By Marla M. Ekola, Pharm.D., BCPS, M.B.A., director of pharmacy, Memorial Healthcare, Pharmacy Systems Inc. 

Since 2004, USP <797> has been the guiding principle for sterile product production. The Joint Commission began enforcement of these standards in 2008, yet still more than half of the pharmacies self-reported being out of compliance with this standards.¹ All the while, several high profile issues occurred to remind the pharmacy world of the high risks of sterile product production. The New England Compounding Center caused a disastrous outbreak of fungal meningitis in 2012. In 2014, Governor Rick Snyder signed into law the amendment to the pharmacy licensure and drug control provisions of the Michigan Public Health Code.² This amendment defined a compounding pharmacy and established limits on compounding activities and recordkeeping requirements.

There was much discussion regarding the intent of this amendment. Initially, it was believed this did not apply to hospital pharmacies but rather to compounding pharmacies exclusively. Ultimately, it was determined that all pharmacies that compound sterile products were impacted by these changes.  This meant all hospital pharmacies in Michigan would need to seek accreditation from one of the accepted accreditation bodies of Pharmacy Compounding Accreditation Board/Accreditation Commission for Health Care (PCAB/ACHC) or National Association of Boards of Pharmacy's Verified Pharmacy Program (VPP). The Board was successfully petitioned to accept The Joint Commission (TJC) accreditation in addition to the other previously mentioned organizations. The initial set of requirements were set to be enforceable on Sept. 30, 2015. Michigan Health and Hospital Association (MHA)/Michigan Pharmacists Association (MPA)/Michigan Society of Health-System Pharmacists (MSHP) worked collaboratively to secure a legislative fix that delayed the deadline until Sept. 30, 2016. At that time, all Michigan pharmacies that compound sterile products should be in process of accreditation and should have completed the accreditation by June 30, 2017³.

The purpose of the accrediting bodies is to ensure that our patients have access to safe sterile compounds. Their standards follow the basic guidelines set by USP <797> for each of the following areas:

• Design of the Facility
• Environmental and Engineering Controls
• Environmental Testing
• Personnel Training and Competency Testing
• Standard Operating Procedures and Documentation
• Quality Assurance
• Patient Monitoring and Adverse Events Reporting
• Storage and Dating⁴

As with all quality initiatives, the bar is constantly moving, and as we gather more data and draw more comprehensive conclusions, we often see areas that could compromise safety and cause patients harm. While this article is being published, the latest update of USP <797> is being republished for a second round of comments; however, there is not an anticipated date for the chapter’s republication.

This constantly moving target can come with a very hefty price tag. Updating IV rooms to meet the environmental and engineering standards required by <USP 797> can cost millions for some facilities. Ever increasing requirements for environmental testing and training come with reoccurring fees. This does not include the daily nonpatient charges of sterile gloves, sterile alcohol and other items required by the standards. All of this at a time when payment models are shifting and reimbursement is becoming more unreliable. It can be difficult to get the full backing from the C-Suite when the standards will continue to evolve. Even now, the next standard <USP 800> looms at our doors.

Hospital pharmacies have been compounding sterile products for decades. It can be difficult for our profession to accept that our previous practices created an environment fraught with potential patient safety issues. It was not so very long ago that washing your hands was enough, now we scrub, use hand sanitizer and don sterile gloves, then sanitize again prior to compounding a sterile product. As with many things in our profession, practice standards continue to evolve to improve patient outcomes. Patient safety and quality assurance are what make these changes a positive step in the right direction.

References:

1. Douglass K, Kastango ES, Cantor P. The 2012 USP <797> compliance survey: measuring progress. Pharm Purchasing Products. 2012;8(10):S4–24
2. Legislative Service Bureau. Senate Bill 0704 (2013). Michigan Legislature website.  http://www.legislature.mi.gov/(S(jzkp350cpjgobvcdjch4hnmr))/mileg.aspx?page=GetObject&objectname=2013-SB-0704.  Accessed February 2017.
3. State of Michigan. Michigan Department of Licensing and Regulatory Affairs Bureau of Professional Licensing, Board of Pharmacy. Michigan.gov website. http://www.michigan.gov/documents/lara/Pharmacy_license-full_052014_456621_7.pdf. Accessed February 2017.
4. U.S. Pharmacopeial Convention. USP Compounding Standards. USP.org. http://www.usp.org/usp-healthcare-professionals/compounding. Accessed February 2017.

By Deborah Isopi, B.S. Pharm, M.B.A., PGY1 residency program director, Detroit Medical Center

The American Society of Health-System Pharmacists (ASHP) Commission on Credentialing (COC) is currently updating the goals and objectives for all ASHP accredited residency programs. ASHP recognized that the previous documents were out-of-date and burdensome, so experts from across the country have been consulted to comment on the draft program goals, objectives and evaluation process. Eventually all residency program objectives will be revised. The following programs have already been approved by the COC: PGY1 in hospital pharmacy and community pharmacy practices and PGY2 programs in critical care, oncology, pediatric and psychiatric pharmacy.

Many of the residency programs in the state of Michigan will be undergoing reaccreditation in the next few years. It will be important to review several areas within your residency program for a successful survey. These areas include the program structure, learning experience descriptions and resident development plans. However, in order to interpret the new standards, a review of the terminology used in the standards is necessary. “Principles” has been replaced by “standards” to similarly match The Joint Commission jargon. Standards are defined as the required elements to be completed by each resident enrolled in the program.¹ Standards are subdivided into competency areas, which are categories of the residency graduates’ capabilities and can be considered 1) required, 2) additional for the program and 3) elective for specific residents.¹ Essentially competency areas are broad areas of practice which a resident should be proficient before graduating from the program. A program only has to select the required competency areas; however, it can choose to encompass other areas from the elective categories. The term "competency areas" replaces "outcomes" in the old standards. Expertise in a particular competency area can be achieved by successful completion of the goals and objectives assigned in the competency area, similar in structure to the old standards. Additionally, what was previously termed as the customized plan is now called the "development plan."

In the past, site residency programs had to develop their own purpose statement. On accreditation visits, the ASHP surveyors would critique these statements to be sure that they supported the intent of the standards. In the new standards, the COC has defined the purpose statement for all programs. The creativity of each program now lies in the program structure. The program structure document should be a formal written document that facilitates the residents' achievement of the goals and objectives. It should list the required rotations and length of each rotation and should be standardized to allow residents sufficient practice with diverse patient populations, a variety of disease states and a range of patient problems.² This is the first document that is requested by the survey team. The program structure document is considered a critical factor, which is an element the COC determined to carry more weight than others when they are assessing compliance and is used to determine length of accreditation.²

Another area of review will be the learning experience documents. Each rotation or learning experience should have a written document which includes a general description and expectations and evaluation schedule of the resident. Also, included are the educational goals and objectives that will be achieved by the resident during the rotation. Each objective must have learning activities assigned that will facilitate the achievement of the objective. The learning activities will be examined to be sure they are at a level to achieve the objective and are specific in nature using action verbs. Each objective is written using verbs taken from Bloom's taxonomy³ and the learning activity verbs should match the same level or higher than the verbs in the objective. For example, a learning activity of participating in daily rounds can be better described as "the resident should arrive to the nursing unit five minutes before patient care rounds, with all medication levels collected and a plan documented on the monitoring form." The learning descriptions are a critical factor, and the ASHP website has additional education in this area. It is recommended to review the ASHP online programs before the accreditation survey.

The initial and quarterly development plans are other areas that will be reviewed by the survey team. The initial assessment of the resident must be completed and documented by the end of orientation and must be shared with preceptors. Documentation of the assessment in PharmAcademic™ is not adequate to meet the standards and a mechanism of active review with preceptors should be implemented. For example, each residents' initial plan could be reviewed with preceptors at the Residency Advisory Committee meeting. Also, the quarterly residents' development plans should document the modifications of the rotation schedule based on the evaluations and comments of the preceptors.  

ASHP develops a guidance document to assist sites in navigating through the standards. The guidance document will be updated by ASHP every six months and will specify how the COC will interpret the standards when conducting the reaccreditation visit. The Detroit Medical Center will have all of their residency programs reaccredited in October 2017, so feel free to contact me at disopi@dmc.org if you have any questions. Good luck in your survey visit.

References:

1. American Society of Health-System Pharmacists. ASHP Accreditation Standard for Postgraduate Year One (PGY1) Pharmacy Residency Programs. ASHP website. http://www.ashp.org/DocLibrary/Accreditation/Newly-approved-PGY1-Standard-September-2014.pdf. Accessed February 2017.
2. American Society of Health-System Pharmacists. Guidance Document for the ASHP Accreditation Standard for Postgraduate Year One (PGY1) Pharmacy Residency Programs. ASHP website. http://www.ashp.org/DocLibrary/Residents/ASO-PGY1-Standards-Guidance.aspx. Accessed February 2017.
3. Bloom, BS, Krathwohl DR. Taxonomy of educational objectives: the classification of educational goals. Book 1: Cognitive Domain. New York: Longman; 1984.

By Derek Vander Horst, Pharm.D., BCPS, PGY2 infectious diseases pharmacy resident, Munson Medical Center 

I am sure by now you have heard rumblings of new regulations that would require all acute healthcare facilities to have a formal antimicrobial stewardship program (ASP) to improve and monitor how antimicrobials are prescribed within their institution. As of Jan. 1, 2017, The Joint Commission (TJC) followed through on its promise and put these requirements into place. If you have been wondering what a survey from TJC will look like, I am here to help. TJC recently released a new accreditation survey guide for healthcare organizations in 2017 outlining what institutions may expect in relation to the new ASP regulations.¹ This article is aimed at assisting you in understanding what materials regarding antimicrobial stewardship you will need to be prepared for a survey from TJC.  

Document List for TJC 2017 Accreditation Survey Guide for Antimicrobial Stewardship:

TJC has added several ASP requirements to the necessary document packet that must be presented to the survey team upon arrival at your institution. Many of these documents are utilized in several different sections of TJC’s survey. TJC surveyors will expect to see proof of the following upon review of your document packet:¹

1. Document(s) describing how the institution utilizes the Center for Disease Control and Prevention’s (CDC’s) Core Elements of Hospital Antibiotic Stewardship²

2. Institution specific ASP protocols

a. Policies and procedures for ASP-specific actions (i.e., restricted antimicrobial lists, prospective audit and feedback, etc.)

b. Individuals on a multidisciplinary team responsible for antimicrobial stewardship and their corresponding functions

c. Institution-specific order sets for common infectious diseases (i.e., pneumonia, urinary tract infections, etc.)

3. Institution specific ASP metrics

a. Days of therapy, defined daily doses, cost, etc.

4. Institution specific ASP reports documenting improvement

5. Specific lists of patients that are prescribed antimicrobials to be utilized in the tracer activity. Patient lists will only be needed for the week of the survey and no retrospective computer-generated lists are necessary. These specific patients include:

a. Emergency department patients who are prescribed antimicrobials

b. Hospitalized patients that will be discharged on antimicrobials

c. Ambulatory and/or clinic patients who are surveyed under the hospital program that are prescribed antimicrobials

Individual and System Tracer Activities:

A “tracer” is a specific patient that a surveyor will follow throughout the patient’s care at your institution. During the tracer, TJC will expect to see a few new interventions in regards to your hospital’s ASP. TJC will want to ensure that education is provided on the appropriate use of antibiotics to any patients prescribed antimicrobials in the following settings: the emergency department, affiliated ambulatory care clinics being surveyed under the hospital program and/or hospitalized patients that will be discharged on antimicrobials.¹ TJC will only interview patients and/or their families to ensure they have been provided education on antimicrobials if they are being discharged on them.¹ For informational handouts on patient education, I encourage you to search the CDC Get Smart About Antibiotics website.³ During this tracer activity, the surveyors will interview any staff they come in contact with to ensure they have received education on antimicrobial resistance and the hospital’s ASP. Of note, during the competence assessment section of your survey TJC will want to learn about your formal educational and training processes for your staff utilized in your institution.¹ They will expect to see some aspect of formal education to all the staff on antimicrobial resistance and stewardship but will not be reviewing human resource records or medical staff records related to this subject.

Leadership and Data Management:

Your survey team will also review your institution’s ASP metrics. TJC would like to see some data and reports showing improvement in antimicrobial stewardship. Possible metrics are outlined in the CDC’s Core Elements of a Hospital Antibiotic Stewardship Program. Included in these metrics, TJC would like to see data documenting antimicrobial stewardship improvement; if your data shows that this improvement is not necessary, ensure that the surveyors are made aware. While meeting with your institution’s leadership, TJC will likely discuss these metrics as well as how the institution’s leadership can demonstrate that antimicrobial stewardship is a priority.¹

There are still many questions surrounding these new regulations; however, at the end of the day, we have to remember the TJC’s intent. Antimicrobial resistance is a worldwide crisis that we as healthcare professionals must combat for the sake of our patients. If you have further questions, I urge you to explore the CDC’s Core Elements of Hospital Antibiotic Stewardship Programs and TJC Accreditation Survey Guide. I also recommend looking at the Michigan Pharmacist’s Association’s webpage on Antimicrobial Stewardship, which includes guidance for starting and maintaining an ASP, and provides contact information for ASP experts in Michigan.⁴ May the Force be with you.

Resources:

1. The Joint Commission. Accreditation Survey Activity Guide for Health Care Organizations, Issue Date: February 6, 2017. The Joint Commission website. https://www.jointcommission.org/assets/1/18/2017_Organization_SAG.pdf. Accessed February 2017.
2. U.S. Department of Health and Human Services. Core Elements of Hospital Antibiotic Stewardship. Centers for Disease Control and Prevention website. https://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html. Accessed February 2017.
3. U.S. Department of Health and Human Services. Get Smart About Antibiotics Week. Centers for Disease Control and Prevention website. https://www.cdc.gov/getsmart/week/. Accessed February 2017.
4. Michigan Pharmacists Association. Antimicrobial Stewardship. MichiganPharmacists.org.  http://www.michiganpharmacists.org/resources/antimicrobial. Accessed February 2017. 

By Tammy Busch, R.Ph., staff pharmacist, Otsego Memorial Hospital, University of Florida-WPPD Pharm.D. candidate, northern region representative

The Northern Michigan Society of Health-System Pharmacists (NMSHP) is on winter break until April; however, we are not hibernating! We are busy planning our spring meetings. New this year, we are planning an extra half-day live continuing education (CE) event Saturday, April 8  from 8 a.m.-12:30 p.m. at the beautiful Otsego Club in Gaylord, Mich. The keynote presentation will focus on transitions of care. Pain will be the topic of our CE during our April 20 meeting at the Gaylord Country Club. Our presenter will be Claire Saadeh, Pharm.D., Ferris State University faculty. Our May meeting will spotlight our Munson Healthcare residents who will present their research projects. This meeting will take place in Traverse City at Munson Medical Center on May 18. All are welcome to attend any of these meetings. Be sure to come early and enjoy a day in Northern Michigan! 

By Jesse Hogue, Pharm.D., pharmacy education coordinator, Bronson Methodist Hospital, MSHP immediate past-president

In January, President Dana Staat wrote an excellent article updating us on the status of the Pharmacy and Medically Underserved Areas Enhancement Act and how we can start to “Gear Up” for practice after approval of the act. After the many articles that Dana, I and many others have written, I do not think I need to go into great detail on the many facets to the Act here. However, I would be remiss if I didn’t give a brief update on the status of the legislation. I am excited to announce that, since the January MSHP Monitor was published, the House version of the bill was reintroduced by Representative Brett Guthrie (R-KY) with an impressive 107 cosponsors! At the time of my writing in early February, the number of cosponsors was already up to 126, but only two of our Michigan representatives (Rep. Tim Walberg and Rep. Mike Bishop) had signed on to support the bill. We were up to 27 cosponsors on the Senate side, but of our two senators in Michigan, only Sen. Gary Peters had signed on to support the bill, so there is still work to be done for us here in Michigan! I encourage you to visit www.Congress.gov for ongoing updates. Once at the site, simply search for S 109 or HR 592 to pull up the status of the bills.

One important topic Dana highlighted in her article that I would like to focus on further was the push to start referring to the bill as “Improving Patient Access to Pharmacists’ Health Care Services” legislation rather than “Provider Status” legislation. I am sure within our professional circles we will continue referring to it as the “Provider Status Bill” since that rolls off the tongue far nicer than the “Patient Access to Pharmacists’ Services Bill,” but it does raise a good point. When we are talking to the public, or our legislators, do they care that we, as pharmacists, want to be considered providers who can bill for our services? Or are they more interested in making sure patients have access to the care they need to achieve optimal health outcomes? These, of course, are rhetorical questions, but I am referring to the legislation as the “Provider Status Bill” while discussing it with a legislator could potentially slant his or her view of pharmacy as self-serving rather than altruistic, which certainly will not help our cause!

This frame of thinking was underscored for me recently as I was advising some of our physician practice directors on how to deal with the new rules expanding prescriptive authority for nurse practitioners, nurse midwives and physician assistants. I was reminded of the fact that these advanced practice providers started in much the same way that we are. They did not lobby initially for broad prescriptive authority; rather, they too focused on expanding access to healthcare services in medically underserved areas. But as I am sure you are all aware, they have effectively demonstrated their effectiveness in expanding access and have been able to “Gear Up” their scope and authority over the past few years. They put the care of patients at the center of their initiative and now are firmly established, valued providers within the healthcare system. I see no reason that our profession cannot be equally as successful if we take the correct approach. I would argue that pharmacist providers will contribute just as much as our advanced practice provider colleagues to expanding cost effective, high quality care for our underserved patients, given the appropriate authority.  

So I encourage you to contact your legislators and ask them to support the “Pharmacy and Medically Underserved Areas Enhancement Act.” Educate them on what we as pharmacists can bring to the table as experts in medication management. Remind them of the critical provider shortage and how it is adversely limiting the delivery of healthcare services to large numbers of their constituents. But most importantly, make sure they know our primary concern is the patient. It may help to recall the following portions of the Pharmacist’s Oath:

• I will consider the welfare of humanity and relief of suffering my primary concerns.
• I will apply my knowledge, experience and skills to the best of my ability to assure optimal outcomes for my patients.
• I will embrace and advocate changes that improve patient care.