Bagaimana meresepkan obat baru

bagi anak
 Five star Doctors
(The Agent of Change)
1. Caregiver
2. Decision maker
3. Communicator
4. Community leader
5. Manager

Good doctors
Definition
Pharmaceutical care is the responsible provision
of drug therapy for the purpose of achieving definite
outcomes that improve the patients quality of life.

(Helper and Strand, 1990)

Pharmaceutical care is:
 a patient centered
 outcome oriented practice

 to promote health
 to prevent disease
 to asses, monitor, initiate and modify medication use

safe & effective drug therapy regimens

(Principles of practice for pharmaceutical care)

http://www.aphanet.org/pharmacare/prinprac.html
 Praktik Kedokteran
UUPK No. 29 Tahun 2004 pasal 35
Dokter dan Dokter Gigi
Mewawancarai pasien
Memeriksa fisik dan mental pasien
Menentukan pemeriksaan penunjang
Menegakkan diagnosis
Menentukan penatalaksanaan & pengobatan pasien
Melakukan tindakan kedokteran dan kedokteran gigi
Menulis resep obat dan alat kesehatan
Menerbitkan surat keterangan dokter dan dokter gigi
Menyimpan obat dalam jumlah dan jenis yang diizinkan
Meracik dan menyerahkan obat kepada pasien,
bagi yang praktik di daerah terpencil
yang tidak ada apotik
Irrational Drug Use
Complex problems

Factors:
 Bad prescribing habits (doctors)
 Aggressive drug promotion
 Drug availability
 Drug regulation system
 socio-cultural
 Health care system
 Ethical Principles in Pediatric Patients

 “Pediatric patients” = patients who are not empowered

to provide authorization (inform consent to their care)
 In principle similar to in adults, but children are by nature
incompetent for giving informed consent
 Child assent is required whenever appropriate, besides
parenteral consent or permission
 Those who care children will be the most appropriate
in dealing ethical issues in pediatric care

Ref. Sastroasmoro S. Raker IDAI, Dec. 2008

 Drug Use in Pediatric Patients
A complex problem:
A child is not a little adult

 Different pharmacokinetic and pharmacodynamic

properties
 Shortage of clinical trials of drug use in children
 Lack of information: drug dose, formulation, etc
 Most available drugs: not recommended in
A Child pediatric age groups
is not  “For use in children: consult your doctor”
a little adult

THERAPEUTIC ORPHAN
 Technical / Practical Difficulty in Giving
Drug in Children
 Unit dose for neonates, premature baby, small children:
mg/kgbw? Mg/sq.m of body surface, Young’s formula?

 Preparation: solution, liquid preparation, pulveres or

minitab/capsules

 Taste problems

 Bad compliance

 etc
 Prescribing a New Drug in Pediatric Patients
A mission impossible (?)

The need for critical assessment of new medicine in

pediatric patients

Adequate resource to obtain information and to

evaluate new drugs are essential
 Primary literature: journal article & unpublished studies
 Secondary literature: indexing/abstracting services, newsletters,
CD-Rom, etc
 Tertiary literature: published textbooks
 Pharmaceutical companies/drug representatives
 Internet

Ref. Holloway K. Drug and Therapeutic committee, 2003.

 Pharmaceutical Promotion

 Influences providers at the level of drug selection

for individual patients

 For many prescribers: the primary source of information

on new medicine

 However their information is often biased

 Thus providers must be sensitized as to how pharmaceutical

promotion can affect their choice of medicines

Ref. de Vries TPGM, Hunning RH, Hoger Zeil HP.

Guide to good prescribing, WHO 1995
 The WHO Ethical Criteria for
Medial Drug Promotion
All promotion – making claims concerning medical drugs
should be:  Reliable
 Accurate
 Thruthful
 Informative
 Balanced
 Up – to – date
 Capable of substantiation and in good taste

Ref. Ethical criteria for medical drug promotion. WHO, Geneva, 1988
Regulating Drug Representatives:

In a private practice doctor: difficult or impossible.

Option: Equal time presentation between drug
representative and hospital pharmacist or
clinical pharmacologist

Directed at consumers as well as prescribers:

 May create inappropriate patients demand
 A DTC cannot prevent such promotional activities
 Suggestion for Prescribers:

 Be sure that you know well the pharmacologic properties

of new drugs before you prescribe it to your
pediatric patients
 Seek adequate information from medical literatures.
Information from pharmaceutical companies should be
used with caution
 Avoid bad prescribing behaviour, remember the process of
rational treatment, especially in pediatric patients

 Thus providers must be sensitized as to how pharmaceutical

promotion can affect their choice of medicines
 Patient Safety

……Safe care is not an option.

It is the right of every patient who entrusts
their care to our Healthcare systems……..

Sir Liam Donaldson, Chair, WHO World Alliance for Patient Safety,
Forward Programme, 2006–2007
Ref. Farmacia, ethical update, Jan, 2009.