OBJECTIVES

1
OBJECTIVES

• At the conclusion of the lecture, the student
  should be able to
• Appraise the need for techniques and instruments
  to create and implement health policy
• Discriminate between the forms of QA, Drug
  utilization and formularies
• Examine the importance and reasons for
  accreditation and identify types of indicators
• Apply concepts of evidence and systematic review
  to clinical guidelines
• Discern the role of the pharmacist in these
  activities

2
HEALTH POLICY

• ROLE OF THE PHARMACIST
• EVOLUTION OF DRUG INFORMATION
• POPULATION-BASED MEDICINE
• MOST HEALTH PROFESSIONALS ARE TRAINED TO TREAT
  THE INDIVIDUAL
• FINITE RESOURCES
• HOW TO BEST CARE FOR THE POPULATION WHILE
  PROVIDING FOR THE 20 WHO USE 80 OF THE
  RESOURCES
• POLICIES ARE DEVELOPED BASED ON THE NEEDS OF THE
  POPULATION

3
HEALTH POLICY

• At its most basic level, high-quality health care
  is doing the right thing, at the right time, in
  the right way, for the right person.
• The challenge that clinicians and health system
  managers face every day is knowing what the right
  thing is, when the right time is, and what the
  right way is.
• Patients and their families are also confronted
  with making choices about treatments and care
  settings with little information on the relative
  quality, risks, and benefits of the options
  available to them.
• AHRQ's WEB SITE

4
IOM REPORTS

• Crossing the Quality Chasm 2001
• To Err is Human 1999
• Unequal Treatment Confronting Racial and
  Ethnic Disparities in Health Care
  2002
• Health Professions Education A bridge to Quality
  2003
• Quality through Collaboration The future of
  Rural Health 2004
• Building a Better Delivery System A New
  Engineering/Health Care Partnership2005
• http//www.iom.edu/topic.asp?
  id3718

5
HELP!!!

• Institute of Medicine (IOM) says
• U.S. Healthcare system is broken
• Reorganization requires
• Access to care
• Cost control
• Quality

6
HEALTH CARE IN THE U.S.

• Health care harms patients too frequently and
  routinely fails to deliver its potential
  benefits.
• Indeed, between the health care that we now have
  and the health care we could have lies not just a
  gap, but a chasm
• IOM, March 2001

7
QUALITY ASSURANCE

• Process used to ensure that something is done (or
  made) well enough
• conforms to appropriate requirements
• Main reason is to improve patient care
• Basic pharmacy QA
• triple checking labels
• good manufacturing processes

8
QUALITY ASSURANCE

• Also called performance improvement
• QA is one aspect of risk management
• Defined as
• deciding what is to be done
• doing it
• measuring how well it was done
• if found unacceptable, undertaking some
  correctional activity to ensure that future
  services will be acceptable

9
QUALITY ASSURANCE

• CONTINUOUS QUALITY IMPROVEMENT (CQI)
• meant to be a pervasive and continuous process to
  improve all care
• CQI PROVIDES THE FOLLOWING
• quality improves
• costs decrease because of fewer mistakes and
  better use of resources
• productivity improves
• organization captures more of the market with
  better quality and lower price
• organization stays in business
• more jobs are provided

10
QUALITY ASSURANCE

• TOTAL QUALITY MANAGEMENT (TQM)
• related to CQI
• managers incorporate quality assurance and
  improvement into all aspects of the organization

11
QUALITY ASSURANCE

• THE PROCESS INVOLVES
• Identification of the most important aspects of
  care
• Use of measurable indicators to systematically
  monitor these aspects in an ongoing way
• Evaluation of the care when thresholds are
  reached identify opportunities for improvement
  or problems in quality of care
• Taking action to improve care or solve problems
  and evaluation of the actions

12
QUALITY ASSURANCE

• Necessary to the practice of pharmacy
• Performed by nearly all pharmacists to some
  extent
• Drug information specialists
• quality assurance programs for the drug
  information center
• development of drug utilization processes

13
ACCREDITATION

• THE JOINT COMMISSION ON ACCREDITATION OF
  HEALTHCARE ORGANIZATIONS (JCAHO)
• Evaluates and accredits health care organizations
  and programs in the United States.
• An independent, not-for-profit organization
• Most recognized standards-setting and accrediting
  body in health care.
• Improves safety and quality of care
• Supports performance improvement in health care
  organizations.
• Accreditation by the Joint Commission indicates
  that an organization meets certain performance
  standards.

14
ACCREDITATION

• The Joint Commission evaluation and accreditation
  services are provided for the following types of
  organizations
• Hospitals
• Health care networks
• health plans, integrated delivery networks and
  preferred provider organizations.
• Home care organizations
• Nursing homes and other long term care facilities
• Assisted Living residencies
• Behavioral health care organizations
• Ambulatory care providers
• outpatient surgery facilities, rehabilitation
  centers, infusion centers, group practices and
  others.
• Clinical laboratories

15
ACCREDITATION

• The Joint Commissions standards address the
  organizations level of performance in key areas,
  such as patient rights,
• what the organization has as standards and what
  it actually does.
• Standards set forth performance expectations for
  activities that affect the quality of patient
  care
• Doing the right things well a strong likelihood
  of good patient outcomes.
• The Joint Commission develops its standards in
  consultation with health care experts, providers,
  measurement experts, purchasers and consumers.

16
ACCREDITATION

• In February 1997, the Joint Commission launched
  ORYX
• ORYX are health care indicators intended to
  integrate the use of outcomes and other
  performance measures into the accreditation
  process.
• Data is collected and submitted to JACHO
  electronically
• Institutions will need integrated information
  systems
• Exceptions for small hospitals (lt10 census)
• Metrics are the actual numbers

17
ORYX

• Core measures (January 2005)
• Acute myocardial infarction (AMI)
• Heart failure (HF)
• Pneumonia (PN)
• Pregnancy and related conditions (PR)
• Surgical infection prevention (SIP)
• Each accredited organization will be required to
  address 3 of 5 core measure sets
• Implementation to begin with January 2005
  discharges
• The Specifications Manual for National
  Implementation of Hospital Core Measures, Version
  2.0 4/26/04 http//www.jcaho.org/pms/coremeasures
  /informationonfinalspecifications.htm

18
ACCREDITATION

• The Joint Commission provides a comprehensive
  guide on the Internet named Quality Check.
• List of nearly15,000 Joint Commission-accredited
  health care organizations and programs throughout
  the United States
• accreditation decision, accreditation date, and
  current accreditation status and effective date.
• For more in-depth quality information, consumers
  can check the individual performance reports
  available for many accredited organizations.
• Performance reports provide detailed information
  about an organizations performance and how it
  compares to similar organizations.

19
ACCREDITATION

• Health care organizations seek Joint Commission
  accreditation because
• it assists organizations in improving their
  quality of care
• may be used to meet certain Medicare
  certification requirements
• enhances community confidence
• provides a staff education tool
• enhances medical staff recruitment
• expedites third-party payment
• often fulfills state licensure requirements
• may favorably influence liability insurance
  premiums
• enhances access to managed care contracts and
• may favorably influence bond ratings and access
  to financial markets

20
ACCREDITATION

• Managed care organizations choose to seek
  accreditation for three main reasons
• To demonstrate to their customers and purchasers
  who rely on their services that they have been
  impartially reviewed and found to meet nationally
  recognized standards and best practices.
• To improve quality by identifying areas for
  enhancement through the accreditation process and
  implementing recommended changes.
• To comply with various laws and regulations
  regarding state oversight of managed care.

21
ACCREDITATION

• The National Committee for Quality Assurance
  (NCQA)
• An independent, non-profit organization whose
  mission is to evaluate and report on the quality
  of the nations managed care organizations.  

22
ACCREDITATION

• NCQA evaluates health plans in 3 different ways
• Accreditation
• a rigorous review of key clinical and
  administrative systems and of a plan's
  performance on several important aspects of care
  and service
• The Health Plan Employer Data and Information Set
  (HEDIS -- a set of standardized performance
  measures), INDICATORS
• Protocols on various aspects of care and service
  such as immunization rates, member satisfaction,
  and mammography rates.
• The Consumer Assessment of Health Plans Study
  (CAHPS, a comprehensive survey of member
  satisfaction).  

23
ACCREDITATION

• URAC (also known as the American Accreditation
  HealthCare Commission)
• Also has standards for the managed care industry
  and accreditation programs for managed care
  organizations.
• Because of URACs broad-based standards and
  rigorous accreditation process, purchasers and
  consumers look to URACs accreditation as an
  indication that a managed care organization has
  the necessary structures and processes to promote
  high quality care and preserve patient rights.
• In addition, regulators in over half of the
  states recognize the URACs accreditation
  standards in the regulatory process.
•  

24
INDICATORS

• MEASURING TOOL
• must be measurable
• threshold must be assigned
• CLEAR
• CONCISE
• OBJECTIVE and EXPLICIT
• BP at less than 140/90
• no signs of redness at wound
• CORRECT
• FOCUS ON THE AREAS THAT ARE A PROBLEM
• e.g.timely blood sampling
• rather than all aspects

25
INDICATORS

• CAN BE DEVELOPED INTERNALLY
• CAN BE OBTAINED FROM
• pharmacy organizations
• primary literature
• commercial services
• can use as is or can modify

26
ACTION

• ESTABLISH THRESHOLD FOR INDICATOR
• if not met, action is required

27
ACTION STEPS

• Conduct educational programs for target groups
• Change policies and procedures
• Correct communication
• Provide more information
• Change indicators and/or thresholds
• Restrict or revoke physician privileges
• Change the drugs available on formulary
• any one or more of the above may be done

28
DRUG UTILIZATION

• Drug utilization processes are methods to ensure
  that drugs are used appropriately, safely, and
  effectively.
• DRR Drug Regimen Review
• monthly review of patients drugs
• DUR Drug Utilization Review
• uses pharmacy claims data
• DUE Drug Usage Evaluation
• uses patient chart data
• MUE Medication Usage Evaluation
• DUE that incorporates continuous quality
  improvement concepts
• allows benchmarking

29
DRUG UTILIZATION

• Priorities
• High utilization drugs
• Narrow therapeutic index drugs
• problem prone drugs
• Critical drugs
• must be used in a particular manner
• High cost drugs

30
DRUG UTILIZATION

• Prioritize drugs or categories
• Develop/modify indicators
• Outcome indicators
• determine whether endpoints are met
• desired type
• Process indicators
• evaluate how things are done

31
DUR

• OBRA 90
• Omnibus Budget Reconciliation Act of 1990
• required Medicaid (and will cover Medicare
  prescription plans) to have DUR programs
• Retrospective board evaluates patient data
  after the fact
• board must have plan to correct any deficiencies
  in prescribing habits
• Prospective -- counseling
• point of sale request for reimbursement for the
  prescription is approved or denied at the time of
  filling

32
DUE

• Usually a discrete, special activity
• a drug or category is selected and the process is
  done for a period of time
• Can cover any aspect of any drug
• dose, route, timing of blood samples, following
  of policy, disease state
• usually an adverse drug reaction DUE exists all
  the time
• Plan exists so that some DUEs are conducted at
  all times
• different drug classes
• programs at different stages
• plan must be in place several months in advance
  so that indicators can be developed

33
MUE

• Continuous quality improvement program
• Focuses on
• prescription of appropriate medications
• preparation and dispensing of medications
• administration of medications
• monitoring of effects of medications
• system management control
• Medication error programs
• Time consuming
• computers will assist

34
ADVERSE DRUG EVENTS

• Special DUE/MUE
• Nearly every institution at all times
• Adverse drug reactions
• any noxious or unintended response to a drug that
  occurs at usual doses used in therapy
• Medication errors
• any variation from the prescription
• Interested in harm from these
• Programs are focused on prevention

35
CLINICAL PRACTICE GUIDELINES

• Clinical practice guidelines are systematically
  developed statements to assist in decisions about
  health care
• Midway between a standard (very inflexible) and
  an option (extremely flexible)

36
CLINICAL PRACTICE GUIDELINES

• Evidence-based Clinical Practice Guidelines
• also called practice parameters or therapeutic
  guidelines

37
LEVELS OF EVIDENCE

• GOOD EVIDENCE
• Levels I-III
• I. Large, well-conducted RCTs
• II. Small, well-conducted RCTs
• III. Well-conducted cohort trials
• randomized, controlled trials

38
RULES OF EVIDENCE

• FAIR EVIDENCE
• Levels IV-VI
• IV. Well-conducted case-control trials
• V. Uncontrolled or poorly controlled trials
• VI. Conflicting evidence, but favors one side

39
RULES OF EVIDENCE

• EXPERT OPINION
• Level VII

40
CLINICAL PRACTICE GUIDELINES

• Outline how to prevent, diagnose and treat a
  specific disease (or use a procedure)
• Use flowcharts
• an algorithm is a more sophisticated flowchart
• a clinical pathway uses multiple guidelines
• often uses an algorithm
• Use evidence-based approach and the rules of
  evidence

41
(No Transcript)
42
GUIDELINE DEVELOPMENT

• Valid methods of development require
• Evidence-based approach
• Formal quantitative approach to risk and benefit
• Incorporation of patient preference

43
GUIDELINE DEVELOPMENT

• Similar to traditional drug information work
• Characteristics in common with
• Drug monographs
• Medication Use Evaluation
• Quality improvement
• Use these to develop guidelines or use guidelines
  to do these activities

44
SKILLS NEEDED

• Literature search and evaluation
• Epidemiology
• Biostatistics
• Clinical expertise
• Writing
• Editing
• Formatting
• Education

45
ROLE OF GUIDELINES

• Provide a benchmark against which professional
  behavior can be assessed
• Assist in developing or defending medically
  necessary services in managed care plans
• Eliminate juries establishing the standard of
  care
•  

46
LIMITATIONS

• They can be too rigid
• restricting the ability of the professional to
  try something new
• or to tailor treatment to the specifics of an
  individual patients care.
• They can be out-of-date if not frequently revised
  in light of new information.
• They may be used for political reasons (block
  competition)
• They may be misused in the law.

47
LIMITATIONS

• Outcome-based practice guidelines may be the gold
  standard, but most are consensus-type
• based on opinions and anecdotal experience of
  experts in the field (members of prestigious
  societies or faculty members at major medical
  schools).

48
GOAL OF GUIDELINES

• GETTING EVIDENCE INTO PRACTICE
• Growing evidence of a significant time lag from
  publication to implementation in practice
• Therapies proven effective and underutilized
• Therapies proven ineffective or harmful and still
  used

49
GOAL OF GUIDELINES

• Survey by Kanter Family Foundation
• October 2001
• 300 internal medicine and family practice
  physicians
• Given typical patient problems and asked what
  they would do
• E.g. 19 would use aspirin at the onset of stroke
• Current best-evidence treatment
• Doctors said did not have access to information
  so did not know about best therapies
• Guidelines are cookbook medicine

50
HAVE WE IMPROVED?

• The quality gap is the difference between health
  care processes or outcomes observed in practice,
  and those potentially obtainable on the basis of
  current professional knowledge.
• There is a profound quality gap in the management
  of hypertension.
• In the U.S. in 1999-2000
• 69 of people with hypertension were aware of
  their condition
• 58 were receiving treatment
• 31 had well-controlled blood pressure.
• Studies that focused on improving provider
  adherence with recommendations for the management
  of hypertension had little effect (1.3 reduction
  to 3.3 improvement in adherence across the QI
  strategies).
• Shojania KG, McDonald KM, Wachter RM, Owens DK,
  eds. Closing the Quality Gap A Critical Analysis
  of Quality Improvement Strategies. Technical
  Review 9 (prepared by the Stanford
  University-UCSF Evidence-Based Practice Center,
  under contract 290-02-0017). Rockville, Md
  Agency for Healthcare Research and Quality
  (AHRQ) 2005. AHRQ publication 04-0051-3.

51
AVAILABILITY

• Primary literature
• Organizations
• Government
• Must be adapted to the practice site for
  effectiveness
• Can make own,
• But time consuming, costly and question of
  validity

52
AHRQ

• Agency for Healthcare Research and Quality
• www.ahrq.gov
• Formerly the Agency for Health Care Policy and
  Research AHCPR
• AHRQ sponsors and conducts research that provides
  evidence-based information on health care
  outcomes quality and cost, use, and access.

53
NGC

• The National Guideline Clearinghouse
•  
• http//www.guideline.gov

54
NGC

• The NGC is produced by the Agency for Healthcare
  Research and Quality (AHRQ) in partnership with
  the American Medical Association (AMA) and the
  American Association of Health Plans (AAHP)
  Foundation.

55
NGC

• The NGC is a Web-based resource for information
  on evidence-based clinical practice guidelines
• Key components of the NGC
• Structured, standardized abstracts of each
  guideline
• Can compare two or more guidelines side-by-side
• highlighting areas of similarity and difference.
• Links to full-text guidelines or ordering
  information
• Bibliographies on guideline development
• Updated weekly with new content  

56
OTHER SOURCES

• Cochrane Library
• British
• Subscription service
• Best Evidence
• Set of abstracts and commentaries from
• American College of Physicians Journal Club
• Evidence-Based Medicine (a journal)
• ASHP Commission on Therapeutics
• APhA Drug Treatment Protocols

57
PROGRAMS USING GUIDELINES

• DUR/DUE/MUE
• Disease management programs
• Targeted education
•  

58
PT COMMITTEE

• Pharmacy and Therapeutics Committee
• may be under other names
• Purpose is policy development and education on
  matters related to drugs and drug use within the
  organizations scope.
• Oversees all aspects of drug therapy
• Affects drug therapy for a large number of
  patients (all of those receiving medications from
  the institution)

59
P T COMMITTEE

• MEMBERS
• physicians, pharmacists, nurses, administrators,
  quality-assurance coordinators and others as
  appropriate.
• The chairman is appointed from the physician
  representatives and a pharmacist should serve as
  secretary.
• Medical entity
• May be one of the subcommittees of the Medical
  Executive Committee that oversees all aspects of
  clinical care
• Want physician members who are committed to
  rational drug therapy
• Chair should be advocate for pharmacy

60
P T COMMITTEE DUTIES

• Determine
• What drugs are available
• Who can prescribe which drugs
• Policies and procedures for drug use
• Quality assurance activities
• DUR/DUE/MUE
• Evaluate adverse drug events
• Adverse drug reactions --responsible for
  reporting
• Medication errors will become responsible for
  reporting
• Provide education in drug use

61
POLICIES AND PROCEDURES

• For the operation of the PT committee
• For the use of risky medications in the
  institution
• Risky
• If prepared wrong
• If administered wrong
• If used for inappropriate indication
• Time consuming to create
• Monitor for continuation

62
POLICIES AND PROCEDURES

• Policy
• Broad, general statement that describes the
  purpose and goals
• Procedures
• Specific actions to be taken
• Step-by-step explanation of why and where a drug
  may be used and how to use it
• Includes a statement about why the process is
  necessary

63
PHARMACISTS ROLE

• Planning agendas
• Gathering data
• Evaluating medications
• Addition or deletion
• Producing drug evaluation monograph
• Preparing and conducting quality assurance
  programs
• Preparing policies and procedures
• Communicating information from the PT committee
  to others
• Newsletters and web pages

64
FORMULARY SYSTEM

• A formulary system is a method where the
  institutions medical staff, working through the
  pharmacy and therapeutics (PT) committee
• evaluates, appraises, and selects from among the
  numerous drug products those that are considered
  most useful in patient care.
• Only those so selected are routinely available
  from the pharmacy.
• An important tool for assuring the quality of
  drug use and controlling its cost. Reflects the
  current judgment of the medical staff and
  includes the philosophy of drug use in the
  institution.

65
DRUG FORMULARY

• Central to the formulary system is the drug
  formulary,
• a continually updated list of medications and
  related information
• representing the clinical judgment of physicians,
  pharmacists, and other experts
• in the diagnosis, treatment of disease and
  promotion of health.

66
DRUG FORMULARY

• Open formulary all drugs
• Closed formulary certain drugs as designated by
  the PT committee
• Positive formulary only specific drugs are
  available
• Prior Authorization
• Negative formulary all drugs except those
  listed can be prescribed 

67
FORMULARY

• Needs to be readily available
• hard copy
• electronic copy
• List can be searched by both generic and brand
  name
• some also by therapeutic category
• Contains any limitations
• May contain a condensed monograph
• Contains the policy for obtaining non-formulary
  drugs

68
DRUG EVALUATION MONOGRAPHS

• The information used to make a decision to add a
  drug to formulary and to educate the prescribers
  if it is added.
• SUMMARY PAGE
• Similar to an abstract
• Contains the recommendation
• BODY
• Generic and brand names
• Category (AHFS, DEA, FDA)
• Indications, side effects
• Pharmacokinetics
• Special use directions
• REFERENCES

69
FORMULARY RECOMMENDATIONS

• Added for uncontrolled use by entire medical
  staff
• Added for monitored use
• No restrictions, but will be monitored for
  appropriate use
• Added with restrictions
• Specific specialties
• Specific indications
• Specific policies
• Conditional
• Available for a finite period of time
• Not added or deleted

70
FORMULARY RECOMMENDATIONS

• Clinical decisions are based on the strength of
  scientific evidence and standards of practice
  that include, but are not limited to
• Assessing peer-reviewed medical literature,
• including randomized clinical trials,
  pharmacoeconomic studies and outcomes research
  data.
• Employing published practice guidelines developed
  by an acceptable evidence-based process.
• Comparing the efficacy as well as the type and
  frequency of side effects and potential drug
  interactions among alternative drug products
• Assessing the likely impact of a drug product on
  patient compliance when compared to alternative
  products

71
FORMULARY RECOMMENDATIONS

• Economic considerations include, but are not
  limited to, the following
• Basing decisions on cost factors only after the
  safety, efficacy and therapeutic need have been
  established.
• Evaluating drug products and therapies in terms
  of their impact on total health care costs
• Permitting financial incentives only when they
  promote cost management as part of the delivery
  of quality medical care.
• Financial incentives or pressures on
  practitioners that may interfere with the
  delivery of medically necessary care are
  unacceptable.

72
HOW IS ALL OF THIS USED?

• Numerous interests use the results of these
  processes

73
CLINICAL DECISION MAKERS

• Clinicians and patients
• Use tools and information to make informed
  choices about what treatments work, for whom,
  when, and at what cost.

74
HEALTH CARE SYSTEM DECISION MAKERS

• Health plan and delivery system administrators
• use the findings and tools to make choices on how
  to improve the health care system's ability to
  provide access to and deliver high-quality,
  high-value care.
• Purchasers (insurers and employers)
• use the products to obtain high-quality health
  care services.

75
PUBLIC POLICY DECISIONMAKERS

• Public policymakers
• use the information to expand their capability to
  monitor and evaluate changes in the health care
  system and to devise policies designed to improve
  its performance.
• Include Federal, State, and local policymakers as
  well as private-sector policy advisory groups
  such as the Institute of Medicine (IOM),
  professional societies, patient advocacy groups,
  and health care associations

76
FUTURE TRENDS

• CHANGE
• Computers for continuous quality assurance
  processes
• Computerized prescription entry by the prescriber
• Who may or may not utilize the alerts
• Selection of product with dose and route will be
  automatic
• Will need to manually input different information

77
ROLE OF INFORMATION TECHNOLOGY

• AHRQ is to advance the use of information
  technology for coordinating patient care and
  conducting quality and outcomes research.
• Promote the use of information systems to develop
  and disseminate performance measures.
• Create effective linkages between health
  information sources to enhance health care
  delivery and coordination of evidence-based
  health care services.
• Promote protection of individually identifiable
  patient information used in health services
  research and health care quality improvement

78
NEW DRUG INFORMATION WORLD

• FACTORS
• Changes in information technology
• Sophisticated drug therapy
• Pharmacy practice philosophy
• Pharmacy education
• Knowledgeable patients
• HUMAN GENOME PROJECT
• HIPAA
• Health Insurance Portability and Accountability
  Act
• Need patient consent to transmit and to USE their
  information
• STEM CELLS and THERAPEUTIC CLONING
• COST OF HEALTH CARE
• MEDICARE PRESCRIPTION BENEFIT?