Title: "Therapeutic Drug Monitoring: Optimizing Medication Management" Slide 1: - Title: Introduction to Therapeutic Drug Monitoring - Brief overview of TDM's importance in healthcare Slide 2: - Title: Why TDM? - Explain the need for monitoring drug levels in patients Slide 3: - Title: Key Drugs Monitored - List commonly monitored drugs and their therapeutic ranges Slide 4: - Title: TDM Process - Describe the steps involved in TDM, from sample collection to interpretation Slide 5: - Title: Indications for TDM - Discuss situations where TDM is crucial (e.g., narrow therapeutic index drugs) Slide 6: - Title: TDM Benefits - Highlight the advantages of TDM, such as optimizing dosages and minimizing side effects Slide 7: - Title: Challenges in TDM - Address obstacles in TDM, like cost and limited access to testing Slide 8: - Title: TDM in Clinical Practice - Real-world examples of TDM's impact on patient care Slide 9: - Title: TDM Technologies - Overview of analytical methods used for drug level measurement Slide 10: - Title: Case Studies - Present cases where TDM made a significant difference in patient outcomes Slide 11: - Title: Future of TDM - Discuss emerging trends and technologies in therapeutic drug monitoring Slide 12: - Title: Conclusion - Summarize the key takeaways and emphasize the importance of TDM in modern healthcare Slide 13: - Title: Questions? - Open the floor for questions and discussions. Therapeutic drug mornitoring optimization, plasma drug concentration,. Drug level. Study protocol. Individualization for therapeutic drug mornitoring

1. PRESENTATION ON
THERAPEUTIC DRUG
MONITORING
By
K.Sai Chaitanya
Pharm d IV year
Jagan’s college of pharmacy Nellore

2. Therapeutic drug monitoring
• Therapeutic drug monitoring is a clinical practices of measuring specific
drugs at a designated intervals to maintain a constant concentration in a
patient blood stream there by optimising individual dosage regimens.
• In others words TDM refers to the individualization of drug dosage by
maintaining plasma (or) blood drug concentration with in a targeted
therapeutic range (or) Window .
• The goal of this process is to individualizes therapeutic regimens for optimal
patient benefit .
• TDM is based on the Principle that for some drug there is a close relationship
between the plasma levels of the drug and it’s clinical effect.
1. Introduction

3. • Another assumption is that drug metabolism
varies from patient to patient.
When a precise therapeutic end point is
difficult to define, monitoring of drug levels
may be of considerable therapeutic assistant .
Therapeutic drug monitoring aims to promote
optimum drug treatment by maintaining serum
drug concentration with in a Therapeutic
Range.

5. Therapeutic Drug Monitoring History
• The science of the therapeutic drug monitoring grew out of the
recognition that:
• Certain drugs have a narrow therapeutic range .
• In concentration above the upper limit of the range ,the drug can be
toxic .
• Not all patients have the same response at similar doses
• These findings led to the development of clinical pharmacology
department.
• Today there are over 20 therapeutic drug which are routinely
monitored.

6. Therapeutic Drug Monitoring in India
• Therapeutic drug monitoring was introduced in India in mid 1980s
and last 20years have seen it’s growth.
• Therapeutic Drug Monitoring in India exist in mainly two setting:
• In Large Teaching Hospital through the department of clinical
pharmacology.
• In private sector ( biochemistry labs, dedicated CPU units in corporate
hospital like Apollo).

7. Therapeutic Drug Monitoring include

8. Criteria for Therapeutic Drug Monitoring
• An appropriate analytical test for drug and active metabolites must
exist.
• Drug should have a narrow therapeutic range.
• Patient not showing adequate clinical response to a drug despite
being on adequate dose.
• The therapeutic effect can not be readily assessed by the clinical
observations.
• Ex: anticonvulsants, antidepressants
• Large individual variability in steady state plasma concentration exist
at any given dose.

9. • There are several classes of drug commonly monitored
to ensure correct blood concentration, including the
following:
• Antiepileptics
• Eg : phenytoin,valproic acid
• Antiarrhythmics
• Eg: digitals,lignocaine
• Antibiotics
• Eg: gentamycin ,amikacin,tobramycin
• Antineoplastics
• Eg : methotrexate

10. Indications for Therapeutic Drug Monitoring
1. While there may be specific individual circumstances for Therapeutic
drug monitoring,most indications can be summarised as follows:
• Low therapeutic index
• Poorly defined clinical endpoint.
• Non compliance
• Therapeutic failure
• Drug with saturable metabolism
• Wide variation in the metabolism of drugs.
• For diagnosis of suspected toxicity and determining drug abuse.
• Drug with steep dose alter the relationship between dose and plasma
concentration.

11. • Ex: plasma concentration of lithium is increased by thiazide
• Renal disease

12. Therapeutic Drug Monitoring Process
• Therapeutic Drug Monitoring is a multidisciplinary function and
requires collaboration and good communication between scientist,
clinicians, nurses and pharmacolgists.

13. Therapeutic drug
monitoring
Process

14. Clinical significance of Therapeutic Drug
Monitoring
• Maximizes efficacy
• Avoid Toxicity
• Identifices therapeutic failure
• Facilitate the therapeutic effect of drug by achieving targets drug
concentration.
• Identify poisoning,drug toxicity and drug abuse.

15. Limitations of Therapeutic Drug Monitoring
Process
• Scientific accuracy of the drug assay.
• Laboratory variability in reporting.
• Limitations assesscibility and Infrastructure facilities in rural areas.
• Validity of suggested targets area.
• Lack of training and skills.
• Cost involved.

16. Advantages
• Side effects monitoring
• Short hospital stay
• Better disease control
• Dose adjustment
• Dose guidelines
• Individualized dose requirement
• Usefulness to clinical pharmacist

17. TDM of certain drugs
Drug Half life (h) Therapeutic range (ng/ml)
Gentamicin 2 hours 6-8
Amikacin 2.3 hours 20-25
Carbamazepin 24.4 hours 4-12
Digoxin 36 hours 0.9-2
Cyclosporine 5.6 hours 100-250
Theophylline 7-12 hours 10-15
Lithium 6-8 hours 16-30

18. Study protocol for TDM
1. Title of the study / project
2. Investigators
• chief investigator
• Joint investigator
• co investigator
3. Place of the study
4. Patient recruitment place
5. Need for TDM study

19. 6.Objective for study
7.Criteria for selection of patient
8.Patient history
9. Withdrawal of blood sampleband storage
10. Instruments for
• Measurement of drug level
• Measurement of clinical parameter
(ECG,EEG, Respiration etc)

20. 11. Report preparation
12. Clinical interpretation.
Patient data case Report from
1 . Case number (OPD/Indoor)
2. Name of the physician
3. Name of the patient
4. Address of patient
• Age,sex, weight, phone number.

21. 6. Diagnosis
7.Case history
8.Past history
9. Family history
10. Drug treatment
11.Dose and frequency
12. Duration of the treatment
13. Reason for TDM

22. 14. Time of last dose taken
15. Time of sample collection
16. Concomitant therapy
17 . Any other biochemicaltests.
Disease details
1. Complaints
2. frequency of initial complaints
3. Duration
4. Precipitating factors

23. 5. Etiology
6. Treatment
7. Discontinued with the reason
8. Present treatment
dose ,date ,drug, frequency, duration , response, ADRs if any
9. Investigator.

24. Induction for TDM
• Routine. Non responder. Check complaince
• Toxicity. Drug interactions. Pregnancy
• Discontinuation of the treatment Any other
• Date signature of physician
• Approval of ethics committee
• Patient consent from

25. Conclusion
• Therapeutic Drug Monitoring may be useful for establishing intial
dosing and monitoring certain medications.
• Therapeutic drug monitoring can not compensate for errors in
diagnosis,poor choice of drugs, errors in dispensing and dosages,
errors in sampling, non compliance etc…
• However, when used in combination with good clinical
observations,it can lead to optimal drug therapy with minimal side
effects.

26. REFERENCE
1. A text book of clinical pharmacy practice – G . Parthasarthi ,karin
Nyfort , Hansen , Milap C Nahata .
2. Clinical pharmacy and therapeutics 5th edition Roger Walker and
cate whittlesea
3. http://www.ncbi.nlm.govt/PMC/article/pmc2014358.