Current drug delivery systems track and validate prescription drugs from manufacturer to retailer, thereby curtailing fraud. However, the industry also requires systems that validate the product at patient level to avoid drug misuse.
Drug counterfeiting and fraud within the pharmaceutical industry’s supply chain ranges from conservative estimates of $30bn to more than $50bn in annual losses to corporations, according to market studies by the WHO and the FDA. A report released in September 2005 by the Center for Medicines in the Public Interest projects counterfeit drug sales to reach $75bn by 2010.
In attempts to curb drug counterfeiting, the pharmaceutical industry, with the support of the FDA is developing a pedigree system that will track prescription drugs from manufacture to retail pharmacies using a variety of technologies including radio frequency identification. However, the envisioned systems end at the pharmacy. Drug delivery systems are needed that validate the pedigree of the drug at the device and patient levels – steps that could significantly curtail the use of counterfeit drugs and the misuse of correctly prescribed drugs.
Formulators also require improved nasal delivery devices that promote and support patient compliance. Traditional spray bottles, while convenient, lack advanced features such as dose counters and alarm reminders, which can improve patient acceptance and compliance.
Intelligent nasal delivery systems
Intelligent nasal drug delivery technologies can curtail the use of counterfeit drugs, decrease misuse of correctly prescribed drugs, and improve patient compliance. In choosing nasal drug delivery systems, formulators should consider the advantages of intelligent systems compared with traditional devices such as spray pumps.
Lock out counterfeits
Pedigree confirmation technology identifies or confirms specific drug information, such as product name, total number of doses in the prescription and expiration date by reading a coding technology placed on the drug packaging or unit dose ampoule. The attempted use of an unapproved or counterfeit drug renders the device inoperable.
Enhancing efficacy
Based on the drug type identified with pedigree confirmation, an intelligent nasal drug delivery device matches parameters such as droplet size, atomisation rate and cleaning frequency to the specific formulation. Aligning operational parameters of the device with the drug in real time results in optimal nasal cavity saturation and enhanced treatment efficacy.
Improve patient compliance
Dose reminders and information via an electronic display can be extremely effective in increasing patient compliance numbers. Intelligent nasal drug delivery devices can enhance patient compliance by:
- Setting specific dose time in minutes per day or number of doses per day
- Setting the total number of doses per prescription
- Sounding an alarm when a dose is required
- Sounding an alarm when cleaning is required
Monitor compliance
With intelligent drug delivery technology, information such as drug identification numbers, drug type, prescription order number, time/date of doses, total amount of drug delivered, and operating parameter records can be saved to a data storage card or downloaded to a PC or PDA. This information is useful for physicians, pharmacies and clinical trial coordinators.
Advanced nasal dispensing systems
Traditional nasal delivery devices such as spray pumps do not meet the pharmaceutical industry’s new requirements for pedigree confirmation, data transfer and improved patient acceptance. Formulators spending hundreds of millions of dollars to develop new compounds should consider intelligent nasal delivery systems to increase the odds of patient and physician acceptance, and thus commercial success.