Compounded Medicines: New Laws, New Responsibilities, New Questions

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2 Compounded Medicines: New Laws, New Responsibilities, New Questions ACTIVITY DESCRIPTION The implementation of the Drug Quality and Security Act, enacted by Congress in 2013, has created conflicts between FDA federal law and state pharmacy practice law. Pharmacists engaged in compounding of medications in all practice settings need to understand what new requirements exist. TARGET AUDIENCE The target audience for this activity is pharmacists, pharmacy technicians, and nurses in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist will be able to: Identify specific areas in which federal and state compounding laws differ or appear to be in conflict. Compare and contrast the components of the Drug Quality and Security Act of 2013 with previous federal requirements. List resources for staying current on changing regulatory and legislative issues. After completing this activity, the pharmacy technicians will be able to: Identify four specific areas in which federal and state compounding laws differ or appear to be in conflict. Compare and contrast the components of the Drug Quality and Security Act of 2013 with previous federal requirements. List resources for staying current on changing regulatory and legislative issues. ACCREDITATION Pharmacy PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Nursing PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number ). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit: Universal Activity No.: H03-P Credits: 1.0 contact hour (0.1 CEU) Release Date: 01/14/2016 freece Expiration Date: 1/14/2018 ACPE Expiration Date: 7/14/2018 ACTIVITY TYPE Knowledge-Based Live Webinar FINANCIAL SUPPORT BY PharmCon

3 David Miller, R.Ph Exec. VP & CEO, International Academy of Compounding Pharmacists ABOUT THE AUTHOR David G. Miller, R.Ph. is Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents more than 4,00 practitioners and 163,000 consumers who recognize the value of customized medication solutions provided by the art and science of pharmacy compounding. After receiving his bachelor of science in pharmacy degree from the University of Maryland School of Pharmacy in 1985, he joined the staff of the National Community Pharmacists Association (formerly NARD) as Director of Professional Affairs. In 1988, he accepted a position as Director of Professional Affairs for the Maryland Pharmacists Association and was promoted to serve as that organization s Executive Director three years later. Miller left the pharmacy association world in 1996 to become the Director of Pharmacy Affairs at Merck where he was responsible for corporate relations with the profession at the national and state level as well as with the academic community. In 2010, he took over as CEO for IACP as it began its twentieth year. FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. David Miller reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, faculty may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not intended as a substitute for the participant s own research, or for the participant s own professional judgement or advice for a specific problem or situation. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this activity and other unrelated sources. Neither freece/pharmcon nor any content provider intends to or should be considered to be rendering medical, pharmaceutical, or other professional advice. While freece/pharmcon and its content providers have exercised care in providing information, no guarantee of it s accuracy, timeliness or applicability can be or is made. You assume all risks and responsibilities with respect to any decisions or advice made or given as a result of the use of the content of this activity.

4 Compounding Medicines: New Laws, New Responsibilities, New Questions Activity ACCREDITATION Universal Activity Number L03 Activity INSTRUCTION Faculty Credits 1.0 contact hour(s) David Miller, RPh Exec. VP & CEO, International Academy of Compounding Pharmacists Faculty Disclosure Mr. Miller has no actual or potential conflicts of interest in relation to this activity. Learning OBJECTIVES Identify specific areas in which federal and state compounding laws differ or appear to be in conflict Compare and contrast the components of the Drug Quality and Security Act of 2013 with previous federal requirements List resources for staying current on changing regulatory and legislative issues Legal DISCLAIMER The material presented here does not necessarily reflect the views of PharmCon, Inc. or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. FACULTY: David Miller, RPh 1/14/ Disclosures David G. Miller declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. Learning Objectives At the conclusion of this program, the pharmacist or technician attendee will be able to: Identify specific areas in which federal and state compounding laws differ or appear to be in conflict. Compare and contrast the components of the Drug Quality and Security Act of 2013 with previous federal requirements. List resources for staying current on changing regulatory and legislative issues. 1/14/ /14/

5 What Are The Real Objectives? I want to know Why should I even care about this? I don t compound. At least I don t think I do. Is the FDA coming to see me? Can I still get compound [fill in blank]? Who are these 503B ers what s going on there? How do I protect my patients? Myself? 1/14/ /14/ ,676 Doses Shipped 1/14/ /14/

6 745 Cases, Deaths The System Failed Pharmacy Regulators Purchasers 1/14/ /14/ Pharmacy Failure New England Compounding Center (NECC) Failed to adhere to USP <797> Standards Personnel Contaminated environment Technology/Tools Compounded commercially available products Multiple violations of non-resident state pharmacy permits Engaged in illegal manufacturing Pharmacy Failure New England Compounding Center (NECC) History of disciplinary actions Massachusetts Board of Pharmacy FDA Warning Letters 2003, 2006 Previous deaths from products Out-of-court settlement 2007 Methylprednisolone acetate December indictments, second degree murder, criminal and civil violations 1/14/ /14/

7 Regulatory Failure Massachusetts Board of Pharmacy Comprehensive regulations in place No regular pharmacy inspections Lack of trained inspectors Outsourced NECC inspection in 2008, inspector jailed Consent Agreement with NECC Other state Boards depended on MA Board Regulatory Failure Food and Drug Administration (FDA) Multiple on-site inspections of NECC Complaints filed by pharmacists/others about NECC 2006 warning Letter to NECC No evidence of any further follow-up 1/14/ /14/ Purchaser Failure Past, Present, Future Hospitals and clinics and purchasing departments contributed to the problem Low price drove decisions No review of disciplinary history No verification of status with FDA or Board 2012 NECC Tragedy 74 deaths, 745 in limbo, contaminated steroid 2013 Congressional Response The Drug Quality & Security Act 2014 FDA begins implementation of DQSA 2015 Ongoing implementation, possible technical corrections to the bill 2016 Practice adjusts/life goes on 1/14/ /14/

8 HR DQSA HR DQSA The Drug Quality and Security Act Enacted 27 November 2013 Three Sections Reaffirmation of FDCA 503A with changes Addition of new FDCA 503B outsourcing facilities National track-and-trace system for distributors and manufacturers The Drug Quality and Security Act HR 3204 The Compounding Stuff Not S. 959 Not HR 3089 AThree Two Sections Reaffirmation of FDCA 503A with changes Addition of new FDCA 503B outsourcing facilities National track-and-trace system for distributors and manufacturers 1/14/ /14/ Are You Sure About That? I Don t Compound Federal definitions USP Definition Reconstitution Combining two or more drugs All parenterals Alteration of a dosage form Splitting tablets, creating a suspension, flavorings Nuclear pharmacy 1/14/ /14/

9 Not Just Pharmacists Section 503A of the FDCA (21 USC 353a) Applies to all licensed physicians and pharmacists who are: Engaged in compounding anywhere, any time Compound for individual patients based upon a valid prescription In order to be exempted from requirements for: cgmps - FDCA 501(a)(2)(B) FDA approved labeling FDCA 502(f)(1) Submitting a new drug application FDCA 505 FDCA Section 503A Let s Review Bulk Ingredients Do Not Compound Drugs The MOU Limits State Reporting to FDA Ask Yourself What s Changed or New? Does this Apply to Me? What Might Happen Next? 1/14/ /14/ What s in 503A? Regulatory Implementation Bulk Ingredients May Be Used to Compound APIs must have a USP/NF monograph or Are components of an FDA approved drug or Appear on a list approved by the Secretary of HHS (delegates to the FDA) and Is from an FDA registered supplier and Has a valid certificate of analysis This is not new!!! Bulk Ingredients FDA has asked for lists of APIs that are non-usp/non-fda approved (March/September 2014) They will be reviewed by a Pharmacy Compounding Advisory Committee (First meeting was 23/24 February 2015) Subsequently reviewed and approved by the FDA Eventually published Still unknown. How will FDA handle? Compounding of homeopathic products, naturopathic products, dietary supplements, OTCs 1/14/ /14/

10 API Drug Lists It is not out yet. There were thousands of drugs submitted for review. The PCAC has to review every submission. Ten are done. There are no exemptions. Patient and practice impact What s in 503A? There Are Some Things You Can t Compound Drugs removed from the market for safety and efficacy reasons Published on a list by the FDA Last updated in 1999 and 2003 FDA has asked for recommendations for other nominations to update the list List was issued for comments on 2 July 2014 The current do not compound list must be followed until revisions are released This is not new!!! 1/14/ /14/ Drugs Removed From the Market There is a new do not compound list drugs added More are under review by the PCAC. It will be going into effect soon What s in 503A? There Are Some Things You Can t Compound Drug products that present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product Published on a list by the FDA FDA asked for submissions of drugs and classes of drugs to create the list (Deadline: 4 March 2014) This is kinda new!!! 1/14/ /14/

11 Regulatory Implementation Do Not Compound Lists FDA has asked for lists of demonstrably difficulty drug products (Deadline: 4 March 2014) They will be reviewed by the Pharmacy Compounding Advisory Committee (First meeting was in February, 2 nd in June) Subsequently reviewed and approved by the FDA and eventually published (Sound familiar?) Still unknown. How will we handle? DESI drugs (previously determined as ineffective) Who determines what is really demonstrably difficult? Proposed definition is very broad. Demonstrably Difficult It is not out And we don t know when it will be. There are extensive criteria proposed by FDA. The PCAC has to review every submission. Expect a fight with the industry over this. 1/14/ /14/ What s in 503A? Regulatory Implementation There Are Some Things You Can t Compound Drug Products that are commercially available Essentially copies of a commercially available drug product except for when A change is made for an identified individual patient which produces a significant difference between the compounded drug and the commercial product This is not new!!! Do Not Compound Lists Commercially Available Applies only to individual patient prescriptions FDA monitoring marketing, promotion, websites, Facebook postings, etc. Still unknown How will this be enforced? Who is responsible for maintaining documentation of a significant difference in the patient s therapy. Repackaging (e.g., Avastin ), compounding of certain commercial products paid or required by third-party payers (e.g., Makena ) 1/14/ /14/

12 Commercial Drugs Document the need in the patient s chart Shortages? Allergies? Intolerance to dosage form? Compounds are NOT generics The FDA does not consider cost or affordability to be a legitimate clinical patient need. What s in 503A? The Memorandum of Understanding An agreement between a state and the FDA addresses the distribution of inordinate amounts of compounded drug products interstate provides for appropriate investigation by a State agency of complaints If no MOU exists, then the default limits Interstate distribution of compounds to no more than 5 percent of the total prescription orders dispensed or distributed This is not new!!! 1/14/ /14/ Regulatory Implementation The MOU FDA developed a template/model MOU with NABP The Draft MOU is out and limits interstate distribution FDA intends to begin enforcement 90 days after final But Individual states have to follow their own hearing and publication rules Board of Pharmacy comment periods Still unknown. MOU with a Board of Pharmacy doesn t apply to physicians Is dispensing a patient prescription considered distribution? What happens if the FDA and state can t agree? 1/14/ The MOU WILL IMPACT HOW YOU OBTAIN COMPOUNDS Not out yet Limits interstate shipments Distribute Dispense Deliver 1/14/

13 State Legislative Focus Requiring out-of-state pharmacies to have a permit Special permits for sterile compounding Additional inspections by Boards of Pharmacy Funding for expanded staff and inspectors Mandatory compliance with USP standards for <795>/non-sterile and <797>/sterile Not a peep about physicians, nurses, dentists Something New 1/14/ /14/ FDCA Section 503B Let s Review What s an outsourcing facility? Who are they? What can they compound? Ask Yourself What s Important? What s Changed or New? What s This Mean to Me? What s in 503B? Establishes Outsourcing Facilities An entity that: Compounds and distributes sterile drugs but does not need a patient specific prescriptions to do so Voluntarily registers with the FDA Must comply with cgmps Compounding must be done by or supervised by a pharmacist Does not have to be a pharmacy Can fill patient specific prescriptions This is new!!! 1/14/ /14/

14 What s That Mean to Me? Outsourcing Facilities A new competitor in the marketplace 54 registered but Endorsed by the FDA in a letter to physicians, medical societies, boards of pharmacy, hospitals Still unknown Can a non-pharmacy outsourcing facility fill prescriptions? What regulatory authority will individual state Boards have over this new entity? What s in 503B? What Can Outsourcing Facilities Do? Produce sterile compounds and sell or distribute them to hospitals, physicians, clinics, other pharmacies OFs are required to Comply with specific labeling requirements Submit regular reports to the FDA Be subject to inspections by the FDA Demonstrate ability to follow REMS requirements for certain drugs Report all adverse events to the FDA 1/14/ /14/ What s in 503B? What Can t Outsourcing Facilities Do? Compound drugs that are on the: do not compound list Are considered demonstrably difficult to compound Use bulk ingredients unless They are on the drug shortage list or The bulk ingredient is on a formally approved list Sell to someone that will resell the compound (e.g., a wholesaler) What s That Mean to Me? Outsourcing Facilities There are many limitations to being an OF Significant compliance requirements Significant capital investment to become cgmp compliant There s no such thing as a non-sterile outsourcing facility An outsourcing facility could be a supply source for pharmacies that don t do sterile compounding Still unknown Can a 503A compounder produce sterile medications for office-use if the state permits them to do so? 1/14/ /14/

15 503B Outsourcing Facilities Can compound sterile drugs and sell them to you Have to follow CGMPs like the industry Regulations and inspections ongoing Not all 503B will compound the same things VERIFY YOUR SUPPLIER And If That Isn t Enough 1/14/ /14/ And Still More And Yet Even More Senate Bill 1406 changes DQSA Permits office-use Requires USP <795> and <797> compliance Alters language for the MOU section State and federal laws currently conflict Office-use compounding Interstate shipment/licensure Guidance Documents Provisions for repackaging of sterile and non-sterile manufactured drugs Provisions for repackaging of biologics Open Docket FDA is soliciting comments on anything related to DQSA Patient access impact remains unknown 1/14/ /14/

16 Exam Questions: 1. Which law gives the FDA the authority to enforce compliance with federal compounding regulations? a. USP <797> b. The Drug Quality and Security Act (DQSA) of 2013 c. The Federal Food, Drug, and Cosmetic Act (FDCA) d. None of the above 2. According to USP, which of the following is considered compounding? a. Mixing I.V. fluids b. Splitting tablets in half for a patient c. Reconstituting an oral antibiotic powder d. All of the above are compounding 3. In order to compound using a Bulk Active Pharmaceutical Ingredient (API), the ingredient must meet how many of the following conditions: have a USP/NF monograph; be a component of an already FDA approved drug; appear on the Secretary of HHS s list of approved bulk ingredients? a. One b. Two c. Three d. None of these conditions must be met 4. If a bulk API does appear on the list approved by the Secretary of HHS, it is also essential that purchasers verify: a. That the supplier is registered with the FDA b. That the bulk API has a valid certificate of analysis c. Both a and b d. None of the above

17 5. All of the following are reasons that a medication cannot be compounded except: a. FDA has removed the drug from the market b. The drug is not manufactured in the dosage form needed c. The drug is demonstrably difficult to compound d. The drug is identical to a manufactured product 6. Section 503(a) of the FDCA allows for a Memorandum of Understanding between a state and the FDA. This agreement: a. Addresses the distribution of excessive amounts of compounded drug products between states b. Gives the power to investigate distribution complaints to the FDA c. Makes unlimited distribution of compounded drugs between states legal d. Restricts physicians from distributing compounded drugs 7. From the point of view of many state Boards of Pharmacy, some of the concerns with the new and in progress compounding regulations are regarding which of the following: a. Funding needed to accommodate additional inspections by Boards of Pharmacy b. Requiring permits for out-of-state pharmacies c. How new compounding regulations will affect healthcare professionals other than pharmacists and pharmacies d. All of the above are concerns 8. The new Section 503(b) of the FDCA establishes a new type of entity which: a. Compounds and distributes hazardous materials for non-specific orders b. Compounds and distributes non sterile medications for non-specific orders c. Compounds and distributes sterile medications for non-specific orders d. None of the above

18 9. Outsourcing Facilities are required to do all of the following except: a. Comply with cgmps b. Submit regular reports to the FDA c. Obtain a patient specific prescription d. Follow REMS requirements for applicable drugs 10. Examples of state and federal laws currently in conflict include: a. Compounding for office-use b. Allowable quantities of interstate shipment of compounds c. Licensure requirements for interstate shipment of compounds d. All of the above