Prescribing unlicensed medicines to sick patients, who have exhausted all other viable options, can be an effective life-saving treatment option. However, physicians may be wary of using such a procedure as unlicensed medicines are either not officially approved, or are not officially approved for use by a particular subgroup or for treating a particular condition.

However, if a physician is careful to abide by certain guidelines, he/she can avoid any legal or ethical problems, and can be confident in their decision to prescribe an unlicensed medicine.


First of all, a physician must be sure that there are no licensed options available that would successfully meet a patient’s needs. There must be sufficient evidence available to support a physician’s decision to reject licensed options in favor of an unlicensed option. This evidence must also demonstrate that the medication is suitable in terms of safety and efficacy. If a physician is unsure about this, in any way, he/she should contact a suitable advisory before prescribing the medication.


A physician must then relay this information to the patient, or the family if the patient is a minor, in a comprehensive and thorough manner so that the patient/family is sufficiently informed. The patient/family must know why an unlicensed medication is being used, what the known side effects are, and must be alerted to the fact that there are potential unknown risks involved as well. The physician must also educate the patient/family on any funding issues that might arise, as insurance companies, often, refuse to cover unlicensed medicines.

Take Responsibility

Once the patient has agreed to receive the unlicensed medication, the physician must be sure to take complete responsibility for prescribing the medication. He/she must be the one to oversee the patient’s care and monitor the progress. He/she must also make clear and legible records of what medication is being used, in what dosage, and how often, etc. These records must include reasons for prescribing an unlicensed treatment and must be readily available to any governing health body at any time.