August 18, 2006

RxSpec ensures prescription safety, accuracy

BOULDER – Pharmaceutical errors cause at least one death every day and injure approximately 1.3 million people annually in the United States, according to PharmaceuticalDrugLitigation.com.

To help prevent such mistakes in the dispensing of prescription pharmaceuticals Boulder-based Analytical Spectral Devices Inc. created RxSpec drug verification system.

The innovative product has earned a 2006 IQ Award for medical and health products and services.

Sometimes the error is the result of counterfeit drugs being slipped into the system, and sometimes it’s just an oversight. About one-tenth of all prescription drugs on the market today are counterfeit, according to the World Health Organization, and that number is expected to double by 2010.

In 2002 a 16-year-old boy in New York received prescription medication to boost his red blood cell count after a liver transplant. When his health continued to deteriorate, it was discovered that the medication he received was a fake pharmaceutical with a label indicating it was the real thing.

In 2001 a pharmacist in Kansas made the news because he was accused of under-medicating cancer patients. The pharmacist later admitted to intentionally tampering with the prescriptions.

“I brought that article in to our management team and asked if they thought we could have prevented this,´ said Dave Rzasa, president and chief executive of Analytical Spectral Devices. “Two months later we were in front of Wal-Mart’s vice president of pharmacies, and they were interested in what we had to offer.”

The technology initially was used for remote sensing needs. Its instrumentation – portable spectrometers and spectrometers – enables researchers to measure and verify materials in terms of radiance, irradiance, reflectance and transmission. Company principles realized that same technology could be used to help prevent drug errors, and they created the patented product: the RxSpec drug verification system.  RxSpec brings to the prescription medicine industry what airport screening systems bring to security: a look inside.

In a pharmacy, RxSpec is used to examine drugs directly in the dispensing vials and to confirm that the correct drug and dosage are being dispensed.  With advanced analytical and imaging technology, the system reads the chemical composition and dosage of a drug and then compares the information with a drug identification library.  

It then can confirm quality compliance with FDA drugs. The method compares to ASD’s other instruments in that it uses light to reflect off samples to be able to decipher chemical properties.

The patented system is the only product in the marketplace that confirms the composition of prescription medications in pill and tablet form. The first commercial RxSpec system was sold in November 2004. About 62,000 retail pharmacies in the U.S. and Canada are potential customers, according to Rzasa.

Hospital pharmacies are on the list of potential clients as well. “Counterfeit drugs are becoming a worldwide problem, and the FDA is doing a lot in regard to it,” Rzasa said.  “It’s more prevalent in places like China and India, but it is still substantial in the U.S. Counterfeit may mean a placebo or a lower dosage of the right drug,” he added.

“The other issue is errors and the time constraints of pharmacists,” he explained.  “There’s a shortage of pharmacists in the U.S., and the current system of making sure the right drug is in the vial turns pharmacists into line checkers.”

The current system actually relies on visual inspection of vials – a method that does nothing to confirm the chemical composition of drugs. Rzasa points out that some drugs vary only slightly in size, making visual inspection even less effective as a backup check.

“Our hope is to free up pharmacists by automating the job of checking to make sure drug dosages and chemical compositions are correct,” he said.

ASD maintains a strategic alliance with McKesson, the largest pharmaceutical distributor in North America.  McKesson sells the RxSpec system.

Cost of the system varies according to the market. Retail pharmacies can purchase systems in the $5,000 to $10,000 range.  Certain models jump up to the $50,000 to $100,000 range.  High-volume pharmacies look at models with the latter capacity.

The Department of Veteran’s Affairs Consolidated Mail Outpatient Pharmacies fills about 35,000 prescriptions daily. Being used by the VA puts RxSpec one step closer to full acceptance by the pharmacy industry, according to Rzasa.

ASD is a privately held company that has been around since 1990. The self-funded venture employs 42 individuals and brings in annual revenue in excess of $2 million.

“If you get 45 people together and ask them how many have ever had a mistake made on the prescription drug or how many know someone who has, one or two people will always raise their hand,” Rzasa said.  “Bar codes on bottles can be checked, but they don’t say anything about what’s inside.”

Analytical Spectral Devices Inc.

5335 Sterling Drive, Suite A, Boulder, CO 80301

303-444-6522

www.asdi.com

Dave Rzasa, president and CEO

Employees: 42

Primary service: Manufactures precision instruments for remote sensing

Founded: 1990

BOULDER – Pharmaceutical errors cause at least one death every day and injure approximately 1.3 million people annually in the United States, according to PharmaceuticalDrugLitigation.com.

To help prevent such mistakes in the dispensing of prescription pharmaceuticals Boulder-based Analytical Spectral Devices Inc. created RxSpec drug verification system.

The innovative product has earned a 2006 IQ Award for medical and health products and services.

Sometimes the error is the result of counterfeit drugs being slipped into the system, and sometimes it’s just an oversight. About one-tenth of all prescription drugs on the market today are counterfeit, according to the World Health Organization, and that number…

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