Henri R. Manasse, Jr., Ph.D., Sc.D. Executive Vice President and Chief Executive Officer American Society of Health-System Pharmacists ~ University of.

Henri R. Manasse, Jr., Ph.D., Sc.D.Executive Vice President and Chief Executive Officer

American Society of Health-System Pharmacists~

University of NottinghamSafer 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.)

EXPERIMENTATION IN DRUG COMPOUNDING -- 130-200 A.D.)

THE FIRST APOTHECARY SHOPS – LATE 8th CENTURY

Prescribing

SEPARATION OF PHARMACY AND MEDICINE

Prescribing

FIRST HOSPITAL (1751) & HOSPITAL PHARMACY(1752) IN COLONIAL

AMERICA

Prescribing

AMERICAN PHARMACY BUILDS ITS FOUNDATIONS – 1820s

A REVOLUTION IN PHARMACEUTICAL EDUCATION -- 1868

THE STANDARDIZATION OF PHARMACEUTICALS -- 1883

BOOM in PHARMACEUTICAL RESEARCH -- LATE 1930s- EARLY

1940s

Prescribing

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

Source: Spear et al. (2001, May). Clinical application of

pharmacogenetics, Trends in Molecular Medicine.

Therapeutic AreaRate 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%

Patient Safety and Effectiveness• Morbidity and Mortality – Specific Drug Classes

High-Alert MedicationsHigh-Alert Medications11

- 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-intermediary- doctrine-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

Source: 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.

• 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

• Prescribing Influence by the Pharmaceutical Industry

Unresolved and Controversial Issues

• National Drug Use Patterns1

Source: 1) National Center for Health Statistics. (2007). Therapeutic Drug Use. http://www.cdc.gov/nchs/fastats/drugs.htm

Unresolved and Controversial Issues

• National Drug Use Patterns1

Source: 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 case-control 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

committeesSource: 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?QUESTIONS?