Drug Control Regulations Quiz

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Questions and Answers

What type of professional is a licensed pharmacist?

Has no specific education requirements

Holds a bachelor degree in pharmacy or equivalent (correct)

Holds a diploma degree in pharmacy

Is not allowed to practice under any supervision

Which of the following substances is categorized as a toxin?

Medication for treating common diseases

Any substance causing danger to living organisms (correct)

Any substance used for diagnosis

Devices used in conjunction with medications

What is NOT a service provided by the Pharmacy Licensing Department?

Drug pricing regulation (correct)

Licensing pharmaceutical establishments

Licensing and renewal of pharmacist licenses

Inspection of pharmaceutical establishments

How many sections does the Pharmacy Licensing Department have?

Three sections Signup and view all the answers

What role does a licensed assistant pharmacist perform?

Practices under the supervision of a licensed pharmacist Signup and view all the answers

Which department is responsible for human drug registration?

Drug Control Department Signup and view all the answers

What is required for a substance to be classified as a drug/medication?

It must be composed of one or more substances used for treatment Signup and view all the answers

What is an essential function of the follow-up & evaluation section in the Pharmacy Licensing Department?

Monitor compliance with pharmaceutical practice laws Signup and view all the answers

What is one of the responsibilities of the Surgical Instruments Registration Section?

Registration of surgical imported devices. Signup and view all the answers

Which committee ensures compliance with professional standards for pharmacists in Oman?

Pharmaceutical Violation Committee. Signup and view all the answers

What does the Technical Committee for Registration of Pharmaceutical Companies oversee?

Approval of registration requests for pharmaceutical products. Signup and view all the answers

Which committee is responsible for the safe disposal of damaged narcotic medications?

Narcotic and Psychotropic Committee. Signup and view all the answers

What is one responsibility of the Pharmaceutical Licensing Committee?

Approval of licensing requests for pharmacists. Signup and view all the answers

Which committee may recommend banning certain pharmaceutical products?

Technical Committee for Registration of Pharmaceutical Companies. Signup and view all the answers

What is a primary function of the Medical Device Vigilance Section?

Receiving adverse events related to medical devices. Signup and view all the answers

What is one primary responsibility of the Pharmaceutical Violation Committee?

To determine consequences of pharmacy law non-compliance. Signup and view all the answers

What is one of the primary functions of the Drug Control Department?

Regulate the import and export of medicines Signup and view all the answers

Which section of the Central Quality Control Department is responsible for microbiological analysis?

Microbiological Analysis Section Signup and view all the answers

What is a key objective of the Pharmacovigilance and Drug Information Department?

Monitor and analyze adverse drug reactions Signup and view all the answers

Which section falls under the Equipment and Medical Devices Control Department?

Medical Device Registration Section Signup and view all the answers

Which of the following is NOT a service provided by the Central Quality Control Department?

Registration of pharmaceutical companies Signup and view all the answers

What type of medicines does the Pharmacovigilance Department specifically monitor?

Herbal medicines and health products Signup and view all the answers

What is a major focus of the Drug Control Department concerning medicines?

Pricing and registration of medicines Signup and view all the answers

Which additional activity is involved in the responsibilities of the Pharmacovigilance Department?

Preparing reports on adverse reactions Signup and view all the answers

What is the main purpose of law in the context of pharmacy practice in Oman?

To restrict the sale or supply of medicinal products and poisons Signup and view all the answers

Which body is primarily responsible for drug control activities in Oman?

Drug Safety Center (DSC) Signup and view all the answers

What role does the Ministry of Health (MOH) play in Oman’s health sector?

It oversees the coordination and stewardship of the health sector Signup and view all the answers

What is the primary function of the Drug Safety Center (DSC)?

To ensure effective, safe and good quality drugs Signup and view all the answers

What is defined as the rules made by a government or authority to control behavior?

Regulation Signup and view all the answers

Which of the following services is NOT provided by the Drug Safety Center (DSC)?

Conducting financial audits of pharmacies Signup and view all the answers

Which Royal Decree is related to the Pharmacy Practice Law issued in Oman?

Royal Decree No 41/91 Signup and view all the answers

Which aspect of the Drug Safety Center's responsibilities does NOT involve its various technical committees?

Marketing strategies of pharmaceutical companies Signup and view all the answers

Study Notes

Drug Control Department Services

Regulates import of medicines by registering pharmaceutical companies and pricing medicines.
Oversees import, export, and circulation of controlled medicines in the health sector.
Facilitates release of medical products from customs ports.

Central Quality Control Department

Comprises several sections:
- Quality Assurance
- Chemical Analysis
- Physical Analysis
- Herbal Medicine & Health Products
- Analysis Requirements Follow-up
- Microbiological Analysis
- Biotechnology & Pharmacological Analysis
Ensures analysis of drug samples and imported pharmaceutical products meet standard specifications.

Pharmacovigilance and Drug Information Department

Divided into three sections:
- Pharmacovigilance of Human Medicines
- Pharmacovigilance of Herbal Medicines & Health Products
- Drug Information
Focuses on post-marketing surveillance of medicines, assessing adverse reactions and quality defects.
Encourages public awareness regarding medicines' effects and coordinates with health institutions for safety measures.
Produces periodic and annual reports on adverse drug reactions in the Sultanate.

Equipment and Medical Devices Control Department

Includes four sections:
- Medical Device Registration
- In Vitro Diagnostic Devices
- Surgical Instruments Registration
- Medical Device Vigilance
Oversees registration and quality assurance of medical and diagnostic devices, collecting data on adverse events.

Definitions

Law: Set of rules to protect rights and ensure fairness; in pharmacy, restricts sale of medicinal products.
Regulation: Government-made rules to control behavior and processes.
Ministry of Health (MOH): Main agency managing the health sector and drug control via the Drug Safety Center.
Drug Safety Center (DSC): Regulatory body ensuring the safety, efficacy, and quality of drugs in Oman, established by Royal Decree No 41/91.

Key Terms

Drug/Medication: Substances for diagnosing, preventing, or treating diseases in humans/animals.
Medical Supplies: Devices or products aiding treatment or diagnosis.
Toxins: Substances causing danger to living organisms, leading to organ damage or death.
Pharmacy Profession: Encompasses all activities related to medicine handling.
Licensed Pharmacist: Graduate licensed to practice pharmacy.
Licensed Assistant Pharmacist: Diploma holder practicing under supervision.

Pharmacy Licensing Department

Consists of sections for establishing and renewing pharmacy licenses and inspections to ensure compliance with laws.

Drug Control Department Structure

Comprising sections for human and herbal drug registration, controlled drugs, drug pricing, surgical instruments, and in vitro diagnostic devices.
Responsible for registration of medical devices and vigilance over their quality.

Pharmaceutical Technical Committees

Established by ministerial decisions, with various responsibilities:
- Pharmaceutical Licensing Committee: Approves licensing for pharmacists and establishments.
- Pharmaceutical Violation Committee: Ensures professional standards and adjudicates law compliance.
- Technical Committee for Registration of Pharmaceutical Companies: Approves registrations and pricing, evaluates banning of harmful products.
- Narcotic and Psychotropic Committee: Manages disposal of expired or damaged narcotic medications from health institutions.

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Description

Test your knowledge on the drug clearance and export services provided by the Drug Control Department. This quiz covers the regulation of medicine import, export, and pricing in the Sultanate. Challenge yourself on the procedures surrounding controlled medicines in the health sector.