PRESERVING PATIENT ACCESS TO COMPOUNDED MEDICATIONS H.R. 2871

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Spencer Shelton
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1 PRESERVING PATIENT ACCESS TO COMPOUNDED MEDICATIONS H.R BACKGROUND: Compounded medications are used to treat patients with unique medical conditions that make them resistant to standard medications. For example, using active ingredients without preservatives or allergenic substances, or putting an active ingredient in substances to be used topically or intravenously instead of orally for patients with digestive issues. Many nutritional and herbal remedies are also only available through compounding pharmacies, because large pharmaceutical manufacturers do not make small batches of these products. These compounded products are used to treat a variety of conditions, including digestive disorders, chronic viral infections, anemia and vitamin deficiencies; migraine, colitis, asthma, hepatitis, diabetes, Parkinson s, chronic fatigue and other autoimmune disorders, or supportive therapies to mitigate side-effects of chemotherapy. They are essential for millions. Historically, naturopathic doctors, along with Dermatologists, Opthamologists and many other provider types, maintain a supply of compounded medications to administer to a patient in the physician s office for the immediate treatment of a problem, a practice governed by state law and referred to as office-use. This supply is obtained by the physician, without requiring an advance prescription for each individual patient. The Drug Quality & Security Act (DQSA, P.L ) was enacted in response to a meningitis outbreak from contaminated sterile drugs compounded that tragically resulted in dozens of deaths. The DQSA gives the FDA new oversight over some compounding facilities to address these safety concerns. Neither office use or the rejection of dietary supplement monographs have anything to do with the meningitis outbreak, and in passing the DQSA, Congress made clear statements noting the importance of maintaining patient access to office-use drugs and ensuring that compounding regulations should not interfere with the practice of medicine. Since passage of the DQSA, the FDA has interpreted certain provisions of the law in a manner inconsistent with legislative intent to expand its oversight over physicians and compounding pharmacies, and the medications compounded by these pharmacies. ISSUE #1: OFFICE-USE FDA has issued non-binding guidance for industry (GFI) documents that do not have the force of law or administrative rule to restrict office-use of compounded medications. FDA guidance now requires that physicians may not use compounded medications for office-use to treat patients in real time. Instead, a physician must write a patient-specific prescription.

2 What formerly could be treated in the same visit now requires: 1) a trip to the physician office for evaluation and diagnosis, 2) a trip to the pharmacy to obtain the prescription, and 3) a follow-up visit to the physician office to administer the treatment. This causes a number of problems: Delays in patient care Increased patient cost of care through additional co-pays Increased risk of patients not adhering to a treatment protocol Increased risk to patients if the prescriptions - many of which require refrigeration or degrade easily - are not handled or stored safely by the patient Decreased supply of drugs, some pharmacies have stopped providing some compounded drugs Increased cost of prescriptions since each prescription is made specific for the patient instead of available in bulk through the physician ISSUE #2: DRUG INGREDIENTS FDA has also started a process to take long-used safe ingredients that are compounded for patients off the market. They have required that any substance that does not have a Drug Monograph in the US Pharmacopeia or National Formulary must be nominated for approval to compound. Of 453 ingredients that were nominated for the FDA s Pharmacy Compounding Advisory Committee (PCAC) to review, they have refused to review 390 ingredients. PCAC has further rejected 71% of the 49 ingredients that they have reviewed to date, despite a long history of safe use and patient need. Yet many of these ingredients have U.S. Pharmacopeia Dietary Supplement monographs, which Congress intended to also be available for compounding but which FDA has refused to accept. If these monographs are not accepted, this will have the effect of restricting patient access to over 400 compounded drugs currently being used by hundreds of thousands of patients. LEGISLATIVE ASK: Representatives Morgan Griffith (R-VA) and Henry Cuellar (D-TX) have introduced the Preserving Patient Access to Compounded Medications Act (H.R. 2871), which would clarify congressional intent regarding key provisions of the Food, Drug and Cosmetic Act (FDCA) as amended by the DQSA. H.R would allow traditional compounding pharmacies to distribute compounded drugs for office-use without a patient-specific prescription in all states that allow office-use compounding, and would clarify acceptance of ingredients for compounding with dietary supplement as well as drug monographs. HOUSE: Cosponsor the Preserving Patient Access to Compounded Medications Act (H.R. 2871) introduced by Representatives Morgan Griffith (R-VA) and Henry Cuellar (D-TX) Request a hearing for H.R SENATE: Sponsor or cosponsor a Senate companion bill, and support H.R. 2871

3 SECTION-BY-SECTION SUMMARY OF H.R. 2871: SECTION 1. SHORT TITLE. The bill is to be titled the Preserving Patient Access to Compounded Medications Act of SECTION 2. OFFICE-USE COMPOUNDING WHEN AUTHORIZED BY STATE LAW. This section of the bill amends Section 503A of the Food, Drug and Cosmetic Act to state that the compounding of medications by a licensed pharmacist or licensed physician for officeadministration to a patient in an office or clinical setting is permissible under 503A when done in accordance with State law. The compounding must be done pursuant to a valid prescription order or drug order and distributed or dispensed to a licensed prescriber in accordance with State law, for administration to a patient in an office or clinical setting. SECTION 3. UNITED STATES PHARMACOPOEIA OR NATIONAL FORMULARY REQUREMENT. This section of the bill clarifies that it is permissible under Section 503A(b)(1)(A) of the Food, Drug and Cosmetic Act for a licensed pharmacist or a licensed physician to compound a drug product using bulk drug substances that comply with the monograph standards of the United States Pharmacopoeia or National Formulary, including a drug substance or dietary supplement monograph. The section does not change the current requirements of 503A(b)(1)(A) that if a monograph does not exist, the drug substance may only be used for compounding if it is a component of an FDA approved drug or if it appears on a positive list developed by the Secretary. SECTION 4. DEFINITIONS. This section of the bill adds two new definitions to Subsection (e) of section 503A of the Food, Drug and Cosmetic Act. The section defines Distribute or Distribution to clarify that those terms do not include the act of dispensing a compounded drug product in accordance with Section 503A. Section 4 of the bill also defines Dispense to mean, for a drug product compounded in accordance with Section 503A, the act of the drug product leaving the facility in which it was compounded for delivery to a patient, patient s agent, or health care facility (including a hospital, physician s office, or other health care setting) pursuant to a valid prescription order for an identified patient. SECTION 5. APPLICABILITY OF RECORDS EXEMPTION FOR COMPOUNDING PHARMACIES. This section of the bill clarifies that when inspected by FDA, the records exemption provided in existing Section 704(a)(2)(A) of the Federal Food, Drug and Cosmetic Act to pharmacies which maintain establishments in conformance with local laws regulating the practice of pharmacy and medicine, apply to compounding pharmacies that are also in compliance with the provisions of 503A of the Food, Drug and Cosmetic Act as amended by this bill. This section of the bill also

4 clarifies that the exemption from FDA manufacturer registration requirements provided in existing Section 510(g)(1) of the Food, Drug and Cosmetic Act for pharmacies which maintain establishments in conformance with local laws regulating the practice of pharmacy and medicine, apply to compounding pharmacies that are also in compliance with the provisions of 503A of the Food, Drug and Cosmetic Act as amended by this bill. SECTION 6. REGULATIONS. This section of the bill requires the Secretary of Health and Human Services to, within 90 days of enactment of this Act, promulgate rules on the record to carry out the amendments to the law made by the bill. This section will also require the Secretary to promulgate rules on the record to carry out other provisions of Section 503A of the Food, Drug and Cosmetic Act not amended by the bill (the provisions of 503A in existing law).

5 NATUROPATHIC DOCTORS AND THE COMPREHENSIVE ADDICTION AND RECOVERY ACT 2.0 (S and H.R. 5311) BACKGROUND: Chronic and acute pain is one of the most common complaints seen in all medical practices, including those of naturopathic doctors. Ineffective pain control and relief has led to billions of dollars in lost productivity, a galloping increase in the prescription use of opioid pain relievers, and unprecedented deaths from addiction and drug abuse. Licensed Naturopathic Doctors use a variety of safe and effective therapies to relieve pain, mostly focused on non-pharmacological approaches but in some states also using Medication-Assisted Treatment (MAT) for recovery options. Studies show that naturopathic treatments compared to conventional medical treatments show similar or greater pain relief, with an increase of quality of life, diminished costs, fewer missed work days, and the best, no addiction to prescription medications. Savings of nearly $1,000 per patient with low back pain using naturopathic therapies, with missed work due to illness diminished by 6.7 days, leading to return on investment 1 of 7.9 percent. 60 percent pain reduction in patients of naturopathic doctors in a complementary and 2 alternative medicine pain clinic. 54 percent reduction in pain, better outcomes and diminished disability in a randomized controlled trial (RCT) study on rotator cuff tendinitis in postal workers from therapies 3 administered by licensed naturopathic doctors. PROBLEM: ENSURING PATIENT ACCESS TO MEDICATION-ASSISTED TREATMENT Only one in 10 people in the U.S. with an addiction receive treatment. According to the Pew Charitable Trusts, that s in large part because of a shortage of trained medical providers, 4 especially ones who can prescribe buprenorphine. 1 Herman PM, Szczurko O, Cooley K, Mills EJ. Cost-effectiveness of naturopathic care for chronic low back pain. (2008) Altern Ther Health Med Mar-Apr 14 (2): Secor ER, Markow MJ, Mackenzie J, Thrall RS. Implementation of outcome measures in a complementary and alternative medicine clinic: evidence of decreased pain and improved quality of life. (2004) J Altern Complement Med 10: Szczurko O, Cooley K, Mills EJ, Zhou Q, Perri D. Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial. (2009) Arthritis Rheum 61:

6 Section 303 of CARA was previously amended to allow physician assistants and nurse practitioners to prescribe buprenorphine under the direction of a qualified physician, and is set to sunset in S makes a permanent addition of nurse practitioners and physicians assistants as Qualifying Other Practitioners who can prescribe buprenorphine. H.R would add a variety of other nurses as well as physicians assistants to the list of Qualifying Other Practitioners. Licensed naturopathic doctors receive more training and education than both physician assistants and nurse practitioners, and several states authorize naturopathic doctors to prescribe the DEA schedules necessary for Medication-Assisted Treatment like buprenorphine. Many naturopathic doctors treat patients with addiction involving opioid use, and should be added to H.R and S Otherwise patients of NDs will be denied access to this life-saving treatment option, at a time of crisis when we need all available providers to practice to the full extent of their scope and education. LEGISLATIVE ASK: Fill the addiction treatment gap by leveling the playing field for patients of naturopathic doctors to be able to access the same Medication-Assisted Treatment options as other providers by amending Section 303 of CARA 2.0 to include NDs. HOUSE: Co-sponsor H.R Request a legislative hearing for H.R Energy & Commerce Committee members, especially members of the Health Subcommittee, offer an amendment to H.R to include Naturopathic Doctors to the list of providers eligible to prescribe Medication-Assisted Treatments SENATE: Co-sponsor S Request a legislative hearing for S Health, Education, Labor and Pension Committee members offer an amendment to S to include Naturopathic Doctors to the list of providers eligible to prescribe Medication-Assisted Treatments

7 American Association of Naturopathic Physicians Naturopathic Doctors and Pain Relief Chronic and acute pain is one of the most common complaints seen in medical practice. Ineffective pain control and relief has led to billions of dollars in lost productivity, including missed days from work. As a consequence of pain, there has been a galloping increase in the prescription use of opioid pain relievers, leading to unintended consequences, such as increased addiction and drug abuse. Licensed Naturopathic Doctors use a variety of safe and effective therapies to relieve pain, which - in head to head studies - show at the least a similar pain relief, with an increase of quality of life, diminished costs, fewer missed work days, and the best, no addiction to prescription medications. Some of the studies include: 1. In one trial, naturopathic therapies were estimated to save nearly $1,000 per patient with low back pain. Importantly, missed work due to illness diminished by 6.7 days, leading to return on investment of 7.9%. (Herman PM, Szczurko O, Cooley K, Mills EJ. Cost-effectiveness of naturopathic care for chronic low back pain. (2008) Altern Ther Health Med Mar-Apr 14 (2):32-39.) 2. In a complementary and alternative medicine pain clinic, Naturopathic Doctors achieved a 60% pain reduction. (Secor ER, Markow MJ, Mackenzie J, Thrall RS. Implementation of outcome measures in a complementary and alternative medicine clinic: evidence of decreased pain and improved quality of life. (2004) J Altern Complement Med 10: ) 3. In a randomized controlled trial (RCT) study on rotator cuff tendinitis in postal workers, therapies administered by Naturopathic Doctors decreased pain by over 54 percent, better than other arms in the trial, and diminished disabilities. (Szczurko O, Cooley K, Mills EJ, Zhou Q, Perri D. Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial. (2009) Arthritis Rheum 61: ) 4. In another RCT, naturopathic therapies were compared to standard therapies for low back pain and were found to significantly benefit patients, both in decreasing pain and increasing range of motion, and were at the very least comparable to standard therapies, yet without the use of prescription medications. Quality of life improved significantly. (Szczurko O, Cooley K, Busse JW, Seely D, Bernhardt B. Naturopathic care for chronic low back pain: a randomized trial. (2007) PLoS One 2: e919) 5. In a pilot clinical trial at an HMO, Naturopathic Doctors showed significant decrease in temporomandibular jaw pain as compared to standard care. (Ritenbaugh C, Hammerschlag R, Calabrese C, Mist S, Aickin M. A pilot whole systems clinical trial of traditional Chinese medicine and naturopathic medicine for the treatment of temporomandibular disorders. (2008) J Altern Complement Med 14: ) An example of this approach is found at Southwest College of Naturopathic Medicine, where the Pain Relief Center is housed and uses a collaborative interdisciplinary approach of Naturopathic Doctors, medical doctors, and acupuncturists. Contact: Paul Mittman, ND, EdD; President/CEO Southwest College of Naturopathic Medicine, p.mittman@scnm.edu th St. NW, Suite 250, Washington, DC (202)

9 [Excerpt] Request to amend by adding naturopathic physician after physician assistant.

10 [Excerpt] Request to amend by adding naturopathic physician after physician assistant.

Guidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry DRAFT GUIDANCE This guidance