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?

    <p>Z (B)</p> Signup and view all the answers

    Which regulatory act prohibits certain advertisements related to medical matters?

    <p>Medicines (Advertisement and Sale) Act 1956 (C)</p> Signup and view all the answers

    What is the primary purpose of provisional registration for pharmacists?

    <p>To obtain experience prior to full registration (C)</p> Signup and view all the answers

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

    <p>Pharmacy Board (B)</p> Signup and view all the answers

    What condition must be met before applying for full registration?

    <p>Employment as a pharmacist for at least one year (A)</p> Signup and view all the answers

    What examination must be passed to achieve full registration?

    <p>Pharmacy Jurisprudence Examination (B)</p> Signup and view all the answers

    Which of the following titles is restricted under the act?

    <p>Pharmaceutical Chemist (C)</p> Signup and view all the answers

    Which of the following documents specifies qualifications for provisional registration?

    <p>First Schedule (C)</p> Signup and view all the answers

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

    <p>It must be a continuous period of not more than 3 years (C)</p> Signup and view all the answers

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

    <p>Exemption from experience requirements (A)</p> Signup and view all the answers

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

    <p>To define responsibilities for pharmacists (D)</p> Signup and view all the answers

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

    <p>Registration of Pharmacists Act 1951 (B)</p> Signup and view all the answers

    What do regulations in pharmacy legislation primarily dictate?

    <p>How the legal provisions of the act should be applied (A)</p> Signup and view all the answers

    Which piece of legislation controls drugs and cosmetics?

    <p>Sale of Drugs Act 1952 (D)</p> Signup and view all the answers

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

    <p>Regulation of medicine advertisements (B)</p> Signup and view all the answers

    Which regulations were associated with the Poisons Act 1952?

    <p>Poisons (Psychotropic Substances) Regulations 1989 (A)</p> Signup and view all the answers

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

    <p>1989 (D)</p> Signup and view all the answers

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

    <p>An official law passed by a legislative body (B)</p> Signup and view all the answers

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

    <p>A product intended for internal or external use on humans or animals for medicinal purposes (C)</p> Signup and view all the answers

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

    <p>Drug Control Authority (DCA) (B)</p> Signup and view all the answers

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

    <p>Retailer's licence (A)</p> Signup and view all the answers

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

    <p>It must be registered and the manufacturer must hold the appropriate licence (C)</p> Signup and view all the answers

    What does the registration number format 'MAL19976399X' indicate?

    <p>The type of product and registration details (B)</p> Signup and view all the answers

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

    <p>N (D)</p> Signup and view all the answers

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

    <p>Over the counter medicines (OTC) (A)</p> Signup and view all the answers

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

    <p>Sale of Drugs Act 1952 (D)</p> Signup and view all the answers

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

    <p>Asthma (A), Diabetes (B)</p> Signup and view all the answers

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

    <p>Practicing contraception among human beings (A)</p> Signup and view all the answers

    Which legislation regulates the sale and advertisement of medicines?

    <p>Medicines (Advertisement and Sale) Act 1956 (D)</p> Signup and view all the answers

    What is included in the Schedule of prohibited diseases?

    <p>Heart diseases/ defects (B)</p> Signup and view all the answers

    What is the classification of opium under the legislation?

    <p>A dangerous drug with tight regulations (A)</p> Signup and view all the answers

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

    <p>Trafficking (B)</p> Signup and view all the answers

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

    <p>Preventing common illnesses (B)</p> Signup and view all the answers

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

    <p>Mandatory recording for hospitals (A)</p> Signup and view all the answers

    What does the principle of nonmaleficence primarily emphasize in healthcare?

    <p>Preventing unnecessary harm to patients (A)</p> Signup and view all the answers

    How can the principle of nonmaleficence be violated?

    <p>By intentionally causing patient harm (A)</p> Signup and view all the answers

    What does the principle of justice in healthcare advocate for?

    <p>Equality in care across all patient demographics (B)</p> Signup and view all the answers

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

    <p>She may refuse to take the drug due to side effects (A)</p> Signup and view all the answers

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

    <p>Ensure equitable access to necessary medications (B)</p> Signup and view all the answers

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

    <p>Negligently causing harm through incorrect medication dispensing (A)</p> Signup and view all the answers

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

    <p>Healthcare professionals may prioritize financial interests over patient needs (A)</p> Signup and view all the answers

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

    <p>To provide complete and honest information about risks (C)</p> Signup and view all the answers

    Flashcards

    Acts

    Laws passed by a legislative body, establishing the framework for pharmacy practice.

    Regulations

    Rules that specify how the provisions of a law should be applied in real-world scenarios.

    Pharmacy Legislation

    Encompasses an array of laws and regulations that govern the profession and practice of pharmacy.

    Registration of Pharmacists Act (1951)

    An act that sets the requirements for becoming a registered pharmacist.

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    Poisons Act (1952)

    An act that regulates the sale and distribution of poisonous substances.

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    Sale of Drugs Act (1952)

    An act that oversees the sale and distribution of drugs to ensure quality and safety.

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    Medicines (Advertisement and Sale) Act (1956)

    An act that governs the advertising and sale of all medicines to ensure accurate and ethical practices.

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    Pharmacy Regulations

    Regulations and Acts that govern the practice of pharmacy, ensure quality, safety, and responsible use of medications.

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    Provisional Registration

    Allows pharmacists to gain practical experience under the supervision of a registered pharmacist. This helps them gain the necessary skills before full registration.

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    Experience Required for Provisional Registration

    A practical experience requirement for pharmacists before they can apply for full registration. It involves working under a registered pharmacist in a designated setting.

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    Training Premises for Provisional Pharmacists

    These are where provisional pharmacists can gain their practical experience. They are carefully selected and approved because they provide the necessary learning environment for pharmacists.

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    Pharmacy Jurisprudence Examination

    A mandatory examination that assesses a pharmacist's knowledge of pharmacy laws and regulations essential for practice.

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    Requirements for Full Registration

    A requirement for full registration, ensuring that pharmacists have the practical experience and theoretical knowledge necessary for responsible practice.

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    Public Service Requirement for New Pharmacists

    A mandatory period of public service that new pharmacists must fulfill for a period of 3 years. This commitment helps the country meet the healthcare needs of its population.

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    Dangerous Drugs Act 1952

    An act regulating the production, possession, and use of controlled substances, aiming to prevent drug abuse and protect public health.

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    What does the term 'drug' encompass?

    Any substance used for medical purposes, including those applied externally or internally, on humans or animals.

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    What is the Drug Control Authority (DCA)?

    The governing body responsible for overseeing the safety and regulation of pharmaceuticals in Malaysia.

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    What is the requirement for pharmaceuticals in Malaysia?

    All pharmaceuticals, including traditional medicines, must be registered with the DCA.

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    Who needs licenses related to pharmaceuticals?

    Licences are required for various activities involving pharmaceuticals, such as manufacturing, wholesaling, importing, and clinical trials.

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    What does Subregulation 7(1) ensure in Malaysia?

    The DCA sets regulations to ensure only registered products are dealt with and that individuals with appropriate licenses are involved.

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    What does the registration number 'MAL19976399X' represent?

    Provides a unique identifier for a registered pharmaceutical product in Malaysia.

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    How are medicines classified using registration numbers?

    The registration numbers include codes used to classify medicines into various categories.

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    How are medicines categorized by their registration codes?

    Medicines are classified based on their availability and regulation, commonly denoted using letters like 'A' for controlled medicines, 'X' for OTC, 'T' for traditional medicines, and 'N' for health supplements.

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    Administrative Code

    An administrative code used to classify medicines based on their manufacturing or import status. It includes codes like 'C' for contract manufactured, 'E' for export only, and 'S' for second source.

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    Contract Manufactured (C)

    Refers to medicines that are manufactured by a third-party company under contract with the original manufacturer.

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    For Export Only (E)

    Medicines exclusively intended for export outside of Malaysia, typically not available within the country.

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    Repacked (R)

    Medicines that are repacked or relabeled, often for different packaging or presentation.

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    Second Source (S)

    Medicines supplied by a different manufacturer or source than the original holder of the marketing authorization.

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    Dangerous Drugs

    These substances are heavily regulated due to their potential for misuse and addiction.

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    Trafficking

    Possession of quantities exceeding legal limits is considered trafficking.

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    Strict Recording Requirement

    Hospitals and pharmacies must maintain strict records of dangerous drug usage.

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    Severe Penalties

    Offenses against this act carry severe penalties.

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    Nonmaleficence

    The ethical principle that emphasizes a healthcare professional's duty to do no harm to their patient, both intentionally and through negligence.

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    Justice

    This principle highlights fairness, equity, and just treatment for all individuals, requiring equal care and attention for every patient, regardless of their background or financial situation.

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    Conflict between autonomy and nonmaleficence

    A situation where the patient's autonomy and a healthcare professional's duty to do no harm might clash.

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    Intentional violation of nonmaleficence

    A scenario where a pharmacist knowingly and intentionally acts in a way that causes harm to a patient.

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    Negligent violation of nonmaleficence

    A scenario where a pharmacist's negligence, or failure to act with due care, leads to harm to a patient.

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    Patient autonomy

    The patient's right to make decisions about their own healthcare, including refusing treatment.

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    Challenges to the principle of justice

    Situations where it is challenging to balance the ethical principles of justice and beneficence, such as providing healthcare to financially disadvantaged individuals.

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    Patient's lack of understanding

    A patient's lack of understanding regarding a medication's purpose and potential side effects.

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    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.

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