Florida firm uses RFID to bolster patient safety and the integrity of drugs in the pharmaceutical supply chain.
By Larry Maloney
Contributing Editor
It’s a frightening statistic: roughly 98,000 deaths
occur in hospitals annually as a result of preventable medical error, according
to an Institute of Medicine Report. Many of these deaths are caused by adverse
events due to medication errors.
Still more patients who have chronic illnesses, such as asthma or hypertension,
do not take their prescribed drugs as scheduled for fear of side effects or long-term
adverse reactions. The problems this undermedication causes lead the patients to
go back for additional medical treatment when they inevitably become ill again.
Conversely, patients who overmedicate due to forgetfulness can have immediate
and severe adverse physical reactions.
To help mitigate these problems–which cost patients, healthcare organizations,
pharmaceutical companies, pharmacies, physicians, and insurance companies billions
of dollars annually–innovative drug delivery systems that leverage the power
of RFID are being developed within the packaging realm to track and trace drugs
through the supply chain, as well as afford the real-time monitoring of patient
compliance at home, in hospitals, and nursing homes.
One such innovative solution is being developed by DDMS (Drug Delivery
Management System) Holdings, LLC, Ponte Vedra Beach, Fla.
Tracking the individual pill
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DDMS Holdings, Mark Niemiec |
Mark Niemiec, president of DDMS Holdings, conceptualized his
solution, which marries RFID technology and blister packaging, in 1999. According
to Niemiec–an industrial
engineer who had previously worked for General Foods, Campbell’s Soup, and
several other global consumer products companies–the DDMS solution goes beyond
individual package tagging, and affords the tracking, tracing, and monitoring of
the individual pill, once packaged, at any point throughout the supply chain.
“DDMS technology places the RFID chip and antenna right onto the blister package,” Niemiec
explains. A grid of circuitry connected to the chip is positioned over the area
where the foil will rupture when a pill is removed. When the foil is ruptured,
a circuit is broken, which provides a defined event that can be sensed by the
RFID chip.
Niemiec states that either fixed or handheld RFID readers
can monitor the integrity of the pill throughout the supply chain. “At each transactional point in the
distribution system, the drug can be monitored to determine if drug integrity has
been maintained, or whether it has been tampered with, removed, or adulterated,” he
says.
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When the foil is ruptured on a DDMS blister pack, a circuit
is broken and a defined event sensed by the RFID chip. |
DDMS technology also offers the option to include environmental sensors that can
monitor heat, light, or moisture during the life cycle of the drug. Sensors can continuously
monitor these important factors by making the RFID tag active with the addition of
a printable battery.
Measuring the value DDMS’s capability of providing pill-level data enhances
current RFID technology that solely tracks pallets, cases, and individual packages
of product to distributors, wholesalers, and retailers.
Says Niemiec, DDMS provides information on whether the individual pill has
been removed, tampered with, replaced, expired, or has been exposed to
environmental conditions rendering the drug harmful or ineffective. This data can
be accessible to all supply-chain partners through the use of the Internet or other
dedicated computer networks. These robust track-and-trace features create a formidable
anti-counterfeiting system by providing visibility throughout the supply
chain, Niemiec states.
 DDMS’s use of RFID tags provides drug integrity capabilities that other, more
antiquated methods such as barcodes, cannot offer, continues Niemiec. “RFID
tags aren’t limited to unidirectional information,” he asserts. “The
tag can be remotely queried to communicate and monitor information regarding temperature,
heat, and light.” This data then can be recorded within an enterprise
resource planning software system to ensure the quick processing of unacceptable
products.
Niemiec says that this capability also allows for the recall
of unacceptable products due to expiration, or because of the drugs’ exposure
to environmental conditions that may have altered their efficacy or safety.
Helping to ensure patient compliance But a high-quality advanced pharmaceutical is only helpful to a patient
if it is taken as directed by a physician.
DDMS addresses this issue as well, as the technology enables the
real-time monitoring of the administration of medication, whether
it be a patient in a:
- hospital/nursing home, which, though a more controlled environment, is not
immune to drug compliance problems and human error;
- clinical trial, in which participants are provided with a supply of drugs
and a set of instructions as to when to take their medication. Currently, there
is very little that can be done to verify that the participant followed the instructions;
or
- self-dosing a prescribed drug at home, the least regulated and by far the
most prevalent area for drug non-compliance. A 2003 study by the World Health
Organization determined that only 50% of participating patients complied with
their doctors’ instructions for taking their medications. Non-compliance
was more prevalent in patients who take drugs for chronic illnesses such as
depression, high blood pressure, and acute asthma. Here, patients cited fear
of long-term side effects as the main reason for non-compliance.
The patented DDMS solution incorporates the use of a blister package with a grid
of circuitry, an RFID tag, and wireless information transceiver. Says Niemiec,
when the healthcare provider or the patient gains access to the unit-dose of
medication by puncturing the breakable wall associated with the given cell, the
computer chip senses the breaking of a circuit.
Sending out signals “A radio-frequency transmitter is coupled to the computer chip,” he explains. “This
antenna then sends information to an RFID-enabled, battery-powered mobile information
transceiver, such as a cell phone or PDA, indicating that a circuit is broken
and that a pill has been removed.”
The mobile transceiver collects the information for the caregiver
and patient to read. “The transceiver then sends the data to a local LAN or Web site, where
the information can be accessed by the stakeholders in the health and well being
of the patient, like the doctor and family members,” Niemiec states.
Far-reaching potential Niemiec believes pharmaceutical companies using DDMS technology
will improve both the quality of the data collected in clinical trials, as well
as the efficiency with which it is collected. “This, in turn, will lead to lower costs associated
with FDA clinical trials,” he says.
Coupled with DDMS’s potential to reduce mistakes made
in hospitals and other healthcare institutions, improving the way patients take
their drugs as prescribed, and hopefully helping to enable a corresponding decrease
in healthcare costs in general, DDMS technology offers far-reaching benefits.
With three established U.S. patents and several pending,
Niemiec’s group is
in the process of putting development partners together to implement the DDMS technology. “We
see DDMS painting the RFID canvas with a broad stroke so that it will have an impact
on the greatest number of people and applications,” he states. “We don’t
want to put a lot of restrictions in the path. We will do everything
we can to make it ubiquitous.”
DDMS Holdings can be reached at (904) 543-1945 or manpkg@aol.com.
Drug Distribution in the U.S.: The Quest for Integrity
Consumers have come to expect that drugs purchased at a licensed
pharmacy in the U.S. are safe if used as directed. Today, however, there are
serious issues such as drug diversion, counterfeiting, and importation that
are eroding the reliability of the U.S. drug-distribution system, and jeopardizing
public safety.
In the traditional “closed” U.S. pharmaceutical supply chain–which,
until the 1990s, was considered by many as the gold standard for product safety–the
FDA approved drugs and strictly controlled the importation of pharmaceuticals
from other countries. Here, the pharmaceutical manufacturer formulates FDA-approved
drugs, and packages them in-house or at a contract packager. The drugs then
are shipped from the pharmaceutical manufacturer to a distributor in large
quantities. At the distributor, the drugs are separated into smaller quantities
or shipped in bulk to the retail location (pharmacy). The pharmacy then dispenses
the prescribed amount of the drug to the consumer.
The U.S. drug-distribution market is changing, however. Several factors
pushed our closed system open, thereby jeopardizing the U.S. drug-distribution
system and the American public, according to a recent report by M. Shepherd
in Managed Care magazine. Pharmaceutical product integrity has become a major
concern, as the majority of pharmaceuticals imported into the U.S. are not
FDA-approved, says Shepherd.
Further, the high price of drugs and the variation in price across countries
has motivated unscrupulous counterfeiters to partake in illegal importation
and drug diversion (the illegal removal or the reintroduction of a pharmaceutical
product from an authorized drug distributor).
As such, the FDA and Healthcare Distribution Management Association (HDMA)
are recommending that all pharmaceutical drugs be individually RFID/EPC
tagged by 2007 to improve drug integrity and safety (FDA Final Report,
2004).
To implement the FDA and HDMA recommendation, RFID readers will be required
at the pharmaceutical manufacturer, wholesaler, and retailer to allow
for the tracking of drug products through the supply chain. This will
vastly improve the ability to determine when drugs are diverted and re-imported.
It also provides some protection against counterfeiting. |
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