CPHT Pharmacy Law
Terms
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- Administrative Code
- Lists the penalty associated with each violation of pharmacy law
- FDA
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Approves new durgs
regluates package inserts
refulates advertising
issues recalls - DEA
- Enforces controlled substances laws
- CSA
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Controlled substances act
Created the five scheduled classification - BOP
- State board of pharmacy
- The Federal Food and Drug Act
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1906
Deals with the purity of products 1912 admendment required manufactures to provide scientific evidience for all claims made - Food, drug and Cosmetic act
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FDCA 1938
clarifided the food and drug act and before the drug came to market must prove safety -
The Durham-
humphrey Amendment -
1951
Created class legend drugs
RX only - The Kefauver-Harris Amendment
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1962
Proof of effectiveness, regulated manufacturing, regulated advertising - The harrison Narcotic Act
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1916
created stamps for legall narcotics - Drug Abuse Control Amendment
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DACA 1965
Expands Harrison to add barbituates and stimulants. No more stamps - Bureu of Narcotics and Dangerous Drugs
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1968
Harriosn and DACA combined under this act. Was renamed to DEA in 1973 - Comprehensive Drug Abuse Prevention and Control
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CSA 1970 -Controlled substance act-
Tracks transactions between manufacutre, supplier, practitiners, and consumers - Poison Prevention Packaging Act
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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?
- JCHAO
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Commision on Accrediation of Healthcare Organizations
Conducts voluntary inspections - NDA
- 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
- NDA Phase III
- 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
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Pre Clinical -6-7 years
Phase I 1-2 years
Phase II 2-3
Phase III 3-4 - IND
- Investigational New Drug Review- Allows for interstate shimpent of unapproved drug products
- Valid DEA Number
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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
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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
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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
- MAR
- 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
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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
- OBRA 90
- 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
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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
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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
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1. patient name address phone dob gender
2. history of disease allergies drug reactions concurrent meds
3. pharmacist comments relevant to individual drug therapy