PHARMACEUTICAL LAW AND ETHICS

“CRIMINAL CODE (KUHP) RELATED

TO PHARMACEUTICAL
MALPRACTICE”

BY:
GROUP III
KADEK SUASTINI ( D1A119001 )
ELA AFRIANA ( D1A119003 )
NATANIEL PALINOAN ( D1A119010 )
ZAKIAH TAJUDDIN ( D1A119013 )
ARJUDIN MUSTAFA ( D1A119076 )
 
APOTEKER PROFESSIONAL EDUCATION STUDY PROGRAM FACULTY OF
PHARMACEUTICAL, HOSPITAL INFORMATION TECHNOLOGY
UNIVERSITAS MEGAREZKY
2020
 PHARMACIST
MenKes No. 1332/Menkes/SK/X/2002
“a pharmacist is a pharmacist who has
graduated and has taken the oath of a
pharmacist's position based on the
legislation in force and is entitled to do
pharmaceutical work in Indonesia as a
pharmacist”.
 PHARMACIST RIGHTS
• Entitled to do pharmaceutical work
• Entitled to be the person in charge of the pharmaceutical wholesaler and the drug raw
material distributor
• Entitled to carry out compounding drugs (actions or delivery of drugs for health
purposes)
• Authorized to organize a pharmacy somewhere after receiving an pharmacist license
(SIA) from the Minister
• Authorized to be in charge of the traditional medicine industry business
• Authorized to be in charge of quality control in the finished pharmaceutical industry
and drug raw materials
• Authorized to receive and distribute hard drugs through pharmaceutical wholesalers or
pharmacies
• Conducting pharmacist service in government health facilities or other health facilities,
such as state-owned public (BUMN) / BUML's health facilities, pharmaceutical industry,
traditional medicine industry, industry, food and beverage industry, pharmacies outside
the national capital, pharmaceutical wholesalers, hospitals, higher education and
private sector pharmaceutical intermediate (as a student), or research and
development institution (as a researcher)
 PHARMACIST OBLIGATIONS
• Providing, storing, and delivering good quality pharmaceutical supplies and their
validity is guaranteed
• Serve recipes in accordance with the responsibilities and expertise of the profession
based on community interests
• Consult a doctor for more appropriate drug selection
• Provide information relating to the use of drugs that are recommended to patients and
drug users in an appropriate, safe, and rational manner at the request of the community
• Provide information relating to the use of drugs that are recommended to patients and
drug users in an appropriate, safe, and rational manner at the request of the community
• Appoint a companion pharmacist or a substitute pharmacist if unable to carry out their
duties
• Responsible for the implementation of activities carried out by a companion pharmacist
or substitute pharmacist in managing the pharmacy
• Submit prescriptions, narcotics, drugs and pharmaceutical supplies; keys to storing
narcotics and psychotherapists; and the news of the event if submitting responsibility
for pharmaceutical management.
• Safeguarding pharmaceutical supplies in accordance with applicable laws and
regulations if the pharmacist license (SIA) is revoked
 Malpractice
Mistakes or negligence committed by health
workers in carrying out their profession that is not
in accordance with professional standards and
operational procedure standards, due to the error
or negligence the patient suffered serious injuries,
disabilities and even died.
A pharmacist service practice can be categorized as a
pharmacist malpractice seen from 3 aspects / things:
• Intensional Professional Misconduct,
Pharmacists practice irresponsibly by doing wrong / bad
practices and in practice committing violations
intentionally not heeding the standards in the existing
rules and there are no elements of negligence /
negligence
• Negligence or accidentally (negligence) Pharmacists
who due to negligence (culpa) which results in disability
or death of the patient.
• Lack of Skill A
Pharmacists who perform services but beyond their
competence or authority.
 Types of Malpractice
1. Malpractice Ethics: pharmacists take actions
that are contrary to pharmacist ethics.
2. Juridical Malpractice / Legal Malpractice :
Civil malpractice occurs when there are things that
cause the agreement (default) is not fulfilled in the
transaction.
Next,,,
Criminal malpractice: occurs when a patient
dies or suffers from disability due to a doctor
or other health worker who is careless, or
carelessly carries out efforts to cure a patient
who has died or has a disability..
Administrative Malpractice: the health
worker has violated administrative law
 Case Examples Regarding Pharmaceutical
Malpractice
1. Case 1:
The pharmacist in charge of the pharmacy ordered a 20 mg
diazepam tablet, but the order was rejected by the pharmaceutical
wholesaler. In this case, what permits have been used up?
Settlement:
Permits that have expired are SIPA (Pharmacy Practice License). The
government has determined that every health worker who practices
in the field of health services is required to have a permit Article 46
Paragraph (1) Law No. 36 of 2014 CONCERNING HEALTH PERSONNEL.
If the Pharmacist continues to practice without taking care of SIPA,
the Pharmacist has violated Article 86 paragraph (1). Every health
worker who practices without a license is liable to a maximum fine
of Rp 100,000,000 (one hundred million rupiah).
 Next,,,
2. Case 2: A 50-year-old man came to the pharmacy by showing a packet of herbal
medicine to overcome sexual disorders. The patient complained that his heart was easily
pounding and often had headaches after consuming the herbal medicine. The herbal
medicine turned out to be a product that was pulled by BPOM because there were
chemical drugs (BKO). What was contained in the herbal medicine?
Settlement:
• The ingredients contained in these herbs are sildenafil citrate. The Government has
stipulated in PP NUMBER 72 of 1998 CONCERNING SAFETY OF PHARMACEUTICAL AND
MEDICAL DEVICES article 2 paragraph (b) that the requirements for quality, safety and
benefit of pharmaceutical preparations in the form of traditional medicines are in
accordance with the requirements in the Indonesian Materia Medika book set by the
Minister of Health. The trader has violated Article 76, who is intentionally producing
and / or distributing pharmaceutical preparations in the form of traditional medicines
that do not meet the requirements and producing and / or distributing pharmaceutical
preparations in the form of cosmetics that do not meet the requirements of being
sentenced to a maximum imprisonment of 5 (five) years and / or a maximum fine of Rp
100,000,000 (one hundred million rupiah).
• Violating Article 386 of the Criminal Code (KUHP), selling, offering or handing over drugs
which are known to be fake, and concealing, is punishable by a maximum imprisonment
of four years.
 Next,,,
3. Case 3:
Chronology of events or cases that occurred in
December 2014 in Oregon USA, brain surgery patients
died due to incorrect administration of drugs because
pharmacists were not careful in reading recipes. Doctor
Boileau who treats patients feels it is right to prescribe
phosphenitoin to reduce seizures, but a pharmaceutical
worker, who is a pharmacist, mistakenly gives the drug
rocuronium which is a drug that functions to paralyze,
resulting in patients dying. The events above if they
occur in Indonesia will be related to several rules,
namely: the Criminal Code and Law Number 36 of 2009
concerning Health.
 Next,,,
Settlement:
1. If negligence committed endangers patient safety, then negligence committed will
turn into criminal acts. If the result of negligence is caused the death of the patient
then the negligence can be categorized as a criminal offense and a violation of the
law.
Negligence resulting in death is regulated in Article 359 of the Criminal Code (KUHP)
Stating that: "Anyone who due to his mistake (negligence) causes another person to
die, is threatened with a maximum imprisonment of 5 (five) years or a maximum
imprisonment of one year.
2. In terms of demanding compensation Patients can associate with Article 58 of Law
Number 36 Year 2009 regarding Health states that:
• Every person has the right to claim compensation for a person, health worker, and /
or health provider who causes losses due to errors or negligence in the health services
he receives.
• The claim for compensation as referred to in paragraph (1) does not apply to health
workers who carry out life-saving measures or prevent someone's disability in an
emergency.
• Provisions regarding the procedure for filing a claim as referred to in paragraph (1)
shall be regulated in accordance with the provisions of the legislation
THANK YOU

GROUP III