Hot Topics in Pharmacy Purchasing: Regulatory Requirements, New Drugs, and GS1 Initiative

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Hot Topics in Pharmacy PurchasingRegulatory
Requirements, New Drugs, and GS1 Initiative

• Lyle Matthews, Pharm.D, MAM
• Director, Pharmacy Services
• Eisenhower Medical Center

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Goals

• Describe the three most challenging regulatory
  requirements of regulatory agencies and State
  Boards of Pharmacy involving Pharmacy Purchasing
  Professionals today.

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Goals (cont.)

• List the three most interesting new medications
  coming in late 2011 and 2012.
• Describe what the GS1 or Serial NDC number
  initiative is and what it means to Pharmacy
  Purchasing Professionals

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Disclaimers

• One Directors Thoughts (Mine)
• Each Organization is Different
• General Ideas And Philosophies
• Goal is to present concepts that can be related
  to your individual health systems

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Regulatory Challenges Facing Pharmacy Purchasing
Professionals

• What are the Issues?
• Who is responsible for them?
• How do we comply?
• Without losing our minds
• Without losing our friends

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Regulatory Agencies

• Joint Commission on Accreditation of Healthcare
  Organizations
• Centers for Medicare Medicaid Services
• State Boards of Pharmacy
• State Departments of Public Health
• Drug Enforcement Administration
• Food and Drug Administration

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What are the Regulatory Issues Involving
Medications?

• Ordering
• Receiving
• Delivery
• Storage
• Security

• Access
• Control
• Monitoring
• Record Retention

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Ordering and Receiving

• Who can Order?
• Do you Reconcile Receipt?
• Controlled Substances
• Are There Any Openings in System?

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Delivery

• Licensed Personnel?
• Volunteers or Transport Staff?
• Onsite
• Offsite
• Any process for security and control?
• Reconciliation

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Storage

• Refrigerate or not?
• Monitoring of Temps.
• Vaccines, Vaccines, Vaccines
• Sound Alike - Look Alike (SALA)
• Functional Separation
• Floor Stock
• Crash Carts Emergency Boxes

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Security

• Medication Rooms
• Automated Dispensing Cabinets (ADCs)
• Lockable Cabinets
• Lockable Refrigerators
• Controlled Substances

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Access

• Who has access to our Meds?
• Seemingly Everyone
• Who controls who has Access to
• Medication Rooms?
• ADCs?
• Controlled Substance Room?

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Control

• Who can change things without you knowing?
• Hospital Formulary
• Automated Dispensing Cabinets
• PAR levels
• Locations

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Answer to Question
Who Can Change Things?

• Seemingly Everyone
• Seemingly Constantly
• Seemingly Forever

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Monitoring

• Who is watching?
• Is anything Missing?
• Has Anything Changed?
• Controlled Substance Ordering Patterns

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Record Retention

• Recalls
• Trailer Theft
• Invoices (3 years on site?)
• Controlled Substances
• Invoices
• 222 Forms
• CSOS

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Who is Responsible For Helping Control Things?

• Director of Pharmacy?
• Operations Manager?
• Technician Supervisor?
• Nursing Staff?
• O.R. and E.D. Staff?
• Everyone

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Sound Familiar?

• I dont know how the vaccines are stored, ask
  the Buyer.
• I dont know what temperature the refrigerators
  are supposed to be kept, ask the Buyer.
• I dont know who has access to the Automated
  Dispensing Cabinets, ask the Buyer.

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How Do We Control These Challenges

• Communicate With The Pharmacy Management Team
• Ensure They Realize You Have to Know What is
  Happening
• Ensure You are Included In all Discussions
• PT Committee Membership?

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Regulatory Summary

• Everyone is responsible for Regulatory Compliance
• Everyone Has Their hands in Our Meds Try to
  control them.
• Communicate and Solve Problems Together As a Team

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Joint Commission Survey Aug.
9-12, 2011

• Magnesium Sulfate
• Recalls
• Notification of Nursing/Medical Staffs
• Expired and Recalled Medication Storage
  Segregation
• Are you a County/State Cache Site?

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New Medications for2011 and 2012

• Some have Financial Impact
• Some have Clinical Impact
• Some will just have Psychological Impact on Us
  and Make Our Lives Difficult

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Pradaxa(dabigatran etexilate mesylate)

• Highly Controversial
• Expensive compared to Coumadin
• BID dosing (vs. daily Coumadin)
• Leap of faith for patients who are used to having
  INRs drawn
• Reports of Bleeding

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Effient(prasugrel)

• Oral Antiplatelet Medication for patients
  following angioplasty
• No proven reversal agent
• Cardiac Surgeons are largely opposed and/or
  skeptical

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Provenge(Sipuleucel-T)

• For Advanced Prostate Cancer
• FDA Approved April 2010
• Very complicated administration
• 93,000 for course of Treatment
• Controversial extends life by approximately 4.5
  months
• All sorts of problems for Dendreon

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Xarelto(rivaroxaban)

• DVT prophylaxis in knee and hip replacement
  patients
• FDA Approved July 1, 2011
• Marketed against Lovenox/Coumadin
• Taken orally (10mg daily)
• Applying for indication for A-fib pts.
• Available in Europe since 2008

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Arcapta Neohaler(indacaterol)

• Long acting beta-2 adrenergic agonist for COPD
  patients
• 75 mcg capsule daily using the Neohaler
• Not for asthma patients
• Will be available in 1st quarter of 2012

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Brilinta(ticagrelor)

• FDA Approved July 2011
• 7.24 per day (20 more than Plavix (clopidogrel)
• Shown superior to Plavix when combined with low
  dose aspirin to prevent heart attacks and strokes
• clopidogrel generic in May 2012.

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Yervoy(ipilimumab)

• Unresectable or Metastatic Melanoma
• Dose is 3mg/kg IV over 90 min. every 3 weeks x 4
  doses
• 50 mg and 200 mg vials
• Extends life avg. of 4 months
• 120,000 for 4 dose course

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Victoza(liraglutide)

• For Type 2 Diabetes
• GLP-1 analog Targeting Pancreatic beta cells
• Increases Insulin Secretion and move sugar into
  cells
• Watch for hints of weight loss help

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Dificid(fidaxomicin)

• Already Released
• For Clostridium dificile associated diarrhea
• One 200mg tablet BID x 10 days
• 140 per tablet
• More expensive that oral Vanco
• (less that IV Vanco given orally)

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Avastin(bevacizumab)

• Not new
• Very Expensive and Very Popular
• Controversial indication for Breast Cancer
• Keep watching Changes are Coming

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Expiring Patents in 2011

• Lipitor
• Zyprexa
• Levaquin
• Concerta
• Protonix
• Total sales of 10 Billion in 2010

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Lipitor(atorvastatin)

• Patent expired June 2011
• Ranbaxy Generic Atorvastatin available Nov. 2011
• Significant potential cost savings, but probably
  further down the road
• Guess what Pfizer has proposed?

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GS1 Initiative

• GS1 or Serial NDC Number Project
• Guidance for Securing the Drug Supply Chain
  Standardized Numerical Identification for
  Prescription Drug Packages

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Who are GS1?

• GS1 is a global organization dedicated to the
  design and implementation of global standards and
  solutions to improve efficiency and visibility in
  supply and demand chains.
• From GS1 letter to the FDA April, 2009

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What does it mean to us?

• Their goal is to standardize NDC standards
  globally
• This would potentially enhance supply chain
  tracking and tracing
• Could embed product specific information

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• Thank you for having me again.
• Best wishes to the NPPA and all of the Pharmacy
  Purchasing Professionals
• Questions?