TEKS SOEMPAH PEMOEDA 1928

Formularium

Obat merupakan salah satu komponen yang memberikan andil cukup besar dalam peningkatan biaya. Kondisi ini didukung oleh persaingan ketat sekitar 200 pabrik farmasi dan 18.000 obat yang terdaftar di Indonesia. Norwegia, Australia, Inggris dan banyak Uni Eropa umumnya hanya memiliki beberapa ribu item obat. Kondisi demikian perlu disikapi dengan menerapkan prinsip kehati-hatian dan mengutamakan efisiensi. Keragaman merek serta sediaan obat memberikan pilihan luas kepada konsumen namun disisi lain hal ini menciptakan peluang terjadinya ineffisiensi. Kecenderungan inefisiensi tersebut dapat disebabkan oleh berbagai faktor seperti kolusi antara dokter dan perusahaan farmasi, persaingan harga yang tidak rasional, dan penyalahgunaan sehingga menimbulkan dampak siknifikan pada biaya dan kualitas serta keamanan pengobatan. Kondisi ini jelas bertentangan dengan prinsip kendali mutu dan biaya.[1]

Harus dicari cara agar pelayanan kesehatan menjadi lebih efisien dan ekonomis. Perkembangan farmakoepidemiologi saat ini tidak hanya meneliti penggunaan dan efek obat dalam hal khasiat dan keamanan saja, tetapi juga menganalisis dari segi ekonominya. Farmakoekonomi adalah studi yang mengukur dan membandingkan antara biaya dan hasil atau konsekuensi dari suatu pengobatan, tujuannya adalah memberikan informasi yang dapat membantu para pembuat kebijakan dalam menentukan pilihan atas alternatif-alternatif pengobatan yang tersedia agar pelayanan kesehatan menjadi lebih efisien dan ekonomis.[2]

Prinsip mendasar pelayanan obat adalah harus dilakukan secara bermutu dengan biaya rasional. Untuk tujuan tersebut ditetapkan formularium atau daftar obat standar, yaitu daftar produk obat-obatan yang dapat digunakan dimana obat-obatan tersebut telah terseleksi dan terbukti memiliki tingkat keamanan berdasarkan hasil uji klinis. Formularium seyogyanya menjadi panduan penulisan resep dan pemberian obat, telah memenuhi aspek-aspek akuntabilitas, reabilitas serta validitas yang diperlukan dalam melaksanakan pelayanan kesehatan yang bermutu dan rasional.

Dalam formularium ditetapkan posisi obat apakah termasuk kelompok eksklusif, tidak dianjurkan atau netral. Apakah obat termasuk kelompok yang hanya dapat diresepkan oleh spesialis tertentu saja, atau yang hanya dapat digunakan untuk kondisi tertentu dan dokter harus menentukan indikasi peresepan. Contohnya adalah penggunaaan PPI (proton pump-inhbitor) pada kasus GERD hanya bila H2 blocker tidak berhasil. Formularium menetapkan obat yang menjadi subyek step-care protocol, yaitu obat hanya digunakan bila telah mencoba obat yang lebih aman dan dianjurkan, umumnya lebih murah, dan obat-obat subyek preotorisasi yang perlu persetujuan lebih dulu. Berikut adalah contoh panduan di formularium untuk pemilihan obat pada kondisi medis infeksi sinus akut.

Example of Provider-Directed Formulary
Medical Condition: ACUTE SINUSITIS[3]

First Line Agents (10 day regimen)(initial/uncomplicated acute sinusitis)
Target organisms: S. pneumoniae; H. influenzae; Gram-negative organisms
Oral Antimicrobial Management (single agent):

• Amoxacillin: 500 mg-PO TID
• Trimethoprim/Sulfamethoxazole: TMP component = 5-10 mg/kg/day-PO divided q12h
• Erythromycin/Sulfisoxazole:400 mg/1200 mg-PO BID

Symptomatic Management:

• + Pseudoephedrine 30 mg-PO q8h pm stuffy nose
• +/- Chlorpheniramine 4 mg-PO q6h pm allergy symptoms
• +/- Guaifenesin (Robitussin): 400 mg-0PO q6h pm excess phlegm
• +/- Oxymetolazone (Afrin): 1-2 sprays each nostril BID (NTE 3 days)
• (oral decongestants are preferred)

If failed therapy or considered complicated sinusitis

Second Line Agents (10-14 day regimen) (repeat RX/complicated sinusitis)
Target organisms: S. pneumoniae (PCN-resistance); H. influenzae (+ B-lactamase); resistant gram-negative organisms
Oral Antimicrobial Management (single agent):

• Amoxicillin/clavulanate: 875 mg-PO BID
• Cefpodoxime Proxetil: 200 mg -PO BID
• Clarithromycin: 500 mg-PO BID
• Azithromycin: 500 mg-PO X 1 dose then 250 mg-PO QD
• Levofloxacin: 500 mg-PO BID

Symptomatic Management:

• + Pseudoephedrine 30 mg-PO q8h pm stuffy nose
• +/- Chlorpheniramine 4 mg-PO q6h pm allergy symptoms
• +/- Guaifenesin: 400 mg-0PO q6h pm excess phlegm
• +/- Oxymetolazone: 1-2 sprays each nostril BID (NTE 3 days)
• (oral decongestants are preferred)

Sistem formularium yang disusun dan diterapkan secara benar dapat mendorong pengobatan yang rasional, aman, memadai secara klinis, dan efektif-biaya. Dalam formularium terdapat prinsip pedoman menerapkan formularium secara benar guna pelayanan pasien. Pedoman tersebut perlu diperiksa secara cermat agar tidak ada yang kurang. Kesepakatan atas prinsip-prinsip sistem formularium dapat membantu pembuat keputusan yang harus menyeimbangkan antara kualitas pelayanan dan biaya. Lebih lanjut, prinsip-prinsip panduan merupakan alat edukasi bagi banyak pihak, para pembuat kebijakan lokal maupun nasional, administrator pelayanan kesehatan, para praktisi medis, pengusaha sebagai pembayar atau pembayar pihak ketiga, dan konsumen maupun perwaliannya. Semua pihak ini berkepentingan pada rancangan sistem formularium yang dapat menjamin pasien dapat memperoleh pengobatan yang rasional, memadai secara klinis, aman, dan efektif-biaya, dan dapat mendukung ketersediaan dan kesinambungan program manfaat obat.[4]

Penyusunan formularium PT Askes (Persero) dilakukan oleh tim independen yang terdiri dari para pakar dibidang obat-obatan, perwakilan dokter spesialis dari berbagai disiplin ilmu kedokteran dari rumah sakit rujukan nasional, para akademisi dari berbagai universitas di Indonesia. Selain itu tim juga melibatkan perwakilan pihak regulator yakni Kementerian Kesehatan dan Badan POM. Tim tesebut diketuai oleh Prof. Iwan Darmansjah, SpFK. “Tim yang terdiri berbagai ahli di bidangnya tidak terpengaruh apapun. Sama sekali tidak ada intervensi, baik dari penyelenggara maupun pabrikan. Kami tidak bisa disuap,” paparnya. [5]

Formularium perlu disusun secara seksama dan dilengkapi dengan prinsip-prinsip pedoman yang jelas, kemudian seyogyanya dapat diterapkan secara benar oleh para pengambil keputusan dalam perencanaan pengadaan obat, termasuk para praktisi medis. Dijumpainya fenomena cenderung inefisien dalam transaksi pengadaan dan/atau peresepan obat mencerminkan integritas dalam penyelenggaraan pelayanan kesehatan. Bila dijumpai penyimpangan, alih-alih bertanggungjawab untuk memberikan penjelasan dan menunjukkan komitmen sesuai pakta integritas, formularium bisa menjadi salah satu kambing hitam.

Berikut adalah contoh prinsip-prinsip pedoman dalam sistem formularium di Amerika Serikat yang digunakan oleh institusi sebagai berikut: Academy of Managed Care Pharmacy, Alliance of Community Health Plans, American Medical Association, American Society of Health-System Pharmacists, Department of Veterans Affairs, Pharmacy Benefits Management Strategic Healthcare Group, National Business Coalition on Health, dan U.S. Pharmacopeia.

Formulary System Guiding Principles[6]

Formulary system decisions are based on scientific and economic considerations that achieve appropriate, safe, and cost-effective drug therapy.

Clinical decisions are based on the strength of scientific evidence and standards of practice that include, but are not limited, to the following:

• Assessing peer-reviewed medical literature, including randomized clinical trials (especially drug comparison studies), pharmacoeconomic studies, and outcomes research data.
• Employing published practice guidelines, developed by an acceptable evidence-based process.
• Comparing the efficacy as well as the type and frequency of side effects and potential drug interactions among alternative drug products.
• Assessing the likely impact of a drug product on patient compliance when compared to alternative products.
• Basing formulary system decisions on a thorough evaluation of the benefits, risks, and potential outcomes for patients; risks encompass adverse drug events (adverse drug reactions and medication errors, such as those caused by confusing product names or labels).

Economic considerations include, but are not limited, to the following:

• Basing formulary system decisions on cost factors only after the safety, efficacy, and therapeutic need have been established.
• Evaluating drug products and therapies in terms of their impact on total health care costs.
• Permitting financial incentives only when they promote cost management as part of the delivery of quality medical care. Financial incentives or pressures on practitioners that may interfere with the delivery of medically necessary care are unacceptable.

The formulary system encompasses drug selection, drug utilization review, and other tools to foster best practices in prescribing, dispensing, administration, and monitoring of outcomes.

The formulary system:

• Provides drug product selection and formulary maintenance (see above).
• Provides drug use evaluation (also called drug utilization review) to enhance quality of care for patients by assuring appropriate drug therapy.
• Provides for the periodic evaluation and analysis of treatment protocols and procedures to ensure that they are up-to-date and are consistent with optimum therapeutics.
• Provides for the monitoring, reporting, and analysis of adverse results of drug therapy (e.g., adverse drug reactions, medication errors) to continuously improve the quality of care.

The Pharmacy and Therapeutics (P&T) Committee, or equivalent body, comprised of actively practicing physicians, pharmacists, and other health care professionals, is the mechanism for administering the formulary system, which includes developing and maintaining the formulary and establishing and implementing policies on the use of drug products.

The Pharmacy and Therapeutics Committee:

• Objectively appraises, evaluates, and selects drugs for the formulary.
• Meets as frequently as is necessary to review and update the appropriateness of the formulary system in light of new drugs and new indications, uses, or warnings affecting existing drugs.
• Establishes policies and procedures to educate and inform health care providers about drug products, usage, and committee decisions.
• Oversees quality improvement programs that employ drug use evaluation.
• Implements generic substitution and therapeutic interchange programs that authorize exchange of therapeutic alternatives based upon written guidelines or protocols within a formulary system. (Note: Therapeutic substitution, the dispensing of therapeutic alternates without the prescriber’s approval, is illegal and should not be allowed.)
• Develops protocols and procedures for the use of and access to non-formulary drug products.
• Physicians, pharmacists, and other health care professionals provide oversight of the formulary system.
• Health care organization policies should ensure appropriate oversight of the P&T Committee and its decisions by the medical staff or equivalent body.

The formulary system must have its own policies, or adhere to other organizational policies, that address conflicts of interest and disclosure by P&T committee members.

Formulary system policies should:

• Require P&T committee members to reveal, by signing a conflict of interest statement, economic and other relationships with pharmaceutical entities that could influence Committee decisions.
• Exclude product sponsor representatives from P&T committee membership and from attending P&T committee meetings.
• Require P&T committee members to adhere to the formulary system’s policy on disclosure and participation in discussion as it relates to conflict of interest.

The formulary system should include educational programs for payers, practitioners, and patients concerning their roles and responsibilities.

The formulary system should:

• Inform physicians, pharmacists, other health care professionals, patients, and payers about the factors that affect formulary system decisions, including cost containment measures; the procedures for obtaining non-formulary drugs; and the importance of formulary compliance to improving quality of care and restraining health care costs.
• Proactively inform practitioners about changes to the formulary or to other pharmaceutical management procedures.
• Provide patient education programs that explain how formulary decisions are made and the roles and responsibilities of the patient, especially the importance of patient compliance with drug therapy to assure the success of that therapy.
• Disclose the existence of formularies and have copies of the formulary readily available and accessible.
• Provide rationale for specific formulary decisions when requested.

The formulary system should include a well-defined process for the physician or other prescriber to use a non-formulary drug when medically indicated.

The formulary system should:

• Enable individual patient needs to be met with non-formulary drug products when demonstrated to be clinically justified by the physician or other prescriber.
• Institute an efficient process for the timely procurement of non-formulary drug products and mpose minimal administrative burdens.
• Provide access to a formal appeal process if a request for a non-formulary drug is denied.
• Include policies that state that practitioners should not be penalized for prescribing non-formulary drug products that are medically necessary.

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[1] Umbu M. Marisi, Direktur Operasional PT Askes (Persero); Maya A. Rusady, Kepala Divisi Jaminan Pelayanan Kesehatan PT Askes (Persero). FOKUS. Buletin Info ASKES Edisi September 2010.

[2] Prof. dr. Iwan Dwi Prahasto. FOKUS. Buletin Info ASKES Edisi September 2010.

[3] Alan Silverman, MD, FACP. Development of Drug Formularies. Proceedings of UCLA Healthcare - Fall 2000, Vol. 4,No. 3 http://www.med.ucla.edu/modules/wfsection/article.php?articleid=134 (Retrieved: March 18, 2011)

[4] American Society of Health-System Pharmacists Board of Directors | June 4, 2000. Principles of a Sound Drug Formulary System. The endorsement of this document was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate http://www.ashp.org/DocLibrary/BestPractices/FormEndPrinciples.aspx (Retrieved: April 30, 2011)

[5] Prof. Iwan Darmansjah, SpFK. FOKUS. Buletin Info ASKES Edisi September 2010.

[6] American Society of Health-System Pharmacists Board of Directors | June 4, 2000. Principles of a Sound Drug Formulary System. The endorsement of this document was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriatehttp://www.ashp.org/DocLibrary/BestPractices/FormEndPrinciples.aspx (Retrieved: April 30, 2011)