Pharmacy Regulations Quiz
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Questions and Answers

What does the administrative code 'E' stand for?

  • For Export Only (FEO) (correct)
  • Packed and/or repacked
  • Contract Manufactured
  • Orphan products
  • Which legislation established the Medicines Advertisement Board?

  • Medicines (Advertisement and Sale) Act 1956 (correct)
  • Dangerous Drugs Act 1952
  • Poisons Act 1952
  • Sale of Drugs Act 1952
  • What is indicated by the administrative code 'Y'?

  • Products gazetted as zero-rated
  • Second source products
  • Packed and/or repacked products
  • Orphan products (correct)
  • What is the main purpose of the Medicines (Advertisement and Sale) Act 1956?

    <p>To prohibit certain advertisements relating to medical matters</p> Signup and view all the answers

    Which code represents 'Products gazetted as zero-rated under the Goods and Services Tax Act 2014'?

    <p>Z</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.</p> Signup and view all the answers

    What requirement must a candidate fulfill to apply for full registration?

    <p>Gain employment as a pharmacist for at least one year.</p> Signup and view all the answers

    What is one of the key transformations proposed in the new pharmacy bill?

    <p>Reclassification of medicinal products</p> Signup and view all the answers

    Which of the following describes a limitation imposed on pharmacists under the act?

    <p>Pharmacists cannot use certain titles such as pharmaceutical chemist.</p> Signup and view all the answers

    Which act is NOT mentioned as being replaced by the new pharmacy bill?

    <p>Patients Rights Act</p> Signup and view all the answers

    What is a key responsibility of the Pharmacy Board as stated in the act?

    <p>To oversee the registration of pharmacists.</p> Signup and view all the answers

    What aspect of pharmacy practice is being liberalized according to the new pharmacy bill?

    <p>Pharmacists' practice license to more than one premise</p> Signup and view all the answers

    What document must a pharmacist pass to qualify for full registration?

    <p>Pharmacy Jurisprudence Examination.</p> Signup and view all the answers

    What is the purpose of the proposed more deterrent penalties for serious offences in the new pharmacy bill?

    <p>To deter unethical practices in pharmacy</p> Signup and view all the answers

    Under what circumstance can a candidate be exempt from gaining employment for the full registration experience?

    <p>If exempted by the Pharmacy Board.</p> Signup and view all the answers

    Which regulation allows for the control of psychotropic substances?

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

    Which statement is true regarding the Pharmacy Board and its formation?

    <p>It was formed under the Registration of Pharmacists Act.</p> Signup and view all the answers

    What ethical concern arises from Ms. Izzy's situation regarding her new medication?

    <p>Insufficient information on drug side effects</p> Signup and view all the answers

    What is the maximum period a pharmacist must serve in public service after full registration?

    <p>Three years.</p> Signup and view all the answers

    What is a potential consequence of Ms. Izzy's lack of understanding about her medication?

    <p>Refusal to take the medication due to fear of side effects</p> Signup and view all the answers

    Which of the following is NOT a part of the overview of pharmacy practice legislation?

    <p>Drug Enforcement Agency Regulations</p> Signup and view all the answers

    Which of the following diseases is NOT listed in the Schedule for prohibited advertisements?

    <p>Arthritis</p> Signup and view all the answers

    What is the primary purpose of the Dangerous Drugs Act 1952?

    <p>To regulate the manufacture and sale of dangerous drugs</p> Signup and view all the answers

    Which of the following is allowed in advertisements under the current regulations?

    <p>Legitimate health supplements</p> Signup and view all the answers

    Which statement regarding the prohibition of advertisements is true?

    <p>Advertisements for drug addiction treatments are prohibited.</p> Signup and view all the answers

    What action is required if a pharmacist possesses above a certain quantity of controlled substances under the Dangerous Drugs Act?

    <p>It is considered as trafficking.</p> Signup and view all the answers

    Which of the following acts regulates the advertisement and sale of medicines?

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

    Which type of substances requires strict recording in hospitals under the Dangerous Drugs Act?

    <p>Dangerous drugs like morphine</p> Signup and view all the answers

    What are the penalties for violating the Dangerous Drugs Act?

    <p>Severe penalties including imprisonment</p> Signup and view all the answers

    What is the primary focus of professional ethics according to the content?

    <p>The interpretation of societal expectations by professionals</p> Signup and view all the answers

    Which ethical principle emphasizes a patient's freedom to make their own choices?

    <p>Respect for autonomy</p> Signup and view all the answers

    What does the principle of beneficence require from health professionals?

    <p>To act in the best interest of the patient</p> Signup and view all the answers

    Which of the following is NOT one of the five elements of informed consent?

    <p>Legal representation</p> Signup and view all the answers

    How does medical confidentiality relate to patient autonomy?

    <p>It protects the privacy of patient decisions</p> Signup and view all the answers

    What role does ethics play in the decision-making process for professionals?

    <p>It provides a framework to resolve ethical questions</p> Signup and view all the answers

    What is the dynamic aspect of professional ethics highlighted in the content?

    <p>It changes based on societal expectations</p> Signup and view all the answers

    Which ethical principle requires health professionals to balance the benefits and harms of therapy?

    <p>Beneficence</p> Signup and view all the answers

    What principle is primarily focused on preventing harm to the patient?

    <p>Nonmaleficence</p> Signup and view all the answers

    Which of the following actions would violate the principle of nonmaleficence?

    <p>Negligently administering the wrong dosage</p> Signup and view all the answers

    What does the principle of justice require healthcare professionals to do?

    <p>Treat all patients fairly and equitably</p> Signup and view all the answers

    How could a pharmacist violate the principle of justice?

    <p>By refusing to provide medication to someone who cannot afford it</p> Signup and view all the answers

    What is a potential consequence of failing to inform a patient about medication side effects?

    <p>The patient's autonomy may be disrespected.</p> Signup and view all the answers

    Which situation best illustrates a potential conflict between patient autonomy and the principle of beneficence?

    <p>A pharmacist insists on giving a treatment regardless of patient wishes.</p> Signup and view all the answers

    What ethical dilemma might arise regarding patients unable to afford medication?

    <p>Finding ways to assist financially disadvantaged patients</p> Signup and view all the answers

    What is the main concern when a patient is unclear about their medication or potential side effects?

    <p>They might refuse their medication based on misinformation.</p> Signup and view all the answers

    Study Notes

    • Laws and regulations govern the profession and practice of pharmacy.
    • They define responsibilities for pharmacists and others involved in medication use.
    • Acts are laws passed by a legislative body.
    • Regulations dictate how acts are applied.

    Current Legislations Relevant to the Practice of Pharmacy

    • Registration of Pharmacists Act 1951 (Revised 1989): An act relating to the establishment of a Pharmacy Board and the registration of pharmacists.
      • Includes provisions for the establishment of the Pharmacy Board and its duties and powers.
      • Outlines persons eligible for provisional and full registration.
      • Details conditions prior to registration.
      • Sets limits on the use of titles (e.g., pharmaceutical chemist, pharmaceutist, chemist and druggist, pharmacist).
    • Poisons Act 1952 (Revised 1989): Regulates the importation, possession, manufacture, compounding, storage, transport and use of poisons.
      • Includes provisions for the establishment of a Poisons Board.
      • Classifies poisons into schedules.
      • Covers importation, packaging, labelling, and storing of poisons.
      • Addresses the sale and supply of poisons (retail, wholesale).
      • Includes regulations for licenses, permits, and authorizations.
      • Requires maintaining records and registers for poisons.
    • Sale of Drugs Act 1952 (Revised 1989): This act controls the sale of drugs and cosmetics.
      • Establishes the Drug Control Authority (DCA).
      • Covers the registration of pharmaceuticals (including traditional medicines) and cosmetics.
    • Medicines (Advertisement and Sale) Act 1956: Regulates the advertising and sale of medicines.
      • Establishes a Medicines Advertisement Board (Lembaga Iklan Ubat) to approve and reject advertising applications for services, medicines, and remedies.
      • Requires approval serial numbers (e.g., KKLIU 1379/2014).
      • Prohibits advertisements relating to certain diseases.
      • Outlines the prohibited diseases or conditions for advertising (e.g., kidney diseases, diabetes).
    • Dangerous Drugs Act 1952: Regulates the importation, exportation, manufacture, sale, and use of opium and other dangerous drugs (e.g., morphine, cocaine, opium).
      • Includes strict control measures on dangerous drugs.
      • Requires strict recording of dangerous drugs in hospitals.
      • Outlines severe penalties for violating the act.

    Provisional Registration

    • This is for gaining experience before full registration.
    • Requirements (First Schedule): Specific qualifications, and qualifications deemed suitable by the Minister.
    • Experience before full registration: Employed as a pharmacist for at least a year at premises listed in the Second Schedule.

    First/Second Schedules (Contains lists of specific medicines)

    • Detailed lists of substances and qualifications, regulated by the Poisons act.

    Prescription Form for Group B Poisons (Poisons Act 1952)

    • Provides details on the form for prescribing Group B poisons (medicines).

    Ethics in Pharmacy Practice

    • Pharmacists have an ethical obligation to care for their patients.
    • Includes ethical principles like Respect for Autonomy, Nonmaleficence, Beneficence, and Justice.
    • Autonomy: Patient's freedom to choose, respecting their rights and well-being.
    • Nonmaleficence: Avoiding harm to patients.
    • Beneficence: Acting in the best interest of the patient.
    • Justice: Fair and equitable care for all patients.

    Case Study: Ms. Izzy

    • Discusses ethical considerations in prescribing medication for schizophrenia and patient autonomy.
    • Importance of informed consent and the doctor's responsibility to disclose relevant information.

    Code of Ethics

    • A set of minimum standards for professional conduct covering various aspects of pharmacy.
    • Includes examples such as the Hippocratic Oath and other professional codes.

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    Description

    Test your knowledge of pharmacy regulations and legislation with this quiz. It covers important acts such as the Medicines (Advertisement and Sale) Act 1956, registration processes, and key responsibilities of the Pharmacy Board. Are you well-versed in the codes and transformations that impact the pharmacy profession?

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