The pharmaceutical supply chain is broken, but if you’re facing a drug shortage, you have more power than you think.
By the time people get to Laura Bray, they’ve been failed by the US government, all of its agencies, and the entire global pharmaceutical supply chain.
So when someone calls her at Angels for Change, the patient advocacy organization she founded in 2019 with a mission of ending drug shortages, one of the first things Bray does is reassure them that they’re not the problem. “I want you to know that drug shortages are real. You deserve access to their medicine,” she tells them. “And it’s not their fault, and somebody should have done better. And they all cry,” she says.
Bray gets it. When her young daughter was getting leukemia treatment, one of the chemotherapy drugs she needed was unavailable due to a global shortage. She was stunned: A professor of business in Tampa, Florida, she knew other distribution channels weren’t nearly so brittle. A bank about to run out of cash would never be allowed to fail. Redundancy and resilience is built into our monetary, food, and oil supply chains, she thought, “but it’s just not there for pharmaceuticals. Why?”
Five years later, drug shortages in the US are at a 10-year high. The putative reasons are manifold: As the Food and Drug Administration has scrambled to catch up on inspections of routine drug manufacturing facilities in the wake of pandemic closures, the deficits they’re finding — and the production delays they’re leading to — are piling up all at once, says Erin Fox, a doctor of pharmacy and medication shortage specialist at the University of Utah, whose drug information service provides content to a drug shortage database run by the American Society of Health-System Pharmacists (ASHP). Simultaneously, a large chemotherapy drug plant shut down due to quality problems; opioid settlement rules have reduced pharmacy ordering capacity for controlled substances, including ADHD drugs; and rising rates of syphilis are chewing through an already-low supply of injectable penicillin.
The real reason shortages keep happening, says Bray, is because patient outrage never reaches the supply chain. She’s on a quest to change that: After thousands of phone calls eventually got her daughter the treatment she needed, she created an organization aimed not only at serving individuals’ medication needs but at unifying their voices to demand better.
Few people have the time or the background to spend hours on the phone with hospitals, pharmacies, lawmakers, and pharmaceutical companies to get a medication. And while there’s been more awareness about drug shortages in the past year than the US has seen in some time, they’re not going away any time soon.
You can and should get hopping mad about drug shortages. And if you’re affected by one yourself, you have more power than you might think when it comes to getting the medication you need.
Broken financial incentives and a lack of transparency are at the heart of drug shortages
Fundamentally, shortages are related to problems that decrease a drug’s supply and increase its demand. Most shortages are rooted in supply problems — and in about two-thirds of cases that the FDA reports in its own drug shortage database, Fox says, quality problems at a manufacturing facility are at the heart.
Many of the quality problems affect the production of generic drugs, which are both most commonly used and cheapest for consumers. “It’s just a race to the bottom with these companies trying to gain market share,” says Fox. Pharmaceutical companies make so little money on generics that many eventually either stop making them, cut corners on quality, or opt not to upgrade the facilities that produce them. All of that makes production lines that produce generic drugs particularly vulnerable to shutdown — which, because the drugs are used so widely, ends up affecting a lot of people.
[Related: The ongoing, unnecessary Adderall shortage, explained]
Profit considerations also have a lot to do with the other one-third of drug shortages that the FDA reports, says Fox, which include related production stoppages unrelated to quality. For example, if a manufacturer can produce a more profitable drug in the same plant where it produces a less profitable drug, it might simply choose to make more of the one that nets more money. Nobody can force the company to make the less profitable drug.
Production problems related to raw material shortages or natural disasters — like Hurricane Maria, which shut down a Puerto Rico factory that made bags of saline, and a tornado that hit a Pfizer plant in North Carolina — can also cause big disruptions in the drug supply.
These shortages would be a problem even if there were a robust system for reallocating the drugs they affect. But that system doesn’t exist, says Mariana Socal, a physician and researcher who studies the US pharmaceutical industry at Johns Hopkins University’s Bloomberg School of Public Health. Part of the reason: Nobody outside the FDA knows exactly where the problems are.
“There’s no transparency” around what triggers any one shortage because private entities are allowed to keep that information under wraps, says Socal. She thinks about drug shortages every time she unpacks her groceries: “A box of fruit or vegetables says ‘Produced in California’ or ‘Origin: Mexico,’” she says, but you have no idea where a container of generic Tylenol came from or whether you can feel confident in the product.
The opaqueness of the production system, and the absence of a method for equitably allocating drugs when there is a shortage, means that only the savviest pharmacies get what’s left of a drug supply when it’s running low. “It’s like Hunger Games,” says Fox. “Whoever can order ahead, whoever has the most resources to kind of hear about a shortage first, to try to put in as many back orders with different companies as possible — those places are more likely to get some product in.”
Fox has tried to change this herself. Ten years ago, when there was a spate of pediatric cancer drug shortages, she asked the FDA and pharmaceutical companies to reserve the remaining drug supply for sale only to pediatric cancer centers. “Everyone was like ‘Oh, it’s a free market — we can’t tell these manufacturers what to do,’” she says.
So when waves of illness increase the demand for certain drugs — as surging syphilis rates have done for penicillin, and as cold and flu season does for fever reducers and amoxicillin — consumers are left holding the (empty) bag.
Jesse Ehrenfeld, a physician and current president of the American Medical Association, says solving drug shortages requires a multipronged approach. Any fix should prioritize developing more capacity for producing key medications, putting plans in place to minimize supply chain disruptions, creating a larger pool of generic drug manufacturers, and changing FDA processes to allow more drugs into the marketplace.
There’s hope for seeing some of this happen: Despite the US government’s reluctance to regulate private business — especially in industries with powerful lobbies — Fox says there’s been more advocacy before Congress on drug shortages this year than she has seen in her two decades following the issue.
Much of the draft legislation is what Bray describes as “pet projects”: bills too narrowly focused on one part of the supply chain to really fix the problem. However, she was pleased to see a more robust approach in a white paper the Senate finance committee recently released and says the Senate energy and commerce committees have also been doing good work.
Bray also says the White House plan to address drug shortages announced in late 2023 is a good start. Notably, that plan proposed designating a government employee to provide the service Bray has been providing for people who reach out for help. Currently, she is the only person she knows of who directly links people affected by drug shortages with emergency supplies of their medications — and she’s a private individual, effectively a one-woman operation, alone in a Tampa office park except for a single employee who helps her with social media. “I could do it so much better if I had more people,” she says.
What to do if there’s a shortage of a drug you need
Bray gets an average of four requests a day, and depending on who’s calling, the work she does in response may help anywhere from a handful to thousands of patients. Although many of her calls come from clinics, hospitals, and manufacturers, she often hears from individual patients — and when she does, she suggests they take the series of steps outlined below, which I’ve interspersed with tips from the other experts I spoke with.
Although it’s easy to feel a sense of panic when facing down a shadowy tangle of dysfunctional institutions, take a deep breath and know that there is a path forward, and there are resources and advocates out there that can help.
It’s obviously less stressful to have a few days to deal with a drug shortage rather than a few hours. When you can, plan ahead: If you’re reupping a drug you’re already taking, “give it a few extra days as opposed to waiting until the last minute to request a refill,” says John Beckner, a pharmacist who directs strategic initiatives at the National Community Pharmacists Association (NCPA).
Before you do too much work, it’s worth seeing whether an independent pharmacy in your area can locate a supply of the drug you need. They’re less likely to just say “We’re out of stock — we can’t get it,” says Beckner. “They’re going to explore other means to try to obtain that drug.” That may mean calling around to smaller drug wholesalers or buying a small quantity of a medication that might not be on the radar of a drugstore that buys medications by the pallet. You can find a local independent pharmacy using the NCPA’s pharmacy locator website.
If you’re still unable to get the medication you need, here’s what Bray counsels people to do. Parts of this process are things patients must do on their own, but Bray is happy to help people who get stuck at any point along the way and welcomes contact by phone or email.
1) Look for the generic form of the drug in the two drug shortage databases that contain all the information available to the American public about specific medicines’ availability: the one maintained by the FDA and the one run by the ASHP. They’re similar, although the ASHP database has a lower threshold for reporting a shortage, says Bray.
This first step helps patients determine not only which brands and dosages of a drug are unavailable, but also which are available.
2) Call your insurance company, ask to speak with a manager, explain that you are affected by a drug shortage, and ask them to give you coverage for whatever alternative form, brand, or dose of the drug you might be able to get access to.
The reason to do this is that insurance companies cut deals with various drug intermediaries — called pharmacy benefit managers — for specific medicines within each class of drugs and specific dosages of those medicines. Ostensibly, they do this so they can buy those specific medicines in bulk quantities at a discount and cover most of their cost when they are prescribed to you. The list of medicines and dosages an insurance company covers, its hot list of sorts, is called its formulary.
But where there’s a hot list, there’s a not list: If you’re prescribed a dosage or brand of a medicine that isn’t on your insurer’s formulary, or a similar medicine that isn’t on its formulary, the company won’t cover it — and you’ll have to pay for it out of pocket, which can be wildly expensive.
Patients can ask their insurers to temporarily cover a drug that isn’t on their formulary in a shortage situation like this, says Bray. “Say, ‘I’m going to be talking to my physician about giving me access to the [forms, brands, or dosages of the drug] that are available here and changing my prescription. Can you ensure that you open up the formularies while this shortage is happening so that I can get access to any of them?’”
Bray suggests explaining that you would not be asking for this change if the on-formulary drug were available to you, but it’s not. The conversation — one patients or their policy holders must have with their providers themselves — is usually successful, she says.
3) Contact the health provider who prescribes the unavailable drug, let them know there’s a shortage, and ask which of the available alternatives they can prescribe you. Bray suggests sending them a link to these alternatives. They’re easy to find in the ASHP database — just click on the name of the drug in shortage and scroll down to “Available Products.”
Providers are often aware of shortages and generally want to do the right thing to help patients get through them, says Ehrenfeld.
If your provider sends the alternative prescription to your pharmacy (or a hospital’s pharmacy, if you’re calling on behalf of a hospitalized patient) and the drug is in stock, this might be the triumphant end of your road. If not …
4) Seek an alternative pharmacy. If your usual pharmacy is part of a large chain, staff may be able to check the inventory of other local chain outlets, either online or over the phone — just ask.
Again, nimbler independent mom-and-pop pharmacies may be better able to fill in drug availability gaps. In addition to having access to different supply lines, their staff may have more time to make calls about small quantities of scarce medications or their alternatives. In general, says Beckner, your pharmacist — whether independent or at a chain — “can really become your advocate and confidant,” especially if you’ve established a good relationship.
5) Call Angels for Change if you’re still struggling to find the medication you need after all of this, urges Bray. She can work to identify the supply map for a medication, and she can reach out to its manufacturers to inquire about any emergency supply they may have on hand and clarify the timeline for having more supply available.
It might be tempting to look online for a medication when you’re affected by a shortage, either on social media or by ordering from a sketchy internet pharmacy. All of the experts I spoke to recommend against this approach. You never know whether the medication was stored properly or whether it’s counterfeit, and you’re at risk for being price-gouged, says Fox.
Bray’s strategy is one “that requires sophistication and a lot of work that just should not be necessary in this day and age, with all the technology that we have and all of the resources in the nation,” says Ehrenfeld. “It’s because we have erected barriers to getting people the care that they need.”
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By: Keren Landman, MD
Title: Is your medication out of stock? Here’s how to get it anyway.
Sourced From: www.vox.com/even-better/24062409/medication-shortage-drug-stock-medicine-pharmaceutical-supply-chain-angels-for-change
Published Date: Tue, 06 Feb 2024 12:30:00 +0000
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