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Frequently asked questions

Click on a link below to view answers to frequently asked questions regarding the following topics:

About PULMICORT RESPULES

About Pharmacy Manufacturing

About Nebulizers

Helping Patients and Caregivers with Nebulizer Use

About pharmacy manufacturing

1. What is the difference between compounding and pharmacy manufacturing?

Pharmacy compounding, or compounding, is the practice of specially mixing or altering prescription medicines to meet the specific needs of an individual patient.1 The practice of compounding has traditionally been characterized by the consent and cooperation of the physician, patient, and pharmacist, often referred to as the triad of care. Pharmacies may legally compound medicine only for identified individual patients upon receipt of a valid, unsolicited prescription.2

Some pharmacies and home health care companies characterize compounded products as generic versions of products; they are not. The FDA has never reviewed nor approved a generic equivalent of PULMICORT RESPULES.

The U.S. Department of Health and Human Services has identified several mitigating factors that make compounding illegal. The following circumstances exceed the boundaries of traditional compounding and may warrant FDA enforcement action:

  • Violating the triad of care1
    • Medication is compounded without the prescribing physician’s specific authorization3
  • Manufacturing or compounding mass quantities of drug products before receipt of a prescription and intended for large numbers of patients1
  • Compounding commercially available drug products1
  • Receiving, storing, or using drug components that do not meet compendia requirements (eg, sterility)1

2. Why is pharmacy manufacturing occurring?

Sometimes well-meaning pharmacists compound batches of liquid budesonide with other medications in an attempt to improve patients’ convenience or to save patients money. Some patients don’t know that PULMICORT RESPULES is reimbursed by 97% of U.S. prescription plans and by Medicare under J code 7626. In addition, some pharmacists and many patients are unaware that no data confirm the potency, purity, effectiveness or compatibility of mixed compounds.

Although not common, some pharmacies and home health care companies have started illegally manufacturing large amounts of FDA-approved medications to generate higher revenues.

3. What are the differences in FDA requirements between pharmacy compounded and manufacturer-supplied medicines?

Manufacturers of branded and generic drugs must meet FDA purity and dosage specifications. Compounded medications are not subject to this requirement. The FDA does not frequently review the conditions under which pharmacy-manufactured medications are made, and no data exist to confirm safety or efficacy of compounded products, particularly when multiple prescriptions are combined. Only manufacturer-supplied drugs undergo continued post marketing surveillance to help assure safety.

4. Mixing nebulized agents seems like it would be convenient for patients; why is this a problem?

Ipatroprium or levalbuterol, both commonly prescribed asthma medications, are often included in nebulizer medication mixtures. However, no studies have explored whether these compounds have compatible physical or chemical properties; thus, the efficacy and safety of the components may be compromised.

5. What risks could pharmacy manufacturing pose to my pediatric patients?

When compounding is done properly and under observance of the FDA-approved circumstances, the risks are minimal. However, when the proper procedures are not followed or medications are manufactured without approval of the triad of care, the risks increase.

In response to an increased incidence of illegal pharmacy manufacturing professional physicians’ societies, including the American College of Allergy, Asthma and Immunology (ACAAI) and the American Academy of Allergy, Asthma and Immunology (AAAAI), joined forces with a coalition of pediatric, pharmaceutical, and consumer groups to form Consumer Health Alliance for Safe Medication (CHASM).4 The primary aim of this group is to ensure that patients with respiratory conditions have access to safe and effective medications and are protected from products that may pose unwarranted risks.4

In a 2004 communication to their members, the presidents of both the ACAAI and the AAAAI raised concerns about potential illegal pharmacy manufacturing risks for patients.

Potential risks include5:

  • Reduced safety and efficacy based on variable potency
  • Infection due to microbial contamination
  • Respiratory complications due to the presence of adulterants

6. How can I help protect my patients?

To ensure that your patients receive the medication you prescribed, follow these simple suggestions:

  • Check Dispense as Written (DAW) or write Do Not Substitute on all prescriptions
  • Review all prescription faxes prior to authorizing them with your signature
  • Question all pharmacy-generated changes to prescriptions that specify the brand name
  • Dispute any claims that pharmacists can provide you with an equivalent drug. Remember, compounded budesonide is not the same as PULMICORT RESPULES
  • Check patients’ medications during follow-up visits
  • Ask patients or caregivers to inform you if they do not receive PULMICORT RESPULES as prescribed
  • Report incidents of unauthorized substitution of compounded budesonide for PULMICORT RESPULES to your State Board of Pharmacy or FDA

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.

Common adverse events reported in clinical trials, regardless of relationship to treatment, included respiratory infection, rhinitis, coughing, otitis media, viral infection, gastroenteritis, ear infection, oral thrush/candidiasis, and epistaxis.

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.

Particular care is needed for patients who are transferred from systemically active corticosteroids to less systemically available corticosteroids, because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids (see WARNINGS 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 (PDF).]

References

  1. ACAAI. Member information. American College of Allergy, Asthma and Immunology. Available at: http://www.acaai.org/Member/CHASM+letter.htm. Accessed November 3, 2006.
  2. Testimony of the American Pharmacists Association On Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients. Before the Committee on Health, Education, Labor and Pensions, United States Senate. October 23, 2003. Available at: http://www.aphanet.org/AM/Template.cfm?Section=Search§ion=Compounding&
    template=/CM/ContentDisplay.cfm&ContentFileID=381    . Accessed September 19, 2006.
  3. Are there fakes and frauds in your nebulizer? Allergy and Asthma Today. 2004; Fall. Available at: http://www.breatherville.com/pdf/pu_fakes_frauds.pdf Accessed September 19, 2006.
  4. Consumer Health Alliance for Safe Medication (CHASM). About ANNMA/CHASM (PDF). Available at: http://www.aanma.org/pdf/chasm_about.pdf Accessed November 16, 2006
  5. Appleby J. Safety concerns grow over pharmacy-mixed drugs. USA Today. March 23, 2005. Available at:http://www.usatoday.com/news/health/2005-03-23-cover-compounding_x.htm. Accessed April 1, 2005.