Clinical Pharmacy Part 2

1. Clinical PharmacyPart 2 Basma Y. KentabMSc.

2. Outline • Describe the activities of clinical pharmacists • Define Therapeutic Drug Monitoring • Discuss the pharmacist role in Therapeutic Drug Monitoring

3. Practice Guidelines for Pharmacotherapy Specialists Guideline I • The pharmacotherapy specialist designs, implements, monitors, evaluates, and modifies patient pharmacotherapy to ensure effective, safe, and economical patient care. ACCP, Pharmacotherapy 2000;20(4):487–490

4. Guideline I Assessment Factors • Collaborates with other health professionals to make therapeutic decisions such as drug and drug product selection, therapeutic drug monitoring, and drug dosing • Reviews patient records and orders regarding drug therapy and recommends and initiates changes as appropriate • Evaluates patients by means of interview and physical assessment to determine past & present medical history, past & present medication use, and response to therapy

5. Guideline I Assessment Factors • Utilizes available state-of-the-art knowledge and technology to assess, improve, and monitor drug therapy regimens • In conjunction with licensed medical practitioners, develops, manages, and assists in the implementation of pharmacotherapeuticprotocols • Works with other health care providers and relevant committees to develop programs for improving drug use and quality of patient care

6. Practice Guidelines for Pharmacotherapy Specialists Guideline II • The pharmacotherapy specialist retrieves, analyzes, evaluates, and interprets the scientific literature as a means of providing patient- and population-specific drug information to health professionals and patients.

7. Guideline II Assessment Factors • Identifies and retrieves the best available information about pharmacotherapy by searching appropriate tertiary, secondary, and primary sources • Evaluates biomedical and pharmacoeconomic literature to determine criteria for optimal use and monitoring of therapeutic agents

8. Practice Guidelines for Pharmacotherapy Specialists Guideline III • The pharmacotherapy specialist participates in the generation of new knowledge relevant to the practice of pharmacotherapy, clinical pharmacy, and medicine.

9. Guideline III Assessment Factors • Identifies pharmacotherapeutic questions to be studied or problems to be solved • Develops, implements, evaluates, and participates in scientifically valid and ethically designed studies • Collects data regarding the outcomes of patients managed by the pharmacotherapist • Presents research results at scientific meetings and publishes results in the scientific literature

10. Practice Guidelines for Pharmacotherapy Specialists Guideline IV • The pharmacotherapy specialist educates health care professionals and students, patients, and the public regarding rational drug therapy.

11. Guideline IV Assessment Factors • Assumes responsibility for the education of all members of the health care team • Participates in continuing education programs • Develops patient education materials and participates in patient instruction programs to facilitate appropriate medication therapy and compliance

12. Practice Guidelines for Pharmacotherapy Specialists Guideline V • The pharmacotherapy specialist continually develops his/her knowledge and skills in applicable practice areas and demonstrates a commitment to continued professional growth by engaging in a lifelong process.

13. Guideline V Assessment Factors • Participates in professional organizations related to areas of expertise • Increases personal level of knowledge and skills by reading professional journals, and attending or participating in professional seminars, professional symposia, and national and international conferences • Obtains board certification

14. Pharmacist’s Role in Clinical Pharmacokinetic Monitoring

15. Clinical Pharmacokinetics • Clinical pharmacokinetics is the process of applying pharmacokinetic principles to determine the dosage regimens of specific drug products for specific patients to maximize pharmacotherapeutic effects and minimize toxic effects.

16. Clinical Pharmacokinetics • Application of PK principles requires an understanding of the absorption, distribution, metabolism, and excretion characteristics of specific drug products in specific diseases and patient populations. • The influence of factors such as age, sex, diet, pathophysiologic conditions, and concomitant use of other drug products must also be understood.

17. Therapeutic Drug Monitoring (TDM) • Is the measurement and interpretation of drug concentrations in biological fluids, and use of the results in individualizing dosage regimens or assessing drug effects • TDM is necessary when the range between minimal effectiveness and toxicity is narrow and • the results of the drug assay provide significant information for clinical decision-making

18. When is TDM Required ? • Noncompliance • Inappropriate dosage • Poor bioavailability • Drug interaction • Kidney and liver disease • Altered protein binding • Genetically determined fast or slow metabolizers

19. The Pharmacist Responsibilities • Designing patient-specific drug dosage regimens • Recommending or scheduling measurements of drug concentrations in biological fluids (e.g., plasma, serum, blood, cerebrospinal fluid) or tissues in order to facilitate the evaluation of dosage regimens ASHP, Am J Health-SystPharm. 1998; 55:1726–7.

20. The Pharmacist Responsibilities • Monitoring and adjusting dosage regimens on the basis of pharmacologic responses and biological fluid and tissue drug concentrations in conjunction with clinical signs and symptoms or other biochemical variables • Evaluating unusual patient responses to drug therapy for possible pharmacokinetic and pharmacologic explanations

21. The Pharmacist Responsibilities • Communicating patient-specific drug therapy information to physicians, nurses, and other clinical practitioners and to patients orally and in writing, and including documentation of this in the patient’s health record • Educating pharmacists, physicians, nurses, and other clinical practitioners about pharmacokinetic principles and appropriate indications for clinical pharmacokinetic monitoring, including the cost-effective use of drug concentration measurements

22. The Pharmacist Responsibilities • Developing quality assurance programs for documenting improved patient outcomes and economic benefits • Promoting collaborative relationships with other individuals and departments involved in drug therapy monitoring to encourage the development and appropriate use of pharmacokinetic principles in pharmaceutical care.

23. The Pharmacist Responsibilities • Pharmacists with specialized education, training, or experience may assume the following additional responsibilities: • Designing and conducting research to expand clinical pharmacokinetic knowledge • Developing and applying computer programs and point-of-care information systems to enhance the accuracy and sophistication of PK modeling • Serving as an expert consultant to pharmacists with a general background in clinical pharmacokinetic monitoring.