H-IPPE: Investigational Drug Service

For my first rotation for the month of May, I visited one of the different departments at the hospital.  The Investigational Drug Service (IDS) controls the distribution of all drugs related to clinical trials taking place throughout the hospital.  Not every hospital runs 200-400 clinical trials at the same time and often lack an IDS department.  The investigational drug service dispenses every drug related to clinical trials with the UNC system, including the hospital, Medicine, Dentistry, Pharmacy, Public Health, etc.  The drugs include some commercial products being tested for other indications, but also drugs from companies with just letter-number designations.  The third floor office takes care of the IV preparations of drugs.  We had Zithromax for C-section s and a few others.  They have to be very careful about storing the medications and keep detailed records about the temperatures of the refrigerator.  While I was there the electrician changed over the circuits for the wing, which shut down the refrigerators for 10-15 minutes.  They eyed the thermometers as the temperature approached 8 degrees C - the point that they would have to fill out special forms for each and every one of the drugs in the refrigerator.

My favorite part of the department is the use of placebos.  In more modern clinical trials, the traditional placebo is used less frequently. If a new drug needs to be tested, it must be compared to the current, accepted standard method of treatment. So the "placebo" group will receive the standard treatment, and the experimental group will receive both the standard treatment and the added treatment to be investigated. In most cases, a protocol exists and the new drug seeks to improve upon it. These standards change with new drugs every year. For instance, if Sovaldi becomes the standard treatment every ongoing clinical trial comparing the old protocol will become invalid. Most modern placebo experiments involve adding a drug to the current treatment. If a disease is treated with A+B, a clinical trial may determine if A+B+C works better. Double-blinding begins at the IDS office. In most trials, they enter the patient into a computer database that randomly assigns them to the new drug or placebo. In some trials, even the pharmacist does not know which group the patient belongs to. Other trials are "open label" and will indicated exactly what the treatment is on the drug label itself and all parties will know exactly what treatment is being administered. This method is implemented in trials that use a standard of care as a base treatment.

To protect the doctors and nurses doing the trials for themselves or for big pharmaceutical companies, the IDS controls the blinding process by randomly assigning the new drug or the placebo to the patient.  Often, only the pharmacists and technicians in IDS know whether they have given the drug or placebo.  When an order comes in, the request is put into a computer system that spits out the result of an algorithm to determine what the patient should receive.  Sometimes, the nurses are accidentally unblinded through the process.  In one instance, the trial was to determine the appropriate strength of drug - 10mg/mL vs 15 mg/mL.  However, the new computer system requires a strength to print the label to dispense the medication.  As soon as 15 mg/mL shows up on the label, everyone knows what group the patient belongs to - thus unblinding trial.  When I left for the month, they were attempting to enter zeros for the concentration.  I never learned of the resolution.   

The IDS could be a really interesting area, at the forefront of future medicine.  There is a ton of paper work with monitors coming every so often from the companies to make sure everything is documented correctly.  But they could be dispensing the trial drugs that are the next wave of pharmacy.  They performed several sofosbuvir trials that have have a lot of HIV and HCV researchers and clinicians excited.  If you appreciate the scientific method with blinds, placebos, and protocols, you would enjoy the IDS.