Medicines Advertisement Regulations Quiz

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Questions and Answers

What does the administrative code 'C' signify?

Repacked products

Contract Manufactured (correct)

Orphan products

Second source

Which Act establishes the Medicines Advertisement Board?

Medicines (Advertisement and Sale) Act 1956 (correct)

Poisons Act 1952

Dangerous Drugs Act 1952

Sale of Drugs Act 1952

What is the primary purpose of the Medicines Advertisement Board?

To approve and reject advertisements related to medicines (correct)

To regulate drug sales

To oversee the importation of drugs

To register pharmacists

What code is assigned to products gazetted as zero-rated under the Goods and Services Tax Act?

Z Signup and view all the answers

Which regulatory act prohibits certain advertisements related to medical matters?

Medicines (Advertisement and Sale) Act 1956 Signup and view all the answers

What is the primary purpose of provisional registration for pharmacists?

To obtain experience prior to full registration Signup and view all the answers

Which body is responsible for the registration of pharmacists according to the act?

Pharmacy Board Signup and view all the answers

What condition must be met before applying for full registration?

Employment as a pharmacist for at least one year Signup and view all the answers

What examination must be passed to achieve full registration?

Pharmacy Jurisprudence Examination Signup and view all the answers

Which of the following titles is restricted under the act?

Pharmaceutical Chemist Signup and view all the answers

Which of the following documents specifies qualifications for provisional registration?

First Schedule Signup and view all the answers

What does the act state about the time served in public service post-registration?

It must be a continuous period of not more than 3 years Signup and view all the answers

What exception can be granted by the Board regarding experience for full registration?

Exemption from experience requirements Signup and view all the answers

What is the primary purpose of acts in the context of pharmacy legislation?

To define responsibilities for pharmacists Signup and view all the answers

Which act was revised in 1989 and relates to the registration of pharmacists?

Registration of Pharmacists Act 1951 Signup and view all the answers

What do regulations in pharmacy legislation primarily dictate?

How the legal provisions of the act should be applied Signup and view all the answers

Which piece of legislation controls drugs and cosmetics?

Sale of Drugs Act 1952 Signup and view all the answers

What is the focus of the Medicines (Advertisement and Sale) Act 1956?

Regulation of medicine advertisements Signup and view all the answers

Which regulations were associated with the Poisons Act 1952?

Poisons (Psychotropic Substances) Regulations 1989 Signup and view all the answers

Which year had a significant revision concerning the Registration of Pharmacists Act?

1989 Signup and view all the answers

What does the term 'act' refer to in the context of pharmacy legislation?

An official law passed by a legislative body Signup and view all the answers

What is defined as a 'drug' in the Sale of Drugs Act 1952?

A product intended for internal or external use on humans or animals for medicinal purposes Signup and view all the answers

Which authority is established under the Sale of Drugs Act 1952?

Drug Control Authority (DCA) Signup and view all the answers

Which of the following licenses is NOT mentioned in the context of dealing with pharmaceuticals?

Retailer's licence Signup and view all the answers

What is required for a product to be manufactured or supplied according to Subregulation 7(1)?

It must be registered and the manufacturer must hold the appropriate licence Signup and view all the answers

What does the registration number format 'MAL19976399X' indicate?

The type of product and registration details Signup and view all the answers

Which category corresponds to health supplements in the registered product coding?

N Signup and view all the answers

What does the code 'X' signify among the registered product categories?

Over the counter medicines (OTC) Signup and view all the answers

Which legislation governs the registration and control of pharmaceuticals and cosmetics?

Sale of Drugs Act 1952 Signup and view all the answers

Which of the following diseases is prohibited from being advertised as a treatment or remedy?

Asthma Signup and view all the answers

What condition is specifically mentioned as prohibited for advertisements regarding contraception?

Practicing contraception among human beings Signup and view all the answers

Which legislation regulates the sale and advertisement of medicines?

Medicines (Advertisement and Sale) Act 1956 Signup and view all the answers

What is included in the Schedule of prohibited diseases?

Heart diseases/ defects Signup and view all the answers

What is the classification of opium under the legislation?

A dangerous drug with tight regulations Signup and view all the answers

What does possession of certain amounts of dangerous drugs constitute under the Dangerous Drugs Act?

Trafficking Signup and view all the answers

Which of the following is NOT included in the prohibited advertisements for certain conditions?

Preventing common illnesses Signup and view all the answers

What is a notable feature of the Dangerous Drugs Act regulations?

Mandatory recording for hospitals Signup and view all the answers

What does the principle of nonmaleficence primarily emphasize in healthcare?

Preventing unnecessary harm to patients Signup and view all the answers

How can the principle of nonmaleficence be violated?

By intentionally causing patient harm Signup and view all the answers

What does the principle of justice in healthcare advocate for?

Equality in care across all patient demographics Signup and view all the answers

What concern arises regarding Ms. Izzy's understanding of her new medication?

She may refuse to take the drug due to side effects Signup and view all the answers

What responsibility does the principle of justice imply towards patients who cannot afford treatment?

Ensure equitable access to necessary medications Signup and view all the answers

Which action could indicate a violation of nonmaleficence by a pharmacist?

Negligently causing harm through incorrect medication dispensing Signup and view all the answers

What is a potential complication in applying the principle of justice in healthcare?

Healthcare professionals may prioritize financial interests over patient needs Signup and view all the answers

What should a pharmacist consider when discussing medication with Ms. Izzy?

To provide complete and honest information about risks Signup and view all the answers

Study Notes

Laws and regulations govern the profession and practice of pharmacy.
Acts: Laws passed by a legislative body.
Regulations: Rules that detail how acts are applied.
Key acts and regulations related to pharmacy practice are covered.

Current Legislations Relevant to Pharmacy Practice

Registration of Pharmacists Act 1951 (Revised 1989) & Registration of Pharmacists Regulations 2004
Poisons Act 1952 (Revised 1989) & Regulations 1952, Poisons (Psychotropic Substances) Regulations 1989
Sale of Drugs Act 1952 (Revised 1989), Control of Drugs and Cosmetics Regulations 1984
Medicines (Advertisement and Sale) Act 1956 (Revised 1983), Medicine Advertisements Board Regulations 1976
Dangerous Drugs Act 1952, & Regulations 1976.

Legislation 1 - Registration of Pharmacists Act 1951 & Regulations

This act establishes a Pharmacy Board and pharmacist registration.
Provisions include the establishment of the Pharmacy Board and its duties and powers.
It outlines the eligibility criteria for provisional and full registration.
The act also provides conditions prior to registration and limitations on the use of specific titles like "pharmaceutical chemist", "pharmaceutist", "chemist and druggist", and "pharmacist".

Provisional Registration Requirements

Provisional registration is for gaining experience prior to full registration.
Requirements specify qualifications found in First Schedule.
A suitable qualification can be determined by the Minister.
Experience with employment as a pharmacist for at least one year, with locations listed on the Second Schedule is required.

First Schedule - List of Registrable Qualifications

Lists specific institutions and qualifications for pharmacist registration within Malaysia.
Provides the name of the institution, the country in which the qualification is granted, and the qualification description.

List of Training Premises for Provisionally Registered Pharmacists

PRP training is required at premises listed in the Second Schedule.
This list details different training premise types, such as government hospitals, institutions, and government clinics across multiple states.
Full details of the list of training premises are available in the Second Schedule document.

Legislation 2 - Poisons Act 1952 & Regulations

This act regulates importation, possession, manufacture, compounding, storage, transport, and use of poisons.
Poisons are classified into schedules.
This act outlines the importation, packaging, labelling, and storage of poisons.
Further regulations govern the sale and supply of poisons by retail and wholesale entities, along with licenses, permits, and authorizations.
There are record-keeping requirements for poisons

First Schedule (Poisons List)

Specific categories of poisons are grouped and listed.
The document details various poisons, and some exemptions are stated.
The different parts describe various groups of poisons.

Legislation 3 - Sale of Drugs Act 1952 & Control of Drugs and Cosmetics Regulations 1984

Defines "drug" as a substance used on humans or animals, for medicinal purposes internally or externally.
Establishes the Drug Control Authority (DCA).
Outlines the registration of pharmaceuticals and notifications pertaining to cosmetics.
The act also contains licensing and application procedures for those working with pharmaceuticals.
These regulations also include requirements, including registration numbers.

How to Identify Registered Medicines with MOH

Different categories, such as controlled medicines, over-the-counter medicines, natural products/traditional medicines, health supplements, and veterinary products, are stated with their respective administrative codes.

Legislation 4 - Medicines (Advertisement and Sale) Act 1956 & Regulations

An Act prohibiting advertisements relating to medical matters.
Establishes a Medicines Advertisement Board (Lembaga Iklan Ubat).
The functions of the board include approving and rejecting advertisements, and governing medicine and remedy services' advertisements.
Provides advertisement authorization codes.
Lists prohibitions, including those relating to preventing/treating diseases.

Prohibition of Advertisements

Advertisements referring to articles as medicines for the prevention and treatment of specified diseases, contraception, conditions improving human kidney or heart function, or sexual performance are prohibited.
Specific diseases outlined in the Schedule are prohibited from advertising.

Legislation 5 - Dangerous Drugs Act 1952 & Regulations

This act controls the importation, exportation, manufacture, sale, and use of opium and other dangerous drugs and substances.
Dangerous drugs, such as morphine, cocaine, and opium, are included in this control and are regulated by penalties.
Strict recording procedures in hospitals are mandated
Penalties are specified for offenses.

Full Registration

Requirements entail gaining experience as required unless exempted by the Board.
The Pharmacy Jurisprudence Examination must be passed.
Service in public service for a continuous period of no more than 3 years, unless a reduced period, exemption or postponement from the Minister is granted.
Policy changes in 2011 shortened the compulsory service requirement to one year after a PRP year.

Temporary Registration

Temporary registration is for those registered outside Malaysia.
A written application is required.
Such applicants are exempted from provisional registration.
Temporary registration certificates are issued by the Board.

Ethics in Pharmacy Practice

Pharmacists have an ethical obligation to care for patients.
Relevant ethical principles involve respect for autonomy, nonmaleficence, beneficence, and justice.

Autonomy

Patients have the freedom to make choices about their treatment and health care.
This contrasts with paternalism, where healthcare professionals make decisions for patients.
Informed consent is a critical aspect, including competence and disclosure of relevant information.

Beneficence

Act in the best interest of patients .
The benefits and harms of medication should be carefully weighed by both the patient and healthcare professional.

Nonmaleficence

Avoid harming patients and acting responsibly.
Intentional harm by a pharmacist or harm resulting from negligence violates this principle.

Justice

Emphasizes fair and equitable treatment of all patients.
Focus should be on patient medical needs.
Issues like affordability of drugs for varying socioeconomic groups need careful consideration as well.

Case Study

Ms. Izzy is starting medication for schizophrenia.
Ms. Izzy has questions about the medication's purpose and side effects.
Her doctor mentioned other patients on this drug are fine, not providing sufficient information.
There are issues with lack of informed consent and patient confidentiality.

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Description

Test your knowledge on the Medicines Advertisement Board and related regulations. This quiz covers codes, acts, and the purpose of the board within the context of advertising for medical products. Challenge yourself to understand the legal framework governing medicinal advertisements.