June 27, 2013
Senate Releases Revised Compounding Bill, Today
The Senate has just released its revised version of the Compounding Bill. Please click here to review. The IACP Legislative Team currently is reviewing this Bill line-by-line, and will provide a comprehensive report as soon as completed. Please see IACP's initial comments below:
The language in S. 959 released on Thursday, 27 June 2013 includes the following:
- A definition that all compounded drugs are "new drugs" as defined within the FDCA (page 57)
- Defines the repackaging and distribution in interstate commerce of sterile drugs without individual patient prescriptions as the activities of a "compounding manufacturer." (page 59)
- Provides for anticipatory compounding only in instances where the historical volume is directly associated with an individual patient prescription (page 64)
- Hospitals and health-systems with wholly owned inpatient and outpatient facilities are exempted from being considered compounding manufacturers even if they ship interstate (page 66)
- Traditional compounding is exempted from the "new drug" requirements of an NDA/ANDA and the AERS if the pharmacy is in full compliance with this section of the law as well as state law. (page 66)
- The FDA may develop a "do not compound" list based upon "demonstrably difficult" criteria (which is undefined). (pages 68/69)
- The FDA may develop a "do not compound" list for drugs which are currently under a REMS when produced by manufacturers (page 69)
- Compounding of "commercially available" products are restricted to "documented clinical differences" for an individual identified patient or, if in drug shortage, subject to a 3 day notification to the FDA requirement (page 72-74)
- Compounding manufacturers who are preparing drugs that are in shortage must notify the FDA 14 days in advance before preparing any compounds. (page 73)
- The repackaging of a currently marketed drug into a format/dosage form that is also currently marketed (e.g., Avastin and Lucentis) is prohibited. (page 74)
- Prior to compounding a medication under REMS may only be done so with prior advance proof and submission to the FDA that the pharmacy is capable of meeting the REMS requirements (page 77)
- API-based compounding must still be upon the existence of a monograph or when using a drug product that appears on a list to be established by the FDA. No mention is made of other nationally recognized compendia (e.g., homeopathic medicines). (Page 77)
- The FDA is empowered to prohibit the compounding of a preparation with an API-based ingredient even if there is a monograph published in the FDA (Page 80)
- The GAO will prepare an analysis and report on veterinary compounding. (page 106)
- False and misleading advertisements of a compounded preparation by either a traditional compounder or manufacturer has defined penalties (107)
References to compliance with USP standards that appeared in an earlier draft have been removed. No language provided by IACP to preserve the ability of prescribers to order "office-use" medications was included.
IACP Comments on House Draft Compounding Bill
Last week, IACP was asked to submit comments on a House draft bill being put forth by U.S. Representative Morgan Griffith (R-VA). Please click here to read IACP's comments.
TriCare Latest to Deny Compounded Medicines
TriCare, the federal health benefit program for active military and their families, began sending letters to plan participants informing them that effective July 24, 2013 any compounded medicine prepared with APIs would no longer be covered. These letters, issued by TriCare's contracted pharmacy benefit management company Express Scripts (ESI), claim that the plan does not cover "non-FDA approved drugs." Click here to view letter. This in spite of an internal document which IACP obtained which shows that TriCare and ESI have been reimbursing for compounded medications based on APIs for the past ten years.
"Denying access to necessary medications -- based on the decision of a patient's physician and individual health needs -- is bad enough," said IACP President Wade Siefert upon hearing the news. "To have that burden be placed upon a man or woman serving our country is shameful. Congress needs to know how our military and their families are being treated."
And that's exactly the tact which IACP has taken. In addition to reaching out to select members of the Washington DC media to educate them about this issue, IACP's lobbying team has already met with both Senators and Congressmen to call attention to this sudden and unprecedented change. "The response we've had in our meetings has been one of both surprise and determination," said IACP Vice-President of Government Affairs Sarah Dodge. "That TriCare can make such a drastic change without considering the financial impact on their beneficiaries or what additional costs the federal government will have to pay as patients have hospital and physician visits to unnecessarily change their medicines is troubling. Especially in these times of tight budgets."
Neither TriCare nor ESI appear to have considered how unbalanced their decision is. The program continues to reimburse for non-FDA approved manufactured products such as thyroid hormone, codeine, digoxin and the more than 200 medicines that predate the existence of the 1938 Food Drug and Cosmetic Act that established an FDA review process. More importantly, rather than acting as a benefit management plan, ESI appears to have abandoned that responsibility entirely instead of establishing commonplace processes like prior-approval or step-care. Instead, it has advised TriCare to simply stop paying for medicines without regard to patient needs.
While IACP will continue to raise this issue at the federal level, every member who provides services to TriCare patients can do their part as well. Watch for a special IACP Member Alert tomorrow with tools and resources to use in helping your TriCare enrollees reach out and express their own concerns to Congress.
As President Siefert says: "They've protected us… now we have to protect them."
IACP's P2C2 Advocacy Postcards Now Available for Member Download!
IACP's Patients and Professionals for Customized Care (P2C2) advocacy group now encompasses more than 164,000 patients and practitioners who have enlisted to protect and preserve pharmacy compounding! IACP is working to increase this support base to 200,000 members in 2013 to make our voices even stronger! P2C2 brings together people who know first-hand that compounded medicines are a critical part of modern, individualized health care and provides them the necessary tools to ensure that access to personalized medication solutions remains possible.
As part of this effort, IACP designed a selection of P2C2 postcards to help you communicate to your patients and practitioners about the immense value of compounding, and how they can help protect their access to personalized medications. IACP is now offering these postcards to you for FREE download. Click below to access P2C2 Postcard Artwork. Printed P2C2 postcards can still be ordered from IACP - Click here for an Order Form.
Pharmacy Compounding - General
Compounding for Bio-identical Hormone Patients
Compounding for Veterinary Patients
Compounding for Pediatric Patients
Compounding for Geriatric Patients
AORN Includes IACP's Assessment Tool in Perioperative Standards and Recommended Practices
Recently the Association of periOperative Registered Nurses (AORN), contacted IACP to request usage its Compounding Pharmacy Assessment Questionnaire (CPAQ™) in its recommended practices. AORN is a non-profit membership association headquartered in Denver, Colo., that represents the interests of more than 160,000 perioperative nurses by providing nursing education, standards, and clinical practice resources—including the peer-reviewed, monthly publication AORN Journal—to enable optimal outcomes for patients undergoing operative and other invasive procedures. AORN’s 42,000 registered nurse members manage, teach, and practice perioperative nursing, are enrolled in nursing education, or are engaged in perioperative research. The association defines and advances best nursing practices for surgical patients by researching and distributing scientifically based recommendations.
According to Terri Link, MPH, BSN, CNOR, ambulatory education specialist at AORN, “IACP’s CPAQ tool is important for Ambulatory Surgery Center nurses to use when they select a compounding pharmacy. Ambulatory Surgery Centers will use and contract with compounding pharmacies since often there is no pharmacist on site. Knowing what questions to ask is important in assuring surgery patients are receiving safely compounded medications.” AORN plans to include IACP’s CPAQ tool in the Recommended Practices for Medication Safety which will be released in the 2014 edition of Perioperative Standards and Recommended Practices.
IACP debuted CPAQ two years ago to provide practitioners and patients with a comprehensive checklist of what to look for in a compounding pharmacy practice. CPAQ is based upon United States Pharmacopeia (USP) standards which compounding pharmacists are obligated to follow according to state board of pharmacy regulations or standards of practice.
CPAQ was originally developed by IACP’s Hospital Shortage Workgroup , led by IACP Board Member Scott Karolchyk, MS, RPh, FIACP, as practitioners were looking for a tool to help select resource partners as they dealt with the ongoing and serious medication shortages. IACP’s Hospital Shortage Group also includes IACP Foundation Board Member Lisa D. Ashworth, BS Pharm, RPh, and Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA. Click here to read more!
CMS Spends Millions on Invalid Prescriptions
The Health and Human Services Office of the Inspector General has just released a report that shows the Centers for Medicare & Medicaid Services (CMS) is paying for thousands of prescriptions totaling millions of dollars in taxpayer money prescribed by individuals without prescribing authority. Click here to review the report.
To be covered under Medicare Part D, drugs must be prescribed in accordance with State law, which specifies the types of health care providers that have the authority to prescribe drugs in the State. Although these health care providers can vary by State, some types clearly do not have the authority to prescribe in any State. If drugs are being ordered for Medicare beneficiaries by individuals who do not have the authority prescribe, it raises concerns about the appropriateness of Part D payments and about patient safety.
A review of 2009 Part D payments nationwide showed that Medicare inappropriately paid for 72,552 prescriptions ordered by 14 prescriber types that clearly do not have the authority to prescribe in any State. The OIG selected these 14 prescriber types for review; they do not represent all types without the authority to prescribe. The 14 types included massage therapists, athletic trainers, and dental hygienists. None have the training necessary to prescribe drugs. In total, Medicare paid $5.4 million for prescriptions ordered by those prescriber types.
An in-depth analysis of ten States revealed that Medicare Part D inappropriately paid for 344,714 prescriptions ordered by other selected types that did not have the authority to prescribe. In total, Medicare paid $26.2 million for drugs ordered by counselors, chiropractors, social workers, physical therapists, registered nurses, occupational therapists, and speech-language pathologists. Click here to read more.
Tennessee Clinics Served with Records Subpoena
Specialty Surgery Center of Crossville has been served a subpoena for records related to tainted medication from a drug compounding firm blamed for a nationwide fungal meningitis outbreak. Also served with subpoenas were St. Thomas Outpatient Neurological Center and PCA Pain Clinic, the Tennessee clinics that received medications from the New England Compounding Center. Click here to read more.
FDA Issues Guidance on Heparin
FDA is announcing the availability of a guidance for industry entitled “Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.” This guidance provides recommendations that will help active pharmaceutical ingredient (API) manufacturers, pharmaceutical and medical device manufacturers of finished products, and others, to prevent the use of crude heparin that might contain oversulfated chondroitin sulfate (OSCS) or non-porcine material (especially ruminant material) contaminants. This guidance on crude heparin recommends strategies to test for contamination and should be used in addition to the United States Pharmacopeia (USP) monograph testing required for other forms of heparin to detect the presence of OSCS. Click here to read FDA's Heparin Guidance.
Pharmacy Practice News Interviews IACP's David Miller
The June issue of Pharmacy Practice News features interview with IACP's David G. Miller, RPh in an article, "Does HELP Bill Go Far Enough."
"The International Academy of Compounding Pharmacists (IACP) strongly disagreed that health-system pharmacies should be exempt from rules preventing batch preparation. 'We would note that health systems were the primary client of NECC and they purchased these injections in large quantities without a patient script and without a doctor’s order,' said David G. Miller, IACP’s executive vice president and chief executive. 'All legislation or regulation pertaining to compounding should cover all pharmacy practices, whether they are freestanding or located within a hospital or health care facility.'” The exemption is 'especially questionable in light of the volume and types of compounding done in hospital pharmacies, a substantial amount of which includes sterile compounded preparations,'” he said in written testimony. Click here to read the entire article.
IACP Member Mike Pavlovich Running for APhA President Elect: Voting Closes July 10th
The American Pharmacists Association (APhA) elections are underway. IACP Member Mike Pavlovich, PharmD, co-owner and pharmacist-in-charge of Westcliff Compounding Pharmacy in Newport Beach, Calif., is running for President Elect. Voting closes on July 10, 2013. "Compounding has been a hot issue on our board as well and, APhA will keep it as a high priority issue," says Dr. Pavlovich. "Having someone like me involved could be a huge benefit for IACP members."
Dr Pavlovich has served as a Trustee of APhA since 2008. He is a 1989 graduate, cum laude, of the University of the Pacific School of Pharmacy in Stockton, Calif., and is Associate Clinical Professor for Western University of Health Sciences, and adjunct faculty for several universities across the country. Please click here for his complete bio.
IACP Member Media Tools: Protect the Public and Preserve Pharmacy Compounding Op Ed
IACP is providing you with an op ed for you to place in your local newspaper. An op ed, which stands for “opposite the editorial page,” is a guest commentary that the newspaper will run at no expense to you, if they have space and if they think the commentary meets their standards.
To customize the op ed piece for your local newspaper, we have indicated on the bottom of the piece where to include your name and your pharmacy’s name. Once you have done this, you can contact your local newspaper and send it to the editor there, and clearly indicate when sending it that it is an op ed submission. IACP’s public relations firm is available to assist you in the placement of the op ed.
IACP's PR firm, Ball Consulting Group, stands ready to assist you with this op-ed. Their contact information is included in the following link. Click here for more information, and to access the op-ed.
IACP Corporate Partner Spotlight: PCCA
Someone once said, “The only constant is change.” For the compounding industry, that’s never been truer. With a regulatory climate in flux, innovations in compounding techniques and equipment,advances in treatment approaches, and rapidly changing business and marketing trends, our industry can be overwhelming.
But one thing that hasn’t changed is PCCA’s commitment to giving compounders the highest quality products, education and support – everything they need to grow their businesses. And that’swhy our 2013 International Seminar is focused on helping you not only navigate these changes, but also influence them. It’s all about harnessing the transformative power of innovation for your practice and your patients.
As always, the 2013 International Seminar will be the compounding industry’s largest, most informative conference. By attending, you’ll be able to take advantage of educational sessions, workshops, and roundtables while also exchanging ideas and best practices with your fellow compounding pharmacists about clinical, technical, business and marketing issues. This year, we’re excited to feature motivational speaker Jim Carroll, an international futurist, trends and innovation expert who will discuss the challenges and opportunities of high-velocity change in healthcare.
So join us this October in Houston – and see what thinking next is all about. Go to www.pccarx.com/thinknext to find out details and register, today!
IACP Welcomes New Corporate Partner
The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 2,700 pharmacists, technicians, students, and members of the compounding community. We encourage all IACP members to support these corporate partners that are instrumental in our joint effort to protect and grow this vital part of quality health care. Thank you for your continued support of pharmacy compounding! Click here for more information about IACP's Corporate Partner program.
Save the Date & New Location!
Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 5-8, 2014 at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.
What you can expect in 2014:
- Benefit from multiple education tracks; practice-based, compounding, and veterinary clinical and compounding.
- Learn the fundamental steps to successfully work with your local media.
- Develop a Social Media campaign about your pharmacy and its role in the community.
- Leverage the latest tools and resources to implement a quality improvement plan in your pharmacy.
- Hear what your peers are doing in the This Works for Me! sessions.
- Tips for hiring and retaining good employees for a successful pharmacy.
- What’s New in Veterinary Pharmacy, and much more!
- Visit with companies showcasing services that can improve your business.
Click here to read more!
Compounders on Capitol Hill 2013 Report
Thank you for joining us at IACP’s 19th Annual Compounders on Capitol Hill, June 1-4, 2013! More than 415 of your fellow colleagues convened in Washington, D.C. to take part in a comprehensive program of Continuing Education with captivating speakers, a full Exhibit Hall featuring 37 leading companies, and many professional networking opportunities. Among the group traveling to D.C. were 100 first-time participants in the Compounders on Capitol Hill legislative conference. Thank you for playing an active role to ensure your patients have continued access to customized medications. The future of your practice, your patients’ well-being and your compounding profession depends in great part upon your participation at this important annual event. Thank you for going to D.C.! Click here to read the complete 2013 CCH report!
A CCH 2013 photo gallery is now available. Click here to view.
Send out a CCH Press Release!
Let your local press and community know about your participation in this year's Compounders on Capitol Hill. Click here for a CCH press release providing stats and background on the event. To obtain a customizable copy of this press release, please email Dagmar Climo, IACP Marketing & Communications Director at email@example.com.
IACP's David G. Miller is Headed to Chicago, IL, Austin, TX, Houston, TX, and Salt Lake City, UT!
The IACP Regional Education Meeting brings 2.0 contact hours (.20 CEUs) of live pharmacy law continuing education credit to pharmacists and technicians all across the United States. At this seminar, you will hear from IACP's Executive Vice President & CEO David G. Miller, RPh as he presents Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that affect you and your practice.
The seminar is designed for any pharmacist, technician or pharmacy student currently involved in or interested in building their understanding about compounding pharmacy. Whether you’re a veteran compounder or just thinking about implementing this critical health service for your community, we hope you’ll join us for an evening of education and fellowship. For more information, please visit www.iacprx.org/RegionalEducationMeetings.
At the conclusion of this seminar, the pharmacist and technician attendee will be able to:
- Explain how compounders are regulated and enforced by the State Boards of Pharmacy, Food and Drug Administration (FDA), and Drug Enforcement Administration (DEA).
- List four different regulatory initiatives and two court cases that have defined FDA’s oversight to compounders.
- State what authority the FDA has when inspecting compounding pharmacies.
- Define “bulk ingredients” and the difference between “FDA-approved” products.
- Define “office use” and describe how compounding for office use differs from wholesaling.
- Describe key components of federal proposed legislation that may change the balance of existing federal and state authorities.
Chicago, Illinois – July 25, 2013
7:00 - 9:30 p.m.
Mark Drugs Roselle
384 E. Irving Park, Roselle, IL 60172
Click here to view the event flyer for more details!
Austin, Texas – August 6, 2013
7:00 - 9:30 p.m.
Peoples Rx Pharmacy
3801 South Lamar, Austin, TX 78704
Click here to view the event flyer for more details!
Houston, Texas – August 8, 2013
7:00 - 9:30 p.m.
IACP Corporate Headquarters
4638 Riverstone Blvd, Missouri City, TX 77459
Click here to view the event flyer for more details!
Tulsa, Oklahoma – September 2013
DoubleTree by Hilton Hotel Tulsa Downtown
616 W. Seventh Street, Tulsa, Oklahoma, 74127
Registration opening next month!
Salt Lake City, Utah – September 26, 2013
Time: 7:00 - 9:30 p.m.
9:30 - 10:00 p.m. Q&A with David Miller and Department of Professional Licensing's Compounding Task Force
Roseman University of Health Sciences
10920 S. River Front Parkway, South Jordan, UT 84095
P2 Classroom, 1st Floor
Click here to view the event flyer for more details!
Would You Like to Sponsor or Host an IACP Regional Education Meeting in Your City?
If you would like IACP to plan a Regional Education Meeting in your city, please email Michelle Greene or call 281.933.8400. For more information on sponsorship, please click here. For more information on hosting, please click here.
IACP is your one-stop resource for all things compounding! CompounderCalendar provides a comprehensive listing of compounding events and continuing education programs.
Click here to view IACP’s Upcoming Events.
IACP Career Center
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