Abstract
For the last three decades, the challenge of poor medication adherence has been discussed by the healthcare industry, while the rates and associated costs of non-adherence continue to rise. Medication non-adherence is a significant risk to patient safety and substantially elevates the cost of care. Children, seniors, and many chronically ill patients are more prone than others to use medications incorrectly. The healthcare industry continues efforts to improve medication use, developing innovative drug delivery systems and packaging to ensure that patients take the right dose at the right time. Recent advances in drug delivery systems to meet the needs of today’s lifestyles include user-friendly single-dose packaging with blow-fill-seal and stick-pack technologies.
Lack of patient adherence to their prescribed drug regimen is a common problem that compromises patient safety and escalates costs to both patients and healthcare systems. In the US, more than 50% of prescribed medications are taken incorrectly or not at all.1 Failing to take medications as prescribed can increase the chances of severe medical complications or even death. Yet a 2013 survey of 800 American adults showed that nearly two-thirds of those who take prescription medications do not take their medication properly. The same patients also report poorer health than those who take medicines properly.2
Many other studies have shown additional negative consequences of non-adherence, and the statistics are surprising. For example, one- to two-thirds of hospital admissions resulting from drug-related adverse events are related to poor medication compliance,1 up to 40% of nursing home admissions can be attributed to non-adherence,3 and as many as 125,000 Americans die each year due to non-adherence.1
On the other hand, compliance with a drug regimen typically improves or maintains an individual’s health. Taking an antibiotic may prevent a more severe infection, and adhering to a drug regimen for a chronic condition such as diabetes or high blood pressure may prevent complications. Either situation can avert hospital admissions, which in turn, reduces the use and cost of medical services.
Poor patient adherence also contributes significantly to rising healthcare costs. Remarkably, Americans incur avoidable costs of more than $200 billion each year as a result of irresponsible use of medications, according to a 2013 report by IMS Institute for Healthcare Informatics.4 Non-adherence leads to $47 billion in drug-related hospitalizations each year, according to the National Council on Patient Information and Education (NCPIE).5
Taking the incorrect dosage is a common non-adherence error. Other reasons patients fail to take their medications as prescribed include forgetting to take a dose, having difficulty measuring the right dose because of frailty or tremors, taking higher doses than prescribed in an effort to improve their health condition faster, failing to pick up medication from the pharmacy, taking less than a prescribed dose to save costs, and stopping use of the medication early.
Every patient demographic segment can benefit from improved delivery methods to assure precise doses. This approach provides many benefits for patients who self-administer medications and for caregivers, as well as for pharmacists and clinicians.
Children and seniors are significantly more prone than other demographic segments to use medications incorrectly. Young children require the assistance of parents or other caregivers to ensure they receive the proper dose at the right time, but children often resist, causing a spoonful of medication to spill. A recent study of data from the US National Poison Database System revealed that during the period 2002 to 2012, 696,937 children under six years old experienced out-of-hospital medication errors, which is equivalent to one child every eight minutes. The majority (80%) of incidents involved liquid doses, and the causes ranged from “inadvertently taking or being given medication twice” (27%), “incorrect dose,” and “confused unit of measure,” to “wrong medication taken or given.”6
Seniors who live independently often struggle with administering their own medicines. Some are vulnerable because they typically use multiple medications, and may have declining vision, memory, and functional abilities. Nearly 20% of community-dwelling seniors (65 years and older) take ten or more medications,7 contributing to adherence challenges. Common medication errors for seniors include taking an incorrect dosage, forgetting, and mixing up medications or taking out-of-date ones. Elderly patients often forget to take their medications, and unwittingly may take a medication again.
Chronically ill patients are another vulnerable population, whose medication adherence drops after the first six months of treatment. Approximately half of patients with chronic illness do not take medications as prescribed.8 These patients are more prone to suffer poor health outcomes if they do not adhere closely to their medication regimen, which can lead to more outpatient medical visits and hospitalizations,5driving up the costs of healthcare.
Today, an active lifestyle is the norm for children, teenagers, adults, and seniors alike. All of these patient segments — including patients who have careers, travel frequently, and engage in sports outings such as biking and hiking — need safe, accurate easily portable dosing options.
How is the pharmaceutical industry addressing the issue of non-adherence? What are good medication practices for patients on the go, in the care of others, or dealing with sensory shortcomings?
Drug manufacturers, as well as physicians, are seeking more patient-centered solutions, looking at delivery systems and packaging options that are most likely to encourage patients to take their medicines as directed. Accurately measured doses and easy-tohandle packaging with clear labeling are essential to meet today’s needs for self-care. The packaging must also have child-resistant features and provide deterrence to counterfeiting.
Unit-dose packaging in innovative forms is increasingly being adopted as a solution to improve patient adherence to their prescribed drug regimen. A single- dose package or container is accurately filled to hold only the quantity of drug intended for one dose. Single-dose packages are meant to be opened only once, and are typically clearly labeled. These features reduce medication error because the identity of a drug is easy to confirm, and the packaging ensures patients are taking the proper dose. Other benefits of single-dose packaging include reduced risk of contamination, less drug waste, and greater convenience for patient self-administration. Drug-makers are now focusing on drug delivery systems that provide ease of use, portability, and a level of comfort for patients taking medicine outside of their home.
Additional benefits of single-dose packaging are reducing or eliminating the preservatives, which can cause allergic reactions; dispensing a single dose in a more sanitary manner; and reducing concern over contamination of the drug because of the protective packaging around each dose.
Packaging medications in a unit-dose format is also the solution for most hospitals in the US and many in Europe. Both hospitals and pharmacies benefit by saving dispensing time, ensuring better dose accuracy, and often reducing waste due to better management of medication dispensing operations. For manufacturers, single-dose technology assures greater consistency of results in clinical trials and full-scale manufacturing, distinguishes their products, and can extend product lifecycle.
Oral, topical, and injectable medications in the form of tablets, capsules, creams, and liquids can all be packaged in unit-dose containers, which come in many sizes and shapes. Blister or pouch packages are widely used for tablets, capsules, and other oral solid formulations. Single-dose packaging units for liquid medications are available for oral administration, and as injectables in the form of plastic syringes with rubber tips and squeeze tubes. Typical unit-dose containers for injectable drugs are prefilled syringes and cartridges.
Unither Pharmaceuticals, which specializes in the development and contract manufacturing of sterile single-dose pharmaceutical products, offers a range of dosage forms and delivery systems that are convenient and easy to use. Forms include single-dose vials using blow-fill-seal (BFS) technology, stick-packs, and effervescent-tablet technologies. For vials, many different shapes are possible, and with premolded, presterilized inserts, it is possible to achieve different methods of drug delivery. Stick-packs are another type of single-dose package that is convenient, portable, and easy to open and administer. The premeasured sticks can be filled with powders or liquids. Liquid stick-packs reduce the likelihood of spilling a spoonful of medication while trying to gain a resisting child’s compliance or when administering liquids to geriatric patients with tremors.
Recently, liquid stick-packs were introduced for solutions, suspensions, and gels for both the oral and topical administration of liquids as an alternative to glass bulbs, tubes, sachets, and conventional bottles. The portable, easy-to-carry packs are appealing because no device is required for delivery. Also, the strength of the stick-pack material ensures their safety and security throughout the supply chain.
Conclusion
Medication non-adherence is a significant issue that is likely to grow as the US population ages and patients take more medications to treat chronic conditions.10 The issue is a growing concern to clinicians, healthcare systems, and payers. Reducing dosing errors saves lives and reduces massive costs to governments and other stakeholders. Single-unit dosing offers significant potential to improve patient adherence and reduce medication errors. Drug delivery systems using blow-fill-seal and stick-pack technologies help ensure accurate dosages and provide a safe, more convenient, portable way for patients to comply with their treatment regimen. For manufacturers, these singledose systems offer the benefits of distinguishing drug products and extending product lifecycle.
References
- Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487-489.
- Lack of Medication Adherence Harms American’s Health. Greenberg Quinlan Rosner Research and Public Opinion Strategies. May 2, 2013. Accessed at: http://adhereforhealth.org/wp-content/uploads/pdf/2013PublicPollMemo_CAHC.pdf
- Pan F, Chernew M, Fendrick AM. Impact of fixeddose combination drugs on adherence to prescription medications. JGen Intern Med. 2008; 25:611-614.
- IMS Institute for Healthcare Informatics, IMS Health Study Identifies $200+ Billion Annual Opportunity from Using Medicines More Responsibly, Press Release, June 19, 2013. Accessed at: http://www.imshealth.com/portal/site/imshealth/menuitem.c76283e8bf81e98f53c753c71ad8c22a/?vgnextoid=12531cf4cc75f310VgnVCM10000076192ca2RCRD.
- Pharmacist Communication Shown to Increase Medication Adherence and Reduce Errors. National Association of Boards of Pharmacy. April 30, 2010. Accessed at: http://www.nabp.net/news/pharmacistcommunication-shown-to-increase-medicationadherence-and-reduce-errors/.
- Smith MD, Spiller HA, Casavant MJ, Chounthirath T, Brophy TJ, Xiang H. Out-of-hospital medication errors among young children in the United States. Pediatrics. Nov. 2014;134(5):867-876. Accessed at: http://pediatrics.aappublications.org/content/early/2014/10/15/peds.2014-0309.abstract.
- Wick JY. Adherence Issues in Elderly Patients. Pharmacy Times. Jan. 13, 2011. Accessed at: http://www.pharmacytimes.com/publications/issue/2011/January2011/RxFocus-0111.
- Brown MT, Bussell JK. Medication Adherence: WHO Cares? Mayo Clin Proc 2011 Apr;86(4):304-314. Accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3068890/.
- Miseta E. Patient-centric design: the next frontier in drug delivery. Pharmaceutical Online. March 4, 2014. Accessed at: http://www.pharmaceuticalonline.com/doc/patient-centric-design-the-next-frontier-in-drug-delivery-0001.
- Ho PM, Bryson CL, Rumsfeld JS. Key Issues in Outcomes Research. Circulation. 2009;119:3028- 3035. Accessed at: http://circ.ahajournals.org/content/119/23/3028.full.pdf.
Kevin Haehl is responsible for developing and growing Unither Pharmaceutical’s contract pharmaceutical manufacturing business for North America in niche fields such as sterile unit dosage forms using Blow-Fill-Seal technologies and Unistick® single-dose liquid stick-packs, and the strategic leadership of the newly acquired manufacturing site in Rochester, NY. He has over 25 years of broad experience across pharmaceutical manufacturing, sales support, engineering, process development, financial, quality, and supply chain. Prior to Unither, Mr. Haehl held management positions at Evonik and Eli Lilly & Company, and worked in engineering at DuPont.