Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Current Drug Shortages

The drug shortages updates from the FDA have included a lot of drugs commonly used in emergency medicine, but some of the recent shortages may be more likely to point out the lack of importance and misuse of these drugs.

I apologize for the formatting. Formatting is not my strength. The link above will take you to the original document. All of my further comments are in blue on the page below.

Drug Name Company
Information
Reason for Shortage Related Information
Amikacin injection

updated
7/8/2010

Bedford
Customer service
1- 800-562-4797
Manufacturing delays Bedford anticipates availability by mid-August, 2010.

RSI (Rapid Sequence Induction/Intubation) medication. Rocuronium and succinylcholine are still available.

Drug Name Company
Information
Reason for Shortage Related Information
Calcium Chloride Injection

New!

7/20/2010

Hospira Inc.

1-877-946-7747



American Regent, Inc.

1-800-645-1706

Unanticipated Increased Demand Information on Anticipated Availability for Syringes (PDF – 15KB)


American Regent, Inc. currently has Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial available. Due to increases in demand, American Regent, Inc. may not be able to fill all orders. Contact your wholesaler regarding product availability.

Calcium chloride can be replaced by calcium gluconate, which is one third as strong as calcium chloride.

Drug Name Company
Information
Reason for Shortage Related Information
Dextrose 50% injection

updated
7/13/2010

Hospira Inc.
1-877-946-7747
Unanticipated Increased Demand Information on Anticipated Availability (PDF – 18KB)

Dextrose 50% can be, and should be replaced with Dextrose 10%. The studies of the use of 10% Dextrose, rather than 50% dextrose, for acute hypoglycemia make it clear that 10 Dextrose is no less effective, but is less likely to cause complications. I will write about this in another post.

Drug Name Company
Information
Reason for Shortage Related Information
Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34)
updated
7/16/2010
Hospira Inc.,
1-877-946-7747
Unanticipated increased demand Hospira Supplies (PDF – 15KB)

Please see the American Society of Health Systems Pharmacists link below for important safety information regarding the use of alternate epinephrine injectables during the shortage: Epinephrine 0.1 mg/mL Emergency SyringesExit Disclaimer

This is 1:10,000 epinephrine. There is no research to show epinephrine produces any improvement in cardiac arrest outcomes that matter.

1:1,000 epinephrine for anaphylaxis is a whole different story, but there is no shortage of 1:1,000 epinephrine. There are warnings about the confusion between 1:1,000 and 1:10,000 epinephrine. Since we should only be giving epinephrine IV (IntraVenous) to dead people, the warnings of arrhythmia and/or death are pointless. If you are in the habit of giving 1:10,000 epinephrine to living patients, you are in the wrong business. The only appropriate routes of administration to living patients are IM (IntraMuscular), SC/SQ (SubCutaneous, or SubQ for the hard of writing), and IV Drip. The IV drip is usually 1 mg epinephrine in 250 ml NS (Normal Saline) or D5W (Dextrose 5% in Water).

There is no significant difference between the concentrations, when diluted in 259 ml. If you add 1 mg of 1:1,000 epinephrine to 250 ml, you end up with 1 mg in 251 ml or 3.98 mg mcg/ml. That is micrograms/ml – not milligrams/ml. If you think that you should not round that off to 4 mg/ml, you do not understand dosages. If you add 1 mg of 1:10,000 epinephrine to 250 ml, you end up with 1 mg in 260 ml or 3.85 mg mcg/ml. This should also be rounded off to 4 mg/ml, even though it is a much bigger difference from the 4 mg mcg/ml. The reason is that both are not significant differences.

When administering epinephrine by IV, we should only be giving it as a slow infusion. The rate is 2 mcg/minute to 10 mcg/minute (I did write these down correctly). The maximum rate is 4 times more than the starting dose. That is 400% more than the starting dose. That is compared to a difference of less than 4%, which is the difference between 3.98 mg mcg/ml and 3.85 mg mcg/ml.

400% more vs. less than 4% more. If you think that the difference of less than 4% is significant, please stop treating patients. Your patients deserve better.

If you are worried about the resuscitations, don’t. The only reason we get away with giving such large doses of epinephrine to these patients is that they are already dead.

It is not safe to give 1 mg epinephrine IV to somebody if it is 1:,1,000 epinephrine (1 ml of 1:1,000).

It is not safe to give 1 mg epinephrine IV to somebody if it is 1:,10,000 epinephrine (10 ml of 1:10,000).

If you do not know this, consider the exciting world of fast food order satisfaction. TOTWTYTR should be able to get you an application. He claims that he carries them with him for people making the wrong career choices. He isn’t doing this for you. He is doing this for the patients. Maybe he has an extra one for me.

Edited 8/02/10 at 05:50 also see More on Drug Calculations for more details on problems with my drug calculation. Thank you to Matt J for pointing out my error.

For more on epinephrine.[1] [2] [3] [4] [5]

Drug Name Company
Information
Reason for Shortage Related Information
Furosemide Injection 10mg/ml

updated
7/29/2010

Hospira Inc.
1-877-946-7747

American Regent, Inc.
1-800-645-1706

APP
1-888-386-1300

Manufacturing delays

Increase in demand

Increase in demand

Hospira is working to restore availability.

American Regent, Inc., the distributor of Furosemide Injection, USP 10 mg/mL manufactured by Luitpold Pharmaceuticals, Inc., will continue to notify its wholesalers of the product release dates for all three presentations of Furosemide Injection, USP 10 mg/mL (2 mL vial, 4 mL in a 5 mL vial and 10 mL vial) so they can communicate product availability and appropriately allocate to the end user..

APP has the 10 mg/mL injection 4 mL vial (NDC 63323-0280-04) available. APP anticipates that the 2 mL vials will be released by end of July and the 10 ml vials by late-September, 2010.

Furosemide (Lasix) is not an important emergency medicine drug, either. If your patient has an onset of ADHF/CHF (Acute Decompensated Heart Failure/Congestive Heart Failure), then there are several treatments that may decrease the likelihood that your patient will end up intubated. CPAP (Continuous Positive Airway Pressure), High-dose nitrates (usually NTG – NiTroGlycerin), and/or ACE Inhibitors (Angiotensin Converting Enzyme Inhibitors, such as enalapril [Vasotec]).

Furosemide is good for filling the patient’s bladder, but the patient probably did not call for help filling his/her bladder. If you have a stable ADHF/CHF patient, you can mess around with furosemide. If you have an unstable patient with ADHF/CHF and you are considering giving furosemide, then call 911 and get the patient some emergency treatment. Furosemide isn’t it. I will write more about treatment of ADHF another time.

Drug Name Company
Information
Reason for Shortage Related Information
Haloperidol Decanoate Injection

updated
7/14/2010

Teva Pharmaceuticals
1-800-545-8800

Ortho-McNeil Janssen
1-800-526-7736

APP Pharmaceuticals
1-888-386-1300

Bedford Laboratories Customer Service
1-800-562-4797

Manufacturing delays

See Related Information

See Related Information

Manufacturing delays

Teva has all presentation on back order with an estimated release date of November of 2010.

Ortho-McNeil has Haldol Decanoate available in 50 mg/mL 1 mL ampoules in 3 count (NDC 00045-0253-03) presentations and 100 mg/mL 1 mL ampoules (NDC 00045-0254-14).

APP has haloperidol decanoate available in 50 mg/mL 1 mL vials (NDC 63323-0469-01), 50 mg/mL 5 mL vials (NDC 63323-0469-05), 100 mg/mL 1mL vials (NDC 63323-0471-01), and 100 mg/mL 5 mL vials (NDC 63323-0471-05). The dating on the haloperidol decanoate 50 mg/mL 1 mL is 8 months. Additional batches of 100 mg/mL 1mL and 50 mg/mL 5 mL will be available late-June.

Bedford has not yet reported an estimated date of availability.

Haloperidol decanoate is a long acting version of haloperidol (Haldol), so this is as relevant as furosemide. This is only for after the patient has been sedated and determined to need longer term sedation.

Drug Name Company
Information
Reason for Shortage Related Information
Naloxone Injection

updated
7/29/2010

Amphastar
1-800-423-4136

Hospira
1-877-946-7747

See related information section

Manufacturing delays

Amphastar-IMS has both naloxone 1mg/ml syringes in the needleless (NDC 0548-3369-00) and fixed needle (NDC 0548-1469-00) versions available for immediate shipment.

Hospira anticipates for NDC 0409-1215-01 (0.4 mg/mL, 1 mL vial) and NDC 0409-1219-01 (0.4 mg/mL, 10 mL vial) they will have releases in August with full recovery by late September. The NDC 0409-1782-69 (0.4 mg/mL, 1 mL Carpuject) is anticipated for release first quarter of 2011.

If you have a BVM (Bag Valve Mask resuscitator), you should not need naloxone. The problem is inadequate respiration, not inadequate naloxonation. Manage the airway first, then, if you have naloxone and desire to use appropriately titrated naloxone, go ahead.

Drug Name Company
Information
Reason for Shortage Related Information
Pancuronium Injection

updated
7/29/2010

Teva Pharmaceuticals
1-800-545-8800

Hospira
1-877-946-7747

Teva initiated withdrawal of multiple lots of pancuronium injection from the market on 5/4/2010.

Increased demand

Teva has no immediate plans to re-enter the market

Hospira plans to have their pancuronium 1 mg/mL, 10 mL vial, package of 25 (NDC 00409-4646-01) released in early August 2010 with anticipated full recovery in mid October 2010.

RSI (Rapid Sequence Induction/Intubation) medication. Rocuronium and succinylcholine are still available.

Drug Name Company
Information
Reason for Shortage Related Information
Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s
updated
6/10/2010
Teva Pharmaceuticals
1-800-545-8800

Hospira Inc.
1-877-946-7747

APP
1-888-386-1300

Teva Pharmaceuticals has discontinued their propofol injection.

Hospira Inc. recalled specific lots because some containers may contain particulate matter. Hospira has implemented improvements to its manufacturing process and is coordinating with the FDA to begin distribution of propofol manufactured under a new process as soon as possible.

APP has increased production in response to the increased demand. Please see additionalinformation on availability in the Related Information section

Additional Information on Propofol Supplies

Questions and Answers on the Propofol Shortage

Please see the Dear Health Care Professional Letter (PDF – 41KB) from APP.

The links in the box give a lot of information. Some of the replacements are benzodiazepines (such as lorazepam, diazepam, and midazolam) possibly mixed with an opioid (such as fentanyl, morphine, and hydromorphone), ketamine, etomidate, barbiturates , and other sedatives or anesthetics.

Drug Name Company
Information
Reason for Shortage Related Information
Vecuronium Injection

updated
7/29/2010

Bedford Laboratories Customer Service
1-800-562-4797

Sun Pharmaceutical Industries, Inc.
1-800-818-4555

Teva Pharmaceuticals
1-800-545-8800

Hospira, Inc.
1-877-946-7747

Increase in demand

Increase in demand
On manufacturing hold
Manufacturing Delays

Bedford has vecuronium available in 20 mg vials (NDC 55390-0039-10) and anticipates the 10 mg vials will be available by August. There is emergency supply available of the 10 mg vials.

Sun Pharmaceutical Industries (Distributor: Caraco Pharmaceutical Labs, Ltd.) is continuing to release product as it becomes available.
Vecuronium Bromide for Injection 10 mg 10 vials NDC 41616-0931-44
Vecuronium Bromide for Injection 20 mg 10 vials NDC 41616-0932-44

Teva has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on backorder and supply is anticipated to be available in September.

Hospira will be off-market for an undefined period.

RSI (Rapid Sequence Induction/Intubation) medication. Rocuronium and succinylcholine are still available.

Edited 8/02/10 at 05:50 also see More on Drug Calculations for more details on problems with my drug calculation. Thank you to Matt J for pointing out my error.

Footnotes:

[1] Risk for Serious or Fatal Medication Error.
National Alert Network Message. EPINEPHrine pre-filled syringe shortage.
American Society of Health System Pharmacists and the Institute for Safe Medication Practices.
Updated June 16, 2010.
Alert

[2] It doesn’t pay to play the percentages.
Medication Safety Alert.
Institute for Safe Medication Practices.
October 16, 2002.
Alert

[3] Epinephrine 0.1 mg/mL Emergency Syringes
American Society of Health-System Pharmacists
July 28, 2010
Alert

[4] Epinephrine
EMS Drugs
Street Watch: Notes of a Paramedic
Article

[5] Medication Errors – Epinephrine
Street Watch: Notes of a Paramedic
Article

.

Trackbacks

  1. […] have also covered these drug shortages here, here, here, here, here, here, here, and […]

  2. […] my last post, Current Drug Shortages, I was pointing out ridiculing concerns about the use of 1:1,000 epinephrine IV, since it should […]

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