Pharmaceutical packaging can play a vital role in promoting medication adherence, which in turn has a dramatic effect on healthcare. But while many ingenious tools exist, they are still not widely used. Walter Berghahn, executive director of the Healthcare Compliance Packaging Council, explains why our current packaging conventions are in desperate need of an overhaul.
Poor medication adherence is a significant healthcare problem for the world. Hundreds of billions of dollars, euros, yen and so on are spent developing, manufacturing and delivering pharmaceuticals, only to have the benefits of these products dramatically curtailed by poor medication adherence. The impact on healthcare caused by poor adherence is broad and far-reaching both in dollar and human terms. Problematic patients play a part, but the industry, having been well aware of this problem for decades, has generated few solutions to effect change, even though tools are available from many sources.
One underused ally in this fight is compliance-prompting or reminder packaging. These packages feature graphics and text aimed at prompting the patient to take medications on time and hopefully to educate them about their condition and the importance of adherence. Compliance-prompting features can include calendar features or secondary components motivating the patient to take their dose on time. There are a variety of secondary containers that range from two-piece injection-moulded containers, such as MWV’s Shellpak, to the multipiece SBS paperboard wallets produced by many manufacturers. The latter offer more space for messaging that will stay with the product throughout patient use.
In their best form, calendar features are employed that not only remind the patient to take their dose but also serve as a visual record of doses taken, which can help prevent accidental overdosing in elderly patients, for example, while clarifying to caregivers what has been taken. Several forms have been adopted by Walmart for use in its pharmacies on a significant scale.
A $290-billion problem
Packaging is probably the last component considered when discussing how pharmaceuticals affect healthcare. And yet, primary packaging, whether manufacturer or pharmacy-based, is the only component other than the drug itself that reaches each and every patient. Unlike cartons and leaflets, which may not survive the pharmacy, and well-intended advice, which travels in one ear and out the other, primary packaging will reach the patient and is capable of communicating critical information about the drug, the regimen and the condition being treated.
If all this sounds foreign to you, you are not alone. All of these possibilities exist, but they are only realised in a small percentage of packages in the US and global supply chain. Wonderful tools exist but they are grossly underused.
According to a white paper published by the New England Healthcare Institute in 2009, poor medication adherence is estimated to cost the US healthcare system a staggering $290 billion a year. Considering that pharmaceuticals represent about 10% of the US healthcare spend, or $320 billion a year, the existing system of producing and delivering medication has an error cost almost equal to the gross income from product sales. $320 billion in gross income plus $290 billion in error correction means a total cost of $610 billion to the US healthcare system.
Much of the blame lies in the antiquated delivery and dispensing system that eliminates the manufacturer’s container and introduces all manner of risk to the products being distributed.
The basic function of the pharmaceutical industry is to develop drugs that help defeat or control diseases, but the current system of administering drugs in the US fails the patient more than 50% of the time. Effects of poor adherence include unnecessary disease progression, disease complications requiring additional treatment or hospitalisation, reduced functional abilities, loss of work time, need for professional care or long-term care (nursing homes), lower quality of life, increased healthcare costs, additional prescriptions to combat complications, and even premature death.
Loss of control
The underlying problem is that, in the US market, as in most global markets, there is a dramatic disconnect between the manufacturer of the drug, the prescriber, the dispenser, the payer and the user. This can be summarised as follows:
1. Manufacturers know their products aren’t used properly but they lose control in today’s system once products leave their loading docks.
2. Physicians know their patients don’t take their medication as directed but they lose control once they hand a prescription to the patient. A full third of prescriptions in the US are never filled.
3. Pharmacists lose control once the patient redeems their prescription (for the 66.66% that do get filled) and declines the offer to consult on the drug and its use.
4. Pharmacists know customers don’t get refills on time, if at all. The drop-off rate for refills is staggering. Some pharmacy chains have started auto-refills in an attempt to increase medication adherence (they refer to it as the medication possession ratio) and this practice may help already-adherent patients refill in a more timely manner, but whether the practice improves adherence and outcomes is another question.
5. Patients for the most part don’t understand the value of adherence nor do they appreciate the impact of missed doses, especially for conditions with no overt symptoms.
6. Health insurers know that poor adherence costs in excess of $300 billion a year in the related events outlined above, but have been reluctant to do much about it because, well, there’s a good chance that next year, that patient will belong to someone else. Why spend the money and effort? Sadly, this attitude is not unusual under the current system (although Medicare Part D five-star ratings should help change this).
Communication is key
Packaging technology has evolved dramatically in the last 50 years, affecting almost everything we buy and bring into our homes. And yet, these dramatic developments, for the most part, missed the trip into the world of solid-dose pharmaceuticals. Consider the technological developments around inhalable drugs, transdermals and self-injected products, which even allow for dose adjustment by the patient. These all represent forms of product package interaction that facilitate proper administration by the end user. Solid-dose drugs are primarily packaged the way they were in the 1950s and the results are terrible.
Now, to be clear, drugs do benefit millions of patients, but the impact of non-adherence tarnishes that benefit significantly. Consider the following: healthcare costs continue to hit all-time highs, with patient non-compliance a significant contributing factor. Poor adherence causes an estimated 125,000 deaths annually and accounts for 10-25% of hospital and nursing home admissions. This makes non-compliance one of the largest concerns facing the healthcare system and managed care.
Then, if we overlay the related costs of treating prominent chronic conditions properly (see table opposite), we find that the poor management of outcomes for these conditions represents a large portion of the $290 billion lost each year (three out of four healthcare dollars are spent on chronic conditions) and these results are achieved under a system that repacks pharmaceuticals received from the manufacturer’s bulk container and delivers products to patients in containers with minimal labelling, no dosing reminders, no condition education and limited instructions.
At the heart of the problem is a lack of communication with the patient about the condition being treated, what the medication is doing, what they might feel while the medication is working, and the importance of adherence to the regimen.
These critical messages should be front and centre on the packages that reach the consumer, not buried in the fine print on leaflets that are seldom read. Dosing reminders and a visual record of doses taken should be readily visible. This is why compliance-prompting packaging is such an important tool in this fight to improve adherence, influence health outcomes and save lives. The status quo is unacceptable. Our system of packaging and delivering solid-dose pharmaceuticals is in desperate need of a paradigm shift.
Blister benefits
One study, conducted in 2004-05 by Ohio State University, US, provided an example of the improved performance that is possible when compliance packaging is used. The study compared bottled Prinivil (lisinopril) with blister-packed wallets that contained a calendar reminder and a visual reminder of refill needs. Of those patients receiving blister packs, 48% saw improved blood pressure over the term of the study, while fewer than 20% of the control group using bottles saw any improvement. This means that 80% of those patients receiving Prinivil standard bottles saw no improvement in blood pressure during the study. The study group using the blister wallet also had a 14% improved refill rate.
The blister pack is often used as compliance packaging as it provides protection from mechanical and environmental hazards that bottles and vials cannot. A recent study demonstrated the ability of PVC/Aclar blisters to maintain product integrity better than any other package form. By their nature, blisters add to supply chain security, since special machines are involved in their production. This is not to say that blisters are immune to counterfeiting; but, when blister compliance packs are used in combination with serialisation, they present a robust barrier against counterfeiting and diversion, which the bottle cannot replicate.
In the US, when manufacturers’ containers are opened in pharmacy or central-fill facilities, all the security that brought that product to that point in the supply chain is lost. History has shown us that counterfeit, diverted, outdated and returned products can still find their way into the supply chain, as legislation focuses on serialisation and the primary container. Compliance-prompting blister packages will pass through the pharmacy to the consumer in the original serialised container, eliminating that risk.
Each attempt at providing medication adherence support falls into one of these categories:
- Passive tools: simple graphics or text represent an attempt to get the consumer’s attention.
- Active tools: inclusion of basic lights, buzzers and timers; no proof yet that these work.
- Interactive tools: features that require action from the consumer. An active response is required to verify that the prompt was at least seen or heard.
- Verifiable use: the holy grail of compliance packaging is verifiable use; we know the dose was taken.
When you combine the needs to improve medication adherence, to protect the product until patient use, and to secure the package through the pharmacy, the case for compliance-prompting packaging becomes clear. What is illogical is continuing with the current situation; whether to change is not the question, but how quickly to do so.
As daunting as the task may seem, it is not insurmountable, and should be addressed like any large task: one step at a time, starting with medication for the most costly chronic conditions. As the healthcare community begins to see improvements in performance by patients, and an associated reduction in costs, it will further drive adoption and dictate the next steps.
We have the tools to improve medication performance. We simply need to decide to do it.