Virginia Herold is the executive officer of the California State Board of Pharmacy. In her role there, Herold works closely with and advises the 13 Board of Pharmacy members in the development of policy and in the administration of the board’s enforcement, licensing and regulatory programs to further the board’s consumer protection mandate. The Board regulates over 130,000 licensees in 13 separate regulatory programs including pharmacists, pharmacies and drug wholesalers.
Herold talked at the Pew Health Group After Heparin conference in March about finding recalled heparin in California hospitals during the 2008 heparin crisis and how the state has moved to prevent future safety failures. I caught up with her again last week to talk about how recalled drugs get back into the drug supply, why counterfeits can be so hard to track down, and how we might begin to fix the system.
PS: Your talk at the After Heparin conference in March showed a recall system that is really broken – nearly 8,000 patients in California were exposed to heparin after the recalls began. How did such a broken system become the standard, and how do we start to fix it?
VH: I’m not certain what the solution is. However, we do know wholesalers and pharmacies do not track drugs by lot number or expiration date, which is how manufacturers issue recalls. The manufacturer will release the lot number and expiration date—info that isn’t really available to the wholesaler and pharmacist except by a visual check. That is very difficult given the large number of drugs moving through the pharmaceutical supply chain, and especially considering number of recalls we’re having now.
Secondly, the distribution systems are relatively complex, especially in a hospital setting. Some drugs are in the pharmacy. Some are outside the hospital pharmacy on the floor in carts. Some are on Pyxis machines.
A perfect example of the complexity of a recall call is [last week’s] recall of Tylenol, which is an over-the-counter product, but the recall complexity is similar. Right now, some of those products are in transit — in boxes, crates or pallets on trucks. Two days from now when those trucks unload those drugs, unless they are caught on the other end, may not be pulled as part of the recall (because the recall occurred Wednesday, and the receiver of the drugs missed the search review that happened Wednesday or figures the recalled drug product would not have been shipped.)
And we’ve learned that even when recalled drugs are returned to the wholesalers as part of the recall, they may be inadvertently placed back into active stock and then reshipped to new pharmacies. We saw three instances of this with the heparin recall, where a batch of the returned drug isn’t quarantined, and then, because it is still part of active stock, the recalled product was shipped to another hospital.
Another problem is the use of the world “voluntary” on a manufacturer’s recall notice. The manufacturing companies initiate these recalls, sometimes after the FDA finds a problem and asks them to recall a drug, more often on their own. If a problem appears and the manufacturer doesn’t act, the FDA can take action, but it rarely does this.
Typically the manufacturer “voluntarily” recalls the drug from the supply chain. Recalling a drug is perhaps the most sensitive thing companies will do. And so recall notices are carefully worded, and often use the word voluntary. But when that recall notice lands on the pharmacist’s desk, he or she doesn’t always recognize that it doesn’t mean voluntary on the part of the pharmacy to take action. It means the pharmacy should take action to remove it, and not dispense it to patients.
I think we need to recognize upfront that the recall system needs to be in the hands of the FDA as the regulator. You don’t want every state to set up its own separate system. Drug distribution is national, it needs a national solution.
PS: There’s been a lot of talk in the last week or so about drug shortages and FDA’s role in them. How do shortages figure into this equation?
VH: Sometimes the recall of a drug could cause a shortage of a drug for practitioners and patients. Other times a shortage may be due to other factors. One issue here is an ethical question: what if a recalled drug is the only drug appropriate for treatment and there is no other substitute drug available? If the removal of the drug from the market is done for a health care reason, and it’s a necessary drug, is it better to have a contaminated drug, or no drug at all? Should the recalled drug be provided in such circumstances, and what type of consent should occur if this is the only lifesaving solution?
How do you decide? Should there be some consent form for patients facing a severe condition and their providers that says: this drug has been recalled but there are not other options available? These questions are way out of my pay grade–the FDA should be deciding that.
The FDA’s in a tough spot, too. They are expected to keep the drug supply safe, but with all the manufacturing of drug products and ingredients off-shore, they don’t have the resources to inspect everything worldwide. If you are the patient that needs a drug or a treatment, you want anything that’s available anywhere in the world that will help you. But in the U.S., the FDA has to approve the drug before it is sold.
PS: In the case of heparin, I understand FDA asked Baxter to wait on a full recall until enough alternative supply could be procured. How do you think about potentially contaminated drugs that may have still been in circulation?
VH: In April or May 2008, we somehow heard that 50 percent of the total heparin products were unavailable due to the multiple recalls. Actually, we discovered recalled heparin still in California hospitals after the recalls because we were beginning to have concerns about the shortage of this drug.
In late March 2008, a pharmacy director told me they had received a fax in the pharmacy offering heparin at $130 for an amount they used to pay $8 for. Such offers concern us as regulators, because it immediately connects – we probably have unlicensed activity and possibly counterfeit or diverted drugs. If the licensed wholesalers cannot obtain a drug, where is this supplier getting the drug?
So we started off by inspecting 40 hospitals. We thought we were going to find counterfeit heparin in the hospitals and unlicensed sales to hospitals. Instead, we found recalled heparin in 40 percent of them. We never even got around to searching for counterfeit drugs because we were so concerned about the recalled supply still in hospitals, and a climbing death count nationwide from exposure to it.
PS: As I understand it, right now pharmacies and distributors don’t have to tell the FDA when they suspect a drug has been stolen or adulterated.
VH: In California, if someone has knowledge of, or reason to believe a drug has been adulterated or counterfeited, they are required to report that to the Board of Pharmacy.
PS: And at the Board, are you required to tell the FDA?
VH: I am not aware of a specific law requiring this, but by practice we tell the FDA everything of such a nature that we find. They have bigger field of vision — and if it’s happening in California, there’s a pretty good chance it’s not just in California.
In terms of counterfeit prescription drugs, we have had some rare problems here stumbling upon a couple of counterfeit drugs. It is hard to detect a counterfeit drug. There’s nothing in a pharmacy that shines for us with neon light saying:” This is a counterfeit, come over here!” In some cases, a patient will stop responding to a medication. Usually when that occurs, no one even suspects the efficacy of the drug itself. More typically the therapy is no longer working, switch to a new one.
Right now California, like the rest of the nation, has a problem with prescription drug abuse. This means there is high demand for certain types of prescription drugs, which leads to drug diversion from the supply chain.
And the economy is bad. So some of our licensees may get offered a great deal on a drug from someone they don’t normally do business with. Nobody stops to think ‘Why am I getting this good deal?’
People trust the drug supply in the U.S. But when drugs are bought and enter the supply chain by any of the supply-chain partners through unauthorized means, it’s hard for the other partners to identify this. It is like buying that TV out in the Wal-Mart parking lot: It’s a good deal! But we need to ask why it is a good deal.
PS: How does California’s e-pedigree law fit in?
VH: We believe that this will greatly aid all supply chain partners in ensuring the visibility and lineage of where a particular drug container has been: who has owned it at every step, back to the manufacturer. The system requires a certification of each sale and purchase down to the pharmacy level that will make it harder to introduce drugs at any transaction in the pharmaceutical supply chain. This information will be available by reading a code on the container. There is a need to review information readily, and in a certified way, that holds everyone accountable. A weak link in the supply chain undoes all the security, compliance and care that’s been used by other supply chain partners.
We don’t want the quality of the drug supply in the U.S. to come into question the way it has in some other countries. The U.S. still has a strong secure drug system, but we see some faults in it, and we are working to plug these.
The public doesn’t need to be afraid or overly suspicious of their drug supply—they just need to be a bit cautious. And to beware of Internet drug buys where you can obtain drugs without a prescription or from an unlicensed pharmacy. A great deal of counterfeit medication is obtained this way.
–interview by Kate Petersen, PostScript blogger