ASEPTIC DISPENSING SERVICES

Pengertian Aseptic Dispensing Services

            Aseptic Dispensing Services didefinisikan sebagai preparasi produk medis steril yang memerlukan pengenceran ataupun manipulasi lain sebelum diberikan kepada pasien (Anonim, 2009). Preparasi ini dilakukan di unit pelayanan aseptik oleh farmasis, teknisi dan asisten yang terlatih di dalam ruangan yang kondisinya terkontrol. Preparasi ini diracik menurut resep yang diberikan kepada pasien yang bersifat individual serta di bawah pengawasan farmasis. Suatu contoh pelayanan aseptik dilakukan oleh Northumbria Healthcare NHS Foundation Trust disediakan dari unit aseptik pusat yang berada di Rumah Sakit Umum Wansbeck (Anonim, 2009).

Tujuan Aseptic Dispensing Services

Aseptic dispensing services menjamin kualitas pengobatan sebelum diberikan kepada pasien dengan tujuan sebagai berikut: mengurangi kontaminasi mikroorganisme dan partikel, memastikan cara melarutkan yang benar, menjamin stabilitas dan kompatibilitas, menjamin rute pemberian yang sesuai, menjamin keselamatan staf medis dalam peracikan terutama pada peracikan obat-obatan sitotoksik, menghindari ketidaktepatan penggunaan obat (terutama untuk obat yang mahal) (Anonim, 2009).

Penerapan Aseptic Dispensing Services

            Aseptic services disediakan oleh pusat unit aseptic yang ada di rumah sakit. Untuk menjamin penghantaran pengobatan pada waktu tertentu, maka unit tersebut harus mendapatkan resep yang telah ditanda tangani paling tidak 24 jam sebelum pengobatan dilakukan. Kadang-kadang, dengan persetujuan tertentu, unit tersebut dapat menangani resep yang diberikan kurang dari 24 jam sebelum pengobatan dilakukan.

            Staf yang terlibat pada unit aseptic diantaranya: farmasis penanggung jawab, manager pelayanan aseptic, dan asisten yang bertugas menyiapkan. Unit Aseptic memiliki Farmasis Penangung Jawab, tetapi diatur, secara full time, oleh teknisi farmasis senior. Semua perlakuan aseptik diambil alih oleh tim yang terdiri dari asisten terlatih yang bertugas untuk menyiapkan sediaan.  Penjaminan yang lebih lanjut dilakukan oleh farmasis yang telah terlatih dan teknisi farmasis, yang bekerja di unit tersebut secara bergantian. Teknisi farmasis berpartisipasi dalam pemeriksaan sistem teknis, dan bila perlu memiliki kemampuan untuk melakukan manipulasi aseptik (aseptic manipulation) (Jonathan et al., 2001).

Sediaan-sediaan yang memerlukan Aseptic Dispensing Services

1. Nutrisi Parenteral

Nutrisi parenteral merupakan pemberian nutrisi melalui rute intravena untuk pasien mengalami gangguan jika diminum secara per oral. Kebutuhan total untuk 24 jam diberikan dalam satu kantung infus yang disiapkan di departemen Pelayanan Aseptik. Infus ini dibuat berdasarkan resep dokter bersama dengan ahli nutrisi. Farmasis memberikan saran terkait dengan regimen dengan mempertimbangkan stabilitas dan kompatibilitasnya. Bahan-bahan yang dibutuhkan dicampur dan larutan yang bersifat lemak serta vitamin dimasukkan ke dalam wadah yang berbeda untuk menjaga stabilitas (Anonim, 2009).

3. Injeksi Pre-filled

Injeksi i.v secara perlahan (bolus) masih digunakan di bangsal pasien ketika dibutuhkan. Injeksi hanya boleh diberikan oleh perawat yang sudah mendapatkan pelatihan. “Injeksi yang terus menerus” untuk digunakan di pompa syringe, juga disiapkan di bangsal pediatric (Anonim, 2009).

4. Preparasi Bahan Tambahan untuk Obat Intravena

     Beberapa obat intravena perlu dilarutkan di dalam larutan infus sebelum diberikan kepada pasien. Departemen Pelayanan Aseptik dapat melarutkannya pada cairan infus yang sesuai, diberi label yang berisi satabilitas dan dosis yang dapat diberikan kepada pasien (Anonim, 2009).

5. Injeksi Sitotosik

        Injeksi sitotoksisk berbahaya untuk pasien dan tenaga kesehatan, sehingga untuk mengurangi resiko tersebut, sebaiknya  disimpan dalam bentuk yang langsung diinjeksikan. Rekam medis pasien digunakan untuk menghitung dosis sesuai dengan tinggi badan, berat badan dan luas permukaan tubuh oleh farmasis sitotoksi yang disetujui oleh konsultan onkologis (Anonim, 2009).

Fasilitas yang tersedia pada unit aseptic

            Di dalam unit aseptik, terdapat dua ruang standar Kelas C yang masing-masing dikondisikan dengan isolator bertekanan negatif. Isolator merupakan ruang yang di dalamnya memiliki standar Kelas A, yang dapat menjamin produk steril yang dihasilkan dapat terlindung dari lingkungan luar. Isolator yang bertekanan negatif juga melindungi operator dari bahaya produk di dalam isolator (Anonim, 2009). Masing-Masing dari isolator ini diakses oleh suatu sistem dengan pintu perpindahan yang tersambungkan.

Baju pelindung digunakan setiap kali personel memasuki unit aseptik. Jenis dan jumlah baju pelindung tergantung pada ruang dimana personel tersebut bekerja.

Unit aseptik juga memiliki ruang peralihan, yaitu collation room dan ruang persiapan, sedangkan aktivitas harian berlangsung di kantor yang ada di dekat unit tersebut.

Daftar Pustaka

(1)  Anonim. 2009. Pharmacy and Aseptic Services. University Hospital of South Manchester.http://www.uhsm.nhs.uk/patients/Pages/PharmacyAsepticServices.aspx. Diakses pada tangga 28 Maret 2010

(2)  Merills Jonathan, Fisher Jonathan. 2001. Pharmacy Law and Practice. Amerika Serikat: Maxwell Scientist Ltd.

GLYBURIDE AS TREATMENT IN GESTATIONAL DIABETES MELLITUS

REVIEW ARTICLE

GLYBURIDE AS TREATMENT IN GESTATIONAL DIABETES MELLITUS

Background: Insulin was primary choice in Gestational Diabetes Mellitus (GDM) treatment which diet intervention no longer give any significant responses. Sulfonilurea rarely used in pregnant women with GDM because its teratogenic and neonatal hypoglycemia effects. Since 2000, some studies reported successful treatment use glyburide.

Method: Reviewed articles reported glyburide as treatment in GDM.

Results: GDM in pregnant women could be treated with Glyburide because its safety although there are no significant difference between glyburide and insulin macrosomia risk (baby born more than 4000 gram weight); lung complication; and neonatal hipoglycemic. Beside the safety reason, glyburide has lower price than insulin. This cost model can be used by health professional to choose the medicine which has equality in effect.

Conclusion: Glyburide could be used as therapeutic and costly effective alternative treatment than insulin in GDM therapy.

Keywords: Gestational Diabetes Mellitus (GDM); insulin; glyburide

INTRODUCTION

Diabetes mellitus in pregnancy in medical terms is called gestational diabetes mellitus. Diabetes mellitus may only take place during pregnancy but can also continue though it was no longer pregnant. The disease is present in approximately 1% of women of reproductive age and 1-2% of them will suffer from gestational diabetes. Diabetes mellitus (DM) is a group of metabolic diseases with hyperglycemia characteristic (increased blood sugar levels ) that occurs cause abnormalities in insulin secretion, insulin action or both.

Classification of DM with Pregnancy by Pyke:

Class 1             : Gestational diabetes, which is diabetes that arises during pregnancy and disappears  after childbirth.

Class II            : Pregestasional diabetes, namely ranging from pre-pregnancy diabetes and continued after pregnancy.

Class III          : Pregestasional diabetes accompanied by complications of the disease blood vessels such as retinopathy, nephropathy, a disease of blood hunters pelvic and peripheral blood vessels.

Mayor of women with DM  controlled with diet and exercise, but 30% - 40% of them require pharmacological therapy. The principle arrangement of blood sugar levels in pregnant women with diet therapy is, or with additional insulin if therapy diet alone is not enough. Insulin therapy is effective for dealing with gestational diabetes but it is not comfortable and relatively expensive. Handling with sulfonilurea not recommended for pregnant women because of the the risk of defects in the fetus and neonatal risk hipoglicemia. However, some studies , glyburide and glipizide are drugs commonly used today. Glyburide or also known as glibenclamide in the treatment of gestational diabetes mellitus proven effective, safe, and inexpensive addition to insulin.

Glyburide is currently classified as category B by the FDA for use in pregnant women, which means that there is no evidence of risk in humans. In 2001, the American College of Obstetricians and Gynecologists (ACOG) recommends that careful in applying oral agents to handle DM Gestational. particular agency is aware that further studies need to be done for safety criteria for diabetes drugs. In 2004, ACOG reported that 13% of obstetricians 1400 America use these glyburide as first-line therapy in case of failure of a dietary intervention pad GDM women diagnosed.

Use of total glyburide during pregnancy based on shared pathophysiology of GDM and type 2 diabetes. Class of drugs sulfonilurea has been used to treat type 2 diabetes for decades involving pa n pancreatic function in lowering blood sugar levels by inhibiting
effluks potassium through adenosine 5'-triphosphate (ATP). This action causes depolarization cellular and stimulate insulin from the pancreas. effect u all This drug is an m k eningkat insulin secretion. Medication sulfonilurea reduce glucose toxicity and
increase insulin secretion after a meal, thus reducing postprandial hyperglicemia. Research has show that, these drugs also can increase sensitivity of peripheral tissues to insulin.

The purpose of writing this article is to determine the safety glyburide on gestational diabetes and able to conclude that glyburide is choices therapy GDM safe, effective and in expensive.

METHOD

In this article, the data used is obtained by reviewing electronic scientific articles related to gestational diabetes mellitus (diabetes that occurs during pregnancy), its handling, its effectiveness in terms of both effect and cost.

The data is taken from several websites that provide scientific journals related to gestational diabetes keyword: Gestational Diabetes Mellitus; insulin; glyburide in the search field (search).

RESULTS AND DISCUSSION

Clinical experience pe ngoba tan with glyburide for GDM has progressed. Since 2000, several studies have shown that glyburide is ernatif alt effective when compared with insulin to achieve adequate glycemic control in women with GDM. however, it should be noted that the differences in the criteria of glycemic control may affect the results. In addition, differences in population (ethnic and geographic location), sample size, method, dose of the drug could significantly affect the results.

Despite the concerns about the significant teratogenic effects and the possibility of baby makrosomia associated with the use of oral hypoglycemic medications during pregnancy, especially sulfonylurea class, Elliott et al. Showed that only a few of glyburide was detected capable placental aspirated tested in vitro perfusion model. And than, based on observations of  Langer et al, concluded that glyburide did not detect on the umbilical cord / placenta and there was no significant difference between glyburide and insulin except on the reduction of maternal hypoglycemia episodes on premises glyburide (2%) compared to insulin (20%).

To determine whether glyburide distributed into breast milk in women with a history of GDM have done research, where study previously with two first-generation sulfonylureas, tolbutamide and chlorpropamide showed that his transfer there is significant drug into breast milk. In nonrandomized controlled observation study conducted on sulfonilurea second generation, glyburide and glipizide in breast milk, suggesting that glyburide not found in breast milk and blood glucose on all infants Breastfed normaly.

A study randomized controlled trial to glyburide versus insulin showed that treatment with glyburide can provide a relatively safe alternative of insulin therapy. According Glyburide including the FDA category B drug for use in pregnant women, which means that there is no evidence of risk in humans. Then retrospective trials have shown up even wa 20% of GDM patients, especially pretreatment with substantial hyperglycemia, likely to require adjuvant or alternative therapy with insulin. At a later study showed that treatment with glyburide compared with insulin resulted in lower sugar levels and higher percentage of the 'excellent glycemic control' with fewer hypoglycemic episodes.

Most physicians assume that cost is one of the aspects to consider in deciding which nursing care they created. The cost of becoming a more important factor when physicians must choose drugs with similar effectiveness.

Glyburide significantly cheaper than insulin. Analysis / cost model can be useful for physicians in deciding the selection of drugs, especially drugs that have the same properties. It is described by Goetzl et al, that glyburide significantly cheaper than insulin for the treatment of gestational diabetes can save the cost of treatment.

CONCLUSION

Given the effects / risks of drug entry into the placenta and can harm the fetus glyburide a synthetic drug can be recommended for women with diabetes during pregnancy. Since 2000, several studies have shown that glyburide is an effective alternative to insulin to achieve adequate glycemic control in women with GDM. however, it should be noted that the difference of control glycemic criteria may affect the results. Further more, differences in populations (ethnic and geographic location), sample size, method, drug dose significantly affect the results.

A study randomized controlled trial to glyburide versus insulin showed that treatment with glyburide can provide a relatively safe alternative of insulin therapy. Further retrospective trials have shown that up to 20% of GDM patients, especially with pretreatment substantially hyperglycemia likely to require adjuvant or alternative therapy with insulin.

Some studies also show that glyburide is not found in the umbilical cord / placenta and showed that glyburide  not found in breast milk and blood glucose levels in all breastfed infants is normal. Additionally, glyburide significantly cheaper than insulin that can be used as a consideration in deciding the selection of drugs, especially drugs that have the same efficacy.

REFERENCES

Elliott, B. D, Langer O, Schenker, S, Johnson, R. F., 1991, insignificant transfer of glyburide across the human placenta Occurs. Am J Obstet Gynecol 165:807 - 812.

Goetzl, L., and Wilkins, I., 2002, Glyburide Compared to Insulin for the Treatment of Gestational Diabetes Mellitus: A Cost Analysis, Journal of Perinatology, 22: 403-406.

Langer, O., Conway, DL, Berkus MD, Xenakis, EMJ, Gonzales, O., 2000, A Comparison Of Glyburide And Insuli n In Women With Gestational Diabetes Mellitus, T he Massachusetts Medical Society, Vol ume 343.

Moore, TR, 2007, Glyburide for the Treatment of Gestational Diabetes, Diabetes Care, Volume 3.

Trojnar, AK, Marciniak, B., Gorzelak, have done, BL, Trojnar, M., Oleszczuk, J., 2008, Glyburide for the treatment of gestational diabetes mellitus, Medical University of Lublin, Staszica 16, Pharmacological Reports, 60, 308-318.