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

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Presentation on theme: "Henri R. Manasse, Jr., Ph.D., Sc.D. Executive Vice President and Chief Executive Officer American Society of Health-System Pharmacists ~ University of."— Presentation transcript:

1 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

2 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






8 Definitional 1 - "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)

9 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

10 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)

11 Prescribing Prescribing in Drug Use Process - Decision-Modeling in Prescribing Authoritative Scientific and Evidence Based Information - Western Medicines - TCM/Complementary Medication Adherence 1 - 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.

12 Patient Safety and Effectiveness Definitions PATIENT SAFETY - NPSF 1 : The prevention of healthcare errors, and the elimination or mitigation of patient injury caused by healthcare errors - IOM 2 : 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). 2) To Err Is Human: Building a Safer Health System. (2000). Institute of Medicine

13 Patient Safety and Effectiveness Definitions (contd) PATIENT SAFETY - AHRQ 1 : 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).

14 Patient Safety and Effectiveness Morbidity and Mortality Source: Spear et al. (2001, May). Clinical application of pharmacogenetics, Trends in Molecular Medicine. Therapeutic Area Rate of EFFICACY with standard drug treatment Cancer (all types)25% Alzheimers disease30% Incontinence40% Hepatitis C47% Osteoporosis48% Rheumatoid arthritis50% Migraine (prophylaxis)50% Migraine (acute)52% Diabetes57% Asthma60% Cardiac arrhythmias60% Schizophrenia60% Depression62%

15 Patient Safety and Effectiveness Morbidity and Mortality – Specific Drug Classes High-Alert Medications 1 - 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). ISMPs List of High-Alert Medications,

16 Patient Safety and Effectiveness Morbidity and Mortality - Systems Errors 1 - 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.

17 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)

18 Patient Safety and Effectiveness Comparative Effectiveness 1 - 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).

19 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 patients needs and preferences 3) Provide informed shared decision-making

20 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

21 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 retinopathy 1 -Provides that manufacturers of prescription drugs and medical devices discharge their duty of care to patients by providing warnings to the prescribing physicians 2 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

22 Legal Contexts Learned Intermediary Doctrine - Implications on Direct-to-Consumer (DTC) advertising 1 : - 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, doctrine-and.html

23 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 individuals 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

24 Legal Contexts Brothers 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:

25 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

26 Unresolved and Controversial Issues Pharmacists Becoming the Prescriber - Evolution of Profession: Apothecary to Clinical - Three Major Issues - Competence - Quality Assurance - Safety

27 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, Kings College London, 2002. Avoiding the Mistakes of Medicine - Doctors initiate discussions about medication but then dominate the interaction. Often 1 : - 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 - Patients understanding of medication and ability to follow treatment plan is not verified Prescribing Influence by the Pharmaceutical Industry

28 Unresolved and Controversial Issues National Drug Use Patterns 1 Source:1) National Center for Health Statistics. (2007). Therapeutic Drug Use.

29 Unresolved and Controversial Issues National Drug Use Patterns 1 Source:1) National Center for Health Statistics. (2007). Therapeutic Drug Use.

30 Unresolved and Controversial Issues Evidence-based Medicine; Quality indicators 1 -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 committees Source:1) U.S. Preventive Services Task Force (USPSTF). (2007). Agency for Healthcare Research Quality.

31 Unresolved and Controversial Issues Evidence-based Medicine; Categories of Recommendations 1 - 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.


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