All medications that are taken by the patients are considered as concomitant medications in clinical trials and they are critical for proper monitoring of patient safety and well-being. However, it is often a big challenge to collect full information on medications that the patients are taking. There are different reasons for this:
• Often over the counter medications are taken “as needed” and patients forget to mention them.
• Often patients do not realize that any herbal medications that they take should be mentioned as well to the clinical trials team. Just because these products are herbal does not mean that they cannot have drug interactions with the clinical trial medication.
• The fact that physician has prescribed medications does not mean that the patient is taking them.
• Patients who have condition affecting their memory may not be able to provide this information at all.
Patient remains the main source of information regarding concomitant medications. However, not all patients understand the importance of disclosing the medications they are taking or they are not able to do so.
What can clinical trials teams do to assure they have full history of concomitant medications?
1. Educate your patients about the clinical trial requirements – During the consent process the physician can explain to the patient the importance of disclosing all medications that the patient is on. Often in clinical trials there are prohibited medications, which could interact with the clinical trial drug(s) and increase the safety risks for the patient. By not providing this information, patients put themselves at risk and do not allow the physician to properly evaluate patient`s condition.
2. Discuss with relatives – Often family members are looking after the patient and they may have better information on the medications that patient is taking. It is important that relatives understand what medications should not be given to the patient and keep a track on current treatment medications.
3. Contact GP / Care assistant / Nurse – Often patients may not be able to provide information on their medications due to varies reasons like dementia, patient is confused, etc. In such cases clinical trial teams should approach GP or care assistant who is looking after the patient.
Using experimental drugs always have some potential risks so it is critical that patients are aware of these risks and do not use medications that could increase this risks or even threaten their life.
1 May 2014
Author: Olga Peycheva, Director at Solutions OP Ltd.
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.
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