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Pharm Laws Florida

Chapter 2 Orange Tech

What does the DEA do Prevent illegal distribution and misuse of controlled substances.
NPTA National Pharmacy Technician Association
Negative Formulary Drugs Estrogen, Digitoxin, Conjugated Estrogen, Dicumarol, Chlorpromazine (Solid Oral Dosage form) Theophylline ( Controlled release) Pancrelipase (Oral Dosage forms)
Florida Negative Drug Formulary The negative drug formulary is comprised of medicinal drugs that demonstrate clinically significant biological or therapeutic in equivalence and which, if substituted, could produce adverse clinical effects,
Non-Delegable Tasks Are those tasks that may not be performed by a Pharm Tech, they can only be done by the pharmacist
Delegable Tasks Tasks that a Pharm Tech can do under the supervision of a Pharmacist, and they do not require independent professional judgement.
PPI Patient package insert, information about medication being dispensed
PPI Medications Estrogen and Oral Contraceptives
Florida Right to Know Act Makes employers disclose info on toxic substances that an employee may come into contact with on the job and how to use them safely, as well as to let the local fire department know where they are stored and the characteristics of said chemicals.
Monograph labeling a product ( must include directions for use, unsafe dosages , manufacture, packer distributor , quantity and weight
1906 Pure Food and drug act Harvey Wiley Truthful info on drug label and stop the sale of inaccurately labeled drugs
1938 Federal, Food, Drug and cosmetic act Adulteration and misbranding “ Warning may be habit forming”
What can a pharmacy technician NOT do dispense medication without authorization ,consult patient, take verbal prescription orders over the phone, override system alerts
1987 Prescription drug market avoid counterfeit drug (Supply chain)
1914 Harrison Narcotics Act Required prescriptions, restrictions of transportation, distribution, and implementation of importation, sale, of opium, coca leaves, and any products of the plant.
Controlled Substance Act Control over manufactures, import, export, distribution, ordering, dispensing, storage and recordkeeping and other actions involved with the distribution of controlled substances.
Controlled Substances Medications that are subject to stricter controls through laws and regulations because of potential for abuse, misuse, diversion and addiction
2000 Drug addiction treatment (DATA) prescribe controlled substances to people suffering from opioid addiction
DAW Dispense as Written, No substitutions
OTC Over the counter Medications, no RX required
Brand Name Drugs Maker given a patent for a number of years normally 11 giving exclusive rights
Generic Drugs After patent expires others can formulate the meds and market them as long as they have the same active ingredients, and dosage forms, strength and formulations as the brand name.
Legend Drugs Prescription drugs requiring an RX
Board of pharmacy (BOP) Regulates the practice of pharmacy and Pharm Techs (3:1) One Pharmacist to three techs
1972 Drug Listing Act Required an NDC number on all medications Labeler, product and trade package size, the first set of numbers is from the FDA, 2nd set product code specifics of the product, 3rd set package code package size and types
1983 Orphan drug act Allows manufactures to create drugs for rare diseases faster with assistance
Protected health information (PHI) Patients personal health data
2003 Medicare Modernization Act Gives drug cards to low income people .
2005 Combat Methamphetamine Epidemic Act strict guidelines that address areas in manufacturing of methamphetamines from pseudoephedrine and limiting sales enforcement only 3.6 g in a calendar day 9g in 30 days retail and 7.5 g in a 30 day period by mail
1970 Poison Prevention Packaging act safety caps on medications
Omnibus Budget Reconciliation (OBRA'90) Must consult all patients who receive new prescriptions
Any name of a controlled substance Narcotics
Controlled substances definition Any drug or other substances that is scheduled 1 through 5
1951 Durham -Humphrey Prohibits dispensing without a prescription (Caution) , Legend drugs and OTC were designated
Counseling of patients of (MTM) Counseling of patients on their medications and making recommendations to the doctors is the pharmacists notices a tag disease like diabetes
1990 Anabolic Steroids Control act Enforce regulations on steroid abuse
1970 Comprehensive Drug abuse prevention and control act Created stair - step schedule for controlled substances based on the safety and dependency on the drug, C I being the most restrictive no medical use
1996 Health insurance portability and accountability act (HIPPA) protecting the patients right
1962 Kefauver Harris amendment Ensure the safety and effectiveness of all new drugs , puts the burden on the manufacture to prove it is safe for patient
class 1 recall serious /fatal harm
class 2 recall slight threat/ serious harm
class 3 recall Minor defect / not harm patient
Class I Drugs No accepted medical use, high potential for abuse, not available by prescription.
Class II Drugs High potential for abuse and dependence, FDA approved for medical use
Class III Drugs Moderate potential for abuse, misuses and dependency
Class IV Drugs Low potential for abuse and limited risk of dependence
Class V Drugs Lower potential for abuse, misuse or dependence
Exempt meds from Child resistant packaging Sublingual nitroglycerin and oral contraceptives
Examples of C I Heroin, LSD
Examples of C II Acetaminophen/hydrocodone, meperidine, methadone, oxycodone
Examples of C III Acetaminophen/codeine, Suboxone
Examples of C IV Valium, Ativan, Ambien
Examples of Class V Lomotil, Cough meds with Codeine
2010 Patient Protection and Affordable Care Act Made preventable care more accessible and affordable, and required insurance companies to cover preexisting conditions
Non-formula Drug Drugs that are not on the formulary list
Occupational Safety and health administration (OSHA) Safety in workplace , and SDS sheets
Form 106 Theft or loss of controlled substances
form 224 dispense controlled substances
form 222 ordering/transferring scheduled 2 substances
form 41 Destroying damaged controlled substances , Retail pharmacies can do once a year and Hospitals file for blanket form and can do multiple per year
What does the DEA number represent They represent the doctors last name first initial. Fist letter has to be an A or B and then the second letter represents the doctors last name first initial followed by numbers afterwards.
How do you tell if the DEA number is correct Add the 1st 3rd 5th numbers together and then add the 2nd 4th 6th number together. then times the answer by 2 (Example DEA #AB3652989 1st + 3rd + 5th Number = 3 + 5 + 9 = ___17 2nd + 4th + 6th Number = 6 + 2 + 8= 16 X 2
Ordering controlled substance form must be kept form 2yrs, 8 years for Florida
Refills C2: 0 C3-C4: 5 times within 6 months non-controlled prescriptions: multiple times up to 12months
Prescribing Error Error occurring during the prescribing process
Compliance Error Patient does not take meds as prescribed
Monitoring Error Failure to review a med order or associated lab results
Improper Dose Error A dose that is greater than or less than ordered by the prescriber
Wrong Time Error Medication given outside the time frame
Wrong Dose Error Incorrect medication dosage given ( Type or form)
Omission Error A dose that was never given, omitted
Wrong Administration Technique Error Medication is given or taken by the wrong route or use of improper procedure
Unauthorized Drug Error Medications given or taken by an unlicensed prescriber or no privileges at a hospital
Deteriorated Drug Error Expired or improperly kept medication is given
Medication Error Any error occurring in the medication use process
MTM Medication therapy management, done by pharmacists, they receive compensation for this service
Medication Misadventure A general term to describe drug related incidents
High Alert Medication Medications that have a high risk of causing patient harm when used in error
PHI Protected Health Information
REMS Risk Evaluation and Mitigation Strategy for high risk drugs that treatment may outweigh the side effects, and may cause fetal damage, rosiglitazone, isotretinoin medications.
Ipledge Program by the FDA that requires labs and follow up by doctor and a pass code for pt. to pick up meds from the pharmacy. Pharmacy must also check.
5 Rights for Pateints’ The right patient, The right Dose, The right time, The right route, The right medication
Ethics The values and morals used within a profession
Morals Standards concerning or relating to what is right or wrong in human behavior.
MedWatch FDA program used for adverse events and safety alerts and label changes
MedMARX National internet accessible database for hospitals and healthcare workers to track Medication errors and adverse drug reactions.
Created by: roseoforlando



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