State Regulations Regarding Sterile Compounding

State Regulations Regarding Sterile Compounding

Michael Pavlik, Pharm. D. Candidate 2017, Ferris State University

Background

USP <797> is a chapter of the United States Pharmacopeia that outlines proper sterile compounding and regulations for any pharmacy that produces sterile compounding products. Before USP <797>, the U.S Food and Drug Administration (FDA) found that nearly one out of every three sterile compounded products contained some degree of deficiency. The chapter USP <797> was first published in 2004 to regulate sterile compounding pharmacies and laboratories to guide safer practices nationally. Since the initial publication, there have been many revisions to this chapter with the most recent in January of 2016.

As of April 2012

At the time this article was published, 8 years have passed since USP chapter <797> became the national standard for sterile compounding. Despite a national standard, state laws and regulations vary widely in regard to referencing USP <797>, whether it be full compliance requirements or no mention at all. In 2011, five states (including Michigan) had no laws or regulations that reference sterile compounding or parenteral nutrition practices in any way. The majority of the remaining states at this time had laws that did not specifically site USP <797>, but had regulations in place regarding sterile compounding and parenteral nutrition. Whether or not states had laws and regulations that were in compliance with, or referenced USP <797>, the average actual compliance rate was only 73.3 percent With such a large margin of non-compliance regarding USP <797>, it is not difficult to understand why new laws and regulations are becoming more popular within states.

Newer Regulations – June 2014

Governor Rick Snyder signed a new law that regulates compounding pharmacists and pharmacies for both sterile and non-sterile pharmaceutical products. This law also included penalties and sanctions for certain violations. A larger influence for this comprehensive law was the fungal meningitis outbreak in fall of 2012 in which Michigan suffered the most infections and highest number of fatalities. This outbreak was tracked by the Centers for Disease Control and Prevention (CDC) and was attributed to contaminated epidural steroid injections from a compounding facility in Massachusetts.

The new comprehensive law amends parts 161 and 177 of the public health code and includes, but is not limited to, the following:

1.      Any applicant for a pharmacy license that involves compounding must submit verification of accreditation through a national organization.
2.          Pharmacies cannot compound commercially available products unless the product is significantly different from an already available product.
3.   .      Any pharmacy charged with a violation out of state or with federal law must notify the Department of Licensing and Regulatory Affairs (LARA) within 30 days.
4.          There are criminal penalties imposed for violations of certain provisions and requirements and a license may be suspended if an imminent risk to public health or safety is reported from the FDA or CDC.

Current Regulations in Michigan compared to other states

Since legislature regarding sterile compounding has become more popular since the meningitis outbreak in 2012, the National Conference of State Legislators (NCSL) began holding records of state laws on this topic. The NCSL holds records on whether or not the state compounds sterile preparations, if they comply with the USP, how many pharmacies are accredited in that state to compound sterile products (voluntary) and recent additions to sterile compounding laws within each state. According to the NCSL’s website, 21 states currently do not practice sterile compounding (16 of which have compounding pharmacies that are accredited by the Pharmacy Compounding Accreditation Board) or are pending approval, three states use state regulations instead of USP regulations and 26 states have pharmacies that compound sterile products and follow USP regulations. According to the NCSL’s current website, Michigan is one of the states that does not yet follow USP regulations but has pharmacies that are accredited by the Pharmacy Compounding Accreditation Board.

            

Michigan’s newest laws regarding sterile compounding were released in 2014 and signed by Governor Snyder including those outlined above. These new laws distinguish Michigan from other states in a number of ways. In Florida, for example, a sterile compounding facility must apply for a permit from the state instead of a national accreditation program. The sterile compounding permit requires a background and history check, and has statues that outline punishment for failure to comply. In Texas, it is also illegal to compound sterile products that are commercially available and the pharmacy must also receive national accreditation status. Since the early 2010s, regulations requiring national or state accreditation have become ubiquitous to ensure safer compounding measures for sterile compounds. More stringent guidelines for accreditation and sterile compounding practice have been implemented, and pharmacies across the nation have been increasingly compliant with new standards. As time goes on, there will likely be a continuous reevaluation and adaptation to sterile compounding standards across the nation.

References

http://www.pharmacy.texas.gov/files_pdf/comparison%20final.pdf

http://www.michigan.gov/documents/lara/Compounding_Pharmacy_New_Law_Memo_09-2014_468552_7.pdf

http://floridaspharmacy.gov/licensing/sterile-compounding-permit/

http://www.pppmag.com/article/1113/april_2012_state_of_pharmacy_compounding/state_regulations_impact_usp_797_compliance/

I’m Just a Bill: Current Pharmacy Legislation in Michigan

by Benjamin Daunais, 2016 Pharm.D. Candidate, Ferris State University College of Pharmacy

As a student pharmacist, it has become apparent to me how important it is to stay current in the profession. The world of pharmacy rapidly changes and evolves and we must do everything in our power to adapt lest we become obsolete. One of the things that pharmacists should stay current with is legislation in their state. For your convenience, I have provided summaries of some bills that are currently in our legislature that will affect the practice of pharmacy in Michigan.

Summary of Current Bills

       Senate Bill No. 778 – Statewide Protocol for Naloxone. This bill would allow for the Chief Medical Executive of Michigan to issue a statewide standing order, which does not identify a specific patient, for the purpose of dispensing an opioid antagonist. This would allow pharmacists to dispense Naloxone to any individual, without the need for a prescription. This bill also dissolves the pharmacist of any liability for Naloxone that was properly stored and dispensed but was the proximate cause of harm due to the administration or failure to administer Naloxone. This bill was introduced to the Senate on February 10, 2016, and was then referred to the Health Policy Committee where it currently is today. With this issue being a top priority, we expect this bill to gain traction before the end of the legislative session.

       House Bill No. 4812 - Biologic Product Substitution. Interchangeable biologic products are defined in this proposed amendment to the public health code. HB 4812 would allow pharmacists upon the receipt of a prescription for a brand name biologic product to substitute it for an interchangeable biologic product  (if one is available – without the intervention of a physician). Essentially, it would treat interchangeable biologics the same in the Michigan Public Health Code as current substitution practices exist for other drugs. There would also be a requirement for pharmacists to keep an electronic record of interchangeable products dispensed for a period of two years. HB 4812 was introduced in the House on August 8, 2015, was revised by the Health Policy Committee and is currently still in committee.

Senate Bill No. 769 – Requirements for Prescribers to Check MAPS. SB 769 would require prescribers who hold controlled substance licenses to obtain a MAPS report before dispensing controlled substances to a new patient, starting in January 2019. This requirement would not apply, however, if the prescriber was dispensing a controlled substance in the emergency department, hospice or oncology department. SB 769 was introduced in the Senate on February 9, 2016, and was referred to the Health Policy Committee where it currently stands today.

Newly Enacted Legislation

      Senate Bill No. 150 – Medication Synchronization. SB 150 was recently passed and will require health plans that provide prescription drug coverage to provide a program for synchronizing multiple maintenance medications for patients. Patients should benefit from the convenience of only having to stop by the pharmacy once to receive all of their medications. Additionally, this will help to ensure adherence for the patient as he/she will receive all of their long-term medications at once, and it is more likely he/she will be taking their medications if said medications are available to him/her. In order to qualify for the medication synchronization program the following must occur:

• The patient’s pharmacist and physician must agree that medication synchronization is in the best interest for the management of the patient’s chronic long-term conditions.
• Medications have to be covered by the insurance.
• Medications must have refills.
•  Medications must be used to treat chronic conditions.
•  Medications cannot be controlled substances.
• Medications must meet prior authorization requirements at the time of initiation.
• Medications must be in a formulation that may be split to achieve synchronization.
• Insurers or health management organizations will also be required to offer prorated daily cost-sharing rates for medications for the purpose of synchronization

I hope that you found the above summaries informative. There are some exciting possibilities that will come to light if the above bills pass. If you feel strongly about any of the above bills, by all means please contact your legislator to advocate for pharmacists.

Online Resources:

·        To view the bills, visit https://www.legislature.mi.gov/(S(pfdmgn0w22dnjutgqfqrsu4h))/mileg.aspx?page=Bills

    

            For more information on advocacy, visit the MPA website at MichiganPharmacists.org/Advocacy/WhoAreMyLegislators

For further questions contact: 

Amanda Lick, M.A., MPA manager of advocacy, governmental and regulatory affairs, at (517) 377-0254 orAmanda@MichiganPharmacists.org 

or

Eric Roath, Pharm.D., MPA director of professional practice, at (517) 377-0224 or Eric@MichiganPharmacists.org

Hello? Public Office? Is that You Calling?

by Sarah Barden, Pharm.D., M.B.A.

On Oct. 6, 2015, I woke up in the wee hours of the day and drove through the foggy morning haze to a stately brick building in downtown Lansing, the venue for MPA’s Campaign School. If anyone had told me a year ago that I would be attending a seminar to learn about running for office and managing a political campaign, I would have scoffed.

“Me? Run for public office?” The question I asked myself was followed quickly by the answer “No.” A campaign would be too much work, cost too much money, destroy any semblance of privacy and take me away from pharmacy. In my mind, running for office was simply not an option.

By the end of the seminar, however, I had a much different perspective, and I began to ask myself other questions such as “Would being a public official really take me away from pharmacy or might it provide new opportunities to serve my community as an elected official and as a pharmacist?” My thoughts continued. “What if I could run? What if I could win? Could I run in Michigan? Is there really any higher calling than serving your fellow people by representing them in state government so they have a voice?” As Joe Palamara, former seven-term State Representative, said, “It was not always the best job, but it was the best public service I have ever done.” Serving the public, while challenging and frustrating at times, can be one of best ways to give back to society. With my education and background, I wouldn’t just be serving the public; I would be serving pharmacy as well. The Michigan Legislature has not had a pharmacist serve for some time now. I could be that voice.

So what exactly is MPA’s Campaign School and how did it get me thinking about the unimaginable?

It is a full-day seminar filled with expert advice from politically-savvy and experienced public officials designed to encourage and prepare health care professionals to run for public office. Current and former Senators and Representatives from both parties drop by to share words of advice and encouragement. Campaign consultants provide insight into planning, strategizing, budgeting and fundraising. It is a great way for committed and registered candidates to take the next steps in getting their campaigns off the ground, and it is a great place for questioning, and maybe considering, hopefuls (aka me) to learn more about the process and what it would really take not just to run, but to win.

Some Tips (I Gathered) for Success

• Deciding to Run. Deciding to run for public office at any level, whether a local commissioner or State Senator, is potentially one of the most life-changing decisions someone can make. It is not something decided on a whim. Campaign School guest speaker Julie Calley, wife of Michigan Lt. Gov. Brian Calley, gave sage advice related to families on the campaign trail and beyond. The entire family, not just the candidate, is affected by the choice to run for office. Everyone needs to be committed to the campaign and the work that comes afterward if you win. The job actually begins once the race is won. The negotiations, time commitments, conflicts and sacrifices are only just beginning during the campaign, but good communication and setting aside time to be with family separate from the campaign are keys to success.

• Setting the Campaign Strategy. Once you decide to run for office and have your family’s support, you then have a myriad of other decisions. Where do you currently live? Is it a red or blue district? Do your political views align with how your district votes? If not, do you need to move to where you have a chance at winning? One important thing I learned is that 90 percent of Michigan’s elected officials are decided during the primary elections. Most districts are so solidly Republican or Democrat that the “real campaign” is against the other people within your own party during the primary to get onto the general election ballot. Once there, the district will vote party lines. One more thing: do not run as an independent if you actually want to win. It does not work, and you will waste a lot of money. You can be a moderate, but you have to decide whether to be a moderate Republican or moderate Democrat. These questions and decisions form part of your campaign strategy.

• Financing the Campaign. Another important thing to consider is that campaigns cost money. A run for state Senate in a highly-contested election could cost half a million dollars. Do you have enough capital to finance it yourself or do you need to raise money for the campaign? If you have to raise the money, who will you ask to donate? How will you ask them? How much will you ask them for (keeping the legal donation limits in mind, of course)? You definitely need to hire an accountant to keep track of the money and open a separate bank account to keep campaign money separate from personal money.

• Executing the Campaign. Next, you have to decide how to manage the campaign effectively. Will you run the campaign yourself or hire a campaign manager? How are you going to research your constituents and your opponents so you can best complete your campaign plan? You must be thoughtful about each and every decision, create a plan and execute that plan. But, as MPA Pharmacy PAC Chairman Hank Fuhs says, you have to be able to “turn on a dime” and adjust your plan as your campaign evolves in order to be successful. Find resources with experience to help you and be nimble and quick to adjust.

Is public office calling my name? Maybe, just maybe, I hear a tiny whisper. Do you?

P.S. If public office is calling your name, be sure to join MPA’s next Campaign School in 2017! Please contact MPA Manager of Advocacy, Governmental and Regulatory Affairs Amanda Lick at (517) 377-0254 or Amanda@MichiganPharmacists.org with any questions or to get more information.

MPA-UP Division Fall Seminar: Why YOU Should Attend Next Year!

by Emma Holmi, 2016 Pharm.D. candidate, Ferris State University College of Pharmacy

Each year, the Michigan Pharmacists Association (MPA)-Upper Peninsula Division hosts a Fall Seminar. This year, the seminar was held in Marquette and since I was on my Advanced Practice Pharmacy Experience rotation with MPA, I literally jumped at the opportunity to head to the Upper Peninsula. Now, I may be biased since both of my parents are originally from the better upper-half of Michigan, but I think everyone should make time to attend this annual seminar. Not only was this year’s event informative and a great opportunity to earn continuing education, but more importantly, it is a great way to network with fellow pharmacists.

Some of the highlights of the seminar in Marquette included a presentation from Nicholas Torney, Pharm.D., a Postgraduate Year 2 infectious disease resident from Munson Medical Center, on penicillin skin testing, along with addiction psychiatrist, Dr. Michael Notorangelo’s much anticipated speech on handling the treatment of pain in an environment of diversion.

The seminar also included an update on pharmacy law and the lessons learned from the board disciplinary subcommittee from Rosalie Baran, Pharm.D., and her husband Gregory Baran, R.Ph. Not only was the presentation informative, but it was a great forum to ask questions on a variety of pharmacy law-related topics. The excellent agenda also included updates on pharmacy advocacy presented by Amanda Lick, MPA manager of advocacy, governmental and regulatory affairs; the 2014-2015 new Food and Drug Administration drug approvals presented by Dr. Timothy Jones; a 2015 Beer’s criteria update presented by Dr. Alicia Thatcher and Dr. Timothy Jones; and a presentation on the Upper Peninsula Health Plan by Sheryl Waudby, R.Ph.

The Ferris State University Alumni Board graciously hosted a happy hour for the seminar attendees at the Ore Dock Brewing Company in downtown Marquette. Marquette is located on the shores of Lake Superior and has a charm you won’t forget, especially after you stroll downtown, eat at delectable restaurants, explore the numerous bike trails, climb to the top of Sugarloaf Mountain and take advantage of all the other outdoor activities the area has to offer.

MPA strives to provide its members, pharmacists, technicians and students alike, with considerable opportunities for professional growth and networking. I would urge everyone to take advantage of this wonderful opportunity to visit the Upper Peninsula for the annual Fall Seminar; if you are lucky, you might even be able to see the peak of amazing fall colors. Mark your calendars for a soon-to-be-announced weekend next October and I hope to see you up in Houghton for the seminar in 2016!

What if Pharmacy Day at the Capitol was Every Day?

by Eric Szydlowski, Pharm.D., MPA/PSI executive fellow

In case you haven’t noticed, there is an event that’s been going on for the past 15 years. It’s called Pharmacy Day at the Capitol, or PDAC for short. For those who have attended, THANK YOU! It is your contribution of time and advocacy that makes this event so successful. Others in the pharmacy profession benefit from your hard work. If you haven’t attended or heard about it, PDAC is a single-day event where pharmacists, student pharmacists, pharmacy technicians and other pharmacy professionals from all over Michigan join together at the State Capitol to advocate on behalf of the profession of pharmacy and their patients. This year it was held on Sept. 22 and was our biggest turnout yet, with almost 400 student pharmacists and pharmacy professionals registered as volunteers.

The activities at the event include pharmacy services in a tent on the State Capitol lawn, where pharmacists and student pharmacists provided immunizations and health screenings to legislators and their staff. Pharmacy technicians also discussed the important roles they serve in to support pharmacists as well as the recent technician licensure and certification requirements.

Additionally, each year we hold a community drug take-back event, the Medication Disposal Event @ the Captiol. In the medication take-back tent, volunteers, in conjunction with the Michigan State Police and the City of Wyoming, collected and properly disposed of 581 pounds of unused, unwanted and expired medications from the public. Over the past six years, the event has brought in 1.6 tons of medications, removing them from households where they could potentially be diverted, therefore keeping our communities and environment safe.

Students also participated in a legislative debate workshop in which teams of students read, evaluated and debated current bills relative to pharmacy practice. Volunteer participants, including Deans of pharmacy from Ferris State University, Wayne State University and the University of Michigan, visited legislator offices to speak to them about important pharmacy issues. Some students had the chance to view a live Michigan House of Representatives session and a press conference organized by MPA. The press conference featured Lt. Gov. Brian Calley, MPA President Jennifer Hagerman, Michigan State Police Captain Chris Stolicker, Michigan Department of Environmental Quality Chief Deputy Director Jim Sygo and MPA Chief Executive Officer Larry Wagenknecht. Each year, the Association also takes a large group photo of all the volunteers on the Capitol steps!

If you are a new student pharmacist who is just beginning pharmacy school or you are new to advocating for the profession of pharmacy, PDAC is a really great opportunity to join your colleagues and peers who have already developed advocacy as a good habit. You can see firsthand the legislative process and how pharmacists can positively contribute to it. You can also establish a working relationship with your elected officials or strengthen existing ones.  As citizens of America and Michigan, we all have the right to bring our concerns and suggestions to our elected representatives, but as pharmacists (or future pharmacists) we have the responsibility of ensuring the growth of our profession for the benefit of our patients.

There are many important legislative issues at hand right now. If you enjoyed your experience during PDAC or you feel you want to make a positive political impact, you still can! Recently, MPA rolled out the new Advocacy Action Center and an introductory video to help you get oriented. Please check out this new tool that includes e-mail and letter templates for you to customize. As a MPA member, you can use it to write to your elected legislators and urge them to support pharmacists as providers.

A very important bill at the federal level is House Resolution 592, which would establish provider status for pharmacists in medically underserved areas/populations (MUA/P). Michigan cities such as Detroit, Grand Rapids, Ann Arbor, Lansing and others, along with large swaths of the state are classified as MUA/Ps (click here to see a map of select shortage areas). If we can gain more support for this bill, pharmacists, one of the most trusted and accessible health care professionals, could better serve patients in these areas and improve the health of our communities.

As of now, only four of the 14 U.S. Representatives from Michigan have signed on to support the bill (Reps. Candice Miller, Mike Bishop, Tim Walberg and Dan Kildee). As Michigan pharmacists, I know we can do better! The Advocacy Action Center is a great place to start, where MPA members can make a difference. The Association has challenged its members to send 500 letters to Congress in support of provider status. Thus far, we have approximately 100 sent. Will you join the effort and help us make a difference?

If you have any questions about pharmacy issues, please contact MPA Manager of Advocacy, Governmental and Regulatory Affairs Amanda Lick at (517) 377-0254 or Amanda@MichiganPharmacists.org.