By CRAIG FREILICH

POTSDAM -- Local hospital officials say the reported nationwide shortage of some drugs, including some critical life-sustaining drugs, is more serious now than at any time since shortages began reaching a point of concern about two years ago.

“Yes, there is a shortage of some drugs,” said Canton-Potsdam Hospital’s Vice President for Administrative Services Marlinda LaValley. “It's not new. It's been going on for a couple of years, but it's worse now.”

However, LaValley said, so far, “We have not experienced the severity that other organizations are experiencing.”

The shortages have reached a level where the Medical Society of the State of New York late last month declared “a state of emergency regarding the national shortage of life-saving and life-sustaining medicines that have impacted patients in New York.”

“There continue to be challenges,” LaValley said. “This is the worst it has been since this began a couple of years ago. The problem has existed for at least that long.”

The Wall Street Journal reported in July that more than 80 percent of hospitals surveyed by the American Hospital Association said they had to delay treatment, and nearly 70 percent said patients received less effective substitute drugs, due to the shortages.

According to the state medical society, the shortage involves more than 180 drugs, particularly concerning “sterile injectable medications, chemotherapy agents, anesthetics used for patients undergoing surgery, drugs needed for emergency medicine, electrolytes needed for patients on IV feeding, and other critical medications.”

“There are many factors that contribute to drug shortages, including, but not limited to, manufacturing issues and economic forces,” said U.S. Food and Drug Administration spokeswoman Shelly Burgess.

Staying Ahead of Problems

LaValley said the pharmacy and staff from other units at Canton-Potsdam Hospital so far have been staying ahead of the problem.

“We've been proactive in educating staff about alternatives to some of the drugs that are in short supply.

“We've also worked to find alternatives or order medications in different fashion. For example, in some cases we have been ordering some drugs in ampules versus vials. We have switched, for some medications, to ampules,” which can be a little harder to work with, but are more readily available.

They have also made available to staff “narcotics conversion information,” educating staff about equivalent drugs and dosages.

One significant challenge around the country is with chemotherapy drugs, “but we have had no pattern of difficulty with chemotherapy agents yet,” LaValley said.

“We were careful to review crash carts” -- which hold emergency medicines that can be moved quickly where they are needed -- “and find substitutes where necessary.”

And LaValley said hospital staff have worked with local EMS personnel “on a plan of action to address critical shortages, but we have never needed to activate the plan.”

In such a situation, there are frequently people who will want to take advantage of a shortage.

“There are a number of third party sellers who have some of these meds for sale at rather dramatically higher prices, but we have not had to go there,” LaValley said.

“So far we've been successful” in coping and finding substitutes, LaValley said. “It ebbs and flows.”

Manufacturing, Other Issues

FDA says that manufacturing and quality issues have contributed to the shortages. Correcting process problems and maintaining quality can be significant expenses. Production delays or quality breakdowns at the manufacturer’s sites can create gaps in supply. Delays, shortages, or shortcomings in raw materials or components needed in manufacture will have an effect, FDA says.

“Discontinuations are another factor contributing to shortages,” Burgess said. “FDA can't require a firm to keep making a drug it wants to discontinue.

“Drug manufacturers have a responsibility to manufacture quality drugs and to have a process to ensure supply continuity of drugs that will have a public health impact if discontinued,” the FDA’s Burgess said, but at the same time, “the agency has no legal authority to compel drug manufacturers to manufacture or continue to manufacture a drug.”

Nor do manufacturers have to inform authorities when a drug’s supply might be delayed or discontinued.

The Wall Street Journal article said that many of the drugs in short supply are generics that are not highly profitable. That leads some to believe that when manufacturers run into problems with such a product, they are more likely to drop it and focus on more profitable items.

“Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs,” said Burgess.

“With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities,” according to Burgess.

“This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs.”