Study Guide Basic Pharmaceutical Medicine & Drug Etics 2017: Student Contract

Study Guide Basic Pharmaceutical Medicine & Drug
Etics 2017
CONTENTS
Hal
Contents ......................................................................................................................... 1
Student contract .............................................................................................................. 2
Curriculum ...................................................................................................................... 4
Block Team ..................................................................................................................... 5
Facilitators ...................................................................................................................... 6
Time Table ...................................................................................................................... 7
Learning Programs ......................................................................................................... 9
Appendix 1. Common Latin Words ................................................................................. 21
Appendix 2. Template of A Complete Prescription.......................................................... 23
Appendix 3. Student Project Fasilitators Assessment Form ........................................... 24
Appendix 4. Student Project Presentation Assessment Form ........................................ 25
Appendix 5. Template of A Prescription.......................................................................... 26
Appendix 6. Form P-Drug ............................................................................................... 27
Appendix 7. Cases ....................................................................................................... 28
References ..................................................................................................................... 29
Curriculum Map .............................................................................................................. 30
STUDENT CONTRACT
BLOCK : PHARMACEUTICS MEDICINES, ETHICS AND DRUG USED
Udayana University Faculty of Medicine, DME, 2017 1

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SEMESTER : II
LEARNING METHODS : Lectures, SGD, Student Project, Practicum
ASSESSMENT METHODS :
Assessment will be carried out onFriday, 13 July 2017. There will be 100 questions consisting
of Multiple Choice Questions (MCQ). The grading system will employ the current grading system
at Faculty of Medicine Udayana University. Students’ final score is a summation of student’
attendance in SGD and lectures and active role during small group discussion (5%), a score of
student project (20%) and a score in final assessment (75%).
STUDENT PROJECTS (SP) :
1. Write a literature review ofthe importance of rational drug prescribing amongst medical
students
2. Write a review of drug classifications, their dosage forms and route of administration for
drug used as analgesic, antipyretic and in peptic ulcer diseases. Please give three
examples of each indication.
3. Analyze complete components of prescriptions
This student project is a group project. Each group needs to submit a report of SP 1-3 to their
facilitator by the latest on Thursday, 6 July 2017. SGD 1 to 3 will present on SP 1; SGD 4 to 6 will
present on SP 2; and SGD 7-10 will present on SP 3 during SP presentation session.
The format of a review on student project of rational drug prescribing is as follows:

1. Introduction
2. Content
- What is rational prescribing
- The importance of rational drug prescribing amongst medical students
3. Conclusion
The format a review on student project of drug dosage forms is as follows:

1. Introduction
2. Content
- The importance of understanding drug dosage forms amongst medical students
- Drug classifications, their dosage forms and route of administration for drug used as
analgesic, antipyretic and in peptic ulcer diseases
3. Conclusion
4. Please adopt Vancouver referencing style into your report
The format of analysis of prescriptions can be seen on Appendix 2.

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SANCTIONS :
Students who do not attend ≤ 75% of attendance including lectures, plenary and SGD are unable
to sit in the examination test.
Denpasar, 22 June 2017

Team Planner Students’ coordinator Semester II
2017
Desak Ketut Ernawati., Ph.D Apt
Acknowledged
DME
(dr. I Gde Haryo Ganesha, S.Ked)
CURRICULUM
This block is designed to meet the needs of medical students in understanding of drug
development and their uses. Prescribing is accounted for more than 60% of patients visiting
medical practitioners. In order to obtain the skills in drug prescribing, medical students’ knowledge

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of pharmaceutics 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 biopharmaceutics 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
pharmacokinetics, bioavailability, dosage forms, and potential medication misadventure are also
included in this module. These understandings are essential for medical students prior to
prescribe medication to their patients. Highlight of the module will be focused on drug used from
the selection of personal drug (P-Drug) to the process of drug prescribing.
OUTCOMES
- Integrating good prescribing to medical education
- Developing moral, ethics, and attitudes related to legal aspect of drug regulation to
medical students
- Integrate rational prescribing and legible hand writing to medical practice
LEARNING OBJECTIVES:
- Describe areas of pharmaceutics medicines
- Describe phases of clinical trial in drug development
- Describe rules in drug promotions and ethics
- Understand drug dosage forms and their pharmaceutical properties which may influence
medication safety
- Be able to calculate drug dosing based on patient’s needs
- Be able to calculate drug dosing based on patient’s needs
- Be able to select personal drug (P-Drug)
- Be able to understand and implement the rules in prescribing and Latin words used
PLANNERS TEAM
No Name Department Phone

1 Desak Ketut Ernawati., PhD., Apt Pharmacology 081236753646
2 Ida Ayu Alit Widhiartini, dra., Apt., M.Si Pharmacology 081936005559

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LECTURERS
NO NAME DEPT PHONE

1 Desak Ketut Ernawati., PhD., Apt Pharmacology 081236753646
2 Ida Ayu Alit Widhiartini, dra., Apt., M.Si Pharmacology 081936005559
3 Prof. I.G.M Aman SPFK Pharmacology 081338770650
4 Dr. dr I Made Jawi M.Kes Pharmacology 08179787972
FACILITATORS
Regular Class
NO NAME GROUP DEPT PHONE ROOM

dr.I Made Oka Negara, Andrology 085935054964 3rd floor:
1 A1
FIAS R.3.01

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Dr.dr. I Made Jawi, M.Kes Pharmacology 08179787972 3rd floor:

2 A2
R.3.02
Dr.Ni Wayan Tianing, S.Si, Biochemistry 08123982504 3rd floor:
3 A3
M.Kes R.3.03
Prof.Dr.dr.I Nyoman Physiology 0811397971 3rd floor:
4 A4
Adiputra, M.O.H PFK R.3.04
dr.I Nym Gede Wardana, Anatomy 087860405625 3rd floor:
5 A5
M.Biomed R.3.05
dr.I Wayan Gede Biochemistry 082144071268 3rd floor:
6 A6
Sutadarma, M.Gizi R.3.06
Dr.dr. I Dewa Made Microbiology 081338291965 3rd floor:
7 A7
Sukrama, M.Si, Sp.MK(K) R.3.07
dr.I Gde Haryo Ganesha, DME 081805391039 3rd floor:
8 A8
S.Ked R.3.08
dr.Luh Ariwati Parasitology 08123662311 3rd floor:
9 A9
R.3.21
dr.I Made Krisna Dinata, Physiology 08174742566 3rd floor:
10 A10
M.Erg R.3.22
English Class
NO NAME GROUP DEPT PHONE ROOM
Dr.dr.Susy Purnawati, M.KK Physiology 08123989891 3rd floor:
1 B1
R.3.01
Desak Ernawati, S.Si, Pharmacology 081236753646 3rd floor:
2 B2
PGPharm, M.Pharm, PhD R.3.02
IBN Putra Dwija, S.Si, Microbiology 08179747502 3rd floor:
3 B3
M.Biotech R.3.03
Dr. LM Indah Sri HA, S.Psi, Physiology 081337095870 3rd floor:
4 B4
M.Erg R.3.04
Dr.dr. Desak Made Biochemistry 081338776244 3rd floor:
5 B5
Wihandani, M.Kes R.3.05
Dr.dr.Ni Made Linawati, Histology 081337222567 3rd floor:
6 B6
M.Si R.3.06
dr.Gede Putu Biochemistry 082146558748 3rd floor:
7 B7
Supadmanaba, S.Ked R.3.07
dr.Putu Yuliandari, S.Ked Microbiology 089685415625 3rd floor:
8 B8
R.3.08
dr.IDA Inten Dwi Physiology 081337761299 3rd floor:
9 B9
Primayanti, M.Biomed R.3.21
Dr.dr.I Made Sudarmaja, Parasitology 08123953945 3rd floor:
10 B10
M.Kes R.3.22
TIME TABLE

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Day Date Topics Learning Regular English PIC

situation Class Class
1. Thursday, Overview of Introductory 08.00 – 09.00 09.00 – 10.00 Desak Ketut Ernawati.,
22 June Pharmaceutics Medicine, lecture PhD., Apt
2017 Drug Development and
Pharmacovigilance Individual learning 09.00 – 10.30 12.00 – 13.30 Facilitators
SGD 10.30 – 12.00 13.30 – 15.00
Break 12.00 – 12.30 11.30 -12.00
Student Project 12.30 – 14.00 10.00 – 11.30
Pleno 14.00 – 15.00 15.00 – 16.00 Desak Ketut Ernawati.,

PhD., Apt
2. Thursday, Drug promotion, ethics and Introductory 08.00 – 09.00 09.00 – 10.00 Desak Ketut Ernawati.,
29 June regulations (drug lecture PhD., Apt
2017 management)
Individual learning 09.00 – 10.30 12.00 – 13.30 Facilitators
SGD 10.30 – 12.00 13.30 – 15.00
Break 12.00 – 12.30 11.30 -12.00
Student Project 12.30 – 14.00 10.00 – 11.30

PhD., Apt
3 Friday, 30 Biopharmaceutics; Drug Introductory 08.00 – 09.00 09.00 – 10.00 Desak Ketut Ernawati.,
June Dosage Form and Route of lecture PhD., Apt
2017 Administration Individual learning 09.00 – 10.30 12.00 – 13.30 Facilitators
SGD 10.30 – 12.00 13.30 – 15.00
Break 12.00 – 12.30 11.30 -12.00
Student Project 12.30 – 14.00 10.00 – 11.30

PhD., Apt
4. Monday, 3 Medication safety Introductory 08.00 – 08.30 09.30 – 10.00 Desak Ketut Ernawati.,
July lecture PhD., Apt
2017
Drug interaction 08.30 -09.00 09.00 – 09.30 Dr.dr I Made Jawi M.Kes
Individual learning 09.00 – 10.30 12.00 – 13.30 Fasilitator
SGD 10.30 – 12.00 13.30 – 15.00
Break 12.00 – 12.30 11.30 -12.00
Student Project 12.30 – 14.00 10.00 – 11.30

PhD., Apt
Dr dr I Made Jawi M.Kes

Tuesday, 4 Pharmacodynamics and Introductory 08.00 – 09.00 09.00 – 10.00 Prof I.G.M Aman SPFK
5 July Pharmacokinetics lecture
2017 Individual learning 09.00 – 10.30 12.00 – 13.30 Fasilitator
SGD 10.30 – 12.00 13.30 – 15.00

Break 12.00 – 12.30 11.30 -12.00

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Day Date Topics Learning Regular English PIC

situation Class Class
Student Project 12.30 – 14.00 10.00 – 11.30
Pleno 14.00 – 15.00 15.00 – 16.00 Prof I.G.M Aman SPFK
6 Wednesday Drug dosing and Introductory 08.00 – 09.00 09.00 – 09.30 Ida Ayu Alit Widhiartini,
, 5 July calculations lecture dra., Apt., M.Si
2017
Individual learning 09.00 – 10.30 12.00 – 13.30
Fasilitator
SGD 10.30 – 12.00 13.30 – 15.00
Break 12.00 – 12.30 11.30 -12.00
Student Project 12.30 – 14.00 10.00 – 11.30
Pleno 14.00 – 15.00 15.00 – 16.00 da Ayu Alit Widhiartini,

dra., Apt., M.Si
P-drug Introductory 08.00 – 08.45 09.30 – 10.15 Ida Ayu Alit Widhiartini,
7 Thursday, 6 lecture dra., Apt., M.Si
July
2017 Prescribing 08.45 – 09.30 10.15 – 11.00
Individual learning 09.30 – 10.30 08.00 – 09.30 Fasilitator
SGD 10.30 – 12.00 11.00 – 12.30
Break 12.00 – 13.00 14.00 – 15.00
Student Project 13.00 – 14.00 12.30 – 14.00
Pleno 14.00 -15.00 15.00 – 14.00 Ida Ayu Alit Widhiartini,

dra., Apt., M.Si
8. Friday, 7 Presentation of Student Presentation of 08.00 – 12.00 12.00 – 16.00 Desak Ketut Ernawati.,
July Project Student Project PhD. Apt
2017 Individual learning 12.00 – 16.00 08.00 – 12.00
9. Monday, 10 Demonstration of Drug Individual learning 12.00 – 16.00 08.00 – 14.00

July Dosage Forms and dose
2017 calculation Demonstration of 08.00 – 09.00 12.00 – 13.00 Ida Ayu Alit Widhiartini,
Drug Dosage dra., Apt., M.Si
Forms Desak Ketut Ernawati.,
PhD. Apt
Practice of dose 09.00 – 12.00 13.00 – 16.00 Ida Ayu Alit Widhiartini,
calculation dra., Apt., M.Si
Desak Ketut Ernawati.,
PhD. Apt
10 Tuesday, 11 Practice of Prescribing and Individual learning 12.00 – 16.00 08.00 – 12.00
July 2017 Practice of reporting
MESO Practice of 08.00 – 11.00 12.00 – 15.00 Ida Ayu Alit Widhiartini,
Prescribing dra., Apt., M.Si
PhD. Apt
Practice of 11.00 – 12.00 15.00 – 16.00 Ida Ayu Alit Widhiartini,
reporting MESO dra., Apt., M.Si
PhD. Apt
LEARNING PROGRAMS

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ABSTRACTS OF LECTURES
DAY 1
Overview of Pharmaceutics Medicine, Drug Development, and Pharmacovigilance
Objectives:
Students understand pharmaceutics medicine, phases of clinical trial in drug development
and pharmacovigilance
Pharmaceutics Medicine Overview

Pharmaceutics 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 to prescriptions 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 used of medication in practice.
Drug Development
Prior to conducting clinical research aiming for an international recognition and or to generate
clinical trial which is intended to registered to regulatory authorities, researchers need to have
knowledge and skills which meet the Good Clinical Practice (GCP). By definition, GCP is an
international ethical and scientific quality standard for designing, conducting, recording and
reporting trials which involved the participants of human subjects. There were four phases in drug
development.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of
adverse drug reactions or any other potential drug related problems (WHO, 2002). Adverse drug
reactions may be identified during drug development, voluntary reporting and record linkage.
Physician plays a significant role in pharmacovigilance.
Learning Task:
1. Discuss the term pharmacology, clinical pharmacology and therapeutics

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2. Discuss what is pharmaceutics medicines

3. Discuss the role of physician in drug development
4. Discuss phases of clinical trial in drug developments
5. Discuss physicians’ responsibility in pharmacovigilance
DAY 2
Drug promotion, ethics and regulations (drug management)
Learning objectives:
1. understand OTC and ethical drug promotion
2. understand the potential for marketing process to change attitudes in prescribing
3. understand uses and abuses of drug promotion
4. understand drug ethics
5. understand reasons for drug regulation
6. be able to describe some regulations on drugs used in Indonesia
7. be able to explain drug classification based on Indonesian regulations
Drug Promotion
Advertisement and promotion on health and drugs have been regulated by the Indonesian
Government with Permenkes 1787/Menkes/Per/XII/2010. 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.
Drug Ethics and Regulation

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 PeraturanPemerintah 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

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Permenkes No 1787/Menkes/Per/XII/2010. Those regulations aim to ensure consumers/patients

in this instance should get the utmost benefits of their treatment.
Learning Task:
1. 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.
2. A medical representative comes to you to promote their ‘me too’ product (X). You already
use other brand name of X and prescribe lots of prescriptions of that brand name. How to
decide which product to use?
3. Analyze the promotional material given to you. Do you think this promotional material meet
your expectation from promotional materials?
DAY 3
Biopharmaceutics, drug dosage form and route of administration
Objectives:
1. Students be able to describe considerations when selecting dosage forms to prescribe
based on the patient’s needs
2. Students be able to describe advantage and disadvantages of drug dosage forms
3. Students be able to understand aspect of biopharmaceutics in drug dosage form
4. Students be able to understand drugs’ route of administration
Biopharmaceutics
Biopharmaceutics 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 cholorquine, 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, cyclosporine
Dosage Forms
Knowledge of drug dosage form is also essential in rational drug prescribing because patient’s
conditions, biopharmaceutics 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,

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their level of consciousness and the diseases – topical or parenteral used. Further, there are
several reasons in selecting certain dosage forms in drug formulation.
Learning Task:
1. Discuss the importance of biopharmaceutics in drug discovery and regulatory practices.
2. Discuss advantages and disadvantages of dosage forms based on their route of
administrations.
3. Case scenario:
Krisna, 14months boy was experiencing fever, cough and cold. Please discuss which
dosage form is the most rational to this patient?
4. Discuss the rational 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.
Day 4
Pharmacokinetics and Pharmacodynamics
(Prof Aman)
DAY 5
Medication safety and drug interaction
Learning Objectives:
- Be able to describe the role of prescriber in medication safety
- Be able to define medication safety
- Be able to describe classification of drug interaction
- Be able to describe significant drug interaction
Medication safety
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.
Drug Interaction

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Drug interactions may make the drug less effective, cause unexpected side effects or increase the
action of a particular drug. Some drug interactions can even be harmful to the patients. Drug
interactions fall into three broad categories: ■ Drug-drug interactions occur when two or more
drugs react with each other. This drug-drug interaction may cause you to experience an
unexpected side effect. For example, mixing a drug you take to help you sleep (a sedative) and a
drug you take for allergies (an antihistamine) can slow your reactions and make driving a car or
operating machinery dangerous. ■ Drug-food/beverage interactions result from drugs reacting
with foods or beverages. For example, mixing alcohol with some drugs may cause you to feel
tired or slow your reactions. ■ Drug-condition interactions may occur when an existing medical
condition makes certain drugs potentially harmful. For example, if you have high blood pressure
you could experience an unwanted reaction if you take a nasal decongestant. Drugs interaction
also can be categories as pharmacodynamic interaction and pharmacokinetic interaction.
Pharmacodynamic interactions refers to interactions in which drugs influence each other’s effects
directly, for example, sedatives can potentiate each other. The same is true of alcohol, which can
potentiate the sedative effects of many drugs. Pharmacokinetic interactions influencing of
absorption, distribution in the various compartments, metabolization, and elimination can affect
the effective concentrations at their sites of action. The causes can be formation of complexes,
competition for uptake transporters, or induction of metabolizing enzymes and efflux transporters.
A necessary consequence of this is the danger that interactions between drugs will lead to serious
adverse effects or will reduce the therapeutic effect of some compounds. Potential interactions
can arise at any age in life, but the frequency of polypharmacy in older life increases the risk
substantially. Knowing about interactions and their causes may help to avoid the serious adverse
effects of the drugs.
Learning Task:
1. Discuss about technical and non-technical problems which contribute to prescribing errors
2. Discuss about physicians’ contribution to ensure medication safety
3. Case scenario:
MrsKori received a prescription from a private physician practicing in Denpasar. For the
sake of her convenience, she brought her prescription to a pharmacy closed to her house
in Gianyar. However, the pharmacy was unable to dispense the medication because the
prescription is unclear/ unreadable. Thus, she went to other pharmacies just to find the
same fact. Discuss what happen to this patient, and how to prevent this from happening?
Day 6
Drug Dosing and Calculation

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Several drugs are available in different dosage form such as solid and liquid dosage forms
with different potency. Sometimes, physicians prescribe drug dose which may not be the same as
that written on drug label. The drug dose may also need mathematic conversion using dose
calculations. There are several way to do dose calculation such as ratio, proportion, dose
formulas (Fried’s rule, Young’s rule, andClark’s rule) and dimensional analysis. The dose
calculation which assigned for individual patients will bring positive therapeutic outcomes, thus it
avoids drug toxicity.
Learning Task:
Calculate the dose properly to the patients need:
Dose recommendation Dosage form and potency Patient’s need

a. Digoxin 0,125 Digoxin tablet 0.25mg ..… tablet
b. Mefenamic acid 250 Mefenamic acid capsule …..capsule
…mL/ …cth
mg 250mg
Mefenamic acid suspension
…..capsule
125mg/5ml
c. Clindamycin 300mg
Clindamycin capsule 150mg ……cth
twice daily, for 7
Amoksisilin Dry syrup
days
d. Amoksisilin 125mg/5mL
10mg/kgBB
Day 7
P-drug and Prescribing
Objectives:
1. Students be able to describe rules in prescribing
2. Students be able to write steps involved in p-drug
3. Students be able to write prescription based on case vignettes provided
Drug Prescribing
This topic covers common rules in rational prescribing and steps in order to achieve the rational.
Rational prescribing encompasses the five rights and alertness of adverse drug events.
Prescription is a written request from physician/dentist/veterinologist to pharmacist to prepare
medication in certain dosage form to patients. Prescription must be written in Latin because it is
an International language in medicine. The language is not developing anymore thus there is no
dualism in interpreting the prescription. Components of complete prescription are as the following:
1. Physician’s identity: name, address, phone number, registration number, date of practicing

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2. Date and place of the prescription written

3. R/ sign – recipe (Superscriptio)
4. Name of medication - generic active compound and the strength (Inscriptio)
5. Dosage form or intended dosage form (Subscriptio)
6. Instruction to take/use the medication (Signatura)
7. Patient’s identity (pro): name, age, weight, address
8. Physician’s signature/sign
These components must be 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.
The prescription shows physician’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.
Rational Prescribing: P-drug
The World Health Organisation (WHO) suggested six steps to ensure the rational prescribing
using A Guide to Good Prescribing. The six steps are:
1. Define the patient’s problems based on objective diagnosis.
2. Specify the therapeutic objectives to achieve with the treatment.
3. Verify whether your p-drug (personal drug) is suitable for this patient. The p-drug
consists of possible drugs based on a comparison of their efficacy, safety, suitability,
and cost. The list may be from clinical teacher, existing national or local treatment
guidelines or formularies. The list is started from groups of drug classification then drug
selection, dosage form, dosage schedule and duration of therapy.
4. Start the treatment
5. Give information, instruction and warnings
6. Monitor/stop treatment

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A problem of patients should be evaluated on the basis of their information such as: sign,
symptom, patient’s history (disease, allergy, adverse drug reaction or side effect while taking food
or medications), physical examination, clinical laboratory, radiology/imaging and or another clinical
examination/test. Those information aims to define the working diagnosis enforcing the
medication need. Sometimes, patients do not need particular intervention (e.g. medication) but
they may only need advicefor their current complains. Further, they patients may need referral to
medical specialist.
Specific therapeutic objectives must be defined when developing P (personal)-treatment. It is
followed by choosing a P (personal)-drug or P’drug. The therapeutic objective most likely the
description of the drug effect related to the patient’s problem and their symptoms, so it reflects
the therapeutic outcome of the drug at any given time and route of administration.
The P-drug consists of possible drugs based on a comparison of their efficacy, safety,
suitability, and cost. It is not only a name of the active ingredients/pharmacological names of the
drugs but also the dosage regimen such as: dosage form, dosage schedule and duration of
treatment (WHO, 1996). The P-drug which is suitable for general patient is not always suitable for
particular patients. The P-drug fulfilled the patient’s need including the physiologic patient’s
condition, allergy, and lifestyle, so it is the best choice for given indication for a particular patient.
P-drugs will differ from country to country, and between doctors, because of varying availability
and cost of drugs, different national formularies and essential drugs lists, medical culture, and
individual interpretation of drug information, population characteristic. The list may be referred
from clinical teacher experience based on evidenced based, existing international, national or
local treatment guidelines or formularies, drug essentials.
The success of therapeutic outcomes comprises of initiating drug therapy, communicating,
informing, and educating the patient. The patients need reminders about their medicine,
especially the name of the drug, how to administration, how long and how many times must take
or apply the drugs
Learning Task:
1. Describe the meaning of prescription signature and subscription below

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1. gtts. iia.u. b.i.d. 15. 3 d dgtt V Aur D et S for 3 days

2. ung. p.a.a. q12h 16. prn 3 d d tab I
3. caps ii stat, then 1 q6h a.t.c. 17. 1 dd applied on the spot HS
4. 1 suppp.r. q6h prn N & V 18. 6 gtt I eye drop D
5. tabs i q.i.d., 1/2 hra.c. and h.s. 19. 1 d d chew tab.
6. 2 tsp. pulv ex aqp.o.t.i.d., p.c. 20. q 8h cth II for 7 days 21. M. fla dissolve
7. tab i ssh.s., p.r.n. sleep. Non rep. sach I in aqua 200mL
8. tab i q.o.d. in am 22. M.flapulveresdtd No XV da in caps 23.
9. gtts i o.d. q.d. 23. M. flapulvis No XV
10. 4 tbls. in O aq. dist.; gargle 1 f oz. q4h 24. M. fla cream da in pot II
11. 2 d d tab I, mane et vesp. 25. M. flaoint da in tube I
12. u e
13. pro nasal 2 d d nasal spray II
14. i.m m
II. Prescribing analysis

Dr Desi RM #51101
SIP:......
JlJepun, 9, Denpasar Bali
Telp: 255-123
Denpasar, 2 Mei 2017
R/
Acetaminophen 0.650
Codeine hydrochloride 0.010
M.fla. pulvvdtd caps No XX

Sig: i q4-6h prn pain
Nama:vDani (20 TAHUN)
Alamat: Jl Raya HayamWuruk 72,Denpasar Telp: 254-124
Dr Rosita
SIP………….
Jl. Kecubung 20, Denpasar
Phone: 555-1234

Etics 2017
Tabanan, 23 Mei 2016
R/ Hydrocortisone cream 1%
Sig: apply to face b.i.d. after cleansing
Nama : Lyoni
Alamat: JlKamboja No. 8, Denpasar Telp: 555-5678
Ne iteratur
1. Analyze the prescription based on good prescribing concept
2. Describe the problem, therapeutic objective, prescribing information, instruction, and warning to
the patient, and how the patients do monitoring the outcome therapy by her-self.
3. How many mg of acetaminophen for every 6 hours?
4. How many mg of codeine phosphate will be dispensed for that formula?
5. Rewrite your prescription properly
Day 8
Student Presentation
Objectives:
1. Students will be able to showcase their work to other groups
Students will present their project as follows:

KUA/B SGD 1 – 3 will present their report on SP 1.
KUA/B SGD 4 – 6 will present their report on SP 2.
KUA/B SGD 7-10 will present their report on SP 3.
Evaluation of students presentation can be seen on Appendix 4.
Day 9
Demonstration on drug dosage forms; drug dose calculation; and reporting ADR (yellow
form)

Etics 2017
Scenario for Dose Calculation
Case scenario:
a. You consider that your patients, Krisna need an analgesic and antipyretic Paracetamol
360mg divided in 3 doses a day. There are varieties of drug dosage form such as
Parasetamol elixir syrup 120mg/5ml, drop 6mg/0,6ml, and tablet 500mg. Calculate drug
dosage Paracetamol for him for every 8 hours and per day for every dosage form.
b. Rina (5th) is considered to take antibacterial Amoxicillin 20mg/kg BW/day divided in 3
doses a day. The patients had the Amoxicillin dry syrup 250mg/5mL, patient’s body weight
was 20kg, and safety dose interval Amoxicillin was 20-40 mg/kg/day, how much is the
proper doses for her?
There are several dosage forms will be provided in the class and the student have to
observe each of them for learning the proper dose for patients as it written on the drug
leaflet or packaging and complete the table Doses.
Dosage form Group of Patient Dose

Recommendation
Day 10
Practice of P-drug and Prescribing
Scenario 1: There are several cardswhich describe clinical cases and or symptom of diseases
which is chosen at introduction session (see Appendix 7). Each group consist of minimal 10
students must develop P-treatment and P-drug completely with description and type in the form P-
treatment and P-drug enclosed in this study guide (Appendix 6). The students have to prepare
this assignment together out of class while presenting this individually in the class.
Scenario 2: The are several prescription and clinical case or symptom card which are going to
share to students and must assess 1 prescription and 1 case per group. First, for the prescription,
the student must analyzed the prescription based on prescribing rule’s and medication safety
concept and rewrite the good prescription in prescription form enclosed. Second, for the clinical
case and or symptom card, the student must calculate the dose properly and write a good
prescribing based on the patient’s need.

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APPENDIX 1
COMMON LATIN WORDS
Aa ana samabanyak
a.c ante coenam sebelummakan
a.n ante noctem malamsebelumtidur
ad lib ad libitum secukupnya (yang diinginkan)
a.u.e = ad us.ext ad usumexternum untukobatluar
a.u.p= ad us.prop. adusumproprium untukdipakaisendiri
u.p= us.prop ususpropius dipakaisendiri
m.i mihiipsi dipakaisendiri
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 sendokbubur (sebaiknyatidak
dipakai)
c.th. cochlear theae sendokteh = 5 cc
collut.or. collutiooris, collutorium obatkumur (cucimulut)
collyr collyrium obatcucimata
d.i.d da in dim/da in dimidio berikanseparuhnya
d.c.form. da cum formula tuliskandenganresepnya
d.d de die sehari
1d.d.=s.d.d semel de die sekalisehari
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 kanandankiri
o.d/o.s. oculusdexter et oculus matakanandanmatakiri
siniter
d.t.d da tales doses berikansebanyakdosis
tertentu
emuls emulsum emulsi
enem enema lavement
extr. Extractum ekstrak
f fac,fiat,fiant buat, harapdibuatkan
f.la faclegeartis buatmenurutcarasemestinya
garg. Gargarisma obatkumur
h.m. horamatutina pagihari
h.s horasomni jam sebelumtidur
inf infusum air rebusan
inj. Injectio obatsuntik
iter iteretur 1x harapdiulang
iter. 1 x iteretur 1 x harapdiulangsatu kali
liq. Liquidus cair
lot lotio obatcairuntukobatluar,lotion
m.f misce campurlah&buatlah
m.f.l.a miscefaclegeartis buatlahmenurut
carasemestinya
m.et.v. mane et vespere pagidan sore
p.p pro paupere untuksimiskin
P.I.M periculum in mora berbahayabiladitunda

Etics 2017
p.r.n pro re nata kalauperlu

pulv. pulvis serbuk ( tunggal )
pulv.adsp. pulvisadspersorius bedak
q.s quantum satis/sulfficit secukupnya
R/ recipe ambillah
Rec.par recenterparatus dibuatbaru
S. Signa tandailah(tulislahaturanpakai)
Sol. Solutio larutan
Spir. Spiritus spiritus
u.c ususcognitus aturanpakaidiketahui
u.e. ususexternus obatluar

Etics 2017
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%)

Etics 2017
APPENDIX 3
STUDENT PROJECT
FASILITATOR’S ASSESSMENT FORM
GROUP :
Name of Facilitator :
Time Table of Consultation
No Point of Discussion Date Tutor Sign

1 A literature review of rational
prescribing
2 A literature review of drug
dosage form
3 Analysis of prescriptions
Score of Assessment:
No Description Maximum Score Score
1 Quality of review (e.g. current 100
literature)
2 Critical thinking 100
3 Ability to analyze the prescription 100
Total score (1+2+3)/3 100
Denpasar, ______________________
Facilitator:

Etics 2017
APPENDIX 4
STUDENT PROJECT
PRESENTATION ASSESSMENT FORM
Group :
SP : 1/ 2 / 3
Date of presentation :
No Description Maximum Score Evaluator Peer Score

Score (ES) (PS)
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

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Study Guide Basic Pharmaceutical Medicine &
Drug Etics 2017
dr dr
Jl Jl
Telp. Telp.
SIP SIP:
Denpasar, Denpasar,
Pro: Pro:
Udayana University Faculty of Medicine, DME, 2017 Pro Pro: : 54

Umur/ BB Umur/
: BB :
Alamat Alamat
: :
Study Guide Basic Pharmaceutical Medicine & Drug Etics 2017
4. GROUP CHOICES [mark (+/-)]
GROUP Efficacy Safety Suitability Cost

(PK/PD) (SE/ADR) (CI)
CHOICES OF P-DRUG Efficacy Safety Suitability Cost

(PK/PD) (SE/ADR) (CI)
Active substance, dosage form:

Dosage schedule:
Duration:
6. COUNSEL THE PATIENT
-----------------------------------------------------------------------------------------------------------------------
APPENDIX 7
CASES
Card 1.Arman, 50 y.o suffered from chronic cough, and he come to primary health
center in the afternoon as he got fever since in the morning. He felt uncomfortable
every night, he got cough and he could not sleep well. He was a heavy smoker. There
is no information about his disorder also a specific physical examination about his
inflammation on his throat. The doctor asked him to stop smoking and prescribed three
medications: Codein 15 mg Tablet, Dextromethorphan 15 mg tablet, Ambroxol 30mg
tablet, but he thought he just prescribed just one of threefor short term 3days, 3 times
daily. Write a prescription for this patient on the templateprescription provided.
Card 2.A mother and his 4years old boy (Tony) come to primary health care. Her boy
complained fever, temperature axial 39.50C since in the morning and cough. The doctor
consider that he suffered pneumonia infection, after physical examination he considers
to prescribe Tetracycline capsule 250mg, every 8 hours, for 7 days, but he confused to
adverse drug reaction. Give a suggestion for treatment.
Card 3.Reny 20 y.o. came to GP for her rash and itchy on his leg and neck. She told
that she ate seafood at her lunch 2 hours ago. She got food allergy before but she
wanted to try just small seafood at a moment. What is your solution for her if the GP
prescribes oral tablet and topical preparations. The following are her potential drugs to
choose from: Dipenhydramine 25 mg tablet; Salicilate acid Talcum; Hydrocortisone
Cream 1%. Write a prescription for this patient on the templateprescription provided.


Study Guide Medical
Communication 2017

Study Guide Medical
Communication 2017
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Study Guide Basic Pharmaceutical Medicine & Drug Etics 2017: Student Contract

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Study Guide Basic Pharmaceutical Medicine & Drug

BLOCK : PHARMACEUTICS MEDICINES, ETHICS AND DRUG USED

Udayana University Faculty of Medicine, DME, 2017 1

STUDENT PROJECTS (SP) :

The format of a review on student project of rational drug prescribing is as follows:

The format a review on student project of drug dosage forms is as follows:

The format of analysis of prescriptions can be seen on Appendix 2.

Udayana University Faculty of Medicine, DME, 2017 2

Denpasar, 22 June 2017

Desak Ketut Ernawati., Ph.D Apt

(dr. I Gde Haryo Ganesha, S.Ked)

Udayana University Faculty of Medicine, DME, 2017 3

of pharmaceutics medicines and pharmacotherapy are prominent. Pharmaceutical medicine can

No Name Department Phone

Udayana University Faculty of Medicine, DME, 2017 4

NO NAME DEPT PHONE

NO NAME GROUP DEPT PHONE ROOM

Udayana University Faculty of Medicine, DME, 2017 5

Dr.dr. I Made Jawi, M.Kes Pharmacology 08179787972 3rd floor:

Udayana University Faculty of Medicine, DME, 2017 6

Day Date Topics Learning Regular English PIC

SGD 10.30 – 12.00 13.30 – 15.00

Break 12.00 – 12.30 11.30 -12.00

Student Project 12.30 – 14.00 10.00 – 11.30

Pleno 14.00 – 15.00 15.00 – 16.00 Desak Ketut Ernawati.,

SGD 10.30 – 12.00 13.30 – 15.00

Break 12.00 – 12.30 11.30 -12.00

Student Project 12.30 – 14.00 10.00 – 11.30

Pleno 14.00 – 15.00 15.00 – 16.00 Desak Ketut Ernawati.,

SGD 10.30 – 12.00 13.30 – 15.00

Break 12.00 – 12.30 11.30 -12.00

Student Project 12.30 – 14.00 10.00 – 11.30

Pleno 14.00 – 15.00 15.00 – 16.00 Desak Ketut Ernawati.,

Individual learning 09.00 – 10.30 12.00 – 13.30 Fasilitator

SGD 10.30 – 12.00 13.30 – 15.00

Break 12.00 – 12.30 11.30 -12.00

Student Project 12.30 – 14.00 10.00 – 11.30

Pleno 14.00 – 15.00 15.00 – 16.00 Desak Ketut Ernawati.,

Dr dr I Made Jawi M.Kes

SGD 10.30 – 12.00 13.30 – 15.00

Udayana University Faculty of Medicine, DME, 2017 7

Day Date Topics Learning Regular English PIC

Student Project 12.30 – 14.00 10.00 – 11.30

Pleno 14.00 – 15.00 15.00 – 16.00 Prof I.G.M Aman SPFK

Break 12.00 – 12.30 11.30 -12.00

Student Project 12.30 – 14.00 10.00 – 11.30

Pleno 14.00 – 15.00 15.00 – 16.00 da Ayu Alit Widhiartini,

Individual learning 09.30 – 10.30 08.00 – 09.30 Fasilitator

SGD 10.30 – 12.00 11.00 – 12.30

Break 12.00 – 13.00 14.00 – 15.00

Student Project 13.00 – 14.00 12.30 – 14.00

Pleno 14.00 -15.00 15.00 – 14.00 Ida Ayu Alit Widhiartini,

9. Monday, 10 Demonstration of Drug Individual learning 12.00 – 16.00 08.00 – 14.00

Udayana University Faculty of Medicine, DME, 2017 8

Pharmaceutics Medicine Overview

Udayana University Faculty of Medicine, DME, 2017 9

2. Discuss what is pharmaceutics medicines

Drug Ethics and Regulation

Udayana University Faculty of Medicine, DME, 2017 10

Permenkes No 1787/Menkes/Per/XII/2010. Those regulations aim to ensure consumers/patients

Udayana University Faculty of Medicine, DME, 2017 11

Udayana University Faculty of Medicine, DME, 2017 12