Methods: The drug classification systems of the United States, the United Kingdom, Japan, Singapore, Malaysia, the Philippines, and Canada were selected to study alongside Thailand's system. The regulatory review was conducted through each country's drug regulatory agency website and available published research. Complementary interviews with drug regulatory authorities were conducted when written documentation was unclear and had limited access. Fifty-two common drugs were selected to compare their actual classifications across the different countries.
Results: All selected countries classified drugs into two major groups: prescription drugs and non-prescription drugs. The studied countries further sub-classified non-prescription drugs into 1-4 categories. Principles of drug classification criteria among countries are similar; they comprised of three themes: disease characteristics, drug safety profile, and other drug characteristics. Actual drug classification of antibiotics, dyslipidemia treatments, and hypertension treatments in Thailand are notedly different from other countries. Furthermore, 77.4% of drugs studied in Thailand fall into the behind-the-counter (dangerous) drug category, which varied from antihistamines to antibiotics, dyslipidemia treatments, and vaccines.
Conclusion: Thailand's drug classification criteria are comparable with other nations; however, there is a need to review drug classification statuses as many drugs have been classified into improper drug categories.
RESULTS AND DISCUSSION: Given the current lack of evidence on quality and safety improvements and on the cost-benefits associated with the introduction of eHealth applications, there should be a focus on implementing more mature technologies; it is also important that eHealth applications should be evaluated against a comprehensive and rigorous set of measures, ideally at all stages of their application life cycle.
METHODS: All English-language medical literature published from inception till October 2014 which met the inclusion criteria were reviewed and analyzed.
RESULTS: A total of nine papers were included, reviewed and analyzed. The total sample size was 4276 patients. All studies used either of the two DPP4 inhibitors - Vildagliptin or Sitagliptin, vs sulphonylurea or meglitinides. Patients receiving DPP4 inhibitors were less likely to develop symptomatic hypoglycemia (risk ratio 0.46; 95% CI, 0.30-0.70), confirmed hypoglycemia (risk ratio 0.36; 95% CI, 0.21-0.64) and severe hypoglycemia (risk ratio 0.22; 95% CI, 0.10-0.53) compared with patients on sulphonylureas. There was no statistically significant difference in HbA1C changes comparing Vildagliptin and sulphonylurea.
CONCLUSION: DPP4 inhibitor is a safer alternative to sulphonylurea in Muslim patients with type 2 diabetes mellitus who fast during the month of Ramadan as it is associated with lower risk of symptomatic, confirmed and severe hypoglycemia, with efficacy comparable to sulphonylurea.
METHODS: We did a network meta-analysis based on a systematic review of randomised controlled trials comparing fibrinolytic drugs in patients with STEMI. Several databases were searched from inception up to Feb 28, 2017. We included only randomised controlled trials that compared fibrinolytic agents as a reperfusion therapy in adult patients with STEMI, whether given alone or in combination with adjunctive antithrombotic therapy, against other fibrinolytic agents, a placebo, or no treatment. Only trials investigating agents with an approved indication of reperfusion therapy in STEMI (streptokinase, tenecteplase, alteplase, and reteplase) were included. The primary efficacy outcome was all-cause mortality within 30-35 days and the primary safety outcome was major bleeding. This study is registered with PROSPERO (CRD42016042131).
FINDINGS: A total of 40 eligible studies involving 128 071 patients treated with 12 different fibrinolytic regimens were assessed. Compared with accelerated infusion of alteplase with parenteral anticoagulants as background therapy, streptokinase and non-accelerated infusion of alteplase were significantly associated with an increased risk of all-cause mortality (risk ratio [RR] 1·14 [95% CI 1·05-1·24] for streptokinase plus parenteral anticoagulants; RR 1·26 [1·10-1·45] for non-accelerated alteplase plus parenteral anticoagulants). No significant difference in mortality risk was recorded between accelerated infusion of alteplase, tenecteplase, and reteplase with parenteral anticoagulants as background therapy. For major bleeding, a tenecteplase-based regimen tended to be associated with lower risk of bleeding compared with other regimens (RR 0·79 [95% CI 0·63-1·00]). The addition of glycoprotein IIb or IIIa inhibitors to fibrinolytic therapy increased the risk of major bleeding by 1·27-8·82-times compared with accelerated infusion alteplase plus parenteral anticoagulants (RR 1·47 [95% CI 1·10-1·98] for tenecteplase plus parenteral anticoagulants plus glycoprotein inhibitors; RR 1·88 [1·24-2·86] for reteplase plus parenteral anticoagulants plus glycoprotein inhibitors).
INTERPRETATION: Significant differences exist among various fibrinolytic regimens as reperfusion therapy in STEMI and alteplase (accelerated infusion), tenecteplase, and reteplase should be considered over streptokinase and non-accelerated infusion of alteplase. The addition of glycoprotein IIb or IIIa inhibitors to fibrinolytic therapy should be discouraged.
FUNDING: None.
Methods: Articles published in the English language on the PubMed database that were relevant to surgical tourism and the complications of elective surgical procedures abroad were examined. Reference lists of articles identified were further scrutinized. The search terms used included combinations of 'surgery abroad', 'cosmetic surgery abroad', 'cosmetic surgery tourism', 'cosmetic surgery complications' and 'aesthetic tourism'.
Results: This article critically reviews the epidemiology of cosmetic surgical tourism and its associated economic factors. Surgical complications of selected procedures, including perioperative complications, are described. The implications for travel medicine practice are considered and recommendations for further research are proposed.
Conclusion: This narrative literature review focuses on the issues affecting travellers who obtain cosmetic surgical treatment overseas. There is a lack of focus in the travel medicine literature on the non-surgery-related morbidity of this special group of travellers. Original research exploring the motivation and pre-travel preparation, including the psychological counselling, of cosmetic surgical tourists is indicated.
SUMMARY: Background rVIII-SingleChain is a novel B-domain truncated recombinant factor VIII (rFVIII) comprised of covalently bonded FVIII heavy and light chains, demonstrating a high binding affinity to von Willebrand factor. Objectives This phase III study investigated the safety, efficacy and pharmacokinetics of rVIII-SingleChain in previously treated pediatric patients < 12 years of age with severe hemophilia A. Patients/Methods Patients could be assigned to prophylaxis or on-demand therapy by the investigator. For patients assigned to prophylaxis, the treatment regimen and dose were based on the bleeding phenotype. For patients receiving on-demand therapy, dosing was guided by World Federation of Hemophilia recommendations. The primary endpoint was treatment success, defined as a rating of 'excellent' or 'good' on the investigator's clinical assessment of hemostatic efficacy for all treated bleeding events. Results The study enrolled 84 patients (0 to < 6 years, n = 35; ≥ 6 to < 12 years, n = 49); 81 were assigned to prophylaxis and three to an on-demand regimen. Patients accumulated a total of 5239 exposure days (EDs), with 65 participants reaching > 50 EDs. In the 347 bleeds treated and evaluated by the investigator, hemostatic efficacy was rated as excellent or good in 96.3%. The median annualized spontaneous bleeding rate was 0.00 (Q1, Q3: 0.00, 2.20), and the median annualized bleeding rate was 3.69 (Q1, Q3: 0.00, 7.20) across all prophylaxis regimens. No participant developed an inhibitor. Conclusions rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy and a favorable safety profile in a clinical study in children < 12 years of age with severe hemophilia A.
Methods: A cross-sectional, questionnaire-based study was conducted among 103 pharmacists from 74 different community pharmacies to assess their knowledge about the use of herbal medicines and its adverse drug reaction reporting by using a pre-validate knowledge questionnaire consisting of 12 questions related to it. The pharmacists' responses were measured at a 3-point Likert scale (Poor=1, Moderate=2, and Good=3) and data was entered in SPSS version 22. The minimum and maximum possible scores for knowledge questionnaires were 12 and 36 respectively. Quantitative data was analyzed by using One Way ANOVA and Paired t-test whereas Chi-square and Fisher exact test were used for qualitative data analysis. A p-value of less than 0.05 was considered statistically significant for all the analyses.
Results: About 92% of the pharmacist had good knowledge regarding the use of herbal medicines and its adverse drug reaction reporting with a mean knowledge score of 32.88±3.16. One-way ANOVA determined a significant difference of employment setting (p<0.043) and years of experience (<0.008) with mean knowledge scores of Pharmacists. Pharmacists' knowledge was significantly associated with their years of experience with the Chi-square test.
Conclusion: Pharmacists exhibit good knowledge regarding the use of herbal medicines and its adverse drug reaction reporting. However, with an increasing trend of herbal medicine use and its adverse drug reaction reporting it recalls the empowerment of experienced pharmacists with training programs in this area for better clinical outcomes.
METHODS: We searched the official Web sites and homepages of the responsible leading patient safety agencies of the three countries. We reviewed all publicly available guidelines, regulatory documents, government reports that included policies, guidelines, strategy papers, reports, evaluation programs, as well as scientific articles and gray literature related to the incident reporting system. We used the World Health Organization components of patient safety reporting system as the guidelines for comparison and analyzed the documents using descriptive comparative analysis.
RESULTS: Taiwan had the most incidents reported, followed by Malaysia and Indonesia. Taiwan Patient Safety Reporting (TPR) and the Malaysian Reporting and Learning System had similar attributes and followed the World Health Organization components for incident reporting. We found differences between the Indonesian system and both of TPR and the Malaysian system. Indonesia did not have an external reporting deadline, analysis and learning were conducted at the national level, and there was a lack of transparency and public access to data and reports. All systems need to establish a clear and structured incident reporting evaluation framework if they are to be successful.
CONCLUSIONS: Compared with TPR and Malaysian system, the Indonesian patient safety incident reporting system seemed to be ineffective because it failed to acquire adequate national incident reporting data and lacked transparency; these deficiencies inhibited learning at the national level. We suggest further research on the implementation at the hospital level to see how far national guidelines and policy have been implemented in each country.
SUBJECTIVE: Thirty-nine VLBW infants who were admitted to our NICU in 2013 were retrospectively analyzed.
RESULTS: Mean birth weight and gestational age was 1042.7 gram and 28.5 weeks, respectively. Total duration of indwelling PIDLCC was 1121 days (mean 28.5+18.2 days) with 85 PIDLCCs used. Dressing at the insertion site was done twice weekly with 10% povidone iodine. Four (10.3% with mean of 48 days) infants had catheter-related blood stream infection (CRBSI), with a 3.57 infection per 1000 catheter-day. The mean for days of PIDLCC in 35 infants without CRBSI was 26.5 days. Organisms isolated were Staphylococcus epidermidis, Staphylococcus aureus and Staphylococcus capitis ureolytic. Our study showed significant difference in the duration of indwelling catheter (p = 0.023) and intraventricular hemorrhage (p = 0.043) between the CRBSI group and non-CRBSI group. Five (12.8%) infants had abnormal thyroid function test, in which two infants required thyroxine supplementation upon discharge. However, duration of PIDLCC and abnormal thyroid function test was not statistically significant (p = 0.218). One (2.5%) infant died (death was not related to CRBSI). There was no serious adverse effects secondary to PIDLCC.
CONCLUSION: It is concluded that the use and maintenance of PIDLCC is safe for VLBW infants, but close monitoring should be observed to detect early signs of infection.