Currently, Indonesia is in the 5th rank of the highest tuberculosis prevalence over the world. The treatment of tuberculosis is going complicated due to the side effect experienced by the patients. The four combination of antituberculosis agent used in minimally 6 months of treatment could stimulate the hepatotoxicity as the one of the dominant side effect in tuberculosis treatment. Thus, it is important to do the Therapeutic Drug Monitoring (TDM) to optimize the tuberculosis treatment. This study is aimed to validate the TDM of pyrazinamide in human plasma using High Performance Liquid Chromatography-UV. We recruited 6 TB patients in the validation of pyrazinamide study. The C18 column shim-pack VP-ODS (250 mm x 4.6 mm, id 5 µm) and aquabidest-acetonitrile as mobile phase were applied in this study. We used Shimadzu HPLC system with a model AT LC20 LC 10AT pump, detector SPD 20A and LC solution software. We performed the analysis for linearity, system appropriateness, accuracy and recovery to develop the validation method. This study has been approved by National Ethics Committee of Health Research. Our study shows that the linearity is good with value of r2> 0.99 and the equation y = 16740.876x - 2953.615. The CV TR and CV peak area for system suitability are 1.46% and 0.29%, respectively. The LoD and LoQ value are 2.532 and 7.672 µg/mL, respectively. The accuracy on the concentration of 1.00, 8.00, 60.00 ug/ml are 108.80 %, 92.57 % and 100.98 %, respectively for intraday accuracy and 103.18 %, 92.44%, and 94.94%, respectively for interday accuracy. Furthermore, the precision on the concentration of 1.00, 8.00, 60.00 ug/ml are 1.17%, 3.57%, 3.32%, respectively for intraday precision and 3.66%, 1.37% and 1.59%, respectively for interday precision. In conclusion, the method which we applied in this study was sensitive and reliable for routine TDM of pyrazinamide.
The coronavirus disease 2019 (COVID-19) pandemic has put a great burden on countries as a result of the demand for laboratory diagnostic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This paper reports our experiences in rapidly assessing Indonesia's COVID-19 laboratory testing capacity in the early phase of the pandemic response. Through a questionnaire-based survey carried out between 23 March and 2 April, we estimated the daily tests that could be done by the 44 facilities, excluding the national referral laboratory, first assigned to be COVID-19 diagnostic laboratories. The capacity constraints were lack of reagents and equipment, and limited human resources; because of these constraints, most of the laboratories were not yet operational. A major hindrance was reliance on imported supplies and the associated procurement time. Expanding real-time polymerase chain reaction testing capacity, through increased numbers of laboratories and optimization of existing facilities, was clearly the main priority. We also assessed the potential yield from using rapid molecular testing machines in the country's referral hospitals. Even assuming this potential could be tapped, several provinces would still be poorly served by diagnostic services in the event of a surge in cases. Since this rapid assessment, the number of designated COVID-19 laboratories has increased and, by 1 July 2020, was 163. On 29 July 2020, for the first time, the number of specimens examined in a day reached more than 30 000, achieving the WHO testing capacity target of 1 in 1000 inhabitants per week.
Abstract
Off label medicine refers to any medicine that is used to treat any ailment beyond of its approved / licensed indication by National Regulatory Authorities, such us FDA in USA and BPOM in Indonesia. Off-label medicines are used because the available and approved drugs do not have the desired effect, then doctors try medicine that have not been licensed indications. Some other reasons in practice off-label medicines use and prescribing are that drugs in the same category have the same effect (although have not been approved by indication), the expansion to a lighter form than the licensed indication, or extension of use for certain related conditions. At the opposite, the disadvantage of the practice off-label medicine use is generally not included in any health insurance benefit package, also not covered by mandatory insurance scheme (JKN-BPJS). Patients should pay for the price of a drug that has not been assured or proven of its efficacy and safety. It needs strong evidence based on scientific research to ensure the safety and effectiveness of off-label medicines to be included in the list of medications (national formulary) to put it on National Health Insurance (BPJS) benefit package.
Abstrak
Obat off-label adalah obat yang digunakan di luar indikasi yang disetujui oleh lembaga yang berwenang, kalau di Amerika Food and Drug Administration (FDA), sedangkan di Indonesia Badan POM. Obat off label digunakan karena obat yang tersedia dan approved tidak memberikan efek yang diinginkan, sehingga dokter mencoba obat yang belum disetujui indikasinya. Beberapa alasan lain adalah adanya dugaan bahwa obat dari golongan yang sama memiliki efek yang sama (walaupun belum disetujui indikasinya), adanya perluasan ke bentuk yang lebih ringan dari indikasi yang disetujui, atau perluasan pemakaian untuk kondisi tertentu yang masih terkait. Kerugiannya adalah obat off-label umumnya tidak dicover oleh BPJS sehingga pasien harus membayar sendiri harga obat yang belum terjamin efikasi dan keamanannya. Perlu dukungan penelitian yang kuat terhadap keamanan dan efektivitas obat off label agar dapat dimasukkan dalam daftar obat (formularium nasional) yang ditanggung BPJS.
Isoniazid is one of anti-tuberculosis agent which can cause hepatotoxicity. However, not all of the TB patients and health providers can recognize early symptoms of antituberculosis-induced hepatotoxicity. Thus, the Therapeutic Drug Monitoring needs to be performed to monitor the hepatotoxicity symptoms. The aim of this study is to establish the validity of the Isoniazid assay method using High-Performance Liquid Chromatography from human plasma. We recruited 6 healthy subjects for this validation study. The validation was performed using Shimadzu HPLC system with a model AT LC20 LC 10AT pump, detector SPD 20A and LC solution software. We used C18 column shim-pack VP-ODS (250 mm x 4.6 mm, id 5 µm) as well as other tools such as centrifuges, vortex, appliance glass (Pyrex IWAKI) and other supporting tools. Chemicals and solvents was used from Merck Germany. Isoniazid standard compounds were obtained from SIGMA. Our study has been approved by National Ethics Committee of Health Research. Our study shows that the method applied in HPLC has the good linearity (r = 0.998) with coefficient of variance (CV) of system appropriateness test is 0.61% and the equation of linearity was y = 8756.87x+27724.82. The value of Limit of Detection (LoD) and Limit of Quantification (LOQ) were 1.517 µg/ml and 4.597 µg/ml, respectively. The precision on the concentration of 0,5; 5.0; 15.0 ug/ml are 5.24%, 0.79%, 2.83%, respectively for intraday precision and 4.86%; 2.18%; 2.01%, respectively for interday precision. The recoveries on the particular concentrations are 100.79%; 108.91%; 92.19%, respectively for intraday recovery and 101.73%; 99.63%; 82.75%, respectively for interday recovery. This validation method is a good alternative for the application of TDM in monitoring the treatment of TB patients' clinical practice
Antiretroviral (ARV) is the drug to reduce varemia and enhances CD4+ level. ARV cannot cure HIV-AIDS but it increases the life expectancy of people living with HIV-AIDS (PLHA). ARV is a lifetime treatment that needs a high adherence. The meaning of ARV which vulnerable to low adherence is related to stigma and discrimination. It is also related to the changing of life pattern in which taking ARV is considered as a burden. This research suggests the need to include the meaning of ARV for a successful therapy. Because using ARV for a long time can make PLHAs feel boring and sometimes they drop out the treatment.
The research was conducted in Bandung, Cimahi, Denpasar and Badung districts in 2011. The subjects were 17 PLHAs consist of 9 females and 8 males, aged 20-42 years. Data were
collected by doing in depth interview which then analyzed with content analysis method.
The meanings of ARV which give positive impact on adherence including the function of ARV that not merely as medical stuff but also have the function related to psychological or spiritual meaning (miracle); the changing on life pattern (consider as a habit); and the hope for life (the second chance)
The study recommends to include the meaning of ARV related to the function on spiritual/ psychological matter, the changing on life pattern and the hope for life other than just give councelling on medical function of ARVs and handling side effects.
Key words: ARV, antiretroviral, PLHA
Off label medicine refers to any medicine that is used to treat any ailment beyond of its approved / licensed indication by National Regulatory Authorities, such us FDA in USA and BPOM in Indonesia. Off-label medicines are used because the available and approved drugs do not have the desired effect, then doctors try medicine that have not been licensed indications. Some other reasons in practice off-label medicines use and prescribing are that drugs in the same category have the same effect (although have not been approved by indication); the expansion to a lighter form than the licensed indication, or extension of use for certain related conditions. At the opposite, the disadvantage of the practice off-label medicine use is generally not included in any health insurance benefit package, also not covered by mandatory insurance scheme (JKN-BPJS). Patients should pay for the price of a drug that has not been assured or proven of its efficacy and safety. It needs strong evidence based on scientific research to ensure the safety and effectiveness of off-label medicines to be included in the list of medications (national formulary) to put it on National Health Insurance (BPJS) benefit package.
Tuberculosis (TB) is one of the disease as the highest contributor to the disease burden in Indonesia. Tuberculosis can affect the patients’ quality of life, such as psychological, physical, and social functioning. St. George's Respiratory Questionnaire (SGRQ) is a special instrument which was widely used to measure the patients’ quality of life with respiratory disease. The objective of this study was to validate the Indonesian version of the SGRQ as instrument to collect data. A descriptive cross section design with 61 subjects was conducted at the Pulmonary Clinics and Primary Health Centers in the region of Yogyakarta within 3 months. The validation process included the known group validity, convergent and discriminant validity and factor analysis. There were 14 items question numbers which did not meet the criteria for convergent validity and 9 items which did not meet the criteria for discriminant validity. Known group validity analysis on gender showed that of the three domains of SGRQ, the activity domain gave statistically significant result. The factor analysis showed the result of Kaiser Meyer Olkin analysis (KMO) was less than 0.5. With a few modifications, the Indonesian version of SGRQ is valid and reliable for measuring quality of life in tuberculosis patients.
Background: Dried blood spot (DBS) sampling is a blood collection tool that uses a finger prick to obtain a blood drop on a DBS card. It can be used for therapeutic drug monitoring, a method that uses blood drug concentrations to optimize individual treatment. DBS sampling is believed to be a simpler way of blood collection compared with venous sampling. The aim of this study was to evaluate the quality of DBSs from patients with tuberculosis all around the world based on quality indicators in a structured assessment procedure. Methods: Total 464 DBS cards were obtained from 4 countries: Bangladesh, Belarus, Indonesia, and Paraguay. The quality of the DBS cards was assessed using a checklist consisting of 19 questions divided into 4 categories: the integrity of the DBS materials, appropriate drying time, blood volume, and blood spot collection. Results: After examination, 859 of 1856 (46%) blood spots did not comply with present quality criteria. In 625 cases (34%), this was due to incorrect blood spot collection. The DBS cards from Bangladesh, Indonesia, and Paraguay seemed to be affected by air humidity, causing the blood spots not to dry appropriately. Conclusions: New tools to help obtain blood spots of sufficient quality are necessary and environmental specific recommendations to determine plasma concentration correctly. In addition, 3% of the DBS cards were rejected because the integrity of the materials suggesting that the quality of plastic ziplock bags currently used to protect the DBS cards against contamination and humidity may not be sufficient.
