The Pharmacy & Therapeutic Committee (PTC) is an advisory group composed of at least three physicians, one pharmacist, and one nurse. It serves as a line of communication between medical staff and the pharmacy department. The PTC's primary roles are advisory and educational. It meets regularly to recommend drugs for use in the hospital and develop policies regarding drug safety, utilization review, adverse drug reaction monitoring, and the hospital formulary.
Instructions for Submissions thorugh G- Classroom.pptx
PTC & Hospital Formulary
1.
2. Pharmacy & Therapeutic Committee (PTC) is an advisory group
of the medical stuff and serves as the organizational line of
communication between medical stuff and pharmacy
department.
The committee is composed with minimum three (03) physician,
one (01) pharmacist one (01) nurse.
Purpose of PTC
Primary purposes of PTC are –
Advisor
Educational
3. PTC composed of minimum 03 physician, a pharmacist & a nurse,
who are appointed by governing board or elected medical stuff
Hospital administrator or his designated should be an ex officio
member of the committee.
Chairman of the committee from among the physician & pharmacist
is designated as secretary.
PTC will meet regularly, no les than twice in a year.
Committee can invite experts from within or without hospital who
can contribute his specialized knowledge and experience.
An agenda should prepare and circulated to the members in
sufficient time before meeting.
Minutes should prepared and preserved by the pharmacist.
Recommendations of the PTC shall be placed to the medical stuff or
appropriate committee for adsorption.
4. Functions of PTC
serve as an advisory capacity in all matters related to the
use of drug.
serve as an advisory capacity in the selection & choice of
drug.
evaluate clinical data regarding new drugs or proposed
drugs for hospital use.
prevent unnecessary duplication of same basic drug or
their combination.
recommend additions and deletions from the list of drug
accepted for use in the hospital.
develop a basic drug list or formulary, which require
constant review.
5. Functions of PTC
recommended drugs to be stocked in patient unit.
plan suitable educational programme for medical stuff on
drug & their uses.
recommend policies regards the safe use of drugs in
hospital.
study on the problems involve in proper distribution &
labeling of drugs for in & out patient.
study problems related to the drug administration.
review reported adverse reaction of drugs.
evaluate medical records in term of drug therapy.
6. 6
Drug safety includes responsibility from dispensing of
drugs to drug-administration and then to observe
possible adverse effects. PTC can play a major role in
ensuring the drug-safety.
Following guidelines may sub serve the committee in
ascertaining the adequate safety factor of the hospital
pharmacy.
1. Appoint a registered pharmacist
2. Not permit non-pharmacist perssonel for dispensing
3. A sufficient numbers of qualified perssonel appoint
4. Adequate safe, work space, and storage facilities
5. Have necessary equipment
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6. Automatic stop for order-narcotics, hypnotics, anti
coagulants
7. Firm policy for research drugs
8. Should have a complete drug formulary
9. Arrange out side its working hours (off hour
dispensing)
10.Segregate poisonous materials- non poisionous
materials
11.Separate external use drugs-internal use drugs
12.Need quality control measures, GMP during
processing
13.Plan for suitable teaching programme
14.Design periodical inspection
15.Establish adequate reference library
Role of PTC in Drug-Safety
8. 8
An ADR is defined as any unusual of unexpected
harmful reaction including acute poisonings by
narcotics, barbiturates, and amphetamines as well as
industrial poisonings.
PROFORMA FOR MONITORING OF ADR
1. Do not leave any item blank
2. Mark tick in the appropriate box
3. Type or write in BLOCK LETTERS
Role of PTC in Adverse Drug Monitoring
9. Adverse Drug Monitoring Form Proforma
1) Centre Name: ___________________________________________
2) Type of patient: Inpatient (1) Outpatient (2) 3)Serial No: ______
4) Name of the patient: _____________________________________
5) Address(complete): ______________________________________
6) Age: ______ Years 7) Sex: Male (1) Female (2)
8) Occupation: ________________________
9) Hospital Record No.: ________ 10) Registration Date: ________
11) Dietary Habit: Veg. (1) Non-veg. (2)
12) Smoking Habit: No(1) Yes (2); if yes, duration: _______ (yrs.)
13) Alcohol Habit: No(1) Yes (2); if yes, duration: _______ (yrs.)
10. Adverse Drug Monitoring Form Proforma
14) Relevant Medical History: If yes, details
Allergy No(1)Yes (2)
Environmental exposure No(1)Yes (2)
Occupational exposure No(1)Yes (2)
Previous drug reaction No(1)Yes (2)
Pregnancy 0/1/2/3 Trimester
Family history of ADR No(1)Yes (2)
15) Background sings symptoms: ______________________________
_________________________________________________________
_________________________________________________________
16) Provisional Diagnosis: ____________________________________
17) Treatment Schedule (including traditional medicine):
11. Adverse Drug Monitoring Form Proforma
17) Treatment Schedule (including traditional medicine):
Drug Name
Trade & Generic
Indication
(Diagnosis)
Total Daily
Dose
Route Duration
18) Date of End of Treatment: ______________________________
19) Outcome of Management: Recovered (1); Still under Rx (2);
Died (3); Lost to follow up (4); ADR suspected (5)
20) If ADR is suspected fill in the PROFORMA-II: No (1) Yes
(2)
Every case of adverse drug reaction must be first reported by
the attending physician to the chairman of the PTC who in turn
periodically forward essential data to the central committee on
Adverse Reactions formed by the drug control authorities.
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Role of PTC in Developing Emergency
Drug Lists
Since time factor is of very great urgency to most true
emergency situations, it is absolutely necessary for the
PTC of a hospital to get prepared boxes containing
emergency drugs which should be always available
readily for use at the bed-side.
List of such drugs and other supplies should be
complied by the committee, and it should find their
place in emergency kits.
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Role of PTC in Drug Product Defect
Reporting Programme
The drugs purchased by hospital may be defective in
quality. It is for the committee to get information
about the defective drug products and to inform it first
to the manufacturer for appropriate action.
If satisfactory answer is not obtained from the
manufacturer or supplier, it should be reported to the
Food and Drug Control Administration.
14. Name of the Hospital: ____________________________________________
Address: ______________________________________________________
HOSPITAL PHARMACIST’S DRUG DEFECT REPORT
Reference No.: ______________ Date received: _______________
1. Trade Name: __________ Dosage form: _________ Strength: _______
2. Lot No: ___________________ Expiry Date: _______________
3. Date Purchased: ____________________
4.Name of the supplier: ___________________________________________
5. Name and address of the manufacturer: ___________________________
_____________________________________________________________
6. Reporting pharmacist’s name: ___________________________________
7. Defects noted or suspected:
Date:____________ Signature of the chairman of PTC: ________________
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Drug utilization includes prescribing, dispensing,
administering and ingesting of prescription of drugs.
Hospital pharmacist should take medication history that
should include following information.
1)Medication being taken at the time of admission,
during admission, home remedies (OTC) drugs.
2)Drug-allergies and idiosyncrosy towards food
products etc.
Role of PTC in Drug Utilization Review
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Name of the patient: _________________________________________
Address: __________________________________________________
Age: _______ Years Sex: _M / F_ DOA: ____________________
Admission Diagnosis: ________________________________________
Other Pathology: ____________________________________________
Pre Operative Medications Used: _______________________________
Date Drugs Dose Route Started Discontinued Remarks
17. 1. To help improved drug prescribing practices by promoting the
safe and rational use of the drugs.
2. To detect and help prevent drug-interactions.
3. To help detect and prevent adverse drug reactions.
4. To detect and prevents IV additive incompatibilities.
5. To detect drug-induced diseases.
6. To detect possible drug-induced diseases.
7. To help detect and potential drug-toxicities.
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Role of PTC in Drug Utilization Review
19. Hospital Formulary
The hospital formulary is a continually revised compilation of
pharmaceuticals, which reflects the current clinical judgment
of the medical stuff.
Guiding Principle of Hospital Formulary
medical stuff shall appoint PTC & outline it’s purpose,
organization, function & scope .
medical stuff based upon the recommendations of PTC shall
sponsor the formulary.
medical stuff shall adopt written policies & producers governing
the hospital formulary system as develop by the PTC.
hospital formulary shall not contain any policies which hamper
the physician’s judgment, even when he/she prescribe a drug in
proprietary name. However they be encouraged to dispense the
drug in non-proprietary name.
20. Hospital Formulary
medical stuff shall adopt the policy of, and formulate the
procedure for, including drugs in the formulary by their non-
proprietary name.
the pharmacist must dispense the brand prescribed, bearing in
mind his professional right to give with the physician should
the prescribed brand be unavailable, when the written policies
are absence.
nursing personnel are informed in written about the existence
of formulary in hospital.
the terms ‘substitute’ & ‘substitution’ should be avoid in the
formulary.
Guiding Principle of Hospital Formulary
(continue…….)
21. Guiding Principle of Hospital Formulary
(continue…….)
provision shall be made to explain the medical stuff of
changes in the working of the hospital formulary system or in
the content of the hospital formulary.
medical stuff shall make provision for the evaluation & use:
a. of drug(s) not included in hospital formulary
b. of investigational drugs.
pharmacist, with the advice & guidance of PTC, shall
responsible for prepare the specifications of all drugs,
chemicals, biologicals & pharmaceuticals used in the hospital.
labeling of the medications should be in non-proprietary
name.
Hospital Formulary
22. Legal Basis of Hospital Formulary
Different methods are used to implement hospital formulary,
which include –
One common method is the use of suitable worded imprint on
the prescription form. eg. – “Generic Equivalent Permitted” or
“Dispensed in accord with the hospital formulary system” . In
some hospital, the consent statement is followed by a check
box with a ‘yes’ & ‘no’, where physicians can give their
opinion.
Second method is obtaining a consent form medical stuffs
during appointment as by law or the rules & regulations of the
institute.
Third method is obtaining prior consent to the operation of a
hospital formulary system is to express the policy tem in a
separate document & request that all physicians sing it.
The second & third methods have long been criticized on the
basis of their approach. Finally first method is accept by most to
adopt the system in hospital.
23. Admission & Deletion of Drug(s) in
Hospital Formulary
Following criteria are used to select a drug(s) for admission &
deletion from formulary –
First criteria is whether or not the local general & specialty stuff
consider the drug to be proven clinical vale.
Second may be that the BP, USP, NF or their supplements must
recognize the drug.
Third may be that the manufacturer of the drug must be of proven
integrity & dependability as well as having the reputation of initiating
& supporting research activities of merit.
Fourth criterion may be that no prescription of secret composition
will be considered or admitted to the formulary.
Fifth criterion may deal with products of multiple composition.
24. 2
4
• Therapeutic
• Economic
• Educational
• Rational drug use
Advantages of Hospital Formulary
Disadvantages of Hospital Formulary
• Deprive the physician of his right and privilege to prescribe
and obtain the brand of his choice.
• Permits the pharmacist to act as the sole judge of which brands
of drugs are to be purchased & dispensed.
25. Primary objectives:
a) Information on drug
b) Information on hospital policies & procedures
c) Special information about drugs
In accordance with these objectives, the formulary should consist of
three main parts:
a) Information on hospital policies &procedures concerning drugs.
b) Drug products listing
c) Special information
Content and Organization of Hospital Formulary
26. • Drug use
• Description of PTC
• Hospital regulations about prescribing, dispensing & administration of
drug, rules for Medical Reps, emergency drug products,
• Pharmacy operating procedures
• Information on using formulary
Content and Organization of Hospital Formulary
27. Formulary item entries:
Alphabetically by generic name
Alphabetically within therapeutic class
Type of information:
Dosage form, strength, packaging Active ingredients
Adult/pediatric dose
Route of administration Cost
Indexes to the drug products listing:
Generic name/brand name
Therapeutic /pharmacological index
Content and Organization of Hospital Formulary
28. • Equivalent dosages of similardrugs
• Hospital approved abbreviations
• Rules for calculating pediatricdosages
• L i s t of sugarfree drugs
• L i s t of dialyzablepoisons
• Metric conversion tables
• Poison control information
• Tab l e of druginteractions
Content and Organization of Hospital Formulary
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AJ
FORMULARY
• Listing of drugs by their
generic names followed by
information on strength, form,
posology, toxicology, use &
recommended quantity to be
dispensed.
• Prepared locally by its own
clinical staff.
• Information provided is subject
to local needs and desires.
DRUG LIST (e.g. I.N.F)
• Generic names followed by
data on strength & form.
• Prepared by country’s
outstanding clinicians,
pharmacologists and
pharmacists.
• According to their
pharmacological properties
Formulary Vs Drug List