Viewpoint: Smarter Packaging: The Cure for the Insanity behind Nonadherence
By Walter Berghahn, Chairman of the Board, Healthcare Compliance Packaging Council
Vice President, Packaging Technology, AmerisourceBergen Packaging Group
In April 2010, the New England Journal of Medicine published the article, “Thinking Outside the Pillbox—Medication Adherence as a Priority for Health Care Reform.” It was a welcome declaration from a prestigious healthcare publication, placing the spotlight on poor adherence as a major contributor to problems in the U.S. healthcare system. While the article identified many key factors associated with the problem and offered some examples of successful adherence pilot programs, there was much left unsaid.
The article begins by referring to another NEJM article from 2005 that stated “almost 50% of all patients do not adhere to prescription regimens.” Coincidentally, a comparable statistic was noted five years earlier in an article in Drug Benefit Trends, in 2000.¹ That article stated, “one half of the patients for whom appropriate medication is prescribed fail to receive the full benefits because of inadequate adherence to treatment.”
While NEJM’s recent article supports the catastrophic statistic of the earlier one, regrettably we are no nearer to a broad-based solution for noncompliance 10 years later. There have been some impressive performances in pilots and studies along the way, but none have swayed the overall direction of the market. And yet, prescription volume continues to grow, along with nonadherence.
The scope of the problem is up for debate, but some calculations estimate it is a $300-billion-a-year problem.² It has also been estimated that poor adherence is responsible for “125,000 American deaths annually (342 people every day), 10%–25% of hospital and nursing home admissions”³ and finally, “up to 28% of all emergency room visits.”⁴
These startling statistics make up just the tip of the iceberg—what lies beneath is much more ominous. We, as a country, are spending more than $300 billion on pharmaceuticals every year and spending another $300 billion dealing with issues caused by improper use of those same medications. It is nothing short of a disaster.
Resolving this gross misuse of life-saving technology (and yes, pharmaceuticals are a technology) could pay for the proposed healthcare reform several times over. In addition, a solution could positively affect so many lives and relieve a significant burden on institutional care facilities.
Unfortunately, the recent NEJM article neglected to include two significant allies in the battle on noncompliance: the pharmacist and smarter packaging. Numerous problems cited in the article can be partially alleviated by the pharmacist: lack of care coordination, addressing coexisting conditions where multiple medications are involved, reconciling the prescribed regimen, health literacy, and understanding medication side effects. Most notably, the pharmacist should be the common point of care for patients with multiple physicians and numerous prescriptions. The article touches upon pharmacy in the discussion on Medical Homes and new payment models that reward care providers for better outcomes, but it doesn’t quite make the leap.
Ironically, the title of the article, “Thinking Outside the Pillbox” touches upon a key problem—poor prescription packaging—but fails to connect it to the solution. U.S. pharmaceutical prescription delivery relies upon a 55-year-old amber vial for most drug distribution. Think about it: Since the vial’s introduction, the world has evolved from rotary-dial phones to push-button phones to cordless phones to cell phones, and now smart phones. Cars evolved from running on leaded gasoline to unleaded and now biofuels, electric hybrids, and even viable all-electric vehicles. We’ve landed on the moon and have experienced a supersonic Concord, a space shuttle program, a Concord retirement, a space shuttle retirement! How did pharmaceutical prescription packaging miss the technology revolution and evolution? The world has been changing at a rapid pace and prescription packaging is stuck in the 1950s! Pharmaceutical prescription packaging is in desperate need of a paradigm shift.
The industry has the ability to offer numerous styles of packaging that can clearly communicate to the patient: What am I taking? Why am I taking this? What is it treating? When should I take it? Did I take it today? Packaging can provide feedback to the physician, the pharmacist, the patient, and the caregiver in visual or electronic form, even in real time. In studies dating back 20 years, various packaging forms have demonstrated effectiveness in alleviating, not eliminating, the adherence problem, but instead we use amber vials or white bottles with limited instruction, and, in some cases, little ability to communicate to the patient. Prescription vials do less to communicate with the patient than does the average OTC package.
There are, however, glimmers of hope. Smarter solutions have not gone unnoticed. As written in the Institute of Medicine’s 2006 report, “Preventing Medication Errors”: “The strategy of using calendar blister packs could help large numbers of patients (including seniors, children, and those challenged by cognitive, physical, or functional impairment) take their medication more reliably and safely, and enhance their treatment outcomes.”
Aha! Somebody gets it! And some manufacturers, packagers, and pharmacies, too, have been pushing for better solutions. Excellent examples of current market compliance packs include Pfizer’s Toviaz and Wal-Mart’s use of the Shellpak. But these are voluntary moves by organizations that recognized the problem and creatively sought out their own solutions. I applaud them.
What is needed, however, is broader adoption. We need insurance providers (prescription benefit managers; PBMs) that state to manufacturers, “If you want to be in this formulary, you need to provide packaging with compliance-aiding features.” We need a government that recognizes the inherent risks and real damage caused by this antiquated method of delivering pharmaceuticals.
The classic definition of insanity is doing the same thing over and over while expecting a different outcome. Well, expecting better patient outcomes while delivering pharmaceuticals in vials (or bottles) with poor labeling offering no feedback to the patient is fast approaching insanity. Smarter packaging is not a silver bullet, but an important part of a solution that also includes the pharmacist, the physician, family support, and economic support.
The NEJM article made many valid points. It should be applauded by all means, but more needs to be done with the tools available today. The provider industry needs to work with manufacturers and packagers to develop solutions that will protect the product and ensure proper administration by the patient and allow follow up by the pharmacist or physician. Smart solutions exist and need to be employed.
1. "Medication Nonadherence: Finding Solutions to a Costly Medical Problem,” Gottlieb, Drug Benefit Trends 12(6): 57-62, 2000.
3. Journal of Managed Care Pharmacy, Supplement, July 2008, Vol. 14, No. 6-b, Continuing Education Activity.
4. “Drug-Related Visits to the Emergency Department: How Big is the Problem?” Patel & Peter, Pharmacotherapy.
For more details, visit www.hcpconline.org.