Role of pharmacist in civil services

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Questions and Answers

What is the primary objective of educating the public about quality use of medicines?

  • To increase the production of pharmaceuticals
  • To reduce the cost of medications
  • To promote the sale of traditional medicines
  • To enhance medication adherence and improve treatment outcomes (correct)

Which activity is NOT conducted by the National Pharmaceutical Regulatory Agency (NPRA)?

  • Monitoring adverse drug reactions
  • Issuing licenses for cosmetic production
  • Performing surgical procedures (correct)
  • Conducting raids on unregistered product suppliers

What does market surveillance of pharmaceuticals involve?

  • Exporting pharmaceuticals to foreign markets
  • Collecting consumer feedback
  • Advertising new drug launches
  • Random sampling and analytical testing (correct)

What role does the NPRA play in the approval of special exemptions for unregistered products?

<p>Processes applications from various sectors including research labs (B)</p> Signup and view all the answers

How does the NPRA ensure compliance in advertisements for pharmaceuticals?

<p>By monitoring advertisements in both printed and electronic media (B)</p> Signup and view all the answers

Which of the following is involved in the initial registration of drugs and cosmetic products?

<p>Technical data evaluation and laboratory analysis (C)</p> Signup and view all the answers

What is one of the primary functions of the National Drug Information Centre?

<p>Provide drug-related information and support (A)</p> Signup and view all the answers

What is the purpose of conducting raids on manufacturers and suppliers of unregistered products?

<p>To ensure only registered products are available in the market (B)</p> Signup and view all the answers

What was the primary task of pharmacy services prior to independence in Malaysia?

<p>Procurement, storage, and distribution of drugs (D)</p> Signup and view all the answers

Which act was NOT enforced in the early development of pharmacy services in Malaysia?

<p>Dangerous Substances Act 1952 (C)</p> Signup and view all the answers

What significant division was established in Malaysia's pharmaceutical services in 1969?

<p>Pharmaceutical Chemistry Division (B)</p> Signup and view all the answers

What activity is NOT part of the responsibilities of the Pharmacy Services Programme, MOH?

<p>Conducting pharmaceutical experiments (C)</p> Signup and view all the answers

Which section focuses on the optimization of pharmacy staff placement across Malaysia?

<p>Human resource &amp; career (A)</p> Signup and view all the answers

Which of the following is a key aspect of the National Medicines Policy (DUNAS)?

<p>Implementing stakeholder review processes (D)</p> Signup and view all the answers

What is one of the objectives of the government in the pharmaceutical sector?

<p>To improve health outcomes through equitable access to essential medicines (D)</p> Signup and view all the answers

What ensures that pharmacy services' strategic plans are followed through in Malaysia?

<p>Effective distribution of human resources (A)</p> Signup and view all the answers

Which component is essential in ensuring drug affordability according to the content?

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

What is a primary focus of Continuous Professional Development (CPD) for pharmacy personnel?

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

What is the primary role of the Pharmacy Board?

<p>To manage applications for registration and deregistration of pharmacists (C)</p> Signup and view all the answers

Which section focuses on planning and managing procurement practices in Ministry of Health institutions?

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

What is an important training aspect for the members of the Pharmaceutical Services Program?

<p>ICT-related trainings (D)</p> Signup and view all the answers

Why is effective pharmacy practice critical in improving pharmacy services?

<p>It ensures quality in drug procurement and usage. (B)</p> Signup and view all the answers

What does the formulation of tracking indicators such as KPI and QAP primarily relate to?

<p>Quality monitoring in pharmaceutical services (B)</p> Signup and view all the answers

What is one way to promote rational use of medicines?

<p>By ensuring affordability and good quality of medicines (D)</p> Signup and view all the answers

Flashcards

Pharmacy service before independence

The primary task of the pharmacy service before Malaysia's independence was focused on acquiring, storing, and distributing drugs from the United Kingdom.

Pharmaceutical Chemistry Division

Established in 1969 to address the growing needs of pharmaceutical services, the Pharmaceutical Chemistry Division plays a crucial role in quality control and drug development.

Pharmaceutical Services Programme (PSP)

The Pharmaceutical Services Programme (PSP) is responsible for overseeing and guiding the implementation of pharmaceutical services nationwide.

Director General of Pharmaceutical Services (DGPS)

The Director General of Pharmaceutical Services (DGPS) holds the top position within the PSP, responsible for setting the overall direction and policies.

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DGPS - Oversight

The DGPS oversees several key organizations, including the Malaysian Pharmacy Board, the Drug Advertising Board, and the Poisons Board, ensuring compliance and ethical practices.

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DGPS Policy Roles

The DGPS is responsible for developing and implementing comprehensive policies to improve and regulate pharmaceutical services in Malaysia.

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Manpower Planning

One of the major functions of the DGPS is planning for the adequate number and distribution of pharmacists across the country.

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Continuous Professional Development (CPD)

The PSP emphasizes continuous training and development for pharmacy personnel to enhance their skills and knowledge.

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Relations & Innovation

Ensuring quality systems for pharmaceutical services, including key performance indicators (KPIs), quality assurance procedures (QAP), 5S methodology, innovation initiatives, and client charters.

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Pharmacy Information Management

Planning, coordinating, and implementing ICT training for pharmacy personnel to improve their skills and knowledge.

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National Pharmaceutical Policy

A document by the Malaysian government outlining the vision, objectives, and strategies for the pharmaceutical sector.

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National Pharmaceutical Policy Objectives

Improving health outcomes by promoting equitable access to essential medicines and encouraging the rational use of safe, effective, and affordable medications.

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Pharmaceutical Services Division

Ensuring the quality of drug procurement and usage through effective pharmacy practice to improve pharmacy services in Malaysia.

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Clinical & Technical Services

Planning, developing, and coordinating pharmaceutical care services, such as medication counseling, medication therapy adherence counseling (MTAC), and clinical pharmacy services.

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Formulary & Pharmacoeconomics

Conducting drug evaluations using pharmacoeconomic principles for formulary listing, ensuring cost-effectiveness.

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Pharmaceutical Logistics

Planning, coordinating, and managing the development of procurement practices and store management in Ministry of Health institutions.

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What is the NPRA?

The National Pharmaceutical Regulatory Agency (NPRA) is the governing body responsible for ensuring the quality, safety, and efficacy of pharmaceutical products in Malaysia.

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What is the primary role of the NPRA?

The NPRA's main role is to regulate the pharmaceutical industry, including licensing, monitoring, and surveillance of drug products.

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How does the NPRA ensure the quality of drugs and cosmetics?

The NPRA evaluates technical data, conducts laboratory analysis, and researches information from international agencies to register drugs and notify cosmetics.

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What types of licenses does the NPRA issue?

The NPRA licenses pharmaceutical manufacturers, importers, and wholesalers in Malaysia. This includes a dedicated licensing scheme for clinical trials.

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How does the NPRA protect consumers?

The NPRA plays a crucial role in protecting consumers by monitoring adverse drug reactions. This includes gathering and analyzing data on reported side effects of medicine.

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What measures does the NPRA take to ensure consistent product quality?

The NPRA conducts regular market surveillance of pharmaceutical products. This involves random sampling and analytical testing to ensure that products meet quality standards.

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How does the NPRA contribute to promoting quality use of medicines?

The NPRA plays a leading role in promoting quality use of medicines. This includes educating the public on how to use medications safely and effectively.

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How does the NPRA ensure ethical marketing of drug products?

The NPRA is responsible for monitoring advertisements related to pharmaceuticals, traditional medicines, and cosmetics. This ensures compliance with existing rules and regulations.

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Study Notes

Introduction

  • Pharmacy services began in the country in 1951, with the implementation of the Registration of Pharmacist Act 1951, the Poisons Act 1952, and the Dangerous Drugs Act 1952.
  • Prior to independence, the primary function was procuring, storing, and distributing drugs from the UK via Crown Agents.

Pharmacist in the Civil Service

  • The title "Pegawai farmasi (Pharmacist)" was established.
  • The Pharmaceutical Chemistry Division was officially formed in 1969 to meet the growing pharmaceutical needs.
  • Previous titles included Ahli Kimia Ubat (Pharmaceutical Chemistry Superintendent) and Penguasa ahli kimia ubat (PAKU).

PPF KKM

  • This is the Pharmaceutical Services Programme under the Ministry of Health (MOH).
  • The roles include:
    • Leading the Pharmaceutical Services Division.
    • Managing the Secretariat for Lembaga Farmasi Malaysia, Lembaga Iklan Ubat, and Lembaga Racun.
    • Developing and implementing pharmaceutical policies in Malaysia.
    • Planning for staff needs.
    • Managing pharmacists and their services under the MOH.

Pharmacy Policy & Management

  • Ensuring strategic plans and policies are implemented correctly.
  • Ensuring proper allocation of human resources.
  • Providing relevant and continuous training.
  • Guaranteeing quality maintenance across all service levels.
  • Managing financial matters according to rules and guidelines.
  • Subsections include:
    • Human resource and career planning and distribution.
    • Continuous Professional Development (CPD) to improve competence and skill development.
    • National Medicines Policy (DUNAS): planning, coordinating, and monitoring of all activities. National Medicines Policy evaluation and review with stakeholder engagement.
    • Relations and innovation: coordinating quality management systems (KPI, QAP, 5S, and Client Charter), and implementing relevant IT-based training programmes for PSP members.

Malaysian National Medicines Policy (DUNAS)

  • An official Malaysian government document.
  • Defines and prioritizes medium- to long-term pharmaceutical sector goals.
  • Strategies for improving health outcomes.
  • Main objectives include providing equitable access to essential medicines, promoting rational use of safe, effective and affordable essential medicines of good quality.
  • 8 Components: quality, safety, efficacy, drug affordability, and research and development.
  • 2nd edition reviewed in October 2012.

Pharmacy Practice & Development

  • Ensuring the quality of drug procurement and usage through effective practice.
  • Aimed at improving pharmacy services in Malaysia to meet standards with other developed countries.
  • Subsections include:
    • Clinical and Technical: planning and coordinating pharmaceutical care services (e.g., medication counseling, MTAC, clinical pharmacy services) in MOH facilities.
    • Formulary and Pharmacoeconomics: drug evaluation for formulary listing, using pharmacoeconomic principles.
    • Pharmaceutical Logistics: planning, coordinating, and managing procurement practices.
    • Medicine Prices: disseminating information on medicine pricing to consumers, providing recommended retail prices (RRP) reported by wholesalers.
    • Pharmacy Board: managing the application registration and deregistration for pharmacists and bodies corporates. Conducting the relevant exams for pharmacist registration. Improving and monitoring the quality of pharmaceutical services Division’s research and studies.
    • Quality Use of Medicines: educating the public on the appropriate use of medication to promote understanding and adherence to improve treatment outcomes.

Pharmacy Enforcement

  • Securing that all pharmaceuticals, traditional medicines, and cosmetics in the market are genuine, through proper registration and notification.
  • Subsections include:
    • Intelligence and Operation: conducting raids on premises selling unregistered products or un-notified cosmetics.
    • Licensing and Control: coordinating screening and inspection of imported products and controlled substances.
    • Legislation: Processing applications for special exemptions to import unregistered products from relevant sources.
    • Advertisement and Innovation: monitoring advertisements to ensure compliance with rules and regulations. Consumer awareness regarding registered products.

NPRA (National Pharmaceutical Regulatory Agency)

  • Formerly known as the National Pharmaceutical Control Laboratory and the National Pharmaceutical Control Bureau (Biro Pengawalan Farmaseutikal Kebangsaan).
  • Established in October 1978 under the Pharmacy and Supply Programme.
  • Responsible for implementing quality control of pharmaceutical products.
  • NPRA's Roles:
    • Registration of drugs and cosmetics.
    • Regulation of the pharmaceutical industry.
    • Licensing for manufacture, import, and wholesale of pharmaceutical products, including clinical trials.
    • Monitoring of adverse drug reactions.
    • Market surveillance of pharmaceuticals with random sampling and testing.
    • Providing quality control for drugs.
    • Operating the National Drug Information Centre.

Enforcement Division MOH

  • Responsible for control at entry points (conducting surveillance and raids).
  • Prosecutions related to unregistered, counterfeit, and adulterated products beginning in 1978.
  • Inspections of records related to controlled substances.

Education

  • Teaching responsibilities at public universities.

Research

  • Conducting research at various research institutes.
  • FRIM (Forest Research Institute), PORIM (Palm Oil Research Institute), IMR (Institute of Medical Research), SIRIM, and MINT (Malaysian Institute of Nuclear Technology).

Military

  • Providing pharmacy services in war and disaster.
  • Supplying medicine to soldiers in the field and jungle hospitals.

Hospital

  • Pharmacist roles within hospitals services are omitted.

Advantages and Disadvantages

  • Advantages: stable employment, healthcare benefits, scholarships and loans, service focus.
  • Disadvantages: potential salary concerns, relatively slow career advancement, and transferring between locations.

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