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What is Compassionate Use?

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  • Written By: Mary McMahon
  • Edited By: O. Wallace
  • Last Modified Date: 29 August 2016
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In the medical community, when a drug which has not yet been approved for use is given to a terminally ill patient who has no other treatment alternatives, this is known as compassionate use. The idea behind compassionate use is that the patient may die before the drug is approved, and if it has a chance of saving the patient's life, it outweighs the potential risks. Many nations have compassionate use programs, reflecting the desire of patients with illnesses like cancer and AIDS to access drugs which could treat their conditions.

There are several different ways in which compassionate use can be organized. As a general rule, compassionate use is permitted in the late stages of drug testing, after basic tests have been used to confirm that the drug is not deadly or completely useless. This does not mean that the drug is harmless, however, as there may be serious side effects which have not yet been uncovered in the testing process, and the dosage level of the drug is also usually not known, because it is still in the testing phase.

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Some nations have what is known as an Expanded Access Program (EAP) or treatment Investigational New Drugs (treatment IND). Drug companies can enroll in these programs so that patients who are not allowed in clinical trials can access the company's medication. In an EAP or treatment IND program, doctors apply on behalf of their patients, and if the patients meet the requirements, they will be allowed access to the drugs. Some nations require drug companies to provide treatments for free or at low cost in EAP/IND programs.

In other instances, a drug company may indicate that it is willing to give patients access to its drugs under a compassionate use program, but it does not have a formally organized Expanded Access Program. In these instances, doctors apply to the regulatory agency which is responsible for approving the drug for sale, and the patient's case is reviewed by an official who decides whether or not to grant a compassionate use request. The turnaround process in these cases can be less than 24 hours in the case of urgent applications.

Sometimes, a doctor recommends a compassionate use application to a patient, suggesting that a new medication might be helpful. In other instances, patients approach their doctors to discuss compassionate use after learning about a new drug release. If the patient and doctor agree, the doctor is responsible for submitting the application and distributing the medication. If the drugs are not provided for free, patients should be aware that insurance companies do not usually cover compassionate use.

Compassionate use is certainly an option to consider for people who have exhausted all other treatment options. However, patients should be aware that it can be very dangerous, and drug companies usually insist on a liability waiver before providing drugs for compassionate use, making it clear that patients take the medication at their own risk. Compassionate use should be discussed with a doctor and with loved ones before any decisions are made.

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