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FDA: Drug shortages having tangible impact on patients

Posted at 4:12 PM, May 22, 2018
and last updated 2018-11-21 16:56:25-05

UPDATE ON JUNE 22: The FDA has released a Report on Drug Shortages for Calendar Year 2017. The agency says drug shortages "....are having a tangible impact on patients."  

Specifically, the FDA provided details about the shortages of IV fluids, pain meds, and EpiPen.  

The shortage of IV fluids was further impacted by the devastating hurricane in Puerto Rico where Baxter Healthcare operates among other pharmaceutical companies. 

Injectable opioid pain medications including morphine and fentanyl are in short supply. According to the FDA, that traces back to "...a number of changes and upgrades at a Pfizer facility in Kansas." And they cite multiple factors for EpiPen's supply problem noting "regional disruptions and manufacturer issues." 

Upon releasing the report FDA issued a statement which says in part:

Among the biggest challenges health care providers and patients face are shortages of medically necessary medications. These shortages greatly impact patient treatment options and require practitioners to make difficult decisions that can compromise care, such as rationing supplies or using less desirable, but more readily available, alternative therapies. The FDA also understands the impact and concern these shortages may have on patients and we want to reassure them that their care will continue to be our priority. Ensuring access to the drugs patients need means finding creative responses to shortages while also addressing the root causes of the shortage issue. The FDA's role is focused on working with manufacturers, using all of our authorities to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition.

For more information the FDA provided the following: 

FDA Drug Shortages - New [email.prnewswire.com]
FDA Drug Shortages Database [email.prnewswire.com]


LAS VEGAS (KTNV) -- If you ever call 911 for a medical emergency, it's probably a matter of life and death and you count on a fully-equipped response.

But Contact 13 found local paramedics are running short on some critical tools. 

It's a shortage of various medications and it's happening in fire departments across the country. Heart attacks, seizures, serious injuries from car accidents. That's when paramedics often use drugs to keep struggling patients alive, but we've learned EMT's are struggling to keep their ambulances stocked.

Clark County Fire Department keeps about 60 critical meds on board. But the department says there's a problem keeping enough at the ready. 

"Narcotics," says Deputy Chief Jeff Buchanan. "Which is morphine and Ketamine - we've noticed a shortage there."

Las Vegas Fire and Rescue says they're seeing shortages too. And Henderson Fire Department confirmed shortages, providing this statement:

In instances where we are unable to purchase a medication, we have received approval to use an alternative medication from the Southern Nevada Health District, the entity that regulates what meds we use and under what circumstances we use them. Consequently, our patients have not been impacted by a shortage.

Contact 13 learned the shortages are happening all over the country as our sister stations are reporting from Indiana to Florida. 

Click here to see the full list from the FDA of medications in short supply.

Not all of these are used by paramedics but many are including Epinephrine for allergic reactions and sodium bicarbonate for cardiac emergencies. 

Clark County Fire emphasized that patient care will not be compromised but finding replacements and making sure those work creates new challenges. 

"What we have to do is very quickly and efficiently put training out to our men and women," explains Deputy Chief Buchanan. "So they could use the new medication appropriately and accurately."
We contacted the FDA to find out why there are shortages. They provided this statement:

The FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations.

Preventing and mitigating drug shortages continues to be a top priority for FDA, and we are using every tool available to forge solutions. This includes a focus on preventing shortages in the first place, earlier notification from manufacturers, increasing manufacturing quality and focusing on mitigating ongoing shortages.

The agency works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. The FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.

The majority of drug shortage information is provided to the FDA by manufacturers. Communication between the FDA and the public is an essential component of preventing and mitigating drug shortages.  To ensure information is current, the FDA appreciates all information and updates about shortages provided by manufacturers.

Generally speaking, drug companies are responsible for ensuring the quality and safety of the drugs that they manufacture.  The FDA works directly with companies when they experience problems with quality or sourcing of supplies needed to manufacture a drug in order to prevent or mitigate a shortage. The FDA also works with other pharmaceutical companies making the drugs that are in shortage to determine if they have the capacity to assist and if they are willing to do so.

When the U.S. manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for patients, the FDA may look for a pharmaceutical company that is able to redirect product into the U.S. market to address a shortage. The FDA considers a list of criteria to evaluate the product to ensure efficacy and safety, including the formulation and other attributes of the drug, as well as the quality of the manufacturing site where the drug is made.

Overall, the FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. The FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.

Pain Medicine:
The FDA is aware the several injectable opioid pain medications are in currently shortage due to manufacturing quality issues and delays. Specifically, Hospira, Inc. (a Pfizer company), has publicly reported a quality problem with their Carpuject and iSecure prefilled syringes and ampules containing these products. It is the FDA's understanding the manufacturing delays have also been exacerbated by recent issues at Pfizer's fill-finish plant in McPherson, Kansas. The FDA's Drug Shortages webpage [accessdata.fda.gov] lists the reason for shortage and links to the various "Dear Customer Letters" issued by Hospira/Pfizer. Because Hospira is the largest and primary manufacturer of many of the injectable pain medications in shortage, other smaller manufacturers' supplies have been exhausted to meet patient needs - contributing to the overall shortage of several injectable opioid pain medications.

We are working with a variety of manufacturers to ramp up production needed to meet patient needs, including all the companies listed in shortage webpage- Akorn Pharmaceuticals; Fresenius Kani USA, LLC; Hospira, Inc, a Pfizer company; and West-Ward Pharmaceuticals. Because Hospira/Pfizer is a very large manufacturer and distributor of injected pain medication products in the U.S. and has experienced delays and quality issues (as described in the Dear Customer letters posted on the FDA's website [accessdata.fda.gov]), we continue to work very closely with Pfizer on multiple fronts to address this shortage and will share any new supply information as soon as it is available.  We are also working the other companies mentioned above to help increase supply by expediting review of any additional products or manufacturing additions such as sites or suppliers that may be helpful in rectifying this shortage as quickly as possible.

This is a continuously evolving and fast-moving issue. Multiple factors have resulted in limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply disruptions and a manufacturer issue. The FDA has been working closely with Mylan to understand the status of EpiPen production supply and has been in contact with the other manufacturers of epinephrine auto-injectors as well regarding their supply status. There have been reports of local supply disruptions and Mylan has reported intermittent manufacturing constraints, however Mylan continues to release the product and the firm has provided a number which will be posted on our website to help pharmacies and patients locate EpiPens if they experience any difficulties. We posted this due to the intermittent supply disruptions Mylan has reported. Based on the information provided by the manufacturer, the FDA anticipates the issue to be short-term.

The FDA will continue to keep its Drug Shortages website [accessdata.fda.gov] updated with the latest supply information as we receive it. This will include a list of epinephrine auto-injector products that are available from other manufacturers as well as contact information for consumers and health care providers.

In addition to information listed on our Drug Shortages website [accessdata.fda.gov], please refer to recent statements from FDA Commissioner Scott Gottlieb, M.D. in January [fda.gov] and February [fda.gov] regarding ongoing saline shortages  

We have been monitoring this situation closely. This is not currently in shortage since one manufacturer, Baxter, has been able to meet demand and another manufacturer, Teva, has product on allocation. A third manufacturer, Pfizer, has experienced delays and is planning to return to the market in July.

This is currently not reported by manufacturers to be in shortage.

Sodium bicarbonate
Information about this shortage is available on our Drug Shortages website [accessdata.fda.gov]; this issue is resolving as multiple firms have reported products available.

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