RENCANA PROGRAM DAN KEGIATAN PEMBELAJARAN SEMESTER
MATA KULIAH FARMASI RUMAH SAKIT
Oleh Hansen Nasif, S.Si., Apt., Sp.FRS Drs Yufri Aldi, MS, Apt Dr. Dedy Almasdy, Apt
Fakultas Farmasi Universitas Andalas Padang 2012
A. PERENCANAAN PEMBELAJARAN 1. Nama Mata Kuliah : Farmasi Rumah Sakit 2. Kode Mata kuliah : FAR 462 3. SKS :2 4. Sifat : Wajib 5. Prasyarat :6. Semester : VIII 7. Perkiraan banyaknya peserta : 120 mhs 8. Deskripsi singkat mata kuliah Farmasi Rumah Sakit: Mata kuliah ini akan membahas tentang konsep Farmasi Rumah Sakit , sejarah dan perkembangan, fungsi-fungsi serta penerapan dilapangan dalam praktek kefarmasian di rumah sakit sesuai standar pelayanan farmasi No.1197 tahun 2004 di Indonesia 9. Tujuan Pembelajaran: Tujuan pembelajaran Farmasi Klinik adalah mahasiswa memahami dan menguasai konsep kefarmasian rumah sakit, sejarah dan perkembangan, fungsi-fungsi serta penerapan dilapangan dalam praktek kefarmasian di rumah sakit pengertian farmasi klinik dan kegiatan-kegiatannya. 10. Tujuan Pembelajaran khusus Setelah mengikuti perkuliahan ini, mahasiswa diharapkan dapat : 1. Mengetahui perkembangan pelayanan farmasi rumah sakit di Indonesia dan dunia 2. Memahami macam-macam kegiatan pelayanan farmasi rumah sakit B. PELAKSANAAN PEMBELAJARAN Minggu ke (1)
Topik (Pokok Bahasan) (2) Perumahsakitan di Indonesia
Substansi Materi
1
Instalasi farmasi
2
Komite Farmasi dan Terapi 3
(3) Definisi Rumah sakit Pembagian / klasifikasi Rumah Sakit di Indonesia Pelayanan Rumah Sakit Pelayanan Farmasi Rumah Sakit saat ini Pelayanan unggulan farmasi di rumah sakit Bagian dan Instalasi di Rumah sakit Instalasi Farmasi Tugas dan fungsi instalasi farmasi Pelayanan Instalasi farmasi Dasar Komite farmasi dan terapi Fungsi Komite farmasi dan terapi Kegiatan komite farmasi dan terapi
Metode Pembelajaran (4) Ceramah, Tanya jawab
Fasilitas (5) Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Ket (6)
Formularium Rumah Sakit
4
5
Pelayanan farmasi jalan
rawat
6
Pelayanan farmasi inap
rawat
Produksi Instalasi farmasi
7
8
Pelayan medis
gas
IV admixture
9
Pelayanan sitostatika
10
Peran farmasi dalam komite farmasi dan terapi. Batasan formularium rumah sakit Fungsi Formularium rumah sakit Peran farmasi dalam pembuatan formularium rumah sakit Proses pembuatannya Proses pemilihan obat Obat Esensial Pelayanan poliklinik Pelayanan obat dari poliklinik Sisitim apotik sentral rawat jalan Pemberian informasi untuk kepatuhan pasien Pelayanan rawat inap Sistim pelayanan farmasi untuk pasien rawat inap Keuntungan dan kerugian sistim sentral Keuntungan dan kerugian sistim satelit farmasi Peredaran obat di rumah sakit Obat- obat khusus di rumah sakit Dasar- dasar produksi instalasi farmasi Tujuan produksi farmasi Contoh Produksi farmasi dan alasannya Macam-macam gas Gas medis dan non medis Profil beberapa gas medis Penggunaan gas medis Bahaya gas medis Obat intravena Tujuan pemberian obat intravena Macam-macam pemberian obat intra vena Tujuan pencampuran obat intravena Teknik pencampuran obat intravena Obat sitostatika Bentuk pemberian obat sitostika Dasar pemberian obat sitostatika Teknik penyiapan obat sitostatika Keamanan pemberian obat sitostatika Solusi permasaalahan pada pemberian sitostatika
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Kepatuhan pasien 11 Konseling pasien
Definisi kepatuhan pasien Tujuan intervensi dalam kepatuhan pasien Jenis kepatuhan pasien Hal yang dilakukan untuk meningkatkan kepatuhan pasien. Dasar pemberian konseling Tujuan konseling Informasi yang harus diberikan dalam konseling Prinsip menjawab pertanyaan dalam suatu konseling
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
Dasar pemberian informasi obat Tujuan pemberian informasi obat Macam-macam bentuk pemberian informasi obat Teknik pemberian informasi obat Pelayanan farmasi di ruangan Permasalahan obat yang dialami pasien Analisis permasaalahan obat pasien Teknik intervensi pada farmasi worksheet Pemberian Rekomendasi farmasi
Persentasi, diskusi
Laptop, LCD viewer
Persentasi, diskusi
Laptop, LCD viewer
12 Pelayanan Informasi Obat
13 Rekomendasi dan Intervensi farmasi 14
2. Metode pembelajaran dan bentuk kegiatan Perkuliahan diberikan dalam bentuk penjelasan oleh dosen di depan kelas dengan berbagai alat bantu seperti LCD viewer, Laptop, dan white board. Selain itu juga diterapkan casebased learning di mana dipresentasikan berbagai contoh kasus untuk dibahas di dalam kelas. C. PERENCANAAN EVALUASI PEMBELAJARAN 1. Hasil pembelajaran Kriteria penilaian mengacu pada beberapa kriteria berikut ini : - mahasiswa dapat memahami prinsip-prinsip dalam materi perkuliahan Farmasi Rumah Sakit, dan menjelaskan kembali materi perkuliahan tersebut, - kemampuan mahasiswa menganalisis dan mempresentasikan kasusnya di depan kelas Penilaian tersebut akan dilakukan melalui ujian tertulis dan aktivitas diskusi. Ujian tertulis dilakukan pada akhir semester. Adapun prosentase unsur penilaian dan kriterianya adalah sbb:
Unsur - unsur Tugas
Persentase ( %) 15
Quiz Ujian tengah Semester Ujian Semester Total
15 20 50 100
- Kriteria penilaian untuk mata kuliah ini sesuai dengan yang berlaku pada universitas andalas yaitu dari yang terendah nilai E sampai yang tertinggi nilai A+ 2. Evalusi Proses pembelajaran dari mahasiswa Untuk mendapatkan masukan dari mahasiwa mengenai keseluruhan proses pembelajaran, akan dibagikan kuesioner yang berupa SKALA KEPUASAN MENGAJAR.
D. DAFTAR PUSTAKA 1.
Direktorat Jenderal Pelayanan Kefarmasian dan Alat Kesehatan Departemen Kesehatan R. I. , Standar Pelayanan Farmasi di Rumah Sakit., Jakarta, 2004
2. Universitas Surabaya., Farmasi Klinis Menuju Pengobatan Rasional dan Penghargaan Pilihan Pasien (Clinical Pharmacy) , Gramedia, Jakarta, 2003. 3. Siregar, Charles J. P., Farmasi Klinik Teori & Penerapan., ECG, Jakarta, 2005. 4. American Society of Hospital Pharmacists,. Basic Skill in Clinical Pharmacy Practice,. Universal Printing and Publishing, North Carolina, 1983. 5. Cipolle, R. J. et al., Pharmaceutical Care Practice., McGraw-Hill, New York, 1998. 6.
Rovers, J. P. et al. Second edition., A Practical Guide to Pharmaceutical Care., WHO, Washington, D. C. , 2003.
7. Ikatan Sarjana Farmasi Indonesia., Standar Kompetensi Farmasis Indonesia. Jakarta, 2004.
KONTRAK PERKULIAHAN Nama Mata Kuliah Kode Mata kuliah Pengajar
SKS Semester Hari Pertemuan/Jam Ruang Kuliah
: Farmasi Rumah Sakit : PAF 462 : Hansen Nasif, S.Si., Apt., Sp.FRS Yelli Oktavia Sari, S.Si., M.Pharm, Apt. Dedi Almasdy, S.Si., M.Si, Apt. :2 : VIII : Senin/ 08.00-09.40 : Lokal C
1.Manfaat Mata Kuliah Mata kuliah ini diberikan pada mahasiswa agar dapat memahami dan menguasai konsep kefarmasian rumah sakit, sejarah dan perkembangan, fungsi-fungsi serta penerapan dilapangan dalam praktek kefarmasian di rumah sakit, pengertian farmasi klinik dan kegiatan-kegiatannya. 2. Deskripsi Perkuliahan Mata kuliah ini mempelajari mengenai tentang konsep Farmasi Rumah Sakit , sejarah dan perkembangan, fungsi-fungsi serta penerapan dilapangan dalam praktek kefarmasian di rumah sakit sesuai standar pelayanan farmasi No.1197 tahun 2004 di Indonesia 3. Tujuan Instruksional Setelah mengikuti perkuliahan ini, mahasiswa diharapkan dapat Mengetahui perkembangan pelayanan farmasi rumah sakit di Indonesia dan dunia Memahami macam-macam kegiatan pelayanan farmasi rumah sakit 4. Organisasi Materi Organisasi materi dapat dilihat pada jadwal perkuliahan 5. Strategi Perkuliahan Strategi Instruksional yang digunakan pada mata kuliah ini terdiri dari : a. Urutan kegiatan instruksional berupa : Pendahuluan (TIU dan TIK, cakupan materi pokok bahasan, dan relevansi ), penyajian ( uraian,contoh, diskusi , evaluasi ) dan penutup ( umpan balik, ringkasan materi, petunjuk tindak lanjut, pemberian tugas di rumah, gambaran singkat tetang materi berikutnya ) b. Metode Instruksional menggunakan : metode ceramah, demonstrasi, tanya-jawab, diskusi kasus dan penugasan
1. Ceramah berupa penyampaian bahan ajar oleh dosen pengajar dan penekanan-penekanan pada hal-hal yang penting dan bermanfaat untuk diterapkan 2. Tanya jawab dilakukan sepanjang tatap muka dengan memberikan kesempatan mahasiswa untuk memberikan pendapat atau pertanyaan tentang hal-hal yang tidak mereka mengerti atau bertentangan dengan yang mereka pahami sebelumnya. 3. Diskusi kasus dilakukan dengan memberikan contoh kasus/kondisi pada akhir pokok bahasan, mengambil tema yang sedang aktual di masyarakat dan mengajak mahasiswa menganalisisnya 4. Penugasan diberikan untuk membantu mahasiswa memahami bahan ajar, membuka wawasan, dan memberikan pendalaman materi c. Media Instruksionalnya berupa LCD Projector, Laptop, spidol, Whiteboard,artikel ilmiah di surat kabar/ internet, jurnal ilmiah, handout, dan kontrak perkuliahan. D Waktu : 5 menit pada tahap pendahuluan, 40 menit pada tahap penyajian, dan 5 menit pada tahap penutup. 6. Materi/ Bacaan Perkuliahan 1.
Direktorat Jenderal Pelayanan Kefarmasian dan Alat Kesehatan Departemen Kesehatan R. I. , Standar Pelayanan Farmasi di Rumah Sakit., Jakarta, 2004
2. Universitas Surabaya., Farmasi Klinis Menuju Pengobatan Rasional dan Penghargaan Pilihan Pasien (Clinical Pharmacy) , Gramedia, Jakarta, 2003. 3. Siregar, Charles J. P., Farmasi Klinik Teori & Penerapan., ECG, Jakarta, 2005. 4. American Society of Hospital Pharmacists,. Basic Skill in Clinical Pharmacy Practice,. Universal Printing and Publishing, North Carolina, 1983. 5. Cipolle, R. J. et al., Pharmaceutical Care Practice., McGraw-Hill, New York, 1998. 6.
Rovers, J. P. et al. Second edition., A Practical Guide to Pharmaceutical Care., WHO, Washington, D. C. , 2003.
7. Ikatan Sarjana Farmasi Indonesia., Standar Kompetensi Farmasis Indonesia. Jakarta, 2004.
7. Tugas Dalam perkuliahan, diberikan beberapa tugas sebagai berikut : 1.
Materi perkuliahan sebagaimana disebutkan dalam jadwal perkuliahan harus sudah dibaca sebelum mengikutitatap muka. Apabila ada, handout sudah akan diserahkan pada mahasiswa sbelum hari kuloiah
2. Evaluasi mahasiswa dilakukan dengan mengadakan quis dengan waktu yang tidak ditentukan, ujian mid semester dan ujian semester dengan format soal essay
3. Penugasan, jika ada yang sesuai dengan pokok bahasan harus sudah diselesaikan sebelum ujian semester dimulai
8. Kriteria Penilaian Nilai Akhir
Nilai Mutu
Angka Mutu
Sebutan Mutu Sangat cemerlang
≥85-100
A
4,00
≥80<85
A-
3,50
Cemerlang
≥75<80
B+
3,25
Sangat baik
≥70<75
B
3,00
Baik
≥65<70
B-
2,75
Hampir baik
≥60<65
C+
2,25
Lebih dari cukup
≥55<60
C
2,00
Cukup
≥50<55
C-
1,75
Hampir cukup
≥40<50
D
1,00
Kurang
<40
E
0,00
Gagal
1. Pembobotan nilai adalah sebagai berikut : Unsur - unsur Tugas Quiz Ujian tengah Semester Ujian Semester Total
Persentase ( %) 15 15 20 50 100
2. Bagi mahasiswa yang sudah pernah mengikuti mata kuliah ini sebelumnya namun mengambil mata kuliah ini selanjutnya harus mengikuti perkuliahan ini seluruhnya 3. Untuk memacu kreativitas mahasiswa dan mendapatkan update dalam keilmuan ini maka semua quiz dan ujian pada mata kuliah ini, adalah open book dan dibolehkan melakukan koneksi internet.
Jadwal perkuliahan Minggu ke (1) 1 2 3 4
Topik (Pokok Bahasan) (2) Perumahsakitan di Indonesia Instalasi farmasi Komite Farmasi dan Terapi Formularium Rumah Sakit
Dosen Hansen Nasif., Hansen Nasif., Hansen Nasif., Hansen Nasif.,
(3) S.Si., Apt., S.Si., Apt., S.Si., Apt., S.Si., Apt.,
Sp.FRS Sp.FRS Sp.FRS Sp.FRS
5
Pelayanan farmasi rawat jalan
Hansen Nasif., S.Si., Apt., Sp.FRS
6 7 8 9 10
Pelayanan farmasi rawat inap Produksi Instalasi farmasi Pelayan gas medis IV admixture Pelayanan sitostatika Kepatuhan pasien
Dedi Almasdy, S.Si., M.Si, Apt. Dedi Almasdy, S.Si., M.Si, Apt. Dedi Almasdy, S.Si., M.Si, Apt. Dedi Almasdy, S.Si., M.Si, Apt. Dedi Almasdy, S.Si., M.Si, Apt. Yelli Oktavia Sari, S.Si., M.Pharm, Apt.
11 12 13 14
Konseling pasien
Yelli Oktavia Sari, S.Si., M.Pharm, Apt.
Pelayanan Informasi Obat
Yelli Oktavia Sari, S.Si., M.Pharm, Apt.
Rekomendasi dan Intervensi farmasi
Yelli Oktavia Sari, S.Si., M.Pharm, Apt.
Demikan kontrak perkuliahan ini dibuat, agar disetujui dan ditaati oleh semua pihak. Padang, 15 Desember 2011 Menyetujui, Mahasiswa
Mahasiswa
(.......................) NIM................
(.......................) NIM............... Ketua UBI Farmakologi dan Farmasi Klinik
Dr. Husni Muchtar, Apt NIP.......................................
BAHAN AJAR Drug and Therapeutics Committee The Drug and Therapeutics Committee (DTC) is an essential component of a health care organization’s drug selection, use, and distribution program. This committee has many different functions that will contribute to the goal of improving drug selection and rational drug use. This session provides an overview of the role and functions of a DTC and describes all aspects of this important committee. Many countries will spend 30 to 40 percent of their health care budgets on drugs and much of that money is wasted on irrational drug use and inefficiencies in procurement of drugs. Other serious problems that health care organizations face includes the overuse of antibiotics, increasing antimicrobial resistance, increasing adverse drug reactions, and considerably higher costs associated with drug use. DTCs can provide the leadership and structure to select appropriate drugs for the formulary, identify drug use problems, promote rational drug use, and help reduce drug costs to acceptable levels. A health care organization’s Drug and Therapeutics Committee has numerous responsibilities that, when performed successfully, will have a positive impact on health care. The overall value of the DTC is not easily measured, but many authorities agree that it is one of the most importantcomponents of a comprehensive health care system. Some of the important benefits of afunctioning DTC are— Selection of effective, safe, high-quality, and cost-effective pharmaceuticals for the formulary Improved drug use, including antimicrobial use Improved quality of patient care and outcomes Increased staff and patient knowledge
Overview Drug and Therapeutics Committee Decreased adverse drug reactions and medication errors Improved drug procurement and inventory management Control and management of drug expenditures ROLE OF THE DRUG AND THERAPEUTICS COMMITTEE The role of the DTC is to optimize rational drug use by evaluating the clinical use of drugs, developing the policies for managing drug use and drug administration, and managing the formulary system. The committee has broad responsibilities in determining what drugs will be available, at what cost, and how they will be used.
FUNCTIONS OF THE DRUG AND THERAPEUTICS COMMITTEE The functions of a DTC are numerous and may be only partially performed by many committees. The most important functions are— Advising medical, administrative, and pharmacy departments on drug related issues Developing drug policies and procedures Evaluating and selecting drugs for the formulary and providing for its periodic revision Assessing drug use to identify potential problems Promoting and conducting effective interventions to improve drug use (including educational, managerial, and regulatory methods) Managing adverse drug reactions and medication errors Advising Medical Staff, Administration, and Pharmacy The DTC is a valuable asset to the medical staff, administration, pharmacy, and other departments within the health care organization. The committee provides advisory services to these departments on all aspects of drug selection, use, and distribution. Typically, the DTC provides recommendations and advice, while the executive or medical staff committee takes action on these recommendations and implements approved decisions. There are many other departments and services that would benefit from the DTC and its advisory services. These include the nursing department, public health, Infection Control Committee, vaccination programs, and private health care sector drug management programs.
Drug and Therapeutics Committee Overview Developing Drug Policies The DTC is responsible for developing drug policies in the health care organization. These policies are necessary to adequately control important aspects of drug selection, purchase, distribution, use, and administration. The DTC is the logical choice for doing this, since its members have the most experience and training in drug therapy and distribution. Policies and procedures are generally the first order of business in the committee, as they will provide the foundation for other functions that evolve from the committee. Besides general policies about drug use, the following specific policies should be in place: Addition of new drugs Nonformulary drugs Restricted drugs Investigational drugs Generic substitution and therapeutic interchange Automatic stop orders Structured order forms and guidelines Standard treatment guidelines, critical pathways, and treatment algorithms
Drug representative and promotional literature The development of comprehensive policies and procedures are critical to the success of the DTC. These policies will provide the framework for implementing improvements in drug selection and use. Evaluating and Selecting Drugs for the Formulary One of the most important functions of the DTC is the evaluation and selection of drugs for the health care organization’s formulary. Evaluating drugs and consequently approving or rejecting them requires significant expertise and commitment from the committee. The evaluation of drugs will require a rigorous approach that looks at documented efficacy, safety, quality, and cost of all drugs requested for the formulary. There is also a need for a system of periodic review of drugs on the formulary as the information base about drugs is constantly changing. These changes may be reflected in new indications, information about efficacy, safety, and comparative information with other drugs. The cost of a drug, whether it is anew drug or a generic that has been on the formulary for many years, may change frequently andrequires frequent evaluation. Consistent decision making is necessary in the selection of drugsand involves— Evidenced-based medicine Consideration of local context Transparent evaluation process
Overview Drug and Therapeutics Committee The evaluation of drugs for the formulary includes the review of generic drugs and other therapeutic equivalents so the most cost-effective formulary for the hospital and primary care clinic can be established. The evaluation process should include review of the primary drug literature (especially randomized controlled trials), published standard treatment guidelines, pharmacoeconomic studies, review articles, and reliable textbooks. Assessing Drug Use to Identify Problems The DTC should assess the quality of care (related to drug use) in a consistent, ongoing fashion. This component is an important and frequently overlooked responsibility of the committee. Time and attention here will have significant return in the long term with improved quality of drug therapy, improved patient outcomes, and decreased drug cost. There are several drug management areas that need to be assessed to identify drug use problems— Drug procurement and availability
Drug distribution Drug prescribing Administration/use Adverse drug reaction reports Medication error reports Antimicrobial resistance surveillance reports There are many different methods to assess quality of care, including the following that will be discussed in this training series: ABC/VEN analysis, aggregate data analysis, health care indicator methodologies, and drug use evaluation. Promoting Interventions to Improve Drug Use Irrational drug use is a common problem present in all health care systems worldwide. This irrational use contributes to poor patient outcomes and wastes valuable resources. Promoting and implementing effective interventions are necessary to ensure rational drug use. Important interventions to improve drug use are as follows: Educational Educational programs for the professional staff Educational programs for patients and their families Managerial Development of standard treatment guidelines Drug use evaluation Clinical pharmacy programs Structured order forms
Drug and Therapeutics Committee Overview Automatic stop orders Regulatory Drug registration Professional licensing Managing Adverse Drug Reactions The committee must address the issue of adverse drug reactions (ADRs) to medications on a regular basis. ADRs are a serious problem with increasing incidence, as more drugs become available and more people become exposed to them. In the United States, a recent review of prospective studies showed that hospitalized patients in 1994 had 2.2 million adverse drug reactions (6.7 percent incidence) and 106,000 fatalities. Other studies have shown that hospitaladmissions resulting from adverse drug reactions account for three to seven percent of alladmissions. These statistics are just astounding. They become more significant when you
consider that the statistics in these studies do not include errors of administration, which wouldonly increase the total incidence of morbidity and mortality. The Lazarou et al. study has received criticism concerning their meta-analysis methodology, but the study still indicates there are significant problems with adverse drug reactions in the United States. The DTC should have a plan to address the problems of adverse drug reactions including regular monitoring, assessment, reporting, and prevention. Newly released drugs can be particularly bothersome because of lack of knowledge and inadequate clinical experience associated with them. The current trend to “fast track” pharmaceuticals into distribution is also increasing the incidence of adverse side effects, as these new drugs may not have been adequately tested prior to release by regulating authorities. Older drugs may produce just as many side effects, but their effects are largely known and can be anticipated and prevented in many instances. Managing Medication Errors Medication errors may occur in the prescription of a drug, in the preparation and dispensing by a pharmacist, in the preparation and administration by a nurse, and when a patient takes the drug. This is a pervasive problem that occurs with all persons who handle medications. The cause of errors are numerous and include lack of knowledge, fatigued employees, careless work attitudes, poor procedures for drug distribution, and mental mistakes. Errors will occur no matter how ideal a health care setting may be. Therefore, it is incumbent on the DTC to provide the mechanism to monitor, assess, and prevent medication errors.
Overview Drug and Therapeutics Committee ETHICAL CONCERNS OF THE DTC The committee needs to operate in a manner that ensures transparency and avoids conflicts of interest with manufacturers and distributors of drugs or medical supplies. In order for the committee to maintain objectivity and credibility, it is necessary that a strict ethics policy be provided and rigorously enforced. There can be no relationships with the pharmaceutical companies other than a purely professional one that encourages the flow of unbiased information about their drug products. DTC STRUCTURE AND ORGANIZATION The DTC is usually made up of health care professionals from the medical staff, medical staff specialists, pharmacists, nursing personnel, and representatives from administration. Although this mix of personnel would provide the most input from diverse segments of the health care organization, there is no single method that would dictate who is on this committee. Since the
committee regulates to a large extent what physicians will be prescribing and how pharmacists are involved with drug therapy and logistics, it is obvious that these professionals will need a significant voice on the committee. Ideally, a well-known and respected physician will provide leadership for the committee, with a pharmacist as co-chair or executive secretary. These individuals should be appointed by the health care organization’s administration. Figure 1 illustrates the typical organization of the DTC. When specific drugs are being considered, the committee may invite specialists to participate in meetings as needed. These individuals do not have voting privileges. Subcommittees may be formed to carry out specific tasks, e.g., therapeutic class review of antimicrobial drugs or the development of a medication error prevention strategy. It is very important that the DTC meet regularly, at least three to six times a year. If necessary, the committee will need to enforce mandatory attendance to accomplish the functions of the committee. Minutes are prepared for each meeting and distributed to appropriate medical, nursing, and pharmacy departments.
Drug and Therapeutics Committee Overview Antimicrobial Subcommittee Many DTCs have found it necessary to form an associated subcommittee of the DTC, one that deals solely with antimicrobials. The purpose and goal of this subcommittee is to ensure that safe, effective, cost-effective antimicrobials are made available to the health care organization. This subcommittee also dedicates itself to ensuring that antibiotics are used only when clinically indicated, at the correct doses, and for the appropriate duration of time. The subcommittee must also ensure that patients are taking these drugs correctly, as this may have a profound effect on treatment outcomes and the prevention of antimicrobial resistance. Functions of the antimicrobial subcommittee are similar to the DTC, but with an emphasis on antimicrobial drugs. Ideally, an antimicrobial subcommittee would function as follows: Address issues relating to antimicrobials including correct prescribing Develop policies concerning use of antimicrobials for approval by the DTC and medical staff; policies should specifically include sections on methods to limit and restrict use of antimicrobials in the hospital and primary care clinics Assist in evaluating and selecting antimicrobials for the formulary
Organizes educational programs for health care staff Assess and monitor antimicrobial sensitivities and resistance patterns in hospitals and primary care clinics; prepare monthly reports of these activities and disseminate to appropriate departments and health care professionals
Overview Drug and Therapeutics Committee Infection Control Committee The Infection Control Committee is the committee that oversees the hospital’s infection control, prevention, and monitoring programs. This committee operates independently of the DTC, but frequently relies on the DTC’s advisory function. The committee is involved with environmental issues such as food handling, laundry handling, cleaning procedures, visitation policies, and direct patient care practices, including hand washing and immunizations. Infection Control Committees perform the following major functions: Obtain and manage critical bacteriological data and information, including surveillance data Develop and recommend policies and procedures pertaining to infection control Intervene directly to prevent infections Educate and train health care workers, patients, and nonmedical caregivers Recognize and investigate outbreaks of infections in the hospital and community Figure 2 illustrates the organizational structure of these committees within the health care organization.
Drug and Therapeutics Committee Overview MONITORING DTC PERFORMANCE DTCs are present in many hospitals and clinics, but most are not effective in improving the use of drugs or in managing drug distribution. The following process and outcome indicators will help identify when a DTC is being effective and making an impact. Process Indicators Is there a DTC document that indicates terms of reference including goals, objectives, functions and membership? Is a budget allotted to DTC functions? % of DTC members who attend >50% of meetings Number of DTC meetings per year Are there documented criteria for addition and deletion of drugs to the formulary Have STGs been developed/adapted/adopted and implemented? Number of educations programs presented in the last year? Have any interventions studies to improve drugs use been undertaken? Number of drug use evaluations that have been undertaken? Is there any documented policy for controlling access of drug manufacturing
representatives and promotion literature to hospital staff?
ACTIVITY Review of the Participants’ DTC In order to start our activities for this DTC training program, it would be helpful to review the kinds of programs that your DTC provides. Please take a few minutes and answer the following questions using the Drug and Therapeutics Committee Questionnaire (p. I-13). Please tear the completed form from your Participant’s Guide and hand it in to the session moderator. Do you have a Drug and Therapeutics Committee at your hospital or clinic? Does your DTC have a subcommittee on antimicrobials? Does your hospital have an infection control committee? What is the role of this committee? What are the major functions of the committee? Does your DTC have policies and procedures that regulate the functions of the DTC? What professional staff members are represented on the committee? What are the academic backgrounds of the DTC members? How often does the committee meet? What topics are covered? How many members does the committee have and how many typically attend meetings? Does your committee (or another department) routinely evaluate new requests for the formulary? What are the criteria used to select new drugs to the formulary? What sources of information are utilized to evaluate drugs for the formulary or essential drugs list? Does your DTC have an internet connect for information searches? Does your committee regularly review the formulary for availability of the most effective, safe, and cost-effective drugs? Does your committee have established criteria for evaluating notifications of adverse drug reactions? What are the criteria? Is there an established procedure in the hospital for informing the DTC on adverse drug Reactions when they occur?
Drug and Therapeutics Committee Overview Does your DTC have established criteria to assure product quality? If so, what are they? Are there established mechanisms for reporting product defects to the DTC? If so what Actions does the DTC take? Does your DTC participate in evaluating drug cost Does the DTC have established methods for periodically evaluating the use of drugs in the
hospital? If yes, what methods are used? Does your DTC have activities to identify drug use problems? What kind of activities do you use? Has the committee detected any problems in the use of drugs? If yes please describe the problems. Does your DTC have programs to improve drug use? What are these programs? Does the DTC participate in revising tenders and selecting drug suppliers? Is there a system in place to monitor the activities of the DTC? What is the role of pharmaceutical companies or suppliers in providing information on new drugs and promoting drugs in your institution? What are some major accomplishments of the committee? What are the major drawbacks? What would you like to see accomplished with your committee? SUMMARY The Drug and Therapeutics Committee should be a dynamic, integrated, and productive organization that deals with all issues concerning drugs and drug therapy. The committee can provide leadership in promoting rational drug use. Important functions of the committee include— Advising medical, administrative, and pharmacy departments Developing drug policies Evaluating and selecting drugs for the formulary and providing for its constant revision Assessing drug use to identify potential problems Promoting effective interventions to improve drug use including educational, managerial, and regulatory activities Managing adverse drug reactions and medication errors
Developing and Maintaining a Formulary Drug and Therapeutics Committee Drug and Therapeutics Committee Developing and Maintaining a Formulary PURPOSE AND CONTENT This session provides information about the formulary system and how it functions within the Drug and Therapeutics Committee (DTC). There will be discussion about implementing and maintaining a formulary, criteria for evaluation of drugs for the formulary, and a review of drug information resources. As many as 70 percent of all drugs on the market today are either duplicative or of questionable value. This forces the health care system to institute its own complex screening methods to provide the most effective and cost -efficient drugs. This ample selection of drugs will only increase, as more drugs are produced by manufacturers and distributors in search of
greater profits. Benefits arising from the appropriate selection of drugs are numerous and well known and include improved drug therapy, decreased adverse drug reactions, improved efficiency in procurement/inventory management, and decreased overall health care cost.
Developing and Maintaining a Formulary Drug and Therapeutics Committee
KEY DEFINITIONS Formulary —Drugs approved for use in the health care system by authorized prescribers Formulary Manual—The document that describes drugs that are available for use in the hospital and clinics (provides information on indications, dosage, length of treatment, interactions, precautions, contraindications, etc.) Formulary System—The system of periodically evaluating and sele cting drugs for the formulary, maintaining the formulary, and providing information in a suitable manual or list INTRODUCTION Formularies and formulary systems are the backbone of the Drug and Therapeutics Committee. The formulary provides many benefits in providing improved patient care at decreased cost through improved selection and rational drug use. The formulary system also improves efficiency within the procurement and inventory management programs. A comprehensive and active formulary system provides numerous benefits to hospitals and primary care clinics— Approved and efficacious drugs that all practitioners will be required to use: Only the most effective and safe products will be available. Available drugs will have been evaluated in a systematic manner. Drugs will be chosen and approved to treat the disease states of the country. Physicians will develop better experience with fewer drugs. Training will be easier as there will be fewer drugs on which to concentrate teaching activities. Drug therapy at a lower overall cost: Ineffective high-cost drugs will not be available. The most effective drug will be available to treat common health problems, resulting in fewer visits, improved outcomes, and subsequently lower costs. Inventory cost will be reduced. Consistent supply of drugs: Managing and regulating the number of drugs and improving the procurement and inventory management systems will result in the ordering of fewer drugs in larger quantities. These actions will enhance price competition and economies of scale with regard to quality assurance, procurement, storage, distribution, and dispensing and will subsequently lead to improved availability of drugs.
Drug and Therapeutics Committee Developing and Maintaining a Formulary Less money will be wasted, making it possible to be more consistent in purchasing essential drugs and increasing availability. The DTC and formulary system drive the entire health care system in the direction of
improved cost-efficient care and patient outcomes. Every step in the formulary system will result in a more efficient system that will better utilize scarce health care resources.
FORMULARY MANAGEMENT PRINCIPLES The formulary is a periodically revised list of drugs that reflects the current judgment of the medical staff. The formulary system utilizes the medical and pharmacy staff to evaluate, appraise, and select from among the numerous available drugs those products that are the most efficacious, safe, of adequate quality, and at a reasonable price. When completed, the formulary should conform to the following principles: Drugs should be selected based on the needs of the community; they should treat the diseases and conditions that have been identified locally. Drugs selected for the formulary are “drugs of choice.” The formulary list should have a limited number of drugs, only those necessary to provide for the needs of the hospital or clinic; duplication of agents that have therapeutic equivalence should not occur. Use International non-proprietary names (generic ) Use combination products (fixed dose) only in specific proven conditions e.g., TB Drugs need to be selected based on explicit criteria that include proven efficacy, safety, quality, and cost. The formulary must be consistent with any national or regional formulary or approved standard treatment guidelines. Maintaining a Formulary The formulary maintenance process is dependent on two key components, additions/deletions of drugs and therapeutic drug class reviews. Additions and deletions should be handled following specific policies and procedures developed for the DTC. A transparent methodology must be developed for these important decisions concerning addition or deletion of a drug. See the next section for recommended criteria for adding drugs to the formulary. Routine drug class reviews are an important activity to maintain the formulary. The drug class review involves the review of a complete section of drugs (e.g., cephalosporin antibiotics). This review would evaluate current drugs on the formulary in a systematic manner so that the entire formulary is reviewed over a two- to three-year period. This is a cumbersome task, but it will provide the necessary review and analysis of formulary drugs
Developing and Maintaining a Formulary Drug and Therapeutics Committee that is so important in a profession that is changing rapidly. Any new drugs that would offer an advantage over the current selections would be evaluated and considered for the formulary. Drugs that are no longer used or lack sufficient evidence of efficacy, safety, and quality should be recommended for deletion. Drugs that no longer meet the criteria for being
cost-effective should be evaluated and deleted when an acceptable alternative is identified. In order to maintain the formulary, regularly scheduled meetings must be established and attended by committee members. Ideally, the committee would meet monthly or, at the very least, every four months. Longer meeting intervals will necessitate too many agenda items and make it very difficult to accomplish the necessary activities. Each meeting should have an agenda, one that describes exactly what will be addressed during the meeting. Minutes are taken and reviewed at the next scheduled meeting. Typically, an effective committee will provide the following at each session: Action on newly requested drugs and deletions (Addition of a new drug should le ad to the deletion of a similar drug on the formulary in most cases.) Systematic review of therapeutic groups/classes by a competent physician or pharmacist Review of programs to identify and resolve drug use problems Without this review process, the formulary may become a collection of older drugs that may not reflect the most effective products available. It is the DTC’s responsibility to see that review is accomplished on a regular basis. PROCESS FOR SELECTION OF A NEW DRUG Selection of drugs for the formulary should follow carefully considered policies and procedures for determining the most useful drugs. These policies should be followed routinely and accurately each time an evaluation is needed. The following process is recommended for selection of new drugs: 1. A request for addition or deletion of a drug to the formulary, which can be made only by a physician or pharmacist, is made through completion of a Request for Addition/Deletion form. Information needed from the physician or pharmacist includes— List of specific pharmacological actions of the drug Information on why the drug is superior to current formulary drugs Specific literature support for use Background on any financial support received from the supplier or other organization
Drug and Therapeutics Committee Developing and Maintaining a Formulary 2. Obtain drug information resources. These should include primary literature, international newsletters, standard treatment guidelines, textbooks, and Internet sources. All sources of information must be credible and unbiased. 3. Perform the evaluation using established criteria (see page II-7). 4. Write the drug information monograph. The drug monograph should include details about the drug obtained from several information sources. At a minimum, the monograph should include— Pharmacology Pharmacokinetics
Efficacy compared to placebo and other drugs Clinical trial analysis Adverse drug reactions Drug interactions Cost comparison Sources of supply (to ensure availability) 5. Develop formulary recommendations. After a thorough research of the literature, the DTC should formulate recommendations concerning the drugs on the evidence -based drug information. Recommendations should include dosage forms and strengths that will be purchased. If a specific manufacturer or supplier is necessary because of bioavailabililty problems, then this should be addressed in these recommendations. Specific guidelines for administration or use should also be placed in these formulary recommendations. 6. Obtain expert opinions and recommendations. These should be obtained from knowledgeable and respected physicians and pharmacists. Opinions should complement the information provided in a drug information search. 7. Make a formulary decision (at the DTC meeting). Information should be presented to the DTC at a regularly scheduled meeting. The DTC must vote on the recommendations as presented by the individual who performed the drug evaluation. 8. Disseminate the results of the evaluation and DTC’s recommendations. Results of the DTC actions and recommendations must be disseminated to the health care staff in the form of meeting minutes, newsletters, or department meetings.
Developing and Maintaining a Formulary Drug and Therapeutics Committee CRITERIA FOR SELECTION OF DRUGS Selecting drugs for the formulary is the most important function of the formulary system. The process is multifactorial and ultimately brings the best drugs to the health care system. The following represent major criteria to be considered when evaluating all new requests for addition to the formulary: Disease patterns of the country Efficacy, relative efficacy, effectiveness Safety Quality Cost Drugs that are well known Health system personnel and equipment available to manage the drug Financial resources available Disease Patterns The morbidity of the region needs to be assessed carefully before adding or deleting any drugs. Formulary drugs should be approved only after confirmation of actual need to treat the
known diseases and medical conditions of the community. Standard treatment guidelines must be reviewed to determine appropriate drugs for the medical conditions listed in the guideline. Efficacy Proven efficacy is one of the most important criteria in selecting new drugs for the formulary. The methods to accomplish a thorough evaluation of efficacy are presented in later sessions. Information that accompanies a new drug, including the package insert, drug company literature, and advertisements, may not always provide unbiased information for evaluating the drug in question. A comprehensive review of journal articles, especially randomized controlled trials, will provide the best unbiased information. Reviewing information in texts and international newsletters will provide the reviewer with additional supporting information concerning efficacy. Careful evaluation of all sources must be done to ensure that evidence of efficacy is supported by the literature and is unbiased and accurate. Safety Determining the safety of a drug requires close attention to established information on the drug as well as current postmarketing surveillance (provided by the manufacturer or drug regulatory age ncy) of the drug’s safety record. Drugs with excellent safety records are necessary for the formulary, but are not always possible to obtain. A careful assessment of risk-benefit will be necessary for all drugs before they are added to the formulary. The cost of treating adverse drug reactions is very high, both in monetary terms and in lowered patient quality of care. Every effort must be made to evaluate a drug’s safety record
Drug and Therapeutics Committee Developing and Maintaining a Formulary and its potential for adverse reactions. More information concerning safety will be presented in Session Four, “Assessing and Managing Drug Safety.” Quality The quality of a drug that is requested for the formulary is very important. Poor -quality drugs that are administered to patients may have adverse effects, including— Lack of therapeutic effect Toxic and adverse reactions Waste of financial resources Loss of credibility of the health care services Before adding a drug to the formulary it is necessary to determine if the following characteristics of quality can be assured by the health care system:
Identity—Active ingredients are in the dosage form. Purity—The drug contains no contaminants. Potency—The drug has enough, but not too much, of the active ingredient. Uniformity of dosage form—The consistency, color, shape, and size of tablets, capsules, creams, and liquids do not vary from one dose to the next. Bioavailability—Bioavailability refers to the speed and completeness with which a drug administered in a specific form enters the blood stream; different manufacturers of the same drug may have different bioavailability. Stability—A drug product must retain its properties within specified limits in order to be useful. The purpose of a quality assurance program for hospitals and clinics is to ensure that every drug reaching a patient is safe, effective, and meets quality standards. A comprehensive quality assurance program includes both technical and managerial activities from selection to patient use. Many areas within a health care system may be involved with quality assurance, including procurement, pharmacy, medical, and nursing departments, as well as the DTC. Ensuring quality of a product is twofold: 1. Obtaining quality products that are safe and effective through structured selection and procurement methods 2. Maintaining quality products through the appropriate storage, distribution, monitoring, and prescribing methods A comprehensive drug quality assurance program requires procurement, pharmacy, warehousing departments, and the DTC to ensure the following:
Developing and Maintaining a Formulary Drug and Therapeutics Committee Suppliers with acceptable quality standards are selected. Minimum quality standards are met or exceeded and appropriate testing of the end product is performed. Repackaging of supplies maintains quality. Storage and transportation conditions are adequate. Product quality concerns reported by prescribers, dispensers, and consumers are documented, investigated, and resolved. More information on drug quality will be presented in Session Five, “Drug Quality Assurance.” Cost The cost of a drug in relation to its benefits is a very important consideration with any new drug. A drug with questionable benefits at a high cost would have an unfavorable costbenefit ratio. However, a new antihypertensive drug with good comparative efficacy, decreased incidence of adverse drug reactions, and a lower overall cost than current drugs on the formulary would represent an excellent cost -benefit relationship. This drug would therefore
have a favorable status for being added to the formulary. However, when a new drug with equal efficacy and possibly fewer adverse side effects at a higher cost is requested, the decision becomes more complicated. More information on determining the cost of pharmaceuticals is presented in Session Six, “Evaluating the Cost of Pharmaceuticals.” Drugs That Are Well Known Ideally, drugs that are selected for the formulary are ones that are well known, have been on the market for years, and have clinical experience to support their pharmacological profiles. This is not possible for all drugs added to the formulary, but it should be one of the basic parameters to consider when adding a drug. Availability of Appropriate Personnel It is important to have available health care personnel who have the experience, training, and credentials necessary to utilize these drugs. Any drug, no matter how effective and safe, must be measured against the personnel who will actually be using the drug. A system of layered prescribing authority is useful when the health care system has practitioners with different levels of experience and qualifications.
Drug and Therapeutics Committee Developing and Maintaining a Formulary Availability of Financial Resources The health care system must have at its disposal a sufficient amount of money to actually purchase and maintain the drug for an indefinite amount of time. A thorough cost analysis is therefore necessary before the drug is actually accepted for the formulary. If the resources are not available for the consistent procurement of a new drug, then it should not be accepted. Intermittent purchase of a drug that the system cannot afford only serves to foster poor medical services with little or no continuity of care. NONFORMULARY DRUGS Most formulary systems are designed as an “open” system. The open system allows for the introduction of nonformulary drugs on a limited basis, usually f or a single patient use. A closed system reflects the DTC’s choice to exclude all nonformulary drugs from being available in any form. Nonformulary drugs are necessary, in limited amounts, for patients who require specialized treatments or patients who ha ve been stabilized on drugs from practitioners outside of the health care system. Control of nonformulary drugs is important as an open system will invariably become problematic and impede the system of formulary management. Numerous nonformulary drugs will be costly and, because they may not have received the complete evaluation
process, they may be less than effective or unsafe. Management of nonformulary drugs includes— Limiting the number of nonformulary drugs Limiting access to appropriate prescribers Reviewing frequently Policies and procedures on how these drugs will be purchased are necessary and close followup of all nonformulary drugs by the DTC is warranted in order to limit their use. RESTRICTED DRUG USE Restricted drugs include those products that fill a particular need by a specialty within the health system. These drugs need to be defined by the DTC in order to limit their use. Some examples of restricted drugs and their applicability include— Certain antibiotics for infectious diseases Antipsychotic drugs for use by mental health professionals Antineoplastic products for use by physicians with specialized knowledge of these drugs The use of restricted drugs requires that there be close monitoring and evaluation of these drugs. Monitoring of restricted drugs should include determining that appropriate patients are receiving the drugs and that authorized medical staff are prescribing and providing follow up for patients on these medications.
INTERNATIONAL NONPROPRIETARY DRUG NAMES The use of international nonproprietary drug names (generic names) is encouraged for all listings in the formulary, evaluation monographs, and all other communications about drugs. This international nonproprietary name is the drug’s official name, regardless of who manufactures or markets it. Formulary systems that utilize the generic name system will find that it makes for a more efficient system and causes less confusion about the actual products listed. Instead of dealing with 10 to 20 or more trade names for each drug entity, there will be only one. The system will also enhance any therapeutic or generic substitution programs that may exist. INFORMATION RESOURCES FOR EVALUATING DRUGS Adequate resources to obtain information and to evaluate the efficacy, safety, quality, and cost of a drug are essential. This section provides basic information concerning well-known drug information sources. Medical information sources include three categories: primary, secondary, and tertiary resources. Primary literature Includes journal articles and unpublished studies that may be obtained from
journals and services that provide the entire article Represents the most complete information about a subject because all the data discussed in the article are available to the reader Disadvantages include that the reader must have skills to evaluate the article and the amount of time necessary to actually read and analyze Secondary literature Includes indexing and abstracting services that provide abbreviated reviews of articles Usually published in newsletters, CD-ROM databases, and online services Advantages include readily accessible and easy-to-read information Disadvantage is the long time period between publication and the republication in the newsletter or abstracting service Tertiary sources Include published textbooks, which can be an excellent source of information if reputable and current sources are used FORMULARY MANUAL The formulary manual is the publication that brings all of the data concerning the formulary together in a manual or pamphlet. There is no set standard on how this document is arranged or what it includes, but ideally it contains both alphabetically and therapeutically arranged lists of the formulary drugs and a section on drug usage that includes doses, contraindications, side effects, drug interactions, and price. The manual should include a section on the drugs of choice and alternates for treating the medical conditions of the region. This manual is not intended as a book to place on the shelf. It should be pocket-sized to allow practitioners to carry it with them at all times. The design of the manual requires that it be easy to use with appropriate indexing to facilitate location of necessary information.
The following items should be available in a comprehensive formulary manual. The DTC would have to evaluate these items and include only the most appropriate in its formulary manual. Basic information: Formulary list or essential drugs list Alphabetical and therapeutic category lists Brief information about each drug (drug monograph) Generic name Dosage and strengths Indications Contraindications Precautions Side effects Dosage schedule
Instructions and warnings Drug, food, lab interactions Miscellaneous information: Supplementary information for drugs Price Regulatory category Storage guidelines Patient counseling information Labeling information Brand names and synonyms Prescribing and dispensing guidelines Rational prescribing techniques Principles of prescription writing Guidelines on quantities to be dispensed Control drug requirements Adverse drug reaction reporting requirements Dispensing guidelines List of precautionary labels Drug interaction tables Treatment protocols IV drug administration guidelines Drugs used in pregnancy and lactation Drugs used in renal failure Poison guidelines Prescribing for the elderly Other components Metric tables Adverse drug reaction form Product quality report form Formulary request form Nonformulary drug request forms Abbreviations A comprehensive index of all items in the formulary manual is essential. Because of the complexity of this document, an index will facilitate use by practitioners and ultimately improve efficiency within the health care system. ACTIVITIES: ADDING NEW ANTIMICROBIALS TO THE FORMULARY Activity 1. Your DTC is considering a new antibiotic for the formulary. This antibiotic is very similar to a formulary product, cefotaxime, a third-generation cephalosporin. It would be used in the emergency room as a single dose for managing febrile children with the diagnosis of acute respiratory infection (ARI) or otitis media (OM). This drug is an injectable at a very high cost of $5.50 per dose. The physician requesting this drug states that although it is very expensive, use of the drug will decrease overall cost because hospitalizations of these sick children will be decreased with appropriate use. The drug would be used by mid-level providers who staff the emergency room at night. The hospital has a very tight budget and
relies on donors for a significant amount of funding for drugs. Other drugs available in the hospital for these medical conditions include amoxycillin, cephalexin, co-trimoxazole, and chloramphenicol. What criteria are necessary to evaluate this drug for addition to the formulary? Utilizing the criteria discussed in this session, what major concerns do you have before adding this drug to the formulary? What drug information resources would be used to analyze this drug for the DTC? Which source would be the most useful? Activity 2. You are a new member of the DTC for your hospital. A new antimicrobial has been requested by one of your physicians. This antimicrobial has a broad spectrum of activity that includes activity against most common gram-positive and many gram-negative bacteria. The drug is a suspension that is given four times daily for 10 days. The drug is heavily promoted, by a pharmacy company representative, for treating many different pediatric infections. The cost is high, $1.25/day, but it is required (according to the requesting physician) because of a high incidence of antimicrobial resistance in the hospital. This antibiotic is typically used for children with ARI, acute otitis media, and diarrhea. Safety of this drug has not been fully evaluated in clinical trials. Other drugs for these problems that are available on the formulary include amoxicillin, co-trimoxazole, and cephalexin. Typically the DTC has provided very little evaluation of new drugs; a physician’s recommendation was enough for approval by the committee. What are some important considerations when adding a drug such as this to the formulary? What are some potential drug use problems that are depicted in this activity? What functions of the DTC are needed to fully address the antibiotic request? SUMMARY The formulary system adds an important component to the DTC and the health care system. A system of evaluating and selecting the most appropriate drugs for the formulary will bring numerous benefits. These include rational drug use, improved health care outcomes, improved efficiency in the procurement and inventory management systems, regular supply of essential drugs, and a significant decrease in overall health care cost. Listed below are some key points to remember concerning the starting of a formulary system or maintaining one for years to come— Write detailed policies and procedures concerning the functions of the formulary system. Evaluate drugs carefully to obtain the best drug at a favorable cost. Review the formulary in a systematic manner to ensure it is current. Keep nonformulary drugs to a minimum. Restrict drugs to appropriate practitioners.
Keep on hand up-to-date drug information resources that provide unbiased comparative information. Enlist the support of key policymakers and influential health professionals to advocate for the DTC and formulary system. Keep the formulary process ethically correct—the DTC and especially the formulary system must tolerate no influence or pressure from pharmaceutical manufacturers or suppliers concerning any product that is considered for addition to or deletion from the formulary.
Strategies to Improve Drug Use Drug and Therapeutics Committee Drug and Therapeutics Committee Strategies to Improve Drug Use INTRODUCTION The Drug and Therapeutics Committee is responsible for numerous important drug management functions. The DTC evaluates new drugs for the formulary, develops policies for drug use, and identifies and corrects drug use problems. This session concentrates on strategies for improving drug use in the health care system. The evaluation and addition of new drugs to the formulary is one of the most important functions of the DTC. The health care system needs drugs that are of proven efficacy for the medical conditions and diseases of the country. This efficacy must be well recognized and accepted by experts in the field. Safety of any drug added to the formulary is also critical, as is quality of the product. The DTC must have considerable information concerning all aspects of quality to ensure the products added to the formulary meet minimum quality standards. Evaluation of cost is essential, more important today than at any other time, as the cost of drugs as a percentage of the health care budget is increasing dramatically. Once drugs have been added to the formulary and all of the evaluation criteria have been satisfied, then serious consideration must be given to ensuring that the drugs are used appropriately by the health care system. This function of the DTC is important to the overall management of drugs, as the inappropriate use of drugs will compromise any advantages achieved by proper selection. This is the very heart of drug management—appropriate drug selection and then ensuring appropriate use. This session provides the participants with insights into providing programs that improve drug use. There are three types of strategies that will ensure quality of drug therapy: educational, managerial, and regulatory. These strategies are discussed in detail and provide the necessary information to improve rationa l drug use.
EDUCATIONAL METHODS FOR IMPROVING DRUG USE The DTC should be involved in educational programs for health care professionals. Physicians, nurses, pharmacists, and, indeed, all professionals need constant updating of their skills and knowledge. It is not possible for physicians or pharmacists to keep up with the
constant changes in the drug litera ture without intensive efforts by the individual and the health care system. Educational programs include the following: Drug newsletters and bulletins Formulary manuals Face-to-face communications with physicians, health care leaders, and patients Drug Newsletters and Bulletins Drug newsletters can be a valuable instrument for the DTC in providing drug information. These newsletters can be published monthly, quarterly, or at longer intervals and should provide interested staff with unbiased and accurate information concerning drug therapy. Drug newsletters and bulletins have an advantage over formal group presentations because busy practitioners can read the information on their own schedule. There are numerous drug newsletters and bulletins that are already published by international services and distributed worldwide, but a local bulletin would be an invaluable asset. This local bulletin would provide more information concerning drugs and drug-related problems of interest at the hospital or clinic. Drug newsletters are more likely to be effective in improving drug use if they do the following: Describe the reasons for prescribing behavior—Inadequate training in infectious diseases? Distrust of in-country drugs? Reliance on trade name drugs and distrust of generics? Offer concise, up-to-date information that can be used immediately Provide limited information and repetition of key points in the newsletter—(extensive presentations of new information and reviews will lose the interest of most individuals) Provide a graphical, colorful newsletter that will catch the attention of the reader Provide reference in the newsletter to information derived from reputable journals and services Provide brief, simplistic text Provide information oriented toward actions and decisions Formulary Manual The use of a formulary manual has been shown to be valuable in providing drug information to physicians, pharmacists, and nurses. A formulary manual can be described as the publication dedicated to presenting the formulary list and other information concerning the use of drugs. The formulary manual is a concise pocket-size document that provides summary information meant to be readily available for health professionals to use on a daily basis. Formulary manuals vary in scope from a listing of essential drugs to comprehensive references that contain drug information, treatment guidelines, and pharmacy policies and procedures. The following are some examples of content for a formulary manual: Drug formulary list Basic information on each drug (indications, dose, side effects) Supplementary information on each drug, (price, source of supply) Prescribing and dispensing guidelines
Disease management guidelines for selected conditions Pharmacy policies and procedures pertinent to medical staff and pharmacy Drug procurement policies Ideally, the manual should have at a minimum the list of formulary drugs and an information section describing each drug. This manual, when provided in a comprehensive form, provides excellent drug information for physicians and other professionals. Producing the manual is a time-consuming process and a systematic participatory approach is required to keep revisions updated. See Session 2 for more detailed information concerning formulary manuals and their content. Face-to-Face Communications
In -service Education Programs, Workshops, Seminars The information database on drugs and drug therapy is constantly changing. A physician or pharmacist who has recently graduated from a training program will find that his or her knowledge base becomes inadequate in a very short period of time. Since good patient care requires the profess ional to have up-to-date information, in -service education and other educational programs are necessary. The DTC should have a plan to provide these at times when as many of the professional staff as possible can attend. These types of information programs have varying degrees of success, which depends largely on the materials being presented, the style of presentation, and the education and experience of the instructor. The presenter should have in-depth knowledge and interest in the subject and the mater ials presented. The material to be presented must be relevant and of interest to the participants. This type of education has been found to be most useful when it is kept brief and information is repeated to facilitate learning.
Educational Outreach (Person-to-Person or Academic Detailing) Person-to-person education is one of the best ways of changing drug-prescribing behavior. The beneficial effects can be striking, as people will be more attentive and absorb more information with this type of education. The world’s pharmaceutical companies have shown this to be an extremely useful technique; they have hired thousands of representatives to meet face-to-face with prescribers to provide information and market their drugs. The drug representatives have been remarkably successful. Academic detailing can accomplish the same thing but brings a more balanced, objective message. Principles of this type of education include— Focusing on specific problems and targeting the prescribers Addressing the underlying ca uses of prescribing problems such as inadequate knowledge Allowing an interactive discussion that involves the targeted audience Using concise and authoritative materials to augment presentations
Giving sufficient attention to solving practical problems encountered by prescribers in real settings The identification of health care leaders and other influential persons involved in prescribing drugs and then providing education, guidance, and policies to them can have important benefits. These leaders of the health care system may well be in a position to teach or direct other doctors, students, and pharmacists on the appropriate standards of care.
Patient Education Patient education is a vital concept that will influence dr ug prescribing. Providing regular patient education by physicians, nurses, and pharmacists will teach patients appropriate therapy and improve health outcomes. An educated patient population will make fewer demands for inappropriate drugs, especially antib iotics. Patient education will result in a corresponding improvement in how patients perceive drug therapy and comply with their drug regimens. SILABUS MATA KULIAH FAR 462 Farmasi Rumah Sakit Prasyarat : Mata kuliah ini akan membahas tentang konsep Farmasi Rumah Sakit , sejarah dan perkembangan, fungsi-fungsi serta penerapan dilapangan dalam praktek kefarmasian di rumah sakit sesuai standar pelayanan farmasi No.1197 tahun 2004 di Indonesia Buku Pegangan 8. Direktorat Jenderal Pelayanan Kefarmasian dan Alat Kesehatan Departemen Kesehatan R. I. , Standar Pelayanan Farmasi di Rumah Sakit., Jakarta, 2004 9. Universitas Surabaya., Farmasi Klinis Menuju Pengobatan Rasional dan Penghargaan Pilihan Pasien (Clinical Pharmacy) , Gramedia, Jakarta, 2003. 10. Siregar, Charles J. P., Farmasi Klinik Teori & Penerapan., ECG, Jakarta, 2005. 11. American Society of Hospital Pharmacists,. Basic Skill in Clinical Pharmacy Practice,. Universal Printing and Publishing, North Carolina, 1983. 12. Cipolle, R. J. et al., Pharmaceutical Care Practice., McGraw-Hill, New York, 1998. 13. Rovers, J. P. et al. Second edition., A Practical Guide to Pharmaceutical Care., WHO, Washington, D. C. , 2003. 14. Ikatan Sarjana Farmasi Indonesia., Standar Kompetensi Farmasis Indonesia. Jakarta, 2004. FARMASI RUMAH SAKIT Soal dan Jawaban Soal
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Sebutkan tugas dan tanggung jawab seorang farmasis sebagai orang yang paling ahli di bidang obat pada saat ini. 2. Apa akibatnya jika sebuah rumah sakit tidak punya KFT? 3. Saat Saudara bertugas sebagai farmasis di rumah sakit X, tipe B di kota Bukittinggi, ditemukan suatu kasus infeksi yaitu sepsis, pada kultur kuman ditemukan bakteri penginfeksi adalah Stapilokokus Aureus. Tapi Anehnya pada pasien ini obat” an untuk bakteri tersebut seperti ciprofloxacin dan sefalosporin yang ada di formularium rumah sakit saudara resisten. Ternyata kuman penginfeksi adalah MRSA yang hanya sensitive dengan Vancomisin. Apa tindakan saudara selanjutnya sebagai sekretaris KFT. Jawaban 1. Tugas dan tanggung jawab farmasi saat ini • Drug therapy advisor • Drug therapy monitoring • Patient drug counseling • Drug usage review • Drug therapy management 2. Maka akan terjadi theraupetic jungle 3. Kalau tidak ada dalam formularium maka bisa diajukan penggunaan obat di luar formularium dengan persetujuan KFT dengan pengajuan tertulis dari dokter yang merawat dengan dilampirkan bukti yang kuat.
