Pharmacy Practice for Final Year B.Pharmacy Sem-VII, As per PCI Syllabus Therapeutic Drug Monitoring

1. Therapeutic Drug
Monitoring
Prepared By:- Ms.Mali Sunayana
Asst.Professor
Sahyadri College of Pharmacy, Methwade.
Tal-Sangola, Dist-Solapur, Maharashtra, India.
Topic No.7

2. ¶ INTRODUCTION:-
The pharmacist's traditional role in health care delivery
system is procuring,storing,preparing and dispensing
medications to patients.
The pharmacist's responsibility in the drug use process
has greatly expanded in the last decade and so he is now
also expected to monitor drug therapy.
This new responsibility requires pharmacists to actively
ensure that prescribed drug therapy is effective, safe and
economical.

3. A same dose of a drug produce satisfactory
therapeutic activity in some persons causes toxicity
in others and has little effect in some.
Hence to improve the situation, clinical
pharmacokinetics and laboratory technology were
integrated with clinical medicine giving birth to
“Therapeutic Drug Monitoring” (TDM).
Its main aim is to maximize the benefit of a
prescribed drug simultaneously minimizing its
toxicity. With the therapeutic drug monitoring
patient benefits medically and economically.

4. ¶ DEFINITION OF THERAPEUTIC DRUG MONITORING:-
• Drug Monitoring is that process which ensures that a
patient is treated with least expensive, most effective
therapeutic agent, in a manner that will maximize efficacy
and minimize side effects".
• Therapeutic Drug Monitoring (TDM) is a process in
clinical pharmacology which specializes in measuring the
concentration of certain drugs in the body fluids and
clinically interpreting it to obtain useful and often lifesaving
information.
• It is defined as “the use of drug concentration
measurements in body fiuids as an aid to the management
of drug therapy for the cure, alleviation or prevention of
disease."

5. ¶ NEED FOR THERAPEUTIC DRUG MONITORING:-
The number of studies in recent years has pointed to a
need for more intensive monitoring of drug therapy.
These reports have identified following reasons:
1) Polypharmacy
2) Adverse Reaction
3) Medication Errors
4) Non-Compliance

6. ¶ FACTORS TO BE CONSIDERED DURING THERAPEUTIC
DRUG MONITORING:-
1) Collection of Patient Data
2) Statement of Therapeutic Goals
3) Selection of Drug Therapy
4) Establishment of Monitoring Parameters
5) Identification and Confirmation of Problems
6) Communication of Findings

7. ¶ LIMITATIONS OF THERAPEUTIC DRUG MONITORING:-
1) Monitoring of therapeutic drugs is expensive in terms of
equipment's, supplies, technical experts to obtain concentration in
biological fluid, to interpret and investment in research data
collection, etc.
2) Only those drugs with broad therapeutic range are benefited by
the monitoring.
3) For certain drugs,values of serum concentration are less justifiable
than the values of blood pressure measurements and blood
coagulation.
4) The data on serum concentration is not required for the drugs
with broad therapeutic range.

8. ¶ APPLICATIONS OF THERAPEUTIC DRUG MONITORING:-
1) Monitoring of certain drugs theophylline, valproic acid,
methotrexate is associated with the increased efficacy and
decreased incidences and side effects.
2) Monitoring determines the safety of the dosage regimen.
3) Appropriate interpretation of drug concentration measurements
is used in the monitoring for dosage adjustment that minimizes
the proportion of patient with serum concentration outside the
therapeutic range.
4) Monitoring encourages professional interactions between
members of the health teams such as physician and pharmacist.
5) It provides an opportunity for clinical pharmacist to excel in
therapeutic challenges and to work as a vital segment of health
team in the area of pharmacotherapeutics.
6) It provides additional input in pharmacotherapy.

9. ¶ INDIAN SCENARIO FOR THERAPEUTIC DRUG
MONITORING:-
Even though Therapeutic Drug Monitoring has grown itself
into an unavoidable part of the health care system and the
position has gained due respect and support from the patients
and the medical professionals equally, it seems that the Indian
government officials are turning a blind eye to these
developments taking place globally.
In india, there are no regulatory guidelines for having a
qualified clinical pharmacist in the Indian hospitals.
Another point to ponder is that even if regulations are framed
in due course, will there be enough pharmacists with
necessary experience to work in the hospital set up as the
current trend is the mass migration of pharmacist to the
pharmaceutical industries.

10. The main reason for this phenomenon is the lack of
recognition of the post of Clinical pharmacist at the
regulatory level.
The students after completion of their studies are
either forced to take up a job in an industry or move
into academics, the last option being to seek jobs
abroad where the pharmacy profession is well
received.
Though the situation is gradually changing as
students are recognizing the scopes of the profession
beyond the traditional limits the prospect of serving
such a huge, mostly uneducated, exploding population
is a daunting challenge.

11. Many pharmacy schools have started to understand the
importance of PHARMACY PRACTICE and are including it
in the four-year syllabus of the UG course.
Another positive sign is the introduction of Pharm-D
course in a hand full of institutions in India. It is a six-year
doctoral course including one-year rotating internship
aimed at creating competent clinical pharmacists for the
hospitals in India.
The current scenario can only be bought under control
by the timely intervention from the gov. authorities, as a
nurturing regulatory environment is a necessity form
development of health professions like pharmacy and
also with the collaborative efforts from the academic
leaders and the government authorities

12. Therapeutic Drug Monitoring has the bright
potential to grow into a very strong pharmacy wing
in the health care system, particularly in a country
like; India with such a strong medical foundation and
a dynamic and varied population waiting to receive
any additional patient services.
The only way that clinical pharmacy can grow
unhindered in India is by gaining the support and
acceptance of the entire medical profession and the
community as a whole, and this in turn rests in the
hands of the present-day pharmacy students and
pharmacy professionals.

13. REFERENCE
1. A Text book of Pharmacy Practice by the author Dr. Sachin V. Tembhurne, Dr.
Ashwini R. Madgulkar, Dr. Virendra S. Ligade Nirali Prakashan. Page No. 7.1-
7.5
2. A Text book of Pharmacy Practice by the author SOURABH KOSEY Nirali
Prakashan. Page No. 7.1-7.8
3. www.google.com

14. Thank You.....