Pembahasan Antivirus, Antibiotik

PEMBAHASAN

2.1         Definisi Antibiotik

Antibiotik adalah zat yang dihasilkan oleh fungi dan bakteri, yang memiliki khasiat membunuh atau menghambat pertumbuhan kuman, sedangkan toksisitasnya terhadap manusia relatif kecil.

Penggolongan Antibiotik

Antibiotik digolongkan berdasarkan :

·         Struktur kimia,

·         Spektrum kerja,

·         Mekanisme kerja

Berdasarkan struktur kimianya, antibiotik dapat digolongkan menjadi

beberapa macam, yaitu :

a.       Golongan Aminoglikosida

Diantaranya amikasin, dibekasin, gentamisin, kanamisin, neomisin, netilmisin, paromomisin, sisomisin, streptomisin, tobramisin.

b.      Golongan Beta-Laktam

Diantaranya golongan karbapenem (imipenem, meropenem), golongan sefalosporin (sefaleksin, sefazolin), golongan beta-laktam monosiklik, dan golongan penisilin (penisilin dan amoksisilin).

c.       Golongan Glikopeptida

Diantaranya vankomisin, teikoplanin, ramoplanin dan dekaplanin.

d.      Golongan Poliketida

Diantarnya golongan makrolida (eritromisin, azitromisin), golongan ketolida (telitromisin), golongan tetrasiklin (doksisiklin, klortetrasiklin).

e.       Golongan Polimiksin

Diantaranya polimiksin dan kolistin.

f.        Golongan Kinolon

Diantaranya ofloksasin, norfloksasin.

g.       Golongan Sulfonamid

Diantaranya kotrimoksazol dan trimetoprim.

h.      Antibiotika lain yang penting, seperti kloramfenikol, klindamisin dan asam fusidat (Surini, 2006).

2.2        Spektrum Kerja

Berdasarkan spektrum kerjanya, antibiotik digolongkan menjadi :

-          Antibiotik berspektrum luas (broad spectrum)

yaitu antibiotik yang sekaligus dapat menghambat atau memusahkan bakteri gram positif, gram negatif. Contohnya : sefalosporin (Surini, 2006).

-          Antibiotik berspektrum sempit (narrow spectrum)

yaitu antibiotik yang hanya menghambat bakteri gram negatif atau gram positif. Contohnya : penisilin (Surini, 2006).

2.3        Mekanisme Kerja

Berdasarkan mekanisme kerjanya, antibiotik digolongkan menjadi :

1.      Antibiotik yang menghambat sintesis dinding sel mikroba

Antibiotik ini bekerja dengan cara mencegah digabungkannya asam Nasetilmuramat, yang dibentuk didalam sel, ke dalam struktur mukopeptida yang biasanya memberi bentuk kaku pada dinding sel bakteri. Oleh karena tekanan osmotik dalam sel kuman lebih tinggi daripada diluar sel maka kerusakan dinding sel kuman akan menyebabkan terjadinya lisis, yang merupakan dasar efek bakterisidal pada kuman yang peka. Contoh:

penisilin, sefalosporin, basitrasin, amoksisilin (Setiabudy dan Ganiswarna, 1995).

2.      Antibiotik yang menggangu metabolisme sel mikroba

Untuk kelangsungan hidupnya, mikroba membutuhkan asam folat. Kerja antibiotik ini adalah berkompetisi dengan zat pemula asam folat yaitu asam para amino benzoat (PABA) yang akan digunakan oleh mikroba tersebut. Dengan demikian yang terbentuk adalah analog dari asam folat yang mengakibatkan kehidupan mikroba akan terganggu. Contoh : sulfonamid, trimetoprim, asam p-aminosalisilat (PAS) dan sulfon (Setiabudy dan Ganiswarna, 1995).

3.      Antibiotik yang menghambat sintesis asam nukleat

Antibiotik yang termasuk dalam kelompok ini adalah rifampisin dan golongan kuinolon. Rifampisin berikatan dengan enzim polimerase RNA (pada subunit) sehingga menghambat sintesis RNA dan DNA oleh enzim tersebut. Sedangkan golongan kuinolon menghambat enzim DNA girase pada kuman, yang fungsinya menata kromosom yang sangat panjang menjadi bentuk spiral hingga bisa muat dalam sel kuman yang kecil

(Setiabudy dan Ganiswarna, 1995).

4.      Antibiotik yang menghambat sintesa protein

Untuk kehidupannya, sel mikroba perlu mensintesis berbagai protein. Sintesis protein berlangsung di ribosom, dengan bantuan mRNA dan tRNA. Pada bakteri, ribosom terdiri dari dua sub unit, yaitu ribosom 30S dan 50S. Untuk berfungsi pada sintesis protein, kedua komponen ini akan bersatu pada pangkal rantai mRNA menjadi ribosom 70S. Penghambatan sintesis protein terjadi dengan berbagai cara. Misalnya : streptomisin berikatan dengan komponen ribosom 30S dan menyebabkan kode pada mRNA salah dibaca oleh tRNA pada waktu sintesis protein. Akibatnya akan terbentuk protein yang abnormal dan nonfungsional pada sel mikroba. Contoh : golongan aminoglikosida, makrolid, linkomisin, tetrasiklin dan kloramfenikol (Setiabudy dan Ganiswarna, 1995).

Contoh obat Antibiotik

-          Ampisilin

-          Amoksisilin

-          Supertetra (Tetrasiklin)

-          Kloramfenikol

-          Ciprofloksasin

2.4        Antivirus

Obat-obat antivirus dipakai untuk membasmi, mencegah, atau menghambat penyebaran inveksi virus.virus bereplikasi sendiri dalam beberapa tahap. Tujuan dari obat-obat antivirus adalah untuk mencegah replikasi virus dengan menghambat salah satu dari tahap-tahap tersebut, sehingga dengan demikian menghambat virus untuk bereproduksi.kelompok obat-obat ini efektif untuk melawan influenza, spesies herpes, dan human immunodeficiency virus (HIV).

Penggolongan Antivirus

Penggolongan obat Anti Virus

Untuk memudahkan pemahaman, maka obat-obat anti virus digolongkan atas dua golongan besar yaitu :

1.      Antinonretrovirus, yang terdiri dari :

·         Antvirus untuk herpes

·         Antivirus untuk influenza

·         Antivirus untuk HBV dan HCV

2.      Antiretrovirus, yang terdiri dari :

·         NRTI  (Nucleoside Reverse Transcriptase Inhibitor)

·         NtRTI (Nucleotide Reverse Transcriptase Inhibitor)

·         NNRTI (Non Nucleoside Reverse Transcriptase Inhibitor)

·         PI (Protease Inhibitor)

·         Viral entry inhibitor (Viral Entry Inhibitor)

2.5        Antijamur

Obat anti jamur adalah senyawa yang digunakan untuk pengobatan penyakit yang disebabkan oleh jamur. Sebuah jamur adalah anggota kelompok besar eukariotik organisme yang meliputi mikroorganisme seperti ragi dan jamur, serta lebih akrab jamur. Kadang disebt juga Fungi yang diklasifikasikan sebagai sebuah kerajaan yang terpisah dari tanaman, hewan dan bakteri. Salah satu perbedaan utama adalah bahwa sel-sel jamur memiliki dinding sel yang mengandung kitin, tidak seperti dinding sel tumbuhan, yang mengandung selulosa.

Secara klinik, infeksi jamur dapat digolongkan menurut lokasi infeksinya, yaitu :

1.      Mikosis Sistemik (infeksi jamur sistemik) terdiri dari deep mycosis (misalnya aspergilosis, blastomikosis, koksidioidomikodid, kriptokokosis.

2.      Dermatofit, yaitu infeksi jamur yang menyerang kulit, rambut, dan kuku, biasanya disebabkan oleh epidermofitron dan mikrosporum.

3.      Mikosis mukokutan, yaitu infeksi jamur pada mukosa dan lipatan kulit yang lembap, biasanya disebabkan oleh kandida.

Menurut indikasi klinis obat-obat antijamur dapat dibagi atas 2 golongan, yaitu :

1.      Antijamur untuk infeksi sistemik, termasuk : amfoterisin B, flusitosin, imidazol (ketokonazol, flukonazol, mikonazol), dan hidroksistilbamidin.

2.      Antijamur untuk infeksi dermatofit dan mukokutan, termasuk griseofulvin, golongan imidazol (mikonazol, klotrimazol, ekonazol, tiokonazol, dan bifonaloz), nistatin, tolnaftat, dan antijamur topikal lainnya (kandisidin, asam undesilenat, dan natamisin)

Daftar Pustaka

Kee, Joyce L. (1996). Farmakologi : Pendekatan proses keperawatan. Jakarta : 1996

Interaksi manusia dan Ketrampilan Melaksanakan Konseling di Apotek

Tujuan adanya interaksi manusia dan konseling yang dilakukan di apotek adalah antara lain untuk membina hubungan saling percaya antara pasien dan profesionl kesehatan, membantu pasien pulih lebih cepat, membantu psien sehingga kesakitan yang dderita berkurang, membantu pasien dan professional kesehatan mendapatkan manfaat lebih besar dalam hal fisiologis, psikologis dan perilaku.

            Variable – variable yang mempengaruhi proses interaksi manusia :

1.      Komunikasi sebagai pertukaran pesan / informasi : Ide yang muncul diterjemahkan dalam bentuk kata-kata lisan, tulisn dan bahasa tubuh. Selanjutnya akan diterima melalui pendengaran dan penglihatan yang kemudian akan diterjemahkan untuk memaknai maksud pesan. Jika makna yang diterima sesuai maka akan menmbulkan pemahaman, jika tidak sesuai mka akan menimbulkan umpan balik

2.      Aspek Psikologi : sifat manusia dibagi dalam dua kategori umum yaitu Ekstrovert (berfikir keluar untuk bertindak) dan Introvert (orientasi kedalam/ perenungan). Sementara itu, dalam pengambilan keputusan secara umum dibagi menjadi dua yaitu pengambilan keputusan berdasar pikiran (objektif) dan berdasarkan perasaan (subjektif).

3.      Teori Analisis Transaksional : dijelaskan bahwa kepribadian setiap orang terdiri dari 3 status ego yaitu ego orang tua (berdasarkan ajaran yang diterrima dari orang tua), ego orang dewasa (berupa respon analitis, mengumpulkan informasi, member alas an dan prediksi konsekuensi dari tindakan), dan ego anak-anak (repon emosional)

4.      Kebutuhan manusia meliputi kebutuhan fisiologis, rasa aman, kebutuhan untuk dimiliki, penghargaan dan aktualisasi diri

5.      Nilai-nilai individu apoteker dan nilai-nilai individu pasien

6.      Budaya.

Hal-hal yang perlu diperhatikan dalam interaksi Apoteker-Pasien meiputi membangun hubungan yang baik, menunjukkan empati, memperhatikan komunikasi non verbal, bersifat Asertif, menyediakan privasi an menjaga kerahasiaan, serta objektivitas klinis.

Ketrampilan yang harus dimiliki oleh apoteker untuk melakukan konseling diantaranya : 1. Keterampilan mendengar, 2. Keterampilan menyelidiki ( susunan pertanyaan dan susunan kata-kata dalam pertayaan), dan 3. Keterampilan memotivasi.

Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 19

1.                  Scope

1.1 This Annex to the Guide to Good Manufacturing Practice for Medicinal Products (“the GMP Guide”) gives guidance on the taking and holding of reference samples of starting materials, packag-ing materials or finished products and retention samples of finished products.

1.2 Specific requirements for investigational medicinal products are given in Annex 13 to the Guide.

1.3 This annex also includes guidance on the taking of retention samples for parallel imported/ distributed medicinal products.

2.                  Principle

2.1 Samples are retained to fulfil two purposes; firstly to provide a sample for analytical testing and secondly to provide a specimen of the fully finished product. Samples may therefore fall into two categories:

Reference sample: a sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages (e.g. those requiring analytical testing and release) or intermediates, that are transported outside of the manufacturer’s control, should be kept.

Retention sample: a sample of a fully packaged unit from a batch of finished product. It is stored for identification purposes. For example, presentation, packaging, labelling, patient information leaflet, batch number, expiry date should the need arise during the shelf life of the batch concerned. There may be exceptional circumstances where this requirement can be met without retention of duplicate samples e.g. where small amounts of a batch are packaged for different markets or in the production of very expensive medicinal products.

For finished products, in many instances the reference and retention samples will be presented identi-cally, i.e. as fully packaged units. In such circumstances, reference and retention samples may be re-garded as interchangeable.

2.2 It is necessary for the manufacturer, importer or site of batch release, as specified under sec-tion 7 and 8, to keep reference and/or retention samples from each batch of finished product and, for the manufacturer to keep a reference sample from a batch of starting material (subject to certain excep-tions – see 3.2 below) and/or intermediate product. Each packaging site should keep reference samples of each batch of primary and printed packaging materials. Availability of printed materials as part of the reference and/or retention sample of the finished product can be accepted.

2.3 The reference and/or retention samples serve as a record of the batch of finished product or starting material and can be assessed in the event of, for example, a dosage form quality complaint, a query relating to compliance with the marketing authorisation, a labelling/packaging query or a phar-macovigilance report.

2.4 Records of traceability of samples should be maintained and be available for review by com-petent authorities.

3.                  Duration of Storage

3.1 Reference and retention samples from each batch of finished product should be retained for at least one year after the expiry date. The reference sample should be contained in its finished primary

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packaging or in packaging composed of the same material as the primary container in which the prod-uct is marketed (for veterinary medicinal products other than immunologicals, see also Annex 4, para-graphs 8 & 9).

3.2 Unless a longer period is required under the law of the Member State of manufacture, samples of starting materials (other than solvents, gases or water used in the manufacturing process) shall be retained for at least two years after the release of product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. Packaging materials should be retained for the duration of the shelf life of the finished product concerned.

4.                  Size of Reference and Retention Samples

4.1 The reference sample should be of sufficient size to permit the carrying out, on, at least, two occasions, of the full analytical controls on the batch in accordance with the Marketing Authorisation File which has been assessed and approved by the relevant Competent Authority / Authorities. Where it is necessary to do so, unopened packs should be used when carrying out each set of analytical con-trols. Any proposed exception to this should be justified to, and agreed with, the relevant competent authority.

4.2 Where applicable, national requirements relating to the size of reference samples and, if nec-essary, retention samples, should be followed.

4.3 Reference samples should be representative of the batch of starting material, intermediate product or finished product from which they are taken. Other samples may also be taken to monitor the most stressed part of a process (e.g. beginning or end of a process). Where a batch is packaged in two, or more, distinct packaging operations, at least one retention sample should be taken from each individual packaging operation. Any proposed exception to this should be justified to, and agreed with, the relevant competent authority.

4.4 It should be ensured that all necessary analytical materials and equipment are still available, or are readily obtainable, in order to carry out all tests given in the specification until one year after ex-piry of the last batch manufactured.

5.                  Storage Conditions

5.1 Storage of reference samples of finished products and active substances should be in accor-dance with the current version of the Note for Guidance on Declaration of Storage Conditions for Me-dicinal Products and Active Substances.

5.2 Storage conditions should be in accordance with the marketing authorisation (e.g. refriger-ated storage where relevant).

6.                  Written Agreements

6.1 Where the marketing authorisation holder is not the same legal entity as the site(s) responsible for batch release within the EEA, the responsibility for taking and storage of reference/retention sam-ples should be defined in a written agreement between the two parties in accordance with Chapter 7 of the EC Guide to Good Manufacturing Practice. This applies also where any manufacturing or batch release activity is carried out at a site other than that with overall responsibility for the batch on the EEA market and the arrangements between each different site for the taking and keeping of reference and retention samples should be defined in a written agreement.

6.2 The Qualified Person who certifies a batch for sale should ensure that all relevant reference and retention samples are accessible at all reasonable times. Where necessary, the arrangements for such access should be defined in a written agreement.

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6. 3 Where more than one site is involved in the manufacture of a finished product, the availability of written agreements is key to controlling the taking and location of reference and retention samples.

7.                  Reference Samples – General Points

7.1 Reference samples are for the purpose of analysis and, therefore, should be conveniently available to a laboratory with validated methodology. For starting materials used for medicinal prod-ucts manufactured within the EEA, this is the original site of manufacture of the finished product. For finished products manufactured within the EEA, this is the original site of manufacture.

7.2         For finished products manufactured by a manufacturer in a country outside the EEA;

7.2.1    where an operational Mutual Recognition Agreement (MRA) is in place, the reference sam-ples may be taken and stored at the site of manufacture. This should be covered in a written agreement (as referred to in section 6 above) between the importer/site of batch release and the manufacturer located outside the EEA.

7.2.2    where an operational MRA is not in place, reference samples of the finished medicinal prod-uct should be taken and stored at an authorised manufacturer located within the EEA. These samples should be taken in accordance with written agreement(s) between all of the parties concerned. The samples should, preferably, be stored at the location where testing on impor-tation has been performed.

7.2.3    reference samples of starting materials and packaging materials should be kept at the original site at which they were used in the manufacture of the medicinal product.

8.                  Retention Samples – General Points

8.1 A retention sample should represent a batch of finished products as distributed in the EEA and may need to be examined in order to confirm non-technical attributes for compliance with the market-ing authorisation or EU legislation. Therefore, retention samples should in all cases be located within the EEA. These should preferably be stored at the site where the Qualified Person (QP) certifying the finished product batch is located.

8.2 In accordance with 8.1 above, where an operational MRA is in place and reference samples are retained at a manufacturer located in a country outside the EEA (section 7.2.2 above), separate re-tention samples should be kept within the EEA.

8.3 Retention samples should be stored at the premises of an authorised manufacturer in order to permit ready access by the Competent Authority.

8.4 Where more than one manufacturing site within the EEA is involved in the manufacture im-portation/packaging/testing/batch release, as appropriate of a product, the responsibility for taking and storage of retention samples should be defined in a written agreement(s) between the parties con-cerned.

9.                  Reference and Retention Samples for Parallel Imported/Parallel Distributed Products.

9.1 Where the secondary packaging is not opened, only the packaging material used needs to be retained, as there is no, or little, risk of product mix up.

9.2 Where the secondary packaging is opened, for example, to replace the carton or patient infor-mation leaflet, then one retention sample, per packaging operation, containing the product should be taken, as there is a risk of product mix-up during the assembly process. It is important to be able to identify quickly who is responsible in the event of a mix-up (original manufacturer or parallel import assembler), as it would affect the extent of any resulting recall.

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10.              Reference and Retention Samples in the Case of Closedown of a Manufacturer

10.1 Where a manufacturer closes down and the manufacturing authorisation is surrendered, re-voked, or ceases to exist, it is probable that many unexpired batches of medicinal products manufac-tured by that manufacturer remain on the market. In order for those batches to remain on the market, the manufacturer should make detailed arrangements for transfer of reference and retention samples (and relevant GMP documentation) to an authorised storage site. The manufacturer should satisfy the Competent Authority that the arrangements for storage are satisfactory and that the samples can, if necessary, be readily accessed and analysed.

10.2 If the manufacturer is not in a position to make the necessary arrangements this may be dele-gated to another manufacturer. The Marketing Authorisation holder (MAH) is responsible for such delegation and for the provision of all necessary information to the Competent Authority. In addition, the MAH should, in relation to the suitability of the proposed arrangements for storage of reference and retention samples, consult with the competent authority of each Member State in which any unex-pired batch has been placed on the market.

10. 3 These requirements apply also in the event of the closedown of a manufacture located outside the EEA. In such instances, the importer has a particular responsibility to ensure that satisfactory ar-rangements are put in place and that the competent authority/authorities is/are consulted.