Critical Shortages Of Generic Drugs Are Hurting Our Patients

It is high time we take this problem into our own hands

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50 mg of IV diphenhyrdamine, please.”

Doctor, I’m sorry. You can’t order that.

Why not?

It’s on shortage. We don’t know when we will get more.

More and more frequently, this conversation is happening in hospitals across our country. It happens to me on almost a daily basis, and it is extremely frustrating.

According to the American Society of Health System Pharmacists (ASHP), there are currently 200 medications that are currently on shortage. These include critical drugs such as IV amiodarone (a heart rhythm drug), IV cefuroxime (an antibiotic), IV atropine (a life-saving heart medication), and even IV diphenhydramine, which is used for life-threatening allergic reactions. 200 medications!

And it is really making it difficult to take care of very sick patients in the hospital, especially in the ICU. Now, there may be oral versions, but many times, the patient is so sick that he or she can’t take the oral formulation. And so, I am stuck — unable to provide life-saving medications because it is on shortage.

For diphenhydramine, for example, the reasons listed on the website are as follows:

Fresenius Kabi has diphenhydramine injection on shortage due to increased demand.

Hikma did not provide a reason for the shortage.

Mylan did not provide a reason for the shortage.

Pfizer has dipehnhydramine injection on shortage due to manufacturing delays.

As for when more will become available, here it what it says:

Fresenius Kabi has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of late-December 2018. The 50 mg/mL 1 mL syringes are on back order and the company estimates a release date of 1st quarter 2019. Check wholesalers for inventory.

Hikma has diphenhydramine 50 mg/mL 1 mL vials on allocation.

Mylan Institutional has diphenhydramine 50 mg/mL 10 mL vials on back order and the company estimates a release date of mid-January 2019.

Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of 1st quarter 2020.

So what do I do now, today, for my patient with a swollen airway that needs IV diphenhyrdamine? Many times, the pharmacists just shrug their shoulders.

Something has to be done, and a number of hospital systems have now taken matters into their own hands.

The initiative got very little attention. I have only seen press reports about it from last September, but the initiative was actually announced in January of this year:

To help patients by addressing the often unwarranted shortages and high costs of lifesaving generic medications, Intermountain Healthcare is leading a collaboration with Ascension, SSM Health, and Trinity Health, in consultation with the U.S. Department of Veterans Affairs* (VA), to form a new, not-for-profit generic drug company. The five organizations represent more than 450 hospitals around the U.S. Other health systems will soon be joining this not-for-profit initiative, which will make essential generic medications more available and more affordable, bringing healthy competition to the market for generic drugs.

The new company intends to be an FDA approved manufacturer and will either directly manufacture generic drugs or sub-contract manufacturing to reputable contract manufacturing organizations, providing patients an affordable alternative to products from generic drug companies whose capricious and unfair pricing practices are damaging the generic drug market and hurting consumers. The company will also seek to stabilize the supply of essential generic medications administered in hospitals, many of which have fallen into chronic shortage. The new initiative will result in lower costs and more predictable supplies of essential generic medicines, helping ensure that patients and their needs come first in the generic drug marketplace.

The new company is called CivicaRx, and according to the website, they expect to begin placing its first products on the market in 2019. It is about time.

We will have to see what the for-profit pharmaceutical industry does in response. For my part, I have reached out to the company on behalf of my own hospital and am waiting for CivicaRx to get back to me.

The drug shortage is a national health crisis, and I have always joked that I should “start my own drug company.” Well, over 500 hospitals across the country beat me to it, and I am so very glad they did.

The opinions expressed in this post are my own and do not reflect those of my employer or the organizations with which I am affiliated.

NY Times featured Pulmonary and Critical Care Specialist | Physician Leader | Author and Blogger | His latest book is “Code Blue,” a medical thriller.

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