Unit Dose Packaging

A unit dose packaging system supports patient care by delivering liquid and solid drugs in single-use containers.

  • What is unit dose packaging?

    Unit dose packaging is a method of single drug-dose delivery in barcoded, non-reusable containers. Used primarily in hospital or clinic settings, unit dose packaging holds a specified quantity of medication in single-use containers so patients get the exact dose they need.

    Unit dose packaging (also known as "compliance packaging" or "regulatory packaging") is used for both liquid and solid drugs. This type of drug packaging can take many forms, including blister cards, strips, pouches, sticks, vials, and prefilled syringes.

What are the benefits of unit-dose packaging?

Unit dose packaging can lead to better patient outcomes, fewer medication errors, and cost savings for your health care business.

Fewer medication errors, enhanced traceability, and increased packaging safety

A unit dose packaging system reduces errors by dispensing medications to patients in the amount prescribed. It eliminates the need for pharmacists to pull the right bottle off the shelf and count out the right number of pills.

Compliance packaging also prevents product tampering. And barcodes per dose enable all pharmaceutical products to be tracked and traced from manufacturer to patient.

Cost savings, waste reduction, improved speed to market and resource management

When every pill or drop is accounted for in a correctly labeled package, there are no "leftovers" or medication errors. Every piece of drug inventory gets shipped to dispensers. Dispensers, in turn, deliver the right amount of medications to patients. And patients receive exactly the right amount of medication for their course of treatment.

As a result of these efficiencies, unit dose pharmaceutical packaging gives manufacturers the ability to charge for 100% of the medications packaged in a single supply. A unit dose system also speeds the product through the supply chain process: Once properly packaged, drugs can get to patients faster than they would if packaged at the pharmacy counter.

Improved patient education, medication adherence and outcomes

Unit dose packaging can improve patient adherence and outcomes in a number of important ways:

  • Unit-dose blister packs clearly show when a dose has been missed.
  • Unit-dose containers are designed to be child-resistant but easily accessible.
  • Supply duration can be adjusted to reduce trips to the pharmacy.
  • Custom kits can combine all of a patient's medications within a multi-drug regimen into a single pack.

Shelf stability, product efficacy, and patient safety

Choosing the right pharmaceutical packaging option improves both the safety and security of the drug supply chain. In terms of safety, the benefits center on maintaining drug stability through the expiration date determined by the manufacturer.

Whether the drug sits in a drug distribution warehouse, a physician's office, a pharmacy, or a patient's medicine cabinet, the right package ensures it can be used safely and effectively during its entire life cycle.

Improved medication compliance

Compliance regulations for unit dose packaging come from three main sources:

  • Good Manufacturing Practices (GMP)
  • The Food & Drug Administration (FDA)
  • Drug Enforcement Agency (DEA)

Each body has its own rules, regulations, and guidelines that drug manufacturers need to follow. Proper compliance packaging allows manufacturers to comply with each set of rules, regulations, and guidelines.

Each unit dose package includes:

  • Accurate batch and lot numbers
  • Dose and usage instructions
  • Required warnings
  • Expiration dates
  • Unique track-and-trace identifiers to meet the serialization requirements of the Drug Supply Chain Security Act
  • Barcodes

With the right regulatory packaging, drug manufacturers have a record of every product going in and out of their facilities. Manufacturers can use these data to monitor compliance, correct any deficiencies, and stay ready for potential audits.

Types of unit dose packaging

Solid unit dose packaging

Examples of unit dose packaging for solid medications include:

  • Blister cards and cartons
  • Plastic clamshell packaging
  • Medication strips and pouches
  • Medication sticks

Liquid unit dose packaging

Solid dose medication options include traditional bottle packaging and deep-draw thermoforming for large-format products, such as:

  • Vials
  • Prefilled syringes
  • Inhalers

Care settings that benefit from unit dose packaging

Unit-dose prescription drug packaging works particularly well for the needs of acute-care settings, long-term care settings and specialty pharmacies.

Compliance packaging is also an effective solution for clinical trials. Clinical trials typically require limited production runs of a product that gets used in carefully controlled environmental conditions. Unit dose packaging creates predictable parameters for the patient experience. Regulatory packaging makes hiding a drug's identity from trial participants easier and the overall trial therefore more effective.

What to look for in a unit dose packaging partner

When it's time to choose a medical packaging partner, ask for case studies or information on the following key performance indicators (KPIs):

  • Sales: How have packaging choices, or changes in packaging, affected sales?
  • Stability: How well does the medical packaging maintain the drug's effectiveness over the predicted period of time?
  • Miscellaneous: What are some examples of patient complaints, drug recalls and prescription returns?

The right unit dose packaging partner can help manufacturers meet strategic goals for these KPIs. In choosing a partner, consider the following features of a well-managed unit dose pharmaceutical packaging program:

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