drugs. “Based on this information we can see how impactful this has been on the ASC industry,” says Lorraine Charles-Hosten, consultant pharmacist at PharmPro Inc. in Osprey, Florida. “Some manufacturers believed if


they stopped making a low-utilization generic product, it would be more prof- itable,” Tomaka says. “To meet the new regulations, the cost of manufacturing poor-selling drug products exceeded potential profit, so some companies exited the manufacturing field and oth- ers leveraged the products they made.” Injectable drug-makers like Baxter and Hospira remained in the market because they had popular products that were highly utilized, while other companies left the market. “That led to fewer companies making drugs and, consequently, to a hike in drug prices, such as for Glycopyrrolate, which is more than 40 years old and costs 800 percent higher now,” he says. “Hikma Pharmaceuticals increased the price of Glycopyrrolate injection 800 percent in 2012 alone because it claimed it had sustained


challenges obtaining raw


material. There is little transparency, so we don’t know what the company’s sales history or bottom line look like.” Charles-Hosten agrees. “Older drugs,


like Digoxin, used to be $1.88 for 100 mg in 1984. Now, it is $100 for 100 tablets,” she says. “Tetracycline used to be pennies and now it is a couple of hundred dollars for 100 capsules. In ASCs, when they had a shortage of saline solutions, they were paying 200 to 300 percent above the normal price. I know of a center that paid hundreds of dollars for a case of saline.” There were also a lot of drug recalls around 2008–09, Tomaka says. “It had to do with the fact that FDA was holding manufacturers accountable for the new drug integrity guidelines. Homeland Security was investigating purity and integrity of drugs for potential bio-ter- rorism. And those drug recalls hit around the same time. It was a perfect storm.”


rial to a great extent from other countries before this act passed,” he says. “The FDA did not have the authority and nec- essary funds to regulate products coming from other countries. The act also gave us the power to regulate packaging—from raw material to final distribution. India, one of the fastest growing manufactur- ing countries, has a better reputation now than five years ago indirectly because of track-and-trace quality implications. But this also has led to an increase in drug prices and the exit of certain companies from the marketing field.”


The US did not investigate raw material to a great extent from other countries before the Drug Supply Chain Security Act passed in 2013.”


— Norman Tomaka, clinical consultant pharmacist


Some feel that the manufactur-


ers were gaming, he says. “In the 1980s, we needed the system to make an incentive for drugs that had very little sales—orphan drugs, such as Dantrolene, used in ASCs—to pro- tect a small population at risk for malignant hyperthermia,” he says. “In 2015, profits from some orphan drugs were incredibly high. Some found new uses and were not orphan anymore but were protected by old laws. For example, Dantrolene now has emerging utility for auto-immune diseases. Its cost has stabilized since. This added to the overall profit mar- gins of some drug manufacturers.” As the economy picked up, in 2012–13, there was an escalation of increased need that combined with lower drug supplies in place and led to more price increases.


President Obama signed the Drug


Supply Chain Security Act in 2013, and that had a positive effect on drug qual- ity, security and integrity, Tomaka says. “The US did not investigate raw mate-


■


Strategies to Contain Costs “I recommend certain


strategies to


challenge the cost experiences of key drugs for ASCs,” Sones says. They are: ■


■ ■


Maintain vendor relationships with several drug wholesalers;


partake in group purchasing oppor- tunities whenever present;


prepare drugs for administration only as close to the time of adminis- tration as possible;


assure that your antibiotic steward- ship efforts are effective and con- stantly monitored by your consul- tant pharmacist;


■ have your consultant pharmacist


provide current benchmarking data of acquisition costs for his/her facil- ities served;


■


add new drugs to your formulary when there is a perceived value clin- ically and pharmaco-economically;


■


minimize waste by purchasing in volume/strengths most likely to be used; and


■


review with FDA-registered com- pounding pharmacies opportunities for cost containment, for example, compounded ophthalmic preopera- tive drops.


Charles-Hosten recommends that


all ASCs make it a priority to have a good relationship with their drug rep- resentatives. “The ASCs are at a disad- vantage because they buy smaller por- tions and the wholesalers give more


ASC FOCUS JANUARY 2017 13


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