Hospital Formulary-Lecture Notes
Formulary
Formulary is a continually revised compilation of pharmaceuticals and some
important ancillary information that reflects the current clinical judgement of
medical staff.
Formulary System
The 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. Drugs listed in the formulary are routinely available in
the hospital
The hospital formulary system provides the information for procuring,
prescribing, dispensing and administration of drugs under nonproprietary or
proprietary names where drugs have both names. The formulary system is thus
an important tool for assuring the quality of drug use and controlling its cost.
Need for Hospital Formulary
The increasing number of new drugs manufactured and marketed by drug
companies.
Increasing complexity of untoward effects of modern potent drugs.
Newer sales promotion strategies of pharmaceutical industry.
The public interest in getting possible health care at lowest possible cost
Objectives of Hospital Formulary
The primary objectives of a formulary are to provide the hospital staff with:
• Essential information about the drugs approved by the PTC
• Update knowledge/hospital guidelines and procedures governing use of
drugs
• Avoid unnecessary use of medicines in the hospital during treatment
• Reduce cost burden on the patient
• Prevent duplication and wastage of drugs in hospitals
• Facilitate the pharmacist in procurement of new drugs
Benefits of Formulary System
All aspects of drug management, including procurement, storage, distribution and
use are easier if fewer items must be dealt with:
a) Cost containment and enhanced equity in access to essential medicines
Procuring fewer items in large quantities results in more 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.
b) 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 drug reactions better. Quality of care will be further improved if medicine
selection is based on evidence based treatment guidelines
Formulary is made so precise that it is made handy for use by medical staff and
nurses
Demerits of Formulary System
The hospital formulary system deprives the physician of the right and
prerogative to prescribing and obtained the brand of his choice.
The system may sometimes permit the pharmacist to act as the sole judge
to which the brands of the drugs to be purchased and dispensed.
Criteria in Medicine Selection
Selection of drugs depends on many factors, such as the pattern of prevalent
diseases, the treatment facilities, the training and experience of available
personnel, the financial resources, and genetic, demographic and environmental
factors. WHO (1999) has developed the following selection criteria:
• Only those medicines should be selected for which sound and adequate
data on efficacy and safety are available from clinical studies, and for which
evidence of performance in general use in a variety of medical settings has
been obtained.
• Each selected medicine must be available in a form in which adequate
quality, including bioavailability, can be assured; its stability under the
anticipated conditions of storage and use must be established.
• When two or more medicines appear to be similar in the above respects,
the choice between them should be made on the basis of a careful
evaluation of their relative efficacy, safety, quality, price and availability.
• In cost comparison between medicines, the cost of the total treatment, and
not only the unit cost of the medicine, must be considered.
• In some cases, the choice may also be influenced by other factors, such as
pharmacokinetic properties, or by local considerations such as the
availability of facilities for storage or manufacture.
• Most essential medicines should be formulated as single compounds. Fixed-
ratio combination products are acceptable only when the dosage of each
ingredient meets the requirements of a defined population and when the
combination has a proven advantage over single compounds administered
separately in therapeutic effect, safety or compliance.
• Drugs are specified by the international non-proprietary name (INN) or
generic name without reference to brand names or specific manufacturers.
Contents and Organization of Hospital Formulary
Following are the contents of hospital formulary approved by the PTC:
1. Information about drug product
• Main and important part of the formulary and contains contents of each
drug monograph.
• The drug monograph consists of following subheadings such as non-
proprietary name of drug, synonyms, available brands and cost,
reconstitution and administration, dosage forms, indications,
contraindications, precautions, dose, pregnancy risk factors, adverse effects
and interactions.
2. Information on Hospital Policies
3. Pharmacy Operating Procedures
Hours of service, outpatient prescription policies, pharmacy charging system,
inpatient drug distribution procedures, and pharmacy education
programs/pharmacy bulletins.
4. Special Information
Formulary also provides information regarding list of nutritional products,
equivalent dosage of similar drugs, table of drug interactions and adverse drug
reaction reports, list of abbreviations, and poison control information.
Formulary Vs Drug Catalogue or list
Preparation of Hospital Formulary
Identify the most common diseases being treated in the hospital by consulting all
medical departments. For each disease, an appropriate first choice of treatment
should be identified using standard treatment guidelines. An expert committee
can be brought together to identify the appropriate treatment for each of the
common health problems. The alternative method is reviewing the WHO model
list of essential medicines may also be used as a starting point. The capability of
the hospital and its staff to handle specific drugs should not be forgotten during
the selection process.
A draft of the list must be prepared and must be given to each department to
comment on the list. The Pharmacy and Therapeutics Committee must deliberate
on their comments and provide feedback. All information should be discussed
with evidence based reviews where possible.
After the preparation of final list, monographs for each drug should be prepared
and it should contain unbiased information.
Managing a Hospital Formulary (Adding or Deleting drugs)
For a new medicine to be added into the hospital formulary, PTC should consider
the therapeutic equivalency to existing drugs in terms of efficacy, safety, or
convenience of dosing/administration.
For the addition and deletion of drugs the total cost for a course of treatment
with new medicine should be compared with the already listed medicines.
Pruning of Formulary
When a new medicine is added to the list for reasons of improved efficacy, safety
or lower price, serious consideration should be given to delete the medicine
which was previously on the formulary list for the same indication, for two
reasons:
• If the 'new' medicine is better, why continue to have a less good 'old'
medicine on the list?
• If no effort is made to consider deleting medicines, none will be deleted
and the list will grow in size.
Maintaining a Formulary
New drugs and treatments are emerging all the time, and without evaluation the
formulary may become a collection of older, less effective drugs. The formulary
should be reviewed every 2–3 years.
This can be done by evaluating all the formulary medicines within each
therapeutic class in a systematic way on a regular basis and comparing them to
other new non-formulary medicines within that class.
In order to efficiently maintain a formulary, a PTC should meet regularly to discuss
and decide upon:
Requests for the addition of new medicines and deletion of old medicines.
Systematic review of a therapeutic class of medicines.
Review of programs to identify and resolve medicine use problems.
All decisions of the PTC should be documented.
Improving adherence to a Formulary
The existence of a well-maintained formulary does not mean that prescribers will
adhere to it. Methods to promote formulary adherence include the following:
• Reviewing and taking action on all non-formulary medicine use; action may
include adding the medicine to the formulary, educating the prescriber
about the non-formulary status of the medicines or banning use of the
medicine within the hospital.
• Prohibiting the use of non-formulary drug samples in the hospital.
• Establishing procedures and approve drug product lists for therapeutic
interchange or substitution.
• Providing easy access to the formulary list, with copies at each drug
ordering location and in pocket manuals for staff.
• Involving medical staff in all formulary decisions.
• Advertising and promoting all formulary changes.
• Establishing agreed procedures for clinical trials with non-formulary
medicines.
Formulary Manual
The formulary manual is the publication that brings all the important summary
information on medicines in the formulary list together in a manual. There is no
set standard on how this document is arranged or what is in the manual.
Normally it would contain an alphabetically and therapeutically arranged listing of
all the formulary drugs, and a section on drug usage including doses,
contraindications, side-effects, drug interactions and price.
Ideally the manual should include a section on the medicines of choice and
alternates for treating the medical conditions of the region.
Role of Pharmacist
Pharmacist in the PTC has a key role in developing policies and procedures
governing the hospital formulary. The chief pharmacist has the primary
responsibility for the preparation of hospital formulary.
Pharmacist with the advice and guidance of PTC shall ascertain the quantity and
source of supply of all drugs, chemicals, biological and pharmaceutical
preparations used for the diagnosis, and treatment of patients.
Pharmacist should ensure that quality of drugs is not compromised by economic
considerations.
