By Jeffrey A. Patchett, RPh, MBA
WITH THE GROWING IMPORTANCE OF BAR CODED BEDSIDE MEDICATION verification as a patient safety initiative, hospital pharmacies increasingly need solutions to the daunting task of repackaging most, if not all, of their medications in bar coded, unit dose form. Pharmacists find it challenging to consistently purchase bar coded, unit dose packaged pharmaceuticals even in the face of a growing demand and a Food and Drug Administration (FDA) mandate to add a bar code to all packages.
So how do you get unit dose drugs packaged to your specifications? One solution is to outsource the task. More specifically, when you contract with a repackaging service provider, you can reap the benefits of consistent quality assurance/quality control (QA/QC) processes that are performed and managed by someone outside of your staff.
Outsourced repackaging service providers — at least those that are FDA-regulated — follow good manufacturing practices (GMPs) and likely work in ISO-certified facilities, providing a layer of QA/QC processes that you would be hard pressed to match in your pharmacy. Furthermore, if you choose to outsource your repackaging operations, you can greatly reduce management devoted to oversight, as well as redirect staff time to more productive efforts. Bar coded, unit dose medications arrive at your pharmacy just as they would from the manufacturer, ready to dispense.
Selecting a Service Provider
Once you have decided to outsource all or part of your pharmacy’s unit dose repackaging functions, you must select a service provider. Following the guidelines outlined below can ensure that you make a well-informed decision that will allow your department to reap the maximum benefits from outsourcing.
First Things First: QA/QC Considerations
Look for an FDA-regulated repackager that follows GMPs and packages medications in an ISO Class 9000 or 9001 environment. If the service provider has both of those credentials, it can, in theory, deliver drugs packaged in an environment on par with those of large pharmaceutical manufacturers. Ask to see the provider’s FDA registration and inquire about compliance with ISO standards. It is also advisable to visit the provider’s facilities to make sure the provider is meeting
the quality standards it asserts.
Bar Coding and Packaging Flexibility
In addition, ask if the provider has the ability to customize bar codes to suit your particular needs. Depending on your needs and the capabilities of your bar code point-of-care (BPOC) systems, can the provider:
Furthermore, find out if the provider’s services are adaptable. As your progress with bar coding initiatives and your BPOC systems evolve, you will want a provider that has dynamic and customizable bar coding capabilities.
Taking it one step further, can the provider package oral solids, oral liquids, and injectables? Is the provider willing to over-wrap or flag label syringes in the manner you require? What are the service provider’s capabilities for packaging suppositories and creams? Ultimately, you want to seek out a provider that can supply a myriad of repackaging services.
You should also examine closely the size of the proposed vendor’s packaging. Will the unit dose package fit in your automated dispensing cabinets or other storage systems? In addition, will it fit in your medication cassettes and/or medication carts for distribution to nursing floors? Does the provider produce a robot-ready package that is compatible with your automation? Without ques-
tion, package size cannot be overlooked.
Another question you might ask a potential provider is whether they can also supply outsourced sterile IV compounding services. It is sometimes useful to work with a provider that can support multiple areas of your pharmacy’s production function, rather than working with multiple different vendors.
Do not be afraid to check references. Talk to your colleagues to find out if they have had good experiences working with the vendors you are evaluating. A provider’s reputation amongst your peers can be very revealing.
Preserving Your GPO Contract
In working with a repackaging service provider, always keep in mind your pharmacy GPO contract. Some providers insist you buy their generics, versus your GPO’s products. Such an arrangement may ultimately undermine the cost benefits of your GPO contract, even if the repackager is offering the generic at a lesser price.
The Impact on Drug Procurement
In selecting an outsourced repackaging service provider, consider how the company’s processes will effect your drug procurement cycle. A provider may require that you first receive an order from a drug manufacturer or authorized distributor, and then ship the product to its service center, where it will be processed and then shipped back to you when repackaging is complete. The mere fact that the order has to be shipped twice will add time to your procurement cycle, over and above the time it takes to actually repackage the drugs. Some providers will accept delivery of drug orders directly from wholesalers. This sharedservices arrangement saves a significant amount of time, making it the preferred process. Remember to take a careful look at the providers who will guarantee the fastest turnaround time. A careful and thorough assessment of the entire procurement process can ensure you will receive “just in time” rather than “just too
late” drug deliveries.
Cost Versus Quality Control
Depending upon the costs you take into account, it may never be cheaper to outsource your bar coded, unit dose packaging operations. However, the benefitsderivedfromtheuseofanFDAregulated outsourced repackaging service should more than overshadow the small incremental increase in your total drug budget. Even if you are packaging some of your drugs inhouse, outsourcing a significant portion of them can relieve you of the responsibility for overseeing necessary quality control systems. Outsourcers qualified in the areas outlined in this article can increase the safety and quality of your bar coded, unit dose packaging and allow you to allocate your staff’s time to other areas of pharmacy practice that will provide measurable cost savings and patient
Jeff Patchett is the director of pharmacy technology for Premier, Inc. He has extensive experience with pharmacy information systems, pharmacy automation, and bedside bar codeenabled technology implementation and utilization.
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