The problem of clinical trials involving patient-determined dosing is widely recognized. If data obtained in clinical trials where patients take medication once or twice a day are known to be inaccurate, it follows that data from patients taking medication intermittently over longer intervals will be even less accurate.

The researcher studying such medications is generally reliant upon the patient recording the date and time of self-medication.

Are patients likely to remember record the date and time they took the tablet? Probably not. It should come as no surprise that very little is known about how patients self-administer such medications, and that at least two medication categories – opiate analgesics and hypnotic sedatives widely abused by patients.

Medication non-compliance causes:

• $100B annual U. health care system costs
• Over 100,000 patient deaths
• Over 1 million hospital admissions
• Antibiotic resistance
• Erroneous efficacy data from clinical trial studies