Disrupted drug supplies affect patient care, costs

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Across the nation, including in Pittsburgh, hospitals are experiencing drug shortages prompted by factors ranging from Food and Drug Administration-ordered shutdowns over regulatory issues to natural disasters like hurricanes to mergers by manufacturers.

"A lot of times a particular medication is only made at one facility, and if it's shut down for any reason it disrupts the supply chain," said Scott Mark, a pharmacist turned corporate vice president at West Penn Allegheny Health System who is president of the Pennsylvania Society of Health-System Pharmacists.

And when the supply chain is disrupted, hospital labor costs go up as personnel are assigned to assess and work around shortages.

More important, patients also are affected.

In a recent survey by the American Hospital Association, 82 percent of 820 responding hospitals reported they have delayed patient treatment as a result of a drug shortage. More than 60 percent said a patient had received a less effective drug or did not receive recommended treatment; 35 percent said a patient had experienced an adverse outcome.

Fortunately, no such adverse outcomes have occurred within WPAHS or in UPMC facilities served by H C Pharmacy Central, Inc., the South Side firm that handles drug acquisitions for UPMC, Armstrong County Memorial Hospital and Grove City Medical Center..

But a shortage of a leukemia drug, cytarabine, inconvenienced some UPMC patients, said Phil Nerti, director of H C Pharmacy.

"Patients were affected to the extent that some treatments were rescheduled," Mr. Nerti said. "The dilemma is you don't want to schedule [treatments] if you're not sure you're going to have the drug."

So far, cytarabine has been the drug in shortest supply for H C Pharmacy, which maintains a warehouse and which, unlike most hospital systems, buys most of its pharmaceuticals directly from manufacturers rather than wholesalers.

"If we had to pick a category, clearly the oncology segment would be the most problematic for us," Mr. Nerti added. "There are really at this point two drugs we've had to take very aggressive action for.

"Either we couldn't get them for some period of time or got such limited quantities we couldn't use the drugs as we would if we had full supplies."

As a result, he said, drug use would have been limited to patients with no therapeutic alternative. Another option to resolving a shortage would have been to change the brand or form of the drug. For example, a 200-milligram drug in shortage might be replaced by two 100 milligram doses or by taking a portion of, say, a 400-milligram dose.

Cancer drugs and injectable products such as some antibiotics or electrolytes have been problematic at WPAHS, according to pharmacy director Laura Mark.

"I would say oncology is a big player and, in particular, any of the injectable products," she said.

Oncology agents that have been on the list of those in short supply at West Penn Allegheny include fluorouracil, which is used for many cancers, including colon, rectal, breast and ovarian, and mitomycin, which also is used in multiple cancers, including stomach and pancreas.

Treatments were not delayed, but drugs have had to be shipped from one hospital to another, Ms. Mark said.

Electrolytes "that we're bouncing around right now" include potassium phosphate, sodium phosphate and calcium gluconate. Sodium phosphate is short now "because everyone is using [it] as a replacement for potassium phosphate," she said.

Injectable drugs also ranked high on a list for calendar year 2010 of the 30 most recent drug shortages, according to a study recently published online in the American Journal of Health-System Pharmacy.

The three drugs most widely reported as being in shortages were succinylcholine injection, a muscle relaxant; dextrose 50 percent, which is used intravenously to supply water and calories to the body; and epinephrine injection for severe allergic reactions.

According to the hospital survey, the most widely reported shortage by treatment category was surgery/anesthesia pharmaceuticals, with 95 percent of the institutions experiencing a shortage of one or more in the six-month period ended in June.

Clearly, drug shortages have the potential to do harm.

"The danger comes from a couple sources," said Mr. Mark, a WPAHS vice president in the information technology department who holds a doctorate in pharmacy. "They may be taking a medication that they are less familiar with or one that is not as effective for their disease state.

"Another potential source of risk is you get prescribers not as familiar with alternative medication." As a result, they may not understand side effects as well or know the dosing, he said.

For that reason, hospitals around the nation are devoting extra manpower to trying to stay ahead of potential shortages and manage them when they do occur. The labor costs associated with those efforts is estimated at $216 million per year, according to the health-system pharmacy journal report.

"They're most certainly driving up costs," Mr. Nerti said.

For example, he said, work must be done with every alternate product introduced to change "patient safety technology like bar-code scanning" to verify the dose and that it is the correct drug. "So there's an overhead cost with each of those changes.

"And then there's the entire communication process," Mr. Nerti added. "We have to prepare as if we won't have a drug even though it turns out we may end up with the drug."

West Penn Allegheny has a process called On the Horizon that involves regular online monitoring of drug supplies and wholesalers. Once a drug shortage is identified and quantified to the extent possible, staff does an assessment to determine stock on hand and, if needed, looks for alternative sources.

Personnel meet weekly, communicating with pharmacy directors of WPAHS hospitals and even with physicians who would be affected by a shortage.

Buying from alternate sources increases costs by an estimated $10,000 a month, Ms. Mark said.

Federal legislation has been introduced that would give the FDA new tools to deal with potential shortages. According to the health-system pharmacists journal study, the Preserving Access to Life-Saving Medications Act would require manufacturers to report actual or potential interruptions in production that could result in a drug shortage.

"The bill would require FDA to revise the definition of 'medically necessary' to account for drug-use factors," the journal report added. Presently, the FDA does not investigate temporary or self-limiting shortages or those restricted to a specific strength or size of the drug even though those kinds of shortages can bedevil medical facilities.

Pohla Smith: psmith@post-gazette.com or 412-263-1228.

Across the nation, including in Pittsburgh, hospitals are experiencing drug shortages prompted by factors ranging from Food and Drug Administration-ordered shutdowns over regulatory issues to natural disasters such as hurricanes to mergers by manufacturers.

"A lot of times a particular medication is only made at one facility, and if it's shut down for any reason it disrupts the supply chain," said Scott Mark, a pharmacist turned corporate vice president at West Penn Allegheny Health System who is president of the Pennsylvania Society of Health-System Pharmacists.

And when the supply chain is disrupted, hospital labor costs go up as personnel are assigned to assess and work around shortages.

More important, patients also are affected.

In a recent survey by the American Hospital Association, 82 percent of 820 responding hospitals reported they have delayed patient treatment as a result of a drug shortage. More than 60 percent said a patient had received a less effective drug or did not receive recommended treatment; 35 percent said a patient had experienced an adverse outcome.

Fortunately, no such adverse outcomes have occurred within WPAHS or in UPMC facilities served by H C Pharmacy Central, Inc., the South Side firm that handles drug acquisitions for UPMC, Armstrong County Memorial Hospital and Grove City Medical Center.

But a shortage of a leukemia drug, cytarabine, inconvenienced some UPMC patients, said Phil Nerti, director of H C Pharmacy.

"Patients were affected to the extent that some treatments were rescheduled," Mr. Nerti said. "The dilemma is you don't want to schedule [treatments] if you're not sure you're going to have the drug."

So far, cytarabine has been the drug in shortest supply for H C Pharmacy, which maintains a warehouse and which, unlike most hospital systems, buys most of its pharmaceuticals directly from manufacturers rather than wholesalers.

"If we had to pick a category, clearly the oncology segment would be the most problematic for us," Mr. Nerti added. "There are really at this point two drugs we've had to take very aggressive action for.

"Either we couldn't get them for some period of time or got such limited quantities we couldn't use the drugs as we would if we had full supplies."

As a result, he said, drug use would have been limited to patients with no therapeutic alternative. Another option to resolving a shortage would have been to change the brand or form of the drug. For example, a 200-milligram drug in shortage might be replaced by two 100 milligram doses or by taking a portion of, say, a 400-milligram dose.

Cancer drugs and injectable products such as some antibiotics or electrolytes have been problematic at WPAHS, according to pharmacy director Laura Mark.

"I would say oncology is a big player and, in particular, any of the injectable products," she said.

Oncology agents that have been on the list of those in short supply at West Penn Allegheny include fluorouracil, which is used for many cancers, including colon, rectal, breast and ovarian, and mitomycin, which also is used in multiple cancers, including stomach and pancreas.

Treatments were not delayed, but drugs have had to be shipped from one hospital to another, Ms. Mark said.

Electrolytes "that we're bouncing around right now" include potassium phosphate, sodium phosphate and calcium gluconate. Sodium phosphate is short now "because everyone is using [it] as a replacement for potassium phosphate," she said.

Injectable drugs also ranked high on a list for calendar year 2010 of the 30 most recent drug shortages, according to a study recently published online in the American Journal of Health-System Pharmacy.

The three drugs most widely reported as being in shortages were succinylcholine injection, a muscle relaxant; dextrose 50 percent, which is used intravenously to supply water and calories to the body; and epinephrine injection for severe allergic reactions.

According to the hospital survey, the most widely reported shortage by treatment category was surgery/anesthesia pharmaceuticals, with 95 percent of the institutions experiencing a shortage of one or more in the six-month period ended in June.

Clearly, drug shortages have the potential to do harm.

"The danger comes from a couple sources," said Mr. Mark, a WPAHS vice president in the information technology department who holds a doctorate in pharmacy. "They may be taking a medication that they are less familiar with or one that is not as effective for their disease state.

"Another potential source of risk is you get prescribers not as familiar with alternative medication." As a result, they may not understand side effects as well or know the dosing, he said.

For that reason, hospitals around the nation are devoting extra manpower to trying to stay ahead of potential shortages and manage them when they do occur. The labor costs associated with those efforts is estimated at $216 million per year, according to the health-system pharmacy journal report.

"They're most certainly driving up costs," Mr. Nerti said.

For example, he said, work must be done with every alternate product introduced to change "patient safety technology like bar-code scanning" to verify the dose and that it is the correct drug. "So there's an overhead cost with each of those changes.

"And then there's the entire communication process," Mr. Nerti added. "We have to prepare as if we won't have a drug even though it turns out we may end up with the drug."

West Penn Allegheny has a process called On the Horizon that involves regular online monitoring of drug supplies and wholesalers. Once a drug shortage is identified and quantified to the extent possible, staff does an assessment to determine stock on hand and, if needed, looks for alternative sources.

Personnel meet weekly, communicating with pharmacy directors of WPAHS hospitals and even with physicians who would be affected by a shortage.

Buying from alternate sources increases costs by an estimated $10,000 a month, Ms. Mark said.

Federal legislation has been introduced that would give the FDA new tools to deal with potential shortages. According to the health-system pharmacists journal study, the Preserving Access to Life-Saving Medications Act would require manufacturers to report actual or potential interruptions in production that could result in a drug shortage.

"The bill would require the FDA to revise the definition of 'medically necessary' to account for drug-use factors," the journal report added. Presently, the FDA does not investigate temporary or self-limiting shortages or those restricted to a specific strength or size of the drug even though those kinds of shortages can bedevil medical facilities.


Pohla Smith: psmith@post-gazette.com or 412-263-1228.


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