Antiemetic Shortage

[Peeker19]

Sort of a rant but for whatever reason at my facility we are being told there is a shortage of IV compazine, zofran, reglan and now we are running short on IV phenergan and most patients have it set up as IM phenergan. REALLY!!!! How are we so short on all of these drugs! I just do not get it....must be another debacle of the healthcare system

So I have to tell my nauseated uncomfortable rectal cancer pt that not only do we not have much to give them BUT all we have is an IM injection.... let me tell you the response I got "I would rather be nauseated and puke than have another injection" can you blame them????

Oh and not to mention the 5000 Unit SQ heparin shortage that we are now required to pull from the 10,000 unit vial and get a cosign....talk about waste of time and energy.

Thanks for listening

[madwife2002, BSN, RN]

That is appalling, how can we be short on anti-emetics?

[FLmomof5]

We have been short on phenergan for weeks.

Why are we short? A combination of Govt mandates and business profitability. The Govt, in its infinite wisdom (scarcasm here), thought they could mandate competition for drugs to lower cost. To "encourage" this competition, drug companies have to have Govt approval on how much they manufacture.

On the business side, one company decides a drug - say in this case: phenergan, is no longer profitable. See the drug company wants to charge $20 per dose for the drug and the govt (medicare/medicaid) will reimburse only $4. So the company stops making the drug. The other drug companies cannot simply increase production to offset the lower production nationwide...they have to get Govt approval and that is NEVER a quick process.

Add the feature of....oops, drug company had an issue in production of a drug. They report it to the Govt. They recall what they produced....lowering availability. They fix the problem in their plant, but then need Govt approval to restart production and that takes months and months.

No one piece is responsible. It is the calamity of the combination that has caused the shortages.

[Altra, BSN, RN]

... To "encourage" this competition, drug companies have to have Govt approval on how much they manufacture.

...

The other drug companies cannot simply increase production to offset the lower production nationwide...they have to get Govt approval and that is NEVER a quick process.

Do you have a citation/source for your statement that pharmaceutical companies are mandated to produce x amount (and only x amount) of specific drugs?

[FLmomof5]

Let me go search for it again. When we first had our phenergan shortage, I researched the cause on the internet.

I did not give credence to any stories that were from political sites. These were medical sites. One article was written by a cardiologist about the recall and production approval issue after a bad batch.

Be back soon....

[tokmom, BSN, RN]

Short too. We have to do IV phenergen or PO zofran

[blondy2061h, MSN, RN]

We've been giving phenergan like crazy because of the compazine shortages. Haven't seemed to have a problem with Zofran (thank God!).

[FLmomof5]

This site shows many of the causes....but here is a highlight:

Drug Shortages in the United States

"Submissions by manufacturers that the FDA will expedite include requests to increase capacity, extend expiration dates, use a new source for a raw material, and change product specifications"

So, by inference, one can see that manufactures must request permission from the FDA to increase production (aka: capacity).

Another site:

Seeking solutions to “incredibly complex issue” of drug shortages DFM News | Delaware First Media

“One of the goals of the Drug Shortage Prevention Act is to encourage manufacturers to make investments in increasing their capacity,” Carney said. “Expediting the FDA approval process and authorizing the Drug Enforcement Agency to change its existing quota system are critical to accomplishing that goal."

Haven't found the cardiologists article yet....but this is a start.

[FLmomof5]

We've been giving phenergan like crazy because of the compazine shortages. Haven't seemed to have a problem with Zofran (thank God!).

I wish we could! We had to BEG the pharmacy to give us phenergan for a currently vomitting pt for whom zofran did nothing.

[psu_213, BSN, RN]

According to our pharmacy, there is no IV compazine in the house (d/t a nationwide shortage). Compazine had been our 2nd line tx for N/V (zofran is the first) and compazine is our first line tx. for migrane even if it is without N/V.

We have had no shortage issues with IV zofran. We almost never give phenergan. In the rare instances the docs order it, we have had no issues getting it from pharmacy.

[DookieMeisterRN]

The only shortage we had was compazine at our hospital and that was last summer. We would def know if there was a shortage now. Why is it that some facilities are short and not others? Does it vary by region? Or do some hospitals stockpile?

It's just horrendous how saving money at 'the top' trickles down to the 'little people'.

[Altra, BSN, RN]

This site shows many of the causes....but here is a highlight:

Drug Shortages in the United States

"Submissions by manufacturers that the FDA will expedite include requests to increase capacity, extend expiration dates, use a new source for a raw material, and change product specifications"

So, by inference, one can see that manufactures must request permission from the FDA to increase production (aka: capacity).

Another site:

Seeking solutions to "incredibly complex issue" of drug shortages*DFM News | Delaware First Media

"One of the goals of the Drug Shortage Prevention Act is to encourage manufacturers to make investments in increasing their capacity," Carney said. "Expediting the FDA approval process and authorizing the Drug Enforcement Agency to change its existing quota system are critical to accomplishing that goal."

Haven't found the cardiologists article yet....but this is a start.

Thank you for that link to an American Bar Association article/publication. After reading it and its accompanying citation list, I went on to read one of the sources cited:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM277755.pdf

This October 2011 document, "A Review of FDA's Approaches to Medical Product Shortages" is worth reading, for anyone who's interested. The section devoted to sterile injectable drugs (which comprise the vast majority of drugs of which there has been a shortage in the last decade) explains that the manufacture of these drugs is regulated in that FDA approval of ingredients, sources of ingredients, and actual physical inspection of existing and proposed new facilities used to manufacture these drugs is required by law.

The report also explains that manufacturing facilities of sterile injectables typically run at near-maximum capacity. So while the FDA does not directly require pharmaceutical companies to manufacture x quantity of Drug A ... the regulatory process does mean that production cannot be quickly increased to meet increased demand or to compensate for manufacturing problems.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

This very helpful page of the FDA website lists current shortages. There appear to be 11 manufacturers of Ondasteron, with several of these shortages expected to resolve within this month.