EVALUASI PENGGUNAAN OBAT ANTIHIPERTENSI PADA PASIEN GERIATRI RAWAT JALAN DI RSUD DR. A. DADI TJOKRODIPO

Hypertension is a condition in which systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg. Hypertension is often found in geriatrics that can affect the onslence of heart disease and blood vessels. Increased cases of hypertension, the rational use of drugs by hypertensive patients is one of the important elements in achieving health quality. The purpose of this study is to find out the harsh use of antihypertensive drugs in outpatient geriatric patients at Dr. A. Dadi Tjokrodipo Hospital bandar Lampung. This type of research is non experimental with a descriptive design using retrospective data with purposive sampling methods. The results of the study were based on the pattern of use of antihypertensive with the ATC/DDD method in hypertension patients in Dr. A. Dadi Tjokrodipo Bandar Lampung city is 5331,03 DDD/1000 KPRJ, there are nine types of antihypertensive used, namely amlodipine, lisinopril, candesartan, irbesartan, furosemide, spironolactone, ramipril, bisoprolol and captopril. Antihypertensive in the drug uses segment 90%, namely amlodipine 44.37%, lisinopril 16.88%, candesartan 15.46% and irbesartan 13.65%. The study was based on 100% patient accuracy criteria, 100% indication accuracy, 89.3% drug accuracy and 92% dose accuracy. The conclusion of this study, the pattern of use of antihypertensive widely used is amlodipine amounting to 2365.52 DDD/1000 KPRJ, antihypertensive that enters the drug uses segment 90% namely amlodipine, lisinopril, candesartan and irbesartan.Keywords: Antihypertensive, Geriatrics, Outpatient, Drug Use

Development of weight and age-based dosing of daily primaquine for radical cure of vivax malaria

Background In many endemic areas, Plasmodium vivax malaria is predominantly a disease of young adults and children. International recommendations for radical cure recommend fixed target doses of 0.25 or 0.5 mg/kg/day of primaquine for 14 days in glucose-6-phosphate dehydrogenase normal patients of all ages. However, for many anti-malarial drugs, including primaquine, there is evidence that children have lower exposures than adults for the same weight-adjusted dose. The aim of the study was to develop 14-day weight-based and age-based primaquine regimens against high-frequency relapsing tropical P. vivax. Methods The recommended adult target dose of 0.5 mg/kg/day (30 mg in a 60 kg patient) is highly efficacious against tropical P. vivax and was assumed to produce optimal drug exposure. Primaquine doses were calculated using allometric scaling to derive a weight-based primaquine regimen over a weight range from 5 to 100 kg. Growth curves were constructed from an anthropometric database of 53,467 individuals from the Greater Mekong Subregion (GMS) to define weight-for-age relationships. The median age associated with each weight was used to derive an age-based dosing regimen from the weight-based regimen. Results The proposed weight-based regimen has 5 dosing bands: (i) 5–7 kg, 5 mg, resulting in 0.71–1.0 mg/kg/day; (ii) 8–16 kg, 7.5 mg, 0.47–0.94 mg/kg/day; (iii) 17–40 kg, 15 mg, 0.38–0.88 mg/kg/day; (iv) 41–80 kg, 30 mg, 0.37–0.73 mg/kg/day; and (v) 81–100 kg, 45 mg, 0.45–0.56 mg/kg/day. The corresponding age-based regimen had 4 dosing bands: 6–11 months, 5 mg, 0.43–1.0 mg/kg/day; (ii) 1–5 years, 7.5 mg, 0.35–1.25 mg/kg/day; (iii) 6–14 years, 15 mg, 0.30–1.36 mg/kg/day; and (iv) ≥ 15 years, 30 mg, 0.35–1.07 mg/kg/day. Conclusion The proposed weight-based regimen showed less variability around the primaquine dose within each dosing band compared to the age-based regimen and is preferred. Increased dose accuracy could be achieved by additional dosing bands for both regimens. The age-based regimen might not be applicable to regions outside the GMS, which must be based on local anthropometric data. Pharmacokinetic data in small children are needed urgently to inform the proposed regimens.

Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation

Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders. Patients with these diseases may experience manual dexterity challenges. Autoinjectors may improve dose accuracy, treatment adherence and quality of life; and reduce injection-site reactions. Studies have indicated patients prefer autoinjectors to other injection methods, however, patients must be able to demonstrate safe and effective use of an autoinjector for it to be a viable option. The YLB113 etanercept autoinjector may be a substitutable biosimilar to reference etanercept (Pfizer Manufacturing, Puurs, Belgium). This study sought to confirm intended users of the YLB113 etanercept autoinjector could demonstrate safe and effective use. Methods: The evaluation was performed among 79 participants representative of intended YLB113 etanercept autoinjector users; and included patients, caregivers and healthcare providers (HCPs). Results: All participants successfully delivered two simulated doses of etanercept into the foam pad using the autoinjector. Some participants experienced user errors, use difficulties, or close calls while simulating injection or answering knowledge questions. Discussion: In this usability evaluation, study patients, caregivers and HCPs demonstrated a high rate of injection success using the YLB113 etanercept autoinjector. Conclusions: The study results support demonstration of safe and effective use of the YLB113 etanercept autoinjector, a substitutable biosimilar to reference etanercept.

Accuracy and Reliability of Tempo Pen and Tempo Smart ButtonTM

Background: Understanding the extent and causes of suboptimal insulin dosing is key for the coordinated diabetes management. Integrating the benefits of monitoring, education, and clinical support can facilitate self-care among people with diabetes mellitus. Methods: This study presents the technical aspects and performance tests on Tempo Pen, a new connection-enabled insulin pen available for Humalog (insulin lispro), Basaglar/Abasaglar (insulin glargine), and Lyumjev (ultra-rapid lispro) U100 formulations. Tempo Pen, as part of the connected care system, work with the Tempo Smart ButtonTM (pending CE mark), which captures insulin dosing information and transmits it to mobile applications to display. The Tempo device (Tempo Pen + Tempo Smart ButtonTM) can track the date, time of day, insulin dose, and type of insulin accurately. Results: The pen met the ISO 11608-1:2014 requirements for dose accuracy at all doses and conditions tested, and all results were within the ISO specification limits. Tempo Smart ButtonTM has been found to be compatible with Tempo Pen, and met the acceptance criteria and target k-values for glide force, dose accuracy, and attachment/detachment force testing. It demonstrated >95% dose recording accuracy with 95% confidence, and also met requirements for data transfer after every injection. Battery life of Tempo Smart ButtonTM was found to be at least one year. Conclusions: Tempo device is the first connected system with a smart disposable pen. It accurately captures real-time insulin dosing information which can help patients and healthcare professionals address suboptimal insulin management to reach the desired glycemic goal.

Comparison of entrance surface air kerma measurement with MTS-N (LiF: Mg, Ti) chips with a kilovoltage X-ray source

Objective: Radiation detectors are key components that ensure the accuracy and performances of dosimetry equipment. The study is aimed to compare the mean entrance surface air kerma (ESAK) between a DCT-10mm ionization chamber (IC) and MTS-N (LiF: Mg, Ti) chips when both detectors are exposed to ≤ 5mGy with a 10 by 10 field size, with an X-ray source and to determine the accuracy of the Thermoluminescent (TL) chips. Also, the dose will be compared to similar studies. Materials and Methods: A functional, Digital Radiography (DR) X-ray System was used. A DCT-10mm ionization chamber (IC) and an XR Multidetector was positioned at a Source to Image Distance (SID) of 100cm on polystyrene, about 20cm thick. An X-ray spectrum generated at a Practical Peak Voltage (PPV) of 60-107kV with Half Value Layer (HVL) of 2.4-4.3mmAl and filtration > 3mmAl was used. The same setup was used for the MTS-N chips. Results: The mean doses for 1-5 mGy with the MTS-N chips were 1.07±0.07, 1.60±0.13, 2.23±0.11, 2.58±0.07 and 3.45±0.10 mGy respectively, with accuracies of 7, 20, 26, 36 and 31%. Dose accuracy at 1and 2mGy was within 25% respectively. Dose accuracies at 3, 4 and 5mGy was within >25%. The correction factor for 1-5mGy was 0.94, 1.25, 1.35, 1.55 and 1.45 respectively. Conclusion: Validation of the MTS-N chips with the reference ionization chamber to this study was within 36%. The Radiation and Nuclear Safety Authority (STUK) recommends that ESAK be within 25% for entrance surface dose. ESAK accuracy mostly increased with dose as observed in this study.

Development of Weight and Age-based Dosing of Daily Primaquine for Radical Cure of Vivax Malaria

Background In many endemic areas, Plasmodium vivax malaria is predominantly a disease of young adults and children. International recommendations for radical cure recommend fixed target doses of 0.25 or 0.5 mg/kg/day of primaquine for 14 days in glucose-6-phosphate dehydrogenase normal patients. As for many antimalarial drugs there is evidence that children have lower exposures than adults for the same weight adjusted dose. We, therefore, aimed to develop 14-day weight-based and age-based primaquine regimens against high-frequency relapsing tropical P. vivax. Methods The recommended adult target dose of 0.5 mg/kg/day (30 mg in a 60 kg patient) is highly efficacious against tropical P. vivax and was assumed to produce optimal drug exposure. Primaquine doses were calculated using allometric scaling to derive a weight-based primaquine regimen over a weight range from 5 to 100 kg. Growth curves were constructed from an anthropometric database of 53,467 individuals from the Greater Mekong Subregion to define weight-for-age relationships. The median age associated with each weight was used to derive an age-based dosing regimen from the weight-based regimen.Results The proposed weight-based regimen had 5 dosing bands: (i) 5 – 7 kg, 5 mg, resulting in 0.71 – 1.0 mg/kg/day; (ii) 8 – 16 kg, 7.5 mg, 0.47 – 0.94 mg/kg/day; (iii) 17 – 40 kg, 15 mg, 0.38 – 0.88 mg/kg/day; (iv) 41 – 80 kg, 30 mg, 0.37 – 0.73 mg/kg/day; and (v) 81 – 100 kg, 45 mg, 0.45 – 0.56 mg/kg/day. The age-based regimen had 4 dosing bands: 6 – 11 months, 5 mg, 0.43 – 1.0 mg/kg/day; (ii) 1 – 5 years, 7.5 mg, 0.35 – 1.25 mg/kg/day; (iii) 6 – 14 years, 15 mg, 0.30 – 1.36 mg/kg/day; and (iv) ≥ 15 years, 30 mg, 0.35 – 1.07 mg/kg/day.Conclusion The proposed weight-based regimens showed less variability around the optimal dose within each dosing band compared to the age-based regimen and is preferred. Increased dose accuracy could be achieved by additional dosing bands. Pharmacokinetic data in small children are needed urgently to inform the proposed regimen.