Screening Controlled Substance Screening Controlled Substance Screening Controlled Substance Screening Controlled Substance Prescriptions For Legitimacy: Prescriptions For Legitimacy: The VIGIL System The VIGIL System David B. Brushwood, David B. Brushwood, R.Ph R.Ph., J.D. ., J.D. Professor of Pharmaceutical Outcomes & Policy Professor of Pharmaceutical Outcomes & Policy The University of Florida The University of Florida
There Is A Storm Brewing There Is A Storm Brewing � Patients in pain need their Patients in pain need their � medications and they don’t medications and they don’t y deserve pointless hassles. deserve pointless hassles. � Abuse of Prescription Abuse of Prescription � Medications is Increasing. Medications is Increasing Medications is Increasing. Medications is Increasing � Drug Diverters Target Drug Diverters Target � Pharmacies. Pharmacies. � The Failure to Prevent Th The Failure to Prevent Th F il F il P P � Diversion is Costly in Diversion is Costly in Economic and Social terms. Economic and Social terms. � It is Easy to Confuse It is Easy to Confuse � Successful Practice With Successful Practice With Diversion. Diversion. � All Parties Share This All Parties Share This � Concern. Concern.
Definitions Definitions (Federation of State Medical Boards) (Federation of State Medical Boards) � Pain: An unpleasant sensory and emotional � Pain: “An unpleasant sensory and emotional Pain: An unpleasant sensory and emotional Pain: “An unpleasant sensory and emotional � � experience associated with actual or potential experience associated with actual or potential tissue damage or described in terms of such tissue damage or described in terms of such damage.” damage.” � Chronic Pain: “Chronic pain is a state in which pain Chronic Pain: “Chronic pain is a state in which pain � persists beyond the usual course of disease or persists beyond the usual course of disease or healing of an injury, or that may or may not be healing of an injury, or that may or may not be associated with an acute or chronic pathologic associated with an acute or chronic pathologic associated with an acute or chronic pathologic associated with an acute or chronic pathologic process that causes continuous or intermittent pain process that causes continuous or intermittent pain over months or years ” over months or years ” over months or years. over months or years.
The Pharmacist’s Dilemma The Pharmacist’s Dilemma The Pharmacist s Dilemma The Pharmacist s Dilemma � The Therapeutic Imperative: The Therapeutic Imperative: e e e apeut c e apeut c pe at e pe at e “Always dispense opioid analgesics, and other “Always dispense opioid analgesics, and other controlled substances, when they are controlled substances, when they are appropriate for a patient.” appropriate for a patient.” i i f f i i ” ” Help the patients who need help. Help the patients who need help. � The Regulatory Imperative: The Regulatory Imperative: “Never dispense opioid analgesics when they are “Never dispense opioid analgesics when they are “Never dispense opioid analgesics when they are “Never dispense opioid analgesics when they are inappropriate for a patient.” inappropriate for a patient.” Push the pushers out of the pharmacy Push the pushers out of the pharmacy Push the pushers out of the pharmacy. Push the pushers out of the pharmacy.
Federal Law: Federal Law: Corresponding Responsibility Corresponding Responsibility 21 CFR 21 CFR § 1306 04 Purpose of Issue of Prescription 21 CFR 21 CFR § 1306.04 Purpose of Issue of Prescription 1306 04 Purpose of Issue of Prescription 1306.04 Purpose of Issue of Prescription (a) A prescription for a controlled substance to be effective must (a) A prescription for a controlled substance to be effective must be issued for a be issued for a legitimate medical purpose legitimate medical purpose by an individual by an individual practitioner acting in the practitioner acting in the usual course of his professional usual course of his professional practice practice. The responsibility for the proper prescribing and . The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing dispensing of controlled substances is upon the prescribing dispensing of controlled substances is upon the prescribing dispensing of controlled substances is upon the prescribing practitioner, but a practitioner, but a corresponding responsibility corresponding responsibility rests with the rests with the pharmacist who fills the prescription. An pharmacist who fills the prescription. An order purporting to order purporting to be a prescription issued not in the usual course of professional be a prescription be a prescription issued not in the usual course of professional be a prescription issued not in the usual course of professional issued not in the usual course of professional treatment or in legitimate and authorized research is not a treatment or in legitimate and authorized research is not a prescription and the person prescription and the person knowingly knowingly filling such a purported filling such a purported prescription, as well as the person issuing it, shall be subject prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the law. to the penalties provided for violations of the law.
The Key To Compliance: The Key To Compliance: VIGIL VIGIL G � How can pharmacists meet the needs of � How can pharmacists meet the needs of How can pharmacists meet the needs of How can pharmacists meet the needs of chronic pain patients and avoid chronic pain patients and avoid “knowingly” filling purported prescriptions? “knowingly” filling purported prescriptions? knowingly filling purported prescriptions? knowingly filling purported prescriptions? Suggestion: VIGIL VIGIL � Suggestion: � Verification erification � Identification dentification � Generalization eneralization � Interpretation nterpretation � � Legalization egalization
Good and Bad Decisions Good and Bad Decisions What is our What is our Dirty Little Secret Dirty Little Secret ? State of the World State of the World Patient Is Patient NOT Legitimate g Legitimate g Pain Patient* Pain Patient Opioids are Good Good Bad Bad Prescribed/ Decision Decision Dispensed HCP A ti it Activity Opioids NOT Bad Good Prescribed/ Decision Decision Dispensed p *Assume that opioids are appropriate therapy for the patient.
Bad Decisions Cannot Be Eliminated Bad Decisions Cannot Be Eliminated Bad Decisions Cannot Be Eliminated Bad Decisions Cannot Be Eliminated State of the World State of the World Patient Is Patient NOT Legitimate g Legitimate g Pain Patient* Pain Patient Opioids are Good Good Bad Bad Prescribed/ Decision Decision Dispensed HCP A ti it Activity Opioids NOT Bad Good Prescribed/ Decision Decision Dispensed p *Assume that opioids are appropriate therapy for the patient.
Using Balance to Using Balance to Reduce Bad Decisions Reduce Bad Decisions State of the World State of the World Patient Is Patient NOT Legitimate Legitimate Legitimate Legitimate Pain Patient* Pain Patient Opioids are Opioids are Good Good Bad Bad Prescribed/ Decision Decision HCP Dispensed A ti it Activity Opioids NOT Bad Good Prescribed/ Decision Decision Decision Decision Dispensed *Assume that opioids are appropriate therapy for the patient.
Distinguishing Pain Behaviors Distinguishing Pain Behaviors From Suspect Behaviors From Suspect Behaviors � There is confusion between patients with the There is confusion between patients with the p disease of addiction and those with the disease disease of addiction and those with the disease of pain. of pain. � Focus on the impact of medication on patient � Focus on the impact of medication on patient Focus on the impact of medication on patient Focus on the impact of medication on patient function, when opioids are provided: function, when opioids are provided: � Increased function = desired use (patient has disease Increased function = desired use (patient has disease of pain) of pain) of pain) of pain) � Decreased function = undesirable use (patient has Decreased function = undesirable use (patient has disease of addiction) NB: Perhaps also the disease of disease of addiction) NB: Perhaps also the disease of pain pain pain pain � We must filter out red herrings We must filter out red herrings � Dose, frequency, duration. Dose, frequency, duration. � Physician “reputation.” Physician “reputation.” � Patient appearance. Patient appearance.
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