What are the Risks of Pharmacy Manufacturing?

Professional societies raise concerns

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).5 The primary aim of this group is to ensure patients with respiratory conditions have access to safe and effective medications and are protected from products that may pose unwarranted risks.5

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 include6:

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

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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

  1. Consumer Health Allience for Safe Medication (CHASM). About ANNMA/CHASM (PDF). Available at: http://www.aanma.org/pdf/chasm_about.pdf Accessed November 16, 2006
  2. 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.