The document discusses hospital formularies, which are lists of approved medications used in hospitals. A pharmacy and therapeutics committee is responsible for developing and revising the formulary. This includes adding and removing drugs based on efficacy, safety, and cost. The formulary provides guidelines for procuring, prescribing, dispensing, and administering drugs in the hospital. It aims to promote rational and cost-effective drug use. Restrictions may be placed on certain drugs to ensure appropriate usage. Exceptions can be made for nonformulary drugs in special cases.
2. At its most basic level, a formulary is a list of medicines.
The hospital formulary is a continuously revised compilation of
pharmaceutical dosage agent and their forms etc. which
reflects the current clinical judgment of the medical staff.
3. National formulary of India
• NFI is not a regulatory document.
• NFI would serve as a guidance document to medical practitioners,
pharmacists, nurses, medical and pharmacy students, and other
healthcare professionals and stakeholders in healthcare system.
The Criteria for Inclusion of Drugs in NFI:
• Drugs in National List of Essential Medicines 2011, India.
• Drugs used in National Health Programmes.
• Drugs listed in Indian Pharmacopoeia.
• Drugs not covered but recommended by panel of experts.
• Any drug (s) considered appropriate by the IPC.
4. Physician Desk Reference
• The Physicians' Desk Reference (PDR) is a commercially published
compilation of manufacturers' prescribing information on prescription
drugs, updated annually.
• While designed to provide physician with the full legally mandated
information relevant to writing prescriptions (just as its name suggests), it
is widely available in libraries and bookstores, widely used by other
medical specialists, and sometimes valuable to the layman.
• The compilation is financially supported in part by pharmaceutical
manufacturing corporations which create drugs listed within its pages.
5. • The hospital formulary system is a method whereby the medical staff of a
hospital with the help of pharmacy and therapeutic committee , selects
and evaluates medicinal agents and their dosage forms which are
considered to be most useful in the patient care. it provides information
for
• Procuring,
• Prescribing,
• Dispensing And
• administration of drugs under brand names where the drug have both
names.
6. The formulary process is critical to good health care and consists of
developing and implementing:
• a formulary list (essential medicines list) consisting of the most cost-
effective, safe, locally available drugs of assured quality that will satisfy
the health care needs of the majority ofthe patients
• a formulary manual containing summary information on medicines
• standard treatment guidelines containing essential information on how to
manage common diseases.
7. The formulary list (essential
medicines list)
• Essential medicines are those that satisfy the priority health care needs of
the population.
• They are selected with due regard to disease prevalence, evidence of
efficacy, safety and comparative cost-effectiveness. Essential medicines are
intended to be available within the context of functioning health systems at
all times in adequate amounts, in the appropriate dosage forms, with
assured quality and adequate information, and at a price the individual and
the community can afford.
• The implementation of the concept of essential medicines is intended to be
flexible and adaptable to many different situations; exactly which
medicines are regarded as essential remains a national responsibility
8. WHO model list of essential drug list
• The core list presents a list of minimum medicine needs for a basic
health‐care system, listing the most efficacious, safe and cost–effective
medicines for priority conditions. Priority conditions are selected on
thebasis of current and estimated future public health relevance, and
potential for safe and cost‐effective treatment.
• The complementary list presents essential medicines for priority
diseases, for which specialized diagnostic or monitoring facilities, and/or
specialist medical care, and/or specialist training are needed. In case of
doubt medicines may also be listed as complementary on the basis of
consistent higher costs or less attractive costeffectiveness in a variety of
settings.
10. Appropriate selection of drugs can achieve the following results:
Cost containment and enhanced equity in access to essential medicines: Procuring
fewer items in larger quantities results in more price competition and economies of
scale with regard to quality assurance, procurement, storage and distribution. Such
economies can lead to improved drug availability at lower costs, so benefiting those
who are in most need.
Improved quality of care: Patients will be treated with fewer but more cost-
effective
medicines for which information can be better provided and prescribers better trained.
Prescribers gain more experience with fewer drugs and recognize drug interactions and
adverse reactions better. Quality of care will be further improved if medicine selection
is based on evidence-based treatment guidelines.
11. Guidelines in preparing HF
a) The governing body of the hospital shall appoint a pharmacy and
therapeutic committee composed of physician and pharmacist which will
prepare the hospital formulary system.
b) The medical staff in the governing body shall sponsor and outline the
purpose,organisation function and scope of the hospital formulary system.
it should adopt the principle as per the need of particular hospital.
c) The pharmacy and therapeutic committee shall develop policy and
procedure governing the hospital formulary and the medical staff shall
adopt these policies and procedures subject to administrative approval
d) The policy and procedures shall afford guidance in the appraisal ,
selection,procurment,storage,distribution,use,safety procedures and other
matter relating to drug in the hospital and shall be published in the
hospital’s formulary or other media available to the member of medical
staff.
12. e) To ensure the maintenance of the responsibility and procreative of the
physician in the exercise of his professional judgment.
f) The medical staff shall adopt the policy formula, and procedure for
including drugs in the formulary by their non proprietary names even
though proprietary names even though proprietary names continue to being
use in the hospital physicians. he may be encouraged to prescribe drug
under their non proprietary names, although nomenclature used in entirely
a matter of individual practisner’s discretion.
g) In the absence of written policies approved by the medical staff related to
the operation
h) the hospital shall make it certain that the nursing personnel are informed in
writing though its system of news of communication that there exits the
formulary system in the hospital and the procedure governing its
operations.
13. i) in the formulation of policies and procedure the term substitute or
substitution should be avoid since these term have been used to
imply the unauthorized dispensing of entire different drug,nither of
which takes place under a properly operated hospital formulary
system.
J) it shall be made known to the medical staff about the changes in
the working in the hospital formulary system or in the content of
the hospital system.
K) provision shall be made for the appraisal of the member of the
medical staff for the use of the drug not include in the formulary or
the investigational drugs.
L) the pharmacist with the advice and guidance of the pharmacy and
therapeutic committee ,shall ascertain the quantity and source of
supply of all drugs,chemical,biological and pharmaceutical
preparation used for diagnosis and treatment of patient.
M)the labeling of drug and medicine container with non proprietary
name of the content always should be proper. The use of
proprietary name other than that describing the actual content is
not correct and proper if it is used in a manner that can be taken as
description of the content.
14. A typical formulary have this
composition:
1.Title page
2.Names and titles of the members of the PTC
3.Table of contents
4.Information on hospital policies and procedures concerning drugs
a.Objectives and operation of the formulary system.
b.Hospital regulations and procedures for prescribing and dispensing
drugs
c.Hospital pharmacy services and procedures.
d.Directions on how to use the formulary
15. 5.Products accepted for use at the hospital
a.Items added, deleted and requested for inclusion to PNDF consistent
with therevision made by the NDF.
b.Pharmacologic/ Therapeutic indexes.
c. Description of FD products by pharmacologic/ therapeutic class
6. Appendix
a. Rules for calculating pediatric doses
b. Schedule of standard administration times
c.Forms of addition to/ deletion from formulary and other important
form
16.
17.
18. PREPRATION OF FORMULARY
• Preparation of a hospital formulary is a principal responsibility of the
pharmacy and therapeutic committee. How ever it is also rests primarily
on the chief pharmacist service etc.
• The committee is free to make necessary decisions, regarding the material
to be included in the formulary and pharmacist undertaken the
production of the formulary that is compiling and printing etc.
• Irrespective of the decision arrived at in respect of above. it will be
necessary to formulate a series of rules of guidelines which the committee
may to evaluate drugs for admission to the formulary or the list of drugs.
• If it is decided that the publication is to be a formulary, a decision must be
reached as to the possible contents other than the section on various
therapeutic agents.
i) section on prescription writing.
II)section governing the use of drug.
III) Section on diagnostic reagent and normal pathological investigational
reagent etc.
19. IV)section on pharmaceutical classification etc which are good guidelines for
pharmacist and nurses.
V) poision and their antidote.
VI) posological tablet.
VII) other useful data and feature e.g. tablet of metric weight and measure
and their equivalent of apothecary” and household measures, calculation
and dosages for various age group especially of children.
VIII) it should also be decided at the outset, as what short of format should
the formulary adopt and how should be its-
a)size
b)printed or cyclostyled
C)whether lose leaf or bound, the advantage of the former are that
addiction and deletion of pages of various section or main body of
the drug list are possible.
20. Formulary Additions
• The assessment of new medicines is critical to managing a formulary list, which
involves adding new medicines and deleting old ones. Drugs should be evaluated
and compared on the basis of:
• efficacy, comparative efficacy
• effectiveness, comparative effectiveness
• safety, comparative safety
• cost of use
• quality.
Efficacy, effectiveness and safety can be evaluated from a critical assessment of the
literature.
• A request for inclusion of a drug in the hospital formulary shall be made by
submitting a Formulary Addition Request along with supporting literature and a
signed disclosure of dual interest to the Pharmacy and Therapeutics (P&T
Committee).
• The committee will make one of the following decisions regarding the request:
approval (with or without restriction)
denial
deferment (until pertinent information becomes available)
21. Deletion of a Drug
• Suggestions for deletion of drugs from the formulary may be submitted to
the P&T Committee by any member of the medical, pharmacy, or nursing
staff.
• In order to control growth of the hospital formulary, some additions will
balanced by deletions of another drug.
• P & T committie shall periodically review its stocks and various therapeutic
classes on an ongoing basis to effect deletion of duplicate drugs whose
usage is low or those which can readily be replaced by less costly but
equally
22. Generic Substitution
• The formulary system which admits a drug
under the nonproprietary name implies
permitted substitution of chemically and
pharmacologically equivalent products
(generics).
23. Restricted Drugs
• In order to promote and ensure rational use of drugs, P&T
Committee approves specific usage criteria that must be met prior
to dispensing certain drugs. These drugs are referred to as
“priveleged drugs” in the formulary and the prescribing bounded by
one of the following types:
• by indications
• by specialty
• by a group of patients
• by protocol or guidelines
• It is the responsibility of the physician to ensure that all specific
criteria are met before prescribing the drug.
• The pharmacist, upon receiving an order for a use priveleged drug,
shall review and may call the physician for verification of the usage
criteria before dispensing.
24. Nonformulary Drugs
Drugs which are not currently approved by the P&T Committee for
use at hospitals are termed as nonformulary.
Only those drugs which are listed in the formulary of the will be
stocked in the pharmacy and accordingly prescribed by the medical
staff.
However, in special clinical situations an attending physician may
request procurement of a specific drug if, in his opinion:
• none of the currently available formulary products meet the
therapeutic needs of the patient
• all acceptable therapeutic alternatives listed in the formulary
have been tried and failed v
• the nonformulary product is superior to the available
alternatives
25. Procedure for Requesting a
Nonformulary Drug
1. supporting literature to his/her Section Head or Department Chair for
approval. on ce signed, the Form and literature are sent to the Head of
Pharmacy for approval.
2. The Head of Pharmacy may consult experts within the hospital orthe P&T
Committee Chair for their opinion of the request.
3. If the Head of Pharmacy approves the request, he will then arrange
procurement of the medication. The time required to make this drug
available depends on its local availability.
4. A nonformulary drug is only to be used by the requesting physician for a
single patient and is not intended for use by the general staff for the
general patient population. Proper documentation of use will be
maintained by the pharmacy.
5. The requesting physician is required to complete a Form followup letter
describing the treatment outcome with the nonformulary drug.
6. A summary of all nonformulary drug requests will be presented periodically
to the Pharmacy and Therapeutics Committee for review.
26.
27. Rational drug use
• The rational use of drugs requires that patients receive medications
appropriate to their clinical needs, in doses that meet their own individual
requirements for an adequate period of time, and at the lowest cost to
them and their community.
• correct drug
• appropriate indication
• appropriate drug considering efficacy, safety, suitability for the patient,
and cost
• appropriate dosage, administration, duration
• no contraindications
• correct dispensing, including appropriate information for patients
• patient adherence to treatment