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Restricted Drugs and Non Formulary

Certain drugs require special criteria to be met before being prescribed due to their restricted nature. These "privileged" drugs have criteria for indications, specialty, patient group, or guidelines that physicians must ensure are followed before prescribing. Pharmacists will verify the criteria are met before dispensing. Non-formulary drugs not approved for the hospital may only be requested by physicians in special cases, with approval from department heads, and are intended for single patients, not general use. A process is defined for requesting and procuring non-formulary drugs. Investigational drugs are only used under a principal investigator per an approved research protocol, with signed patient consent.
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0% found this document useful (0 votes)
575 views2 pages

Restricted Drugs and Non Formulary

Certain drugs require special criteria to be met before being prescribed due to their restricted nature. These "privileged" drugs have criteria for indications, specialty, patient group, or guidelines that physicians must ensure are followed before prescribing. Pharmacists will verify the criteria are met before dispensing. Non-formulary drugs not approved for the hospital may only be requested by physicians in special cases, with approval from department heads, and are intended for single patients, not general use. A process is defined for requesting and procuring non-formulary drugs. Investigational drugs are only used under a principal investigator per an approved research protocol, with signed patient consent.
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Restricted Drugs

In order to promote and ensure rational use of drugs, D&T Committee approves specific
usage criteria that must be met prior to dispensing certain drugs. These drugs are referred to as
privileged 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 privileged drug, shall
review and may call the physician for verification of the usage criteria before dispensing.

Non Formulary Drugs

Drugs which are not currently approved by the D&T Committee for use at hospitals are
termed as non-formulary. 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:
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
The non-formulary product is superior to the available alternatives

Procedure for Requesting a Non Formulary Drug

Section Head or Department Chair for approval on signed, the Form


and literature are sent to the Head of Pharmacy for approval

The Head of Pharmacy may consult experts within the hospital


or the D&T Committee Chair for their opinion of the request.

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.
A non-formulary 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.

The requesting physician is required to complete a Form follow


up letter describing the treatment outcome with the non-
formulary drug.

A summary of all non-formulary drug requests will be


presented periodically to the Drug and Therapeutics
Committee for review.

Investigational Drugs

An investigational drug is defined as an agent, the use of which has not been approved
on a commercial basis by a regulatory body in the Philippines. The Clinical Research Committee,
reviews protocols involving drug use in patients. The Investigational Drug Services Section of
Pharmacy Services shall act as the center for procurement, storage, and distribution of
investigational drugs and will provide information regarding their preparation and use.

An investigational drug shall only be used under the direct supervision of the principal
investigator, who shall be a member of the medical staff and who shall assume responsibility for
securing the necessary consent from the patient(s) and/or the patient(s) family members,
monitoring the therapeutic and adverse side effects of the drug and informing the patient(s) and
patient(s) family members beforehand of the possible risks and benefits of the drug therapy. The
principal investigator alone is responsible for signing the appropriate release forms, if any, for
obtaining the investigational drug from the manufacturer.

Signed consent forms must be placed in the patients chart. Pharmacy will dispense the
drug and maintain pertinent records upon receipt of the physicians order, assuming that a
signed patient consent form has been placed in the patients chart.

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