HHC Health & Home Care Clinical Policy And

HHC HEALTH & HOME CARE Section: 8-12
Medications: Safe Administration of Investigational / New Therapies __RN
PURPOSE:
To provide accurate and safe administration of
investigational/new therapies.
CONSIDERATIONS:
1. Investigational medications may be administered
upon the order of a physician in accordance with
state and federal regulations.
2. An investigational/new therapy is defined as:
a. A therapy that is investigational.
b. A therapy that is non-routine or of questionable
safety for the patient.
c. A therapy that the pharmacist indicates is one
that requires compounding and one whose
stability is not documented in a Standard
Operating Procedure (SOP).
d. The therapy involves the use of an approved
drug for a non-approved indication.
e. The therapy involves an unusual dosage.
f. Whenever the pharmacist or nurse has a
question about the appropriateness of the
therapy, monitoring plan or plan or treatment.
3. The drug must be approved by the FDA for
investigational use in humans. The pharmacist and
nurse must have as much information as possible to
adequately assess the referral. The clinicians
administering the drug(s) should know the principal
investigator responsible for each drug. Information
should include:
a. Patient birth date
b. Patient weight
c. Patient height
d. Body surface area
e. Diagnosis
f. Medical history
g. Medication history
h. Allergies
i. Prescription details
j. Projected length of therapy
k. Method of administration
l. Treatment goals
m. Monitoring plan
n. Prior patient experience with the therapy
o. Physician experience with the therapy
p. Home support
q. Applicable investigational protocol or supporting
literature citation
4. A pharmacist should be identified as a resource for
clinical information regarding the therapy.
5. A copy of the investigational drug protocol will be
kept on file with the patient file and/or pharmacy file.
6. All drugs, drug containers or prepared doses should
be marked investigational.
7. The patient and/or legal guardian have given
consent to the use of an investigational therapy and
have met all the elements of informed consent.
8. Use at least two (2) patient identifiers prior to
administering medications.
PROCEDURE:
1. The referral is screened by the Admission
Department once it is determined to be
investigational.
2. Any further clarification should be directed to the
managing physician.
3. Specific clinical treatment questions should be
discussed with the Clinical Manager prior to
accepting the referral.
4. Once the referral is accepted, a copy of the
clinical/investigational protocol should be obtained
prior to patient admission to be filed in the patient’s
chart.
5. Upon admission to the agency, the nurse should
verify the following:
a. The patient/legal guardian has given written
consent to any investigational therapies.
b. All investigational therapies.
6. Any untoward side effects or adverse reactions are
reported immediately to the primary care physician.
AFTER CARE:
1. Document in patient’s record:
a. Investigational therapy utilized.
b. Instructions given to patient/caregiver regarding
the investigational therapy.
c. Patient’s response to the instruction.
d. If actual administration of the drug occurred, the
patient’s response, side effects and
management.
e. Communication with physician
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