Pharmacy Laws, Federal Requirements, & Regulations Flashcards
Class II recall
A class II recall occurs when medication may cause temporary adverse health effects that are reversible or if there is a small risk of serious adverse effects.
class I recall
A class I recall occurs when a medication is likely to cause severe adverse effects or even death.
class III recall
A class III recall occurs when a medication is not likely to cause a patient to have adverse effects.
class IV recall
A class IV recall does not exist—there are only three classes of FDA recalls.
acceptable way to store prescription records
Prescription records can be stored in only three possible ways:
2 files: (CII) and (non-controlled + CIII-V)
2 files: (CII-V) and (non-controlled)
3 files: (CII) and (CIII-V) and (non-controlled)
DEA 222 form
The DEA 222 form is used to order medications from a pharmacy supplier or another pharmacy.
DEA 224 form
The 224 form is used to register a retail pharmacy with the DEA.
DEA 106 form
The DEA 106 form is used to report the lost or theft of controlled substances
DEA 41 form
The 41 form is to describe the destruction of controlled substances.
Validity of DEA number
Following the steps below, the sum at the end of step 4 is 56, and so the last digit of the DEA number needs to be 6 to be considered a valid DEA number.
Step 1: Add the first, third, and fifth numbers together ( 2 + 6 + 8 =16).
Step 2: Add the second, fourth, and sixth numbers together (4 + 7 + 9=20).
Step 3: Multiply the sum in the second step by 2 (20 x 2 =40).
Step 4: Add the total from steps 1 and 3 together (40 +16 =56).
Please note: There are ongoing revisions in the letters that can appear first in a DEA number. Changes have been made over the years to accommodate the increasing number of practitioners. C, as well as other letters, can now be the first letter and is usually used for specialists rather than general practitioners.
How long do prescription records need to be retained onsite by a pharmacy?
Pharmacies must keep records onsite of all prescriptions for a minimum of 2 years and they must be organized in such a way that they can easily be inspected by the DEA or state BOP.
There are other relevant regulations to keep in mind, however:
Under federal law alone the prescription records should be kept for at least 5 years. See the last regulation, below.
The FDA has also stated that it will look at prescriptions records dating back 5 years.
Under the Medicare Modernization Act of 2003, prescriptions for Medicare are required to be retained for 10 years.
There is a different requirement for being kept in the pharmacy (onsite) versus being retained in general. There are a whole set of laws for central storage of prescriptions (and other pharmacy records) at an offsite location. Under this regulation, the pharmacy itself needs to retain records for at least 2 years onsite but a total of 5 years.
Combat Methamphetamine Epidemic Act of 2005 (CMEA)
CMEA limits the quantity of pseudoephedrine that can be purchased by an individual customer. The limit is 3.6 grams at one time and a 9 gram total over a 30-day period. Limits may be different for mobile vendors or for mail orders. For example, only 7.5 grams in a monthly purchase may be by mail order.
What needs to be documented by the receiving pharmacy of a transferred controlled substance (CIII-V) prescription?
All transferred controlled substance prescriptions must contain the following:
Original prescription date and dispensing date
Original # of refills authorized and current # remaining
Transferring pharmacy’s DEA number and demographics
Original prescription number
Name of transferring pharmacist
When purchasing products containing pseudoephedrine, what needs to be documented in the logbook (hand-written or electronic)?
According to the CMEA of 2005, the logbook needs to contain the personal information of the person purchasing the product and quantity, strength, date, and time of the product sale. The day of the week, last purchase date, and purchaser’s date of birth are not required.
The Occupational Safety and Health Administration (OSHA)
The Occupational Safety and Health Administration (OSHA) has standards to protect employees who work with hazardous materials. It also outlines the proper personal protective equipment needed in various pharmacy practice settings such as compounding.
HIPAA
HIPAA relates to confidentiality and the PPA governs the practice of pharmacy but does not explicitly cover employee safety.
USP 795
USP 795 focuses only on non-sterile compounding.
Safety Data Sheets (SDS)
Safety Data Sheets (SDS) outline appropriate handling, storage requirements, and cleanup procedures for the hazardous product. They are specific for the product listed.
When a state pharmacy law and federal pharmacy law conflict, which law should be followed?
the more strict law
Explanation:
In the event a state law conflicts with or contradicts a federal law, the law that is more strict is the one that should be followed. This is not optional if a pharmacy is to operate within legal boundaries.
What is the maximum number of refills that is allowed on a Schedule III-V controlled substance prescription?
A controlled substance in the Schedules of III-V is allowed a maximum of 5 refills, within 6 months of the date of issue.
Common reasons for a medication recall
Common reasons for a medication recall include product mislabeling, presence of impurities, and contamination. A medication with a high cost or copay does not warrant a medication recall.
CSOS (Controlled Substance Ordering System)
CSOS (Controlled Substance Ordering System) is the online platform for Schedule II controlled substance ordering that has largely replaced the traditional paper format.
PMP
PMP stands for Prescription Monitoring Program.
REMS
REMS stands for Risk Evaluation and Mitigation Strategies.
Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA)
The act requires all products to include a list of ingredients, directions, and safety warnings. It also states that all drugs must be approved by the FDA prior to being marketed and used by patients. It outlines the labeling requirements for all prescription and over-the-counter medications
Risk Evaluation and Mitigation Strategies (REMS) program between the FDA and drug manufacturers
REMS help limit inappropriate dispensing and protects patients. Each drug has different criteria that must be met, and this can include patient education, elements for safe use of the medication, a communication plan between healthcare providers and the patient, laboratory tests, etc.
Scheduled drugs transfer
Schedule III-V drugs can be transferred between pharmacies one time, unless the pharmacies share an online, real-time database. Schedule II drugs cannot be transferred.
take back programs
Take back programs provide a safe way to dispose of unwanted prescription medications. These programs help prevent unwanted medications from getting into the wrong hands, on the streets, or in our waterways.
Personal Protective Equipment (PPE)
PPE should always be worn when handling or cleaning up hazardous materials. This is to keep yourself safe and reduce your risk of exposure.
Class III recall
Class III is the least severe type of recall. The medication in question is not likely to cause a patient to have adverse effects.
Durham-Humphrey Amendment
The amendment defined prescription drugs as those unsafe for self-medication and which should therefore be used only under a doctor’s supervision.
Red Book
leading resource for information on drug pricing
Omnibus Budget Reconciliation Act of 1990
OBRA-90 placed regulations on the pharmacist in how to interact with the patient, with a goal of improving therapeutic outcomes. The law includes prospective drug utilization review (ProDUR) requirements, counseling obligations, and record-keeping mandates.
Orange Book
Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA. It also contains therapeutic equivalence evaluations for generic drugs, using Therapeutic Equivalence codes such as AA, AB, BC, and BD. If the first letter of the code is an ‘A’, the FDA has concluded that the generic formulation is therapeutically equivalent to the reference drug. If the first letter is a ‘B’, the FDA has concluded that the compared drugs are not equivalent. The second letter of the code gives more detailed information about formulations. The Orange Book also lists the patents which are purported to protect each drug.
Kefauver Harris Amendment
known as the ‘Drug Efficacy Amendment.’ It is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced requirements for drug manufacturers to provide proof of the effectiveness and safety of their drugs before they could be approved. It also required drug advertising to disclose accurate information about side effects and efficacy of treatments.
How often must pharmacy scales and weights be evaluated and calibrated?
Pharmacy balances, scales, and weights must be evaluated and calibrated every 12 months
Pure Food and Drug Act of 1906
The Pure Food and Drug Act of 1906 prohibits interstate sales of adulterated or misbranded drugs
Omnibus Reconciliation Act of 1987
The Omnibus Reconciliation Act of 1987 established revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy, requires that resident drug regimen’s be free of unnecessary medications, requires that medications be labeled according to accepted professional principles, requires that behavioral modification and drug holidays be used to evaluate discontinuation, and requires that emergency and routine drugs be provided to patients
Drug Price Competition and Patent Term Restoration Act of 1984
The Drug Price Competition and Patent Term Restoration Act of 1984 was created to establish the modern system for generic drugs
United States Pharmacopeia
Establish standards for medication identity, purity, and strength
Orphan Drug Act of 1983
Medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world
Prescription Drug Marketing Act of 1987
requires that a manufacturer provide Safety Data Sheets (SDS formerly known as MSDS) to a pharmacy for products that are combustible, are flammable or can cause injury to an individual if he or she comes in contact with the substance
drug development phases
The appropriate dose concerning safety and toxicity is determined by Phase I.
Phase II is performed in 100 to 300 patients who have the disease or condition to be treated.
Phase III is conducted in larger (several hundred to several thousand) patients in groups that the medication is finally intended.
A comparison is between the new treatment and the standard therapy or placebo. The medication is used in the manner in which it will be used after approval.
