June 2004 1. | CAM - Complementary & Alternative Medication is defined at Hopkins as a product that contains a vitamin, mineral, herb, botanical, amino acid, or dietary substance and is intended for treatment of a medical condition. |
It is the policy of The Johns Hopkins Hospital to assure that complementary and alternative medications (CAMs) are used in a manner that minimizes potential harm to the patient. Allowing the use of CAMs should not be construed as an endorsement of their use by the Pharmacy and Therapeutics Committee. Patients may take CAMs only after an authorized prescriber has written an order for the CAM. Orders must contain all elements required of standard medication orders.
When possible, patients should continue to use their own supply of CAMs to minimize pharmacologic variation that might be caused by changing the source of the CAM. Given that no definitive means of identifying CAMs is available, CAMs supplied by the patient will only be permitted if they are in the manufacturer’s labeled original container or in a labeled pharmacy prescription container.
The pharmacy department will supply CAMs only if they have been added to the Hospital ’s drug formulary or when the CAMs are part of a JHM-IRB-approved research protocol. More...
2. | DUCI-Drug Use and Control in Clinical Investigations |
A DUCI is defined by the Pharmacy & Therapeutics Committee as any drug, biological, botanical or other substance used specifically for a clinical investigation as described in the investigational protocol. Such drugs shall be either commercially available or not commercially available and used according to, or outside of, FDA-approved indications. More...
3. | Problem/Event Reporting Requirements |
The JHM IRB responsibilities include initial review of human subject research studies, and continuing review after approval. This continuing review responsibility includes reviewing reports of adverse events, unanticipated problems, protocol deviations and other risks. The risks may involve physical, emotional, financial, social, psychological, or legal harm to the participant (or on occasion to others). Some of these risks are anticipated and are described in the protocol and the consent form. More...
4. | Investigator Inquiry About the Need for an Investigational New Drug (IND) Application |
In 2002, the FDA established an office to answer questions from investigators regarding when to submit an IND application before starting a research study. More...
To ask the FDA whether you need an IND for a clinical trial, send the written request to:
Food and Drug Administration,
Division of Drug Information, HFD-240,
5600 Fishers Lane, Rockville, MD 20857.
Fax number:301-827-4577
E-mail address:druginfo@cder.fda.gov.
Contact at the FDA: Barry Poole at 301-827-4570.
5. Literature Search An adequate and comprehensive literature search for drug safety shall be defined as one that produces sufficient information for the investigator and the Institutional Review Board (IRB) to determine if the drug is sufficiently safe for use in the subjects of the study.
6. | Submission of Investigator Brochures to the JHM IRBs |
Research protocols developed by industry often involve development and testing of Investigational New Drugs (INDs). The proposal developed by an industry sponsor to test an investigational agent will include a protocol and an Investigator's Brochure. More...
7. | Pharmacy and Investigational Drug Service (IDS) at The Johns Hopkins Hospital |
Research at The Johns Hopkins Hospital is supported by three main research pharmacies within the Department of Pharmacy. More...
8. | Pharmacy Services: Bayview Campus |
The Pharmacy Service for Clinical Investigations (PSCI) provides support to investigators on the Bayview Campus through the Main Hospital Pharmacy. An additional pharmacy satellite is planned to open in the JHAAC in 2004. More...
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