Federal Requirements

Define this regulation:

Disposal of medications and comply with OSHA, EPA, DOT

Safe Water Drinking Act

Where do you place place needles and vaccine?

Hazardous Drug Waste Only

Where are glass and used needles disposed?

Sharp Containers

Where are nonhazardous materials discarded?

Regular Trash Container

What must a C-2 prescription contain?

• date of issue

• patient's name and address

• practitioner's name, address and DEA numbe

• drug name

• drug strength

• quantity prescribed

• directions for use

• number of refills authorized

• manual signature of prescriber

What must always have a new prescription in order to be issued?

C-2 medications

How many refills can a patient receive within 6 months of the date?

5 refills if authorized for C-3 to C-5

Define this:

Drugs that have no accepted medical use in the US and possess extremely high potential for abuse

Schedule 1 Controlled Substances

What are some examples of Schedule 1 substances?

Heroin, Marijuana, Ectasy, and LDS

Define this:

Have medical use bur possess a high abuse potential with severe psychological or physical dependency

Schedule 2

What are some Schedule 2 substances?

Adderall, OxyContin, Percocet, and Vicodin

Define this:

Have accepted medical use and abuse potential is less than schedule 1 & 2

Schedule 3

What are some Schedule 3 substances?

Tylenol with codeine, Fiorinal with codeine and Fiorinal

Define this:

Preparations abuse potential is less than with schedule 3 but administration may lead to limited physical and psychological dependence

Schedule 4

What are some Schedule 4 drugs?

Ambien, Ativan, Valium, and Xanax

Define this:

Abuse potential is less than C-4 drugs includes exempt narcotics

Schedule 5

What are some Schedule 5 drugs?

Lyrica, Neurontin, and Lomotil

What must be recorded on a DEA form 222 after receipt of medications and for how long should it be kept?

Number of packages and for two years

Where must all C-2 medications be kept?

Locked Safe

How are C-2 drugs ordered?

DEA Form 222

The packing slip for C-2 drugs must contain?

Dated, Signed, and Stamped with red C and retained for 2 years

What should all C-2 to C-5 prescriptions contain?

• pharmacy name and address

• serial number and date of initial filling

• name of the of the patient

• name of the practitioner issuing the prescription

• name of the medication, strength, quantity and directions for use

Are partial refills allowed on C-2 medications?

Yes, if remaining quantity is available to patient within 72 hours

Define this:

When the pharmacy send outdated and unstable drug product back to the drug manufacture
⚠ Outed, damaged or unwanted controlled substance can be destroyed using DEA form 41
⚠Retail pharmacy may submit one DEA form 41 each year

Reverse Distribution

Define this:

A person is able to return unused controlled substance to designed pharmacy for proper disposal in a safe manner

Responsible Drug Disposal Act of 2010

Define this:

1. Pharmacy must notify the nearest DEA and the police

2. Complete DEA form 106

3. The pharmacy must send the original copy of DEA form 106 to the DEA and keep a copy for records

Loss/Theft of Controlled Drugs

How long is a log book maintained?

2 years

Define this:

Include any product marked as non-prescription containing ephedrine, PPA and pseudoephedrine
🔺 Regulated sellers must place the products behind the counter or in locked cabinet
🔺Regulated seller must check the identity of purchaser and keep a log of sale that include
• purchaser's name and address
• signature of the purchase
• product sold
•quantity sold
• date and time
-The log book should be maintained for at least 2 years

Combat Methamphetamine Epidemic of 2005

Define this:

Required risk management plans that use risk minimization strategies beyond the professional labeling to ensure the benefits of certain prescription drugs outweigh their risk as authorized by the FDAA of 2007
🞂 the FDA is responsible for reviewing and approving REMS program
🞂REMS can be required for single or class of drugs
🞂 the FDA may require REMS before and after a drug has been approved

Risk Evaluation and Mitigation Strategies (REMS)

Define this:

Require pharmacist to offer to discuss information about a new & refilled prescriptions with Medicaid patient, also require states to seek reimbursement from the federal government for cost of medications provided to Medicaid patients, also require pharmacist to offer counsel to all patients about there prescribed
Pharmacist must discuss the following during counsel
🡂 Name and description of medication
🡂 Dosage form, dosage, route of administration and duration of drug therapy
🡂Common severe side effects or adverse effects
🡂Proper storage
🡂Special directions for and pres

OBRA (Omnibus Budget Reconciliation Act of 1990)

What are the REMS medications?

‣Clozapine
‣ Fentanyl
‣ Buprenorphine
‣ Isotretinoin
‣ Thalidomide
‣Pseudoephedrine

Why can medical devices be recalled?

Devices can become defective or cause a health hazard (ex: Insulin pumps, glucose meter, and infusion pumps)

Why can supplies be recalled by the FDA?

Faulty components

Why can supplements be recalled?

Contamination, presence of undeclared ingredients super/sub-potency, product mislabeling, and misleading product label claim

Which recall classification is the most severe?

Class 1 (Can occur when a drug is labeled has another drug

Define this:

Medication may cause temporoay adverse health effects that are reversible

Class 2 Recall

Define this:

Medications isn’t likely to cause a patient to have adverse effects

Class 1 Recall

Define this:

Established clear criteria as to what constituted a “prescription drug” and the circumstances in which it can be dispensed to a patient. It outlawed the action of dispensing a prescription drug to those who did not have a prescription – remedying this long-standing problem.

Durham-Humphrey Amendment 1951

Define this:

The amendment sought to guarantee the safety, purity, and efficacy of both prescription and non-prescription medicines; eliminating the risk of dubious or harmful medicines being released into the public sphere.

The amendment was also passed in the wake of the thalidomide tragedy, in which tens of thousands of birth defects were caused by thalidomide; a drug marketed to pregnant women for the treatment of morning sickness.

Kefauver-Harris Amendment

Define this:

This law mandated that all prescription medicines, and most OTC medicines, are contained within child-resistant packaging.

Poison Prevention Packaging Act in 1970

Define this:

• Requires new drugs to be proven safe before marketing

• Authorized FDA oversight on safety of food, drugs, and cosmetics

• Formed basis for current prescription (legend) vs. OTC distinctions

Food, Drug, and Cosmetic Act of 1938

Define this:

Required drug manufactures to register with the FDA and submit a list of all commercially marketed drugs

Introduced National Drug Code (NDC) system

Drug Listing Act of 1972

Define this:

• Allowed for generic drug approval via ANDA

• Balanced brand-name patent protections and generic market entry

Hatch-Waxman Act

Define this:

• Banned reimportation of prescription drugs

• Restricted sample distribution

• Required proper state licensing of wholesalers

Prescription Drug Marketing Act

Define this:

• Protects patient privacy and health data confidentiality

• Pharmacy staff must protect Patient Health Information

• Includes notes of privacy practices, minimum necessary rule, and patients rules

Health Insurance Portability and Accountability Act

Define this:

Created Medicare Part D

Affect billing, formularies, and MTM eligibility

Medicare Prescription Drgus’, Improvement, Moderization Act of 2003

Define this:

• Expanded insurance coverages

• Promoted MTM services and preventative care

• Created accountable care organization

Affordable Care Act (ACA) of 2010

Define this:

• Establishes system to trach and trace prescription drugs through the supply chain

• Requires documentation of Transaction Information, History and Statement

Drug Supply Chain Security Act of 2013

Define this:

Prohibits dispensing controlled substances online without valid prescriptions after at least one in-person visit

Regulated online pharmacies

Ryan Haight Online Pharmacy Consumer Protection Act of 2008

Define this organization:

Enforces drug safety, labeling and approval

FDA

Define this organization:

Controlled Substances

DEA

Define this organization:

Licensure and discipline

State Boards of Pharmacy

Describe this organization:

Standards for drug purity, compounding (USP <795>, <797>, and <800>)

USP/NF

Which law created the system to track and trace prescription medications through the supply chain?

DSCSA (Drug Supply Chain Security Act)

Under the CMEA of 2005, what is the maximum amount of pseudoephedrine a person can purchase in one day?

3.6 grams

The Hatch-Waxman Act primarily deals with:

Generic drug approval

The NDC (National Drug Code) is composed of how many segments?

Three

A pharmacy technician must log pseudoephedrine sales per:

Combat Methamphetamine Epidemic Act

The HIPAA "Minimum Necessary Rule" means:

Only share info directly needed for the task

Which law requires that drug samples may only be given to licensed prescribers?

PDMA (Prescription Drug Marketing Act)

Who assigns and regulates the National Drug Code (NDC) numbers?

FDA

Which law requires that pharmacies provide patient counseling and Drug Utilization Review (DUR) for Medicaid patients?

OBRA '90

The Hatch-Waxman Act allows

Generics to use brand-name research data

A pharmacy accidentally discloses PHI. What law may have been violated?

HIPAA

Which law allowed creation of Medicare Part D, which helps cover prescription costs for seniors?

MMA (Medicare Modernization Act)

The purpose of the Ryan Haight Act is to regulate:

Internet sales of controlled substances

What is required in the pseudoephedrine logbook?

Name, ID, date/time, amount purchased

Which federal law governs patient safety and electronic health records as part of broader health reform?

ACA (Affordable Care Act)