Pharmacy News

Entries for September 2017

Healers Need Healing
By Jocelyn George, Pharm.D., pharmacist, BioMed Specialty Pharmacy, Livonia

My earliest memory of professionalism was the white coat ceremony in which I, with other classmates, donned the white coat and recited the Hippocratic Oath. This was the foundation of my practice in patient care. Throughout the years, the advent of modern medicine has brought positive changes to healthcare and shed light on disconnects within medicine that has led to medical errors. The Institute of Medicine (IOM) published its report in 1999, To Err is Human, and stated that medical errors were the fifth leading cause of death.1 Moreover, Makary et al evaluated the studies from 2000-2008 cited in the IOM report and concluded that medical errors were the third leading cause of death the U.S.2 Both reports have concluded breakdowns such as inefficient processes that lead to system problems and lack of standard protocols. Risk analysis tools such as the ‘Swiss Cheese Model’ and ‘Root Cause Analysis’ identifies those involved in the process and the ‘holes’ in the system that lead to errors. The focus is primarily on restoring the patient, the primary victim; however, studies conclude there is a second victim, the healthcare professional. In 2000, Dr. Albert Wu identified the healthcare professional involved in an incident as the second victim and provided the following definition, “Second Victims are healthcare professionals who are involved in an unanticipated adverse patient event, in a medical error and/or a patient related injury who become victimized in the sense that the provider is traumatized by the event. Frequently, these individuals feel personally responsible for the patient outcome. Many feel as though they have failed the patient, second guessing their clinical skills and knowledge base.”3 This article aims to bring awareness to the post-traumatic effects of medical errors on second victims and the support programs available in hopes to further a culture of safety for better patient outcomes. 

Waterman et al. writes, “Medical errors are unfortunately inevitable in complex healthcare environments.”4 Although this may be obvious, it remains a harsh reality. Research using surveys of second victims expound on the emotional impact of medical errors such as isolation, profound shame/guilt, fear of losing one’s job, decreased job satisfaction, doubt regarding clinical abilities, fear of reputation to litigation.3,4 A survey of 3,171 physicians from the United States and Canada have reported effects of errors such as increased anxiety (61 percent), decreased confidence as a physician, (42 percent), inability to sleep (42 percent), job dissatisfaction (42 percent), and concern for professional reputation (13 percent).4 In addition, as the severity of error increased, the likelihood of emotional impact increases. Astoundingly, 90 percent of the physicians reported that the institutions did not provide support. Furthermore, healthcare professionals that do not receive care for current distress can lead to an increased chance for future errors. West et al. surveyed internal medicine residents every three months regarding quality of life in those that have reported errors.5 The survey demonstrated that the emotional distress experienced by residents has led to further burnout, depression and reduced empathy, which lead to a vicious cycle of errors. Although factors such as professional stigma, lack of medical culture that encourages sharing and protecting reputation may impede change, there are programs available to provide assistance to those in need. 

Medically Induced Trauma Support Services (MITSS) is an organization founded in 2002 by Linda Kenney that provides support to patients, families and clinicians.6 As a patient who has encountered a medical error during a procedure, Kenney was personally affected by a medical error, but she also saw the impact on the physician involved in the procedure. MITSS offers an online toolkit with resources for organizations looking to start a clinician support program. There are institutions that have developed programs such as Resilience in Stressful Events (RISE) at Johns Hopkins Hospital and “forYOU” program at University of Missouri Health Care. In 2010, Edrees and associates of various sectors of patient safety at the Johns Hopkins Hospital developed the peer support program, RISE.7 Peer responders were healthcare professionals who were trained to navigate calls from affected staff and provided emotional support. Data collected from surveys over a five-year period indicated 66 percent of staff involved in an unanticipated adverse event would have responded positively to support from a colleague. Similarly, S. Scott and colleagues at University of Missouri Health Care forYou team have developed a peer support program with real time availability when an incident occurs.8 Data has yet to be published concerning the effectiveness of the peer support group to reducing turnover and consequently reducing medical errors. As efforts for improving patient safety evolves, there is evidence to further the idea of developing a culture of sharing in hopes to strengthen systems of healthcare.
 
Since the 1999 IOM report, advancements in healthcare technology such as Computer Physician Order Entry and Barcoding have reduced the error rates. These represent the parts that contribute to the story of what the National Patient Safety Foundation considers as ‘total systems safety.’9 This is a culture of safety that starts with the core values of how we design processes to give care to patients. As with any culture, there are deficiencies, but the goal is to as a community to fix, learn and improve to build a stronger community. 
 
References:

1. Kohn LT, Corrigan JM, Donaldson MS (2000). To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press. https://www.ncbi.nlm.nih.gov/books/NBK225182/pdf/Bookshelf_NBK225182.pdf. Accessed December 2016.

2. Makary MA, Daniel M. Medical error- the third leading cause of death in the US. BMJ. 2016;353:2139.

3. Scott SD, Hirschinger LE, Cox KR et al. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Quality Safety Health Care. 2009;18:325-330

4. Waterman AD, Garbutt J, Hazel E et al. The Emotional Impact of Medical Errors on Practicing Physicians in the United States and Canada. Joint Commission Journal on Quality and Patient Safety. 2007;33(8):467-476.

5. West CP, Huschka MM, Novotny PJ et al. Association of Perceived Medical Errors With Resident Distress and Empathy: A Prospective Logitudinal Study. JAMA 2006; 296(9):1071-1077.

6. Kenney, LK. Medically Induced Trauma Support Services. http://www.mitss.org/healthcareorgs_home.html. Accessed December 2016

7. Edrees H, Connors C, Paine L et al. Implementing the RISE second victim support programme at the Johns Hopkins Hospital: A case study. BMJ 2016;6(9):1-12.

8. Scott, SD. Second Victims: Gaining a Deeper Understanding to Mitigate Suffering. Per-operative Services Grand Rounds. Beth Israel Deaconess Medical Center, Boston MA. Sept. 1, 2010. Presentation

9. Gandhi TK, Berwick DM, Shojania KG et al. Patient Safety at the Crossroads. JAMA. 2016;315(7):1829-1830

Posted in: Member News
Baxdela (delafloxacin): Next Generation Fluoroquinolone
By Jade L. Abudia, B.S., Pharm.D., PGY1 pharmacy resident, Aleda E. Lutz VA Medical Center, Saginaw and Caleb Divens, M.B.A., Pharm.D., PGY1 pharmacy resident, Aleda E. Lutz VA Medical Center, Saginaw

On June 19, 2017, Melinta Therapeutics announced approval of a new fluoroquinolone (FQ), Baxdela (delafloxacin), by the U.S. Food and Drug Administration (FDA).1 Delafloxacin was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) which is incentivized by a five-year extension to any non-patent exclusivity period.2 New Drug Application (NDA) approvals were supported by two Phase 3 studies in patients with acute bacterial skin and skin structure infections (ABSSSI), demonstrating that IV and PO delafloxacin monotherapy was statistically non-inferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48-72 hours.3 

Delafloxacin was developed to be structurally different through the elimination of a basic group present in other FQs. This modification results in ionic characteristics that allow delafloxacin to pass into the bacterium easily; once inside, the charge characteristics change due to internal bacterium pH. The change causes delafloxacin to be ‘trapped’ inside the pathogen and translates to efficacy at much lower minimum inhibitory concentrations (MICs). MIC is used to determine antibiotic susceptibility and antimicrobials with excess exposure above the MIC have a reduced probability of selecting for resistant pathogens.3

Delafloxacin has activity against gram positive bacteria, gram negative bacteria, anaerobes and atypical bacteria.First and second generation FQs were primarily used in gram negative and atypical bacteria; further modifications led to the development of the third and forth generation FQs which exhibit improved gram positive coverage but increased occurrence of resistance development.5 Of these later generation FQs, moxifloxacin is largely considered the most potent gram-positive FQ. Delafloxacin exhibits a MIC two-to-four fold lower than those of moxifloxacin in gram positive bacteria.4 Interestingly, delafloxacin achieves this feat by the molecular alterations that allow for its accumulation within bacteria rather than by being a more potent topoisomerase inhibitor.3

Adverse effects with delafloxacin have shown to be dependent upon its dose. For its FDA-approved indication, delafloxacin is dosed at 300 mg IV every 12 hours or 450 mg PO every 12 hours for five to 14 days.6 The 450 mg tablet is bioequivalent to and interchangeable with the 300 mg IV dose, and can be dosed without regard to food. For both IV and PO administration, gastrointestinal adverse events were the most reported (nausea and diarrhea).7,8 There were two cases of elevated transaminase levels in a single comparative study.9 Presently, the only recommended dose adjustment is for IV use in patients with eGFR 15-29 mL/min/1.73 m2 who should receive 200 mg twice daily. There are no dose adjustments in the same eGFR range for PO dosing. Delafloxacin IV and PO formulations are not recommended in patients with eGFR <15 mL/min/1.73 m.2,6 The only interaction for delafloxacin that should be avoided is IV line co-administration with any solution containing multivalent cations, e.g., magnesium. Safety data, thus far, does not reveal any delafloxacin-specific adverse events, including prolongation of QTc interval or photosensitivity.3

While delafloxacin is currently FDA approved for ABSSSI, it is currently in other trials to expand its FDA-label approved indications. In respiratory infections, the possible use of delafloxacin in COPD exacerbations has been validated in a recent study comparing it with levofloxacin.4 In vivo, delafloxacin also exhibits especially low MICs against N. gonorrheae or H. pylori. In these cases, activity is expected to be even higher than in vivo, because of the acidic pH prevailing in the vagina or in the stomach. Sixty-five percent of a delafloxacin dose is unaltered when passed via urine; this high concentration of delafloxacin in the urine makes it an attractive option for E. coli or other enterobacteriaceae when involved in urinary tract infections.3 Most likely, the next indication for this drug will be community-acquired bacterial pneumonia (taking advantage of its very high potency on pneumococci and atypical pathogens) for which it was already granted as a QIDP by the FDA and is now in phase three trials.3,10

Considering delafloxacin’s broad spectrum of activity, structural advantages and metabolism, it has a multitude of potential. Safety data are reassuring but still preliminary and time is needed to assess the full implications of this promising but novel agent. 

References:
  1. Ernst D. New Antibiotic Baxdela Gets FDA Approval. MPR. http://www.empr.com/news/delafloxacin-acute-bacterial-skin-structure-infections-abssi-mrsa-melinta/article/669709/. Published June 20, 2017. Accessed July 29, 2017.
  2. Ligand’s Partner Melinta Therapeutics Announces U.S. FDA Approval of Baxdela™ (Delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Business Wire. http://www.businesswire.com/news/home/20170620005605/en/. Published June 20, 2017. Accessed July 29, 2017.
  3. Bambeke FCAV. Delafloxacin, a non-zwitterionic fluoroquinolone in Phase III of clinical development: evaluation of its pharmacology, pharmacokinetics, pharmacodynamics and clinical efficacy. Future Microbiol. 2015;10(7):1111-1123. doi:10.2217/fmb.15.39.
  4. Candel FJ, Peñuelas M. Delafloxacin: design, development and potential place in therapy. Drug Des Dev Ther. 2017;11:881-891. doi:10.2147/dddt.s106071.
  5. Pradhan S. Topical Fluoroquinolones: Current Perspectives. Delhi Journal of Ophthalmology. 2015;25(4):267-271. doi:10.7869/djo.121.
  6. Baxdela [package insert]. Lincolnshire, IL: Melinta Therapeutics, Inc; 2017.
  7. Hoover R, Hunt T, Benedict M, et al. Safety, tolerability and pharma¬cokinetic properties of intravenous delafloxacin after single and multiple doses in healthy volunteers. Clin Ther. 2016;38(1):53–65.
  8. Hoover R, Hunt T, Benedict M, et al. Single and multiple ascending-dose studies of oral delafloxacin: effects of food, sex and age. Clin Ther. 2016;38(1):39–52.
  9. Kingsley J, Mehra P, Lawrence LE, et al. A randomized, double-blind, phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin and skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016;71(3):821–829.
  10. Melinta Therapeutics, Inc. A phase 3, multicenter, randomized, double-blind, comparator-controlled study to evaluate the safety and efficacy of intravenous to oral delafloxacin in adult subjects with community-acquired bacterial pneumonia. Clinical Trials. https://clinicaltrials.gov/ct2/show/NCT02679573. NML Identifier: NCT02679573. Accessed March 15, 2017.

Posted in: Professional Practice
Western Michigan Society of Health-System Pharmacists Update
By Katie Axford, Pharm.D., BCPS, WMSHP president, associate professor, Ferris State University College of Pharmacy, western regional society representative

The Western Michigan Society of Health-System Pharmacists (WMSHP) has enjoyed a summer hiatus from monthly programming. In June, board members spent time together reflecting on highlights from the 2016-2017 year and beginning to make plans for 2017-2018. We are excited for another year of programming, as well as expanded networking and service opportunities for our membership. At the summer planning retreat, the Board also voted to sponsor Allison Rider (Spectrum Health) and Mitch Stein (Borgess) to participate in the Health Professional Leadership Academy through the Michigan Pharmacy Foundation (MPF) beginning in October. We are thankful for this opportunity to support our members in their leadership development and look forward to Allison and Mitch bringing these skills back to WMSHP.

On July 13, more than 20 members and their families went to the ball game for the WMSHP Summer Outing at Fifth Third Ballpark in Grand Rapids. Attendees enjoyed an all-you-can-eat barbeque on the Altogas Patio and watched the West Michigan Whitecaps in a 3-2 win over the Cedar Rapids Kernels. Thanks to all who joined us for a fun social event!

Monthly meetings with live continuing education (CE) for pharmacists and technicians resume in September. For more information about WMSHP or our upcoming programs, please visit www.WMSHP.net.
Posted in: Member News
Highlights of the 2017 ASHP House of Delegates
By Jesse Hogue, Pharm.D., pharmacy education coordinator, Bronson Methodist Hospital, Kalamazoo, MSHP immediate past-president 

The American Society of Health-System Pharmacists (ASHP) convened its 69th Session of the House of Delegates in Minneapolis during their summer meeting in June. In the course of the two House sessions, delegates considered 28 policy recommendations, one new business item and one resolution. Delegates also received board and committee reports and considered a variety of other society business items. Of the 28 policy recommendations, 15 were amended, one was referred back to the Council on Pharmacy Management for further study and 12 were approved as submitted by the Councils, including five approvals for policy discontinuations. Delegates voted to refer the resolution on ‘FDA Criteria for Specialty Drug Products Available through Restricted Drug Distribution’ for further study by the Council on Public Policy, the new business item was referred to the Council on Pharmacy Practice and delegates presented 42 recommendations to ASHP for review and action.

As you may remember from my preview article, your elected delegates this year were Gary Blake, Mike Ruffing, Paul Walker and myself, Jesse Hogue. Gary, unfortunately, was ‘Joint Commissioned’ so we appreciate Lynette Moser and Nancy MacDonald’s willingness to substitute at the House of Delegates sessions. I am proud to say that we participated in several formal caucuses and informal meetings to discuss the policy recommendations and were fully engaged in the process. I would like to take a moment to update MSHP members regarding what happened with the key policy recommendations I presented in the preview article. You can find the details of all the policies approved by the 2017 House of Delegates, along with several other documents that might be of interest here

Any Willing Provider Status for Pharmacists and Pharmacies. This policy was of particular interest considering MSHP’s focus this year on “Gearing Up” for advanced practice. It turns out, however, that this issue was far more complicated than we initially surmised. We had considerable discussion about risks/benefits, transparency and possible impacts on quality, access, cost and choice depending on the use criteria healthcare plans and payors may develop for these services. The House ended up agreeing on a significant amendment to the policy recommendation in an attempt to address these issues, but the ASHP Board recommended in their review of amendments between House sessions that the policy recommendation and its amendment be referred back to the Council on Pharmacy Management for further study. The delegates accepted this suggestion, given that it is a very complex issue and there are existing ASHP policies that would enable staff to advocate on the topic while a more specific policy on any willing provider legislation and regulation is developed. 

Ready-to-Administer Packaging for Hazardous Drug Products Intended for Home Use. I thought this policy was of interest to MSHP members because we increasingly see hazardous medications brought into the hospital as ‘patient supplied’ medications, and we continue to get more actively involved in transitions of care. I was pleased to see support for this policy at the House of Delegates and that it was amended to make it an even stronger policy statement. The delegates recognized that advocacy to the manufacturers would not be successful, so clauses were added encouraging ASHP to advocate that regulators have the authority to impose requirements on manufacturers to provide these hazardous medications intended for home use in ready-to-administer packaging, and that those products be labeled with appropriate warnings. 

Collaborative Drug Therapy Management. If you recall from the preview article, we had some concerns with this policy recommendation. While mostly favorable, and in line with our MSHP theme, we were worried that the recommended use of drug therapy management protocols would actually narrow the scope of our practice in Michigan. I am happy to report that we were successful in having this policy amended before it was accepted by the House of Delegates. The name was also changed to Collaborative Practice to better reflect the amended language, which essentially replaced ‘collaborative drug therapy management protocols’ with phrases including the terms ‘providers’ and ‘collaborative practice.’ As I noted in my Board article this month, one of ASHP’s current areas of focus is on expanding pharmacists’ authority and privileges at the state level in an effort to pave the way for federal expansion. This policy supports those efforts nicely, encouraging advocacy for key laws and regulations such as ones that would allow pharmacists to prescribe and transmit prescriptions electronically. 

Pharmacist Participation in Medical Aid in Dying. As anticipated, this policy recommendation drew a significant amount of discussion on ASHP Connect and in the caucuses and meetings leading up to the House sessions. I am relieved to report that having those forums for discussion in place allowed us to carry on most of the debate and deliberation outside of the formal House sessions, allowing the House sessions to proceed efficiently. 

To refresh your memory, two years ago the ASHP House of Delegates approved a policy opposing pharmacists’ participation in capital punishment, affirming that we, as healthcare providers dedicated to achieving optimal health outcomes and preserving life, should not participate in capital punishment. A recommendation was made after that to evaluate the ASHP position of neutrality on health professional participation in assisted suicide, and subsequently the ASHP Committee on Resolutions proposed a policy amendment strengthening that policy to one of opposition for consideration at the 2016 House. The House voted to refer the motion for further study, and the ASHP Board convened the Council of Pharmacy Management, Council on Pharmacy Practice and the Council on Public Policy as a Joint Council Task Force to study and consider the issue. The Task Force noted in their rationale that many healthcare professionals and organizations (including the American Medical Association, the American College of Physicians and the American Nurses Association) hold that death is not an acceptable therapeutic goal. Others, however (such as the American Academy of Hospice and Palliative Medicine and the American Psychological Association) have a neutral position, with the view that medical aid in dying has as its goal the relief of suffering through a compassionately hastened death while recognizing the risks of such a practice. They also noted that “medical aid in dying” is the currently accepted terminology, rather than “assisted suicide.” 

After researching and discussing the issue, the Task Force proposed a position of studied neutrality on whether pharmacists should participate in medical aid in dying. They defined studied neutrality as “the careful or premeditated practice of being neutral in a dispute … to foster a respectful culture among people of diverse views and to guide action that does not afford material advantage to a [particular] group.”1 The Task Force cited a desire to promote patient autonomy and access to care and to protect pharmacists’ professional integrity and comity as the rationale for this stance. The recommended policy also reaffirmed that a pharmacist’s decision to participate is one of individual conscience, and that participation or refusal to participate should not result in retribution, which was similar to the existing ASHP policy. While some delegates supported an amendment for ASHP to take an opposition stance, in the end the proposed policy passed as written, with the new ASHP Policy 1704 superseding ASHP Policy 9915. 

I again encourage you to review all the new policies on the ASHP website, since this summary only scratches the surface of this year’s House of Delegates activities. On behalf of my fellow delegates, thank you for allowing us to serve as your delegates this year! 


References:
1. Johnstone M-J. Organization Position Statements and the Stance of “Studied Neutrality” on Euthanasia in Palliative Care. J Pain Symp Manag. 2012; 44:896-907.

Posted in: Member News
Growth and Development as a New Practitioner
By Raymond Phung, Pharm.D., pharmacy resident, St. John Hospital and Medical Center, Southfield

Career pathways as a new pharmacy practitioner are ever changing. As a student, we were usually only exposed to what was offered during school. These ideas envelop an individual early on and take on the form of what is believed to be his or her future. I found my niche early on in hospital pharmacy; however, as a recent graduate of 2016 and a new practitioner, I had never been exposed to other pharmacy opportunities aside from hospital and community practice. This all changed when I began exploring organizations and pushing myself to get involved, and it started with Michigan Pharmacists Association (MPA) and Michigan Society of Health-System Pharmacists (MSHP). 

During pharmacy school, it is typically expected that by the end of fourth year, everyone will have an idea of what their career will look like. This can be difficult with a limited introduction to the multiple pharmacy career options, which include hospital, community, managed care, specialty, nuclear, independent community, ambulatory, legislative, academic and many other positions. It is even more difficult to decide on a career without knowing the daily tasks involved. I developed a deeper appreciation for pharmacy as a new practitioner following my involvement with MSHP/MPA. I had the opportunity to meet with many pharmacists and gain valuable insight regarding pharmacy as a profession. They enlightened me about their responsibilities as a pharmacist and encouraged me to explore different opportunities in the field. In addition to my passion as a hospital practitioner, I developed an interest in teaching and learning more about pharmacy in academia through networking with other professors as well as professors at Wayne State University. Additionally, staying involved with MSHP/MPA, I had the chance to stay current with the constant changes and challenges with legislation and how the changes affect pharmacists as practitioners. Furthermore, MSHP/MPA offer valuable resources and educational in-services that continue to help me grow as a clinical pharmacist.

When one door closes, a new one opens. Following the end of my pharmacy school education, I thought I was not going to grow any further, as this was the end of a chapter. However, it also marks the beginning of a new chapter, one as a new practitioner. I stay up-to-date by remaining involved, and I establish stronger bonds with my pharmacy career by networking through MSHP/MPA and continue to grow tremendously as an individual, establishing leadership skills, expanding my network and learning about the many pharmacy career options available. Pharmacy is a small world, and it starts with taking the first step into a network to get involved and becoming a member of a rich association to access it. Students, new practitioners and many generation of pharmacists are ready to share valuable wisdom and help advance the practice of pharmacy and encourage growth in the future of the profession. It is evident that I grew with MSHP/MPS, and like all growth, it is characterized by the investment an individual is willing to put forth. There are many benefits to being involved in MSHP/MPA if one is not afraid to risk a little time and effort in a growing association.

Posted in: Member News
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