Hospitals grapple with drug shortage
A nationwide shortage of key drugs has forced local hospitals to get creative in their treatments of some diseases, including cancer.
“We haven’t run out of anything crucial,” said Becky Caswell, assistant director of pharmacy at Southwest Washington Medical Center.
But the hospital has had to ration, opt for more expensive alternatives to preferred drugs, and work carefully to plan cancer treatments and surgeries with doctors.
Drugmakers say the shortage is the result of tougher federal safety rules, which have prompted them to review manufacturing processes and take some drugs off the market. Consolidation and competitive pressures within the pharmaceutical industry have exacerbated the shortage.
The result: area hospitals have become increasingly vigilant over their use of medication, as they watch to make sure that essential drugs don’t run out.
So far, that has not happened, said Kathy Stoner, pharmacy services director for Legacy Health, which operates Legacy Salmon Creek in Vancouver. But doctors and nurses have been forced to use second-choice medications.
For example, when a preferred anti-convulsant became scarce, Legacy began to use another effective treatment — phenytoin — that can cause tissue damage when it escapes from an intravenous tube.
“We have nurses who weren’t practicing last time phenytoin was in use,” Stoner said. “There was some education needed about the right dose for the drug and how to give it so it’s safe for patients.”
When shortages spur a substitution, patients usually do not even know there was another option.
While local hospital officials say they are unaware of postponed or canceled treatment linked to unavailable drugs, vaccine shortages have affected preventive health. Southwest Washington Medical Center has not had the shingles vaccine in stock since December, and does not expect the next order to arrive until June — despite six pending prescriptions from patients who would like the shot.
Part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies as they respond to the federal government’s crackdown on drug safety. The quality issues can range from finding toxins and “particulate matter” in medicines to workers inaccurately filling out the required paperwork to verify that the drugs, as well as the devices used to intravenously deliver the products to patients, are safe and effective.
Even after a company restarts production of a drug, it takes time for a plant to catch up to the back orders. And injectable drugs in particular, unlike pills and tablets, tend to require long lead times to produce.
There are about 150 drugs — triple the number from just five years ago — that are in short supply, according to the American Society of Health-System Pharmacists, a trade group that works with hospital pharmacists on ways to deal with the shortage. About 60 of those are considered by federal health officials as “medically necessary,” and they include prescription medicines used to treat or prevent a serious disease or medical condition.
Challenging climate
Legacy Salmon Creek has experienced difficulties in obtaining about 75 drugs that it has ordered over the past year.
It’s a challenge to know which drugs will be available, despite industry efforts to publicize supply problems.
“Sometimes we find out when we go to order something, sometimes we know sooner,” said Caswell of Southwest Washington Medical Center. Several times the hospital has had to implement immediate changes to its formulary, or guide to preferred drugs.
Changing a formulary can be a complex process because it requires communication among doctors, nurses and pharmacists.
Drugmakers say they are obeying tougher safety rules put in place by the U.S. Food and Drug Administration, which has intensified scrutiny to avoid allowing unsafe medicines on the market. The FDA came under fire for its role in monitoring the blockbuster pain pill Vioxx, which was pulled off the market in 2004 by its manufacturer, Merck & Co., after the drug was linked to heart attacks and strokes.
The drug shortage is being exacerbated by consolidation in the pharmaceutical industry, which leaves fewer companies making drugs.
In addition, some drug companies have exited the business of making older, generic injectable drugs, which typically aren’t as profitable as newer brand-name medicines. That puts additional production pressure on the remaining makers of these generic treatments.
Take propofol, a popular anesthetic for surgeries and other medical procedures. Teva Pharmaceuticals Ltd. decided to exit the propofol business last year following a quality issue with the drug in 2009. In a statement, the company said it believed its “existing, approved technology is not suitable to ensure that we can consistently produce the product to Teva’s high quality standard.”
Teva’s decision came around the time another propofol maker, Hospira, had to stop shipping the drug due to quality issues in its production process. Last summer, the FDA allowed Hospira to begin production again. But the company said it needed time to ramp up production and fill back orders.
Teva also makes generic forms of certain cancer medications. When quality issues temporarily closed its plant in Irvine, Calif., in April, medical professionals were faced with limited supplies of an array of cancer drugs.
The drug shortages have gained the attention of members of Congress. Earlier this month, Sens. Amy Klobuchar, D-Minn., and Bob Casey, D-Pa., introduced legislation that would require drugmakers to give the FDA an early notification “when a factor arises that may result in a shortage,” according to a joint statement.
“Several major hospitals in our state have experienced shortages that are jeopardizing patient care, and this bill will provide the knowledge required to help address and prevent future shortages,” Casey said. “Knowledge is one of the most important tools for combating problems associated with drug shortages, which are a growing threat to public health in Pennsylvania and across the U.S.”
Hospitals are finding ways to deal with the lack of availability.
Legacy, which has five hospital campuses and a number of clinics, has moved products in short supply from one hospital to another, Stoner said. The hospital has also ordered some medications direct from the manufacturer at greater price than buying through a wholesaler, in order to guarantee shipment.
Turning to secondary suppliers when a primary source for drugs runs out has caused some hospitals to pay double or more for certain drugs.
In Illinois, Advocate Health Care pharmacists had to buy certain dosages of the drug neostigmine, used to reverse the effects of “paralyzing agents” commonly used in surgeries, for $11.50 per vial compared with the usual price of $1.50 to $6.50 per vial from their primary wholesaler, which ran out of the medicine.
Escalating prices are of major concern for those watching the nation’s ever-rising cost of health care, but pharmacists say they’re just relieved that so far their ability to offer treatments has not been substantially altered.
“I’m not worried at this time,” Caswell said, “but you never know.”
Ontario Liberals gear up to battle Shoppers Drug Mart again
Less than a year after trouncing Shoppers Drug Mart in a public fight over prescription costs, Dalton McGuinty’s government is gearing up to do battle again. This time it’s over the pharmacy giant’s attempt to establish its own line of generic drugs.
Last week, the government sought leave to appeal a court ruling that overturned its ban on “private labels” – a ban aimed most obviously at Shoppers, though it would also thwart similar efforts by Rexall. The Liberals are buying time while they decide whether to go back to court or write new legislation that trumps the ruling.
Even among many of those familiar with the issue, the government’s motivation for bothering with either option is a minor mystery. Health Minister Deb Matthews got what she wanted last year – a much lower price for generic drugs, achieved by eliminating the “professional allowances” paid by manufacturers to pharmacies in return for stocking their products. Why would she begrudge efforts by the chains to recoup some of the revenues they lost through those reforms, since their private-label drugs would still be sold under the new set price?
Little credence is given to the argument, made previously by the government, that it would be dangerous for pharmacies to have vested interests in which drugs are dispensed. Generics are by their nature the same, so it really doesn’t matter which are used to fill prescriptions.
Neither is the government all that concerned with protecting independent pharmacies, even though private labels would enhance Shoppers’ (and Rexall’s) already considerable competitive advantage. Ms. Matthews made plain last year that she thinks the province has more pharmacies than it needs, and there’s no indication she’s changed her mind.
The real worry, it seems, is about the future of a domestic industry that on its face seems less sympathetic: generic-drug manufacturers.
The private-label strategy hinges on chains striking (possibly exclusive) deals to get drugs at a wholesale price that’s only a fraction of the sale price, which has been capped at 25 per cent the cost of the brand equivalent. For now, those deals would be with domestic suppliers. But it’s widely believed that, to get the best deals, the chains would soon outsource overseas – likely to India.
A cynic would suggest the Liberals are looking out for Bernard (Barry) Sherman – the chairman and CEO of Apotex, the largest domestic manufacturer. Mr. Sherman cuts an influential figure, and it’s not been lost on some observers that Apotex is a political donor.
A more charitable explanation is that the government is worried about jobs. Combined, the province’s generics companies employ about 8,000 Ontarians, and many of them could wind up out of work.
Then there’s costs. Particularly with the lower prices, the government – which foots the bill for prescriptions bought on its public plan – wants generics to replace brands as quickly as possible. And if the domestic industry declines, that could take longer.
Mr. Sherman is extremely aggressive in challenging patents, and willing to pay the very large legal costs. If he’s out of the picture, it remains to be seen if the chains themselves will step into the void. And it’s also uncertain whether generics manufactured in India or elsewhere would take longer to get regulatory approval.
If generics take longer to come to market, the extra year or two of paying for brand drugs could wipe out some of the savings achieved through last year’s reforms.
A final factor is the availability of the small number of generics that offer minimal profit, because they’re more expensive to produce. There’s already concern that the price cap is affecting that supply. And with a shrinking industry, it could become even more scarce.
That, at least, is what some insiders argue. Of course, there’s a much simpler explanation for the Liberals’ eagerness for renewed hostilities: getting even.
Although they won the last war, Liberal MPPs still hold a grudge over the massive public relations campaigns that Shoppers waged against them in their ridings. So there’s a certain degree of enthusiasm for scorched earth.
If last year showed anything, it’s that picking on the poster child for aggressive retail expansion makes for good politics. But one would like to think the government has something a little nobler in mind.
Report: 50% of pharma serializing in 2011
IDC is bullish on drug serialization. The market researcher says in a report that it expects about 50 percent of the industry to have fully serialized at least one product line to the item level by the end of 2011.
The driver will be big pharma companies preparing for the 2015 deadline of the California Board of Pharmacy serialization mandate and similar upcoming regulations worldwide, says Pharmaceutical Commerce. A U.S. national serialization and pedigree program remains an FDA discussion item. The agency held a public workshop on system attributes for drug track and trace in mid-February. The effort is in line with similar activities in Europe, reports the Association for Automatic Identification and Mobility (AIM).
Many companies are encoding data matrix symbology on preprinted labels, says AIM. And several are embedding RFID tags in labels and encoding them on-the-fly. Mechanics aside, however, housing, managing and securing these data remain challenges. And some non-manufacturing parts of the drug supply chain, including retailers, maintain resistant.