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Pharma Test > Federal Requirements (12.5%) > Flashcards

Federal Requirements (12.5%) Flashcards

1
Q

What are the key agencies impacting pharmacy law?

A

1) Drug Enforcement Admin (DEA): Enforces prescriber and pharmacy comply w/ CONTROLLED SUBSTANCES ACT
2) Food and Drug Admin (FDA): Oversees drug Purity, Safety, And Effectiveness.
3) Center for Medicare and Medicaid: Oversees Medicare and Medicaid
4) Accrediting bodies: Set stnds and grant accred to promote patient safety and quality.
5) State Boards of Pharmacies: Regulate pharms within each state.

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2
Q

What is a “Hazardous” Drug?

A

Drugs consider hazardous if pose HEALTH RISK THRU OCCUPATION OR ENVIRON EXPOSURE.

Specific risks include:
• Carcinogenicity
• Teragenicity – toxic to fetus
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity – potential to alter genomes
• New drugs that are structure similar and have toxicity profiles that mimic other known drugs

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3
Q

How does NIOSH (National Institute for Occupational Safety and Health) categorize hazardous drugs?

A

Category 1: ANTINEOPLASTIC DRUGS KNOWN TO BE HAZARDOUS w/repeated exposure (most chemotherapies).

Category 2: NON- ANTINEOPLASTIC drugs that Meet Previously Listed Criteria For Hazardous.

Category 3: Medications w/ADVERSE EFFECTS ON REPRODUCTION.

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4
Q

List of Agency/Orgs and their published regulations or standards

A

Envir Protect Agency (EPA): Resource Conver and Recovery Act (RCRA) and Mgt Standards for Hazordous Waste Pharaceuticals & Amend to Nicotine Listing

Occupat Safety and Health Admin (OSHA) Hazard Commun Standard (HCS)

National Instit for Occupational Safety and Health (NIOSH): List of antineoplastic (used to treat cancer) and other hazardous drugs

United States Pharmacopeia (USP) General Chapter 800: Hazardous Drug – Handling in Healthcare Settings (and Chapts 795, 797)

Amer Society of Health-System Pharmacists (ASHP) Guidelines on Handling Hazard Drugs

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5
Q

What is included in EPA’s Reource Conserv and Recovery Act (RCRA)?

A
  • P-List: ACUTE HAZARD WASTE from discarded commercial chem prods. Epinephrine, nic patches, nitroglyc, warfarin (>0.3%).
  • U-List: HAZARDOUS WASTE from discarded commercial chem prods. Important listed prods include warfarin, prescript nicotine replace prods, physostigmine, and some chemotherapeutic drugs
RCRA also provides D-List of 4 chars of hazard waste:
• Ignitability
• Corrosivity
• Reactivity
• Toxicity
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6
Q

What are key points about Disposal of hazard waste?

A

2019 EPA rule titled “Manage standards for Hazardous Waste Pharmaceuticals and Amend to Nicotine Listing”, provides fed guide on disposal of hazard drugs.

1) Hazard drugs CANNOT BE SEWERED (toilet/drain)
2) NON-CREDITABLE PHARMACEUTICALS (does not have expectation for manufacturer credit). Must Be Proper Dispose At Healthcare Facility.
3) POTENTIALLY CREDITABLE PHARMACEUTICALS CAN BE SHIP TO A REVERSE DISTRIBUTOR. Unused, less than 1 year past expire date, in manuf original container.
4) Hazard waste either separate contained in or commingled w/non-hazard waste in waste container label “HAZARD WASTE PHARMACEUTICALS”. Waste can only be accumulate FOR 1 YEAR PRIOR TO DISPOSAL

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7
Q

What is Controlled Substance Act?

A

Sign into law by Nixon in 1970. LED TO CREATE OF DEA, which agency in charge of carry out law. Establish initial criteria for determine whether substance should be control, and initial list of control subs. Establish process of add new of change status of exist control subs.

Why would substance be control? POTENTIAL FOR ABUSE:
• Evidence peop taking in high enuf doses to be danger to themselves, others, community
• People take on own volition (outside prescription/advice)
• Significant diversion of drug from legit distrib channels
• Drug closely enuf related to another substance which this determine been made

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8
Q

What are the (5) DEA Schedules for Drugs?

A

Schedule 1
• High potential for abuse, lack of accepted safety even w/medical supervise
• NO CURRENT ACCEPT MEDICAL USE (not in pharmacy)
• Examps: LSD, MARIJ, METHAQUALONE, HEROIN

Schedule 2
• HIGH POTENTIAL FOR ABUSE
• Abuse can lead to SEVERE PSYCHO OR PHYSICAL DEPRESS
• CURRENTLY ACCEPT MEDICAL USE
• Examps: MORPHINE, PCP (PHENCYCLIDINE), FENTANYL, COCAINE, MEPERIDINE (DEMEROL), METHADONE, OXYCODONE (OXYCONTIN), HYDROCODONE, METHAMPHETAMINE

Schedule 3
• Abuse may lead to LOW/MODERATE PHYSICAL DEPEND or high psycho depend
• CURRENTLY ACCEPT MEDICAL USE
• Examps: Codeine w/aspirin or acetamainophen, anabolic steroids, ketamine

Schedule 4
• Abuse may lead to limited physical or psycho depend relative to Sched 3
• Currently accept medical use
• Examps: Many benzodiapzepines (alprazolam, diazepam, clonazepam, lorazepam, etc)

Schedule 5
• Abuse may lead to limited physical or psycho depend relative to Sched 4
• Currently accept medical use
• Examps: Cough medicines w/codeine

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9
Q

What is the DEA number?

A

Import to ID DEA number WHEN PROCESS PRESCRIPTION FOR CONTROL SUBSTANCE

DEA number can be verify at website

9 chars:
1st letter: A, B, F, G
2nd letter: First ltr of last name

1st letter of DEA number:
A/B/F/G: Hosptal, Clinic, Practitioner, Pharma
M: Mid-level practitioner
P/R: manuf, distrib, etc.
G: Dept of Defense contractor
X; Suboxone/Subutex prescribe program

Step 1: 1st+3rd+5th numbers added toget during check
Step 2: 2nd+4th_+6th numbers added toget then multiply by 2
Step 3: Add numbers from Step 1 and 2, last digit should match 7th number

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10
Q

Receiving and refilling Control Substance Prescription

A

Sched 2 prescripts:

  • must be written and sign BY PRESCRIBER, CANNOT BE REFILL
  • CANNOT BE TELEPHONE EXCEPT IN EMERGENCY, in this case prescriber must submit written prescript W/IN 7 DAYS WITH NOTATION OF EMERGENCY VERBAL ORDER.
  • QUANT MUST ONLY COVER EMERGENCY PERIOD; pharmacist must notify DEA if signed prescript is not received.
  • Must be maintain by pharma for 2 years.

Sched 3/4 prescripts:
• can be prescribe via online, phone, fax. can be refill up TO 5 TIMES W/IN 6 MONTHS OF PRESCRIPT.

Sched 5 prescripts:
• Restrictions include: patient > 18 y/o, show ID, info of transaction logged. CAN BE REFILL MORE THAN 5 TIMES BUT 6 MONTHS EXPIRE IN PLACE.

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11
Q

Transferring Control Substance Prescription?

A
  • Sched 2 CANNOT BE TRANSFERRED
  • Sched 3&4 CAN BE TRANSFERRED 1 TIME
    o Pharmacies link thru central/unify system/DB can transfer these prescrips unlimited # of times.
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12
Q

Inventory?

A
  • Federal requires complete physical inventory EVERY 2 YEARS
  • records of sched i and ii must be KEPT SEPARATELY from Scheds III-V BS I AND II MUCH MORE HEAVILY REGULATED.
  • Many pharms lock C-IIs in cabinet. III, IV, V mix other products.
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13
Q

Ordering Sched II, III, IV, V?

A
  • SCHED II DRUGS must be order USING DEA FORM 222 or electronically via DEA Control Order System (CSOS). Form 222 issued in triplicate
    o One copy retain for record-keeping
    o 1 copy to supplier, 1 copy to distributor
    o Records must be maintain for AT LEAST 2 YEARS.
  • SCHED III-V DRUGS NOT REQUIRE SPECIFIC ORDER FORM
    o Records still need to be maintained as previously noted

• Suppliers submit TRANSACTION INFO FOR ALL CONTROLLED SUBSTANCES TO DEA
o Retail estabs ordering abnormal high quants of controlled subs can easily be IDd.

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14
Q

Combat Methamphetamine Epidemic Act of 2005 (CEMA)?

A

Intend to LIMIT SALES OF PRECURSORS TO AMPHETAMINE AND METHAMPHETAMINE. Includes many OTC cough and cold remedies

Following substances subject to this regulation:
o EPHEDRINE
o PSEUDOEPHEDRINE
o PHENYLPROPANOLAMINE

Specifics:
• Limits DAILY PURCHASE TO 3.6 GRAMS
• No more than 9 GRAMS IN 30 DAY can be purchase at PHARMACY
• No more than 7.5 GRAMS IN 30 DAY can be purchase via MAIL-ORDER

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15
Q

What is REMS?

A

Risk Evaluation and Mitigation Strategy (REMS):

Does a treatment need ADDITIONAL WARNING LABELS OR SPECIAL MEASURES beyond the usual disclaimers? Do a drug’s BENEFITS OUTWEIGH ITS RISKS? THE FDA CAN REQUIRE a REMS before or after a drug is approved.”

  • Goal: MITIGATE SERIOUS RISK of particular medication by informing, educating and/or reinforce actions to reduce frequency and/or severity of event.
  • Components of any given REMS ARE SPECIFIC TO THE MEDICATION. Each REMS is unique.

If a manufacturer fails to comply with REMS, it could face a $250,000 fine per incident. The FDA Amendments Act of 2007 allowed the FDA to require manufacturers to comply with REMS. REMS is a restricted drug program. Currently, there are over 100 drugs that contain a REMS program.

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16
Q

Example REMS: Isotretinoin
Goals: Prevent fetal exposure to isotretinoin (known teratogen: agent or factor which causes malformation of an embryo) and inform prescribers, pharmacists, and patients about serious risks and safe use condits.

A

Isotretinoin Prescriber requirements:
1. Enroll in the REMS: Prescribers get certify by fill out form w/their professional info.
2. Before prescribe/initial treatment:
o Counsel patients thorough about risks and need for contraception
o Confirm 2 negative pregnancy tests prior to prescribe
o Enroll patient in REMS
o Prescribe no more than 30 days supply, w/no refills
3. During treatment:
o Counsel at every visit
o Negative pregnancy test
o 30 days prescription at a time
o Report any pregnancies to REMS

Isotretinoin Patient requirements:

  1. Enroll in the REMS: Done by filling out form.
  2. Two methods of contraception for one month prior to starting
    a. Patient must attest to meeting this req
  3. Monthly comprehensive q’naire
    a. Intended to ensure patient maintains understand of REMS reqs

Isotretinoin Pharmacy requirements:
• Designate authorized representative: Typically a pharmacy ops manager or lead pharmacist
• Enroll in EMS: Must be recertify annually
• Provide medication guide at dispensing: Required for each refill
• All scripts must be verify in iPledge system: Risk Manage Authoriz number must be documented on prescription
• Dispense no more than 30 days supply by the dispense by date listed in the iPledge system; May create logistic challenges for patient

17
Q

What is a Recall?

A
  • Removal of a drug from the market BY THE DRUG MANUF
    o may be under OWN VOLITION OR DIRECTION OF FDA
* Reasons can include:
o	Mislabeling
o	Inconsistencies in potency
o	Contamination
o	Fail to adhere to good manuf practices
o	New safety concerns
o	Other issues that pose a public health concern
18
Q

Recall Classifications?

A

Class I Recall: A dangerous or defective product that could cause SERIOUS HEALTH PROBS OR DEATH.

Class II Recall: A product that may cause TEMPORARY HEALTH PROBS, or pose slight risk of serious problem.

Class III Recall: A product that UNLIKELY TO CAUSE ADVERSE HEALTH CONSEQS, but violates FDA label or manuf laws.

19
Q

Technician’s potential role in drug recall?

A
  • Monitor: FDA alerts.
  • Remove: Recalled stock and take action as directed in recall.
  • Notify: patients who received recalled medication.
20
Q

Acts of 1906, 1938, 1951, 1970

A

Pure Food and Drug Act of 1906
* Prohibit interstate commerce of misbrand and adultered drugs, foods, drinks

Federal Food, Drug, Cosmetic Act (FFDCA) of 1938

  • Created bs of shortfalls of 1906 act.
  • Needed Directions of Use, warnings, safety concerns.
  • Mandate premarket approval all drugs.

Durham-Humphrey Act 1951
* Require presripts written by physician

Drug Abuse Prevention and Control Act of 1970 (controlled subs act)

  • Control subs I-V stuff
  • DEA Form 222
21
Q

Refills?

A

C-II CANNOT BE REFLLLED.

C-III, IV can refill up to 5 Times In 6 Months.

22
Q

iPledge

A

REMS program. Goal is to prevent FETAL EXPOSURE TO ISOTRETINOIN, drug w/serious side effects. Computer-based risk mgt. system.

23
Q

Safety Data Sheets (SDS)

A

Written by manuf, provide info about hazard chems, include hazards, handling, cleanup, necess PPE.

24
Q

What is NPI?

A

NPI number = National Provider Identifier

A National Provider Identifier (NPI) is a unique 10-digit identification number issued to healthcare providers by the CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS).

It replaced the unique physician identification number (UPIN).

25
Q

What is HIPAA?

A

Health Insurance Portability and Accountability Act of 1996.

The Privacy Rule standards address the use and disclosure of individuals’ health information (known as “protected health information”) by entities subject to the Privacy Rule. These individuals and organizations are called “covered entities.”

26
Q

DEA Form 222?

A

o USED FOR ORDER/DISTRIB SCHED II CONTROLLED SUBSTANCES
o In triplicate (Supplier, DEA, purchaser), valid 60 days, includ Pharma name, DEA number.
o Must be kept for 2 YEARS
o Valid only for 60 days
o Contain Pharma name, DEA #

27
Q

DEA Form 106?

A

o Used for report THEFT OR LOSS OF SCHED I-V CONTROLLED SUBS

28
Q

DEA Form 41?

A

o Used to report DISPOSAL OF SCHED I-V CONTROLLED SUBS

29
Q

DEAT Form 224?

A

o Used by entity to request permission to dispense controlled substances.

30
Q

Most non-controlled prescriptions valid for?

A

1 year from time of WRITING

Pharma Test (5 decks)

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