Transcript Hot Topics in Pharmacy Purchasing: Regulatory, New Drugs

Hot Topics in Pharmacy
Purchasing:
Regulatory Requirements,
New Drugs, and GS1
Initiative
Lyle Matthews, Pharm.D, MAM
Director, Pharmacy Services
Eisenhower Medical Center
Goals
Describe the three most
challenging regulatory
requirements of regulatory
agencies and State Boards of
Pharmacy involving Pharmacy
Purchasing Professionals today.
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
Disclaimers
One Director’s Thoughts (Mine)
Each Organization is Different
General Ideas And Philosophies
Goal is to present concepts that
can be related to your individual
health systems
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
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
What are the Regulatory Issues
Involving Medications?
Ordering
Receiving
Delivery
Storage
Security
Access
Control
Monitoring
Record
Retention
Ordering and Receiving
Who can Order?
Do you Reconcile Receipt?
Controlled Substances
Are There Any Openings in
System?
Delivery
Licensed Personnel?
Volunteers or Transport Staff?
Onsite
Offsite
Any process for security and control?
Reconciliation
Storage
Refrigerate or not?
Monitoring of Temps.
Vaccines, Vaccines, Vaccines
Sound Alike - Look Alike (SALA)
Functional Separation
Floor Stock
Crash Carts & Emergency Boxes
Security
Medication Rooms
Automated Dispensing Cabinets
(ADC’s)
Lockable Cabinets
Lockable Refrigerators
Controlled Substances
Access
Who has access to our Meds?
Seemingly Everyone
Who controls who has Access to:
Medication Rooms?
ADC’s?
Controlled Substance Room?
Control
Who can change things without
you knowing?
Hospital Formulary
Automated Dispensing Cabinets
–PAR levels
–Locations
Answer to Question:
Who Can Change Things?
Seemingly Everyone
Seemingly Constantly
Seemingly Forever
Monitoring
Who is watching?
Is anything Missing?
Has Anything Changed?
Controlled Substance Ordering
Patterns
Record Retention
Recalls
Trailer Theft
Invoices (3 years on site?)
Controlled Substances
Invoices
222 Forms
CSOS
Who is Responsible For Helping
Control Things?
Director of Pharmacy?
Operations Manager?
Technician Supervisor?
Nursing Staff?
O.R. and E.D. Staff?
Everyone
Sound Familiar?
“I don’t know how the vaccines
are stored, ask the Buyer.”
“I don’t know what temperature
the refrigerators are supposed to
be kept, ask the Buyer.”
“I don’t know who has access to
the Automated Dispensing
Cabinets, ask the Buyer.”
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
P&T Committee Membership?
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
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?
New Medications for
2011 and 2012
Some have Financial Impact
Some have Clinical Impact
Some will just have Psychological
Impact on Us and Make Our Lives
Difficult
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 INR’s drawn
Reports of Bleeding
Effient
(prasugrel)
Oral Antiplatelet Medication for
patients following angioplasty
No proven reversal agent
Cardiac Surgeons are largely
opposed and/or skeptical
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
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
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
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.
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
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
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)
Avastin
(bevacizumab)
Not new
Very Expensive and Very Popular
Controversial indication for Breast
Cancer
Keep watching – Changes are
Coming
Expiring Patents in 2011
Lipitor
Zyprexa
Levaquin
Concerta
Protonix
Total sales of $10 Billion in 2010
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?
GS1 Initiative
GS1 or Serial NDC Number
Project
Guidance for Securing the Drug
Supply Chain – Standardized
Numerical Identification for
Prescription Drug Packages
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
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
Thank you for having me again.
Best wishes to the NPPA and all
of the Pharmacy Purchasing
Professionals
Questions?