Title from previous

1
Title from previous
2
Learning Objectives

• Understand the formulary background, concept,
  structure, and ways formularies can facilitate
  better prescribing decision-making.  
• Understand the concept of drugs of choice
• Critically discuss specific examples of local
  formulary decisions, and launch student projects
  for in-depth study of a formulary drug
  application case study.
• Analyze controversies and issues surrounding
  formulary implementation and current practices

3
Outline - Hour 1

• Exercise Formulary culture survey
• Background history of formularies
• How formularies work
• Examples from Cook County
• Selective COX2 2. Specific criteria
  ??
• Global perspectives/examples
• CDC Drugs of Choice 2. WHO Essential Drugs

BREAK
4
Outline Hour 2

• FLIP and formularies FLIP tools
• Audience Response Lab
• Culture survey discussion
• Project development
• Assessment

5
An International Battleground
6
(No Transcript)
7
(No Transcript)
8
Baghdad
Basra
9
Baghdad
Basra
10
Ancient Formulary Sumerian Cuneiform Tablet from
Nippur 3000 BC
11
Early U.S. Formularies

• Lititz Pharmacopoeia published in 1778 for use by
  the Continental forces
• Costes Compendium Pharmaceuticum of 1780 used by
  French forces during the American Revolution
• United States Pharmacopeia Convention meets in
  Old Senate Chamber Jan 1, 1820
• Selects drugs for the Pharmacopeia of the United
  States
• Oldest non-profit organization in the U.S.

12
(No Transcript)
13
Balu PT 11/04
14

• Drug Formulary
• A continually updated list of medications and
  related information, representing the clinical
  judgment of physicians, pharmacists and other
  experts in the diagnosis and/or treatment of
  disease and promotion of health.
• Drug Formulary System
• Ongoing process
• Collaboration of physicians, pharmacists, and
  other health care professionals
• Establishes policies on the use of drug products
  and therapies most medically appropriate and
  cost-effective to best serve the health interests
  of a given patient population.
• http//www.amcp.org/amcp.ark?cstuscglossary

15
Types of Formularies in U.S.
Outpatient
Public Sector Medicaid National VA (
regional/local) Privatized-Public
Sector Medicare Part D (2801 private plans)
Private Sector PBMs Other HMO/Insurer Retail
pharmacy chains
Inpatient
Hospital Formularies Nursing Homes
16
UIC vs. County
UIC 2006 County
690 Number of drugs 1000
Inpatient only Type of formulary Inpatient outpatient
22 Drugs reviewed 59
12 Drugs approved 25
7 Drugs rejected 0
2 Drugs removed due to review 15
Generally Stocked Non-formulary process Restrictive (non-stock)
17
Pharmacy and Therapeutics Committee
18
Pharmacy and Therapeutics Committee
Formulary Management
Drug Usage Monitoring
Drug Use Policy-making
Drug Use
Drug Use
Drug Use
Drug Use
Drug Use
Drug Use
Drug Use
19
Pharmacy and Therapeutics Committee
Formulary Management
Drug Usage Monitoring
Drug Use Policy-making

• Additions
• Deletions
• Restrictions
• Ensure Availability
• Periodic Reviews
• Publish Formulary
• Communicate

• Restrictions
• Guidelines
• Therapeutic Interchange
• Lab Monitoring
• Education
• Alerts
• Drug rep policies

• Adverse Reactions
• Med Error Safety
• Overall Utilization
• Non-formulary Usage
• Criteria-Based Monitoring

20
New Drug Requests by M.D.s
Formulary Process
Fill Out Application
Formal Pharmacists Review
Discuss at DF Meeting
Approved /- Restrictions
Approval by Exec Med Staff
Not Approved
Formulary Inclusion
21
Cook County COX2 Approval Mechanism (via Pharm
HELP Desk)

• GI Assessment Tool Scoring
• Age (1-18)
• Health Status (0-4)
• RA (2)
• Prednisone (5)
• Ever GI Bleeding (8)
• GI Side effects (2)
• Score
• gt 20 Automatic OK 16-20 Trial Salcylate

22
Trends in the Use of NSAIDs and Spending for
Coxibs by Medicaid from 1999 through 2003
Fischer M et al. N Engl J Med 20043512187-2194
23
(No Transcript)
24
COX2NSAIDs s Cook County vs. Medicaid
2001 N431/17,259
25
Percentage of Defined Daily Doses of NSAIDs
Accounted for by Coxibs in the Fourth Quarter of
2003, According to Whether a Prior-Authorization
Program Had Been Implemented
Fischer M et al. N Engl J Med 20043512187-2194
26
(No Transcript)
27
from Cook County Formulary New Drug Application
Form
28
(No Transcript)
29
New Drug D F Application 4 Roles of Specific
Criteria

• Organize evidence-based DF review of value,
  indications, role for new drug
• Educate, once drug approved
• Guide real-time utilization of drug, ideally
  computer delivered at time of order
• Retrospective review of appropriateness

30
(No Transcript)
31
Leading Challenges to CCH/UIC Formulary
Committees

• MDs circumventing formulary and formulary
  application process for new drugs by using
  non-formulary ordering route
• Inadequacies of the studies on which to base
  decisions
• Lack of dedicated time of members to fully and
  critically digest literature and deliberate at
  the meetings
• Wrestling with extremely costly (10k/yr) new
  agents that appear to be effective, but pose
  major stain on institutions drug budget
  resources
• Pharmaceutical industry influences and practices
  (including lobbying members, pricing schemes)

32
CDC Drugs of Choice

• Methodology
• This report was produced through a
  multistage process. Beginning in 2004, CDC
  personnel and professionals knowledgeable in the
  field of STDs systematically reviewed evidence,
  including published abstracts and peer-reviewed
  journal articles concerning each of the major
  STDs, focusing on information that had become
  available since publication of the Sexually
  Transmitted Diseases Treatment Guidelines, 2002
  (1). Background papers were written and tables of
  evidence were constructed summarizing the type of
  study (e.g., randomized controlled trial or case
  series), study population and setting, treatments
  or other interventions, outcome measures
  assessed, reported findings, and weaknesses and
  biases in study design and analysis. A draft
  document was developed on the basis of the
  reviews.

33
WHO Essential Drugs List

• In 1977, WHO published the first Model List of
  Essential Medicines containing 208 individual
  drugs which together could provide safe,
  effective treatment for the majority of
  communicable and non-communicable diseases

34
(No Transcript)
35
(No Transcript)
36
Hogerzeil BMJ 2004
37
(No Transcript)
38
(No Transcript)
39
(No Transcript)
40
Bangladesh Essential Drugs Program-1982

• With these models, and inspired by WHOs HFA
  program, in 1982 Bangladesh implemented its
  National Drug Policy (NDP). An expert committee
  assembled a list of recommendations based on
  WHOs EDC, and the NDP aimed to ensure that
  procurement, local production, quality control,
  distribution, and use of pharmaceuticals came
  under the control of a single government body.
  This was to be a major part of national health
  policy.

41

• No sooner had a form of the NDP been implemented
  than foreign-owned drug companies mobilized a
  campaign of misinformation, threats, and
  intimidation. For example, on June 1, 1982, the
  Bangladesh Times publicized the NDP. That same
  morning, the U.S. ambassador made an unscheduled
  call on the government to deliver the message
  that the policy was not acceptable to the U.S.
  government. Although the U.S. government had no
  overt interest in the NDP, drug companies, which
  had made considerable donations to the election
  campaigns of members of the U.S. government,
  assuredly did. They mobilized the influence their
  money had purchased against the NDP, which is why
  a superpower became involved in the internal
  health affairs of a small country on the other
  side of the globe

42
Break?Downstairs

• Audience Response (30 minutes)
• Formulary Myths
• ISMP Data (Myths are still true)
• Projects Tools and drugs

43
Leveraging Formularies for Improved Prescribing

1. Venue for critical review of new drug claims
2. Evaluation of comparative efficacy
3. Less bias and conflict in decision-making
4. Cumulative expertise in reviewing new drugs
5. Experience with pitfalls and biases
6. Identify and weigh potentials for overuse/misuse
7. Weighing of cost benefit  (for individual
   drug/indication)
8. Weigh institutional resource allocation (this
   drug vs. alternatives)
9. Raise/highlight safety concerns
10. Dissemination vehicles and tools (guidance and
    warnings)

1. More rational prescribing
2. Enhanced appropriateness and safety
3. Cost Effectiveness

44
Formulary Leveraged Curriculum Development
Dissemination Model
Drug Info Specialists
12 ModulesPrinciples
Advanced Seminar
Critical Knowledge
Recommendations Drugs of Choice Why
Enhanced Input
Restrictions/Guidelines for Appropriate Use
Marketing Claims
Formulary Decisionmaking
Distillation of Drug Specific Generic Issues
Enhanced Output
OtherLeaders
Specialists
? Credibility
Buy-in
AttgMDs
Residents
Pharmacists
Own Drug
Delivery
Use Criteria
45
Formulary Leveraged Curriculum Development
Dissemination Model
Drug Info Specialists
14 ModulesPrinciples
Advanced Seminar
Critical Knowledge
Recommendations Drugs of Choice Why
Enhanced Input
Restrictions/Guidelines for Appropriate Use
Formulary Decisionmaking
Marketing Claims
Distillation of Drug Specific Generic Issues
Enhanced Output
OtherLeaders
Specialists
? Credibility
Buy-in
AttgMDs
Residents
Pharmcsts
Own Drug
Delivery
Use Criteria
46
Formulary Myths

1. Causal empiricism
2. FDA approval implies everyday use for all
3. Interferes with clinical freedom
4. Every patient is unique
5. Specialist knows best
6. Education requires experience with multiple drugs

1. Widespread use drug of choice
2. Newer is better/safer
3. Sicker patients need more drugs
4. Formulary sacrifices patient care to cost
5. Redundant with drug utilization review

Schiff, Rucker Med Care 1991
47
ISMP 2004 Survey Results Formulary Myths Still
True !!

• 70 reported causal empiricism comments impacting
  formulary decisions
• 73 reported specialist knows best comments
  impacting formulary decisions
• 49 reported never hearing FDA use implies
  everyday use for all comments in formulary
  deliberations

http//www.ismp.org/Survey/surveyresults/Survey200
411R.asp
48
(No Transcript)
49
MediMedia owns PT
50
MediMedia owns Triple I
http//www.tripleimedimedia.com/about_us/
51
Advanstar owns Formulary
They are a leading provider of integrated
marketing solutions and they are the leading
communications company serving the pharmaceutical
industry
They also own
52
How Ive FLIPPED Bill G

• Try to treat any complaint or disease
  non-pharmacologically unless truly. Necessary as
  drugs are poisons and our role is to first do no
  harm.
• New drugs are inherently more risky and likely
  dangerous than old drugs And should be used
  sparingly only when truly necessary.
• One paper does not always tell the whole story,
  a  thorough review of the Literature is
  important if you plan on changing your treatment
  or begin to use a medication.

53
How Ive FLIPPED Gordy S

• Realization that no conflict-of-interest voting
  policy, even on my own Committee
• Different conceptualizations and processes on
  different formulary committees related to PT
  vs. formulary functions
• -Medicaid- completely separate
• Outpatient dominates CCH, inpatient rules at UIC
  w/ resulting entirely different framework for
  discussion

54

• Selected Quotes from Formulary Focus Groups
• What do Clinicians think of their Formulary and
  the Formulary Process?

55
Selected quotes UIC

• What works on our committee is that we make
  decisions based on literature.
• I am generally satisfied with the Drug
  Information Center. Other institutions dont
  have as much detail. The DIC does the best they
  can with the information that is available. For
  new drugs there isnt really that much to work
  with anyway.
• Non-formulary drug requests and discouraging
  people to avoid non-formulary are continuously a
  problem. People dont understand why they
  shouldnt use non-formulary. Improvement is
  needed to understand what the formulary is there
  for.
• The committees been almost the same in format
  for 22 years. Its tried and true and very
  standard. It has a survival or Darwinian
  quality.

56
Selected quotes Cook County

• One strength of the committee is participation
  of clinical pharmacists to give support and do
  good drug evaluations.
• Many departments are represented and this is
  educational.
• The studies available for drugs/new drugs are of
  poor quality. For example, drugs for senile
  dementia or diabetic neuropathy.
• Although the committee communicates what is
  happening in hospital, there are still problems
  with dissemination. Dissemination is not always
  successful.
• Making people jump through hoops is bad for
  patients because people should have their
  medicine.

57
Selected quotes Cook County

• We often say we will audit drugs put on the
  formulary but this does not happen. Doctors feel
  more comfortable with this kind of evaluation.
  We put a lot of drugs on which are expensive with
  marginal benefit. Data does not come back to the
  committee about usage or patient outcome.
• We are trying to treat everything possible when
  we cannot afford to. We make some decisions
  about what to treat and what not to treat, for
  example we stopped doing bone marrow transplants
  but we do give anti-rheumatologics
• If you have patient experience you typically give
  evidence that is more anecdotal, but it does not
  go unchallenged. Sometimes the committee invites
  specialists to talk to the group but they are
  less open now. Some only show up when there is a
  controversial drug.
• It is not the formulary committees role to be a
  pharmacy budget organization but we still have to
  make these kinds of decisions. This causes
  schizophrenic decisions. A lot is lacking in
  decision-making.
• County has an excellent cardiovascular formulary
  which has saved millions of dollars. Not running
  for expensive cures. This restrictiveness is one
  reason we miss some of the major adverse drug
  reactions. By the time treatments become
  cost-effective the ADRs are discovered.