If you have a BVM (Bag Valve Mask resuscitator), you should not need naloxone. The problem is inadequate respiration, not inadequate naloxonation.

- Rogue Medic

Stressful Drug Shortage Update

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The FDA (Food and Drug Administration) reports that their lorazepam (Ativan) injection drug shortage has been updated.[1]

Baxter’s 20 mg/10 ml vials are available, but have the potential for a bit more of a dose than most patients might require.

Baxter’s 2 mg/1 ml vials are on back order until the end of April, as long as things go as planned.

Bedford’s 2 mg/1 ml vials and 20 mg/10 ml vials are on such long term back order, that the company cannot estimate a release date.

Hospira’s 2 mg/1 ml vials, 20 mg/10 ml vials, and 2 mg/1 ml syringes are anticipated to be released in mid to late April, 2011.

The FDA does not provide any information about when Hospira’s 4 mg/1 ml vials and 4 mg/1 ml syringes will be available. The ASHP (American Society of Health System Pharmacists) has different information about the availability of some of the Hospira lorazepam preparations.

Hospira has all injectable lorazepam presentations on back order. The company estimates a release date of mid-April, 2011 for the 2 mg/mL 1 mL and 10 mL vials. The company estimates a release date of late-April, 2011 for the 2 mg/mL 1 mL Carpuject syringes, and the 4 mg/mL 1 mL and 10 mL vials. The 2 mg/mL 1 mL iSecure syringes and the 4 mg/mL 1 mL Carpuject syringes were voluntarily suspended until 2012 to allow increased production of other lorazepam presentations.3 [2]

During this shortage, use alternative injectable benzodiazepines.
There are no direct dosage conversions between the benzodiazepines because each has a distinct pharmacokinetic profile that dictates the agent’s therapeutic use and dosing. The Table compares the pharmacokinetics of injectable benzodiazepines.
[2]

There is no Table provided on this page. There are four related drug shortages listed on the page, but none are benzodiazepines, but both midazolam and diazepam are listed by ASHP as current drug shortages.

The most practical substitute for emergency treatment with lorazepam is midazolam. There are no reported midazolam shortages from the FDA, but the ASHP does list midazolam as a current drug shortage and has 13 updates going back to August of 2010.

Baxter and Bedford could not provide a reason for the midazolam shortage.
APP has their product on allocation due to increase in demand.
Hospira has changed several NDC numbers. The company cites increased demand as the reason for the shortage.
Wockhardt has discontinued all midazolam injection presentations.
Cura has discontinued manufacturing all products.
The 5 mg/mL presentations are not generally affected by this shortage.
[3]

The 5 mg/mL presentations are not generally affected by this shortage.

This raises the question – What is the purpose of smaller dose containers outside of pediatric treatment areas?

If a patient is in need of some sedation, I find that 5 mg midazolam is usually not enough for even 50 kg (110 pounds) patients. For large patients (100+ kg or 220+ pounds) 5 mg midazolam is like whispering sweet nothings in the patient’s ear. It only works when the proper mood has been set. When the patient is agitated/violent, we should assume that the mood is not working and 5 mg midazolam is not going to be effective unless followed with more doses.

This is important –

The treatment for too aggressive dosing of benzodiazepines is supportive care.

The treatment for not aggressive enough dosing of benzodiazepines can be exacerbation of underlying medical conditions, traumatic injuries to the patient, and/or traumatic injuries to those providing patient care.

Now that CMS (Centers for Medicare & Medicaid Services) is discouraging the use of TASERs on violent patients, we need to consider being much more aggressive in providing large enough doses to violent patients – for everyone’s protection. CMS will not show up to resuscitate the patients who arrest due to following their misguided rules.[4]

APP has available midazolam 1 mg/mL injection 2 mL vials (NDC 63323-0411-12), 5 mL (NDC 63323-0411-25) and 10 mL vials (NDC 63323-0411-10). These products are being allocated due to increased demand.
Hospira has available midazolam 1 mg/mL preservative-free injection 2 mL (NDC 00409-2305-17) and 5 mL (NDC 00409-2305-05) vials, 2 mL (NDC 00409-2305-21) and 5 mL (NDC 00409-2305-50) Novaplus vials, and 2mL iSecure syringes (NDC 00409-2306-12). The 2 mL Carpuject syringes are on back order and the company estimates a release date of mid-May, 2011.
Bedford has available midazolam 1 mg/mL 10 mL vials (NDC 55390-0125-10). The 2 mL and 5 mL vials are on back order and the company cannot estimate a release date.
Baxter has available midazolam as 1 mg/mL 2 mL vials in 25 count packages (NDC 10019-0028-04), 2 mL latex-free vials in 10 count packages (NDC 10019-0028-01), 5 mL multiple-dose vials (NDC 10019-0028-05), and 10 mL multiple-dose vials (NDC 10019-0028-10). Other presentations are on back order and the company cannot estimate a release date.
[3]

ASHP also has diazepam listed as being a drug shortage with updates going back to 2008.

Hospira has available diazepam 5 mg/mL injection in 2 mL iSecure syringes (NDC 00409-1273-05) and 10 mL 10 count vials (NDC 00409-3213-120. The 2 mL Carpuject Luer-Lock syringes are on back order with an estimated release date of early-April, 2011. The 10 mL multiple-dose vials in packages of 5 were discontinued.[5]

ASHP states that Hospira is the sole provider of diazepam injection, but DailyMed currently lists three other civilian manufacturers[6],[7],[8] and one supplier to the military.[9]

Footnotes:

[1] Lorazepam Injection
2 mg/ml

Current Drug Shortages
FDA
4/11/2011
Drug shortage Update

[2] Lorazepam injectable presentations
[08 April 2011]
Drug Shortages: Current Drugs
ASHP
Current Bulletin

[3] Midazolam 1 mg/mL Injections
[04 April 2011]
Drug Shortages: Current Drugs
ASHP
Current Bulletin

[4] Patient Safety Versus Workplace Safety – Stun Gun Debate Illustrates Dueling Federal Mandates
Rogue Medic
Part I
Part II

[5] Diazepam Injection
[01 April 2011]
Drug Shortages: Current Drugs
ASHP
Current Bulletin

[6] Diazepam (diazepam) Injection
[Baxter Healthcare Corporation]

Revised: 02/2006
DailyMed
DailyMed HTML of FDA Label

[7] DIAZEPAM (diazepam) injection
[General Injectables and Vaccines, Inc.]

Revised: 06/2010
DailyMed
DailyMed HTML of FDA Label

[8] DIAZEPAM injection, solution
[Rebel Distributors Corp]

Revised: 12/2010
DailyMed
DailyMed HTML of FDA Label

[9] DIAZEPAM injection
[U.S. Army Medical Research and Development Command (MCMR-RCQ-HR)]

Revised: 02/2009
DailyMed
DailyMed HTML of FDA Label

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