Opportunities in pharmaceutical RFID and smart packaging

By Dr Peter Harrop, IDTechEx

RFID in healthcare is growing rapidly and is forecast to become a $2.1 billion global business by 2016. Smart packaging for healthcare has multiple applications, including recording patient use in drug trials, stock tracking, tamper recording, anti-counterfeiting, preventing medical errors, and child-resistant packaging.

Patient compliance

When two equally efficacious drugs enter the market, the one with better compliance by patients is likely to be more widely used as non-compliance is costly and risky. Medication non-compliance costs the US alone about $100 billion and 125,000 deaths yearly. It is responsible for 10% of hospital admissions — $31 billion yearly and 380,000 patients. It is responsible for 23% of nursing home admissions — $15 billion yearly and 3.5 million patients.

Non-compliance also costs the drug industry over $8 billion annually in unfilled new and refill prescriptions. This can be caused by patients being confused over the reason for the medication and not being fully convinced that their treatment is necessary.

Some patients not get their medication in the first case. If they do, then 30-50% is not taken correctly, according to MeadWestvaco. Many patients fail to get refills where prescribed and 28% of over 45 year olds admit to discontinuing the prescribed medication prematurely. Antidepressants are particularly bad in this respect. Drug companies have come to realize that spending heavily on creating new blockbuster drugs is risky and less and less cost-effective, whereas encouraging patients to take medication correctly benefits the patient, reduces load on physicians and hospitals and sell more of existing, non-contentious drugs.

One company, Aardex, has a plastic bottle of pills that is continuously weighed by a load cell in the base, thus recording when a pill is removed. These packages are used in drug trials and they incorporate RFID so that the record can be linked to the patient.

Widespread use will follow cost reduction by use of new finer electronic and electric inks such as the Parelec Parmod silver conducting ink used in litho, flexo and gravure printing. Indeed, even semiconducting and dielectric inks are being developed by Merck and some of these will be suitable for high-speed printing of replacement for the silicon chip in a talking or RFID laminate. The printed alternative is cheaper, more damage tolerant and thinner. Packaging companies Dai Nippon Printing and Mreal are among those developing printed electronics for packaging.

An example of a six-month drug trial involving smart blisterpacks is the National Institutes of Health trial of its antibiotic Azithromycin, using 30,000 smart packages that record which tablet was taken when. Fischer Clinical Services is carrying out the trial using smart blister packs from Information Mediary of Canada. Novartis is also carrying out a drug trial, in this case using smart blister packs from Cypak of Sweden, a company that uses packager MeadWestvaco for some of its marketing.

Compliance through packaging:

• assists the medical provider in explaining the optimal prescribed regime
• enrolls the patient as a participant in their own therapy
• simplifies medication administration for the patient
• provides interaction and prompting, reinforcement and cueing
• creates a permanent and continuous intervention that demands little involvement by the physician or pharmacist
• supports the brand message all the way to the medicine cabinet
• builds efficacy and integrity
• reduces medication errors
• reduces the development of antibiotic resistant bacteria.

The smart blister pack and plastic bottle reduce the amount of false data recorded in drug trials and eventually such packs will appear in the home, probable enhanced by self-adjusting electronic use-by dates (you overheated it for so long, therefore dispose of it at this earlier date) and electronic monitoring of degradation in storage and transport.

Tamper recording and supply chain efficiency

Sometimes printing — or at least partial printing — has been used to make packages that record when tampering is attempted or achieved. This permits investigators to calculate where, in the supply chain, attacks typically occur and arrests have been made using this technology. Cypak is a leader here, incorporating RFID. Indeed RFID, particularly at item level can help to tackle the recall of pharmaceuticals where well over 1000 recalls occur every year and they are less than perfect. The cost is significant, not just the safety aspect. For example the retail and pharmaceutical markets must absorb $2 billion yearly from return of outdated and overstocked products.

Anti-counterfeiting

The World Health Organisation estimates that counterfeit drugs cost the pharmaceutical industry $40 billion yearly. To combat this, RFID on each small package, with unique identification of that precise package ("mass serialization" under EPCglobal numbering and network) permits reverse audit, called "pedigree" by the pharmaceutical industry.

Pedigree, combined with sophisticated software, permits the origin and destination of even the smallest package to be known at all times. The Food and Drug Administration in the US is expected to legislate on this within the next year or so as the best frequency to use and other aspects are resolved.

Meanwhile, Pfizer, who will speak at the above conference, is RFID tagging at item level all Viagra for the US, GlaxoSmithKline is tagging Trizivir and AstraZeneca and others are rapidly following. Cardinal Health, TAGSYS and others have developed smart shelves in cabinets, refrigerators and trolleys that can read such tags for error prevention, automatic reordering and theft prevention. Wal-Mart has taken delivery of about three million tagged drugs at item level for improving automation of stocktaking and customer service and theft prevention in its pharmacies. Omron and Avery Dennison use gravure printing to create the antennas on these packages.

Talking packages

Another technology receiving the attention of the printing and packaging industry is the EnvisionAmerica system by which an RFID label under the regular label of patient information electronically records a duplicate of that information. A device held near then speaks out loud the information to assist the blind, partially sighted, illiterate, dyslexic and those shaking from an affliction or in a dark place when they need to read instructions. That is about one third of all patients, according to studies. Indeed, a study by City University in London even found that 25% of fully sighted consumers can not read or have difficulty reading instructions, the figure being 73% for partially sighted people.

The US Institute of Opthalmology reports that nearly 50% of people over the age of 65 develop one of three chronic eye diseases, the figure rising because of the ageing of the population. The EnvisionAmerica talking label system is now being rolled out across the USA following years of trials in the Chicago region.

Lithographic and other printing techniques will be used to print sensors, antennas and eventually the complete electronic circuits in these and other forms of smart packaging for pharmaceuticals, including packs that speak to give prompts and instructions. Meanwhile, for the small runs currently involved, screen printing usually suffices, with rotary screen printing sometimes in use as with antennas on ASK RFID labels.

Preventable medical errors

The US Institute of Medicine estimates that preventable medical errors in the US cost $17 billion yearly. A study in the UK National Health Service showed 10% of patients suffer an "adverse event".

While a report by the UK National Patient Safety Agency says, "No single technology can solve the NHS's unfortunate habit of giving patients treatments that were intended for other people, and NHS study has shown that unclear packaging and labelling is a contributory factor in 25% of reported medication errors." The demographic time bomb by which patients nurses and physicians are, on average, getting older, cannot help this situation.

The Aventura Hospital Group reports that 2% of administered doses in hospitals in the US are incorrect already. AstraZeneca has been a pioneer in using an electronic handshake based on an innovative form of "chipless" RFID for error prevention and recording procedures with Diprivan anaesthetic, over 30 million RFID enabled syringes having been delivered so far.

New solutions

Packaging that flashes light and even speaks when the patient should take the medication will help. So will packaging with large scrolling instructions in glowing images. Experimentally, we have electrically operated packages that lock, go rough (electroactive polymers) or go black when the contents have expired. There are already packages that call you back if you have taken one pill and should have taken two and one experimental pack shouts "not now" if you touch it at the wrong time. This may seem humorous to a healthy person but it is a lifesaver to the confused elderly and sick, who will increasingly have to self medicate as the population ages.

Child resistant packaging

Another aspect is child resistant packaging where smarter mechanical and electrical technologies are being explored for the packaging. The Child Accident Prevention Trust finds that 20% of under fives can open safety tops and the move to blisterpacks has made things much worse, with most babies penetrating them — they use their teeth.

Now that batteries can be printed on packages or at least applied as very low cost laminates, there is interest in electrical baby proofing technologies and "active" RFID where there is a battery in the tag to give longer range and manage sensors.

Indeed, talking packages and compliance monitoring packages all need batteries and the coin cells currently used are expensive and, with their spring contacts, unreliable compared to printed versions which also have the advantage of being thin and environmental as well. Thin Battery Technologies and Graphic Solutions are among the leading low-cost battery printers.

More information

For more information on RFID applications, attend RFID Smart Labels Europe, London 19-20 September www.smartlabelsEurope.com and read Electronic Smart Packaging www.idtechex.com

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