Monday, September 29, 2014

General Overview of Public Act 285, the Pharmacy Technician Licensure and Certification Bill

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

This post provides a brief overview of the pharmacy technician certification and licensure legislation, Senate Bill (SB) 92. Please note that we are not aware of the exact process of how and when pharmacy technicians can begin to apply for licensure. We will let you know as soon as the Michigan Department of Licensing and Regulatory Affairs notify us of that process. Please read the following information to understand the bill provisions and other licensure details. 

SB 92, which adds mandatory licensure for pharmacy technicians to the Michigan Public Health Code, was signed into law on Sept. 30, 2014, by Michigan Gov. Rick Snyder and is now Public Act (PA) 285 of 2014. PA 285, which will likely take effect on Dec. 22, 2014, specifically outlines requirements for certification and licensure of pharmacy technicians in Michigan. Additionally, it re-distributes the seats of the public members serving on the Michigan Board of Pharmacy to four public members and one pharmacy technician.

How This Affects Pharmacy Technicians
  • Pharmacists and anyone who owns, manages and operates a pharmacy will be responsible for ensuring that the pharmacy technicians working for them will be properly licensed or otherwise authorized by the state.
  • Pharmacy technicians will be required to have one of three pharmacy technician licenses (a regular license, temporary license or a limited license) in order to be employed and perform the tasks of a pharmacy technician. If you have been a pharmacy technician prior to this mandate, please read the limited license section below to learn about how this law affects you.

Section 17739 defines the functions of a pharmacy technician. Pharmacy technicians can:
  • Assist in the dispensing process
  • Handle transfer of prescriptions, except controlled substances
  • Compound drugs
  • Prepare or mix IV drugs
  • Contact prescribers for order clarification, not including drug regimen review or clinical or therapeutic interpretation
  • Receive verbal prescription orders, except for controlled substances
Only pharmacists, pharmacy interns or pharmacy technicians may perform the above tasks, and must be licensed by the state. Pharmacy technicians can only preform the above tasks if they are under the supervision and personal charge of a pharmacist.

Pharmacy Technician License
To become licensed as a pharmacy technician, an individual must
  • Submit a completed application for licensure to the state with a $25 application fee
  • Pay $30 for the initial license
  • Have graduated from high school or passed the GED; and
  • Submit proof of having passed a pharmacy technician certification exam, or employer-based exam, which must be approved by the Michigan Board of Pharmacy.

 Note: The pharmacy technician license must be renewed every two years and costs $30 annually, totaling $60 every two years. To renew the pharmacy technician license, the pharmacy technician must complete 20 hours of approved continuing education within the two-year period immediately prior to submitting the renewal application.

Temporary Pharmacy Technician License
To obtain a temporary license, an individual must:
  • Be preparing to take the pharmacy technician certification exam (e.g., a student in a pharmacy technician program approved by the Michigan Board of Pharmacy
  • Submit a completed application for licensure to the state with a $25 application fee
  • Pay the $15 licensing fee

Note: The temporary license is only good for 210 days after it has been issued. It cannot be renewed.

Limited Pharmacy Technician License
If you have been practicing as a pharmacy technician prior to the implementation of this new statute, there is a grandfather clause in the form of a limited pharmacy technician license. To obtain a limited license, an individual must:
  • Be employed as a pharmacy technician at a pharmacy on the effective date
  • Be continuously employed by that same pharmacy since the effective date
  • Submit a completed application for licensure to the state with a $25 application fee
  • Pay $10 for the initial license
  • Submit proof of completing a minimum of 1,000 hours practicing as a pharmacy technician in the two years immediately prior to submitting the application

Note: The limited pharmacy technician license must be renewed every two years and costs $10 annually, totaling $20 every two years. To renew the limited license, the pharmacy technician must complete 20 hours of approved continuing education within the two-year period immediately prior to submitting the renewal application.

The limited license is no longer valid if:
  • A pharmacy technician is no longer employed by the pharmacy they were employed at and practicing for as a pharmacy technician since the effective date
  • A pharmacy technician practices at any other pharmacy

Note: If either of these two situations occurs, the pharmacy technician’s limited license is void, and they must apply for the pharmacy technician licensure and take a certification exam.

Type of License
Length of Validity
Renewable
Cost
Requirements for Licensure
Requirements for License Renewal
Pharmacy Technician
Two years
Yes
$25 initial application fee

$30 license fee paid initially, then every two years total, $60 for renewal 
Submit a completed application

Have graduated from high school or passed the GED

Submit proof of having passed a pharmacy technician certification exam, or employer-based exam
Submit a completed application

Have completed 20 hours of approved continuing education within the two-year period immediately prior to submitting the application
Temporary License
210 days
No
$25 initial application fee

$15 license fee
Submit a completed application

Be preparing to take the pharmacy technician certification exam
Not applicable
Limited License
Two years
Yes
$25 initial application fee

$10 license fee paid initially, then every two years total, $20 for renewal
Submit a completed application

Be employed as a pharmacy technician on the effective date AND
be continuously employed by that same pharmacy since the effective date

Submit proof of completing a minimum of 1,000 hours practicing as a pharmacy technician in the two years immediately prior to submitting the application
Same as pharmacy technician license

However, becomes invalid if:
A pharmacy technician is no longer employed by the pharmacy they were employed at and practicing for as a pharmacy technician since the effective date

AND/OR

A pharmacy technician practices at any other pharmacy

This document serves as an overview of Public Act 285. If you have any questions about this bill, please contact either Amanda Lick, MPA manager of advocacy, governmental and regulatory affairs at Amanda@MichiganPharmacists.org or Eric Roath, MPA director of professional practice, at Eric@MichiganPharmacists.org.

Thursday, September 25, 2014

Attending Political Fundraisers: A Student’s Experience

by Pang Hang, 2017 Pharm.D. candidate, Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences

On Sunday, Sept. 14, 2014, I attended an event to support Gary Peters for U.S. Senate. This was the first time I attended an event like this in the United States.  I am normally shy and soft-spoken, but I like making connections with others and seeing the impact that I can have. I saw this as an opportunity to make sure that what my classmates and I are studying for in pharmacy school will be intact in the future.

Honestly, I’m not well versed in talking about politics. I went to the event with the goal of making connections. I thought there would be more pharmacists there, but many of the attendees were not. It caught me off guard when I introduced myself as a student pharmacist and people asked me why so many pharmacists were at the event. However, that gave me the chance to explain my interest in being there. Being a shy person who still wants to make a difference, I take a less direct approach to advocacy. I didn’t want to sound like a telemarketer trying to sell them something. I shared my background, why I chose to study pharmacy and the vision of how I see pharmacists helping in health care.

I got to hear U.S. Congressman Gary Peters speak and answer questions before I got to meet him. From this experience, I found him to be an approachable and reasonable man. I liked that he made himself available to people and was willing to speak directly to them. From talking to the other guests, I was able to visualize his history of working with people and fighting for their rights. I met numerous women and men who have seen the laws he worked to introduce and pass make changes within their lifetime. That inspired me and gave me hope that I can make a difference too.

I ended up having such a good time at the event with good food and conversation that it ended too early for me. It was only two hours, but I felt that I was successful in advocating for pharmacy. I was able to talk to people about why, as a student pharmacist, I was at an event supporting a political candidate. I felt like I opened the door for another pharmacy advocate to talk with them. My strength isn’t in talking about politics; it’s in building relationships with people. I can play my part as an advocate by becoming friendly with new people and introducing them to friends of mine who do know more about politics who they can speak with.

Friday, September 19, 2014

Congressman Peters Signs on as Cosponsor of H.R. 4190 (Provider Status Bill)

Thanks to the advocacy and education efforts of Dr. David Kalis and the Michigan Pharmacists Association (MPA) Pharmacy Advocacy Response Team this week, Congressman Gary Peters has now signed on as a cosponsor of House Resolution (H.R.) 4190.


Pictured (left to right): Larry Wagenknecht, pharmacist, MPA chief executive officer; Pang Hang, P2 student pharmacist, Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences; Amanda Lick, M.A., MPA manager of advocacy, governmental and regulatory affairs; Congressman Gary Peters; Ashley Builta, Pharm.D., MPA fellow; and David Kalis, M.S., former director of pharmacy and residency program director, St. Joseph Mercy Oakland.

H.R. 4190 (provider status bill), introduced in March 2014 in the U.S. House of Representatives, would allow for pharmacists to bill Medicare Part B for services provided to patients who need access to health care the most, specifically patients who reside in medically underserved or health professional shortage areas and those who are part of a medically underserved population.

Michigan has 14 congressional leaders in the U. S. House of Representatives. As of Sept. 19, four of the 14 have signed on as cosponsors of H.R. 4190: Congresswoman Candice Miller, Congressman Mike Rogers, Congressman Kerry Bentivolio and Congressman Gary Peters.

We need you to keep the momentum going!
If you haven’t already done so, please take the time to read H.R. 4190 and contact your Congressional Representative and encourage them to sign on as cosponsor of H.R. 4190. If your Congressional leader is one of the four who have already signed on, please call and thank them for their support! If you are unsure of who represents your Congressional district or to access contact information for your Congressional leader, visit MPA’s legislative directory online.

MPA is here to help. Please contact Amanda Lick, MPA manager of advocacy, governmental and regulatory affairs, with any questions you may have at Amanda@MichiganPharmacists.org or (517) 377-0254.





Wednesday, September 17, 2014

Pharmacy Day at the Capitol: Student Pharmacists Give More and Get More

by Amy Parker, 2015 Pharm.D. candidate, Ferris State University College of Pharmacy

MPA Student Pharmacist Executive Council members from Ferris State University College of Pharmacy, the University of Michigan College of Pharmacy and Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences. Pictured, from left to right: Connie Root, Ben Korman, Allison Schepers, Victor Nguyen, Jake Chaffee, Elizabeth Laswell, Amy Parker and Nicole Pearl.

The importance of having student pharmacist participation in advocacy efforts is never more apparent than after an event such as Pharmacy Day at the Capitol. This event, which took place on Sept. 9, 2014, allows students to interact with legislators throughout the day and provides an opportunity for future pharmacists to educate lawmakers and their staffs on issues important to the pharmacy profession. This is one of the many things I love about Pharmacy Day at the Capitol! The opportunity for students to spend valuable one-on-one time with legislators and speak with them about key issues in pharmacy is huge. Students can see first-hand that their legislators are not intimidating, unapproachable individuals who lock themselves away in an office somewhere. Instead, students can see that their legislators are dedicated, passionate individuals who care about the people they serve and truly want to hear about their constituents’ concerns.

I was fortunate enough to meet my State Senator while trying to recruit legislators to come over and see the skills and expo tent on the Capitol lawn. Senator John Moolenaar (R-Midland) was more than happy to stop for a moment and speak with me. He seemed genuinely happy to meet me and told me that if I had any concerns or if I needed anything to feel free to contact his office. While speaking with him, I had somewhat of an epiphany; this was my State Senator taking time out of his day to speak with me, and I truly felt that the issues and concerns that I have, when voiced to him, would be well received and responded to. This exchange is just one example of many like it that take place during Pharmacy Day at the Capitol. Legislators seek out students, pharmacists and pharmacy technicians from their districts during this event. They want to be involved and want us to feel that we can be involved as well.

As student pharmacists, we represent the future of the profession so the things that we believe in, and ultimately advocate for, will help shape what the profession looks like going forward. By taking the time and speaking with those who represent our voice, we give ourselves the best opportunity to have an impact on changes that we want to see in our profession. I truly believe that if you don’t like something you should change it, so if we don’t like something or want to expand our profession, we need to take steps to transform it into the ideal result. How will we ever do this if we don’t advocate for this change to the people who can help us carry it out? We need to have a voice, have an opinion and not be afraid to share our concerns with those who are really listening!

Friday, September 12, 2014

UPDATE: Hydrocodone Combination Products Refills


Since our last post about the rescheduling of hydrocodone combination products (HCPs), we have gained some further insight about how this will affect your pharmacy practice.

As discussed earlier, as of Oct. 6, 2014, the HCP’s will have to be handled as Schedule 2 substances. However, prescriptions written for HCPs before Oct. 6, 2014 for HCP’s that have refills will still be valid for six months (until April 8, 2015). 

Thursday, September 11, 2014

DEA Final Rule on Controlled Substance Take-back

On Sept. 9, 2014, the Drug Enforcement Administration (DEA) released the final rule regarding the changes in the 2010 Secure and Responsible Drug Disposal Act (21 CFR Parts 1300, 1301, 1304, 1305, 1307 and 1317) regarding the take-back and disposal of controlled substances.

Patients are now able to bring all of their prescriptions, including controlled substances Schedules 2-5, to any pharmacy that is registered as a take-back location. Pharmacies will need to modify their current registration to allow for take-back [see 21 CFR 1301.51]. Additionally, authorized manufacturers, distributors, reverse distributors, narcotic treatment programs and hospitals/clinics with an on-site pharmacy may also administer mail-back programs and maintain collection receptacles.  The rule also expands the authority of authorized hospitals/clinics and retail pharmacies to maintain collection receptacles at long-term care (LTC) facilities.  Participation in these programs is voluntary.   

Under this new rule, there is no need for entities conducting medication take-back activities to separate legend drugs and Schedule 2-5 controlled substances. [21 CFR 1317.75 (b)] Any controlled substances that are collected should not be individually counted or inventoried. [21 CFR 1317.75 (c)] Schedule 1 controlled substances, controlled substances that are not lawfully possessed by the ultimate user, and other illicit or dangerous substances may not be collected utilizing general take-back methods. [21 CFR 1317.75 (e) (4)]

If at any point a “registrant” ceases to be a collector, they must notify the DEA in accordance with [21 CFR 1301.52 (f)]. This notice may be submitted online at www.DEAdiversion.usdoj.gov.

The rule did not change the way that drug/pharmaceutical waste generated through normal course of practice is disposed of. For example, if there is leftover morphine in a single-use vial that can no longer be utilized; it must still be disposed of in the original manner. It cannot be disposed of in a hospital/clinic/LTC facility drug take-back receptacle.

The federal rule takes effect on Oct. 9, 2014. The entire final rule, along with sections of the act that have been changed, can be found online at https://www.federalregister.gov/articles/2014/09/09/2014-20926/disposal-of-controlled-substances.

Wednesday, September 3, 2014

Hydrocodone Combination Products Moved to Schedule 2

On Aug. 22, the Drug Enforcement Administration (DEA) issued a final rule that moved hydrocodone combinations products (HCPs) from Schedule 3 to Schedule 2 of the Controlled Substances Act (CSA), effective Oct. 6, 2014. The DEA received more than 600 comments on the rule, a small majority of which supported the change, according to a DEA press release online.

Upon the effective date of this final rule, any person who handles HCPs will be subject to the CSA’s Schedule 2 regulatory controls. In addition, they will be subject to administrative, civil and criminal sanctions applicable to Schedule 2 controlled substances, including registration, security, labeling and packaging, quotas, inventory, records and reports, orders for HCPs, prescriptions, importation and exportation, and liability.
The complete DEA final rule is available in the Federal Register online. In addition, the American Pharmacists Association has provided information online about concerns with the rescheduling, including the short turnaround time to implement the new requirements, as well as the history of the rescheduling of HCPs and a past joint letter submitted by national organizations representing more than 100,000 pharmacists. MPA will keep members updated on the effects of this rescheduling and provide additional details as they become available.