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Redispensing Compounded and Repackaged Medications within a Health System
Linda F. McElhiney, PharmD, MSP, RPh, FIACP, FASHP, FACA
Introduction
With cuts in reimbursement for services and decreasing patient admissions, health systems have been forced to find ways to minimize waste and stay within a very tight operating budget. Drug shortages also have been hard on tight budgets because the cost of these drugs increase with low supplies and high demands. Some newer medications used in a health system may be up to over $1000 per dose. If a patient skips a dose because he or she is gone for a procedure when the dose is due, can that dose be returned to the pharmacy and redispensed?
According to the United States Pharmacopeia <797> standards, compounded sterile preparations (CSPs) may be redispensed if the compounding personnel can ensure that the CSPs are sterile, pure, and stable.1 The American Society of Health-System Pharmacists (ASHP) best practice guidelines allows for redispensing of unused medications returned from an inpatient unit as long as the returned medications are in unopened, sealed packages.2 Since these medications are used only within a facility, there may be environmental and physical factors, such as secured or locked medication rooms and/or automated dispensing devices that also keep medications secure and properly stored. Devices and equipment are available to tamper-proof medications used in health systems.
Equipment
Since the mid-1980s, ASHP has published best practice policies on unit-dose packaging.3 The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) mandated unit-of-use packaging in 2003 to minimize the opportunity for error.4 Although most manufacturers do offer medications in commercially available blister packages, some drugs are not available. Fortunately, there are unit-dose packagers available and affordable for health systems to do their own packaging.
Some of the expensive, fully-automated packaging systems, such as the Talyst, may be leased and packaging is done on-site. These automated systems can be integrated with the hospital operating system and storage systems, such as PYXIS, so that the exact amount of medications needed to replenish the storage systems are packaged to minimize overstocking. The packager uses barcodes to select the correct drug to be packaged, and each tablet or capsule is heat-sealed in a pouch that is USP-approved packaging and labeled with the required information and barcode.
There are semi-automated unit-dose packagers, such as the Medical Packaging Incorporated (MPI) AutoPrint or The Cadet Euclid, that are reasonably priced and can be used to heat-seal package tablets or capsules in foil-backed packaging. The packaging is thinner and can easily fit in the automated dispensing machines, such as PYXIS. There also are semi-automated "wet" unit-dose packagers, such as the MPI Fluidose and The Wet Cadet, that can unit-dose package commercial oral liquids or compounded oral liquids. The liquid dose is added to a USP-approved polyethylene cup and heat-sealed with a foil/plastic top and simultaneously labeled with the required information and barcode.
Overwrap machines are good for tamper-proofing, labeling, light-protecting, and barcoding CSP vials, syringes, oral syringes, or even suppositories. Again, the dose is simultaneously labeled and heat-sealed inside a baggie and not opened by the nursing or medical staff until right before administration.
These automatic and semi-automatic systems are user-friendly and can decrease labor time spent on labeling and unit-dose packaging. All of these options provide tamper-proof packaging and the medication can be redispensed as long as the packaging is intact.
Devices
For smaller facilities that may not need to do a lot of unit-dose packaging, there are manual blister-package systems for tablets and capsules available through vendors, such as Health Care Logistics, Inc. (HCL) or Medi-Dose, Inc./EPS, Inc. These systems have sheets of blister cups (various sizes) and labeling software to print the lid sheets on a regular printer. The packaging is ultraviolet and moisture resistant and also meets USP standards for packaging. It is more time consuming from a labor standpoint, but cost-effective for smaller facilities. These packaging systems also can be used to unit-dose package hazardous drugs.
There are several options for unit-dose packaging oral liquids. The doses may be drawn up into oral syringes, and there are tamper-evident syringes caps for them. There are oral vials where the cap is sealed firmly onto the vial using a pressing device. Small bottles are available that cover and seal the top of the bottle with a foam seal when the lid is tightened. A peristaltic pump can be used to quickly fill the syringes, vials, and bottles. Again, vendors such as HCL, EPS, or compounding suppliers often carry these tamper-evident supplies.
If bulk bottles or jars, such as compounded mouthwashes or topical medications, are being dispensed, there are a couple of options to tamper-seal them for storage and to return if the seal is not broken. Cellulose seals are easy to use. They are put around the neck and cap of the bottle when wet. As the seal dries out, it shrinks and forms a very tight seal. There also are shrink-wrap seals that require heat from a heat gun or hair blow-dryer to shrink and seal around the neck and cap of the bottle. Tamper-tape or tamper-evident foil or paper strips may be used, especially on the topical medications. They do, however, break or tear when transporting, and the preparation may need to be wasted because it may appear to be opened.
A manual system that is similar to overwrap packagers is baggies with a sealing strip. It is a very cost effective way to tamper-proof odd-shaped items, such as syringes or vials. There are even small bubble-pack pouches that also have a sealing strip that are good for sealing samples that are being sent to a lab for testing, and it helps prevent the samples from breaking.
CSPs can be a challenge to tamper proof because of ports and stoppers. There are special sterile foil seals that can be applied to ports and stoppers that leave a tamper warning message when removed. There also are hard-plastic caps that wrap around and seal ports on bags. Overwrapping, manually or automated, is an option that should be considered.
Conclusion
Health-systems, large or small, should have a policy that addresses redispensing medications within the inpatient setting. All staff should receive training on tamper-proof packaging and devices used within the facility and what to do if the packaging is not intact. Tamper-proofing medications within a health system have several advantages:
- It can reduce waste of medications because unused doses can be redispensed.
- Patients and/or third-party payers are paying only for the medications that are actually administered and not an entire bottle.
- There is peace of mind for the person administering the medication and for the patient that the dose has not been altered and it is safe to use.
Do not redispense any returned medication where the packaging or seal has been opened or broken! When in doubt, throw it out!
References
- United States Pharmacopeial Convention, Inc. United States Pharmacopeia 35-National Formulary 30. Rockville, MD: US Pharmacopeial Convention, Inc.; 2012: 350-387.
- American Society of Hospital Pharmacists. ASHP technical assistance bulletin on hospital drug distribution and control. Am J Hosp Pharm 1980; 37: 1097-1103.
- American Society of Hospital Pharmacists. ASHP technical assistance bulletin on single unit and unit dose packages of drugs. Am J Hosp Pharm 1985; 37: 378-379.
- Swain E. PMPNews.com. JCAHO's Unit-of-Use Mandate. [PMPNews.com Website.] July 16, 2002. Available at: www.pmpnews.com/article/jcahos-unit-use-mandate. Accessed October 27, 2014.
Editors Note: IJPC has published several articles on repackaging over the years - including by Linda McElhiney. See http://www.ijpc.com/Products/SearchByKeyword.cfm?searchstr=repackaging for a listing.
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