Taking medication as intended is an issue for many patients — single unit packaging is a solution for better FDA and patient compliance. In May 2011, FDA offered guidance1 suggesting that patients should be given an accurate way to measure their medication even in the case of fixed doses, such as 5 mL or 10 mL.
This suggestion was made based on several years of studying patient compliance. The study found that patients were routinely over- or underdosing themselves due to a wide variation in volume of medication, measured by inconsistently sized teaspoons. Another patient issue observed was with dosing cups. Dosing cups are provided specifically with one product and are not interchangeable — they cannot be used with another medication — though patients were not abiding by this, which led to errors in compliance. Thus, the ability of a patient or caregiver to accurately measure medication is an unmet need. A pre-measured liquid stick pack is the solution.
“Unit dose” is poised to be a game- changer in pharma. Measuring cups, tablespoons, teaspoons and multiple dose containers for oral liquids and eye drops are a thing of the past. Today’s patient is looking for convenience. Doctors are also realizing the value of unit dosing in regards to prescription writing. Parents and caretakers of children and geriatrics, whether at home, in a hospital or at a nursing home, are realizing the benefit of not having to measure an oral liquid, share an oral liquid bottle or request that a doctor write multiple prescriptions of the same medicine.
An added benefit of unit dosing is that it enables doctors to prescribe controlled substance oral liquids without worry, as unit doses address the issue of abuse. It also allows pharmacists to store the oral liquids under lock and key, which is a great new advantage. This innovation allows almost any unit dose oral solid, or multiple dose oral liquid, to be converted to a unit dose oral liquid. It also addresses several challenges, including stability concerns related to multiple dose oral liquids — such as light sensitivity and oxygen headspace. The benefit of introducing ophthalmic unit dose forms, available without preservatives is an immense advantage and provides convenience of transportation. Another prime example of unit dosing includes the Ventolin Nebules used in inhalation and governed by unit dosing.
For patients, the convenience of taking a few liquid stick packs of a preferred cough-cold-fever medicine on the go, without having to carry the whole bottle, is especially promising. Unit dosing will not only allow a patient to take their medicine in any setting, but also creates a situation where they do not have to worry about measuring it. This enhances patient medication compliance and adherence to a medication schedule. It also eliminates medication-dosing errors due to language barriers, which are often not accounted for. This is especially helpful for OTC products, where a pharmacist may not be engaged in explaining the dosing directions, and the patient does not understand the text on the medication.
Patient-Centric Drug Design
Most of pharma has recognized that when a given patient cannot (or will not) take their medications as prescribed, the efficacy and therapeutic value of these drugs are significantly impacted, resulting in poor patient outcomes and higher overall healthcare costs. In the U.S., more than 50% of the population takes their prescriptions incorrectly, contributing to some 125,000 deaths each year. A 2013 IMS Institute for Healthcare Informatics study noted that nonadherence leads to approximately $200 billion in avoidable healthcare costs annually.2 Another report by the National Council on Patient Information and Education explained that nonadherence leads to an extra $47 billion in hospitalization costs related to the issue.
There are multiple causes of poor adherence with no patient or demographic group exempt; however, most studies have shown the reason most people don’t take medication properly is related to dose form, dosing complexity and other, often psychological motivations relating to personal perception. Taking the incorrect dose is a common nonadherence error, but other issues include forgetting to take the medication, mixing up medication or dispensing the wrong amount of a medication from its primary packaging.
Who is most prone to adherence errors? The elderly are especially vulnerable. It is increasingly common for patients aged 65 or older to take 10 or more medications daily. Children are another at-risk group regarding adherence. U.S. National Poison Database statistics revealed that from 2002 to 2012, almost 700,000 of those under age six suffered out-of-hospital medication errors; 80% of those errors involved liquid doses. The same reference also evidenced that adolescents are prone to inadvertent dosing mistakes and waste. Color-free formulations were introduced as a way to address this problem, but such changes merely serve to mask the real problem of nonadherence; much of it is due to the product’s fundamental delivery system —again, in this case, liquid formulations.
Authors of a paper published by the American Association of Pharmaceutical Scientists (AAPS) Journal sought to define the term for the industry in “Defining Patient-Centric Pharmaceutical Drug Product Design.” In concluding its research, the authors offered this one-sentence definition: “The process of identifying the comprehensive needs of individuals or the target population and utilizing the identified needs to design pharmaceutical drug products that provide the best overall benefit to risk profile for the target patient population over the intended duration of treatment.”3
It is evident that every patient group, young or old, can benefit from a patient-centric approach. Improved delivery systems are a benefit to all, from patients who self-administer their medications to caregivers, doctors and clinicians tasked with managing drug products to those under their supervision. In other words, drug designs that aren’t patient-centric in form and delivery are less likely to be consumed as directed, and therefore less likely to be commercially successful.
One at a Time: Addressing the Issue of Nonadherence
In 2017, most drug product manufacturers, including branded Big Pharma, the generics sector, as well as OTC and nutraceutical segments, have embraced patient-centricity in their drug development efforts, introducing products with innovative packaging technology and delivery solutions to better meet patient needs and increase their therapeutic value. These attributes are being integrated into product development earlier into the product cycle.
Today an active, mobile lifestyle is the norm for most people, making the need for portable solutions, including single unit, premeasured dosage forms such as those created by Unither, key. Unither is focused on single unit dose packaging, including sterile single-use primary packaging technologies, blow-fill-seal (BFS) and liquid stick packs. Unither filling systems are flexible and adjustable to suit varied dose measurements. Equipped with advanced, flexible cGMP fill and finish processes and technologies, Unither is experienced at delivering affordable unit dose forms to both consumers and manufacturers on a cost-of-goods basis.
Power to the People
Unit-dose packaging is growing in popularity. For drug developers and drug marketers, single unit dose forms are increasingly seen as an affordable route to improve patient drug adherence and outcomes, empowering consumers to be more effective stewards of their healthcare.
Unither’s Unistick® single unit dose liquid stick packs offer a number of benefits when it comes to delivering pharmaceuticals in convenient forms, including a financial aspect. For example, a heartburn medication delivered in a liquid stick pack form captured 80% of the market in France after it was introduced.
The premeasured Unistick® is designed to accommodate liquids and provide great utility for viscous products like gels and creams — these forms are very functional. Portable and convenient, liquid stick packs reduce spilling, as well as inadvertent under- or overdosing. Stick packs are a great substitute for glass bulbs, small vials and conventional bottles. Similarly, each dose can be imprinted with branding and other information for patient safety and caregiver effectiveness. Other benefits include better package integrity and making secondary devices like droppers or spoons obsolete. Improved delivery systems, like Unistick® single dose liquid stick packs, offer a clear advantage to all, from patients who self-administer their medications to caregivers, doctors and clinicians tasked with managing dispensing and dosing of drug products to those in their care.
Taking all these factors into consideration, single unit, premeasured dosage forms are an answer to the issue of nonadherence. As the number of medications prescribed increases, drug developers must evaluate and incorporate patient-centric properties into their product, and introduce the single unit dose forms that people prefer.
References
- Guidance For Industry Dosage Delivery Devices For Orally Ingested OTC Liquid Drug Products. Department Of Health And Human Services: Food and Drug Administration. May 2011. Web.
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IMS Health Study Identifies $200+ Billion Annual Opportunity from Using Medicines More Responsibly. QunitilesIMS. 19 Jun. 2013. Web.
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Stegemann, Sven, Robert L. Ternik, Graziano Onder, Mansoor A. Khan, Diana A. van Riet-Nales.“Defining Patient Centric Pharmaceutical Drug Product Design.” The AAPS Journal 18.5(2016):1047-1055.
