Modul Pharmed - 2020 - Online - Discussion - Rev 3.06.2020 - Day

2020
PSPSSKPD
STUDY GUIDE
BASIC PHARMACEUTICAL AND DRUG ETHICS
Planners Team
Dr. dra. apt. Ida Ayu Alit Widhiartini, M.Si
apt Desak Ketut Ernawati, S.Si, PGPharm, M.Pharm, PhD
dr. WayanSumardika, M.Med. Ed.,Ph.D
Dr dr Agung WiwiekIndrayani, MSc
dr I G M G Surya Trapika, MSc, PhD
FACULTY OF MEDICINE
UDAYANA UNIVERSITY
2020
i | Study Guide Pharmed 2020

CONTENTS
CONTENTS ................................................................................................................................... i
GENERAL CURRICULUM .............................................................................................................. 1
LEARNING ACTIVITY ................................................................................................................... 1
Face to face meeting on line lectures and Plenary Lectures ..................................................... 1
Small group discussion............................................................................................................ 1
Peer assisted learning and Written Simulation ....................................................................... 1
Student projects ..................................................................................................................... 1
ASSESSMENT METHODS ............................................................................................................. 4

PLANNERS TEAM and LECTURERS ............................................................................................... 5
1. Planners Team .................................................................................................................... 5
2. Lecturers ............................................................................................................................. 5
FACILITATORS............................................................................................................................. 9
1. Facilitator Class A ................................................................................................................ 9
2. Facilitator Class B ................................................................................................................ 9
TIME TABLE .............................................................................................................................. 10

LEARNING PROGRAM ............................................................................................................... 15
L1: Introduction of Basic Pharmaceutical Medicine & Drug Ethics ......................................... 15
L2: Drug Development .......................................................................................................... 16
L3: Drug Regulations ............................................................................................................. 17
L3b : Drug Promotion............................................................................................................ 18
L4: Medication Safety ........................................................................................................... 19
L 5: Pharmacovigilance ......................................................................................................... 20
L 6: Drug Dosage Forms ........................................................................................................ 21
L 7: Drug Bioavalability ......................................................................................................... 23
L 8: Dose Calculation and Dose Regimen ............................................................................... 24
L 9: Rational Irrational Prescribing ........................................................................................ 26
L 10: P(ersonal) drug and P(ersonal) treatments .................................................................. 28
Tutor assissted Learning P(ersonal) Drug .............................................................................. 30
Tutor assissted Learning P(ersonal) Treatment .................................................................... 33
L11: Drug information (How to keep up to date about drugs) ............................................... 37
ii | STUDY GUIDE PHARMED_2020

L12: Drug Compounding........................................................................................................ 38
L 13: How To Assess Prescribing Skills ................................................................................... 40
Tutor assissted learning of prescribing in general practice 1, 2, 3 .......................................... 43
BCS 1: Prescribing Skills Written Virtually.............................................................................. 44
APPENDIX 1 COMMON LATIN WORDS ................................................................................. 56
APPENDIX 2 TEMPLATE OF A COMPLETE PRESCRIPTION ....................................................... 59
APPENDIX 3 FASILITATOR’S ASSESSMENT FORM .................................................................. 60
APPENDIX 4 PRESENTATION ASSESSMENT FORM ................................................................. 62
APPENDIX 5 LEMBAR PENILAIAN PENULISAN RESEP.............................................................. 63
APPENDIX 6 MAPPING CURRICULLUM BLOCKS ..................................................................... 64
APPENDIX 7 STUDENT CONTRACT ......................................................................................... 65
iii | STUDY GUIDE PHARMED_2020

iv | STUDY GUIDE PHARMED_2020
GENERAL CURRICULUM
This course is designed to develop medical student competence to be prescribers. Prescribing

is one of the clinical skills expected of new medical doctors and is a complex process integrating
several knowledge, skills, and understanding of drug regulation and ethical issues regarding
patient medication safety and cost effective use of medicine. Preparing medical students to be
prescribers is a great challenge and some evidence of medication error need to be watch out from
the undergraduate while maintaining their life long learning as long as their medical practice.
In order to obtain the skills in drug prescribing, medical students’ knowledge of
pharmaceutical medicines and pharmacotherapy are prominent. Pharmaceutical medicine can be
defined as ‘the discipline of medicine that is devoted to the discovery, research, development, and
support of ethical promotion and safe use of pharmaceuticals, vaccines, medical devices, and
diagnostics (Edward., et.al, 2007). The discipline covers all medically active agents from
neutraceuticals to cosmeticeuticals and from over the counter to prescription drugs. Meanwhile,
pharmacotherapy is a therapy which involved medication/drugs. Knowledge of diseases,
pathophysiology, pharmacology, and biopharmaceutical are essential in this regards. This means
medical students need to understand how drug is developed/ discovered, to know how drug
promoted ethically and to use the medication/drug safely. Basic knowledge of drugs such as their
pharmacokinetic, pharmacodynamic, pharmacogenomic, drug interaction have been prepared on
1st semester are not discussed here again but drug dosage forms, bioavailability, and potential
medication misadventure are also included in this study guide. These understandings are essential
for medical students prior to prescribe medication to their patients. Highlight of this guide will be
focused on develop prescribing competency including of drug used from the selection of personal
drug (P-Drug) and personal treatment (P-treatment) to the process of drug prescribing. The
concept of prescribing competency frame work refer to Miller’s Pyramide was illustrated on
Figure 1 describe how the good prescribing competence will be develop.
AIMS: to develop rational prescribing skills
1 | STUDY GUIDE PHARMED_2020

LEARNING OUTCOMES:
Prescribing drugs safely, effectively, and economically including of:
- Establish an accurate drug history, covering both prescribed and other medication
- Plan appropriate drug therapy for common indication
o Only prescribe a medicine with adequate knowledge and awareness of
pharmacokinetics (drug fate, dose), pharmacodynamic (drug action),
pharmacotherapy (drug indication, drug interaction, cautions, and side effects)
- Provide a safe and legal prescription
o Aware of how medicines are licenced, sourced, and supplied, and the implications
for own prescribing)
o Write legible, unambiguous, and complete prescription that meet legal
requirements
- Calculate appropriate drug doses and record the outcome accurately
o Accurately calculates doses and routinely checks calculations where relevant to
patients conditions
- Provide patients with appropriate information about their medicine
o Uses up to date drug information (drug product, formulation, doses, storage
conditions,side effects, cost)
o Explains the rationale and the benefit of the drug of choice
o Understand the potential risks of adverse effects and how to communicate to
minimize, avoid, recognize and manage them
- Access reliable information about medicines
o Uses up to date drug information (drug product, formulation, doses, storage
conditions, cost)
- Detect and report adverse drug reactions

Show how and do: Write a safe and legal prescription
(Rational prescribing)
Does
Know how to and Show how to: Establish an accurate drug
history, Plan appropriate therapy Skills: for common
indication (P-drugs), Appraise critically the prescribing of
Shows how others, calculate appropriate doses, provide patients
withappropriate information about their medicies, Access
reliable information about medicines, Detect and report
adverse drug reactions
Knows how
Knows: Drug Dosage Form, Basic and Clinical Pharmacology,
Pharmacokinetics (ADME, dose calculation, bioavailabilitas,
dose regimen), Pharmacodynamic (specific dug target,
mechanism of action), Pharmacogenomic ( polimorphism
Knows genetic- drug metabolisme) Drug interaction, Drug
development, Phamacovigilance, Drug Interaction, P-drugs
and rational prescribing, Drug communication, information,
and education and compliance, Legal aspect of drug use and
drug promotion
Figure 1 Concept of How to develop Prescribing Skills in Faculty of Medicine Udayana

University refer to Miller’s Pyramide

LEARNING ACTIVITY
The course will be performed in several teaching learning strategies include of face to face
meeting on line lectures and plenary lectures supported by webwx meeting,, on line learning in
small group, student project, tutor asissted learning, and written simulation.
Face to face meeting on line lectures and Plenary Lectures

Lectures have been accepted to be the most effective and economic method in delivering
theoritical concepts. Lecture s help students to develop the underpinning knowledge of how drug develop
and use safely and legal. More than half lessons of this block will be delivered by face to face meeting on
line lectures coordinated by team lectures with Cisco webex meeting application.
Small group discussion

Students will be facilitated by facilitator from staff Department in a small group 1-13 students.
Facilitator ensure that the student learn in depth in small group and perform their soft skills competency as
stated on SGD performance assessment. Student performance wil be assessed by facilitator and it is
contributed 5% to final score.
Peer assisted learning and Written Simulation

This learning strategies will be deliver by using written cases or image which access on line.
Students have to prescribe the medicine on line by filling the drug of choice, dosage form, doses, dose
regimen, drug volume/amount, direction of how to dispense and use or apply the medicine at the
appropriate area completed with physician identity at the appropriate area. Then, student should
complete the information about the medicine delivered to patients and documented. The Tutor finally will
assess the prescription based on criteria of rational prescribing on line.
Student projects
The aim of the student project in this block is to prepare a new prescriber to many issues of
drug use in clinical and community which may influence the drug of choice, dose and dose
regimen due to pharmacokinetic changes. Prescription for special populations such as pregnancy
and breast feeding, pediatrics, geriatrics, liver disease and renal disease should always consider
patient’s individual health history and conditions. These issues will be discussed by facilitating

students to develop paper work and presentation. The topics are summarized by group discussion
and evaluators in the following Table 3. The assessment will be performed in the end of block
including of content of paper work and presentation activities as on the assessment form enclosed
in Annex.
Table 3. Topic of student projects
Group
Topic Evaluator
discussion
A1, B1, Prescribing vitamin C injection, Dr IAA Widhiartini, Apt.
A2 B2 efficacy and safety in Covid-19
A3, B3, Prescribing Lopinavir/Ritonavir, dr Wayan Sumardika, PhD
A4 B4 efficacy, safety and suitability in
Covid-19
A5, B5, Prescribing Chloroquin Phosphate, DK Ernawati, Apt., Ph.D
A6 B6 Hydroxychloroquin efficacy, safety
and suitability in Covid-19
A7, B7, Prescribing Favipiravir, efficacy, dr I GM G Surya Trapika, PhD
A8 B8 safety and suitability in Covid-19
A9, B9, Prescribing Azithromycin, efficacy, Dr dr Agung Wiwiek Indrayani
A10 B10 safety and suitability in Covid-19
The short paper work should follow the scientific writing procedure. The reference used in these
paper work and presentation should be the most recent one in 5 years recently and should be
facilitated, examined, and assesses by group facilitator before submitted to evaluator and Block
coordinator on 14 June 2020.
Report Format
Introduction
Review

• Drug description
• Efficacy information: Pharmacokinetic (ADME, Dose, dosage form, duration),

Pharmacodynamic
• Drug safety information: Side effect, adverse drug reaction
• Suitability Information: Contraindication
• Discussion efficacy, safety and suitability
Conclusion
References
Topic, Presentation’s and schedules, Task rules, Assessment by Evaluator will be performed on
June 16h, 2020 by webex meeting.

ASSESSMENT METHODS
Assessment will be carried out by several methods and scheduled as decribed on Table 1.
Table 1. Assesment Methods and time schedule
Formative Assessment Proportion of Score Time
Student Project 10%
Paper work as scheduled
Presentation June 16th 2020
SGD (forum discussion) 10% scheduled
Summative Assessment
Quiz 20% Plenary day
Final Examination 60% June 18th 2020
Total % 100%
Grading Scale
80-100 A
70- <80 B+
65-<70 B
60-<65 C+
55-<60 C
45-<55 D
<45 E

PLANNERS TEAM and LECTURERS
1. Planners Team
NO NAME DEPARTEMENT PHONE
1 Dr. Dra. Ida Ayu Alit Widhiartini, Pharmacology and Therapy 081936005559
Apt, M.Si
2 Desak Ketut Ernawati, S.Si, Apt, Pharmacology and Therapy 081236753646
PGPharm, M.Pharm, PhD
3. dr. Wayan Sumardika, M.Med. Pharmacology and Therapy 082145952088
Ed.,Ph.D
4 Dr dr Agung Wiwiek Indrayani, MSc Pharmacology and Therapy 08886855027
5 Dr I G M G Surya Trapika, MSc, PhD Pharmacology and Therapy 081338367261
2. Lecturers
NO NAME DEPARTEMENT PHONE
1 Dr. Dra. Ida Ayu Alit Widhiartini, Pharmacology and Therapy 081936005559
Apt, M.Si
2 Prof dr I G M A,man, SpFK Pharmacology and Therapy 081338770650
3 Desak Ketut Ernawati, S.Si, Apt, Pharmacology and Therapy 081236753646
PGPharm, M.Pharm, PhD
4 Dr I G M G Surya Trapika, MSc, Pharmacology and Therapy 081338367261
PhD
5 dr. Wayan Sumardika, M.Med. Pharmacology and Therapy 082145952088
Ed.,Ph.D
6 Dr dr Agung Wiwiek Indrayani, Pharmacology and Therapy 08886855027
MSc

FACILITATORS
1. Facilitator Class A
No Name Group Department Phone Venue

1 Dr. I Wayan Juli Sumadi, Sp.PA A1 Anatomy 082237407778 2.09
Pathology
2 dr. Komang Andi Dwi Saputra, Sp.THT-KL A2 ENT 081338701878 2.10
3 dr. Yuliana, S.Ked., M.Biomed A3 Anatomy 085792652363 2.11
4 Desak Gde Diah Dharma Santhi,S.Si., A4 Clinical 0817569021 2.12
Apt.,M.Kes Pathology
5 Dr.dra. Ida Ayu Alit Widhiartini, apt.,M.Si A5 Pharmacology 081936005559 2.13
& Therapy
6 Dr. dr. Luh Putu Ratna Sundari, M.Biomed A6 Physiology 081933070077 2.14
7 dr. I G K Nyoman Arijana, M.Si.Med A7 Histology 085339644145 2.15
8 dr. Luh Putu Ariastuti, MPH A8 Public Health 0818560008 2.16
9 dr. Putu Gede Sudira, M.Sc.,Sp.S A9 DME 081805633997 2.20

10 Desak Ketut Ernawati, S.Si., A10 Pharmacology 081236753646 2.21
Apt.,PGPharm., M.Pharm.,Ph.D & Therapy
2. Facilitator Class B
No Name Group Department Phone Venue

1 dr. Ni Gusti Ayu Agung Manik Yuniawaty B1 Surgery 08123214075 2.09
Wetan, Sp.B(K)Onk
2 Dr. dr. Susy Purnawati, M.KK B2 Physiology 08123989891 2.10
3 dr. I Gusti Made Gde Surya Chandra B3 Pharmacology 081338367261 2.11
Trapika,M.Sc., PhD & Therapy
4 dr. I Dewa Ayu Inten Dwi Primayanti, M. B4 Physiology 081337761299 2.12
Biomed
5 Dr. dr. Komang Januartha Pinatih, M.Kes B5 Microbiology 08123831710 2.13
6 dr. Wayan Citra Wulan Sucipta Putri, MPH B6 Public Health 087761838141 2.14
7 dr.Gede Wirata, S.Ked, M.Biomed B7 Anatomy 081239791628 2.15
8 dr. Ni Putu Wardani, S.Ked.,M.Biomed., B8 DME 08113992784 2.16
Sp.An
9 Prof. Dr.dr. Tjok Gde Bagus Mahadewa, B9 Surgery 0818484654 2.20
M.Kes., Sp.BS(K) Spinal
10 Dr.dr. I Gede Ngurah Harry Wijaya Surya, B10 Obgyn 0811386935 2.21
Sp.OG(K).

TIME TABLE
Date, Day Time Activity Venue Lectures
1 08.00-08.50 Lecture 1:Introduction Block Cisco Webex Dr I AA Widhiartini,

Meeting Apt.
June 4, 2020 09.00-09.50 Lecture 2: Drug Development Cisco Webex Prof I GM Aman, SpFK
Meeting
10.00-10.50 Independent learning
Thursday 11.00-11.50 Break
12.00-12.50 Lecture 3: Drug Regulation and Cisco Webex D Ernawati, Apt. PhD
Drug Promotion Meeting
13.00-13.50 Lecture 4 Medication safety Cisco Webex D Ernawati, Apt. PhD

Meeting
15.00-15.50 Student Project Evaluator/ Facilitator
2 08.00-08.50 Lecture 5: Pharmacovigilance Cisco Webex D Ernawati, Apt. PhD

Meeting
June 5, 2020 09.00-09.50 Independent learning
10.00-10.50 Facilitator
SGD I: L1-5
Friday 11.00-11.50
12.00- PLENARY: Drug development, Cisco Webex Team teaching
12.50 Drug regulation, Drug Meeting
13.00-13.50 Promotion, Medication safety,
Pharmacovigilance

14.00-14.50 Break
15.00-15.50 Student Project Facilitator
3 08.00-08.50 Lecture 6: Drug dosage form Cisco Webex dr IGM G Surya
8-Jun-19 09.00-09.50 Lecture 7: Drug Bioavailability Meeting Trapika, PhD
Monday 10.00-10.50 Independent learning
11.00-11.50 Break
12.00-12.50 Lecture 8: Dose calculation and Cisco Webex dr IGM G Surya

Dose regimen Meeting Trapika, PhD
13.00-13.50 Lecture 9: Rational/Irrational Cisco Webex Dr dr A Wiwiek
prescribing Meeting Indrayani
4 08.00-08.50 Lecture 10: P(ersonal) drug and Cisco Webex Dr I. A. A. Widhiartini,

P(ersonal treatments Meeting Apt.
June 9th 09.00-09.50 Independent Learning

2020
Tuesday 10.00-10.50 SGD II : L6-10 Facilitator
11.00-11.50
12.00-12.50 PLENARY: Drug dosage form, Cisco Webex Team teaching
13.00-13.50 Drug Bioavailability, Dose Meeting
calculation and Dose regimen,
Rational/Irrational prescribing,
P-drugs and P-treatment
14.00-14.50 Break
15.00-15.50 Student Project
5 08.00-08.50 Tutor assisted learning of Team: 1 tutor for 4

selecting P(ersonal) drug SGD group
June 10th 09.00-09.50 Tutor assisted learning of
2020 selecting P(ersonal) treatment
Wednesday 10.00-10.50 Independent Learning
11.00-11.50 Break
12.00-12.50 Lecture 11: Drug information, Cisco Webex dr Wayan Sumardika,

how to keep up-to date about Meeting PhD.
drugs
13.00-13.50 Lecture 12: Drug Compounding Cisco Webex ?
Meeting
14.00-14.50 Independent Learning
6 08.00-08.50 Tutor assisted learning of using Team: 1 tutor for 4

drug information reference and SGD group
Pharmacovigilance
June 11th 09.00-09.50 Independent learning
2020
Thursday 10.00-10.50 Facilitator
SGD III: L11-12
11.00-11.50
12.00-12.50 PLENARY: Drug information, how Cisco Webex Team teaching

13.00-13.50 to keep up-to date about drugs, Meeting
Drug Compliance, Adherence,
and Concordance
14.00-14.50 Break
15.00-15.50 Student Project Facilitator/Evaluator
7 08.00-08.50 Lecture 13: How to assess Dr I A A Widhiartini,

prescribing skills Apt.

June 12th 09.00-09.50 Tutor assisted learning of Google Team: 1 tutor for 4
2020 prescribing in general practice doc/meeting SGD group
Friday 10.00-10.50 Individual Learning
11.00-11.50 Break
12.00-12.50 Tutor assisted learning of Google Team: 1 tutor for 4
13.00-13.50 prescribing in general practice doc/meeting SGD group
14.00-14.50 Individual Learning
8 08.00-08.50 BCS 1: Prescibing Skills and Cisco Webex Team: 1 tutor per 4
Evaluation Meeting/video SGD group
June 15th 09.00-09.50 Independent learning
2020
Tuesday 10.00-10.50 SGD IV: L13 and Evaluation Cisco Webex Facilitator
11.00-11.50 Meeting
12.00-12.50 Break
13.00-13.50 Student Project: Final discussion, Facilitator
Assessment by Facilitator and
Sent to evaluator
14.00-14.50 Plenary: L13, Feedback
15.00-15.50 Prescribing, Evaluation Team teaching
9 08.00-08.50 SP Presentation and Asessment Cisco Webex Team Evaluator
June 16th 09.00-09.50 I. A1, A3, A5, A7, A9 Meeting
2020 10.00-10.50 II. A2, A4, A6, A8, A10
11.00-11.50 Break
Wednesday 12.00-12.50 SP Presentation and Asessment Cisco Webex Team Evaluator
13.00-13.50 Per group: Meeting
14.00-14.50 III. B1, B3, B5, B7, B9
IV. B2, B4, B6, B8, B10
15.00-15.50 Break

10
June 17th
Pre Evaluation Break
2020
Thursday
11
June 18th
10.00-12.00 OASE Udayana
2020 Team Assessment
EXAMINATION
Friday
12
REMEDIAL OASE Udayana Team Assessment
June 29th
2020
Venue: Lecture and Plenary session: see on link of webex meeting (link will be informed later),
Group discussion : Discussion will be held on line by webex meeting or OASE or other on line
application facilitated by group facilitator.

LEARNING PROGRAM
DAY 1
L1: Introduction of Basic Pharmaceutical Medicine & Drug Ethics

Dr I A A Widhiartini, Apt.
Learning Objectives:
1. Comprehend pharmaceutical medicine science and its role in development of drug and drug
use
2. Comprehend prescribing and the core curriculum for future doctors
Abstract
Pharmaceutical medicine can be defined as the discipline of medicine that is devoted to

the discovery, research, development, and support of ethical promotion and safe used
pharmaceuticals, vaccines, medical devices and diagnostics (Edwards et.al, 2007).
Pharmaceutical medicines cover all medically active agents from neutraceutical, through
cosmeceutical and over the counter and ethical drugs. Further, pharmaceutical medicine
involves combination of medical science to evaluate disease, economic sciences to evaluate
the value with respect to the cost, and the ethical and social sciences to evaluate the utility of
any new drug to patients and to society as a whole. Thus, this discipline has a wide range of
knowledge, from drug development, ethics and drug use or prescribing practice.
Prescribing practice is an important activities when pharmacological intervention would

be considered to have a positive impact on the patient’s health. Prescibing represents a
challenging tasks which have to be prepared, involving series of knowledge, skills, and attitude.
Furthermore, many factors from medicine increasingly more complex pharmacology and
pharmaceutical and also patients become more vulnerable to their therapy. Prescribing skills
are involved many subcompetencies beginning from diagnosis to review prescription in the
light of medication safety. (Ross and Maxwell, 2012)
Learning Task:
1. Describe pharmaceutical medicine science field and discuss the specific areas provided new
opportunities fo medical doctor in the future.
2. Describe and map sub competencies involved in the prescribing process.
References:
1. Edward, LD, Fletcher, AJ, Fox, AW, Stonier, PD. (editors). 2007. Practice and principles of
Pharmaceutical medicine. 2nd edition. John Wiley & Sons, Ltd
2. Ross, S and Maxwell, S. 2012. Prescribing and the core curriculum for tomorrow’s doctors:
BPS curriculum in clinical pharmacology and prescribing for medical students. British
Journal of Clinical Pharmacology, 74 (4), p 644-661.
L2: Drug Development

Prof I G M Aman, SpFK
1. Comprehend how the medicine are discovered.
2. Comprehend the milestones of the drug discovery process
Abstract
Drug development begins in the laboratory, undergo laboratory and animal testing then
tested on people to make sure their safety and efficacy before they approve and launch to the
market. Drugs distributed in the market will be monitor whether they are safe for use or
withdrawn from the market circulation due to clinical safety concerns. New drugs are discover
through varieties sources and clinical use of medicine consideration to discover potential drug
candidates as a safe and effective medical treatment. Every process of drug discovery,
however, considering the safety and efficacy of compounds and finally only a small number
even single compound look promising will be finish until the end of study then launch to the
market. Drug development and distribution are regulated and controlled globally by Food Drug
Administration (FDA) and locally in Indonesia by Badan Pengawas Obat dan Makanan Republik
Indonesia (Badan POM RI).

Learning Task:
1. Describe the drug discovery process and what are the specific objective and characteristics
in each process.
2. Describe the sources of potential drugs that are naturally and chemically formed.
References:
1. Edward, LD, Fletcher, AJ, Fox, AW, Stonier, PD. (editors). 2007. Practice and principles of
Pharmaceutical medicine. 2nd edition. John Wiley & Sons, Ltd.
2. Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor 21 Tahun
2015 tentang Tata laksana Persetujuan Uji Klinik.
3. Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor 16 Tahun
2015 tentang Tata Laksana dan Penilaian Obat Pengembangan Obat Baru.
4. https:/www.fda.gov
L3: Drug Regulations

D Ernawati, Apt., PhD
Learning objectives:
1. Understand reasons for drug regulation
2. Be able to describe some regulations on drugs used in Indonesia
3. Be able to explain drug classification based on Indonesian regulations
Abstract
This topic provides introductory information of regulations on medical practice and

drug used in relation to medical practice. Medical doctor needs to have certificate of
competency, to register and to have a license as a medical doctor prior to practicing as a
medical practitioner. Several regulations and policies will be discussed in this topic such as
Undang-undang No 29 Tahun 2004 regulates medical practice in Indonesia, Undang-undang No
36 Tahun 2009 about Health, Undang-Undang No 35 Tahun 2009 on Narcotics, Undang-undang
No 5 Tahun 1997 on psychotropic drugs, and Peraturan Pemerintah No 51 Tahun 2009 on
Pharmaceutical Care. Further, The Indonesian Government created regulations on drug
promotion and advertising on health related service in Undang-Undang No 8 Tahun 1999 on
Consumers Protection and Permenkes No 1787/Menkes/Per/XII/2010. Drug schedule available
in US and Australia will also be discussed in the lecture.
Learning task:
1. Explain reasons medical doctor needs to learn about drug regulations
2. Discuss differences of drug classification in Indonesia, America, Australia, Singapore and
Malaysia
3. Discuss distributions and sanctions of psychotropic and narcotics drugs based on
Indonesian Regulations.
4. Discuss the difference between patent, generic, and brand name drugs and give examples
L3b : Drug Promotion

1. Understand ethics in drug promotion
2. Understand the potential for marketing process to change attitudes in prescribing
3. Understand uses and abuses of drug promotion.
Abstract
Advertisement and promotion on health and drugs have been regulated by the
Indonesian Government with Permenkes 1787/Menkes/Per/XII/2010. The latest regulation on
drug Promotion is regulated under PerKa BPOM No 8 in 2017 on guideline for monitoring drug
promotion The regulation aims to ensure any promotion on health services and product have
to be informative, educative and accountable. The promotion should meet healthcare
professional ethics, advertisement ethics, and other regulations related to the promotion of
products or health services in the country. The product is not limited to medicinal products but

also traditional, alternative and complementary products. In this instance, promotion is
emphasized on drug.
Learning Task:
1. Discuss where to get the medications and how they can be promoted
a. Midazolam Tab
b. Sertraline Tab
c. Oxycodone Injection
d. Extract Curcuma Capsule
2. A foreign pharmaceutical company released a new product in Indonesia. In the leaflet they
reported some testimonial of patients with different diseases. Discuss your arguments
about this phenomenon based on ethics in drug promotion.
3. Criticize drug promotion material provided to you –(will be provided during lecture)
References:
1. World Health Organisation. 1988. Ethical criteria for medicinal drug promotion. Geneva
2. Tripathi CD. 2017. Critical appraisal of drug promotional literature using World Health
Organisation Guideline
L4: Medication Safety

1. Be able to describe the role of prescriber in medication safety
2. Be able to define medication safety.
Abstract
Medication safety may be defined as drug related problems, adverse drug reaction,
adverse drug event, medication misadventure and medication errors in literature. Medication
error is the focus of the lecture because according to National Committee Council of
Medication Error Reporting and Prevention (NCCMERP), the errors are preventable events

while the medications are under the care of healthcare professional. Thus, it is every
healthcare professional business to be aware of their contribution of the errors. Physician has
the role to prescribe medication in the medication delivery. Thus, they may potentially
contribute to the error. The error may result from technical and non-technical problems which
will be discussed in the lecture.
Learning Task:
1. Discuss about individual and system errors which may contribute to medication errors
2. Discuss how prescriber can identify and reduce errors?
3. Discuss how collaboration amongst healthcare professionals potentially reduce medication
errors?
4. Discuss about technical and non-technical problems which contribute to prescribing errors
5. What is high alert medication? Give three examples of this medication.
6. Case scenario:
Mr Wayan is hospitalized for a heart attack and received aspirin 100 mg once daily as one of
his medications on arrival at the hospital. Upon interviewing the patient family, you found
that the patient were also on aspirin 80 mg which was given by his family doctor. It was
revealed that Mr Wayan had took earlier on the day. How do you response on this case?
Discuss what happen to this patient, and how to prevent this from happening?
References:
1. World Health Organisation. 2019. Five moments of medication safety
2. World Health Organisation. Patient safety curriculum guide: multiprofessional edition
DAY 2
L 5: Pharmacovigilance
1. Students will be able to describe the importance of pharmacovigilance (PV) in drug used
2. Students will be able to report cases on adverse drug reactions in yellow form.
Abstract
WHO defined pharmacovigilance as 'the pharmacological science and activities relating

to the detection, assessment, understanding and prevention of adverse effects or any other
drug-related problem‘ Pharmacovigilance is the practice of monitoring of drug after it has been
given drug license to be marketed in the community. It is a Phase VI stage in drug
development. The success of PV will depend on the reporting of suspected adverse drug
reactions. Reporting of suspected adverse drug reaction can be spontaneously and
systematically using pharmacoepidemiological methods. Stakeholders responsible in PV
reporting will be discussed.
Learning task:
1. Explain ways of adverse drug reaction can be reported.
2. Discuss type of adverse drug reactions to be reported in the yellow form.
3. Discuss the importance of prescriber in pharmacovigilance.
4. Discuss role and responsibility of stakeholders in public health program on
pharmacovigilance.
References:
1. Badan Pengawas Obat dan Makanan. 2019. Farmakovigilans (Keamanan Obat): Panduan
deteksi dan pelaporan efek samping obat.
2. Pugatch M, Torstensson D, Laufer M. 2014. Developing a culture of pharmacovigilance:
Towards International Best Practices. Pugatch Consilium.
3. World Health Organisation. 2006. The safety of medicine in public health program:
pharmacovigilance an essential tool.Geneva.
DAY 3
L 6: Drug Dosage Forms

dr I G M G Surya Trapika, PhD
2. Students be able to describe aspect of biopharmaceutical factors in drug dosage form
3. Students be able to describe patient’s considerations when selecting dosage forms
4. Students be able to describe drug dosage forms and their route of drug administration
5. Students be able to describe advantage and disadvantages of drug dosage forms.
Abstract
Drug dosage forms can be classified based on their physical properties such as solid,
semisolid and liquid dosage forms. According to route of administration, drug dosage forms
can be categorized into enteral, parenteral and topical route of administration. Knowledge of
drug dosage form is also essential in rational drug prescribing because patient’s conditions,
biopharmaceutical aspect of drugs and social and economical of the patients will determine
the selection of dosage form. Patient’s condition in this instance may involve their ages, their
level of consciousness and the diseases – topical or parenteral used. Further, there are several
reasons such as biopharmaceutical aspects in selecting certain dosage forms in drug
formulation.
Biopharmaceutical is the area study the relationship between physical, chemical and biological
sciences as they apply to drug, dosage forms, and drug actions. Drug properties such as drug
solubility, dissolution and permeability will determine their classification into
Biopharmaceutical Classification System (BCS). Their classification can be seen in the following:
I. High solubility and high permeability, such as chloroquine, diltiazem
II. Low solubility and high permability, such as carbamazepine, glibenclamide
III. High solubility and low permeability, such as atenolol, captopril
IV. Low solubility and low permeability, such as furosemide, cyclosporin
Learning Task:
1. Discuss the importance of biopharmaceutical in drug discovery and regulatory practices.
2. Discuss the advantages and disadvantages of enteral, topical and parenteral of route of
administrations. Give some examples of drugs in these routes
3. Case scenario:

Krisna, 14 months old boy was experiencing fever, cough and cold. Please discuss which
dosage form is the most rational to this patient?
4. Discuss the appropriate dosage form for the following case
a. An 80 yo woman patient needs a ferrous supplement in her diet.
b. A 55 yo man was found collapsed and unresponsive by his relatives. He was taken to
Emergency Department. Upon arrival he had a history of epilepsy and Type 2
Diabetes.
References:
1. Alen LV, Popovich N, Ansel HC. 2011. Ansel’s pharmaceutical dosage forms and drug
delivery. Lippincott William and Wilkins.
2. Vogenberg, Barash, Pursel. 2010. Personalised medicine: Part 1 Evolution and development
into theranostics.
L 7: Drug Bioavalability
1. Be able to understand drug bioavailability
2. Be able to describe and understand factors affecting drug bioavailability.
3. Be able to describe factors modifying oral bioavailability
Abstract
Bioavailability is defined as the fraction (F) of the administered dose of a drug that
reaches the systemic circulation in an active form after administration. The fraction is 100%,
consider as the entire dose enters the circulation when a drug is administered by IV injection.
However, for other routes of drug administration, especially drugs given orally, the F usually
below 100%. The oral bioavailability of a particular drug is determined by dividing the area
under curve (AUC) of an orally administered dose of the drug (AUC oral ) by the AUC of an
intravenously administered dose of the same drug (AUC IV ). The bioavailability of orally

administered drugs can be reduced by factors affecting drug’s absorption (including
pharmaceutical and biologic factors) and local metabolic degradation.
Learning tasks:
1. Please describe and explain factors affecting drug bioavailability

2. Please explain about first-pass metabolism
3. Please explain strategy or possibility to enhance the oral bioavailability.
4. Case scenario:
Mr. A was diagnosed with hypertension and treated with drug “X”. Mr. A showed inadequate
response to this medication due to poor bioavailability of this drug. What strategies should be
taken to improve Mr A’s treatment?
References:
1. Brown, M.J. (Morris J., Sharma, P. (Neurologist), Mir, F., Bennett, P.N., n.d. Clinical
pharmacology.
2. Katzung, B.G., York, N., San, C., Athens, F., Madrid, L., City, M., 2018. Basic & Clinical
Pharmacology Fourteenth Edition a LANGE medical book.
3. RITTER, J.M., FLOWER R. J., Rang, H.P., MacEwan, D., Lok, Y.K., Henderson, G., 2020. Rang &
dale’s pharmacology, international edition. ELSEVIER HEALTH SCIENCES.
4. Wecker, L., Taylor, D.A. (David A., Theobald, R.J., n.d. Brody’s human pharmacology :
mechanism-based therapeutics.
L 8: Dose Calculation and Dose Regimen

1. Review methods and rules of expressing dose and dosage regimens.
2. Determine dose properly to the patient need.
3. Estimate dose regimen for drug therapy.

Abstract
The goal of therapeutics is to achieve a desired beneficial effect with minimal adverse
effects. When a medicine has been selected for a patient, the clinician must determine the
dose or dosage regimen that most closely achieves this goal. A dose is calculated to get any
specified amount of medication taken at one time. Dosage regimen then prescribed
administration of the dose, number, and frequency of a specific period of time refer to the
drug concentration at the target.
The “standard” dose of a drug is based on trials in healthy volunteers and patients with similar
ADME. The dose will not be suitable for every patient. Several pathophysiological process
indicate dosage adjustment even individualization as pharmacokinetic change. Taking dose
medication improperly can have serious consequences to patient condition.
Pediatric dose may be calculated based on the age and weight rules for pediatric dosing. Some
times when pediatric dose unavailable but adult, the several rule such as Young’s rule,
Cowling’s rule, Clark’s rule and Fried’s rule may useful. The dose and the dosage regimen is a
just a measure and help us to control the treatment at the beginning, the success of
therapeutic outcome will be achieved by doing monitoring and evaluating the patient’ sclinical
condition’s as long as their treatment.
Drug doses are expressed in metric (mass units such as mg/kg BW) and in system
International Units (SI unit) for certain mixture drug such as Insulin which does not have
specific molecular weight. Dose unit could be specified by using apothecary system
measurements such as tea spoon full and grain.
Learning Task:
1. Discuss 4w1H the dose and dosage regimen.
2. Discuss the several rule of pediatric drug dosing such as Young’s rule, Cowling’s rule,
Clark’s rule and Fried’s rule for pediatric dose calculation. Are they differ?
3. The doctor has prescribed Acetaminophen 500mg tablet and told to his patients that he
should take Acetaminofen every 4 to 6 hours and the patient was confuse to the direction .
Discuss which one of the medical term/abbreviation was appropriate to recommended
dose regimen between QID and Q6H?

4. Bobby, a five years old boy was prescribed antibiotics Azithromycin 10 mg/kg BW per day
for 3 days. Discuss the dose and dose regimen. There are 3 types available: dry syrup
200mg/5ml, tablet 250mg, and tablet 500mg, which one is suitable for him.
References:
1. Holford, N.H.G. 2012. Pharmacokinetics & Pharmacodynamics: Rational Dosing & the Time
Course of Drug Action (In: Katzung, B. B., Masters, S.B., Trevor, J. editors. Basic and Clinical
Pharmacology 12th ed.) McGraw-Hill Medical. Pp:37-51. (Standar Text Book)
2. Sunil S. Jambhekar, P. J. B. (2009) ‘Basic Pharmacokinetics - 1st Ed’.Pharmaceutical Press. Pp:
1-12(Additional Readings)
3. Mayor, S. (2017) ‘Pharmacokinetics: optimising safe and effective prescribing’, Prescriber,
28(3), pp. 45–48. doi: 10.1002/psb.1551. (Additional Readings).
L 9: Rational Irrational Prescribing

Dr dr Agung Wiwiek Indrayani
1. To encourage rational use of drugs

2. To enhance understanding of use of medications in accordance with scientific knowledge
3. To ensure the concept of rational prescribing including of: that patient get right medicine in
right dose and to get familiar with organization of Physician’S Desk Reference (PDR) to help
in selecting medications.
Abstract
Prescribing is the most important tool used by physicians to cure illness, relieve
symptoms and prevent future disease. Prescribing is also a complex task that requires
diagnostic skills, knowledge of common medicines, understanding of the principles of clinical
pharmacology, communication skills and the ability to make decisions based on judgement of
potential benefit and risks, having taken into account available evidence and specific factors
relating to the patient being treated.

Rational prescribing describes a logical approach that includes making a differential
diagnosis, estimating prognosis, establishing the goals of therapy, selecting the most
appropriate treatment and monitoring the effects of that treatment. Rational prescribers
should attempt to maximize clinical effectiveness, minimize harms, avoid wasting scarce
healthcare resources and respect patient choice. Use of proper format for prescribing writing
ensures appropriate use of drug and helps in minimizing errors. Physicians must take account
of appropriateness, effectiveness, side effects, contraindications and cost when prescribing any
medicine. Irrational prescribing will happened when physicians lack of knowledge. Physicians
commonly make probabilistic judgements that involve interpreting trial evidence in the light of
specific circumstances such as patients wishes, availability of resources and previous adverse
events
The patients should be fully informed about the goal of treatment before commencing
it, especially for preventive therapy where there is no prospect of immediate improvement in
quality of life and any benefits will only delivered by adherence to treatment over many years.
The treatment of diseases by the use of essential drugs, prescribed by their generic name has
been emphasized by the WHO and the National Health Policy of Indonesia.
Learning Task:
1. Explain the process of rational prescribing ?

2. Explain the goals of therapy ?
3. Explain about the factors that influence rational drug and irrational drug use.
4. What is your opinion about
a. Prescribing of antiviral drugs for influenza in healty adults
b. Prescibing of Statin therapy in patient with a malignancy
c. Prescribing of NSAID for patient with impaired renal function
d. Prescribing of Macrolide antibiotics in patients taking warfarin
3. Please write a process to do rational prescribing in this case below
Case : A 25 year old pregnant women came to clinic complaining of vaginal discharge
from the past three days and itching. Patient name Rita with body weight 50 kg. Doctor
has examined and diagnosed as a candidiasis vaginal infection.

References:
1. Katzung, B.G., and Lofholm, P.W. 2018. Rational Prescribing and Presciption Writing In Basic
and Clinical Pharmacology. Ed 13. Editor Weitz M and Boyle P. Mc Graw -Hill Education
2. Morgan, S. 2017. Teaching rational prescribing to general practice registrars : A guide for
superfisors. AFP. 46(3) 1-5.
3. Maxwell, S.R.J. 2016. Rational prescribing: the principles of drug selection. Clinical Medicine.
6 (5) 459-464.
Day 4
L 10: P(ersonal) drug and P(ersonal) treatments

Dr I A A Widhiartini, Apt.
1. Be able to applied the concepts of P-drugs as a strategy to maintain rational drug use.
2. Be able to choose one between different drugs on the basis of comparative efficacy,
safety, cost, and suitability which is the best for patients individually.
Abstract
The concept of P(ersonal)-drug were introduced by clinical pharmacology expert in

WHO and documented well at Guide to good prescribing book. It is an essential lesson for
medical, dentistry, pharmacy, and also nurse student in implementing rational
pharmacotherapy.
The Personal (P)-drugs are the drugs personal to the doctor. They were familiar drugs
that are going to prescribe regularly for a certain condition. P-drug is a drug that is ready for
action, included of the name of a drug, strength, dosage form, dosage schedule, and duration
of treatment for a specified condition with necessary warnings and information to the patients.
Different countries or region tend to have different epidemiological condition and the doctors
may have different medical culture, and individual interpretation of disease and drug. They
formulate their national formularies and essensial list drug refer to their needs, so P-drugs
may differ and specific between them. P-drug should never be the drug that has been
suggested by others although they are senior clinical peers, senior colleagues, or sales
representatives. It is because of that the latest and the most expensive drug is not necessarily
the best, the safest or the most cost-effective. A set of P-drug that developed by own self may
improve doctors ability to applied pharmacological concepts and drug related data effectively
even change to alternative drugs; and the last important thing is that the doctor should be
responsible to their patient’s.
There are 5 steps when developing P-drug, including of: (1) Define the diagnosis; (2) Specify the
therapeutic objective;(3) Make an inventory of effective groups of drugs; (4) Choose an
effective group according to criteria; (5) Choose a P-drug.
P(ersonal) treatments is a proper treatment needed to overcome patient’s problem.
The treatment could be non pharmacological (non-drug therapy) such as an advice and
information, drug treatments, referral for treatment, or combination of this. Non-drug
treatment might be need to solve minor complaints or illness as your P-treatment. When drug
treatment would be the only tools, the following steps ensure that your therapy appropriate
to your patient’s: (1) Define the patient’s problem; (2) Specify the therapeutic objective;
(3)Verify the suitability of P-drug; (4) Write a prescription; (5) Give informations and warnings;
(6) Monitor (and stop) treatment.
Learning Task:
1. Describe the difference P-drugs and P-treatments.
2. Describe the process of choosing P-drugs schematically.
3. Describe P-treatments for Ani (7-years old girl) who has acute diarhoea with mild dehydration.
References:
1. Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA, 1995, Guide to Good Prescribing, World
Health Organization Action Programme on Essential Drugs, Geneva ( Standard Reference)
2. Scordo, KA. 2014. Teaching students about the WHO Guide to Good Prescribing. The Nurse
Practitioner. March. Lippincott Williams & Wilkins. available at www.tnpj.com
3. Ross, S. and Maxwell, S. 2012. Prescribing and the core curriculum for tomorrow’s doctors:
BPS curriculum in clinical pharmacology and prescribing for medical students. Br J Clin
Pharmacol, 74 (4). p 644-661
Day 5
Tutor assissted Learning P(ersonal) Drug
1. Managing pharmacological concepts

2. Evaluate drug information
3. Compiling an own essensial drug list
Direction for Student and Tutor

Tutor assist virtually the student to compile students essensial drug list, a list of drug of first
choice for one of five common condition on Table Scenario P-drug below. Group will finish all
cases, please share only one cases of five per sub-group in this session. Student can use
pharmacology text book, pathophysiology, and other on line drug information source as
references. One group develop 1 case in detail by fiil in the appropriate section as showed in
Table Scenario P-drug. In the end of session student submit the student’s assignment to
tutor’s group.
References:
2. Milan C, Richir, Jelle Tichelaar, Eric CT Geijteman, Vries TPGM, 2008, Teaching Clinical
Pharmacology and Therapeutics with an Emphasis on the Therapeutic Reasoning of
Undergraduate Medical Students, J Clin Pharmacol 64, 217-224.(Additional reading)
3. Anderson PO, Knoben JE, Troutman WG, 2002, Handbook of Clinical Drug Data, 10th Ed,
McGraw Hill. (Additional reading)
4. Hamilton P and Hui D, 2006, Drugs and Drugs: A Practical Guide to the Safe Use of Common
Drugs in Adult, 2nd Ed, Canadian. (Additional reading).
5. https://student.passassured.com/flash/section_tutorials/learn/calc_08_web_old/2.html

Scenario P-drug
Table Scenario P-Drugs
Scenario P-drugs
Cases
1. Mr Nyoman Bagus, a 40-year old man came to the public health

centre with a sign of white spots on the whole skin. In the examination
of KOH 20 % present short hyphae and spores were obtained. Try to
develop P-Drugs for this case.
2. Ms Made Rani a 37 year old women came to the public health centre
with chief complain diarrhoea since 2 days ago with bloody diarrhoea
and mucous. Patient have high temperature, and have symptom nausea
and vomiting. Laboratory result show E. Histolytica. Try to develop P-
Drugs for this case.
3. Mr Ketut Dona, a 45-year old man came to the public health centre
complaining of yellow discolouration, thickened and crumbly of toenail
Cases since a month ago. The result of physical examination nail plate
separation from nail bed and thickened, discoloured yellow, broken and
dystrophic nail. Try to develop P-Drugs for this case.
4. Anita 15 years old came to clinic with complain cough with sputum.
The doctor has diagnose patient with bronchitis acute ec bacteria.
Patient have allergy with amoxicillin. What kind of antibiotic can give to
this patient ? Try to develop P-Drugs for this case.
5. Mr Putu, 40 years old, has had fever (temperature 39.60C) since 3

days ago. He complaints chills, malaise, and cough also have pleurisy,
dyspnea. On physical examination are finding tachpnea, rhonchi,
bronchial breath sounds, and dullness to percussion over the involved
area of the lung, and show less infiltrates. His vital sign stable, no

altered mental status, no hypoxemia.
Step 1 Define the diagnosis

[describe the disease/disorders, study the pathophysiology of the
disease. which have implication for the treatment i.e preventive,
treatment/ causative or symptom]
Step 2 Specify the therapeutic objective
[describe how can the disease /disorder can be
prevented/treated. The rational based on pathophysiology point
of view]
Step 3 Make an inventory of effective groups of drugs
[compiling the therapeutic objective, select any group based on
criteria efficacy pharmacokinetic and and pharmacodynamic) find
the group of drugs has a specific action ]
Drug action
Group Drug 1
Group Drug 2
Etc. See on Ref. Good Prescribing
Step 4 Choose an effective group according to criteria

[Do the furher comparison of pharmacological action based on
safety, suitability and cost of treatment. Which group have less
side effect, appropriate dosage form, easy to
handle/administration but also have a good price? ]
Efficacy Safety Suitability
Group Drug 1
Group Drug 2
Etc.
Step 5 Choose a P-drug

[Choose an active substance and a dosage form, a standar dosage
schedule, standar duration of the treatment]

Tutor assissted Learning P(ersonal) Treatment
Tutor’s Group
1. Comprehend the process of treating a patient
2. Make a treatment plan
Direction
1. Defining The therapeutic objective

Tutor assist virtually the student to compile students treatment plan systematically. Student
assignment are presented in Table below. Read the cases and make a rational decribed
what the therapeutic objective for the treatment which could be have a similar symptom
or complaint. Then fill in your answer in appropriate section of the Table of Scenario P-
treatment Step-2 below. Students try use or access clinical pharmacology text book,
pathophysiology individually supervising by Tutor’s group on line.
In the end of session student s have to submit the student’s assignment individually.
Scenario P-treatments-Step 2 Define your therapeutic objective
for the treatment of pain
1. a 67-year old female with history of rectal carcinoma, and intractable pain
due to metastasis in lumbar spine; no reaction to paracetamol/codeine
suppositories
2. a 30-year old office clerk with tension headache for 3 months, who smokes
30 cigarettes a day
Cases
3. a 20-year old student with tension headache for 3 months, with an
important examination coming up in one week’s time
4. a 41-year old farmer, kicked by his horse. Pain in the chest while breathing
and coughing, due to 2 fractured ribs.
(Cited from: WHO Guide to Good Prescribing)
1.
RATIONAL 2. etc.
References:

2. Giving Information, instruction, and warning proportionally to the patients
Tutor assist virtually the student to compile what and how to give information, instruction,
and warning to the patients to ensure the adherence and increase patient’s awareness to
the treatment. Student assignment are presented in Table below. Read the cases and make
a priority issues concerning the prescription below. Then fill in your answer in appropriate
section of the Table of Scenario P-treatment Step 5 below. Students try use or access
clinical pharmacology text book, pathophysiology individually supervising by Tutor’s group
on line.
In the end of session student s have to submit the student’s assignment individually
Scenario P-treatments- Step 5

Give information, instructions, and
warning
You prescribed oral anti diabetes tablet
Glimepiride doses 1mg for 30 days therapy
for Ibu Sarini. You asked her to take the
medicine once daily in the morning, about
15 minutes before breakfast. She never
Case 1 takes tablet for treatment Diabetes. She
was so worried about her first treatment.
Which three priority issues concerning the

drug you prescribe would you communicate
with the patients?

• ……………………………………………………..
• ……………………………………………………..
• ……………………………………………………..
You prescribed common cold drugs to a

driver taxi as he got mild flu since
yesterday evening. You aske him to take
common cold syrup 15 ml three times daily
Case 2 if he needed. He was still working but
sleepy.
Which priority issues concerning the drug

you prescribe would you communicate with
the patients?

•
• …
References:
2. Milan C, Richir, Jelle Tichelaar, Eric CT Geijteman, Vries TPGM, 2008, Teaching Clinical
Pharmacology and Therapeutics with an Emphasis on the Therapeutic Reasoning of
Undergraduate Medical Students, J Clin Pharmacol 64, 217-224.(Additional reading)
4. Hamilton P and Hui D, 2006, Drugs and Drugs: A Practical Guide to the Safe Use of Common
Drugs in Adult, 2nd Ed, Canadian. (Additional reading).
5. https://student.passassured.com/flash/section_tutorials/learn/calc_08_web_old/2.html

L11: Drug information (How to keep up to date about drugs)
dr. I Wayan Sumardika, M.Med.Ed., Ph.D
Learning Objective:
1. Able to assess drug information from reliable website.
2. Able to evaluate new drugs information during pandemic.
Abstract
More than thousand drugs are available worldwide, the number of new drugs also
increase every year. Based on the data of Badan Pengawasan Obat dan Makanan (BPOM),
there are 16.630 new drugs have been approved for used in Indonesia in the last 5 years.In US,
until May 2020, there are 20 new drugs are approved for use.The availability of new drugs
often means new treatment options for patients and advances in health care for the publics. In
the other hand, some drugs are also withdrawn from the market because of some reasons
related to patient’s safety or other reasons. As Medical Doctor we need to keep updating our
knowledge about drugs information especially that commonly we use. Updating our
knowledge about drugs information also very crucial during the pandemic, like the pandemic of
Covid-19. The information of drugs, now day, are easily to assess, online or offline. Many
websites now available and provide information about drug, some are government-based
website some are company-based website. Information of drugs trial also are available to asses
from some free journals.
Learning Tasks:
The Covid-19 pandemic has changed how human interact each other’s, it also changed
how the health worker manage the patients. The information about drugs that are used to
treat the Covid-19 patients also updated continuously. Researcher investigated the drugs that
potentially benefit for Covid-19 patients and publish their finding to keep us informed. Please
discus in your group some of the following issues.
1. Please make a list about the drugs that are used to treat Covid-19 in Indonesia.

2. Based on your list, please find the following information about the drug.
a. Indication
b. Mechanism of action
c. Side effect
d. Warning or Contraindication if any.
3. Based on your list, please explain why the drugs potentially benefit for treatment of
Covid-19 patients.
References:
1. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-
therapeutic-biological-products/novel-drug-approvals-2020
2. http://e-fornas.binfar.kemkes.go.id/front/home
3. http://cekbpom.pom.go.id/index.php/home/recall/czF0OGQyYzEzNnJjajEzcWN2cjZtcnQwc
HE4cjN3M2I
4. https://www.mims.com/indonesia
L12: Compounding Medications

Dr dra I A Alit Widhiartini, Apt., M.Si.
Learning Objective:
1. Comprehend the issues of compounding medication on medication safety framework.
Abstract
Before doctors and pharmacies created personal drug therapies. They prescribe and
dispense according to the patient’s needs individually and the medical also scientific
pharmaceutic principles. The development of the commercial manufacturing transitioned
conventional this medicines dispensaries to standardized drug products that regulated under
good manufacturing practices strictly. The drug products currently meet the general patient’s
population. In certain clinical condition compounding medicines are useful but problem arise
regarding the drug indication. This topic will focus on the principles apply to compounding
medicines, the benefit-risk on medication safety frame.
Learning Task:
1. Compare compounding medicines and off label medicines.
2. Decribe the safety and regulation of compounding medication.
3. Decribe the benefit and risks of compounding medicines.
References:
1. Sellers, S. and Utian, W.F. 2012. Pharmacy Compounding Primer for Physicians. Prescribe
Beware. Drugs: 2(16), p 2043-2060.
2. Widyaswari, R. and Wiedyaningsih, C. 2012. Evaluasi Profil Peresepan Obat Racikan dan
Ketersediaan ormula Obat untuk Anak di Pusesmas Propinsi DIY. Majalah Farmasetik: 8 (3).
3.https://www.pharmpress.com/files/docs/Pharmaceutical%20Compounding%20and%20Dispensing%2
0Sample.pdf
4.https://www.researchgate.net/publication/322259081_Compounded_medication_for_patients_with
_rare_diseases
https://www.racgp.org.au/download/Documents/AFP/2009/January/February/200901fois.pdf
DAY 6
Peer assissted Learning: Using drug information reference

Tutor.s Group and Pharmacovigilance
Tutor’s Group
- Using drug information
- Report adverse drug reaction in yellow form
Direction:
Student download the yellow form https://e-meso.pom.go.id then try to make a report by fill
in MESO form. Try to use drug information reference to learn in depth the cases below and
the drug information needs. This activity will be supervised by tutor’s group.

Written Cases Simulation
1. A patient (25 yo, female) took Levofloxacin Tablet 750mg once daily. The patient
experienced swollen eyes, skin rash, nause and vomiting few hours after taking the
medicine. She went to the prescriber and reported her conditions. The prescriber indicated
to replace the medicine. She took paracetamol for antipyretics two hours before taking
Levofloxacin. Upon medical history taking, she had received Levofloxacin Tablet 500mg few
month ago. She reported to have nausea and vomiting but she continued taking the
medicine for five days. If you are the prescriber for this case, please write your finding in the
yellow form.
2. Mr Tan Jatmiko, a-20 years old man, BW 42 kg diagnosed with gastritis and prescribed
Domperidone tablet p.o. therapy three times a day, Sucralfate syr. 15 ml three times a day,
Pantoprazole i.v. : 2 times a day. Therapy began on June 2, 2020. On June 3, 2020. He
experienced swollen lips, itch on the hands and feet after taking Domperidone. On 3 June
2020 Domperidone was stopped, other drugs were still given to patients and patients were
prescribed Cetrizine. On June 5, 2020 the patient condition got better, he did not experience
itchy lips. The patient has no history of previous allergies.
DAY 7
L 13: How To Assess Prescribing Skills

Dr I A Alit Widhiartini, Apt.
1. Describe various methods of prescribing skills assessment
2. Prepare to present prescribing skills
Abstract
Prescribing skills assessment are developed to ensure prescribing skills competence of

medical student. Prescribing skills assessment formats within a medical school might include:
written test and practical test. Written test such as multiple choice question (MCQ), extended
matching question (EMQ), structure short answer questions, modified essay question (MEQ),

project reports or posters, log book/portfolio are easier to conduct at a definite time and save
money. Written test might appropriate to measure more the cognitive aspect but less skills
and attitudes. Practical/clinical aspect of prescribing including of multiple station exams, direct
observation of performance (observe long cases, mini clinical evaluation exercise (Mini-CEX),
oral presentations (e.g projects, case-based discussion), structured oral exams are designed to
mimick or simulated a real clinical situation where patient do consultation to doctor naturally.
They would be accurate for prescribing skills assessment, but they need various resources
including of many clinical assessors, room for setting location naturally, patients or patients
simulation and also instruments which are well designed and prepared. There is no single ideal
format for prescribing skills assessment. British medical council develop a simulator prescribing
skills assessment for medical student even newly doctors by using on line application.
Prescribing skills would be assess by several sub competence which is highlighted in the
prescribing process (Ross and Maxwell, 2012) described on Table 4 below. The assessment
might be develop in stages according to the student’s level competence of human body
system. Udayana design and separate the prescribing skills assessment into 2 stages as
showed on Table 5 and try to use on line learning to enhance the capacity in delivering
prescribing skills training. Developing the right assessment for a rational prescribing skills in
light of medication safety is a challenge as well as e- learning integrated with limited capacity.
Table 4. Sub-competencies involved in prescribing process

Make a diagnosis
Establish therapeutic goal
Choose the therapeutic approach in discussion with the patient
Choose the drug
Choose the dose route and frequency
Choose the duration of therapy
Write the prescription
Inform the patient
Monitor drug effects
Review/alter prescription in the light of further investigation
Cited from: Ross, S. and Maxwell, S. 2012. Prescribing and the core curriculum for
tomorrow’s doctors: BPS curriculum in clinical pharmacology and prescribing for
medical students. Br J Clin Pharmacol, 74 (4). p 644-661
.
Table 5. Concepts of Prescribing Skills Assessment
Level Cemester 2 Cemester 3-7, Junior doctor
Aspect Writing Prescription Prescribing Process
What to do Transform the drug of Solve the problem showed on written cases or
choices, dosage forms, using patient simulation.
dosages,
State the diagnosis, therapeutic goals,
frequency/duration and
establish the drug of choice, dosage forms,
duration of drug use into
dosages, frequency/duration and duration of
prescription sheets
drug use on prescription sheet. Then describe
according to patients
the information of drugs: main effect and
characteristic described
adverse effect for prevention.
on a written case
Forma MCQ, Matching Question, OSCE, MiniCEx

Modified essay question,
OSCE
Learning Tasks:
1. Describe various prescribing assessment format in detail.
2. Describe some strengths and weakness written format dan practical format for a various
typical prescribing skills assessment?
References:
1. Ross, S. and Maxwell, S. 2012. Prescribing and the core curriculum for tomorrow’s doctors:
BPS curriculum in clinical pharmacology and prescribing for medical students. Br J Clin
Pharmacol, 74 (4). p 644-661.

Tutor assissted learning of prescribing in general practice 1, 2, 3
Tutor Group
1. Able to write an appropriate and good prescription: legal, legible, and complete.
Direction:
Prescribing skills training will be designed in groups on line application (1 tutor per 4
groups). Each student should response the 10 written case individually then write the
prescription on the prescription form based on prescription assessment on Appendix
Prescribing Skills Assessment. Tutor in group should give input directly to the group. Students
has to always refer his work to Prescription Assessment. The student use prescription sheet to
complete the task.
Cases:
1. Ana, a 25 years old girl need Adrenalin injection 2 ampoules, Dexametason 0,5mg 2
ampoules, and syringes injection 3 ml 3 pieces for emergency cases. Prescribe appropriately
for her.
2. Agung, a 27 years old came to the doctor and complained of headaches since this morning.
There is no history of drug use. He just fatigue due to staying up late. Patients are advised to
take a rest and take Acetaminophen 500mg tablet three times daily if needed. Prescribe 1
generic name and 1 trade name drugs.
3. Bobby, a five years old boy got respiratory infectious disease and recommended antibiotics
Azithromycin 10 mg/kg BW per day for 3 days. Find the dose, dose regimen, information
how to take the medicine. There are 3 types available: Azitromycin dry syrup 200mg/5ml,
Azitromycin tablet 250mg, and Azitromycin tablet 500mg, prescribe appropriately for him.
4. Joni, a-40 years old diagnosed hyperlipidemia. He recommended Simvastatin 10 mg for 15

days. Write the complete prescription.
5. Dony, a-30 years old man need Hydocortison 2,5% cream and also Urea 10% cream. He
should applied the medicine twice daily after bath as a part of dermatitis treatment. Write
the complete prescription.
6. Mr Ketut Adi, 30 years old need antitusive Codipront expectorant Syr. 60ml. He has to take it
three times daily for 3 days. Write the complete prescription.
7. Ani, 17 years old need Oralit formula (Natrium klorida 0,52 g, kalium klorida 0,3 g, trinatrium
sitrat dihidrat 0,58 g, glukosa anhidrat 2,7 g) 5 sacchets for diarrhea. She was told to dissolve
Oralit in 200ml warm water before drink it. Write the complete prescription.
8. Mr Amir, 35 years old need gargle mouth wash for halitosis problem. Find the complete
drug information for him and write the prescription.
9. Mrs Yeni, 40 years old need antibiotic Ofloxacin for treatment otitis media supurative
chronic. Find Find the complete drug information for her and write the prescription.
10. Made Tony, 20 years old need an inhaler for his Asthma therapy. He need Fenoterol
Hydrobromide 100mcg aerosol inhaler. Write the complete prescription. See the dose and
how to applied it on drug information.
DAY 8
BCS 1: Prescribing Skills Written Simulation

Tutor Group
1. Able to write an appropriate and good prescription: legal, legible, and complete.
2. Able to do communication appropriately to the patient
Direction BCS
Prescribing skills training will be designed in groups on line application (1 tutor per 4 groups).
Each student should response the written case individually. Tutor in group should give input
directly to the group.
There are 2 stages to deliver the prescribing skills in this session, i.e:
1. Thirty minutes. In this stage, students read 3 cases needed pharmacological intervention.
The student's task is to fill in the appropriate section in the Table 4 BCS Prescribing Skills 2
the rational, dose calculation and duration of the drug of choice appropriate to the
statement then write the complete prescription on the prescription form.
2. In the next 90 minutes. Students read 4 written cases need pharmacological intervention for
patients. Students choose minimal 1 cases to finish virtually in this training, beginning with
six steps of rational prescribing individually then write the prescription by filling in the
prescription form virtually described in Table 5 BCS Prescribing Skills Comprehensive. Try to
do simulation how to inform the treatment to the patients.
dr Made Nari
dr X SIP : 1243/DU.1.014.01.20/Dikes.19
SIP : 1243/DU.1.014.01.20/Dikes.19 Jl Praktikum Farmakoterapi, 2, Denpasar
Praktek Jl Nias, 20, Denpasar No. Telp. (0361)234567 No. HP. 0895456777
No Telp. 220121 HP 081234567 ---------------------------------------------------------
Denpasar, 28 Mei 2020
Denpasar, 20 Maret 2019
R/ Metformin 50mg tablet No XXX
R/ Antacida DOEN chewable tablet No X
S 2dd tab I
S 3 d d tab I p.c
#
R/ Famotidine 40mg Tab. No X R/ Glimepiride 1mg tab No XV
S 1 d d tab I
S 1 d d tab I ac
#
R/ Omeprazole 20mg caps No VI
S 2 d d cap I
---------------------------------------------------------------
Pro : Leny Pro : Made Juni
Umur : 37 tahun BB: 55kg Umur : 42 tahun BB: - kg
Alamat : Jl Kamboja 2, Dps Alamat : Jl Melati 2, Dps
Ne Iteratur Ne Iteratur

dr Made Nari dr Made Nari
SIP : 1243/DU.1.014.01.20/Dikes.19 SIP : 1243/DU.1.014.01.20/Dikes.19
Jl Praktikum Farmakoterapi, 2, Denpasar Jl Praktikum Farmakoterapi, 2, Denpasar
No. Telp. (0361)234567 No. HP. 0895456777 No. Telp. (0361)234567 No. HP. 0895456777
--------------------------------------------------------- ---------------------------------------------------------
Denpasar, 28 Mei 2020 Denpasar, 28 Mei 2020
R/ Amoxycillin syrup 125mg/5ml fl No I
S 3 d d cth II for 5 days R/Desonid cream 0,05% 5gm
# S2 d d applic ue
R/Ambroxol syr 15mg/5mL syr fl No I #
S 3 d d cth I R /CTM tab No V
# S 3dd tab ½ prn
R/ Enervon C syr fl No I #
S 1 d d cth I
# ---------------------------------------------------------------
--------------------------------------------------------------- Pro : Made Nara
Pro : Nym Tiwi Umur : 12 tahun BB: 40 kg
Umur : 7 tahun BB: 25 kg Alamat : Jl Melati 2, Dps
Alamat : Jl Melati 12, Dps
Ne Iteratur Ne Iteratur
Figure 2. Prescription
Table 2 BCS Prescription Assessment
SIX STEPs Of Rational Prescribing

Modified from: Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA, 1995,
Guide to Good Prescribing, World Health Organization Action
Programme on Essential Drugs, Geneva ( Standard Reference)
Prescription See on figure 2
STEP 1 Define the patient’s problem
[Type the objectives of the intervention]
STEP 2 Specify the therapeutic objective
[Describe what do you want to achieve with the treatment)
NeANSWER
Iteratur Ne Iteratur
STEP 3 Verify the suitability of your P-drug
[Verify whether your P-drug (the active substance, the standard dosage
schedule, the standard durationNama
Nama pasien:…………………………… treatment) is suitable ( effective and safe) for
pasien:……………………………
the individual patient. How about the drug indication, the convenience of
Umur/BB : ………………………….. Umur/BB : …………………………..
dosage form, contraindication.]
Alamat: Alamat:
STEP 4 Write a prescription
……………………………………………… ………………………………………………
46 | Ne iteratur
STUDY GUIDE PHARMED_2020
Ne iteratur
[Complete prescription sheet]
STEP 5 Give information, instructions and warnings
[Confirm patient adherence, describe drug side effects possible and how can
she detect and what she should do to avoid and treat for a while before she
come to the doctor for her problem]
STEP6 Monitor (and stop?) the treatment
[Confirm the therapetic efficacy and side effects, do history taking, physical
examination, and laboratory tests]
Table 3 BCS Prescription Skills 1

Modified from: Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA, 1995, Guide to
Good Prescribing, World Health Organization Action Programme on Essential Drugs,
Geneva ( Standard Reference)
1. Pasien Ibu Anna, 30 tahun, datang ke dokter dengan keluhan nyeri menelan dan
demam sejak 3 hari. Kondisi ini berulang setelah sebelumnya mengalami demam
dan batuk pilek. Hasil pemeriksaan klinik dan laboratorium menyimpulkan adanya
infeksi tenggorok. Pasien tidak memiliki riwayat alergi obat. Dokter merencanakan
terapi antibiotika oral sebagai berikut: Amoxycillin dengan dosis 500 mg setiap 8
jam sehabis makan selama 7 hari, dan paracetamol dengan dosis 500 mg setiap 8
jam jika demam.
Instruksi: Tuliskan resep yang tepat
CASES
2. Sony (7 th, BB 18kg) didiagnosis mengalami bronchitis kronis. Sony memilik

riwayat alergi penicillin. Dokter merencanakan memberikan antibiotika
Erythromycin dengan dosis 250mg dalam bentuk sediaan syrup 3 kali sehari selama
tujuh hari and Paracetamol syrup dengan dosis 180mg 3 kali sehari jika diperlukan.
Obat yang tersedia adalah Erythromycin Dry Syrup 250mg/5ml kemasan 60 ml dan
Paracetamol 120mg/5mL elixir syrup kemasan 60 ml
Instruksi: Tuliskan resep lengkap untuk Sony.

Sony (7yo, BW 18 kg) is diagnosed Chronic bronchitis and he has penicillin allergy
history. His physician want to treat him with Erythromycin syrup dose 250mg
three times daily for seven days and Paracetamol syrup 180mg three times daily for
three days as he need. There are Erythromycin Dry Syrup 250mg/5ml package: 60
ml and Paracetamol 120mg/5mL elixir syrup package: 60 ml available.
Instruksi: Please write a complete prescription for Sony.
3. Ketut Adnyani, anak perempuan usia 15 tahun (BB: 48kg) dibawa ibunya ke
dokter umum karena mengeluh demam, mual, muntah, tidak mau makan, tidak
nafsu, nyeri otot dan persendian, lemah, letih, lesu. Penderita sering makan
diwarung. Pada pemeriksaan fisik demam, sklera mata dan kulit kuning dengan
hepatomegali. Pemeriksaan lab klinik: urine berwarna seperti teh (bilirubin +) feses
nampak seperti dempul. DL: Kadar HB >, kadar SGPT/SGOT≥2 kali nilai normal
tertinggi. Dokter berencana memberikan antipiretik yang digunakan ketika demam,
obat mual, obat perih dan kembung. Resepkan obat yang sesuai dari sediaan pada
tabel berikut.
Ketut Adnyani, 15 years old girl (BW: 48kg) come to her familiy doctor as he got
fever to night before, nausea, vomiting, loss appetite, muscle and joint ache,
malaise, lethargy. She usually buy some food from “warung”. On physical
examination she was fever, yellowish eye sclera and skin also hepatomegaly.
Clinical laboratory test, urine tea color like (bilirubin +) stool putty like. Complete
blod test HB >, SGPT/SGOT≥2 time normal value. The doctor would like to prescribe
antipiretic when fever and another proper medicines for nausea, vomiting or
bloating for her as in the following table.
Regimen Dosis
Obat Sediaan Waktu, Lama
Interval pemberian
terapi
Ibuprofen Tablet 400mg setiap 12 jam 3 hari , bila diperlukan
Metoklopropamid Tablet 30mg/hari dalam Bila diperlukan

dosis terbagi, setiap
12 jam
Ranitidin tablet 150mg setiap 12 jam Sebelum makan, bila

diperlukan
Omeprazole capsul 20mg /hari Sebelum makan, bila

diperlukan
Instruksi: Tulis resep lengkap untuk kasus tersebut
[Verify whether your P-drug (the active substance, the standard dosage schedule,
the standard duration treatment) is suitable ( effective and safe) for the individual
ANSWER patient. How about the drug indication, the convenience of dosage form,
contraindication.for her]
[Complete prescription sheet with: patient’s identity, date of prescription, R/ sign,

the medicine ( drug name , potency, dose, dosage form, the amount , duration
therapy, how to prepare the medicine, how to use/take the medicine, the
interval/frequency, specific information related to optimal therapy ]

Prescription Form
dr ……………………………………, SKed
SIP : 1243/DU.1.014.01.20/Dikes.19
Jl Praktikum Farmakoterapi, 2, PSSKPD FK Unud Denpasar
No. Telp. (0361)234567
No. HP. 0895456777
-------------------------------------------------------------------------
…...,...............……….
Nama pasien:……………………………
Umur/BB : …………………………..
Alamat: ………………………………………………
Ne iteratur

Table 4 BCS Prescribing Skills Comprehensive

1. Sony, pria berusia 29 tahun menunjukkan dermatitis atopic dengan
pruritus yang intens dengan penebalan pada kedua telapak tangan dan
kaki. Sebagian besar daerah tumitnya kering dan pecah-pecah.
Tuliskan resep lengkap untuk Sony.
Sony, 29 years old man presents an intensely pruritic atopic dermatitis

with lichenification both in palm and soles. Most of his sole’s skin
regions are dry and fissured.
Please write a complete prescription for Sony.
Modified from: PMK No 5. 2014
2. Ony, bayi laki-laki usia 11 bulan di bawa ke klinik umum dengan

keluhan ruam-ruam. Pasien menggunakan popok sekali pakai dan
digantikan setiap 6 jam, saat diperiksa pamper dalam kondisi sudah
basah. Pada pemeriksaan fisik nampak bekas karet pampers, bagian
bokong bayi nampak perubahan warna kulit kemerahan. Bayi rewel
dan menangis. Dokter merencanakan terapi topikal kortikosteroid.
Cases
Instruksi: Tuliskan resep yang tepat.
Ony, 11 months baby boy was brought to the clinic complained with a
rush. The baby uses diapers and replaced every 6 hours. When the
baby was examined, the diaper was wet. On physical examination,
was found macula eritematous on his groin. The baby was fussy and
cried. The doctor has a plan to use corticosteroid for him.
Instruction: Write a prescription appropriately
3. Bapak Amir, usia 42 tahun, datang dengan keluhan penurunan

pendengaran disertai rasa penuh pada telinga yang sangat
mengganggu dan kadang disertai rasa pusing berputar. Pada
pemeriksaan otoskopi terlihat membrane timpani normal namun ada
obstruksi telinga oleh serumen kecoklatan dan mengeras. Dokter
merencanakan terapi dengan cerumen impaction.
Tuliskan rencana terapi untuk Bapak Amir pada lembar resep dan

lakukan komunikasi informasi dan edukasi agar terapi efektif.
Instruksi: Tuliskan resep yang tepat dan lakukan KIE yang tepat untuk
terapi optimal
Mr Amir, a 42 years old, came with complaints of hearing loss

accompanied by a feeling of fullness in the ear. He felt uncomfortable
and sometimes accompanied by a spinning dizziness. From otoscopy
examination tympanic membrane wasv normal but there is ear
obstruction by the cerumen brown and hardened. The doctor plans
therapy with cerumen impaction.
Write a therapeutic plan for Mr Amir on the prescription
Instruction: Write a prescription appropriately.and do communication

information and education for optimizing the therapy.
Modified from: PMK No 5, 2014
4. Ibu Loly, 31 tahun datang ke Poliklinik RS dengan keluhan telinga kiri

terasa nyeri yang dirasakan sejak 3 hari yang lalu. Pasien juga
mengeluhkan telinga kiri terasa penuh, dan pendengarannya berkurang.
Pasien sempat mengorek telinga dengan cotton bud untuk
menghilangkan rasa nyerinya. Pemeriksaan fisik didapatkan telinga kiri
nyeri aurikular, terjad ruptur membran timpani. Bagaimana rencana
terapi yang akan disiapkan, tuliskan pada bagian yang sesuai.
Instruksi: Tuliskan resep yang tepat pada lembar resep untuk terapi
optimal
Ms Loly, 31 years old came to policlinic complained with pain on her left
ear. The pain was felt since 3 days ago. Patient also complained felt
fullnes on her ear, and felt hearing loss. Patient said that she ever use
cotton bud on her ear for relief the pain. On physical examination was
found auricular pain, and rupture of membrane tympani.
Instruction: Write a prescription appropriately on prescription sheet

and do communication, information and education for optimizing the
therapy.

Modified from: Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA, 1995,
Guide to Good Prescribing, World Health Organization Action
Programme on Essential Drugs, Geneva ( Standard Reference)
[Verify whether your P-drug (the active substance, the standard dosage
schedule, the standard duration treatment) is suitable ( effective and safe) for
the individual patient. How about the drug indication, the convenience of
dosage form, contraindication.for her]

ANSWER
[Complete prescription sheet]
STEP 5 Give information, instructions and warnings
[Confirm patient adherence, describe drug side effects possible and how can
she detect and what she should do to avoid and treat for a while before she
come to the doctor for her problem]
STEP6 Monitor (and stop?) the treatment
[Confirm the therapetic efficacy and side effects, do history taking, physical
examination, and laboratory tests]
The prescription shows prescriber’s final competence in pharmacotherapy based on patients’

conditions. The first rule of thumbs in prescribing is the prescription should be clearly written.
Illegible hand writing is one source of prescribing errors. Errors may occur in any stage of
medication delivery process. Meanwhile, different healthcare providers involve in the process.
In this instance, medical students who will be medical doctors in the future need to learn and
acknowledge that they may potentially contribute to the errors particularly in the process of

prescribing. Thus, it is expected medical students need to learn and practice on rational
prescribing to minimize the occurrence of medication errors in healthcare service.
Prescription should be written Latin. it is consider as a universal language since most of medical
term, medical abbreviation are in Latin and it is an international language in medicine. The
language is not developing anymore thus there is no dualism in interpreting the prescription
and it can transcribed by harmacist everywhere without misinterpretation.
Check list of complete prescription should be done are as the following:

1. Physician’s identity: name, address, phone number, registration number, date of
prescription written.
2. Date and place of the prescription written.
3. R/ sign – recipe (Superscriptio).
4. Name of medication - generic active compound and the strength (Inscriptio). Drug name,
dosage form, dose,amount, potency/strength/concentration, route, frequency (include
concentration for oral liquids or mg strength for oral solds Amoxicilin 125mg/5mL PO).
General practictitioner prescribe not more than 10 tablet/capsule for partially ethical drugs
(OKT, in Indonesia we use term OKT, obat keras tertentu). Use MIMS on line, Fornas, DOEN
2018, Medcape, BNF.
5. Dosage form or intended dosage form, quantity to dispense: mL for oral liquids, pieces dor
oral solids (Subscriptio).
6. Instruction to take/use the medication (Signatura).
7. Patient’s identity (pro): name, age, weight, BSA, address (should be complete information
for narcotic/opiate drugs, partially ethical drugs, OKT)
8. Physician’s signature/sign (should be full signature for narcotics/opiate drugs, OKT)
9. Refills: If Appropriate
These physician’s signature and refills components are essential in a prescription. In relation to
prescribing Narcotics, the physician should put their signature along with full and clear
patient’s address. Further, there is no iter (replications) in this kind of prescription and also for
several ethical drugs.

The prescription will beginning with the main drugs which is the causative drugs or essential
drugs to the patients condition (Remedium cardinal) then followed by additional treatment for
relieve the symptoms or patient’s complaints (remedium adjuvants).
Direction for Facilitator and Student
1. Please find the assignment in this book in Annex 1, Choose one of them. The number of
prescription expressed your group.
2. Each student should analyze the prescription based on complete prescription form
presented on Study Guide in Annex 2 and try to analyze the prescription for its clarity and
legality.
3. Develop your own prescription form in this book and do good prescription by rewrite the
prescription which is fulfilled the criteria: complete, legible, and legal.
Please check it again by using check list complete prescription before.
4. Finishing your assignment by facilitator signature.
Training Output.
1. Prescription Analysis
2. Good prescription
Direction For Facilitator and Student

Evaluation
Scenario for SGD

1. Mr. Danan (45 years old) came to the doctor because he got fever and joint pain since 3
nights ago, he also complained of epigastric pain, nausea, and bloating. Doctors
recommended Paracetamol with a dose of 500 mg tablets and Antacid chewable tablets
which he should taken when he needed to reduce complaints of fever, pain and symptoms
of nausea, with administration every 8 hours, for 2 days while waiting for the results of
laboratory tests. Discuss what language should be used for prescribing safety. Rewrite the
drug instructions using clear writing and use the appropriate language and abbreviations.
2. Discuss the prescription form, what information should included in each part of
prescription. Try to design your own prescription form.
3. Discuss the essensial rules for prescribers regarding medication safety issues.

APPENDIX 1 COMMON LATIN WORDS
Aa ana sama banyak
a.c ante coenam sebelum makan
a.n ante noctem malam sebelum tidur
ad lib ad libitum secukupnya (yang diinginkan)
a.u.e = ad us.ext ad usum externum untuk obat luar
a.u.p= ad us.prop. ad usum proprium untuk dipakai sendiri
u.p= us.prop ususpropius dipakai sendiri
m.i mihi ipsi dipakai sendiri
aq.bisdest aqua bisdestillata air yang 2x disuling
aq.dest aqua destillata air suling
aq.steril aqua sterilisata air steril
c. cochlear (cibarium) sendok (makan)= 15cc
c.p cochlear pultis/parvum sendok bubur (sebaiknya tidak

dipakai) =10cc
c.th. cochlear theae sendok teh = 5 cc
collut.or. collutiooris, collutorium obat kumur (cucimulut)
collyr collyrium obat cuci mata
d.i.d da in dim/da in dimidio berikan separuhnya
d.c.form. da cum formula tuliskan dengan resepnya
d.d de die sehari
1d.d.=s.d.d semel de die sekali sehari

2 d..d=b.i.d bis de die=bis in die 2 x sehari
3 d.d=t.i.d ter de dir= ter in die 3 x sehari
4 d.d=q.i.d quater de die= guater 4 x sehari

in die
dext.et.sin dexter et sinister kanan dan kiri
o.d/o.s. oculusdexter et oculus mata kanan dan mata kiri

sinister
d.t.d da tales doses berikan sebanyak dosis tertentu
emuls emulsum emulsi
enem enema lavement
extr. Extractum ekstrak
f fac,fiat,fiant buat, harap dibuatkan
f.la fac lege artis buat menurut cara semestinya
garg. Gargarisma obat kumur
h.m. hora matutina pagi hari
h.s hora somni jam sebelum tidur
inf infusum air rebusan
inj. Injectio obat suntik
iter iteretur 1x harap diulang
iter. 1 x iteretur 1 x harap diulang satu kali
liq. Liquidus cair
lot lotio obat cair untuk obat luar,lotion

m.f misce campurlah & buatlah
m.f.l.a misce fac lege artis buatlah menurut

cara semestinya
m.et.v. mane et vespere pagi dan sore
p.p pro paupere untuk si miskin
P.I.M periculum in mora berbahaya bila ditunda
p.r.n pro re nata kalau perlu
pulv. pulvis serbuk ( tunggal )
pulv.adsp. pulvis adspersorius bedak
q.s quantum satis/sulfficit secukupnya
R/ recipe ambillah
Rec.par recenterparatus dibuat baru
S. Signa tandailah (tulislah aturan pakai)
Sol. Solutio larutan
Spir. Spiritus spiritus
.c ususcognitus aturan pakai diketahui
u.e. usus externus obat luar

APPENDIX 2 TEMPLATE OF A COMPLETE PRESCRIPTION
Assessment points of a prescription:
The students will be examined on their ability to:
1. Assess of components of a prescription based on the above form (50%)
2. Analyze the prescriptions for its clarity and legality (50%).

APPENDIX 3 FASILITATOR’S ASSESSMENT FORM
STUDENT PROJECT
FASILITATOR’S ASSESSMENT FORM
Block :
Name :
Student No. (NIM) :
Facilitator :
Title :
Time table of consultation
Point of discussion Week Date Tutor sign

1.Title 1
2.References 1
3. Outline of paper 2
4.Content 2
5. Final discussion 4
Assessment
A. Paper structure : 7 8 9 10
B. Content : 7 8 9 10
C. Discussion : 7 8 9 10
D. Reference :
Denpasar, 15 Juni 2020
Facilitator

Score
Criteria
65-75 76-80 80-100
Sistematika Memenuhi satu kriteria di Memenuhi dua kriteria di Memenuhi semua kriteria di
laporan bawah ini: bawah ini: bawah ini:
1. Laporan lengkap (Cover, 1. Laporan lengkap (Cover, 1. Laporan lengkap (Cover,

Kata Pengantar, Daftar isi, Kata Pengantar, Daftar isi, Kata Pengantar, Daftar isi,
Daftar Gambar, Daftar Daftar Gambar, Daftar Daftar Gambar, Daftar
Tabel, Daftar Singkatan, Tabel, Daftar Singkatan, Tabel, Daftar Singkatan,
Pendahuluan (latar Pendahuluan (latar Pendahuluan (latar
belakang dan tujuan belakang dan tujuan belakang dan tujuan
Penulisan), Isi, Penulisan), Isi, Penulisan), Isi,
Kesimpulan dan atau Kesimpulan dan atau Kesimpulan dan atau
saran, daftar pustaka) saran, daftar pustaka) saran, daftar pustaka)
2. Terorganisasi dengan baik 2. Terorganisasi dengan baik 2. Terorganisasi dengan baik
3. Font dan spasi benar 3. Font dan spasi benar 3. Font dan spasi benar
Tata Tata tulis tidak benar, dan Salah satunya, tata tulis tidak Tata tulis benar (Penggunaan
penulisan dan Bahasa tidak benar dan tidak benar atau bahasa tidak benar huruf capital, huruf miring,
Bahasa baku dan tidak baku. tanda baca) dan
menggunakan Bahasa yang
benar dan baku
Pendahuluan Uraian latar belakang sesuai Uraian latar belakang kurang Uraian latar belakang sesuai
dengan topik sesuai dengan topik dengan topik
Isi Tidakmengikuti saran Kurangmengikuti saran Mengikutiseluruh saran

darifasilitator/Evaluator darifasilitator/Evaluator darifasilitator/Evaluator
denganbaik denganbaik denganbaik
Kesimpulan Kesimpulan tidak sesuai Kurang tepat menarik Tepat menarik kesimpulan
dengan tujuan penulisan dan kesimpulan, salah satunya, sesuai dengan tujuan
perolehan data karena tidak sesuai tujuan penulisan dan perolehan data
penulisan atau perolehan data
Reference Penulisan referensi tidak Penulisan referensi beberapa Penulisan referensi sesuai
sesuai dengan yang diminta tidak sesuai dengan yang dengan yang diminta dan
diminta
Referensi yang digunakan Referensi yang digunakan
berusia lebih dari 5 tahun Referensi yang digunakan berusia 3 tahun terakhir
berusia 5 tahun terakhir
Ketepatan Tugas dikumpulkan setelah Tugas dikumpulkan lewat Tugas dikumpulkan tepat
Waktu lewat 2 jam atau lebih 1jam setelah batas waktu. waktu atau sebelum batas
waktu.

APPENDIX 4 PRESENTATION ASSESSMENT FORM
STUDENT PROJECT
PRESENTATION ASSESSMENT FORM
Group :
SP :
Date of presentation :
No Description Maximum Score Evaluator Score Peer Score (PS)
(ES)
1 Clarity of topic presented 100
2 Ability to answer questions 100
3 Interaction within group 100
Total score (1+2+3)/3 100
Final Score: (ES + PS) =

2
Denpasar, ______________________
Evaluator Peer

APPENDIX 5 LEMBAR PENILAIAN PENULISAN RESEP
Faktor
Skor Jumlah
No Aspect Pengali
0 1 2
1 Identitas dokter 5
2 Tempat dan tanggal penulisan resep 5
Superscriptio:
3 10
Tanda R/
Inscriptio: Nama obat, potensi, bentuk sediaan,

4 jumlah lengkap dengan kemasan 50
5 Tanda penutup 5
6 Paraf 10
7 Identitas pasien lengkap 15
TOTAL SKOR
Penilaian
0 : tidak ditulis
1 : ditulis tidak lengkap
2 : ditulis lengkap dan tepat

APPENDIX 6 MAPPING CURRICULLUM BLOCKS
Program or curriculum blocks

10 Senior Clerkship
9 Senior Clerkship
8 Senior Clerkship
Health System- Community- Evidence-based Special topics : Elective Study IV Compre
7 based Practice based practice Medical Health Ergonomy (evaluation) Clinic
(3 weeks) Practice & Health Orientation
Environment (Clerkship)
+ medical 18
BCS (1 weeks) (2 weeks) ethic
(4 weeks) (2 weeks) (2 weeks) (4 weeks)
The Medical The Urinary The Reproductive Elective Study III 19
6 Cardiovascular Emergency System and System and
System and Disorders Disorders
Disorders (3 weeks) (3 weeks) (3 weeks) (3 weeks)
(3 weeks)
BCS (1 weeks) BCS (1 weeks) BCS (1 weeks) BCS (1 weeks)
Neuroscience and The Respiratory The skin & Special Topic : Forensic Elective
5 neurological System and hearing system - Palliative med Medicine and Study II
disorders Disorders & disorders - Complemnt & Medicolegal 18
(3 weeks) (3 weeks) (3 weeks) Alternative Med.
BCS (1 weeks) BCS (1 weeks) BCS (1 weeks) (2 weeks) (2 weeks) (2 weeks)
Musculoskeletal Alimentary The Endocrine Clinical Nutrition The Visual
4 system & & hepatobiliary System, and Disorders system &
connective tissue systems & Metabolism and (2 weeks) disorders
disorders disorders Disorders (2 weeks) 18
(3 weeks) (3 Weeks) (3 weeks)
BCS (1 weeks) BCS (1 weeks) BCS (1 weeks) BCS (1 weeks) BCS (1weeks)
Behavior Change Basic Infection Immune system Hematologic Special Topic
3 and disorders & infectious & system & - Andro & aging
(3 weeks) diseases disorders disorder & - - Geriatri 19
(3 weeks) (2 weeks) clinical oncology -Travel medicine
(3 weeks) - (4 weeks)
BCS (1 weeks) BCS (1 weeks) BCS (1 weeks) BCS (1 weeks)
BIOMEDIK III Growth Medical Medical Basic Elective
2 (4 weeks) & communication Professionalism Pharmaceutical Study I
development (2 weeks) (2 weeks) medicine & drug (2 weeks) 17
(2 weeks) etics
BCS: (1 weeks) BCS (1 weeks) BCS (1 weeks) (2 weeks)
Studium BIOMEDIK I The cell BIOMEDIK II
1 Generale and (8 weeks) as biochemical (6 weeks)
Humaniora machinery 19
(2 weeks) (2 weeks)
BCS(1 weeks)
Pendidikan Pancasila & Kewarganegaraan ( 3 weeks )

APPENDIX 7 STUDENT CONTRACT
STUDENT CONTRACT
Block : Pharmaceutical Medicines And Drug Ethics

Semester : II
Learning Activities : Lectures, SGD, Student Project, Simulation
Assessment Methods : Assessment of the whole topics will be perforformed in several ways, including of:
1. Student’s activity on meeting’s online
2. Student’s performance in a scheduled discussion by facilitator
3. Student project will be assessed by facilitator based on process paper writing, consultation and by evaluator based on
paper writing and presentation on June 16th 2020.
4. Quis scheduled every Plenary day at 19.00 managed by OASE Unud
5. Final examination consist of 100 questions consisting of Multiple Choice Questions (MCQ) which will be carried out by
OASE Udayana, coordinated by Block Coordinator and Kordik Sarjana, on Thursday, June 18th 2020.
The grading system will employ the current grading system at Faculty of Medicine Udayana University. Students’ final score
is a summation of all component.
Final mark 65 or more considered to pass this block. Students have an opportunity to take a remedial process scheduled by
assessment team later. The value of marking are distributed as:
80-100 A
70- <80 B+
65-<70 B
60-<65 C+
55-<60 C
45-<55 D
<45 E
SANCTIONS
Students who do not attend ≤ 75% of attendance including lectures, plenary and SGD are unable to sit in for the examination
test.
Denpasar, June 4th 2020
Team Planner, Students’ coordinator Semester II 2020,
Dr dra Ida Ayu Alit Widhiartini, M.Si., Apt.
Acknowledged
Program Coordinator,
Dr dr Komang Januartha Putra Pinatih, M.Kes

Modul Pharmed - 2020 - Online - Discussion - Rev 3.06.2020 - Day

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2020

i | Study Guide Pharmed 2020

Small group discussion............................................................................................................ 1

Peer assisted learning and Written Simulation ....................................................................... 1

Student projects ..................................................................................................................... 1

ASSESSMENT METHODS ............................................................................................................. 4

2. Facilitator Class B ................................................................................................................ 9

TIME TABLE .............................................................................................................................. 10

L2: Drug Development .......................................................................................................... 16

L3: Drug Regulations ............................................................................................................. 17

L3b : Drug Promotion............................................................................................................ 18

L4: Medication Safety ........................................................................................................... 19

L 6: Drug Dosage Forms ........................................................................................................ 21

L 7: Drug Bioavalability ......................................................................................................... 23

L 8: Dose Calculation and Dose Regimen ............................................................................... 24

L 9: Rational Irrational Prescribing ........................................................................................ 26

L 10: P(ersonal) drug and P(ersonal) treatments .................................................................. 28

Tutor assissted Learning P(ersonal) Drug .............................................................................. 30

Tutor assissted Learning P(ersonal) Treatment .................................................................... 33

L11: Drug information (How to keep up to date about drugs) ............................................... 37

ii | STUDY GUIDE PHARMED_2020

L 13: How To Assess Prescribing Skills ................................................................................... 40

Tutor assissted learning of prescribing in general practice 1, 2, 3 .......................................... 43

BCS 1: Prescribing Skills Written Virtually.............................................................................. 44

APPENDIX 1 COMMON LATIN WORDS ................................................................................. 56

APPENDIX 2 TEMPLATE OF A COMPLETE PRESCRIPTION ....................................................... 59

APPENDIX 3 FASILITATOR’S ASSESSMENT FORM .................................................................. 60

APPENDIX 4 PRESENTATION ASSESSMENT FORM ................................................................. 62

APPENDIX 5 LEMBAR PENILAIAN PENULISAN RESEP.............................................................. 63

APPENDIX 6 MAPPING CURRICULLUM BLOCKS ..................................................................... 64

APPENDIX 7 STUDENT CONTRACT ......................................................................................... 65

iii | STUDY GUIDE PHARMED_2020

This course is designed to develop medical student competence to be prescribers. Prescribing

AIMS: to develop rational prescribing skills

1 | STUDY GUIDE PHARMED_2020

2 | STUDY GUIDE PHARMED_2020

Figure 1 Concept of How to develop Prescribing Skills in Faculty of Medicine Udayana

3 | STUDY GUIDE PHARMED_2020

Face to face meeting on line lectures and Plenary Lectures

Small group discussion

Peer assisted learning and Written Simulation

1 | STUDY GUIDE PHARMED_2020

Table 3. Topic of student projects

2 | STUDY GUIDE PHARMED_2020

• Efficacy information: Pharmacokinetic (ADME, Dose, dosage form, duration),

• Drug safety information: Side effect, adverse drug reaction

• Suitability Information: Contraindication

• Discussion efficacy, safety and suitability

3 | STUDY GUIDE PHARMED_2020

Student Project 10%

Paper work as scheduled

Presentation June 16th 2020

SGD (forum discussion) 10% scheduled

Quiz 20% Plenary day

Final Examination 60% June 18th 2020

4 | STUDY GUIDE PHARMED_2020

5 | STUDY GUIDE PHARMED_2020

No Name Group Department Phone Venue

9 dr. Putu Gede Sudira, M.Sc.,Sp.S A9 DME 081805633997 2.20

No Name Group Department Phone Venue

9 | STUDY GUIDE PHARMED_2020

Date, Day Time Activity Venue Lectures