AspekAspek HukumHukum PelayananPelayananFarmasiFarmasi

didi RumahRumah SakitSakit

Drs H. Amir Hamzah Pane, Apt, SH, MH, MM*Medan, 16 April 2011

(*):- Koordinator Penasihat Hukum Tim Penanganan dan Pertimbangan MasalahHukum Tertentu Kementerian Kesehatan RI

- Dewan Pengawas RSKD Dharmais (2007-2011)- Dewan Pengawas RSUP Dr Soeradji Tirtonegoro, Klaten, Jawa Tengah (2011-2016)- Dewan Penasihat Pengurus Pusat Ikatan Apoteker Indonesia (IAI) 2009-2013- Advokat pada AHP Law Office: Health and Pharmaceutical Counselor at Law

2010-04-19 1Seminar Hisfarsi, MedanWebsite:www.amirhamzahpane.com

HAK DASAR DIBIDANG KESEHATAN

SOSIAL

The Rightto Health Care

INDIVIDU

Hak atas

The Rightof Self Determination

Hak atas Hak atas

H A M

KONSTITUSI

Hak atasPelayanan Medis

Hak atasPrivacy

Hak atasBadan Sendiri

Hak atasRahasia Kedokteran

Hak atasInformed Consent

Hak Memilih Dokter/Rumah Sakit

Hak Menolak Perawatan/Tindakan Medik

UNDANG2

UU KES UU RS UU LAIN

2010-04-192 Seminar Hisfarsi, Medan

PELAYANAN FARMASI DI RUMAH SAKIT

UU NO. 36Thn 2009Tentang Kesehatan UU NO. 44Thn 2009Tentang Rumah Sakit

Pasal 30 s/d 35:Fasilitas Pelayanan Kesehatan

Pasal 7 (1):Syarat Rumah Sakit

Pasal 98 s/d 108:Pengamanan dan PenggunaanSediaan Farmasi dan Alat Kesehatan

Pasal 15:Kefarmasian

PP 51Thn 2009TentangPEKERJAAN KEFARMASIAN

PERMENKESTentangSTANDAR PELAYANAN KEFARMASIAN

- KEPMENKES 1197/MENKES /SK/X/2004:Standar Pelayanan Farmasi di RS

- Rancangan Standar Pelayanan Kefarmasian(Sedang Disusun) 2010-04-193 Seminar Hisfarsi, Medan

STANDAR PROFESI

STANDAR PRAKTIK

GMP

GDP

APOTIK

INSTALASIFARMASI RS

Pasal 19 PP 51 Th. 2009

STANDAR PRAKTIK

STANDAR PROSEDUROPERASIONAL

GPP

GLP

PUSKESMAS

TOKO OBAT

PRAKTEKBERSAMA

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UPAYAKESEHATAN

MASSAL INDIVIDUAL

KEGIATAN

PELAYANAN PELAYANAN

KEDOKTERAN

KEFARMASIAN

KEPERAWATAN

KEBIDANAN

KEDOKTERAN

KEFARMASIAN

KEPERAWATAN

KEBIDANAN

2010-04-19 5Seminar Hisfarsi, Medan

PEKERJAANKEFARMASIAN

PRAKTIKKEFARMASIAN

STANDARPROFESI

STANDARPRAKTIK

STANDARPROSEDUR

OPERASIONAL

PHARMACEUTICALCARE

PELAYANANKEFARMASIAN

PASIENTENAGA

KESEHATANLAIN

MASYARAKAT

KOMODITI ORANGNYA

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TUGAS APOTEKER:PHARMACEUTICAL CARE OR PHARMACEUTICAL SERVICE?

-The Idea of Professional care goes beyond the idea of profesional service-While both refer to action, care adds a dimensions of concern and commitmen(Charles D Hepler, David M Angaran)

Pemahaman yang tepat antara “Care” dan “Service” mempunyai implikasiterhadap “niat” (intention) dalam melaksanakan Pekerjaan Kefarmasian,

Pelayanan Kefarmasian dan Praktik Kefarmasian

Pharmaceutical Service:An occupation that distributesdrug products with“business functionsauxiliary to ……distribution”

Pharmaceutical Care:An occupation that provides care,with drug products auxiliary to care

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PHARMACEUTICAL CARE

PEKERJAAN KEFARMASIAN:Pembuatan termasuk pengendalian mutu sediaan farmasi, pengamanan, pengadaan,penyimpanan dan pendistribusian atau penyaluran obat, pengelolaan obat, pelayananobat atas resep dokter, pelayanan informasi obat, serta pengembangan obat,bahan obat dan obat tradisional

PENGERTIAN YANG HARUS DILURUSKAN

PELAYANAN KEFARMASIAN:Suatu pelayanan langsung dan bertanggung jawab kepada pasien yang berkaitan dengansediaan farmasi dengan maksud mencapai hasil yang pasti untuk meningkatkanmutu kehidupan pasien(Bandingkan dengan defenisi Pharmaceutical Care oleh Hepler and Starnd, 1989:“Responsible provision of drug therapy for the purpose of achieving definite outcomeintended to improve a patient’s quality of life”)

PRAKTIK KEFARMASIAN:Pekerjaan dan atau pelayanan kefarmasian yang dilakukan oleh tenaga kefarmasiandi fasilitas kesehatan, fasilitas kefarmasian, fasilitas produksi, fasilitas distribusi,dan di fasilitas sarana pelayanan kefarmasian

2010-04-19 8Seminar Hisfarsi, Medan

POTENSI TERJADINYA PHARMACEUTICAL MALPRACTICEDI RUMAH SAKIT

PEKERJAANKEFARMASIAN

Manajerial

Teknis

- Professional misconduct- Wrongdoing- Neglect of duty

MALPRACTICE

HUKUM

ETIK

Pendidikan

LatihanParadigma Pharmaceutical care

Latihan

Kompetensi

Pengetahuan

Registrasi

Lisensi/Sertifikasi

Paradigma Pharmaceutical caredan Standar Profesi

Standar Pelayanan Farmasidi Rumah Sakit

Penyelenggaraan PekerjaanKefarmasian di Rumah Sakit

HUKUM

Etika Disiplin Peraturan

Administrasi

Pidana

Perdata

Dimensi Pelaku Dimensi Perbuatan Dimensi Akibat

1

2 3 4

5

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THE MOST COMMONCATEGORIES OF ERRORS AND OMISSIONS

Sumber : Pharmacists Mutual claims study, 2000.2010-04-19 10Seminar Hisfarsi, Medan

MAJOR TYPES OF DRUG RELATED PROBLEM- Needing pharmacotherapy but not receiving it (a drug indication)- Taking or receiving the wrong drug- Taking or receiving too little of the correct drug- Taking or receiving too much of the correct drug- Experiencing an adverse drug reaction- Experiencing a drug-drug; drug-food; or drug-laboratory interaction

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- Experiencing a drug-drug; drug-food; or drug-laboratory interaction- Not taking or receiving the drug prescribed- Taking or receiving a drug for which there is no valid medical indication(Strand, L.M, R.J Cipolle, and P.C Morley, “Pharmaceutical care: Introduction”)

Distribution of Adverse Drugs Events

Table. How Wrong Patient MedicationErrors Occur

Order written in correct chart, but order sheetsOrder written in correct chart, but order sheetshave the wrong name stamphave the wrong name stamp

TranscriptionTranscription

Order written in the wrong chart (or entered intoOrder written in the wrong chart (or entered intothe wrong computerized record)the wrong computerized record)

OrderingOrdering

Example ErrorExample ErrorStage at WhichStage at WhichError Is IntroducedError Is Introduced

Figure.Distribution of Adverse Drug EventsAccording to the Stage of the Error in theMedication Process

PROBLEMS OF PHARMACY SERVICE

Nurse helping out a colleague: “Mr. Smith needsNurse helping out a colleague: “Mr. Smith needshis Haldol; can you give it to him, while I takehis Haldol; can you give it to him, while I takecare of Ms. Jones?”care of Ms. Jones?”

AdministrationAdministration

Pharmacist distracted during order entry byPharmacist distracted during order entry byphone call about another patient; resumes orderphone call about another patient; resumes orderentry with the wrong computer record open, soentry with the wrong computer record open, sothat medication becomes part of the pharmacythat medication becomes part of the pharmacyorder record for the wrong patientorder record for the wrong patient

DispensingDispensing

Order correctly written, but transcribed to wrongOrder correctly written, but transcribed to wrongMedication Administration Record (MAR) for anyMedication Administration Record (MAR) for anyof a variety of reasonsof a variety of reasons

TranscriptionTranscription

have the wrong name stamphave the wrong name stamp

Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events andpotential adverse drug events. Implications for prevention. ADE PreventionStudy Group. JAMA. 1995;274:29-34.

ZyloricZyloric//AllopurinolAllopurinol

DoxorubicinDoxorubicin

ChlorpheniraminChlorpheniramin

CarboplatinCarboplatin

Wrong LabelWrong LabelSalahSalah KemasKemas ObatObat(entry(entry benarbenar))

Wrong DrugWrong DrugDaunoribicinDaunoribicinSalahSalah Entry/BacaEntry/Baca

Wrong DrugWrong DrugChloramphenicolChloramphenicolSalah BacaSalah Baca

Wrong DrugWrong DrugCisplatinCisplatinSalahSalah Entry/BacaEntry/Baca

BentukBentukKesalahanKesalahan

ContohContohTranscribing/Transcribing/dispensing errordispensing error

WrongWrong Dose &Dose &andandadministrationadministration

BisolvonBisolvon

Nama adikNama adik

Nairet/TerbutalinNairet/Terbutalin

PanadolPanadol

Elixir 4mg/5mlElixir 4mg/5ml

100 mg100 mg

Wrong DrugWrong DrugNalget/Metampiron&Nalget/Metampiron&VitVit B1,6,12B1,6,12

Salah baca resepSalah baca resep

Wrong LabelWrong LabelNama kakakNama kakakSalah Etiket resepSalah Etiket resep

Wrong LabelWrong LabelAntibiotikAntibiotikSalah label obatSalah label obat

SolSol 10 mg/5ml10 mg/5ml

Salah Dosis danSalah Dosis danBentuk SediaanBentuk Sediaan

300 mg300 mg(entry(entry benarbenar))

ASPEK HUKUMPHARMACEUTICAL MALPRACTICEDI RUMAH SAKIT

PIDANA

PERDATA

Menyimpang dariStandar Profesi

Kesalahan(359 KUHP)

Culpa Lata

Culpa Levis

Menyimpang dariStandar Profesi

Adanya kelalaian

DI RUMAH SAKIT

ADMINISTRASI

Adanya kausalitasantara kerugian dgnkelalaian yg dilakukan

UNSUR STANDAR PROFESI-Berbuat secara teliti-Sesuai ukuran keilmuan-Kemampuan rata-rata dg kategori keahlianyg sama

-Situasi dan kondisi yang sama-Sarana dan upaya yang sebanding danproporsional dgn tujuan konkrit pekerjaankefarmasian yang dilakukan2010-04-19 14Seminar Hisfarsi, Medan

TANGGUNG JAWAB HUKUMRUMAH SAKIT

PERDATA

Rumah sakit bertanggung jawabsecara perdata thd semua kegiatanyang dilakukan oleh tenaga kesehatannya(Psl 1367 ayat3 KUHPerdata)

UU 36/ 2009 ttg Kesehatan:Psl 58

UU 44/ 2009 ttg Rumah Sakit:Psl 46

(Psl 1367 ayat3 KUHPerdata)

Wan Prestasi(Psl 1243, 1370, 1371 KUHPerdata)

Perbuatan Melawan Hukum(Psl 1365 KUHPerdata)

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MASALAH AKTUAL KEFARMASIAN YANG DIHADAPI RS

APAKAH INSTALASI FARMASI DI RS SUDAH MENERAPKAN SISTEM SATU PINTU?(Psl 15 ayat 3 UU No. 44 Thn 2009 tentang Rumah Sakit)

APAKAH PENGADAAN BARANG DAN JASA DI RS (PEMERINTAH) SUDAHMENGIKUTI KETENTUAN PENGADAAN BARANG DAN JASA SEKTOR PEMERINTAH?

(PERPRES 54 Thn 2010 tentang Pengadaan Barang dan Jasa sektor Pemerintah)

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(PERPRES 54 Thn 2010 tentang Pengadaan Barang dan Jasa sektor Pemerintah)

APAKAH TRANSPARANSI HARGA OBAT DI RS SUDAH DAPAT DIAKSES OLEH PASIEN?(Psl 15 ayat 4 UU No. 44 Thn 2009 tentang Rumah Sakit)

APAKAH PELAYANAN SEDIAAN FARMASI DI RUMAH SAKIT SUDAH MENGIKUTISTANDAR PELAYANAN KEFARMASIAN TERKINI?

(Psl 15 ayat 2 UU No. 44 Thn 2009 tentang Rumah Sakit)

KESIMPULAN• Risiko Pharmaceutical Malpractice di rumah sakit

dapat diperkecil jika seluruh tenaga kefarmasianyang melakukan pekerjaan kefarmasian selalumengacu pada: Standar Profesi, Standar Pelayanandan Standar Prosedur Operasional

• RS harus menetapkan standar pelayanan farmasi dirumah sakit sesuai dengan tantangan dankebutuhan yang ada saat inikebutuhan yang ada saat ini

• RS harus menyusun dan melaksanakan Hospital bylaws, Corporate by laws, Pharmaceutical staff by lawyang mengatur tentang kewenangan pekerjaankefarmasian (tindakan kefarmasian) bagi apoteker

• Terapkan Good Pharmaceutical Governance

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The pharmacist maintains control over all pharmacy activities. The ultimateresponsibility rests with the licensed pharmacist

2010-04-19 18Seminar Hisfarsi, Medan

Visit:www.amirhamzahpane.com