Chemo calls for cautionary software

Far from the front lines of emergency or operating room medicine exists the pristine quarters of Rhode Island Hospital’s IV Services Preparation Area, where all chemotherapy potions for inpatient and outpatient, adult and pediatric patients, are prepared.

One such medicine is Cytoxan, and as Christine Berard, the hospital’s manager of pharmacy operations and systems, types in an order for the drug, a red warning light suddenly pops onto the screen, alerting her that the dosage she typed exceeds the drug’s recommended regimen ceiling.

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It’s a simple idea with radical implications – computer software that will detect prescribing errors for chemotherapy medications and protect cancer patients from being given the wrong dose or the wrong drug.

Having such safeguards with such highly toxic medication is “extremely important,” said Chuck Mahoney, director for pharmacy services and materials management at Rhode Island Hospital.

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For unlike a milder drug such as an antibiotic where a double dose probably wouldn’t hurt you, a double dose of chemotherapy can kill. “There’s a smaller window of tolerance,” Mahoney said. “Your room for error is much, much smaller.”

According to the 1999 report by the Institute of Medicine of the National Academy of Sciences, (IOM), more than 7,000 deaths are caused every year by medication errors.

That report also found that 50 percent of hospital medication errors stem from the prescription-ordering process, and recommends using computerized order entry and pharmaceutical software and other technologies to prevent mistakes.

It’s become such a national issue, Berard said, that the lead story in last month’s issue of CIO magazine (for information executives) was about using information technology to reduce medication mistakes.

But hospitals have been slow to adopt the technology, according to the IOM, even though “a computerized system costing $1 million to $2 million could pay for itself in three to five years, while preventing injury to hundreds of patients each year.”

Rhode Island Hospital’s version is called Oncoware Rx, a trademarked computer program “home-grown” at the hospital a dozen years ago to provide pharmacists with automated safeguards to meet the unique demands of pharmacy oncology arising from the sheer complexity of chemotherapy.

Oncoware provides features not currently commercially available, said Berard, a leader of the team that developed the system, which is used for inpatient and ambulatory patients at Rhode Island, Hasbro Children’s and the Miriam hospitals.

Its special safety functions include automatically checking the dose of each drug order against the maximum dose ceiling programmed into the software.

Dose ceilings, also called maximum doses, prevent medication errors by informing the pharmacist immediately of a potential problem, as in the aforementioned situation when the computer displayed a “red alert” when Berard’s order exceeded the established ceiling.

Oncoware has four limits built in, for total daily dose, daily dose per meter squared – which is especially important for pediatric patients – total regimen dose and total regimen dose per meter squared.

The software also provides access to a patient’s previous chemotherapy medication history and other critical clinical data required to ensure proper drug therapy, as well as providing the pharmacist with special drug information needed to monitor and prepare chemotherapy, Mahoney said.

It also automatically performs at all calculations, prints a worksheet that provides instruction for the pharmacists to properly prepare the drug and prints a label that includes any special warnings for nurses and physicians.

Rhode Island Hospital pharmacists have been fully operating the software for about seven years, a full two years before the tragic and landmark chemotherapy mistake at Dana-Farber Cancer Institute, that Berard calls “the error that shook the world.”

In the fall of 1994, Boston Globe health reporter Betsy Lehman, 39, received four times the prescribed dosage of a toxic, experimental anticancer medication – a resident had mistakenly prescribed the total four-day dosage to be given daily for each of the four days. She died three weeks later of heart failure caused by the massive overdose.

Rhode Island Hospital implemented the program because of “the complexity of this type of therapy,” Mahoney said, realizing that in addition to having pharmacists specifically trained in cancer drugs “that we would need basic computer checks as well.”

Mahoney, who served as a consultant to Dana-Farber after the Lehman tragedy, said Rhode Island Hospital has also reviewed its systems practice standard and decided orders could no longer be given verbally but had to be placed on a specialized form, which are also double checked to ensure that not only is the dosage right but also the method of application. Some cancer drugs can be given intravenously and some intrathecally, through the spine. Mix-ups here can also be deadly, he said.

Oncoware Rx has been available to other health care facilities since 1996 and to date, 42 hospitals and health care systems across the country have obtained this software for use in their cancer programs, Berard said. Because the hospital only charges a nominal fee to cover initial support, the program is “quite affordable” at $2,500 — a small amount when you think that “one dose of chemotherapy is about $1,000.”

Berard, who is chairwoman of the National Pharmacy Committee for Cancer and Leukemia, a National Cancer Institute research group, said Oncoware fulfills 100 percent of the safety criteria recommended by the Institute of Safe Medication Practices.

Many hospitals, including Dana Farber, have developed their own, homegrown systems, Berard said, but for those who haven’t, an already refined program like Oncoware is the perfect, inexpensive solution. “I think a lot of people don’t know there is affordable software out there,” she said, although the IOM also reported last year that of the one-third of hospitals nationwide that have installed computer-order-entry systems, only 1 percent require physicians to use them.

“Not all hospitals are doing what they should be doing,” Berard said. “There are still errors occurring.”

Newport Hospital, like Rhode Island and Miriam a Lifespan Hospital, has also begun a system to better track and reduce medication errors.

In April, the hospital put together a multi-disciplinary team of 10 — two doctors, a pharmacist, a risk manager, a nurse administrator, three nurse managers, a nurse educator and a staff nurse — to meet once a month to maintain quality improvement.

According to nursing administrator Nancy Towers, the team adopted the National Coordinating Council for Medication Error Reporting and Prevention’s definition of medication error and then created one reporting form for all departments that are involved in the medication process. The form rates situations according to severity.

They are also working with new software called MedMARx to help the hospital track medication errors.

As America gets grayer and technology increases the creation and use of drugs, medication checking software is only going to get more important, Mahoney said, adding that the last he heard, the number of prescriptions is expected to increase by several million over the next couple of years. “That leads us to believe we’re going to have to continue to refine our prevention systems.”

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