Race in light-based drug validation heats up
By Gregory Roumeliotis
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15/03/2006 - In what is shaping up to be a new promising area in the verification of drugs, Analytical Spectral Devices (ASD) has received another patent for its RxSpec technology which uses near infrared spectroscopy (IR), as rival company CDEX is also targeting the market.
The two companies are the only ones in the US widely marketing spectroscopy systems for the validation of drugs and this week ASD filed a lawsuit in Colorado against CDEX, the maker of the ValiMed system, accusing it of patent infringement.
In-PharmaTechnologist.com contacted CDEX, which said it will soon issue a public statement on the issue.
ADS's RxSpec uses advanced analytical and imaging technology to examine the chemical composition and dosage of the drug using visible light and near IR spectroscopy, then compares that information to a database of FDA approved drugs to confirm that the drugs are the right ones and in quality compliance with the FDA.
The patent-pending technology of the ValiMed system also uses a light source to assess the dilution of a high alert medication, based on a library it has built, and validates the range in which the dose falls in in real time, although this is based on ultraviolet fluorescence and works on compounded solutions.
Irrespective of the outcome of the legal row, this kind of technology carries great potential, primarily because it does not alter the drug it inspects.
The main challenge that had to be overcome is making this kind of sophisticated application widely available commercially to pharmacists who are not experts on spectroscopy.
“There were proprietary mathematics and several technical issues that had to be resolved before our system was ready to be made available to the high volume mail order and central fill pharmacy markets,” ASD's CEO Dave Rzasa told In-PharmaTechnologist.com.
“The average salary for a pharmacist in the US is $75,000 (€62,000), so in a pharmacy that employs say ten people, there is great scope for savings with our technology.”
Apart from the financial aspect, excessive pharmacist workload at retail pharmacies is a major factor leading to a higher occurrence of prescription errors, according to a study published in the January 2005 issue of the journal Pharmacotherapy.
The study concluded that fatal medication errors rose by as much as 25 per cent at the start of each month due to beginning-of-the-month increases in purchases of medications, which result in heavier workloads for pharmacists.
In America, USP 797 and other regulations now require pharmacies to comply with guidelines almost as strict as those required of pharmaceutical manufacturers.
This includes standards in technique, training, and environmental concerns. Most relevantly, these new regulations require that compounded products be tested for accuracy and sterility.
Both RxSpec and Valimed are gaining acceptance within the US pharmacy industry - the Veterans Administration recently ordered RxSpec for use in its high volume consolidated mail outpatient pharmacies while Valimed is being used by some hospitals, the latest being All Children's Hospital in Florida, and the Henry Ford Hospital. |
