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6 Drug Management Cycle

Drug management cycle

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21 views24 pages

6 Drug Management Cycle

Drug management cycle

Uploaded by

esthermarison
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Drug Management

Cycle
Distribusi Obat dan Alat Kesehatan
Oktavia Eka Puspita, M.Sc., Apt.
PSPA Jurusan Farmasi FKUB
Drug Management Cycle ▪ From drug selection to drug use,
passing through procurement, storage
and distribution
▪ A whole range of management
capacities are required and necessitate
using the appropriate tools within a
given legal and policy framework.
Why manage drugs?
Drugs are part of the link between the patient and health services.
Consequently, their availability or absence will contribute to the
positive or negative impact on health.

Poor drug management, particularly in the public sector of


developing countries, is a critical issue, but major improvements are
possible that can save money and improve access.

Finally, drugs are no longer the responsibility of health workers only.


Political, economic, financial and traditional considerations have
become so crucial in health care that it has become imperative to
look at drugs and health care from these perspectives.

farmalkes.go.id
▪ The selection of drugs for use at health center is usually determined at the
national level by the Ministry of Health and is based on a number of factors.
▪ After determination of the quantities required → based on price → delivery
conditions and quality → the selected drugs go through a procurement
process.
▪ → storage and distribution → the use of the drugs requires prescribing,
packaging, dispensing and counseling.
▪ These tasks require qualified health workers or other relevant personnel with
appropriate skills and attitudes.
▪ Management support tools are important for the acquisition of relevant skills
in drug management.
Basis for drug selection

Drugs are selected using the Essential ▪ Quality and type of care provided
Drugs List. Choice based on: Primary, Secondary, Tertiary

▪ National health policy ▪ Available human resources


Free health care, Subsidized health care, Managed Medical care (general and specialist care), Nursing
health care care (nursing, midwifery, psychiatry), Pharmaceutical
care (pharmacists, pharmacy technicians, clinical
▪ National drug policy nurses), Financial resources
Free drug policy, Subsidized cost of drugs or cost
recovery, Cost sharing

▪ Patterns and prevalence of


diseases
▪ International nonproprietary names (INNs), also known as
generic names, are normally used in identifying selected
drugs.
▪ However, the choice of drugs by generic names requires the
existence of an effective Drug Regulatory Authority to ensure
the availability of good-quality, safe, effective and affordable
drugs.
The drugs on the essential drugs list are referred to by their Poor quality?
INN or generic names.

The use of the generic name for these purposes has


certain advantages:

▪ There is easy recognition


▪ Buying at a competitive price;
▪ Product substitution
▪ The confusion with the use of brand names
To gain FDA approval, a generic medicine must:
Originator (New Drug Application - NDA) versus Generic (Abbreviated New Drug
Application - ANDA) Review Process Requirements

NDA: New drug application


ANDA: abbreviated new drug application
Drug procurement
Procurement of drugs is based on selected drugs ▪ Estimation of drug requirements
and dosage forms and available financial ▪ Determining drug types and quantities
resources. required
Procedures adopted in procuring drugs include:
▪ Delivery (lead) time
• Estimating quantity of each drug product ▪ Monthly consumption
required for a given period,
▪ Request indicator (re-order)
• Finding out the prices of the different drug
dosage forms required, ▪ Quantity to be requested
• Allocating funds for each drug dosage form ▪ Price of drugs
depending on: Priority nature of the drug and ▪ Requisition, supply and receipt of drugs
dosage form, Available finances
▪ Supply of drugs from medical stores
▪ Drug storage
Storage, Distribution, Use
▪ storage and distribution → the use of the drugs requires prescribing,
packaging, dispensing and counseling.
▪ These tasks require qualified health workers or other relevant
personnel with appropriate skills and attitudes.
▪ Management support tools are important for the acquisition of
relevant skills in drug management
CARA DISTRIBUSI OBAT YANG BAIK

Manajemen Organisasi dan Bangunan dan


Operasional Inspeksi Diri
Mutu Personalia Peralatan

Keluhan, Kembalian, Sarana


Diduga Palsu, Recall Transportasi Dokumentasi
Distribusi
Implementasi CDOB

• Pengawalan mutu sepanjang rantai


distribusi harus memperhatikan
CDOB agar integritas mutu obat
dapat dipertanggungjawabkan
hingga ke tangan konsumen atau
masyarakat
• Sertifikasi CDOB untuk distributor
obat (PBF)
Manajemen Mutu ▪ Menjamin bahwa standar
mutu untuk distribusi obat
yang sudah ditetapkan
dilaksanakan dan
terdokumentasi
▪ Bagaimana menjamin supaya
proses pengiriman untuk
pengadaan bahan tidak
menyebabkan kerusakan
mutu?
▪ Bagaimana menjamin bahwa
pengiriman vaksin tidak rusak
selama di perjalanan
distribusi?

“melakukan analisis manajemen


risiko”
Menilai Risiko

1. Apa yang mungkin menjadi salah (what can go wrong)? → Identifikasi


Risiko : Identifikasi bahaya menyangkut risiko yang dipersoalkan atau
deskripsi masalah
2. Probabilitas akan terjadi kesalahan? → Analisis Risiko: Estimasi
terhadap risiko terkait bahaya yang diidentifikasi
3. Apa konsekwensi yang mungkin terjadi (tingkat keparahan)? →
Evaluasi Risiko: Membandingkan risiko yang sudah diidentifikasi dan
dianalisis terhadap kriteria risiko yang ditentukan
Mengendalikan Risiko

1. Apakah risiko melebihi tingkat yang dapat diterima?


2. Bagaimana cara menghilangkan/mengurangi risiko?
3. Apa keseimbangan yang layak antara keuntungan, risiko, dan sumber
daya?
4. Apakah muncul risiko baru sebagai hasil identifikasi risiko yang
sedang dikendalikan?
Bangunan dan Peralatan
Operasional

▪ Standard Operating
Procedure
▪ Menguraikan apa saja
kegiatan di PBF →
process business
▪ Dibuat dokumennya
Dokumentasi
Inspeksi Diri
• Merancang tempat penyimpanan sesuai peraturan perundangan untuk
menjamin kualitas bahan baku, sediaan farmasi, alat kesehatan.
• Merencanakan dan menetapkan penyimpanan bahan baku, sediaan farmasi,
What to alat kesehatan berdasarkan bentuk sediaan, legalitas, farmakologi, aspek

expect?
toksik, dan alfabetis.
• Melakukan penerimaan bahan baku, sediaan farmasi, alat kesehatan
berdasar kriteria dengan baik dan benar sesuai prosedur.
• Memilih cara transportasi yang mampu menjamin mutu, kemanfaatan serta
Penyimpanan Dan
Pendistribusian Bahan Baku,
keamanan bahan baku, sediaan farmasi, alat kesehatan.
Sediaan Farmasi, Alat Kesehatan • Memilih metode distribusi yang sesuai dengan kondisi pasien/konsumen di
area pelayanan kefarmasian.
• Melakukan distribusi bahan baku, sediaan farmasi, alat kesehatan sesuai
Mampu merancang dan prosedur, serta menjamin mutu, kemanfaatan serta keamanannya.
melakukan penyimpanan serta • Melakukan pengawasan mutu terhadap bahan baku, sediaan farmasi, alat
pendistribusian bahan baku, kesehatan yang diterima maupun yang disimpan sehingga terjamin mutunya
sediaan farmasi, alat kesehatan sesuai standar.
sesuai ketentuan perundangan • Mengendalikan tingkat persediaan bahan baku, sediaan farmasi, alat
secara efektif dan efisien.
kesehatan berdasarkan analisis informasi persediaan & rasio yang
ditetapkan.
• Mengidentifikasi dan menetapkan bahan baku, sediaan farmasi, alat
kesehatan yang mengalami penyimpangan mutu, kemanfaatan, dan/atau
keamanannya.
• Mengendalikan faktor yang berpengaruh terhadap mutu, kemanfaatan serta
keamanan bahan baku, sediaan farmasi, alat kesehatan.
• Mendokumentasikan data dan proses penyimpanan dan distribusi bahan
baku, sediaan famasi, dan alat kesehatan.
THANK YOU

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