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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5739_Библиотеки_им_академика_М_И_Перельмана.pdf
Pharmacy Practice68
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evision of Fevision of F
evision of Fevision of F
evision of F
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• The PTC holds meetings to discuss about the revision of the
formulary.
• The annual revision is necessary because of the changes in
the drug products, removal of certain drugs from the
market and changes in the hospital policies.
• The addition of details of a drug is done by attaching the
supplement sheets at the back of the formulary.
• The addition of any drug to the formulary is a complex
decision.
• All steps prior to the addition or deletion of a drug must be
reported to the medical staff.
Difference between hospital formulary and drug list: The
difference between hospital formulary and drug list is listed in
Table 6.1.
Addition and Deletion of New Drugs in the FAddition and Deletion of New Drugs in the F
Addition and Deletion of New Drugs in the FAddition and Deletion of New Drugs in the F
Addition and Deletion of New Drugs in the F
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It is one of the greatest challenges to the PTC, to frame the
gauzes of selecting criteria’s for the addition or deletion of
drugs or formulations. This is because of the fact that the
majority of the members of committee are not so highly
qualified to evaluate the clinical or therapeutic efficacy of the
drugs; but following factors are being considered, while doing
the activity.
Table 6.1: Difference between hospital formulary and drug list
S. No. Formulary list Drug list
1. Listing of drugs by their generic Generic names followed by
names followed by information data on strength and form
on strength, form, posology,
toxicology, use and recommended
quantity to be dispensed
2. Prepared locally by its own Prepared by country’s
clinical staff outstanding clinicians,
pharmacologists and
pharmacists
3. Information provided is subject According to their pharma-
to local needs and desires cological properties
Hospital Formulary 69
• The drugs must be recognized by the official books or their
supplements.
• The secret formulations may not be added in the formulary.
• The addition of new drugs in the formulary is purely
depends on, whether the drug is found, clinically authentic
by either local general practitioner or a specialty staff
member.
• The drug produced by the manufacturer must comply with
the recommended standards; if found inferior, such drugs
may be deleted.
• A general policy regarding multiple compositions of drugs,
not to incorporate in the formulary is adopted by the
majority of hospitals.
ISOLISOL
ISOLISOL
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TED KEY POINTSTED KEY POINTS
TED KEY POINTSTED KEY POINTS
TED KEY POINTS
• Hospital formulary is a continually revised compilation of
pharmaceuticals including important ancillary information
that reflects the current clinical judgment of the medical
staff”.
• Hospital formulary is defined as a list of drugs used in the
hospital. The hospital formulary should be revised conti-
nuously and it reflects the current clinical judgment of the
medical staff.
• The formulary provides for obtaining, prescribing, dis-
pensing and administering both the branded and generic
drugs
• A typical formulary must have the following composition:
i. Title page
ii. Names and titles of the members of the PTC
iii. Table of contents
iv. Information on hospital policies and procedures
concerning drugs
v. Products accepted for use at hospital
vi. Appendix
Pharmacy Practice70
PRAPRA
PRAPRA
PRA
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONS
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t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. What is hospital formulary?
2. How is the hospital formulary revived?
3. How are the drugs to be addition and deleted in hospital
formulary?
4. Write two applications of hospital formulary.
ShorShor
ShorShor
Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Write the need for hospital formulary in a hospital.
2. Write the guiding principles involved in the use of hospital
formulary.
3. Write the advantages of hospital formulary.
4. What are the objectives of hospital formulary?
5. Write the contents of a hospital formulary.
LL
LL
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ong Answer Tong Answer T
ong Answer Tong Answer T
ong Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Define hospital formulary. Explain in detail the contents of
hospital formulary.
2. What is hospital formulary? Give its guiding principles and
contents?
3. Describe the steps involved in the preparation of hospital
formulary.
4. Give the objectives, need, advantage and disadvantage of
hospital formulary.
Objective TObjective T
Objective TObjective T
Objective T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. The formulary provides for obtaining,_______________,
______________ and _____________ both the branded and
generic dugs.
2. Miscellaneous section of a hospital formulary does not
include:
A. Metric units
B. Children’s dose
C. Use of IV drugs
D. Diagnostic aids
Hospital Formulary 71
3. Who frames policy guidelines regarding the entry or dele-
tion of drugs from hospital formulary?
A. Pharmacy and therapeutic committee
B. Administrator
C. Governing body
D. Medical committee
4. Hospital formulary consists of:
A. List of drugs
B. List of surgical instruments
C. List of patients
D. None of these
5. The drug list consists of list of therapeutic agents by their
generic names followed by information on:
A. Strength and dosage form
B. Pharmacokinetics
C. Directions of use
D. Toxicity
AnswersAnswers
AnswersAnswers
Answers
1. Prescribing, dispensing and administering 2. C 3. A
4. A 5. A
Therapeutic drug monitoring (TDM) is the “Clinical process
of measuring specific drugs at designated intervals to maintain
a constant concentration in a patient’s bloodstream, thereby
optimizing individual dosage regimens”.
Or
“Therapeutic drug monitoring refers to the monitoring of
drug dosage by maintaining plasma or blood drug concen-
trations within a targeted therapeutic range”.
NEED FOR TDMNEED FOR TDM
NEED FOR TDMNEED FOR TDM
NEED FOR TDM
The need for TDM is to promote optimum drug treatment by
maintaining serum drug con-centration within a “Therapeutic
range” (Fig. 7.1).
Generally, therapeutic window is a ratio between minimum
effective concentrations (MEC desired) to the minimum
effective concentrations (MEC adverse). If any drug crosses
MEC adverse then it will surely elicit toxic effects and if drug
is unable to surpass MEC desired then it will cause therapeutic
failure. Therapeutic drug monitoring can guide the clinician
to provide effective and safe drug therapy in the individual
patient using serum drug concentration.
Certain drugs have a narrow therapeutic range in con-
centrations above the upper limit of the range, the drug can be
toxic. In concentrations below the lower limit of the range, the
drug can be ineffective. Not all patients have the same response
at similar doses. The drug graph should fall between
Therapeutic Drug Monitoring
7
Therapeutic Drug Monitoring 73
Fig. 7.1: Therapeutic window
therapeutic range to be efficacious lower or higher graphs lead
to sub-therapeutic level and toxic effects respectively.
Performing TDM requires a multidisciplinary approach.
Accurate and clinically meaningful drug concentrations are
attainable only by complete collaboration by a TDM team,
typically comprised of scientists, clinicians, nurses, and
pharmacists. Hence, following below mentioned points are
needed for TDM:
• Patient with an inadequate clinical response.
• Patient with signs or symptoms which may indicate drug
toxicity.
• To minimize the risk of drug toxicity.
• To individualise dosing for some drugs with an unpre-
dictable dose response curve.
• To help predict a patient’s dose requirements.
• To assess medication compliance.
• To identify poisons and to assess the severity of poisoning
in a poisoning emergency.
Applications of TDMApplications of TDM
Applications of TDMApplications of TDM
Applications of TDM
• To predict patients dose requirement and to access medi-
cation compliance.
Pharmacy Practice74
• To access the appropriateness of dosing regimen to main-
tain the minimum concentration required to exhibit efficacy.
• To minimize the time period needed for dosage adjustment.
• To identify poisons and to assess the severity of poisoning
on an emergency basis.
FF
FF
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AA
AA
A
CTORS AFFECTING TDMCTORS AFFECTING TDM
CTORS AFFECTING TDMCTORS AFFECTING TDM
CTORS AFFECTING TDM
• Patient demographics: Age, sex and body weight are impor-
tant for renally cleared drugs indicating creatinine
clearance.
• Patient compliance: If the concentration of the drug is lower
than expected, the possibility of noncompliance should be
considered before a dose increase is recommended.
• Individuals pharmacokinetics, i.e. ADME:
Absorption: The rate of absorption and extent of absorption
are dependent on various factors. Bioavailability depends
on absorption and is the fraction of the administered dose
that reaches the systemic circulation. Bioavailability is 100%
for IV injection.
Distribution: Amount of drug distributed to various organs
including peripheral organs and tissues.
Metabolism: In addition, drug metabolites can be either
protein bound (inactive) or free (active). The drug dosage
will depend on how the drug metabolizes. Factors affecting
drug metabolism includes genetics, environment, nutrition,
and age.
Excretion: Drug excretion is done through the kidneys or
fluids excreted through the lungs, GI or skin.
• Genetic factors: Like prevalence of any disease, e.g. diabetes.
• Concomitant disease, tropical disease and nutritional deficiencies:
This includes diseases highly prevalent in infestations,
tuberculosis, nutritional deficiencies, plus a high pro-
portion of patients with diabetes and AIDS
• Alternative system of medicine: India is unique in having at
least three systems of medicine, i.e. allopathy, ayurveda,
homoeopathy and unani. Hence, if one system does not
work for a particular person alternate medicine system can
be used.
Therapeutic Drug Monitoring 75
• Alcohol and tobacco use: Excessive use of alcohol leads to
several hepatic complications like non-specific hepatic
microsomal enzyme induction, resulting in increased
clearance and decreased serum concentrations of hepati-
cally cleared drugs. Similarly, cigarette smoking increases
the hepatic clearance of theophylline and patients who have
recently stopped smoking may have unexpectedly high
theophylline concentrations.
• Medication or sampling errors: In cases where the TDM result
is incompatible with drug administration records, the
possibility of a medication or sampling error should be
considered. For example, the drug may have been given to
the wrong patient, or blood may have been mistakenly
drawn from a patient in a neighboring bed.
• Cost effectiveness: Cost-effective measurement of most drugs
for which TDM is indicated can be achieved using com-
mercial kits run on automated analyzers using a number of
different methodologies including fluorescence polarisation
immunoassay.
• Laboratory errors: If a laboratory error is suspected, the
laboratory should be contacted and asked to repeat the
assay. Alternatively, a new blood sample can be drawn and
sent to a different laboratory for assay.
INDIAN SCENARIOINDIAN SCENARIO
INDIAN SCENARIOINDIAN SCENARIO
INDIAN SCENARIO
TDM was introduced in India in mid 1980s and last 20 years
have seen its growth. TDM in India exists in mainly 2 settings:
In large teaching hospitals through Department of Clinical
Pharmacology. In private sector (Biochemistry Labs, dedicated
CPU units and in corporate hospitals like Apollo). It is currently
limited to a few academic medical centres and teaching
hospitals. Apart from the immunosuppressive drugs, several
other therapeutic areas, such as anticancer, antifungal,
antibiotic and antitubercular, have demonstrated great
potential to improve patient outcomes in Indian settings.
Factors such as the higher prevalence of nutritional deficiencies,
tropical diseases, widespread use of alternative medicines,
unalike pharmacogenomics and sparse population-specific data
Pharmacy Practice76
available on therapeutic ranges of several drugs make the
population of this subcontinent unique regarding the relevance
of TDM. Despite the impact of TDM in clinical science and its
widespread application, TDM has failed to receive the attention
it deserves in India. Following are some below mentioned
points for TDM in India:
• Still no regulatory guidelines for qualified clinical
Pharmacist in Indian hospital.
• Need support and acceptance of entire medical field and
community to enrich this profession Pharm D course
introduced by PCI.
• There should be constructive collaboration between
individual pharmacist, academic leader and hospital
administration for training and resource
• Differences in formulation between the various same drug
may result in same drug significant variation in bio-
availability.
ISOLISOL
ISOLISOL
ISOL
AA
AA
A
TED KEY POINTSTED KEY POINTS
TED KEY POINTSTED KEY POINTS
TED KEY POINTS
• Therapeutic drug monitoring (TDM) is the “Clinical process
of measuring specific drugs at designated intervals to
maintain a constant concentration in a patient’s blood-
stream, thereby optimizing individual dosage regimens”.
• Therapeutic window is a ratio between minimum effective
concentrations (MEC desired) to the minimum effective
concentrations (MEC adverse).
• Various factors affecting TDM are:
a. Patient demographics
b. Patient compliance
c. Individual Pharmacokinetics, i.e. ADME
d. Genetic factors
e. Concomitant disease, tropical disease and nutritional
deficiencies
f. Alternative system of medicine
g. Alcohol and tobacco use
h. Medication or sampling errors
i. Cost effectiveness
j. Laboratory errors
Therapeutic Drug Monitoring 77
• TDM in India exists in mainly 2 settings
• In large teaching hospitals through Department of Clinical
Pharmacology
• In private sector (Biochemistry Labs, dedicated CPU units
and in corporate hospitals like Apollo).
PRAPRA
PRAPRA
PRA
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONS
VV
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erer
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t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. What are objectives of TDM?
2. List any four drugs for TDM monitoring.
3. Define TDM.
4. Draw graph of therapeutic window.
ShorShor
ShorShor
Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Explain the TDM process.
2. Briefly write the Indian scenario for therapeutic drug
monitoring.
3. What are the principles of TDM?
4. Discuss the applications of TDM.
5. What are the factors affecting TDM?
LL
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ong Answer Tong Answer T
ong Answer Tong Answer T
ong Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Define TDM. Write the steps involved in performing TDM.
2. Explain the factors to be considered during the therapeutic
drug monitoring.
3. Write note on the following:
A. Indian scenario on TDM
B. Need for TDM
Objective TObjective T
Objective TObjective T
Objective T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. MEC stands for ______.
2. Therapeutic window is a ratio between ______________ to
__________.
3. ADME does not include:
A. Absorption B. Metastasis
C. Distribution D. Excretion