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Course Detail

Course Name Principles of Quality Use of Medicines
Course Code MPP201T
Program M.Pharm Pharmacy Practice
Semester 2
Credits 3
Campus Kochi

Syllabus

Unit 1
UNIT I- Introduction to Quality use of medicines (QUM) 6 hours

Definition and Principles of QUM (1 Hr)

Key partners and responsibilities of the partners (1 Hr)

Building blocks in QMC (1 Hr) Evaluation process in QMC(1 Hr) Communication in QUM (1 Hr) Cost effective prescribing. (1 Hr)

Unit 2
UNIT II 10 hours

Concepts in QUM

Evidence based medicine: Definition, concept of evidence based medicine (1Hr) Approach and practice of evidence based medicine in clinical settings. (1Hr) Essential drugs: Definition, need, concept of essential drug(1Hr)

National essential drug policy and list (1Hr)

WHO criteria for the selection of Essential drugs and advantages of Essential drug list. ( 2 Hrs )

Maintenance of health records quality in general practice ( 2 Hrs)

QUM in critical care Quality use of medicine indicators ( 2 Hrs)

Additional reading Topics

Currently added drugs to WHO essential drug list and essential drug list children

Unit 3
UNIT III- QUM in various settings 9 hours

Hospital settings, Ambulatory care/Residential care (1Hr) Role of health care professionals in promoting the QUM(1Hr) Strategies to promote the QUM(1Hr)

Impact of QUM on E-health(1Hr)

Integrative medicine and multidisciplinary care. (1Hr)

QUM in special population: Pediatric prescribing, Geriatric prescribing (2Hr)

Prescribing in pregnancy and lactation(1Hr)

Prescribing in immune-compromised and organ failure patients. (1Hr)

Unit 4
UNIT IV 8 hours

Prereading Materials

OTC sales, Rational use of common Over the counter medications

Regulatory aspects of QUM in India

Regulation including scheduling (2 Hrs) Regulation of complementary medicines (2Hrs) Regulation of OTC medicines (1Hrs) Professional responsibility of Pharmacist(1Hr)

Role of industry in QUM in medicine development (2 Hrs) Additional reading Topics

Role of regulatory agencies in ensuring the postmarketing surveillance of medications

Overview of National and international regulations governing Pharmaceuticals

Unit 5
UNIT V- Medication errors 4hours
  • Definition, categorization and causes of medication errors (2Hrs)
  • Detection and prevention of medication errors(1Hr)
  • Role of Pharmacist in monitoring and management of medication errors(1Hr)
Unit 6
UNIT VI – 8 hours

Prereading Materials

Pharmacovigilance:

Basic concept of pharmacovigilance, Types, predisposing factors and mechanism of adverse drug reactions (ADRs), Detection, reporting and monitoring of ADRs Management of ADRs, Professional responsibility of Pharmacist

Pharmacovigilance

Causality assessment of ADRs (2Hrs)

Standardised MedDRA queries(1Hr)

Establishing pharmacovigilance centres in Hospitals and industry(2Hrs) Various Pharmacovigilance safety data base – Vigiflow, Aris G, Argus. (1Hr) Yellow card and Blue card scheme in Pharmacovigilance(1Hr)

Green forms, IRD & CRD in Pharmacovigilance(1Hr)

Additional reading Topics

Recent recalled medical devices from India as per materiovigilance Latest drug safety alerts issued by IPC / CDSCO

Recent advancements in vaccine safety surveillance

Scope

This course in “Quality Use of Medicines” is meticulously designed to impart essential knowledge and skills vital for practicing safe and effective medication management across diverse healthcare settings. Emphasizing an evidence-based medicine approach, it equips students with the ability to identify and address various types of medication errors while promoting medication safety. The primary aim is to cultivate a comprehensive understanding of principles and practices ensuring the safe, effective, and appropriate use of pharmaceuticals in patient care.

Through critical evaluation of quality, efficacy, and safety of medicines, students learn to make evidence-based decisions in clinical settings.

Furthermore, the subject fosters awareness of the social, economic, and ethical considerations surrounding medication use, promoting responsible and patient-centered pharmaceutical care. It develops competencies in rational drug use and effective communication with healthcare professionals and patients. Applying the principles of Quality Use of Medicines it ensures that medications are used safely, effectively, and appropriately in critical care settings. It Investigates the regulatory frameworks governing scheduling, complementary, and over-the-counter (OTC) medicines to ensure compliance with legal standards and safe medication practices.

Ultimately, graduates are equipped to actively contribute to healthcare teams, advocating for judicious medication use to enhance patient well-being and healthcare system efficiency.

Objectives and Outcomes

Upon successful completion of this course ,students shall be able to ;

KNOWLEDGE

K1: Explain the principles of quality use of medicines

K2: Outline the benefits and risks associated with use of medicines

K3: Discuss the regulatory aspects of quality use of medicines

K4: Differentiate various adverse drug reactions

K5: Describe the quality use of medicines in special population

K6 Analyze the potential causes of medication errors and their impact on patient safety

.

SKILL

S1: Detect and resolve drug-related problems

S2: Practice medication error reporting

S3: Recommend the quality use of medicines

S4: Formulate a comprehensive patient care plan that integrates the latest evidence-based guidelines, clinical expertise, and patient preferences.

S5: Assess the appropriateness of prescribed medications in various clinical scenarios

S6: Evaluate the Vaccine safety surveillance

ATTITUDE

A1: Support the regulatory aspects of quality use of medicine

A2: Participate in Pharmacovigilance awareness program in India

A3: Communicate effectively with patients and other healthcare professionals

A4: Follow the patients till completion of the treatment

A5: Determine the role of Pharmacist in connection between prescribers and patients

A6: Participate in all health care initiatives

Text Books / References

REFERENCE BOOKS:

  1. G.Parthasarathi, Karin Nyfort-Hansen and Milap Nahata. A text book of Clinical Pharmacy Practice; Essential concepts and skills. 2nd edn. Orient Blackswan Pvt.Ltd;2012
  2. K G A textbook of Pharmacy Practice. 2nd edn. Career publications; 2019
  3. Cohen, Michael R. Medication errors 2nd Washington, D.C: American Pharmacists Association, c2007.
  4. Andrews EB, Moore Mann’s Pharmacovigilance. 3rd edn. Wiley Blackwell; 2014
  5. Amy M Guide to preventing medication errors.1st edn. Lippincott Williams and Wilkins;2003

ONLINE SOURCES

https://www1.health.gov.au/internet/main/publishing.nsf/Content/3B48796D9E2DDD8ACA2 57BF00021DDB8/$File/National-Strategy-for-Quality-Use-of-Medicines.pdf

JOURNALS:

  1. Drug safety (Springer )

https://linkspringer.com.Drug Safety

  1. Journal of Pharmacy Practice and Research (Wiley) https://ores.su/es/journals/journal-of-pharmacy-practice-and-research/

Assignment

ASSIGNMENTS:

  1. Case studies related to adverse drug reactions
  2. Case study related to medication errors
  3. Develop a list of OTC medications for common ailments
  4. Prepare and present treatment guidelines for selected diseases based on evidence based concept by reviewing recent literatures.
  5. Prepare latest WHO model Essential drug list

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