CONSULTANT PHARMACIST / FORUM

Automation's Emerging Role as a New Quality Assurance Tool for the Long-Term Care Pharmacist

Automated medication dispensing systems bring great promise for highly accurate performance at unprecedented levels of productivity. Indeed, automation today is being put to good use in pharmacy operations of all types and sizes. It may be tempting to suppose that such sophisticated devices can automatically monitor and self-regulate their quality performance as well. But automation actually creates a whole new set of quality assurance challenges for today's long-term care pharmacist.

My fellow pharmacy professionals at Specialized Pharmacy Services and other automated pharmacies across the nation are meeting these quality challenges in everyday practice. Specialized Pharmacy Services helped pioneer high-volume pharmacy automation with a system that automatically dispenses, packages, and labels medications.¹ Experience has taught us that automation works wonders if people do their work, too.

In 1997 the Automation in Pharmacy Initiative, a collaborative endeavor of the American Society of Consultant Pharmacists and several other professional associations, commissioned a White Paper on Automation in Pharmacy.2 This paper concisely presents the major quality assurance issues facing the automated pharmacy, enumerates the desirable features of error-reducing systems, and recommends specific areas of focus for the quality assurance initiative. Certain of these items bear repeating and elaboration for pharmacists whose automated operations service skilled nursing, assisted living, and other long-term care facilities.

Balancing Technology and Human Elements

Implementing an automated pharmacy system is by no means a "plug-and-play" proposition. The automation challenges and solutions are different for every setting, information system, and staff of pharmacists and technicians. "Successful implementation of automation," the White Paper authors quite correctly insist, "requires re-engineering of the process to be automated." A robust re-engineering effort, they continue, should strive to reduce reliance on memory, improve information access, "error-proof" tasks and standardize processes where possible, provide training in procedures and problem solving, build "buffers" into each system, and redesign work schedules, division of responsibilities, task descriptions, and work environments.

To ensure an effective re-engineering of processes and the re-deployment of people around automated technologies, the paper further lists several "desirable features." Specifically, it champions the development of integrated systems in which controls are comprehensive from order entry to point of dispensing. The authors also insist that safe and effective systems must control "error-prone" components, dispense unit doses, signal dosing time, machine-print labels on the package, use barcode identification, limit and control access to medications, capture dose administration, provide drug use information, and feature controls that are not easily compromised. Today's automated pharmacy systems meet these ideals in the dispensing and distribution phases of the pharmaceutical care process.

Quality Assurance Focus

• Order entry
• Downtime and system failures
• Education and training
• Servicing equipment
• Medication error detection

Mastering these aspects of pharmacy automation can drive the few curses away from the technology's many blessings.

TABLE 1. Recommended Focus For Quality Assurance Of Automated Pharmacy Systems

The following areas should be the focus of both policies and procedures and quality assurance activities: Order Entry-Order-entry errors are particularly troublesome because of the risk that an input error will be repeatedly carried without detection. Automated pharmacy systems integrated with patient medication information will only be as accurate as the data entered. Downtime and system failures-A contingency plan should be developed and rehearsed periodically. Filling and refilling of medication containers-Barcode technology should be used to verify accuracy of these tasks. Expired and recalled medications-Policies and procedures must be in place to monitor and track expired and recalled medications. Storage-Storage conditions (temperature, light, humidity) must be monitored to protect drug integrity. Education and training-All persons working with automated pharmacy systems must receive appropriate training in the purpose and capabilities of the system, how system failures can occur, and the competencies required of the operators. A formal orientation and training program should be developed, and standardized, and its effectiveness routinely evaluated. Machine errors-Automated pharmacy systems are capable of producing unanticipated errors, which may be due to faulty software or other defects. Accuracy and reliability data should be sought from other users, particularly to characterize the failures peculiar to the system in question. All systems users should be thoroughly tested before implementation. Labeling-Labeling should be machine-printed, contain all required information, and be easily readable. Packaging should provide sufficient space for readable labeling. Servicing equipment-Policies and procedures must be in place to allow for routine servicing of automated pharmacy systems without disruption of work flow. Medication error detection-Medication dispensing and administration errors should be measured, monitored, and evaluated as part of the quality assurance program. Source: White Paper on Automation in Pharmacy, Barker et al.2

Order Entry

Automation itself can prevent, detect, or resolve some order-entry mistakes by making impossible the ordering and distribution of certain combinations of drugs or specific drugs for specific kinds of patients. Most important, the automated system should accurately dispense all accurate orders. The Secure-Fill System, which complements Baxter's ATC Profile System, safeguards against putting wrong medications into dispensing canisters. This system ensures that pharmacists match stock medications with appropriate canisters through barcode technology. In addition, a security "pinning" system matches each canister to its correct location within the machine. These features protect against system errors. But occasional order-entry errors must be addressed via tailored solutions that necessarily involve people.

Human beings write the policies, carry out the procedures, and operate the machines. Such a chain of command can never be made foolproof. All inputs and end-products of the automated operation-every dispensing canister, every tray, and a representative sample of individual medication packages–therefore must be checked for accuracy.

Downtime and System Failures

Andy Hill, Jr., President of Elder-Care Pharmacy in Hawkinsville, Georgia, has just such a plan. Thankfully, he adds, Elder-Care has never had to put the plan into practice. Basically, Hill's operation has prepared to revert to its old manual punchcard system at a moment's notice. The pharmacy software system's batch-printed labels would serve as a reliable guide to orders that might have been skipped, and "minibags" would be used for backup packaging.

"We always fill orders 24 hours in advance," Hill explains. "Should we experience downtime, we'd have a one-day window to catch up." In the case of extended downtime, he adds, Elder-Care could use the backup drug carts used by some of its facilities that still prefer punchcards. "We could quickly swing into action manually," Hill contends, "taking refill and new orders via fax, having technicians and pharmacists typing orders at computer stations, running vast numbers of labels, and distributing them to filling stations."

Elder-Care has a six-hour supply of emergency backup power. Hill also emphasizes the critical importance of well-trained personnel in an emergency situation, or even in just a tough jam that results from scheduling glitches. His professional staff are all cross-trained on a punchcard system, and all qualified operators can run the automated dispensing system alone. Still, it is Elder-Care's advance fill operation that provides a well-demonstrated practice in contingency planning for downtime and system failures.

Education and Training

Tom Bartos, pharmacy purchasing specialist/automation specialist at UPC Health Network in Milwaukee, combines off-site training by the equipment manufacturer with on-site simulations and periodic follow-up competency assessments to ensure, as the White Paper suggests, that all persons working with automated pharmacy systems understand "the purpose and capabilities of the system, how system failures can occur, and the competencies required of the operators."

Technical training starts with basics: raising routine operational issues and thoroughly familiarizing technical personnel with the automation's capabilities. But a lot of training still needs to be done after this "boot camp." It is important for the manufacturer of any automation equipment to offer an extensive train-the-trainer program, furnishing workbooks, tests, and other follow-up training materials for people to bring back to their facilities.

UPC follows up with extensive hands-on simulations at its own network facilities. Bartos says, "We make it fun, and make it as live as you can get without actually dispensing meds." For example, he encourages trainees to create fictitious patients (often the technicians themselves) being administered various candies (Skittles, Tic Tacs, etc.). The resulting simulation allows them to get a feel for the time involved in the process and how the packets feel and look.

When it comes to building competency, Bartos insists, "Only real-world experience will suffice. You have to conduct all training with the computer system and interface that is unique to your operation."

Next comes a simulation using live data from real patients. UPC staff walk through the dispensing process with the help of a guide Bartos has developed. This simulation gives technicians a feel for real-time operation pressures. Actual patient data are used, but still no medications are actually dispensed.

After comprehensive early training, ongoing training covers any new capabilities, each requiring additional training and cross-training. One person dedicated to training and education at each site takes ownership and creates acceptance among other staff. "Training and education," Bartos adds, "offer a golden opportunity to champion cutting-edge technology. Most professionals are easily excited about automated dispensing, given a stimulating learning environment."

Again, the manufacturer should play a key role in training and education, including pre-implementation training, on-site customer installation support, follow-up training after going live, and ongoing technical support.

Servicing Equipment

We clean both of our dispensing machines every day, and thoroughly every week. The weekly procedure involves taking the machines apart, vacuuming thoroughly, and cleaning a number of belts. We also use compressed air to blow out medication canisters whenever they are refilled. Canisters stocked with powdery tablets may require more frequent cleanings than do canisters holding capsules or coated tablets.

In the highly sensitive automated environment, even the simplest cleaning and maintenance functions require qualified personnel. Strict monitoring and competency assessment are essential. Remember, errors may occur if even one machine part is improperly reassembled. Only routine maintenance, expertly performed, ensures the continuing accuracy of the system.

Each piece of automated technology arrives with its own special requirements for cleaning and servicing. For routine tasks your personnel can perform themselves, the manufacturer should provide the basic training and education. But users are not qualified to perform some maintenance tasks. The equipment manufacturer must be relied upon to perform preventive maintenance and provide ongoing field support.

Taking proper care of a major piece of equipment is a lot like good car maintenance. Certain tasks you can do yourself, such as adding windshield washer fluid or maybe changing the oil, but others you shouldn't touch, such as diagnosing and fixing engine problems. And just as with your car, you should base the preventive maintenance schedule on machine utilization, not the calendar.

Medication Error Detection

Three separate logs are used for inventory tracking and control: a Controlled Substance Log, a Universal Tablet Case (UTC ) Log, and an ATC Log. The Controlled Substance Log, obviously, is kept for security purposes. The UTC Log pinpoints the appropriate placement of medications that are not in canisters for the pharmacist, who initials the inventory sheets. All trays are checked, double-checked, and proofed before the run even starts. The ATC Log documents medications stored in canisters. For security reasons, only pharmacists can place medications in dispensing equipment.

Each medication-Grube Pharmacare uses some 800-also has its own control log. Medications are logged in the moment they arrive, with documentation of the expiration dates, lot numbers, manufacturers, and pull dates. "First, make sure what goes into the machine is correct," Ketola urges.

At the end of each run, the medication strips pass through an audit station where technicians hold packages in front of a light, check contents against label descriptions, and look for any possible errors. A log sheet documents the technicians' manual corrections for a double-check by the pharmacist on duty and a triple-check before shipping. A red "X" is marked on incorrect or superfluous packages not to be used. A sticker indicating "manipulation verified by RPh" is placed on packets that were manipulated but are now safe to use.

"Because we check so thoroughly before the run," says Ketola, "we feel we can rest assured that the right medications drop into the right packets." The most common packaging issues at Grube Pharmacare are crushed pills, which Ketola finds easy to detect visually and correct before the medication is actually dispensed.

"By thorough logging and careful tracking," Ketola claims, "any automated pharmacy operation can almost eliminate its risk of equipment-related medication error." Since automation was introduced, Grube Pharmacare customers have not reported any crushed pills or wrong pills in their multi-dose packages.

Taking Control of Our QA Future

Although we have come a long way toward making automation work in everyday pharmacy operations, unresolved questions abound. Pharmacists need to check a statistically valid sample of each run, for instance, but how many final products should we check? Manufacturers, working with their customers and professional associations, will be working to develop meaningful protocols for sampling.

The ultimate question is, How can automation most wisely be deployed to improve patients' health care? The proven principles and techniques of continuous quality improvement and total quality management can make sense of raw data from the quality assurance process, assimilate it, and put it to work for improved outcomes. We pharmacists will keep our automated technologies in smooth operating condition because it is good for our patients. Yes, to err is human, but so is the endeavor to prevent and detect errors-especially considering that patient safety and well-being are our collective and paramount responsibility.

Douglas C. Josephson, RPh, FASCP
Vice President for
Western Operations
Specialized Pharmacy Services,
an Omnicare Company
Grand Rapids, Michigan

References and Footnotes

1. Specialized Pharmacy Services and the other companies highlighted in this article use the ATC Profile Automated Medication Dispensing System manufactured by Baxter Healthcare Corporation.
2. Barker KN, FelkeyBG, Flynn EA et al. White Paper on Automation in Pharmacy. Department of Pharmacy Care Systems, School of Pharmacy, Auburn University, 1997. Commissioned by the Automation in Pharmacy Initiative, a collaborative endeavor of the Academy of Managed Care Pharmacy, American Pharmaceutical Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, National Association of Chain Drug Stores, National Community Pharmacists Association, and Pharmaceutical Care Management Association.