Transcript Prescribing - University of Nottingham

Henri R. Manasse, Jr., Ph.D., Sc.D.
Executive Vice President and Chief Executive Officer
American Society of Health-System Pharmacists
~
University of Nottingham
Safer Prescribing Across Occupational Boundaries Conference
January 22, 2008
Objectives
•
To examine the cultural and social aspects of prescribing and address
their influence on the professional and social issues within the
pharmacy profession
•
To address the patient safety issues currently impacting the profession
of pharmacy and discuss key morbidity and mortality data associated
with medication errors
•
To integrate the concepts of prescribing and patient safety and further
examine their professional and legal implications within the profession
of pharmacy
•
To identify unresolved and controversial issues associated with
prescribing and patient safety, and address the implications of both on
the future of pharmacy practice
Prescribing
BEFORE THE DAWN OF THE
CENTURY
PHARMACY IN ANCIENT BABYLONIA
– ABOUT 2600 B.C.)
Prescribing
EXPERIMENTATION IN DRUG
COMPOUNDING -- 130-200 A.D.)
THE FIRST APOTHECARY SHOPS –
LATE 8th CENTURY
Prescribing
SEPARATION OF PHARMACY
AND MEDICINE
FIRST HOSPITAL (1751) & HOSPITAL
PHARMACY(1752) IN COLONIAL
AMERICA
Prescribing
AMERICAN PHARMACY BUILDS ITS
FOUNDATIONS – 1820s
A REVOLUTION IN PHARMACEUTICAL
EDUCATION -- 1868
Prescribing
THE STANDARDIZATION OF
PHARMACEUTICALS -- 1883
BOOM in PHARMACEUTICAL
RESEARCH -- LATE 1930s- EARLY
1940s
Prescribing
•
Definitional1
- "Rx" - symbol for recipe
- an exhortation to the pharmacist by the doctor:
"take the following components and compound this
medication for the patient.“
- Modern prescriptions are "extemporaneous prescriptions“ (Latin-ex
tempore for "at/from time“) – written on the spot for a specific patient
with a specific ailment
- “Extemporaneous prescriptions“ terminology now reserved for
"compounded prescriptions" -- requirement of pharmacist to mix or
"compound" the medication in the pharmacy for the specific needs of
the patient
Source: 1) http://www.m-w.com/cgi-bin/dictionary?book=Dictionary&va=extemporaneous
Prescribing
•
Transactional
- Concluding a consultation with the patient
- Bringing value to patient care
- Empowering patient decisions and choices
•
Treatment and Power Gradients
- Knowledge as power
- Profession as power
- Patient as ‘supplicant’
Prescribing
•
Prescribing in Drug Use Process
- Evolved with the separation of the role of the pharmacists from that
of the physician
- Prescriber takes responsibility for the clinical care and outcomes
that may or may not be achieved
- Legislative intentions in state practice acts
- Independent prescribing
- Collaborative practice with protocols (supplementary prescribing)
Prescribing
•
Prescribing in Drug Use Process
- Decision-Modeling in Prescribing
•
Authoritative Scientific and Evidence Based Information
- ‘Western’ Medicines
- TCM/Complementary
•
Medication Adherence1
- 49% of patients forget to take a prescribed medicine
- 31% do not fill their prescribed medicine
- 29% stop taking the medicine before the supply ran out
- 24% take less than the recommended dosage
Source: 1) Take As Directed: A Prescription Not Followed.” Research conducted by The Polling Company.™
National Community Pharmacists Association. December 15, 2006.
Patient Safety and Effectiveness
•
Definitions
PATIENT SAFETY
- NPSF1: “The prevention of healthcare errors, and the elimination or
mitigation of patient injury caused by healthcare errors”
- IOM2:
Three domains:
1) Quality – freedom from accidental injury
2) Provision of services – consistent with current medical
knowledge and best practices
3) Customer-specific values and expectations – permit the
greatest responsiveness to individual values and
maximize personalization of care
Sources: 1) National Patient Safety Foundation (2007). http://www.npsf.org/au/
2) To Err Is Human: Building a Safer Health System. (2000). Institute of Medicine
Patient Safety and Effectiveness
•
Definitions (cont’d)
PATIENT SAFETY
- AHRQ1: Goal is to strengthen quality measurement and improvement
by:
1) Identifying factors that put patients at risk
2) Using computers and other information technology to
reduce and prevent errors
3) Developing innovative approaches that reduce errors and
improve safety in various health care settings and
geographically diverse locations
4) Disseminating research results and improving patient
safety education and training for clinicians and other
providers
Source: 1) Agency for Healthcare Research and Quality. (2007). http://www.ahrq.gov/about/whatis.htm
Patient Safety and Effectiveness
•
Morbidity and Mortality
Therapeutic Area
Rate of EFFICACY with
standard drug treatment
Cancer (all types)
25%
Alzheimer’s disease
30%
Incontinence
40%
Hepatitis C
47%
Osteoporosis
48%
Rheumatoid arthritis
50%
Migraine (prophylaxis)
50%
Migraine (acute)
52%
Diabetes
57%
Asthma
60%
Cardiac arrhythmias
60%
Schizophrenia
60%
Depression
62%
Source: Spear et al. (2001, May).
Clinical application of
pharmacogenetics, Trends
in Molecular Medicine.
Patient Safety and Effectiveness
•
Morbidity and Mortality – Specific Drug Classes
High-Alert Medications1
- Adrenergic agonists
- Epidural or intrathecal medications
- Adrenergic antagonists
- Hypoglcemics, oral
- Anesthetic agents, general, inhaled, IV
- Inotropic medications
- Antiarrhythmics, IV
- Liposomal forms of drugs
- Antithrombotic agents (anticoagulants)
- Moderate sedation agents, IV
- Cardioplegic solutions
- Narcotics/opiates, IV, transdermal, oral
- Chemotherapeutic agents
- Neuromuscular blocking agents
- Dextrose, hypertonic, 20% or greater
- Radiocontrast agents
- Dialysis solutions
- Total parenteral nutrition solutions
Source: 1) Institute for Safe Medication Practices (ISMP). (2007). ISMP’s List of High-Alert Medications,
http://www.ismp.org/Tools/highalertmedications.pdf
Patient Safety and Effectiveness
•
Morbidity and Mortality - Systems Errors1
- Organizations must test and implement changes to existing processes
in order to reduce harm from medications in these four key areas
• Develop a culture of safety
• Reduce harm from high-hazard medications
• Improve medication core processes
• Improve medication reconciliation
Source: 1) Institute of Health Improvement (IHI). (2007). Medication Systems. http://www.ihi.org/IHI/Topics/PatientSafety/MedicationSystems/Changes/
Patient Safety and Effectiveness
•
Challenges in Effectiveness
- Poor evidence base on real world outcomes (end to certainty)
• Little evidence on comparative effectiveness
• Widespread off-label use of medications
• The issue of clinical effectiveness will be a dominant discussion
in America due to potential for cost containment
- Challenges posed by genetics (e.g. Warfarin, Codeine)
Patient Safety and Effectiveness
•
Comparative Effectiveness1
- The Effective Health Care Program (Initiated 2005)
- Aimed to help consumers, health care providers, and others in
making informed choices among treatment alternatives
- Conduct systematic appraisals of existing scientific evidence
regarding treatments for high-priority conditions
- Promote and generate new scientific evidence by identifying gaps
in existing scientific evidence
- Three areas of focus:
- Effectiveness
- Efficacy
- Outcomes
Source: 1) Agency for Healthcare Research and Quality (2007). www.effectivehealthcare.ahrq.gov/reports/final.cfm
Integration:
Prescribing and Patient Safety
•
The Patient as the Diagnostician
- Three themes:
1) Involving patients and families in the design of care
2) Reliably meet patient’s needs and preferences
3) Provide informed shared decision-making
Legal Contexts
•
Licensure
- States regulate not only who may practice pharmacy and where it
may be practiced, but also how pharmacy is practiced
- Objectives of Licensure:
1) To assure the quality of health care at some minimum level
2) To reduce the cost of health care
3) To inhibit the criminal abuse of drugs
4) To safeguard the drug supply
5) To provide government with a tool for prosecution
6) To remove unworthy practitioners and pharmacies
•
Scope of Practice and Privilege
- Boundaries within the health professions
- Credentialing and privileging in U.S. hospitals
Legal Contexts
•
Learned Intermediary Doctrine
- Originated in a 1966 liability suit brought against the producer of
chloroquine phosphate for failing to warn physicians of its potential to
cause irreversible retinopathy1
- Provides that manufacturers of prescription drugs and medical
devices discharge their duty of care to patients by providing
warnings to the prescribing physicians2
Source:
1) Sterling Drug Inc v Cornish, 370 F.2d 82, 85 (8th Cir 1966)
2) Justin T. Toth, Prescription Drugs and Medical Devices: The Impending Impact of the Restatement (Third) of Torts in Texas,
HOUSTON LAWYER, March/April 1998, at 40, 41
Legal Contexts
•
Learned Intermediary Doctrine
- Implications on Direct-to-Consumer (DTC) advertising1:
- Consumers are now trying to use other areas of state law, i.e.,
consumer protection statutes and fraudulent/negligent
misrepresentation, to support claims against overzealous DTC
campaigns
- Limited authority still remains on DTC advertising liability
Source:
1) Hill, J.C. (2005, October). The learned intermediary doctrine and beyond: exploring direct-to-consumer drug advertising liability in
the new millennium. Defense Counsel Journal, http://goliath.ecnext.com/coms2/gi_0199-5119028/The-learned-intermediarydoctrine-and.html
Legal Contexts
•
Duty to Warn – When is the Patient Informed?1
- An informed decision about treatments is one based on:
- an accurate assessment of the information about the relevant
decision alternatives and their consequences,
- accurate assessment of their likelihood and desirability in
accord with the individual’s priorities,
- a trade off between these factors
Source: 1) Elwyn, G., Edwards, & Britten, N. (2003). Doing prescribing: How might clinicians work differently for better, safer care.
Qual Saf Health Care, 12, i33
Legal Contexts
•
‘Brother’s Keeper’ Doctrine
- Pennsylvania Case: Makripodis v. Merrell-Dow Pharmaceuticals Inc.1
- Parents of a deformed infant brought a products liability action
against the manufacturer of Bendectin, a prescription drug taken
during the early stages of pregnancy to prevent nausea, and the
pharmacy from whom the plaintiffs purchased the drug
- Plaintiffs alleged that the pharmacy "was strictly liable in tort as
Bendectin was a defective product, unreasonably dangerous due
to the absence of proper warnings"
- The trial court granted summary judgment for the pharmacy on the
ground that retail pharmacists have no independent duty to warn
patient-consumers of the risks of prescription drugs they dispense
Source: 1) Louisiana State University Law Center. Medical and Public Health Law Site:
http://biotech.law.lsu.edu/cases/vaccines/mazur_v_merck.htm
Legal Contexts
•
Liability and Accountability
•
The ‘Label’
-
•
Prescription Only
Pharmacist Only (Behind the Counter)
Over the Counter
‘Restricted Drugs’
* Isotretinoin * Biosimilars * Thalidomide
Prescription Labels (Barriers)
- Improvements needed in providing:
- Clarity and comprehensibility
- Redesign and standardization of text and format of existing
primary and auxiliary labels
- Less complex and more explicit dosing instructions
- Genetic revolution
Unresolved and Controversial Issues
•
Pharmacists Becoming the Prescriber
- Evolution of Profession: Apothecary to Clinical
- Three Major Issues
- Competence
- Quality Assurance
- Safety
Unresolved and Controversial Issues
•
Avoiding the Mistakes of Medicine
- Doctors initiate discussions about medication but then
dominate the interaction. Often1:
- Name of prescribed medicine is not used
- Descriptions of how new medicines differ in mechanism
or purpose from those previously prescribed is not
provided, or
- Patient’s understanding of medication and ability to follow
treatment plan is not verified
•
Source:
Prescribing Influence by the Pharmaceutical Industry
1) Cox K, Stevenson F, Britten N, et al. A systematic review of communication between patients and health care professionals
about medicine-taking and prescribing. London: GKT Concordance Unit, King’s College London, 2002.
Unresolved and Controversial Issues
•
Source:
National Drug Use Patterns1
1) National Center for Health Statistics. (2007). Therapeutic Drug Use. http://www.cdc.gov/nchs/fastats/drugs.htm
Unresolved and Controversial Issues
•
Source:
National Drug Use Patterns1
1) National Center for Health Statistics. (2007). Therapeutic Drug Use. http://www.cdc.gov/nchs/fastats/drugs.htm
Unresolved and Controversial Issues
•
Evidence-based Medicine; Quality indicators1
- U.S. Preventive Services Task Force – created a system to rank
evidence on the effectiveness of treatments or screening by quality:
- Level I: Evidence obtained from at least one properly designed
randomized controlled trial
- Level II-1: Evidence obtained from well-designed controlled trials
without randomization
- Level II-2: Evidence obtained from well-designed cohort or casecontrol analytic studies
- Level II-3: Evidence obtained from multiple time series with or
without the intervention.
- Level III: Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert committees
Source:
1) U.S. Preventive Services Task Force (USPSTF). (2007). Agency for Healthcare Research Quality. http://www.ahrq.gov/clinic/uspstfix.htm
Unresolved and Controversial Issues
•
Evidence-based Medicine; Categories of Recommendations1
- Five classifications (A,B,C,D,I)
- Range from Level A: Good scientific evidence suggests that the
benefits of the clinical service substantially outweighs the potential
risks. Clinicians should discuss the service with eligible patients
to
- Level I: Scientific evidence is lacking, of poor quality, or conflicting,
such that the risk versus benefit balance cannot be assessed.
Clinicians should help patients understand the uncertainty
surrounding the clinical service.
Source:
1) U.S. Preventive Services Task Force Ratings: Strength of Recommendations and Quality of Evidence. Guide to Clinical Preventive
Services, Third Edition: Periodic Updates, 2000-2003. Agency for Healthcare Research and Quality, Rockville, MD.
http://www.ahrq.gov/clinic/3rduspstf/ratings.htm
QUESTIONS?