A New Jersey health care system meets weekly to discuss its acute drug shortage.
Another was forced to communicate regularly.
And one oncologist says he has enough life-saving cancer drugs for his patients, at least for now.
It really is at a crisis level, said Dr. Eleonora Teplinsky, an oncologist at Valley-Mount Sinai Comprehensive Cancer Care in Paramus.
Fourteen cancer drugs are officially in short supply nationwide, according to the US Food and Drug Administration. Among them: two vital chemotherapy treatments carboplatin and cisplatin.
Some oncologists in the United States have been forced to delay treating patients and even rationing medications due to shortages.
Just from what I’ve heard and read in the news, some patients have had their treatment adjusted, meaning they’ve had to switch protocols completely, Teplinsky said. Some patients in the country have not been able to get their medication. Some people are waiting to get a drug.
And so it really impacts patients on a day-to-day level.
Dr. Julie Gralow, chief medical officer and executive vice president of the American Society of Clinical Oncology, has never seen anything like it.
I don’t know of a worse time than this, he told NBC News. What’s different about this shortage is… just the broad applicability of these drugs, how important they are globally, in the United States, in treating many diseases.
Several New Jersey health care systems say their cancer drug supplies were holding up for now. But they vary according to the structure.
And no one seems completely comfortable.
Carboplatin and cisplatin shortages were the main cause hospitals had to address, Teplinsky said.
I don’t think there is anyone right now swimming in drugs, he said.
It’s a frightening reality for patients who hope to receive treatment without worrying that a drug is suddenly unavailable.
Valley, the Ridgewood-based hospital ranked among the best in the state, has maintained a supply for its patients, according to Teplinsky. And those supplies have grown slightly in the last few weeks.
But we’re definitely not out of the woods, he said, and the hospital is still very careful with its stock.
Other places are completely closed, Teplinsky said.
Carboplatin and cisplatin shortages are particularly concerning because they are used to treat a variety of cancers and tumor types, experts say.
What it looks like is that a patient, say, who needs carboplatin for her uterine cancer, might not be able to get it, Teplinsky explained. And unfortunately, it’s not as simple as substituting one drug for another.
The other drugs may not be as effective in that type of cancer. It can have different side effects and different impacts and how that patient will experience it. So it’s really very stressful and potentially it can negatively impact (on) the outcome.
Its uncharted territory. So much so that the American Society of Clinical Oncology is still developing guidelines in case doses need to be adjusted or alternative treatments should be considered.
Valley oncologists regularly contact the base to ensure they have adequate supplies.
A lot depends on: will we have other newly diagnosed patients who will need more chemo? said Teplinsky. So we may have enough based on our projected numbers, but we’re in close contact on a very regular basis with (our) pharmacy and talking to our colleagues and really working out a system of how we can make sure that every one of our patients who have need the drug can they get it?
It begs the question: What if stocks run out? What criteria will be taken into consideration?
Some of the options were once unthinkable for doctors.
This was kind of proposed by ASCO in terms of how to ration, who to prioritize, because I think that’s something nobody thinks about, Teplinsky said. Again, you think as a patient, Hey, I need chemo. I’ll take it and everything will be fine.
But they talk about: Do we give more of it to people who need it for healing purposes, rather than to people who have metastatic disease? And it’s really awful that we’re here in 2023 and we have to ration chemotherapy.
Drug shortages are nothing new, but the COVID-19 pandemic has exacerbated the problem.
Nearly 80 percent of manufacturing facilities that produce active pharmaceutical ingredients, the key ingredients that deliver the desired effect of drugs, are located outside the United States, according to a government report released in March outlining drug supply of the nations reduced.
The report, authored by the Senate Homeland Security and Governmental Affairs Committee, found that critical generic drugs, especially sterile injectable products regularly used in hospitals, are at the greatest risk of shortages.
Drugs such as and cisplatin and carboplatin.
The shortage of carboplatin, a chemotherapy that treats ovarian, cervical, endometrial and non-small cell lung cancers, is in short supply due in part to a manufacturer in India halting production over quality issues.
It’s a common problem. Often, only a handful of manufacturers and sometimes only one produces vital drugs or the active ingredients they contain. When that company faces a manufacturing or financial problem, there’s often nowhere else to turn.
Supply chain problems and the United States’ continued dependence on both foreign and geographically concentrated sources for drugs and their raw materials are at the heart of dozens of drug shortages, the Senate committee report said.
Such deficiencies have cascading effects on patient care, causing treatment delays, increasing the risk of medication errors and requiring the use of less effective alternative treatments, he noted.
U.S. Representative Frank Pallone, D-6th Dist., the ranking member of the House Energy and Commerce Committee, called the shortages of drugs like carboplatin and cisplatin excruciating and unacceptable in a May statement. .
He said the FDA was pursuing all options to increase supply.
The agency is working with manufacturers to expand production of the drugs by expediting the overhaul of new production lines, facilities and ingredient suppliers, Pallone said in the statement. He is also identifying and contacting potential sources for temporary importation of carboplatin and cisplatin to ensure patients have access to these critically needed cancer treatments.
He added: Unfortunately, carboplatin and cisplatin are just the latest in a string of drug shortages that are becoming all too common.
In late May, the FDA cleared a China-based pharmaceutical company to import cisplatin as a temporary fix.
Even well-supplied hospitals and healthcare systems must constantly evaluate their stock.
Sure, it’s on our radar, said Robert Pellechio, senior vice president and director of pharmacy for RWJBarnabas Health.
The health care system has been lucky, he said, but he noted that it holds weekly meetings dedicated to identifying which drugs are in short supply and how to move supply to the right spots where they’re needed most.
We have a number of hospitals within our network and along with pharmaceutical suppliers who have kept us whole, Pellechio said.
Some hospitals have better access to providers than others.
RWJBarnabas has cultivated relationships not only with pharmaceutical wholesalers but also with the pharmaceutical companies themselves, according to Pellechio. Pay in emergency situations, he added.
Many healthcare systems do not deal directly with Pfizer or Accord and some of the pharmaceutical companies do deal through wholesalers. And so they have to wait for the wholesaler (for) that drug before they can order it, he said.
Though Valley’s supplies have held up, Teplinsky said he’s still early on patients.
I’m a firm believer that patients are being informed and I’d rather they hear from me sooner than hear about it on the news and sort of panic, she said.
Here are the cancer drugs on the FDA shortage list:
- Dexamethasone sodium phosphate
- Fludarabine phosphate
- Hydrocortisone sodium succinate
- Leucovorin calcium
- Lutetium lu 177 vipivotide tetraxetan
For more information on drug shortages, visit FDA.gov.
Our journalism needs your support. Please sign up today at NJ. com.
Spencer Kent can be reached at [email protected].
#vital #cancer #drugs #short #supply #reached #crisis #level