinc and diabetes mellitus: understanding molecular mechanisms and clinical implications.

BACKGROUND: Diabetes mellitus is a leading cause of morbidity and mortality worldwide. Studies have shown that Zinc has numerous beneficial effects in both type-1 and type-2 diabetes. We aim to evaluate the literature on the mechanisms and molecular level effects of Zinc on glycaemic control, ß-cell function, pathogenesis of diabetes and its complications. METHODS: A review of published studies reporting mechanisms of action of Zinc in diabetes was undertaken in PubMed and SciVerse Scopus medical databases using the following search terms in article title, abstract or keywords; ("Zinc" or "Zn") and ("mechanism" or "mechanism of action" or "action" or "effect" or "pathogenesis" or "pathology" or "physiology" or "metabolism") and ("diabetes" or "prediabetes" or "sugar" or "glucose" or "insulin"). RESULTS: The literature search identified the following number of articles in the two databases; PubMed (n = 1799) and SciVerse Scopus (n = 1879). After removing duplicates the total number of articles included in the present review is 111. Our results show that Zinc plays an important role in ß-cell function, insulin action, glucose homeostasis and the pathogenesis of diabetes and its complications. CONCLUSION: Numerous in-vitro and in-vivo studies have shown that Zinc has beneficial effects in both type-1 and type-2 diabetes. However further randomized double-blinded placebo-controlled clinical trials conducted for an adequate duration, are required to establish therapeutic safety in humans.

Genetic variants in the cytochrome P450 2D6 gene in the Sri Lankan population.

INTRODUCTION: Cytochrome P450 2D6 (CYP2D6) enzymes are involved in the metabolism of a large number of commonly prescribed drugs such as antidepressants and cardiovascular drugs. The CYP2D6 *3, *4 and *14 variants associated with the loss of enzyme function; CYP2D6 *10 and *17 variants with reduced enzyme function; and CYP2D6 *2 variant with no effect on enzyme function. Establishing the frequency of these variant alleles in Sri Lankan population would be useful for optimizing pharmacotherapy with CYP2D6-substrate drugs. OBJECTIVE: The objective of this study was to determine the prevalence of CYP2D6 *2, *3, *4, *10, *14 and *17 variants in the main ethnic groups in the Sri Lankan population. MATERIALS AND METHODS: A total of 90 deoxyribonucleic acid (DNA) samples (30 each from Sinhalese, Tamils and Moors) were selected from a DNA resource at the Human Genetic Unit, Faculty of Medicine, University of Colombo. This collection had been made for population genetic studies from a random population based volunteers. Genotyping was performed using published polymerase chain reaction/restriction fragment length polymorphism methods. RESULTS: The prevalence of the CYP2D6 variants in Sinhalese, Sri Lankan Tamils and Moors respectively were CYP2D6 *2: 37%, 41.6% and 37.9%; CYP2D6 *3: 60.3%, 45% and 30%; CYP2D6 *4: 21.6%, 6.6% and 8.3%; CYP2D6 *10: 40%, 35% and 44%. CYP2D6 *14 and *17 variants were not identified. CONCLUSION: CYP2D6*3, *4 and *10 variants, which are associated with reduced or loss of CYP2D6 enzyme function were found in our population in significant frequencies. CYP2D6*4, which is reported to be a Caucasian variant was also found in all three ethnic groups.