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Complementary and Alternative Medication (CAM)
Complementary and Alternative Medication (CAM) 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 CAMs are used in a manner that minimizes potential harm to the participant. Allowing the use of CAMs should not be construed as an endorsement of their use by the Pharmacy and Therapeutics Committee. Participants 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, participants 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 participant 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. For more information see the policy: Pharmacy Department: Patient’s Own Medication Supply.
Drug Used in a Clinical Investigation (DUCI)
A Drug Used in a Clinical Investigation (DUCI) is defined by the Pharmacy and 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, the FDA-approved indications. For more information, see the policy: Organization Policy on Drug Use and Control in Clinical Investigations (Policy No. 103.19(a)).
Problem/Event Reporting Requirements
The JHM IRB responsibilities include initial review of human subject research studies and continuing review after approval. The 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 to others). Some of these risks are anticipated and are described in the protocol and the consent form.
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 Investigational New Drug (IND) application before starting a research study. Depending on the type of study, investigators can go to the FDA Center for Drug Evaluation and Research, Pre-IND Consultation Contacts chart to determine the specific person at the FDA who can guide them.
For more information see the guidance: Investigator Inquiry to the FDA about the Need for an Investigational New Drug (IND)Application.
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.
Submission of Investigator Brochures to the JHM IRBs
Research protocols developed by industry often involve development and testing of INDs. The proposal developed by an industry sponsor to test an investigational agent will include a protocol and an Investigator's Brochure. For more information, see the guidance: Submission of Investigator Brochures to the JHM IRBs
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. For more information, see the guidance: Pharmacy and Investigational Drug Service (IDS) at The Johns Hopkins Hospital.
Pharmacy Services: Bayview Campus
The Pharmacy Service for Clinical Investigations (PSCI) provides support to investigators on the JHM Bayview Campus through the Main Hospital Pharmacy. An additional pharmacy satellite is planned to open in the JHAAC in 2004. For more information, see the guidance: Pharmacy Services: Bayview Campus.