Re: Docket No. FDA-2009-N-0294 Regulation of Tobacco Products; Request for Comments

Transcription

1 VIA Electronic Submission to September 29, 2009 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm Rockville, MD Re: Docket No. FDA-2009-N-0294 Regulation of Tobacco Products; Request for Comments Dear Sir or Madam: On behalf of the National Community Pharmacists Association (NCPA) I would like to offer comments and suggestions on the implementation of H.R. 1256, the Family Smoking Prevention and Tobacco Control Act. Specifically we would like to offer our recommendations to reduce the incidence and prevalence of tobacco product use and protect the public health. NCPA represents the pharmacist owners, managers and employees of more than 23,000 independent community pharmacies across the United States. The nation s independent pharmacies, independent pharmacy franchises and independent chains dispense nearly half of the nation s retail prescription medicines. H.R grants new authority to FDA to regulate the manufacture, marketing and distribution of tobacco products. However, the missing piece of the puzzle that is not addressed in H.R is that of smoking cessation. Smoking is the leading case of preventable morbidity and mortality in the United States and is responsible for more than 400,000 smoking related deaths each year. In addition, smoking related illnesses cost the nation more than $96 billion each year. It has also been estimated that on an annual basis, approximately 40% of smokers in the U.S. attempt to quit, but only 6% achieve long-term success. 1 As trained and accessible healthcare professionals, pharmacists are in an ideal position to provide tobacco cessation interventions. In fact, the World Health Organization has long supported the role of the pharmacist in smoking cessation efforts. 2 Studies have indicated that pharmacists are effective providers of tobacco cessation intervention and that a greater utilization of pharmacists in cessation efforts could have a significant impact on smoking rates, prevention of tobacco-related diseases and overall improvement in public health across the country. 3 Require or encourage states to use a percentage of funds received under the tobacco master settlement to fund smoking cessation programs. 1 The Annals of Pharmacotherapy: Vol.43, No. 2, pp , International Pharmaceutical Federation. Tobacco Free Initiative of the World Health Organization 3 The Annals of Pharmacotherapy: Vol. 43, No. 2, pp

2 We feel that in order to effect meaningful progress to implement smoking cessation programs that there needs to be a concerted effort by both the federal government and the individual states, specifically in the area of dedicated funding for smoking cessation programs. In 1998, the four largest US tobacco companies and the Attorneys General of 46 states entered into an agreement known as the Tobacco Master Settlement Agreement (MSA). In addition, four states each negotiated an individual state-specific settlement. The states settled their Medicaid lawsuits against the tobacco industry for recovery of their tobacco-related health care costs and also exempted the companies from private tort liability regarding harm caused by tobacco use. In exchange, the companies agreed to pay, in perpetuity, annual payments to the states to compensate them for the costs of caring for persons with smoking-related illnesses. Specifically, under the MSA, the tobacco companies agreed to pay a minimum of $206 billion over the first twenty-five years of the agreement. Unfortunately, in spite of these annual payments to states under the agreement, most states have failed to utilize any significant portion of those funds to help smokers in their cessation efforts. In the past ten years, the states have received $205.5 billion in tobacco-generated revenue 79.2 billion from the tobacco settlement and $124.3 billion from tobacco taxes. However, they have spent just 3.2% of their tobacco money on prevention and cessation programs. 4 North Carolina is distinctive in that it dedicates one-fourth of the state s annual tobacco settlement funds to the NC Health and Wellness Trust Fund, an entity that funds preventive health initiatives as well as prescription drug assistance programs. The NC Health and Wellness Trust Fund currently funds ChecKmeds NC, a medication therapy management (MTM) program administered by community pharmacists for Medicare Part D recipients, and recently launched a smoking cessation program for prenatal and postpartum women. We recommend that HHS and FDA strongly encourage or require states to utilize at least a portion of the monies that they receive each year from the tobacco industry to fund effective smoking cessation programs, which can be provided by community pharmacists. A number of other organizations and associations including the Campaign for Tobacco-Free Kids and the American Cancer Society have also identified the master settlement monies received by the states as a logical source of smoking cessation funding. Community pharmacists are the most accessible health care professionals and are ideally positioned to deliver cost-effective smoking cessations programs. Within the American health care system, community pharmacists are ideally positioned to promote smoking cessation and carry out effective clinical intervention due to the number of patients they interact with on a daily basis as well as the availability of nonprescription nicotine replacement therapies available in pharmacies. In 1994, the FDA included specific conditions regarding the distribution of nicotine replacement therapy in its Approval Letter to Application Number /S025 and 20-S007. In the letter, the FDA restricts the distribution of nicotine replacement therapy to drugstores, mass merchandisers and supermarkets where other OTC drugs are sold. The products will not be distributed to other channels including convenience stores and vending machines. The letter also prohibits the 4 A Decade of Broken Promises; The 1998 State Tobacco Settlement Ten Years Later. Page 2 of 5

3 offering of trial size or sample packs (e.g., packs small enough to be priced competitively with cigarettes). We urge the FDA to retain its current policy on the restricted distribution of these products. These nicotine-containing items are in no way a safe nicotine delivery system and in fact, are usually available in the form of gum or lozenge a delivery system that may be more attractive to children than other populations. Given that medications approved by the FDA for smoking cessation are available primarily through pharmacies, it seems imperative that pharmacists become active and recognized resources for tobaccocessation assistance. 5 In a recent informal NCPA survey of our pharmacist members, a majority indicated that they either currently provide smoking cessation counseling/services or would be interested in doing so. With the intake of every new prescription, pharmacists can question patients regarding their smoking history, assess patients readiness to participate in smoking cessation programs and with the review of their medication profiles, identify potentially dangerous drug interactions between patients medications and tobacco use. There have been numerous studies and demonstration projects illustrating the effectiveness of pharmacist-managed smoking cessation programs in virtually all care settings including community pharmacies, managed care networks, VA clinics and Medicaid populations. One study of a smoking cessation clinic in a community pharmacy showed that after six and even twelve months, 25% of the patients enrolled were tobacco free. 6 In addition, most schools of pharmacy now include coursework or training in administering smoking cessation programs. 7 Tobacco dependence is a chronic condition like high blood pressure or diabetes-- that can be effectively managed. Management of chronic health conditions by community pharmacists has been successfully demonstrated. The need to manage medications appropriately and adhere to medication regimens for effective disease control management has been recognized by the federal government as well as private payors. The most widely promoted MTM program to date can be seen in the Asheville Project. This initiative was started by two large self-insured employers in North Carolina in 1996 and offers services to employees, dependents and employees by community pharmacists for chronic disease states such as diabetes, asthma, and depression. A smoking assessment/cessation plan is typically included in each intervention if applicable. Community pharmacists carry out monthly monitoring of patients to ensure compliance with medication and other interventions and coordinate care of patients along with their physicians. It has been clearly shown that employees who participate in the program use fewer sick days and employers have experienced a decline in total direct medical costs. The Asheville Project was so successful that it has been replicated in similar programs across the country. Acknowledging the past successes and future potential of MTM in the areas of cost savings and patient outcomes for patients with chronic disease states, CMS requires all Medicare Part D plans to offer MTM to assist beneficiaries with multiple chronic diseases who take multiple Part D eligible drugs. Also, 5 Hudmon K, The pharmacist s role in tobacco cessation. Am J Health-Syst Pharm. 2007; 64: Kennedy DT, Chang ZG, Small RE, Edwards JH. Results of a smoking cessation clinic in community pharmacy practice. J Am Pharm Assoc (Wash). 42(1):51-6, 2002 Jan-Feb 7 Utilization of Community Pharmacies: Implications for Health Care Delivery. Harvard Health Policy Review. Vol. 7, No. 1, Spring 2006 Page 3 of 5

4 under the Medicare Preventative Services program, Medicare will cover tobacco cessation counseling (limited to eight counseling sessions per year) as well as smoking cessation treatments or medications prescribed by a physician. MTM ensures patient understanding about medication use and adherence and can be used to promote positive lifestyle modifications to supplement medication results. As mentioned earlier in these comments, North Carolina has recognized the critical role of the community pharmacist in effecting positive lifestyle changes and medication adherence and has specified that the MTM services for Medicare Part D beneficiaries in state shall be administered by community pharmacists. A pharmacist-run MTM program could easily be used as a model for smoking cessation or intervention programs or an intensive smoking cessation component could easily be added to existing MTM programs. Treatment for tobacco dependence should be recognized as a legitimate reimbursable health care service by the federal and state governments as well as private payors. In order to effect lasting change in reducing tobacco dependence, the entire health care system must be involved and committed to addressing the issue. The influence of health care system administrators, insurers and purchasers could be used to encourage and support the consistent and effective identification and treatment of tobacco users. Significant savings in tobacco- related medical costs and hospitalizations could be realized by acknowledging tobacco cessation treatment as a valid and reimbursable medical expense. In spite of the plethora of evidence indicating that smoking cessation treatment is cost effective, there is still a significant lack of coverage for the service. Medicaid recipients are disproportionately affected by tobacco-related disease because their smoking prevalence is approximately 53 % greater than that of the overall U.S. population. 8 However, there is wide variation among state Medicaid programs in terms of the level of coverage for smoking cessation treatment. Eight states still provide no Medicaid coverage for tobacco-dependence treatments and only seven states cover all FDA-approved smoking cessation medications and at least one form of counseling for Medicaid recipients. In addition, most of the states that do provide some Medicaid coverage for smoking cessation treatment impose significant limitations on coverage inconsistent with federal clinical practice guidelines by requiring co-payments or prior authorization. Some states also place limits on the duration of treatment or provide coverage for only one type of tobacco-dependence treatment at a time. Despite a large body of evidence supporting the cost-effectiveness of smoking cessation treatment, many private payor managed care organizations do not provide full coverage of such services. One explanation offered for this seemingly incongruous behavior is that these organizations may not believe that the cost savings from smoking cessation outweighs the cost of treatment or that due to enrollee turnover savings may accrue to other plans after they have paid for the treatment. However, numerous studies have shown that smoking cessation is highly effective, saving life years at much less cost than most other routinely covered services, such as blood pressure control and mammography. Conclusion It is crucial that the FDA emphasize the cost savings and significant health benefits associated with smoking cessation treatment and work to enhance federal and state funding for such treatment. In addition, the FDA should expand upon the successes of community pharmacy MTM programs to 8 State Level Medicaid Expenditures Attributable to Smoking. Prev. Chronic Dis 2009;6(3) Page 4 of 5

5 provide effective cessation treatment in the Medicaid and Medicare programs. Finally, the FDA must actively engage private payors to encourage or incentivize them to provide smoking cessation services to covered individuals. NCPA appreciates the opportunity to comment on FDA-2009-N-0294 Regulation of Tobacco Products. If you have any questions, please contact me at (703) or Sincerely, John M. Coster, Ph.D., R.Ph. Senior Vice President, Government Affairs National Community Pharmacists Association Page 5 of 5