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"ABSTRAKRuang Lingkup dan Cara Penelitian: Dengan berkembangnya teknologi formulasi obat dan juga kemajuan di bidang pengobatan, telah dibuat teofilin dalam bentuk sediaan lepas lambat (SLLB). Hal ini menguntungkan bagi pasien, karena selain kepatuhan dapat ditingkatkan kadar obat dalam darah dapat terkendali dengan baik.Bioavailabilitas dan bioekivalensi obat SLLB perlu diketahui dengan baik. Untuk teofilin hal ini terutama karena, disamping indeks terapi sempit juga adanya perbedaan antar individu dalam parameter farmakokinetik. Oleh sebab itu telah dilakukan penelitian terhadap tablet Uniphyllin® Continus® yang merupakan teofilin bentuk SLLB baru dibandingkan dengan teofilin sediaan biasa.Penelitian dilakukan terhadap 13 sukarelawan sehat, pria dewasa. Minggu I diberikan teofilin sediaan biasa selama 3 hari, 4x150 mg/hari (9 dosis). Pada minggu II diberikan sediaan lepas lambat selama 3 hari, 2 x 300-400 mg/hari (5 dosis). Pada hari ke-3 dalam keadaan puasa, sebelum dan sesudah makan obat, diambil darah dari vena kubiti. Pada sediaan biasa darah diambil pada jam 0; 0,5; 1; 1,5; 2; 2,5; 3; 6; 9; dan 11. Pada sediaan lepas lambat darah diambil pada jam 0; 2; 3; 4; 5; 7; 9; 12; 15 dan 24. Kadar teofilin plasma diukur dengan metoda enzyme immunoassay-turbidimetry (ACA IV). Dari kadar yang didapat dihitung berbagai parameter farmakokinetik.Hasil dan Kesimpulan: Data farmakokinetik diperoleh dari 12 subyek (satu subyek dibatalkan berhubung efek samping yang berat), sebagai berikut : Cmax tablet sediaan lepas lambat (SLLB) 12,17 μg/mL dan pada sediaan biasa (SBS) 15,75 μg/mL, kedua nilai Cmax berbeda bermakna (p < 0,01). Cmin pada SLLB 8,10 μg/mL dan pada SBS 10,39 µg/mL, kedua nilai berbeda bermakna (p <0,01). Nilai tmax SLLB adalah pada jam ke-4 sedang pada SBS pada jam ke-1,13; keduanya berbeda sangat bermakna (p<0,001). Hasil indeks fluktuasi (IF) antara SLLB dan SBS tidak berbeda (p >0,05; IF SLLB = 0,42 dan IF SBS = 0,44).Dari data farmakokinetik terlihat tablet Uniphyllin® Continus® merupakan suatu sediaan lepas lambat. Variabilitas parameter antar subyek disebabkan oleh variabilitas metabolisme obat, sehingga menimbulkan fluktuasi kadar obat. Oleh karena itu, pada kondlsi tertentu sebaiknya penggunaan teofilin diikuti dengan pemeriksaan kadar obat dalam darah.

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ABSTRACT

Comparative Study Of Plasma Concentration Of Theophylline Using Sustained Released Tablet Uniphyllin® Continus® 300-400 Mg With Plain Capsules Of Theophylline150 MgScope and Method of Study: Advances in drug formulation and therapeutics make it possible to produce various controlled-release (CR) theophylline preparations. Such dosage form has been advocated to be more advantageous than the conventional form as it may in-crease patient?s compliance, and the plasma concentration of the drug to be more controllable.

The bioavailability and bioequivalence of sustained released drugs should be carefully observed. This is particularly important for theophylline, because not only it has a narrow margin of safety but also the capacity to metabolize the drug varies markedly between individuals. Uniphyllin® Continus®, a controlled release theophylline preparation, is to be marketed soon here. The aim of the present study is to confirm its controlled release characteristics compared with a conventional release (CVR) dosage form.

Thirteen healthy Indonesian volunteers participated in this study. They were given 150 mg of CVR theophylline 4 times daily for 9 dosages. Venous blood samples were taken at 0; 0.5; 1; 1.5; 2; 2.5; 3; 6; 9 and 11 hours after the last dosage. After a wash-out period of two weeks, the subjects took the CR tablets twice daily for 5 dosages. Subjects with body weights less than 70 kg were given 300 mg tablets, and heavier subjects were given 400 mg tablets. Blood samples were drawn at 0; 2; 3; 4; 5; 7; 9; 12; 15 and 24 hours. Plasma theophylline concentration was determined by enzyme immunoassay-turbidimetric method (ACA IV, Dupont).

Findings and Conclusions: Data was analyzed from 12 subjects (one subject dropped due to serious adverse reactions). The mean of peak concentrations (Cmax) of the CR and CVR dosage forms were 12.17 and 15.75, μg/mL, respectively (p <0.01). Trough concentrations (Cmin) of the CR and CVR forms were 8.10 and 10.39 µg/mL, respectively (p < 0.01). The time to attain Cmax (tmax) for the CR and CVR forms were 4 and 1.13 hours, respectively (p < 0.001). The fluctuation index (FI) of the CR and CVR forms were 0.42 and 0.44, respectively; which are not significantly different.

The pharmacokinetic data show that Uniphyllin® Continus® tablet is a slow sustain released tablet. Variability between subjects caused by variability in drug metabolism produce fluctuations in the plasma concentration of the drug."

"Pasien bayi dan anak-anak di bawah 8 tahun, dosis maksimum dihitung berdasarkan berat badan dengan perhitungan menggunakan formula Clark dari dosis dewasa yang telah ditetapkan. Aturan Clark adalah persamaan yang digunakan untuk menghitung dosis obat pediatrik berdasarkan berat badan pasien yang diketahui dan dosis obat dewasa yang diketahui untuk digunakan (Delgado, 2022). Perhitungan dosis harus diperhatikan agar tidak kurang dari dosis lazim (underdose) dan melebihi dosis maksimal (overdose) dalam pemakaian sekali dan sehari. Pemberian dosis yang tidak sesuai berupa underdose menyebabkan pengobatan tidak optimal dan pemberian obat melebihi dosis maksimal dapat menyebakan efek toksik yang termasuk kejadian Drug Related Problem (DRP).Ketidaktepatan dosis dapat terjadi akibat kesalahan dalam menghitung dosis ketika penyiapan obat (human error) khususnya pada pasien anak. Sempitnya waktu perhitungan, penyiapan, dan penyerahan resep menjadi salah satu penyebab terjadinya human error pada pemberian obat. Maka untuk meminimalisir ketidaktepatan dosis obat, QR Code dibuat untuk menganalisis kesesuaian dosis secara otomatis berdasarkan formula Clark agar memudahkan peracik mengetahui dosis lazim dan maksimum dan memastikan obat yang diberikan tepat dosis.......the established adult dose. Clark's rule is an equation used to calculate the pediatric drug dose based on the patient's known weight and the known adult drug dose to be used (Delgado, 2022). Dose calculation must be considered so as not to be less than the usual dose (underdose) and exceed the maximum dose (overdose) in one-time and daily use. Giving an inappropriate dose in the form of underdose causes treatment to not be optimal and giving drugs exceeding the maximum dose can cause toxic effects which include Drug Related Problem (DRP) events.Dosage inaccuracy can occur due to errors in calculating doses when preparing drugs (human error), especially in pediatric patients. The narrow time for calculation, preparation, and submission of prescriptions is one of the causes of human error in drug administration. So to minimize the inaccuracy of drug doses, a QR Code was created to automatically analyze the suitability of doses based on Clark's formula to make it easier for compounders to know the usual and maximum doses and ensure that the drugs given are dosed correctly."

"Kegagalan terapi akibat ketidaksesuaian dosis antibiotik masih banyak ditemukan di fasilitas kesehatan di Jakarta. Ketidaksesuaian ini karena tidak adanya pertimbangan terhadap berat badan, tinggi badan, atau umur pasien. Permasalahan tersebut seharusnya dapat diatasi oleh apoteker dengan memastikan kembali dosis obat sebelum diserahkan ke pasien pada saat pengkajian resep. Namun, banyaknya jumlah pasien yang melebihi kapasitas tenaga kesehatan dapat meningkatkan kerentanan terhadap kesalahan dan memperlambat proses pelayanan. Analisis dosis obat dapat dipermudah dengan menggunakan spreadsheet yang sudah dilengkapi dengan rumus secara otomatis. Spreadsheet tersebut terdiri dua bagian, antara lain sheet basis data dan pendeteksi dosis obat. Basis data memuat informasi mengenai nama obat, indikasi, kategori kehamilan, kekuatan sediaan, dosis maksimum harian dewasa dan anak yang mengacu pada formularium Puskesmas Kecamatan Pulogadung serta referensi lain. Sementara sheet pendeteksi obat terdiri dari tabel pengisian resep dan pengecekan dosis. Pada sheet tersebut dosis pada resep dapat dibandingkan dengan dosis dari hasil perhitungan menggunakan rumus Clark. Perhitungan dosis berdasarkan rumus Clark secara otomatis terlihat setelah informasi pada resep dimasukkan ke dalam tabel. Dengan demikian, ketidaksesuaian dosis akan terdeteksi secara langsung. Antibiotik yang digunakan sebagai basis data untuk analisis, antara lain amoksisilin, sefadroksil, doksisiklin, dan kotrimoksazol karena merupakan antibiotik yang paling sering diresepkan. Selain itu, spreadsheet yang sudah dibuat dapat diakses melalui QR Code untuk mempermudah penggunaan....... Medication error due to over or underdose is still commonly found in health facilities in Jakarta. This discrepancy is due to the absence of consideration for the patient's weight, height, or age. The pharmacist should be able to overcome this problem by reconfirming the dosage of the drug before it is handed over to the patient during the prescription assessment. However, the dosage analysis is an error-prone process, especially with a large number of patients that exceeds the capacity of health workers. A spreadsheet complete with a specific formula will help the assessment process significantly. The spreadsheet consists of a database sheet and a drug dose detector. The database contains information regarding drug names, indications, pregnancy categories, dosage strengths, and maximum daily adult and child doses referring to the Pulogadung Subdistrict Health Center formulary and other references. On the second sheet, the drug dose detector consists of a fill-out prescription table and a dosage checker. The dosage calculation is based on Clark's formula and will be automatically displayed after the fill-out table has been filled based on the prescription. Thus, the dose discrepancies can be detected immediately. The antibiotics used in the database include amoxicillin, cefadroxil, doxycycline, and co-trimoxazole due to the highest frequency amongst other prescribed antibiotics. In addition, a QR Code that directs users to the spreadsheet was generated for easier access."

"Pemantauan Terapi Obat (PTO) merupakan suatu proses yang mencakup kegiatan untuk memastikan terapi obat yang aman, efektif dan rasional. Pemantauan terapi obat mencakup pengkajian pilihan obat, dosis, cara pemberian obat, respons terapi dan rekomendasi perubahan atau alternatif terapi. Pemantauan terapi obat harus dilakukan secara berkesinambungan dan dievaluasi secara teratur pada periode tertentu agar keberhasilan ataupun kegagalan terapi dapat diketahui. Dalam hal ini, keberadaan apoteker memiliki peran yang penting dalam mencegah munculnya masalah terkait obat melalui pemantauan terapi obat. Tujuan dari tugas khusus ini antara lain mengevaluasi dosis dan indikasi terapi yang diterima, melakukan analisis potensi interaksi antar obat dan melakukan analisis Drug Related Problem (DRP) dengan menggunakan klasifikasi Pharmaceutical Care Network Europe (PCNE) V9.1. Pengkajian yang dilakukan terhadap pasien dimulai dengan mengambil data dari rekam medis, catatan pemberian obat, catatan terintegrasi dokter, hasil pemeriksaan laboratorium, serta hasil kultur bakteri dan sensitifitas antibiotik. Setelah melakukan kegiatan penelitian tugas khusus terkait dengan pemantauan terapi obat pasien abses skrotum post-debridement dengan multimorbiditas di RSUP Fatmawati, maka dapat diambil kesimpulan sebagai berikut: 1. Pengobatan yang diterima oleh Tn.B sudah sesuai dosis dan sesuai indikasi, kecuali dalam pemberian antibiotik menurut hasil laboratorium. 2. Terdapat tiga macam potensi interaksi antar obat, yaitu cetriaxone dengan ringer laktat, domperidon dengan ondansetron dan ondansetron dengan paracetamol. Selama pemantauan tidak ada efek klinis dari interaksi yang berarti, dan paracetamol dilakukan penggantian terapi dengan natrium diklofenak. 3. Pasien Tn.B, yang menurut uji sensitivitas antibiotik hasilnya resisten terhadap ampicillin sulbactam, dikhawatirkan tidak mencapai efektivitas terapi jika terus diberikan antibiotik ampicillin sulbactam sebagai terapi antibiotik definitif. Namun dengan antibiotik yang diberikan perbaikan tetap terjadi meskipun hasil laboratorium menyatakan bahwa Tn.B resisten. Disimpulkan bahwa dalam uji sensitivitas antibiotik terjadi major error (false resistance) pada hasil uji.......Drug Therapy Monitoring (PTO) is a process that includes activities to ensure safe, effective and rational drug therapy. Monitoring drug therapy includes assessing drug choices, dosages, methods of drug administration, therapeutic response and recommendations for changes or alternative therapies. Monitoring of drug therapy must be carried out continuously and evaluated regularly at certain periods so that the success or failure of therapy can be known. In this case, the existence of a pharmacist has an important role in preventing the emergence of drug-related problems through monitoring drug therapy. The purpose of this special assignment includes evaluating doses and indications for therapy received, analyzing potential interactions between drugs and conducting Drug Related Problem (DRP) analysis using the Pharmaceutical Care Network Europe (PCNE) V9.1 classification. The assessment carried out on patients began by collecting data from medical records, drug administration records, doctors' integrated notes, laboratory examination results, as well as bacterial culture results and antibiotic sensitivity. After carrying out special task research activities related to monitoring drug therapy in post-debridement scrotal abscess patients with multimorbidity at Fatmawati General Hospital, the following conclusions can be drawn: 1. The treatment received by Mr.B was in accordance with the dosage and according to indications, except in administering antibiotics according to laboratory results. 2. There are three types of potential interactions between drugs, namely cetriaxone with Ringer's lactate, domperidone with ondansetron and ondansetron with paracetamol. During monitoring there were no clinical effects from significant interactions, and paracetamol was replaced with diclofenac sodium therapy. 3. Patient Mr.B, who according to the antibiotic sensitivity test results are resistant to ampicillin sulbactam, is feared not to achieve therapeutic effectiveness if he continues to be given the antibiotic ampicillin sulbactam as definitive antibiotic therapy. However, with the antibiotics given, improvement still occurred even though the laboratory results stated that Mr.B was resistant. It was concluded that in the antibiotic sensitivity test there was a major error (false resistance) in the test results."

"Compunding has always been part of pharmacy practice. Today, the need for compounding is growing, with the prevalence of drug shortages, outsourcing of compounding services by hospitals, and patients' needs for individualized preparations. Compounding pharmacies now have the opportunity to obtain accreditation. The Art, Science, and Technology of Pharmaceutical Compounding presents all the information a student needs to understand the purpose and processes of compounding. It includes the essential information on establishing, equipping and operating a compounding pharmacy. It discusses all aspects of good manufacturing practices for compounded medications and it features quality control measures for all aspects of compounding. For practitioners who already compound prescription medications, the book is a ready reference featuring more than 200 sample formulations, including bases, vehicles and ingredient-specific preparations. Each formulation lists the necessary ingredients and gives step-by-step instructions for preparing the product. A new chapter emphasizes the importance of knowing the purity and form of all ingredients to ensure that the proper dose of a compounded product is delivered"