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CPHT Pharmacy Law


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Administrative Code
Lists the penalty associated with each violation of pharmacy law
Approves new durgs
regluates package inserts
refulates advertising
issues recalls
Enforces controlled substances laws
Controlled substances act
Created the five scheduled classification
State board of pharmacy
The Federal Food and Drug Act
Deals with the purity of products 1912 admendment required manufactures to provide scientific evidience for all claims made
Food, drug and Cosmetic act
FDCA 1938
clarifided the food and drug act and before the drug came to market must prove safety
The Durham-
humphrey Amendment
Created class legend drugs
RX only
The Kefauver-Harris Amendment
Proof of effectiveness, regulated manufacturing, regulated advertising
The harrison Narcotic Act
created stamps for legall narcotics
Drug Abuse Control Amendment
DACA 1965
Expands Harrison to add barbituates and stimulants. No more stamps
Bureu of Narcotics and Dangerous Drugs
Harriosn and DACA combined under this act. Was renamed to DEA in 1973
Comprehensive Drug Abuse Prevention and Control
CSA 1970 -Controlled substance act-
Tracks transactions between manufacutre, supplier, practitiners, and consumers
Poison Prevention Packaging Act
PPA 1970
Requires Locking Caps unless
1. patient asks
2. Prescriber asks
3. exempted drug
Standard of Practice
What would the typical practitioner, armed with the knowledge typical of the profession, do in response to the situation at hand?
Commision on Accrediation of Healthcare Organizations

Conducts voluntary inspections
New Drug Application
NDA Phase I
Uses healthy volunteers to test maximum tolerated dose of drug
NDA Phase II
Concered with effectiveness of drug. uses volunteers from disease group
Uses several thousand individuals in the double blind method. After complete application sent to FDA
NDA Phase IV
Follow up after FDA approves for genral use. Continuing review of medication
NDA created
Food Drug and Cosmetic Act
Time Line
Pre Clinical -6-7 years
Phase I 1-2 years
Phase II 2-3
Phase III 3-4
Investigational New Drug Review- Allows for interstate shimpent of unapproved drug products
Valid DEA Number
Add 1st 3rd 5th numbers;
add 2nd 4th and 6th then double the sum; Add two figures together Last number matches last number of DEA number.
Schedule I
No Accepted Medical use High Abuse; Heroin, Merijuana, LSD, peyote, mescaline, psilocybin, methaqualone
Schedule II
High abuse
opium, codeine, hydromorphone, methadone, meperidine, cocaine, oxycodone, oxymorphone, amphetamine, methmphetamine, phenmetrazine, methlphenidate, amobarbital, pentobarbital, secobarbital, fentanyl
Schedule III
barbituric acid, glutethimide, nalorphine, benzphetamine, chlorphentermine, phendimetrazine, paregoric, any compound containtine secobarbital phenobarbital or amobarbital
Schedule IV
barbital, phenobarbital, chloral hydrate, ethinamate, meprobamte, phentermine, propxyphene, benzodiazepines
Schedule V
May be dispensed without a RX
1. dispnsed by pharmacist
2. no more than 240ml or 48 solid doses containing opium
3. 120ml or 24 solid doses of any other V drug in a 28 hour peroid
3. 18 yrs old
Controlled Substance Designation
"C" with Schedule Number
Medication Administration Record
MAR requirements
Name, age, room# billing #, Drug name, dosage, directions ,route, schedule of administration ie exact times, DEA number not required
Date restrictions
Controlled substances = 6 months
Legend drugs =No limit (check state limitations)
Schedule III-V Refills
Limit of 5 refills even if fills were partial fills
Schedule II Refills
None allowed new RX every time, unless partial fill pharmacist has 72 hours to finish the order or it becomes void.
Floor stock; Crash Carts
Drug products stored at nursing statins; Emergency medications available stat
Hospital Drugs
Pharmacy is always responsible for medications ie floor stock and crash carts
Perpetual inventory sheet
Controlled substance inventory in hospital; constant inventory
Abbreviations on MAR
None allowed if TID is written pharmacy will write corresponding times on MAR
Hopsital RX dates
Dictated by the pharmacy. MAR don not have number of fills. time limits are governed by pharmacy policy
Hospital Bulk Drugs
Transfred from the medication cart to new cart each day until used up or patient leaves hopsital
Pharmacy and Therapeutics Committe
Manage the formulary in a hospital
Retail Patient Profile
Name, address, thrid party information, diagnosis, allergy infomration, DOB, concurrent medications prevous RX filled, retail information
Omnibus Budget Reconciliation Act 1990
OBRA requirements
Places mandates on Medicaid programs in eact state. Retrospective reviews on RX use. Wants to decrease costs
Retrospective DUR
used to identify inappropriate use of drugs and generate cost savings by correcting actions
Education of DUR
OBRA directs SBOP to devlop education programs to keep practitioners up to date with DUR review and prescribing guidlines
Prospective DUR
Occurs before the RX is dispensed
DUR pharm responsiblites
1. RX duplication
2. Drug disease contraindication
3. drug interactions
4. Incorrect dosage of duration of use
5. allergy contraindications
6. clinical abuse or misuse
OBRA counsiling
Pharmacist must discuss (medicaid)
1. Medicine name and description
2. dosage form, route, and duration
3. any special directions or precautions
4. side effects
5. therapeuitc contraindications
6. self monitoring techniques
7. proper storage of RX product
8. Refill ino
9. What to do if dose is missed.
Obra counsiling 2
Only required to offer counsel. Must be done by Pharmacist
OBRA documentation obtained by resonable effort
1. patient name address phone dob gender
2. history of disease allergies drug reactions concurrent meds
3. pharmacist comments relevant to individual drug therapy

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