What are the Numbers? Product Quality & Uniformity

FDA concerns

In 2001, the FDA’s Division of Prescription Drug Compliance and Surveillance conducted a limited survey of 12 U.S.-based manufacturing pharmacies⁷. They sampled 29 products for a range of conditions, such as asthma and glaucoma, and found that⁷:

34% failed at least one quality test
90% of the identified substandard products also failed potency testing, with less active ingredients than described on the label

Pharmacy manufactured budesonide

In a study performed in 2004 AstraZeneca tested 31 budesonide inhalation solutions from various compounding pharmacies to determine the actual versus labeled budesonide concentration. It was determined that over half of the vials contained less than 60% of the budesonide content stated. Patients who receive such subpotent drugs may be at risk of suffering an asthma exacerbation.⁸

Inconsistencies Chart

What is the clinical impact?

From this study, AstraZeneca has concluded that:

Variation in dose content for a patient could potentially lead to loss of asthma control. For some pharmacies, drug content varied between batches
Unlike physician–directed changes in therapy, which are known and followed by close clinical monitoring, the dose variations associated with the use of incorrectly labeled pharmacy–manufactured product are unknown and unpredictable
In rare circumstances, some samples tested had budesonide content near the labeled claim. However, this is no guarantee that patients are receiving an adequate dose of budesonide. The efficacy and safety can only be known with proper clinical assessment

Know the difference

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AstraZeneca, the makers of PULMICORT RESPULES, is dedicated to helping you help your patients. Be sure that they know the facts about their medication. Remind them of these important facts:

PULMICORT RESPULES is the ONLY FDA-approved nebulized corticosteroid
Nebulized budesonide does not have an FDA generic formulation
PULMICORT RESPULES is delivered as a sterile nebulized suspension
PULMICORT RESPULES has demonstrated its safety and efficacy through comprehensive clinical trial programs
PULMICORT RESPULES is easily distinguishable from other nebulized products because of its unique 6-sided shape
PULMICORT RESPULES has been monitored for safety through postmarketing surveillance
PULMICORT RESPULES is manufactured in a sterile facility under Good Manufacturing Practices (GMPs)
PULMICORT RESPULES is reimbursed by most U.S. prescription plans. It is also reimbursed by Medicare under J code 7626
PULMICORT RESPULES is available in 2 dose strengths: 0.25 mg and 0.5 mg per 2mL RESPULES

NEXT: Find out how to help protect your patients

Indication and Important Safety Information

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children ages 12 months to 8 years.

PULMICORT RESPULES is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.

The most common adverse events reported in clinical trials, regardless of relationship to treatment, include respiratory infection, rhinitis, coughing, and otitis media.

Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.

PULMICORT RESPULES, like other inhaled corticosteroids, may impact the hypothalamic-pituitary-adrenal axis, especially in susceptible individuals, in young children, and in patients given high doses for prolonged periods.

Adrenal insufficiency may occur when transferring patients from systematic corticosteroids (see WARNING in full Prescribing Information).

Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles.

Please see accompanying full Prescribing Information.

References

Report: limited FDA survey of compounded drug products. Available at: http://www.fda.gov/cder/pharmcomp/survey.htm. Accessed April 26, 2005.
Data on file, DA–RES–23. AstraZeneca LP, Wilmington, DE.

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PULMICORT RESPULES is a registered trademark of the AstraZeneca group of companies.