# Presentation: 885492

## Importation of Lactose Free Long Acting Beta-2 Agonist Inhalers

- Lynda Mitchell, M.A.
- Parents of Food Allergic Kids (POFAK)
- LMITCHELL@kidswithfoodallergies.org

**Notes:**
I am Lynda Mitchell, the founder of Kids with Food Allergies, Inc. and facilitator of our organization’s 2300+-member support group, Parents of Food Allergic Kids (POFAK). Although I am presenting my concerns from a perspective of parents of young children rather than of Medicare beneficiaries, the concerns I raise can apply to Medicare beneficiaries faced with similar difficulties in obtaining allergen-free beta-2 agonist inhalers.

## Current Situation

- Cow’s milk allergy affects over 4.6 million in the U.S.
- Asthma affects over 20 million in the U.S.
- NAEPP guidelines for certain classifications of asthma recommend the use of long acting beta-2 agonist inhalers for optimal management

**Notes:**
The prevalence of cow’s milk allergy (CMA) has been determined to afflict from 1.6% to 2.8% children  (approximately 1.1 to 2 million children), and up to 0.7% and 1.2% of adults (1.5 to 2.6 million adults)1. Milk allergy, as any other food allergy, can be severe and life threatening and dietary avoidance is the current standard of care2.  
According to the Centers for Disease Control, asthma afflicts about 20 million Americans, including 9 million children.  In 2000, there were nearly 2 million emergency room visits and nearly half a million hospitalizations due to asthma, at a cost of almost $2 billion, and causing 14 million school days missed each year3.  Asthma is considered an epidemic in this country, and campaigns by the EPA and other governmental and private organizations have targeted asthma education, awareness and optimal treatment as key objectives to improve the health of asthmatic children and adults nation-wide.
The National Institutes of Health, through its National Asthma Education and Prevention Program, has set forth best practice guidelines for the diagnosis and treatment of asthma. These guidelines include a step-wise approach to asthma maintenance; the preferred treatment guidelines for some classifications of asthma require the use of long acting inhaled beta-2 agonists in combination with inhaled corticosteroids4.    

## Current Situation

- Lactose-free long acting beta 2 agonist inhalers are no longer available in the U.S.; they have been replaced with CFC-free diskus inhalers that contain lactose and trace milk protein that some severely milk allergic asthmatics cannot use
- The same manufacturers still produce the lactose free inhalers versions of these inhalers for the Canadian market

**Notes:**
The Food and Drug Administration has begun the planning and regulatory process for the eventual transition away from chlorofluorocarbon (CFC) metered dose inhalers (MDI) to non-CFC alternatives in accordance with the Montreal Protocol.  The FDA states that its  “primary objective as part of the mandated phase out of CFC-MDIs is to ensure that the health and safety of the millions of patients in the United States who rely on CFC-MDIs is not compromised and that patients continue to have access to a satisfactory number of treatment options5.” In reality, however, the manufacturers of long acting inhaled beta-2 agonists such as Foradil, Serevent and Advair have ceased production of CFC containing versions of these inhalers in the U.S. already, and have replaced them with dry powder inhaler (DPI) diskus formulations, all of which contain lactose, a milk derivative.  
An undetermined, but real, number of atopic individuals have both asthma, which requires their use of long acting beta-2 agonists, and concomitant severe milk allergy. The prescribing information for these diskus inhalers indicates the potential presence of milk protein in them6. Although a recent study indicated that lactose in medications is generally safe for milk allergic individuals7, there have been reports of severe reactions to lactose in diskus inhalers that have been demonstrated by assay to contain variable amounts of contamination with milk protein8. For this reason, Nowak-Wegrzyn et al. recommend that “lactose-containing DPIs be used with caution in patients with severe milk allergy...lactose-free DPI or alternative asthma inhalers should be preferred choices for such patients. Furthermore, product information inserts of the lactose-containing DPIs should include a warning on possible allergic reactions to milk protein contamination9.”
Unfortunately at this time, lactose-free beta-2 agonist DPI or asthma inhalers are not available in the United States, and lactose free beta-2 agonist inhalers using an alternative HFA propellant will not be available in the United States until at least 2005 or later).  The companies which produce these lactose-free asthma medications have chosen to cease production of them in the U.S. in order to comply with the terms of the Montreal Clean Air Act, but continue to still produce them in Canada.  These medications are already being used safely by Canadian asthmatics.   Clearly these medications produced in Canada by the same manufacturers that made them in the U.S. are safe and effective for Canadians, and are equally safe and effective for Americans who still need them. In situations such as these, the medications should not only be legally available for purchase by U.S. citizens, but also the costs should be covered by insurance policies or Medicaid, just as any other physician ordered medications would be. 

## Current Alternatives

- Receive sub-optimal asthma treatment that is not in conformance with NAEPP best practice recommendations
- Purchase lactose free inhalers illegally and out of pocket from Canada that are the same as the ones previously available in the U.S.

**Notes:**
The dilemma of not having lactose free MDIs available leaves one of two options for milk allergic asthmatics needing lactose free beta-2 agonist inhalers: 1) choose sub optimal treatment with medications that are not in line with the (NAEPP) best practices Guidelines for the Diagnosis and Management of Asthma, or 2) purchase the recommended medications illegally from Canadian pharmacies.
These two choices have placed severely milk allergic asthmatic children and adults into an unenviable position of having to choose between sub optimal treatment or breaking federal law. Further exacerbating this issue is that health insurance plans, including Medicaid, do not cover medications purchased from Canadian pharmacies even though these were previously covered when they were available in the U.S.  Families either have to pay out of pocket if they can afford the medications from Canada, or if unable to afford the out-of-pocket cost, the asthmatic child does not receive optimal asthma medication management in line with NAEPP guidelines. In some instances, the lack of availability of lactose free long acting beta-2 agonists for asthma maintenance has resulted in asthma exacerbations and complications resulting in emergency room visits and increased health care costs for some children and adults.

## Solution

- In situations such as this, where a drug previously FDA approved as safe and effective is no longer available in the U.S. but is available in Canada, importation should be legal, allowable and reimbursable just as when that drug was available in the U.S. market.

**Notes:**
There needs to be a way to allow families such as the ones faced with these types of untenable situations to purchase medications from Canada and have their health insurance, Medicare or Medicaid cover the costs, just as they were covered when they were available for purchase in the United States. Any perceived potential risk of a pharmaceutical company losing money on the importation of Canadian medication is outweighed by the very real risk of sub optimal asthma care for individuals with milk allergy who are unable to obtain lactose free asthma inhaler medication.  
Please consider situations such as these as you move forward with your decision-making regarding the circumstances under which prescription drugs would be legally imported for use in the U.S. There are exceptions to every rule, and this is a good example of one.  The decision to allow the importation of lactose free MDIs from Canada, and to encourage or mandate insurance coverage by insurance plans that cover the therapeutic equivalents in the U.S, will have a positive and potentially life saving impact on the health of many milk allergic asthmatic children and adults. In a broader sense, this type of scenario could potentially apply to other life-saving medications that may be taken off the U.S. market though still available in Canada.

## References

- 1  Besler, M., Eignenmann, P. & Schwartz, R. (2002). Allergen Data Collection - Update: Cow's Milk  (Bos domesticus).  *Internet Symposium on Food Allergens*.  Retrieved on March 24, 2004 from http://www.food-allergens.de/symposium-4-1/cows-milk/cows-milk-abstract.html
- 2 Nowak-Wegrzyn, A. (2003, June).  Future Approaches to Food Allergy. Pediatrics. Retrieved on March 24, 2004 from http://pediatrics.aappublications.org/cgi/content/full/111/6/S2/1672
- 3 National Center for Health Statistics, Centers for Disease Control and Prevention.  *Asthma Prevalence, Health Care Use, and Mortality, 2000-2001.*
- 4 National Asthma Education and Prevention Program. (NAEPP) (2002).  *Quick reference NAEPP expert panel report for the diagnosis and management of asthma – update on selected topics for 2002.*  Retrieved on March 24, 2004 from   _[http://www.nhlbi.nih.gov/guidelines/asthma/execsumm.pdf](http://www.nhlbi.nih.gov/guidelines/asthma/execsumm.pdf)_
- 5 Center for Drug Evaluation and Research, U.S. Food and Drug Administration. (2001). *Metered-Dose Inhaler Medication: Frequently asked questions*. Retrieved on March 24, 2004 from  _[http://www.fda.gov/cder/mdi/](http://www.fda.gov/cder/mdi/mdifaqs.htm)__[mdifaqs](http://www.fda.gov/cder/mdi/mdifaqs.htm)__[.](http://www.fda.gov/cder/mdi/mdifaqs.htm)__[htm](http://www.fda.gov/cder/mdi/mdifaqs.htm)_
- 6 Glaxo Smith Kline, Inc. (2003).  [Product inserts] Retrieved March 23, 2004 from _[http://us.](http://us.gsk.com/products/assets/us_advair.pdf)__[gsk](http://us.gsk.com/products/assets/us_advair.pdf)__[.com/products/assets/us_](http://us.gsk.com/products/assets/us_advair.pdf)__[advair](http://us.gsk.com/products/assets/us_advair.pdf)__[.](http://us.gsk.com/products/assets/us_advair.pdf)__[pdf](http://us.gsk.com/products/assets/us_advair.pdf)_, and http://us.gsk.com/products/assets/us_serevent_diskus.pdf
- 7 Fiocchi A, Restani P, Leo G, Martelli A, Bouygue GR, Terracciano L, Ballabio C, & Valsasina R. (2003, August). Clinical tolerance to lactose in children with cow's milk allergy. *Pediatrics*. Retrieved on March 23, 2003 from  http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12897287
- 8 Nowak-Wegrzyn, A.,  Shapiro, G.G., Beyer, K., Bardina, L., &  Sampson,  H.A. (2004, March).  Contamination of dry powder inhalers for asthma with milk proteins containing lactose. *Journal of Allergy and Clinical Immunology*. [Letter to the Editor] Retrieved on March 23, 2004 from http://www2.us.elsevierhealth.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=letter&id=as0091674903026770
- 9 Nowak-Wegrzyn, A.,  Shapiro, G.G., Beyer, K., Bardina, L., &  Sampson,  H.A. (2004, March).  Contamination of dry powder inhalers for asthma with milk proteins containing lactose. *Journal of Allergy and Clinical Immunology*. [Letter to the Editor] Retrieved on March 23, 2004 from http://www2.us.elsevierhealth.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=letter&id=as0091674903026770