Re: Fwd: Safety Alert: Reports of Accidental Overdose from Medication Dosing Errors

[Guest guest]

Hi,

I haven't written in years. I was having a lot of symptoms but they went away after I returned to work a few years ago. They act up every now and then, but mostly I'm OK.

I had surgery with a double fusion almost 33 years ago. I now experience pain at the site of the incision of the right hip. I'm curious as to whether this can be related to the surgery. Somedays the pain is unbearable. It bothers me when I'm sleeping and in the morning when I am driving in the car. It usually gets better as the day goes on. I haven't seen a doctor about it, but it's becoming more common now.

Thanks for your help,

Safety Alert: Reports of Accidental Overdose from Medication Dosing Errors

elizabethrgonzalez@...

Safety Alert: Reports of Accidental Overdose from Medication Dosing Errors

January 11, 2011

Roxane Laboratories and the FDA Warn Health Care Providers to Use Vigilance to Avoid Accidental Overdose When Using Oral Morphine Solution Concentrate 100 mg/5mL (20mg/mL)

Roxane Laboratories and the Food and Drug Administration (FDA) recently notified health care providers about serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, particularly the concentrated preparation 100 mg/5 mL. In most of these cases, morphine sulfate oral solutions that were ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) during the dosing of the preparation. New labeling and packaging by Roxane has been FDA-approved to help curb this risk.

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients. For prescribing information, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf.

Old labeling and packaging of morphine sulfate oral solution was marketed with the strength expressed as 20 mg/mL, using a container label and carton label with brown lettering on a white background. The new FDA-approved product labeling and packaging has been revised to reduce the risk of medication errors. Changes include:

A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT†displayed in a box to highlight that the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

The strength presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product.

The drug name, strength and concentration displayed in white lettering on a red background as an additional means of differentiating this product from other concentrations of morphine sulfate oral solutions.

A reminder presented to the pharmacist to dispense the product to each patient with the enclosed medication guide. See: http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM239632.pdf.

A calibrated oral syringe packaged in both bottle sizes of the concentrated solutions (30 mL and 120 mL) to provide accurate dose measurements.

Health care providers should read the instructions in the medication guide that describe the correct use of the oral syringe to help prevent medication errors from occurring and discuss the correct use of the oral syringe with their patients.

For more information, see the MedWatch alert on the FDA website: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239559.htm.

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[Guest guest]

Check out the description of Piriformis Syndrome. I have that and physical

therapy really helped. Now if I start having the pain, I do the stretches and

my husband give me a very deep tissue massage that hurts really bad but

ultimately ends the pain. My physical therapist showed him exactly what to do

and it works great!

>

>

> Hi,

>

> I haven't written in years. I was having a lot of symptoms but they went away

after I returned to work a few years ago. They act up every now and then, but

mostly I'm OK.

>

> I had surgery with a double fusion almost 33 years ago. I now experience pain

at the site of the incision of the right hip. I'm curious as to whether this

can be related to the surgery. Somedays the pain is unbearable. It bothers me

when I'm sleeping and in the morning when I am driving in the car. It usually

gets better as the day goes on. I haven't seen a doctor about it, but it's

becoming more common now.

>

> Thanks for your help,

>

>

>

>

>

>

>

>

> Safety Alert: Reports of Accidental Overdose from Medication Dosing

Errors

> elizabethrgonzalez@...

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> Safety Alert: Reports of Accidental Overdose from Medication Dosing Errors

> January 11, 2011

> Roxane Laboratories and the FDA Warn Health Care Providers to Use Vigilance to

Avoid Accidental Overdose When Using Oral Morphine Solution Concentrate 100

mg/5mL (20mg/mL)

> Roxane Laboratories and the Food and Drug Administration (FDA) recently

notified health care providers about serious adverse events and deaths resulting

from accidental overdose of morphine sulfate oral solutions, particularly the

concentrated preparation 100 mg/5 mL. In most of these cases, morphine sulfate

oral solutions that were ordered in milligrams (mg) were mistakenly interchanged

for milliliters (mL) during the dosing of the preparation. New labeling and

packaging by Roxane has been FDA-approved to help curb this risk.

> Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for

relief of moderate to severe acute and chronic pain in opioid-tolerant patients.

For prescribing information, see

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf.

> Old labeling and packaging of morphine sulfate oral solution was marketed with

the strength expressed as 20 mg/mL, using a container label and carton label

with brown lettering on a white background. The new FDA-approved product

labeling and packaging has been revised to reduce the risk of medication errors.

Changes include:

>

> A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANTâ€

displayed in a box to highlight that the morphine sulfate oral solution 100 mg

per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The

100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory

depression when administered to patients not previously exposed to opioids.

> The strength presented as 100 mg per 5 mL followed by a less prominently

displayed concentration of (20 mg/mL). The intent of this designation is to help

differentiate this product from the 20 mg/5 mL morphine sulfate product.

> The drug name, strength and concentration displayed in white lettering on a

red background as an additional means of differentiating this product from other

concentrations of morphine sulfate oral solutions.

> A reminder presented to the pharmacist to dispense the product to each patient

with the enclosed medication guide. See:

http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHu\

manMedicalProducts/UCM239632.pdf.

> A calibrated oral syringe packaged in both bottle sizes of the concentrated

solutions (30 mL and 120 mL) to provide accurate dose measurements.

>

> Health care providers should read the instructions in the medication guide

that describe the correct use of the oral syringe to help prevent medication

errors from occurring and discuss the correct use of the oral syringe with their

patients.

> For more information, see the MedWatch alert on the FDA website:

www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProduct\

s/ucm239559.htm.

>

>

>

>

>

> SUBSCRIBE | UNSUBSCRIBE

> Privacy Policies & Disclaimers

>

>

> © 2010 American Pain Foundation

> 201 North Street, Suite 710, Baltimore, land 21201-4111

> A 501©3 nonprofit organization.

> Please contact the Webmaster with questions or comments about this site.

>

> Forward this message to a friend | Change your email preferences

>