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Pharm 5018 ETSU NP

ch 4 Legal/Prof Issues in Prescribing

A History of Mishaps Federal Food and Drug Act of 1906: Due to children dying from tainted food products The 1938 Amendment to the Federal Food and Drug Act: After more than 100 children died after taking sulfanilamide 1962: Harris-Kefauver Amendment: Mandated preclinical animal trials before testing drugs in children
FDA Modernization Act of 1997 The U.S. Food & Drug Adm(FDA) can make a request for pediatric data on drugs may be used in children. Provides a 6-month extension of the patent of meds studied in children Implications for pediatric practice: More drugs studied for effectiveness in children
Best Pharmaceuticals for Children Act (BPCA) of 2003 Reinstated pediatric exclusivity Mandates a list of requested studies Experts in pediatrics are consulted. List is updated annually.
Reauthorized in Sept 2007/2012 The research program will address: Therapeutic gaps/Particular pediatric diseases/adequacy of infrastructure to conduct pediatric pharmacology research The BPCA received permanent authorization in 2012.
U.S. Food and Drug Administration The FDA regulates: Approval process for new drugs or /new indications/Official labeling/Surveillance of adv drug events/Methods of manufacture and distribution Medical devices/Adv of prescription drugs The FDA does not regulate prescribing.
New Drug Approval Process Preclinical research Phases of drug testing before approval: Phase I/Phase II/Phase III New drug application Post-marketing research
Official Labeling The FDA reg what goes on a label: Labeling on (OTC) drugs /Insert in prescr drugs Off-label prescribing: Prescribing use not indicated on the official FDA label/Legal Decision based on: Understanding the med being prescribed/Rational scientific principles/Expert med opinion (the literature)/Controlled clinical trials
Controlled Substance Laws Regulates the manufacture and dispensing of drugs identified as “controlled” drugs U.S. Drug Enforcement Administration (DEA) DEA #: registration w/ DEA/Manufacture, prescribe, dispense DEA rules: Record-keeping/DEA registration needed to prescribe controlled sub/DEA # not used as insurance billing number
Controlled Substance Prescribing Precautions Prescription pad should be stored in locked area/Tamper-proof paper/Name, national provider identifier (NPI), address, and telephone number on pad/DEA number if controlled substance/Date/Refills/Spell out quantity/Fax or electronically transmit any prescription except for schedule II drugs.
Controlled Substance Prescribing Precautions: Opioid Prescribing Legitimate for pain control Accurate assessment and diagnosis: Pain is subjective/Use a valid tool/The Screener and Opioid Assessment for Patients in Pain Pain treatment plan: Referral to pain specialist/Pain contract
Prescription Drug Misuse Principles for prescribers: Use of chemical dependence screening skills/Limit-setting regarding controlled drug prescribing/Documentation of a confirmed diagnosis and ruling out of chemical dependence before initiating controlled prescription Practice “just saying no.”
Drug Scams Dealing with scams consists of following steps: Learning to recognize the common ones/Refusing to give in to them/Practicing the skill of turning the tables on scammer Be aware of forging and altering of prescriptions.
Prescriber Issues Pressure to prescribe/Enabling /Dealing with patients who misuse medications: Communication/Confrontation Systemic solutions to patients who misuse: Careful documentation/Electronic medical record
Medication Agreements “Pain Contract” Universal standards for all non-cancer patients Urine drug screens Example of pain contract
State Law Federal government decides what is a prescr drug. States decide who can prescribe: Prescriptive authority varies from state to state/States determine how independent an NP is in prescribing. DEA number is obtained from the DEA, but states determine scope of controlled substance prescribing.
Writing a Prescription Use preprinted prescription pads that contain the name, address, telephone number, and NPI number of the prescriber/Write the complete drug name, strength, dosage, and form/Write the date of the prescription/Use metric units of measure, such as milligrams and milliliters; avoid apothecary units of measure/Avoid abbreviations
Writing a Prescription (cont’d) Avoid the use of “as directed” or “as needed.”/Include the general indication, such as “for infection.”/Write “Dispense as Written” if generic substitution is not desired/Include the patient weight, especially if pediatric or elderly/Indicate if a safety cap is not required, as medications will be dispensed with them by default.
Issues in Writing Prescriptions What may be prescribed: Legend drugs/Controlled drugs/Medical devices/Home health/Home testing equipment, needles, syringes/OTC meds State-specific: Ea state reg prescr details. Electronic health record
Ethical Issues Informed consent Prescribing for family or friends Sale of pharmaceuticals and supplements
Created by: palmerag