USP 800

by Ashley Builta, Pharm.D., MPA fellow of association management and business development

The goal of United States Pharmacopeia (USP) 800 is to provide protection for all health care workers dealing with hazardous drugs (HDs) at all stages. HDs are defined as those drugs on the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, last updated in 2012, published by the Centers for Disease Control and Prevention. Drugs on this list include antineoplastic agents, hormones, antivirals and immunosuppressant agents.

The scope of 800 is wider than 797 or 795, encompassing the entirety of sterile and non-sterile HDs in the health care system from delivery and unpacking to final administration to the patient. The emphasis of USP 800 is on containment of HDs and their potential effects on health care workers to as low a limit as reasonably possible (ALARA). After USP 800 is approved, the language in 795 and 797 will be “harmonized” to reflect the new chapter.

Major recommendations in USP 800 are as follows:

• “HDs shall not be stored, unpacked, compounded or otherwise manipulated in an area that is positive pressure.”
• All handling, storage and compounding of HDs should be done in a negative pressure area, separate from non-HDs with separate engineering controls, called Containment Segregated Compounding Area (C-SCA) and Containment Secondary Engineering Control (C-SEC).
• UNLESS: the HD is a non-antineoplastic agent in a final-coated dosage form. Storage of these agents could be with non-HDs as long as they are well labeled. These agents may also be counted and transferred from the manufacture container to another container without the negative pressure requirements. USP recommends a dedicated set of counting supplies be used for these HDs.
• When compounding HDs, two pairs of gloves will be worn and the outer gloves changed every 30 minutes or they become damaged or contaminated. Goggles should be worn or full eye and face protection, as needed.
• Surgical masks do not provide adequate protection from HDs and should not be worn during compounding or administering drugs. A N95 respirator should be worn. When administering HDs, the person should wear two pairs of gloves and a gown.
• Employers will ensure that health care workers who are exposed to HDs are routinely monitored as part of a medical surveillance program. 

Recently, the American Pharmacists Association, International Academy of Compounding Pharmacists, National Association of Chain Drug Stores, National Alliance of State Pharmacy Associations, National Community Pharmacists Association and Specialty Sterile Pharmaceutical Society submitted a joint letter to USP requesting that the chapter be numbered above <1000>. By doing this, the chapter becomes a general information chapter, providing information on best practices rather than making these changes mandatory.

USP is accepting comments on proposed chapter 800 up until July 31, 2014. To submit a comment, include your comment with the line number(s) corresponding with your comment(s) to CompoundingSL@usp.org. The full proposed wording for USP can be found here, and includes line numbers.

These proposed changes will have a substantial and financially large impact on the pharmacy profession. Michigan Pharmacists Association strongly encourages all members to read the proposed USP chapter 800 and submit their comments by the July 31 deadline.

Treatment #2; Alleviating Your Politicophobia

by Elizabeth Laswell, 2015 Pharm.D. candidate

Hello again! In my previous post, I began to explain the importance of connections through an example featuring Uncle Bob, whose good friend has a sister who works for your local Senator. While I don’t have an Uncle Bob (and you likely don’t either), I made a similar connection to Rep. Jim Stamas. A friend of a friend, who is friends with Rep. Stamas, initiated the conversation for me. I won’t go into detail about who is who, because you get the point, but it shows that you never know who you could connect with through the people you already know. Within approximately four hours of asking for this favor, I received a call from a staff member at Rep. Stamas’ office, and I was thoroughly impressed! We scheduled to meet several weeks later at a local coffee shop in Rep. Stamas’ hometown of Midland (and soon to be my hometown).

Ok, so let’s be honest here, I don’t have a political science background, and taking government/history classes in high school and college was as painful as pulling teeth for me. Needless to say, at the time, I had little understanding of the role Rep. Stamas plays in the Michigan House of Representatives. I like to ask questions and learn (my parents can attest to this.) As a child (ok, so maybe I still do this), I would always ask, “Well, why?” Before this meeting, I had never met a key political figure, and here was my opportunity to ask all the questions my little heart could think of. I started our conversation by asking about his role in Michigan’s Congress and, specifically, the House of Representatives. As majority floor leader of the House, one of his main roles is to schedule and organize the daily legislative activities that will occur on the floor.

According to the 2013-2014 House legislative schedule, Representatives are only at the capitol building (i.e., “in session”) for about 192 days this term (reminder: the House runs on two-year terms, or about 730 calendar days.) Since the start of the term on Jan. 9, 2013, there have been 1,700 bills introduced in the House, and this number doesn’t even include the Senate bills that have passed out of the Senate and were then introduced in the House! I would say that Rep. Stamas has had his hands full this term.

An important bill that was introduced in the Senate at the beginning of the term in early 2013 is Senate Bill (SB) 92. This bill would amend the Michigan Public Health Code to require pharmacy technicians to be licensed by the Michigan Board of Pharmacy. At the time, SB 92 passed out of the Senate with a 35 to 1 vote, and after discussion in the House Committee on Health Policy, it was passed out of the Committee with a unanimous vote of 15 to 0. Patient safety is the absolute No. 1 reason for this bill. In my experiences practicing in a community pharmacy, I am blown away by the amount of passion and time pharmacists and technicians spend advocating for their patients in one form or another. It didn’t take me long to acquire this same passion and devotion to my patients.

In my last blog post, I mentioned that advocacy is simply having passion for something and expressing that passion to others. My meeting with Rep. Stamas was to do just that. As a former technician, and now on my way to becoming a pharmacist, I understand that this change to the Public Health Code is critical for the safety of our pharmacy patients across the state.

Now it is YOUR turn to tell your legislator about what drives you to be the best pharmacist you can be! Stop making excuses and show passion for your profession! Utilize the links below to access information on the MPA Web site to assist you with making contacts and discussing key pharmacy issues.

• Find your legislators here.
• Find current bills that may affect pharmacy/pharmacists and tips for talking to your legislator here.
• Do you need help with the above or assistance with scheduling a legislative appointment? Contact MPA Manager of Advocacy, Governmental and Regulatory Affairs Amanda Lick at (517) 377-0254 or Amanda@MichiganPharmacists.org.

Tramadol Moved to Schedule 4

by Ashley Builta, Pharm.D., MPA fellow of association management and business development

A success for pharmacists noting the abuses of tramadol by their patients!

On July 2, 2014, the Drug Enforcement Administration (DEA) issued a final rule that moved all salts, isomers and salts of isomers of tramadol (first marketed as ULTRAM®) into Schedule 4 of the Controlled Substances Act. This scheduling becomes effective Aug. 18, 2014. All regulatory requirements of Schedule 4 substances (records, inventory, etc.) will apply to tramadol as of Aug. 18, 2014. The Aug. 18 date is 45 days, rather than the usual 30 days, after the ruling to allow for everyone to comply with the new scheduling of tramadol.

As with other Schedule 4 controlled substances, a prescription for tramadol as of Aug. 18 will only be valid for six months after it is written and may be refilled up to five times within that six-month period. Commercial containers of tramadol distributed to pharmacies after Aug. 18 shall have “C-IV” printed on the container.

Pharmacies and other DEA registrants will need to take an inventory of their tramadol stock on hand on Aug. 18. After that, tramadol stock will be included in the inventory of all controlled substances on hand taken every two years. Records for tramadol will also need to be maintained in the same manner as other Schedule 4 controlled substances.

This move is in response to four petitions to the U.S. Food and Drug Administration to have tramadol scheduled as a controlled substance, supported by a recommendation from the Department of Health and Human Services and an investigation by the DEA that found tramadol to have an abuse potential equivalent to other Schedule 4 controlled substances. The DEA published the notice to schedule tramadol in the Federal Register in November 2013. 

The DEA ruling can be found online.

Stateside PBM Regulation Efforts

Bills:

Senate Bill 42

Senate Bill 999

Senate Bill 1000

Senate Bill 1001

Senate Bill 1002

Community pharmacists have long expressed concerns regarding business practices related to pharmacy benefit managers (PBMs) within the state. Well, I have news for you: your legislators are listening. Senate Bills (SBs) 999, 1000, 1001 and 1002 sponsored by Sens. Tom Casperson, Tonya Schuitmaker and Bruce Caswell were introduced during the last week of the legislative session. The bills address PBM licensure (999), pharmacy audits (1000), Maximum Allowable Cost (MAC) pricing (1001) and mandatory mail-order/closed networks (1002). 

These bills are the latest efforts to establish fair business practices between pharmacies and PBMs. The ultimate goal of these legislative efforts is to ensure that pharmacies can continue to provide high-quality services that are both accessible and affordable for their patients. Below I have broken down each of the bills and their desired effects.

SB 999 would require PBMs to register as third-party administrators and would legally define terms such as “Pharmacy Benefit Manager,” “Maximum Allowable Cost Price,” “Multiple Source Drug” and “Orange Book.” Currently, not all PBMs are registered as third-party administrators, and these terms used in the day-to-day operations of pharmacies are inadequately defined by current laws and regulations. 

SB 1000 regulates pharmacy auditing practices. MPA recognizes that audits are important in the regulation of pharmacies. Proper audit practices help ensure accuracy of delivered services, and combat fraud, waste and abuse. It is important, however, that these audits are conducted fairly and do not interfere with the delivery of patient care services. SB 1000 bares marked similarities to SB 42, which was introduced in 2013 by Sen. Caswell.

SB 1001 specifies certain disclosure and updated requirements related to MAC pricing. Unlike SB 656, which pertained only to the Department of Community Health and contracted health plans, SB 1001 would affect all PBMs operating in Michigan.

SB 1002 prohibits plans from incentivizing a beneficiary to use a certain retail pharmacy or mail-order warehouse, or excluding pharmacy providers from their network.

All four of these bills have been referred to the Committee on Insurance chaired by Sen. Joe Hune.  

Alleviating Your Politicophobia

by Elizabeth Laswell, 2015 Pharm.D. candidate

The older I get (at the ripe old age of 27), the more I realize how small the world really is. The degrees of separation between people are shrinking, and it is much easier to discover connections in this age of social media. I find this to be advantageous in fostering good communication. Being able to make a personal connection with someone through a mutual friend, family member or even alma mater is a crucial step in communicating with others. After making this connection, I go from talking at someone to engaging in a meaningful back-and-forth conversation with them. It is also necessary to use the resources around you to help establish these connections even before meeting with someone.

For example, a good friend of your Uncle Bob has a sister who works for your local Senator. First, call your Uncle Bob; he will love to hear from you. You then find out that he is having lunch with his good friend tomorrow, so you ask your Uncle to have his friend pass along your contact information (preferably a business card) to his sister. When the sister contacts you, she is excited to reach out to one of their constituents, and eagerly sets up a time for you to meet with the Senator. Ok, so you might not have an Uncle Bob, but I hope you can think of at least one connection similar to this. If you cannot, the staffers that work for your local congressmen or women’s office are just as passionate about their job as you are about pharmacy, so a phone call to them will likely get you the same result.

I will now step down off of my soap-box, and tell you a little bit about my experience of contacting and meeting with Rep. Jim Stamas of the 98^th District. But first, I have a bone to pick. I hear from so many pharmacists and student pharmacists that they don’t like “politics.” I am still not exactly sure what this means, because when asked to comment on a certain “political” topic I am fairly certain they would openly argue their position (I use Facebook posts as my reference for this). If you have ever asserted your disdain for politics or all things political, the only questions I have for you are:

Why do you like pharmacy?

OR

What does pharmacy or a job as a pharmacist mean to you?

OR

What does quality patient care mean to you?

Being politically involved as a pharmacist, a student pharmacist, or even a technician doesn’t mean you have to have an economics major or be a political science professor. It is just a way to show our legislators how passionate we are about our profession and the patients we serve. If you can answer the three questions above, you are an ADVOCATE, and can talk to a legislator!

Wow, I jumped back on that soap-box really quickly! I guess you’ll have to stay tuned for my post next week to hear about the meeting with Rep. Stamas, or subscribe to The Advocate via e-mail by providing your address under “Follow the Advocate by E-mail.” You’ll receive new posts right to your inbox!

I want you to sleep on this concept, and come back to this post tomorrow and share YOUR answers to these questions, or comment NOW if you can’t hold in your excitement!