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Drug Evaluation and Approval Process
1. Prepared by: Ms. Archana Vanjari
Designation: Assistant Professor
Pharmacy and therapeautic
committee
2. • Proposal of a new drug
• Drug evaluation and approval in following categories
1. Formulary Drug: FDA approval
II. On a conditional trial period: 6 to 12 month period
for
final consideration
III. Specialized formulary drug: FDA approved drug
recommended for use in specialized patient care.
IV. Investigational drugs: Not available commercially.
• Non formulary drugs: The drugs not listed in above
categories considered as Non-formulary drugs. And
these
drugs are not stocked in pharmacy.
POLICIES OF PTC
3. • Responsible for rules and regulations which governs
Pharmaceutical company representative activities in
hospital
• Authorization of dispensing of drugs as per the
policies
and procedure of the committee.
• To avoid pre-signing of blank prescriptions and drug
orders.
• Drug Recall
• Dispensing of drugs as per the generic names of the
drugs.
• In-patient prescription:
a) Routine drug orders: A legible copy of the
medication order must be forwarded to the pharmacy
4. The patient address information
The name of the nursing unit
The name and strength of each drug
The directions for frequency of administration
The route of administration
The signature of the prescribing physician
The date and time that the order was written
Note: Order written by medical students must be
countersigned by a member of the medical staff.
b) IV orders: must be written in the same manner as per
routine drug orders, include following information:
exact quantity of the drugs to be added
exact volume and name of the infusate solution
5. specific directions for administration of IV drip, IV
bolus, IV push etc.
specific times to hang infusate solution and drip rate
specific directions for continuing and discontinuing
IV administration
Automatic stop order: 24 hrs for schedule II control
drugs (narcotics)
7 days for all other drugs
If change in route of drug administration and dosage
–
write new medication order
Total Parenteral Nutrition (TPN):
o Designed to serve nutritional infusion
o Ordering
6. • Self medication
• To avoid keeping of medicines to the hospitals
brought by the patient
• Discharge prescription: A separate prescription is
required for each medication which the patient is to
take home. It includes following information:
Patient address information
Name of the drug and strength
Quantity to be dispensed
Specific instructions for patient administration
Number of refills
Signature and printed name of Physician
7. • Outpatient Prescription:
a) The hospital requires that a prescription be written for
any drug or medical supply which is to be dispensed for
hospitalized patients at discharge, clinic patients and
employees.
Such prescriptions may written only on hospital prescription
forms in compliance with all regulatory agencies.
b) Information requires on prescription:
Patient address information
Name of the drug and strength
Quantity to be dispensed
Specific instructions for patient administration
Number of refills
8. c) Prescription for control drugs have special
requirements which are as follows:
All control drug prescription requires the Physician
number
Narcotics are limited to a 30days supply and no
refills
Drugs like Barbiturates are limited to 30 days supply
and may be refill upto 5 times within 6 months of
issuanace date
Drugs like Benzodiazepines and cough preparations
may be refilled 5 times within 6 months of issuance
date.