The
PTC is a group of persons which formulate policies regarding therapeutic use of
drugs. This committee is composed of physicians, pharmacists & other health
professionals with the inclusion of the medical staff. It serves as the
communication line between the medical staff & pharmacy department. Other
names are Pharmacy Committee, Formulary Committee, Therapeutic committee & PTC.
Purposes
of Pharmacy and therapeutic committee (PTC):
The primary purposes of the P&T committee are
1. Policy Development. The committee formulates policies regarding
evaluation, selection, and therapeutic use of drugs and related devices.
2. Education. The committee recommends or assists in the formulation
of programs designed to meet the needs of the professional staff (physicians,
nurses, pharmacists, and other health-care practitioners) for complete current knowledge
on matters related to drugs and drug use.
Organization /Membership of Pharmacy and therapeutic
committee (PTC):
The PTC should be composed of
►at least 3 physicians,
► a pharmacist,
►a nurse, and
►administrator.
Committee members are appointed by governing unit or elected
medical staff. A representative of physicians will act as chairman of committee
& Pharmacist will be considered as secretary of the committee. The size of
the committee may vary depending on the scope of services provided by the
organization. They should meet regularly, at least six times per year, and more
often when necessary.
Functions and Scope of Pharmacy and therapeutic committee
(PTC):
The following list of committee
functions is offered as a guide:
1. To serve as an advisory council to
medical staff & hospital administration in all matters related to the use
of drugs.
2. To study problems related to the
distribution and administration of medications.
3. To make recommendations concerning
drugs to be stocked in Wards & Emergency.
4. To develop & compile a formulary
of drugs and prescriptions accepted for use in various hospitals. The items are
selected on their therapeutic use, safety, cost etc.
5. To establish programs and procedures
that help ensure safe and effective drug therapy and cost-effective drug
therapy
6. To establish or plan suitable
educational programs for the organization’s professional staff on matters
related to drug use.
7. To participate in quality-assurance
activities related to distribution, administration, and use of medications.
8. To monitor and evaluate adverse drug
(including, but not limited to, biologics and vaccines) reactions in the health-care
setting and to make appropriate recommendations to prevent their occurrence.
9. To initiate or direct (or both) drug
use evaluation programs and studies, review the results of such activities, and
make appropriate recommendations to optimize drug use.
10. To advise the pharmacy department in
the implementation of effective drug distribution and control procedures.
11. To disseminate information on its
actions and approved recommendations to all organizational health-care staff.
12. The committee recommends written
policies &procedures for selection, procurement, storage, distribution
& use of drugs.
Role of pharmacy and therapeutics committee (PTC) in drug
safety
•Drug safety is the moral, legal and professional obligation
of pharmacist in western countries.
•It includes responsibility from dispensing of drugs to drug
administration.
•Following guidelines may subserve the committee in
ascertaining the adequate safety factor of hospital pharmacy:
- The hospital must employ a qualified, atleast, a registered pharmacist with atleast B.Pharm degree as ‘Chief Pharmacist’ and the rest are may be atleast Diploma holders in pharmacist.
- Should not permit non‐pharmacist personnel to dispense drugs and allied materials.
- Must employ a sufficient members of qualified considering the work load of a pharmacist and allow for adequate coverage (7days/week).
- Must provide adequate safe, work space, and storage facilities.
- Should have equipment necessary to safely and adequately carry out the modern practice of pharmacy.
- Must have an automatic stop order regulation for dangerous drugs. e.g: narcotics, anticoagulants etc.
- Should have a drug formulary which periodically revised and kept up to date.
- The poisonous materials are separated from non‐poisonous materials in the pharmacy.
- The external used preparations should be separated from internal used medications.
- Must have adequate quality control measures and follow good manufacturing practices.
- Should provide a teaching programme to teach students, nurses the basic course of pharmaceutical mathematics and pharmacology.
- Should be periodically inspected in order to remove deteriorated and outdated drugs as well as to check all labels for legibility.
- Should have an adequate reference library which contains texts on pharmacology, toxicology, posology, and journals containing information on newer developments in the pharmaceutical world.
Hospital Formulary
Hospital formulary is a continually revised compilation of pharmaceuticals
that reflects the clinical judgment of the medical staff.
Hospital formulary system is a method where the medical staff
working through the P&T committee, evaluates, appraises, and selects from
the numerous available drug products those considered most useful in patient
care. The selection is made on the basis of its toxicity, untoward reactions,
quality, efficacy & bioequivalence.
Guiding Principles to Hospital Formulary System
Following principles
serves as guidelines for physicians, pharmacist and administrator in the
hospital for their professional judgment.
1) The medical staff shall
appoint a multidisciplinary PTC and outline its purposes, organization,
function & scope.
(2) The formulary system
shall be sponsored by the medical staff based upon the recommendations of the
PTC) .the medical staff shall adopt written policies and procedures governing
the formulary system as developed by
the PTC.
(4) Drugs should be
included in the formulary by their nonproprietary names. Prescribers should be
strongly encouraged to prescribe drugs by their nonproprietary names.
(5) Limited no. of drug
product should be included in the formulary for the consideration of financial
benefits .For this purpose generic equivalents and therapeutic equivalent should be considered .The
institution must assure that its medical and nursing staffs are informed about
the existence of the formulary system, the governing procedures, its operation
and any changes in those procedures.
(7) Provision shall be
made for the appraisal and use of drugs not included in the formulary.
(8) The pharmacist shall
be responsible for specifications as quality, quantity and source of supply of
all drugs, chemicals, biologicals and pharmaceuticals.
Legal Basis of Hospital
Formulary System
A written or signed
prescription or a written and signed medication order is the only legal permit
to dispense or administer a prescription legend drug.
If the physician use
chemical or generic name of the drug, the pharmacist may dispense the brand in
his professional judgment. Problems usually arise when prescribers continues to
use the propriety name for the drug desired. To avoid such situations hospitals
should devise many
Ways--
1) One common method is
the use of a suitably worded imprint on the prescription form. For example,
“Generic Equivalent Permitted” or “Dispensed in accord with the hospital
formulary system”.
(2) The 2nd
method is obtaining the prior medical consent to the operation of a hospital
formulary system. In this case the physician is bound to accept the rules and
regulations of hospital formulary system.
(3) The 3rd
method is to obtain the medical consent to the operation of hospital formulary
in a separate documents and all physicians are requested to sign it.
Principles for Admission
or Deletion of Drugs/ (Revision of Formulary) Inclusion or exclusion of a new
drug in the formulary is a very complex process. The PTC frames certain
policies and procedure for inclusion and deletion of drugs. The criteria
followed for inclusion / deletion are as follows—
► The 1st criteria to be established is
whether or not the local general and specialty staff consider the drug to be of
proven clinical value based upon their experience with it. The 2nd may be that the drug must
be recognized by the USP/ NF or supplements.
► The 3rd may be the manufacturer of the
drug product must have proven integrity & dependability as well as having
the reputation of initiating and supportive research activities of merit.
► The 4th criteria may be that no
preparation of secret composition will be considered or admitted to the
formulary.
► The 5th may be that the single agent may
replace the combination therapy.
During revision of
formulary cost effectiveness or cost benefit analysis methods are often used.
Formulary needs to be
revised annually because addition, deletion, changes in the products, removal
of drugs from the market, changes in hospital policies & procedure.
After each revision the
supplement sheets could be attached to the back cover of formulary books. The 2nd
way is to use different color in each edition.
Purchasing agents are
agents who responsible for buying supplies, products, materials and services at
the lowest possible price while maintaining a high level of quality. Purchasing
agents must be skilled in assessing current market conditions as they directly
affect supply and demand for services and products.
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