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Richard S. Irwin, MD, Master FCCP; Brian S. Smith, PharmD
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From the UMass Memorial Medical Center and the Editorial Office of CHEST (Dr Irwin); and the Department of Pharmacy, UMass Memorial Medical Center (Dr Smith).

Correspondence to: Richard Irwin, MD, Master FCCP, Pulmonary, Allergy, and Critical Care Medicine Division, UMass Memorial Medical Center, 55 Lake Ave N, Worcester, MA 01655; e-mail: Richard.Irwin@umassmemorial.org

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Irwin is Editor in Chief of CHEST. Although not employed by the American College of Chest Physicians, a portion of Dr Irwin’s salary comes from the College as a stipend. Drs Irwin and Smith have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed directly or indirectly in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Irwin is Editor in Chief of CHEST. Although not employed by the American College of Chest Physicians, a portion of Dr Irwin’s salary comes from the College as a stipend. Drs Irwin and Smith have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed directly or indirectly in this article.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Irwin is Editor in Chief of CHEST. Although not employed by the American College of Chest Physicians, a portion of Dr Irwin’s salary comes from the College as a stipend. Drs Irwin and Smith have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed directly or indirectly in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


Chest. 2011;140(6):1673. doi:10.1378/chest.11-2480
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To the Editor:

We appreciate and wish to respond to the thoughtful comments of Dr Lee and colleagues concerning our editorial,1 in which we suggest that clinicians may potentially find the need to enlist the services of a licensed compounding pharmacy to make an extended-release product when other options have failed. We did not mean to imply that there was a United States Pharmacopeia-National Formulary monograph2 for specifically compounding an extended-release brompheniramine-pseudoephedrine medication that compounding pharmacies can follow; rather, we meant that compounding pharmacies can follow the guidelines in the general chapters “Dissolution”3 and “Uniformity of Dosage”4 that speak to the issue of dissolution and uniformity of dosage units. We thank Dr Lee and associates for allowing us the opportunity to better clarify this point and to reconfirm that we are in full agreement that clinicians should use US Food and Drug Administration (FDA)-approved cough, cold, and allergy medications whenever possible, and we believe that the alternative FDA-approved cough, cold, and allergy medications suggested by Ostroff et al5 will likely be sufficient to meet the needs of most adult patients.

When these FDA-approved products do not meet the needs of patients because of failure to achieve therapeutic end points, intolerance, and/or poor adherence, clinicians and patients may be faced with the dilemma of providing no treatment or seeking alternatives. In these situations, we believe that physicians may wish to take advantage of a compounded medication made by a licensed compounding pharmacy as an alternative.

Before recommending a compounded medication, we continue to recommend that clinicians speak with the compounding pharmacy to understand limitations of a compounded medication, ask for the data the pharmacist is using to support the compounding of a specific medication, inquire about what quality assurance methods are used, and determine what analytic methods are used by the compounding pharmacy to ensure the appropriateness of the compounded pharmaceutical preparation. If a compounding pharmacy lacks the equipment and/or expertise to perform such quality assurance tests, they should use an independent laboratory to perform such tests.

Irwin RS, Smith BS. Managing cough in the aftermath of the decision of the US Food and Drug Administration to remove unapproved prescription cough medications from the market. Chest. 2011;1402:282-284 [CrossRef] [PubMed]
 
 United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeial Convention
 
United States Pharmacopeial ConventionUnited States Pharmacopeial Convention Dissolution. United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeial Convention:278-284
 
United States Pharmacopeial ConventionUnited States Pharmacopeial Convention Uniformity of dosage. United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeial Convention:403-406
 
Ostroff C, Lee CE, McMeekin J. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications. Chest. 2011;1402:295-300 [CrossRef] [PubMed]
 

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References

Irwin RS, Smith BS. Managing cough in the aftermath of the decision of the US Food and Drug Administration to remove unapproved prescription cough medications from the market. Chest. 2011;1402:282-284 [CrossRef] [PubMed]
 
 United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeial Convention
 
United States Pharmacopeial ConventionUnited States Pharmacopeial Convention Dissolution. United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeial Convention:278-284
 
United States Pharmacopeial ConventionUnited States Pharmacopeial Convention Uniformity of dosage. United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeial Convention:403-406
 
Ostroff C, Lee CE, McMeekin J. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications. Chest. 2011;1402:295-300 [CrossRef] [PubMed]
 
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