Pharmacy News

The pharmacy news section of the MPA Web site is designed to provide members with immediate access to timely and relevant information about pharmacy and our Association. In this section, you will find information on MPA activities, Association members, the latest issues impacting the pharmacy profession and press releases from MPA and its affiliates.

Members are also encouraged to join the conversation by following MPA on Twitter @MIPharmacists for the latest breaking news. For more information on MPA's presence on social networking sites, visit our social media page.

Capital Area Pharmacists Association
Cathleen Edick, Pharm.D., CDE, pharmacy program coordinator, McLaren Greater Lansing

The Capital Area Pharmacists Association (CAPA) started out 2019 with a CE presentation by Heather Schalk, Pharm.D., on Jan. 24 titled "Direct Oral Anticoagulants in Atrial Fibrillation". Heather helped sort out all the differences and dosing for Direct Oral Anticoagulants.
 
March, as usual, was one of the busier months as it has Poison Prevention Week as well a Fifth Saturday and a planned CE. On March 16 during Poison Prevention Week, CAPA members headed to Impression 5 Children's Museum to educate parents and children about the dangers of poisons. It is always fun to see parents and children guess which one is the medication and which is the candy on the medication versus candy display. It is an eye opener for parents and children alike, especially when they think the medication is actually the candy! Later that week, on March 20, Tracey Mersfelder, Pharm.D., delivered a CE titled "A PAINful Decision" where she highlighted the opioid epidemic and discussed areas where gabapentin can be used. The month of March ended with CAPA members providing and serving food at the Advent House for its regular Fifth Saturday of the month on March 30.
 
On May 6, Brett Dragomer, Pharm.D., BCPS, delivered a CE titled "Hot Topics in Antimicrobial Stewardship - A Focus on Shorter Duration." Then on May 9 between 5-9 p.m., participants brought a CAPA flyer to Blaze Pizza and 20 percent of your proceeds were donated to our organization. It was a great way to raise money for CAPA and made for an easy dinner!
 
Things start to wind down for CAPA as summer approaches; however keep watch for more information about a June social event. Tentative plans are to attend an Ignite soccer game at the Cooley Law School Stadium on June 19 and to celebrate together either pre- or post-game at the MichiGrain Distillery. Watch your email for more details!
 
Both June, August and November include a Fifth Saturday so be sure to sign up to serve meals at the Advent House in Lansing on June 29, Aug. 31 and/or Nov 30. In addition, mark your calendars for the following CE events: Oct. 15 with a Wits and Wagers game and the December yearly law review.
Posted in: Member News
Drivers of Drug Costs in Health System Pharmacy
Michael Ruffing, Pharm.D., pharmacy director, Sinai-Grace Hospital
 
The United States spent nearly twice as much per person on healthcare than the average of other wealthy countries in 2017 ($10,224 vs. $5,280).1

In 2016, the U.S. spent $3.34 trillion or 17.9 percent of the gross domestic product (GDP) on healthcare expenditures.2 $329 billion of this was spent on prescription drugs. Centers for Medicare and Medicaid Services (CMS) projects that spending for retail prescription drugs will be the fastest growth in the health category.

In a report conducted by the National Opinion Research Center,drug costs continue to be a large part of the healthcare budget. Between FY 2015-2017, the average total drug spending per hospital admission increased 18.5 percent (28.7 percent outpatient; 9.6 percent inpatient). Growth in drug spending exceeded the growth in Medicare payment and general healthcare expenditures.

Drug costs to health system pharmacy are largely dependent on manufacturer pricing. Two of the largest drivers for new drugs for manufacturers are research and development and patent regulations. In 2016, the top 10 largest pharmaceutical companies spent 17 percent of revenue on research and development.4 This compares to 12 percent on health care overall. The average cost of a single FDA-approved medication (including the cost of drugs not approved) is estimated at $2.87 billion. In general, drug patents last for 20 years, but approximately 10 years of patent protection is appreciated after FDA approval. New formulations and indications along with paying generic companies to delay entering the market prolong the patent and increase cost. Streamlining the drug approval process could reduce costs.

Traditionally, drug manufacturers have used unit based pricing. This, in addition to limited regulations, enable companies to do frequent price increases. When a drug is ready to enter the market the environment often dictates the cost.5 For drugs with a cure, such as hepatitis C regimens, the cost is high as the value to the payer/patient is perceived to be high. New competition to the market results in significant cost reduction. Some drugs are priced high that have incremental improvements over standard of care for chronic conditions and might affect a subpopulation that is not well defined. Lower priced medications include vaccines and generics which have benefit but generally cost little. Manufacturers are looking to use more value based pricing to stakeholders (e.g., private payers, government, physicians, employers) and incorporate the value of the medication in comparison to overall treatment of the disease. This is typically how drug pricing is negotiated in foreign countries where there is one payer.

Nearly 90 percent of manufactured medications are sold to wholesalers. Health system pharmacies largely purchase from a primary and sometimes a secondary wholesaler. The negotiated contract with the wholesaler will have an aggregate effect on reducing drug cost.

Group Purchasing Organizations (GPO) can also have a significant impact on health system pharmacy drug costs. Manufacturers negotiate prices with the GPO based on the purchasing power of the GPO. The aggregate of entities represented by the GPO can realize significant savings provided products are purchased on contract.

Some private nonprofit hospitals that have a disproportionate share (DSH) designation are eligible for 340B pricing. Established as part of the Veterans Health Care Act, 340B pricing allows hospitals to purchase outpatient medication at a discounted price. This price averages up to 25 percent less that the cost when purchased through a GPO.

Drug shortages also play a significant role in drug costs. With fewer manufacturers making products, and in limited locations, manufacturing closures secondary to FDA noncompliance and geographic disasters often result in greater shortages. In the NORC report, drug shortages resulted in most health systems using other means of drug acquisition such as: off contract purchasing, outsourcing pharmacies, secondary contracts, direct purchasing, secondary wholesalers and 503A pharmacies. Each of these can increase cost.

The Trump administration hopes to reduce drug costs by boosting competition, improving incentives for lower drug prices, and out of pocket costs. Others feel that a single payer would be the answer; however, a recent report from the Congressional Budget Office (CBO) says that it would involve substantial changes to the current coverage model and would overburden provider organizations. Although a cost was not attached, some cite cost estimates at $13.8 to $36 trillion. The American Hospital Association (AHA) determined that it would result in a $800 billion cut to hospitals.6

With the complexity of the drug market, it is likely that it will take more than one action to mitigate the growing drug prices.

References

1. How does health spending in the U.S. compare to other countries? Peterson-Kaiser. Health System Tracker. December 7, 2018.
2. Prescription Drug Spending in the U.S. Health Care System. American Academy of Actuaries. March 2018.
3. Recent Trends in Hospital Drug Spending and Manufacturer Shortages. National Opinion Research Center (NORC). January 15, 2019.
4. US Pharmaceutical Pricing: An Overview. Axene Health Partners. May 11, 2018
5. A Roadmap to strategic drug pricing. In Vivo. The Business and Medicine Report. March 2016. Vol 34 (3).
6. New Report Outlines Negative Impact of Medicare Public Option Proposal on Hospitals, Health Systems and Patients. American Hospital Association. March 12, 2019.
Posted in: Member News
Preview of the 2019 ASHP House of Delegates
Jesse Hogue, Pharm.D., pharmacy education coordinator, Bronson Methodist Hospital 

The American Society of Health-System Pharmacists (ASHP) will convene its 71st Annual Session of the House of Delegates in Boston in June to address an agenda that includes considering 18 policy recommendations and a resolution, receiving board and committee reports and considering a variety of other society business items. Your elected delegates this year are Jim Lile, Mike Ruffing, Ryan Bickel and Jesse Hogue, with Curtis Collins and Dianne Malburg serving as alternates. In addition to attending the two official "live" House sessions, the Michigan delegates have participated in Regional Delegate Conferences, and will participate in various other forums and caucuses at the Summer Meeting to fully understand all the issues to be voted upon as well as to discuss possible amending language, new business items and recommendations of delegates. While a full discussion of each of the policy recommendations is beyond the scope of this article, I would like to highlight several that I feel are of interest to MSHP members.
 
Suicide Awareness and Prevention. Acting on a recommendation from a delegate last year, all five ASHP councils collaborated to develop this important policy recommendation. The ultimate aim of the policy is to support the goal of zero patient or healthcare worker suicides. The policy also notes that, while suicide awareness and prevention must be a collaborative effort, pharmacists and technicians can play a key role in those efforts.
 
Safe Administration of Hazardous Drugs. While ASHP has policy on closed system transfer devices (CSTDs), and USP has put forth standards for handling and administering hazardous drugs, there is a potential gap in the handling and administering of hazardous drugs by non-standard routes. This policy calls for ASHP to advocate for pharmacist involvement in the development of policies, procedures and operational (including risk) assessments regarding administration of hazardous drugs, including when CSTDs cannot be used. It also calls for manufacturers and FDA to develop more CSTD-compatible, ready-to-administer hazardous drug products.
 
Compounded Sterile Preparation Verification. This was an existing policy that the Council on Pharmacy Practice extensively reworked to more strongly call for adoption of automation and information technology to facilitate in-process and final verification of compounded sterile preparations (CSPs). Recognizing that this may not be realistic in the short term for all facilities, the policy recommendation calls for independent in-process and final verification of CSPs in the interim, and expressly opposes the syringe pull-back method or other proxy methods of CSP verification.
 
Notification of Drug Product Price Increases and Preventing Drug Product Shortages. These two ambitious policy recommendations from the Council on Public Policy touch on subjects near and dear to all health-system pharmacists' hearts - drug prices and shortages, which are areas in which ASHP is actively advocating on our behalf. These policies should help direct and target ASHP's advocacy efforts. The first policy calls for advocacy for drug manufacturers and suppliers to provide advance notice and justification for drug price increases, and for the manufacturers and suppliers to be transparent in their drug product pricing. The second policy takes a unique approach, calling for federal evaluation of whether drug product shortages present national security risks and for the FDA to require manufacturers to have contingency plans for maintaining drug supplies. It also calls for advocacy for drug manufacturers to be required to disclose manufacturing sites and sources of active pharmaceutical ingredients to facilitate the security risk assessment and for FDA to be required to publicly provide quality ratings for 503B outsourcing facilities preparing copies of drug products under the exemption for products on FDA's shortage list.
 
Credentialing and Privileging by Regulators, Payers and Providers for Collaborative Practice. In this time when we are trying to advance our practice in both the inpatient and ambulatory realms, this key policy calls for ASHP to advocate for expansion of collaborative practice agreements in which the pharmacist initiates, monitors and adjusts a patient's drug therapy, and for payment for these services. It also supports the use of clinical privileging in the same manner as other providers to assess a pharmacist's competence to engage in the services, which would further support our role as providers in these practices.
 
340B Drug Pricing Program Sustainability. As this is an area of significant interest to health system administrators and one in which ASHP is very actively advocating on our behalf, it should be noted that this policy recommendation shifts the advocacy approach slightly. Recognizing that the current legislative climate is antagonistic to the 340B program, the intent is to affirm the importance of the 340B program to our ability to provide services and to shift tactics away from expansion and toward conservation, stewardship and ensuring fair practices.
 
Pharmacist Authority to Provide Medication-Assisted Treatment. Recognizing this is a very important topic for our ambulatory members, the Council on Public Policy crafted this recommendation calling for ASHP to advocate for the role of pharmacists as providers in medication-assisted treatment (MAT) for opioid use disorder, including patient assessment, education and prescribing of pharmacologic therapies, since currently pharmacists are not eligible for the necessary waiver under the Drug Addiction Treatment Act of 2000.
 
Therapeutic Use of Cannabidiol. This is a very hot topic, but one that is likely to generate a LOT of discussion and debate. The policy recommendation supports continued research and education on cannabidiol (CBD), which likely will be universally supported. Where it gets controversial is that the recommendation opposes use of CBD-containing products not approved by FDA and advocates for enhanced public education regarding safe use of CBD and the risks of unapproved CBD-containing products. Many delegates have suggested that because the FDA approved CBD product is unaffordable for many patients who can or do benefit from CBD, actively opposing use of non-FDA approved CBD products may not be in the best interest of our patients. Delegates also noted that there are not clear, established guidelines for converting between CBD products from a formulary standpoint and FDA-approved CBD is not always easily available for purchase by health systems.
 
Pharmacy Technician Training and Certification. Consistent with MSHP's efforts, this policy continues to call for ASHP to foster expansion of ASHP/ACPE-accredited technician education and training programs. Considering updated PTCB standards, the Council on Education and Workforce Development is recommending an update of the current policy to shift the advocacy for the completion of an accredited training program for all new pharmacy technicians from 2020 to 2022. To support the ongoing advancement of pharmacy technician as a profession, the policy also continues to advocate for maintenance of PTCB certification. On a side note, delegates were given good news at the Regional Delegate Conference. The requirements for sterile compounding and retail billing were removed from the core ASHP/ACPE technician education and training program accreditation standards, moving them into specialized certifications, in response to feedback from both health-system and retail employers.
 
Safe Medication Preparation at All Sites of Care. This policy recommendation calls for ASHP to advocate that all sites of care be required to meet the same regulatory standards for medication preparation and compounding. While you might think this would be very non-controversial stance, the rationale given for this stance was entirely due to financial considerations around payors forcing patients toward lower cost-of-care options, with no attention given to quality or patient safety. As it stands, many delegates are vehemently opposed to this non-patient-centric approach to the topic and will likely vote against it unless something along the lines of "to ensure safety and quality" is added and the rationale is reworked to be less overtly self-serving.
 
Pharmacy Technician Student Drug Testing. This year is the inaugural year for the Pharmacy Technician Forum. They have been very active, including drafting this policy recommendation. It is very similar to the policy statements on pharmacist and pharmacy student drug testing passed in the last two years. The unique aspect is that the technician recommendation calls for use of pre-enrollment, random and for-cause drug testing as a mandatory component throughout any accredited or unaccredited pharmacy technician training program and practice experience, based on define criteria with appropriate testing validation procedures.
 
This discussion merely scratches the surface of the policy recommendations. Many of the other policy recommendations will also be of significant interest to MSHP members and will affect us as health system pharmacists. We would encourage all of you to review the proposed policies and contact one of the delegates with any questions or comments you may have (Jesse Hogue: hoguej@bronsonhg.org; Mike Ruffing: mruffing@dmc.org ; Ryan Bickel: ryan.bickel@mercyhealth.com; Jim Lile: lile1j@cmich.edu). Titles of all the policy recommendations are listed below for your review. Members can view the official language of the policy recommendations at the ASHP House of Delegates website as well as follow online discussions via the House of Delegates community via ASHP Connect. There has already been quite a bit of good discussion on ASHP Connect, feel free to join the conversation!
 
Policy Recommendations to be considered by the 2019 ASHP House of Delegates:
 
JOINT COUNCIL POLICY RECOMMENDATION
  1. Suicide Awareness and Prevention
 
COUNCIL ON PHARMACY PRACTICE
  1. Safe Administration of Hazardous Drugs
  2. Compounded Sterile Preparation Verification
 
COUNCIL ON PUBLIC POLICY
  1. Notification of Drug Product Price Increases
  2. Preventing Drug Product Shortages
  3. Emergency Refills
  4. Credentialing and Privileging by Regulators, Payers and Providers for Collaborative Practice
  5. 340B Drug Pricing Program Sustainability
  6. Pharmacist Authority to Provide Medication-Assisted Treatment
 
COUNCIL ON THERAPEUTICS
  1. Therapeutic Use of Cannabidiol
 
COUNCIL ON EDUCATION AND WORKFORCE DEVELOPMENT
  1. Pharmacy Expertise in Sterile Compounding
  2. Pharmacy Technician Training and Certification
 
COUNCIL ON PHARMACY MANAGEMENT
  1. Pharmaceutical Distribution Systems
  2. Safe Medication Preparation in All Sites of Care
  3. Pharmacy Department Business Partnerships
  4. Intimidating or Disruptive Behavior
 
PHARMACY TECHNICIAN FORUM
  1. Pharmacy Technician Student Drug Testing
 
SECTION OF INPATIENT CARE PRACTITIONERS
  1. ASHP Statement on the Role of the Medication Safety Leader
Posted in: Member News
ASHP Statement Supporting Legislation to Reduce Drug Prices
ASHP submitted a statement for the Thursday, May 9, 2019, Health Subcommittee on Energy and Commerce hearing, "Lowering Drug Prices: Deconstructing the Drug Supply Chain." ASHP's President-Elect and MSHP Past President Kathleen Pawlicki was scheduled to testify.

"We continually hear from pharmacy leaders in hospitals and health systems that sudden, inexplicable and unpredictable price increases in connection with some of the most commonly used, longstanding generic medications are becoming more prevalent - and are occurring on a nationwide basis," the American Society of Health-System Pharmacists said in the statement.
  
The statement highlights ASHP's support of legislation to reduce prices, including efforts to loosen restrictions that prevent generic drug companies from obtaining the samples necessary to manufacture a competing product.

Below are five additional issues addressed in the ASHP statement with key quotes from the statement on each issue. 

Competition
  • "Price increases often occur for drugs that have only one or two manufacturers. ASHP encourages the Committee to consider policy approaches to stimulate competition for generic products with few manufacturers."
 Risk Evaluation and Mitigation Strategies
  • "We believe that there may be current cases in which a manufacturer-driven REMS using restricted distribution are causing higher prices for those drugs, having adverse effects on patient access, and delaying treatment."
 Direct and Indirect Remuneration (Pharmacy Benefits Managers)
  • "Pharmacy providers are essentially being penalized with backdoor fees without any requirement that pharmacy benefits managers define, justify or explain these charges to providers and to CMS. It is an arbitrary application of quality measures meant for total plan performance as opposed to pharmacy-level metrics."
 Importation of prescription drugs
  • "We urge the FDA and state boards of pharmacy to vigorously enforce federal and state laws in relation to importation of pharmaceuticals by individuals, distributors (including wholesalers) and pharmacies that bypass a safe and secure regulatory framework."
    •     The 340B Drug Pricing Program
      • "The federal 340B program is not causing high drug prices. The program accounts for less than five percent of annual drug purchases in the United States, while safety-net providers give 30 percent of the care. Given the increasingly high cost of pharmaceuticals, the federal 340B program provides critical support to the entities eligible to participate in the program."
Posted in: Member News
What's Your Purpose?
Katie Axford, Pharm.D., BCPS, associate professor of pharmacy practice, Ferris State University College of Pharmacy and Mercy Health Saint Mary's
 
The month of May represents an annual occasion for me to reflect on another academic cycle, the opportunities embraced and commitments made over the previous year. It is also the time when I intentionally strive to check (and reset, if necessary) my perspective on what is good and important in my life. For many of us, life is busy, and in that busyness, we risk losing sight of our purpose.
 
This Spring semester, I had the opportunity, alongside five of my dedicated colleagues, to teach a leadership and personal development elective for first- and second-year students at Ferris State University College of Pharmacy. We conducted the course in a "book club" format with students and faculty engaging in weekly conversations around topics like motivation, being present, leading change, culture, grit and vulnerability. Through these discussions, the concept of purpose appeared time and again as something that inspires, motivates and brings people together.
 
MSHP President John Clark has selected "Achieving Patient Care Outcomes" as the Society's theme for 2019. As I struggled to identify a topic for my article this month, I realized that Dr. Clark is really just calling us to come together and re-focus on what brought most of us here in the first place: the opportunity to improve the lives of our patients.
 
Daniel Pink describes three elements that govern intrinsic human motivation: autonomy, mastery and purpose. "Autonomy and mastery," he says, "are essential. But for proper balance we need a third leg - purpose, which provides a context for its two mates. Autonomous people working toward mastery perform at very high levels. But those who do so in the service of some greater objective can achieve even more. The most deeply motivated people - not to mention those who are most productive and satisfied - hitch their desires to a cause larger than themselves."1
 
Deeply motivated...productive...and satisfied? Sign me up!
 
Whether you are working to expand the services that pharmacists are able to provide, or to increase the quality of the work we have been doing for years, I hope your "why" is to achieve better outcomes for your patients. That common goal has the power to unite us as a pharmacy community. It also connects us to the rest of the healthcare team - the prescribers, nurses, therapists, social workers and others - who show up every day with the same purpose. Our patients deserve to be cared for by professionals who are motivated and inspired to do our best, not for the paycheck or the recognition, but because helping them achieve better outcomes gives our own work greater meaning.
  
Reference:
  1. Pink DH. Drive: the surprising truth about what motivates us. First paperback edition. New York: Riverhead Books; 2011. 270 p. 
Posted in: Member News
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