The use of unit dose packaging has taken on increased significance during the Covid-19 pandemic. In the midst of the crisis, much attention has been paid to drug administration in hospitals and other care facilities—and one risk factor, perhaps not front-of-mind but now more apparent, is that pouring liquid medication from a bottle into a smaller cup for a patient is likely not safe anymore.
Such realizations have evolved discussions around ways healthcare workers can prevent contamination risks when administering drugs. Unit dose packaging of liquid pharmaceuticals—similar in concept to a single serving coffee creamer cup—can provide an effective solution. These medicines are designed to ensure safe individual dosages and ease of use for children, adults and the elderly who have difficulty with swallowing tablets and capsules or are on restrictive diets. Advantages also include rapidity of drug delivery and occasional topical delivery to the oral cavity.
Pharmaceutical Commerce recently spoke with Kurt Orlofski, CEO of Pharmaceutical Associates Inc. (PAI), an independent manufacturer of unit dose packaging, about the benefits of unit dose cup packaging in current and post-Covid healthcare delivery practice. PAI, based in Greenville, SC, produces over 60 prescription and over-the-counter therapies. Its focus includes brain, immune, metabolic and digestive health, and OTC treatments for allergies and upper respiratory symptoms, minor aches and pains and constipation.
How has the hospital care effort for Covid-19 patients—and the need to administer varying pain and other medications to these patients—put increased spotlight on the advantages of unit dose packaging?
Using unit dose (UD) packaging whenever commercially available has been a clear recommendation from FDA and other pharmacy organizations even before the Covid-19 pandemic. However, the pandemic has heightened the need for further risk reduction. As hospitals have altered and launched many new standard operating procedures to protect both patients and healthcare providers, it has become important to eliminate potential virus transfer through airborne transmission or direct contact. Utilization of UD medicines whenever available may eliminate some of the risk associated with handling and pouring out doses repeatedly from the same bottle.
How has the liquid dosage market in particular expanded in recent years? Do you see adoption of new practices resulting in this area post-pandemic?
Clinically, having medication available in units of use has been well established as safer, and therefore, the preferred format to administer medications. The biggest obstacle has been the additional packaging cost of unit dose. Larger scale utilization of UD in hospitals and long-term care (LTC) facilities will continue to provide economies of scale. This will reduce the need for internal or external repackaging and enable hospitals and LTCs to purchase commercial grade UD products.
What are the general contamination risks with traditional liquid drug dispensing?
(Answer from PAI’s Product Development Team)
Traditionally, most liquid products are sold in larger bottles, usually pints and are then dispensed into smaller bulk bottles, like the bottles we often get from the pharmacy. Individual patients or caregivers must then open these bottles and pour out the required dose. For suspensions, both the pharmacy bottle and the patient bottle must be well shaken to assure the drug is properly resuspended to assure and accurate dose, either into the dispensing bottle or spoon or measuring cup. This means that in order to receive an accurate dose, the patient must depend on both the pharmacist dispensing the suspension and the caregiver dosing the suspension, to adequately shake the product.
Additional concerns arise in this process. First are sanitary issues, as bulk bottles must be opened and closed repeatedly with exposure to air, humidity and the environment. Spillage during patient or caregiver dosing can also occur, both on the bottle and dosing cup or spoon. This can leave residue on the cap or bottle of products that often contain sugars and can lead to microbial growth or further contamination. Accuracy of dosing also becomes an issue for the patient or caregiver to when filling a dose cup or spoon, 5 milliliters can easily become 4-6 or more leading do under and overdosing of 20% or more. Unit dose packaging solves these concerns. The product is fully sealed from the time it leaves the factory until the lid is peeled off, the dose is pre-measured within tight limits, and there is no dose cup or spoon to clean. Lastly, allowance is made for viscosity of the product and “drinking” the product directly from the cup so that an accurate amount of drug is given to the patient every time.
From a sales perspective, Covid-19 risk in the institutional setting, less in hospitals but far more often in LTC facilities, is generally associated with bottle utilization. The repeated handling accentuates the risk of biological contamination. The bottles often become what has been described as a sticky mess. This problem is not contained to the bottle alone, but also the medicine cart and is caused by repeated shaking, opening, closing and spillage. This allows for potential contamination from bacteria or viruses whether airborne or through direct contact (including Covid-19). Many institutions have underscored the need to dispense in UD whenever available along with other protocols, to further reduce risk.
Liquid dosage forms are considered more susceptible to degradation than solid dosage ones. How do unit dose bottle packaging companies ensure product integrity and stability when supplying care-delivery settings?
Liquid products, especially solutions, exhibit inherently shorter stability as a product form. The advantage of the unit dose in this aspect is that the final package given to the end user has been through a rigorous stability testing program. Then the final packaged unit, unaltered by a pharmacist, caregiver, etc., is given to the patient. This ensures that integrity of the product is maintained from production to patient, without manipulation. Bottles, especially pharmacy packs, are opened and re-dispensed into separate containers. Often, the stability of the product in the pharmacy supplied surrogate container has not been previously established. Additionally, the stability of the partial pharmacy pack container is also often not known. Unit dose cups eliminate the need for in use type stability studies, as in the course of normal product use, there never is an unused portion of the package. The unit dose is either sealed with a complete dose, or empty after a single use.
Unit dose packaging is tested to maintain its integrity through the printed shelf life on each cup. Pint bottles in a pharmacy typically are only guaranteed through shelf life if unopened, studies are rarely done for a product that has a partial bottle dispensed and then the balance dispensed many months later. Multiple exposures to uncontrolled environments, either in a pharmacy or a patient setting are eliminated. Manufacturers cannot test for all the permutations of “in-use” variables in a patient setting.
How important are these products during drug launches to market? Is PAI involved in tandem with the developer?
A commercial grade UD presentation is an important differentiator in the marketing of liquid generic medicines. Most hospitals have adopted the need for UD products due to the strong recommendations of the FDA, ASHP (American Society of Health-System Pharmacists) and other well-respected best practice guidelines. Launching of medicines in UD packaging supports guideline adherence and ensures the five rights of medication (right patient, right drug, right time and frequency of administration, the right dose and the right route), which is clinically appropriate. PAI has been the UD innovator in the past and still is, but today we are exploring the development of new products with collaborative partners to ensure important products are made available in new unit dose presentations.