Policy Manual sample

MDT Home Health Care Agency, Inc. 216 USE OF INVESTIGATIONAL TREATMENTS/TRIALS POLICY: • MDT Home Health Care Agency, Inc. does not conduct drug investigational studies or allow Agency personnel to administer investigational drugs/treatments. • MDT Home Health Care Agency, Inc. will accommodate the patient’s participation in investigational drug treatments/trials as deemed appropriate. • Investigational drugs are those drugs which have not yet been released by the Federal Food and Drug Administration (FDA) for general use. Therefore, they include drugs bearing the following cautionary labeling “CAUTION New Drug – Limited by Federal Law to Investigational Use.” PROCEDURE: • In the event that a patient is accepted by MDT Home Health Care Agency, Inc. and is currently enrolled in a clinical drug trial, or the attending physician determines that the patient may benefit from use of an investigational drug or treatment, the physician: • Must submit a request with supporting documentation and investigational protocol to the Executive Director and MDT Home Health Care Agency, Inc. Board of Directors for approval • Must be approved by the FDA to administer the investigational drug • Must have an Investigational Drug Informed Consent form signed by the patient and a copy placed in the medical record • Must provide a copy of the protocol being followed and information about the drug, including all relevant policies and procedures to MDT Home Health Care Agency, Inc. ; a copy of this information is to be placed in the patient’s medical record. • The dispensing pharmacy, in conjunction with the Medical Director, shall develop all relevant policies and procedures for the handling, storing and distribution of any investigational drugs.