The Pharmacy
and Therapeutics Committee is an advisory group of the medical
staff which serves as the organizational line of communication
between the medical staff and pharmacy department. It is a policy
recommending body to the medical staff and the administration of the
hospital on matters related to drug use. This committee is composed
of physicians, pharmacists and other health professionals elected
with the guidance of the medical staff.
The
Purpose of Pharmacy and Therapeutics Committee
A.
Advisory
The
committee recommends the adoption of, or assists in the formulation
of, broad professional policies regarding evaluation, selection and
therapeutic use of drugs in hospitals.
B.
Educational
The
committee recommends or assists in the formulation of programs
assigned 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
and Operation of PTC
A. The PTC
should be composed of at least three physicians, a pharmacist and
representatives of the nursing staff. Committee members are appointed
by a governing unit or elected officials of the organized medical
staff. The hospital administrator or his/her representative should be
an ex – officio member of the committee.
B. A
chairman from among the three physician representatives should be
appointed. A pharmacist usually is designated as secretary.
C. The
committee should meet regularly at least six times per year, and when
necessary.
D. The
committee should invite to its meeting persons within or outside the
hospital who can contribute specialized or unique knowledge, skills
and judgments.
E. An agenda
and supplementary materials (including minutes of the previous
meeting ) should be prepared by the secretary and submitted to the
committee members in sufficient time before the meeting for them to
properly review the material.
F. Minutes
of the committee meetings should be prepared by the secretary and
maintained in the permanent records of the hospital.
G.
Recommendations of the committee shall be presented to the medical
staff or its appropriate committee for adoption or recommendation.
H. Liaison
with other hospital committee concerned with drug use (e.g. infection
control, medical audit) shall be maintained.
Functions
and Scope of PTC
A. To serve
in an evaluative, educational, and advisory capacity to the medical
staff and organiztional administration in all matters pertaining to
the use of drugs.
B. To
develop a formulary of drugs accepted for use in the organization and
provide for its constant revision.
C. To
establish programs and procedures that help ensure safe and effective
drug therapy.
D. To
establish programs and procedures that help ensure cost – effective
drug therapy.
E. To
establish or plan suitable educational programs for the
organization's professional staff on matters related to drug use.
F. To
participate in quality assurance activities related to distribution,
administration, and use of medications.
G. To
monitor and evaluate ADRs in the health – care setting and to make
appropriate recommendations to prevent their occurrence
H. To
initiate or direct (or both) drug use evaluation program and studies,
review the results of such activities, and make appropriate
recommendations to optimize drug use.
I. To advise
the pharmacy department in the implementation of effective drug
distribution and control procedures.
J. To
disseminate information on its actions and approved recommendations
to all organizational health – care staff.
Policies
of the Committee
A. Proposal
for a new drug for the hospital formulary shall be submitted on a
Formulary Request Form. Such request may be submitted by any member
of the medical staff. The Committee will evaluate the request and
notify the proposer as to acceptance or rejection. The proposer shall
have the opportunity to appeal the decision of the Committee.
B. Drugs
evaluated and approved by the Committee will be assigned to one of
the four categories:
- Formulary Drug- An FDA approved drug which is recommended as being essential for good patient care with a well established usage. Once accepted as a Formulary Drug, it may be prescribed by all members of the attending and house staff.
- Drug Approved on a Conditional Trial Period- A drug approved by the FDA for general use but which the Committee will evaluate for a 6 to 12 months period before final consideration. During that period, the drug may be prescribed by all members of the attending and house staff.
- Specialized Formulary Drug- An FDA approved drug which is recommended for use in specialized patient care. The drug may be placed in this category by the proposer or the Committee and either may designate those persons authorized to prescribed the Specialized Formulary Drug.
- Investigational Drugs- A drug which has been approved by the FDA for a special use by its principal investigator and designated associates. Such drugs are not commercially available. A protocol of the study must be submitted to the pharmacy if it is to be used in the hospital.
- The drugs is not necessarily a new chemical substance but may be:
- A. An old or approved drug proposed for a new use
- B. A new combination of 2 or more old drugs.
- C. A combination of old drugs in new proportions
- D. A new dosage form or method of administration.
C. Non
– Formulary Drugs are drugs which do not
qualify for the four categories listed and will not be stocked in the
pharmacy. If prescribed the Pharmacy will obtain and dispense a
limited quantity of the drug.
D. The
pre-signing of prescription blanks or drug orders for any purpose is
prohibited.
E. Formulary
system dictates that all drugs will be
dispensed on the basis of generic names. Authority for the routine
selection of the drug brands is delegated to the Pharmacy Department
utilizing a fair and equitable bid process, when necessary.
F. Drug
Recall may emanate from manufacturers,
regulatory agencies, or the Pharmacy Department, and may be of a
general nature or a specific recall for one or more lot numbers. Once
the recall notice is received, the drugs will be removed and
replaced; and this information will be sent to staff and pertinent
hospital departments.
G. In –
Patient Prescribing
- Routine Drug Orders – A physician's medication order written on in-patient order form is deemed a legal prescription. A legible copy of the medication order must be forwarded to the Pharmacy. Orders written by medical students must be counter-signed by a member of the medical staff. Quantities of drugs to be dispensed need not be specified since the pharmacist will determine the optimum amounts in keeping with greatest economy to the patients and efficiency in handling and storage by the nursing and pharmacy staff.
- IV Orders – Orders for intravenous medications must be written in the same manner as routine drugs and must include then following additional information:
- The exact quantity of the drug/s which must be added.
- The exact volume and name of the infusate solution.
- Specific directions for administration such as IV drip, IV bolus, IV push, etc.
- Specific times to hang infusate solution and drip rate.
- Specific directions for continuing or discontinuing any IV medications.
- Total Parenteral Nutrition (TPN)
- TPN has been designed to serve as a nutritional infusion providing essential amino acids, carbohydrates, and electrolytes for patients incapable of ingesting, digesting, or absorbing food substances given by mouth. Since a standard hyperalimentation solution always be prepared extemporaneously, the pharmacy department shall be responsible for the preparation of these solutions.
- Ordering
- The TPN mixture may only be prescribed by an authorized House Staff physician in conjunction with a Dietician through consultation.
- The written order must be sent to the Pharmacy for verification including the basic solution and all additives.
- Following the original order, subsequent orders must be confirmed every morning and recorded on a card designated for that specific patient.
- A 24 hour supply is to be ordered by the physician each morning.
- Only electrolytes and vitamins may be added to hyperalimentation solution
- Self-Medication – Only nitroglycerin and antacids may be left at the patient's bedside for self administration if so ordered by the physician. The quantity of nitroglycerin is limited to 10 tablets which must be counted by the nurse at the conclusion of each shift and charted in the patient's medical record. Antacids must be recorded and replenished in the same manner.
- Automatic Stop Orders – Applies to instances when the physician did not specify the exact number of doses or duration of therapy (open ended drug order). The automatic stop order policy serves as a protection against indiscriminate and indefinite open ended drug orders that can be harmful to the patient and at the same time ensures continuous therapy if so desired by the physician.
- Automatic Stop Orders requirements for medications are:
- A) 24 hours for controlled drugs
- B) 7 days for all other drugs
- PRN and standing orders for all medications except Controlled drugs expire at 10:00AM of the following Tuesday. All orders shall be renewed between the hours of 4:00PM Monday and 10:00AM Tuesday. Orders which are written on Monday become effective at 10:00AM Tuesday.
- A new medication order must be written by the physician if a change is wanted in route of administration or in dosage.
- Discharge Prescriptions – a separate prescription is required for each medication which the patient is to take home. Discharge prescriptions must be received in the Pharmacy prior to discharge, so that they may be processed and returned to the nursing station. Delays may result in the patient having to wait which is not consistent may result good patient care.
- Emergency (STAT) Orders – Bonafide emergency orders should be rare and in most cases obtained from the nursing station emergency drug supplies. When necessary, these orders should be transmitted in writing on the Pharmacy copy of the in-patient order form. This procedure prevents unnecessary delay and confusion which results from hurried verbal transmission orders. If it is necessary to phone the pharmacy for emergency drugs, calls should be placed either by the physician or the nurse in order to avoid delay and error.
- Emergency Kit or Stat Boxes – contains drugs and supplies which is readily available in case of emergencies. The medications and related accessories are standardized and approved by the medical staff through the Pharmacy and Therapeutics Committee.
The
Hospital Formulary
The
formulary and formularies have existed in the United States since the
days of the American Revolution; they existed in European hospitals
for centuries prior to this. The need for hospital formularies
becomes increasingly great because of: (1) the increasing number of
new drugs being marketed, (2) the increasing influence of biased
advertising and unscientific “scientific” drug literature, (3)
the increasing complexity of untoward effects of the newer more
potent drugs, (4) the highly competitive marketing practices of the
pharmaceutical industry; and (5) the public's interest in seeing that
the health professions are continuously providing the best possible
care at the lowest possible cost. In the interest of better patient
care, the institution should have a program of objective evaluation,
selection, and use of medicinal agents in the facility. This program
is the basics of appropriate, economical drug therapy. The formulary
concept is a method for providing such a program and has been
utilized as such for many years.
Definition
of Formulary and Formulary System
Formulary
System is a method whereby the medical staff of an institution,
working through the PTC evaluates, appraises and selects from among
the numerous available drug entities and drug products those that are
considered most useful in patient care. Only those so selected are
routinely available from the pharmacy. The formulary system is thus
an important tool for assuring the quality of drug use and
controlling its costs.
Formulary
is a continually revised compilation of pharmaceuticals (plus
important auxillary information) that reflects the current clinical
judgment of the medical staff.
Formulary
Content and Organization
The
primary objective of the formulary are to provide the hospital staff
with:
- Information on what drug products have been approved by the pharmacy and therapeutics committee.
- Basic therapeutic information about each approved item.
- Information on hospital policies and procedures governing the use of drugs.
- Special information about drugs such as drug dosing rules monograms, hospital approved abbreviations, etc.
In
accordance with these objectives, the formulary should consist of
three main parts:
PART I –
Information on hospital
policies and procedures concerning drugs
PART II –
Drug products listings
PART III
– Special Information
PART I:
Information of Hospital Policies and Procedures Concerning Drugs
The material
to be included in this section may vary from hospital to hospital.
Generally, the following items may be included: (1) Categories of
drugs, (2) Brief description of the PTC, (3) Hospital regulation
governing the prescribing, dispensing and administration of drugs,
(4) Pharmacy operating procedures, and (5) information on using the
formulary.
PART II:
Drug Product Listing:
This section
is the heart of the formulary and consists one or more descriptive
entries for each formulary item plus one or more indexes to
facilitate the use of the formulary. Formulary item entries are
entries that can be arranged in several ways: (1) alphabetically
generic name with entries for synonyms and brand names containing
only a “see generic name” notation, (2) alphabetically within the
therapeutic class, (3) a combination of the two systems whereby the
bulk of the drug are contained (alphabetically) in a “general”
section which is supplemented by several “special” sections such
as ophthalmic / otic drugs, dermatologicals and diagnostic agents.
PART III:
Special Information
Example of
items found in the special information section of hospital
formularies are: list of hospital-approved abbreviations, poison
antidote charts, etc.
Selection
of Guiding Principles for Admission or Deletion of Drugs
Criteria:
- Drugs must be of proven clinical value based upon experience.
- The drugs must be recognized by USP/NF or their supplement.
- The manufacturers of these drugs must be of proven integrity and dependability as well as having the regulation of initiating and supporting research activities of merits.
- No preparation of secret composition will be considered or admitted to the formulary.
- No product of multiple composition shall be admitted if the same therapeutic value can be obtained through the use of a single drug entity.
