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Federal and MO MPJE 2017

Terms in this set (838)

You must notify BNDD within __ days if your pharmacy changes locations.
30 days
How long must you retain CII inventory records?
2 years
How often is CS inventory required?
Annually (in Missouri)
Which drugs must be hand counted in a CS inventory?
All CIIs and CIII-V in stock bottles containing more than 1000 units
Which drug counts can be estimated in a CS inventory?
CIII-V in less than 1000 count stock bottles
T/F: If a pharmacy keeps a perpetual inventory they are not required to do an annual inventory of CS.
False. Perpetual inventory does not replace required annual inventory.
How long must records of CS destruction be kept?
2 years
How should CS be stored in the pharmacy?
CII locked; CIII-V locked or distributed throughout inventory
What is the day supply limit on CII Rx?
30 days; unless dx is documented can do 90 days
T/F: Prescriber may give patient 3 scripts for Adderall at one visit.
True. Cannot exceed 90 day supply. Must write "Do not fill until ____".
What is required on a CS Rx?
Date written; patient name and address; name, address, and DEA number of prescriber; drug name, strength, and dosage form; quantity to dispense; directions for use; signature of prescriber
Can a CS Rx be faxed to the pharmacy for fill?
Yes. CII may be faxed to get things started; however, must have original to dispense the drug. CIII-V may be accepted via fax. CII fax is allowable if LTCF or hospice patient.
What is MO RPh prohibited from changing on a CS Rx?
Name, name, name. Patient name, drug name, and prescriber name.
When may a RPh partial fill CII?
Out of stock (must give remainder in 72 hours) and LTCF or terminally ill patients.
Who is responsible for the CS drugs in E-Kits?
The LTCF.
Who regulates CS stock (E-kits) in LTCF?
BNDD. DEA does not register or regulate LTCF.
T/F Narcotic drugs can be used to ween patients off narcotics
False.
Can methadone be prescribed for opioid dependence?
Mostly no. Only for infants (must document that patient is an infant) and practitioner may administer methadone for 3 days as patient is getting placed in narcotic treatment program.
T/F: RPh may dispense CS to directly to a prescriber for office use.
False. Must obtain a patient-specific Rx.
T/F: MO prescribers may prescribe CS for themselves.
False.
T/F: MO mid-level practitioners may not prescribe to family members.
True.
How does BNDD define "insignificant loss"?
Insignificant loss is breaking a tablet or liquid sticking to the side of the bottle. You know where the drug is. It was not LOST. Requires documentation and attach to inventory.
How must you report loss or theft to BNDD?
Immediately report via phone, fax, or email. Must submit loss report within 7 days.
T/F An agent from a prescribers office calls to authorize an emergency fill of hydromorphone for pain for a patient requiring potent pain meds ASAP. She states the pain is so severe only hydromorphone will do. She only authorizes a 3 day amount and will have the Rx to you within the next few days. This is legal.
False. Emergency fills can only be verbally authorized by prescriber, not an agent.
How many refills are allowable on CIII-IV Rx?
5 refills
How many refills are allowable on CV Rx?
As authorized by physician.
What is the quantity limit on CIII-V Rx?
90 day supply
How long is a CIII-IV Rx valid?
6 months
How long is a CV Rx valid?
1 year
What does CMEA stand for?
Combat Methamphetamine Epidemic Act
Which form is used for new pharmacy registration with DEA?
DEA Form 224
Which form is used to renew pharmacy registration with DEA?
DEA Form 224a
Which form can be used to renew pharmacy registration with DEA for a chain pharmacy?
DEA Form 224b
What is required when a pharmacy chooses to terminate its registration with the DEA?
Return DEA registration certificate and unused DEA 222 Forms.
Which form is used by manufacturers to register with the DEA?
DEA Form 225
What color is Copy 1, Copy 2, and Copy 3 of DEA 222 form?
Copy 1 is brown. Copy 2 is green. Copy 3 is blue.
What happens to each copy of the DEA 222 Form?
Purchaser keeps Copy 3 for their records. Purchaser sends Copy 1 and 2 to the supplier to request drug order be filled. Supplier retains Copy 1 for their files. Copy 2 is forwarded to the DEA by the supplier. When purchaser receives drug order he/she should record, on Copy 3, the # of each item and date received.
If a supplier cannot fill a particular drug on the Form 222 submitted by the purchaser, how long does the supplier have to ship that item?
60 days.
Which form is used when a registrant destroys CS inventory?
DEA Form 41
When a reverse distributor is used for destruction, who is responsible for submitting DEA Form 41 to the DEA? Pharmacy or reverse distributor?
Reverse distributor is responsible.
T/F In order for a person to work in a pharmacy after having been convicted of a felony related to CS, a waiver must be approved by the DEA.
True.
Theft occurs at your pharmacy. How long do you have to notify the DEA?
Notify DEA within one business day of discovery. Notification should be in writing.
Which form is required to report theft or loss of CS to the DEA?
DEA Form 106
How does the DEA define "significant loss"?
DEA does not define significant loss. They say you should use professional judgement.
A tote containing CS goes missing in-transit from the distributor to the pharmacy. This is recognized before the pharmacist signs for the delivery. Who is responsible for reporting the loss/theft to the DEA? Supplier or pharmacy?
The supplier is responsible.
A tote containing CS drugs is missing one bottle of methylphenidate. The pharmacist discovers the drug is missing while putting the drug order away. Who is responsible for reporting the loss/theft to the DEA? Supplier or pharmacy?
The pharmacy is responsible.
Per the Controlled Substance Registrant Protection Act, when is a federal investigation appropriate following a theft of CS?
Federal investigation is warranted if one of the follow occurs:
1) cost of stolen CS is greater than $500
2) interstate or foreign commerce is involved
3) a person is killed or significantly injured as a result.
T/F Hydrocodone/APAP gets re-scheduled as CII. The pharmacist is required to do a full CS inventory at the time of re-scheduling?
False. The pharmacist is required to take inventory of the particular drug that has been re-scheduled on the day this happens.
T/F The DEA requires documentation of Power of Attorney be submitted to them no later than 14 days after RPh is given this responsibility.
False. DEA does not require this. Power of Attorney information should be filed in the pharmacy.
What does CSOS stand for?
Controlled Substance Ordering System
List the letters that may be the first letter of a DEA number.
A, B, F, X or M (for mid-level practitioners)
What determines the second letter of a DEA number?
First letter of prescribers last name.
What does it mean if a DEA number starts with X?
This indicates the prescriber is authorized to treat patients with Suboxone. The DEA number starting with X must be present on Rx for Suboxone.
How many numbers are in a DEA number?
Seven numbers.
How do you determine a DEA number is valid?
Should begin with A, B, F, X or M. The second letter should be first letter of last name (keep in mind may reflect maiden name for females). Add digits 1, 3, 5. Add digits 2, 4, 6 and multiply by 2. Add sum of first equation and sum of second. The last digit of this sum should match last digit of DEA number.
T/F A patient requests to have Rx for alprazolam transferred to another pharmacy. The pharmacist may delegate the task to a tech if he/she is busy with a customer.
False. CS transfers must be done between two RPhs!
John Smith is a LTCF patient with an order for Oxycontin. The pharmacist received the order from the physician and has been partial filling. How long is the CS order good for in LTCF patients?
60 days
T/F A pharmacy is going to mail a Rx for zolpidem to a patient. They are required to stamp a 2" C on the envelope prior to mailing.
False. CS may be mailed if the mailer has a DEA registration and it is packaged in plain paper with no indication that it contains CS.
What does SLCP stand for?
Scheduled listed chemical products.
How much pseudoephedrine can a person purchase in one day?
No more than 3.6 grams of SLCP-containing product.
How much pseudoephedrine can a person purchase in 30 days?
No more than 9 grams of SLCP-containing product.
What is required on the logbook to dispense SLCP-containing products?
Name and address of purchaser, date and time of purchase, amount of product purchased, and patient signature.
T/F ID is only required if person purchasing SLCP-containing product is less than 18 years of age.
False. Photo ID is required for all SLCP purchases.
Where can the MO Pharmacy Practice Act be found?
Chapter 338 RSMo; 20 CSR-2220
Where is MO Controlled Substance Act found?
Chapter 195 RSMo; 19 CSR-30-1
Describe the composition of the MO BOP?
7 members. 6 members are RPh. 1 is a public member.
Who appoints members to the BOP?
Governor.
Who places drugs in schedules?
Attorney General
How long are MO BOP positions held? Can they be renewed? What is the lifetime limit?
5 years. Can be renewed. No lifetime limit.
Name the pharmacy. Class A.
Retail pharmacy
Name the pharmacy. Class B.
Hospital outpatient
Name the pharmacy. Class C.
LTC
Name the pharmacy. Class D.
Non-sterile compounding
Name the pharmacy. Class E.
Radiopharmaceutical
Name the pharmacy. Class F.
Renal Dialysis
Name the pharmacy. Class G.
Medical gas
Name the pharmacy. Class H.
Sterile compounding
Name the pharmacy. Class I.
Consultant
Name the pharmacy. Class J.
Shared services.
Name the pharmacy. Class K.
Internet pharmacy (90% of volume from internet)
Name the pharmacy. Class L.
Veterinarian pharmacy
Name the pharmacy. Class M.
Specialty (Blood products)
Name the pharmacy. Class N.
Automated dispensing (Healthcare system)
Name the pharmacy. Class O.
Automated dispensing (ambulatory)
Name the pharmacy. Class P.
Practioner's office
What format is required for a MO prescription form?
Two signature lines. Left side: substitution permitted. Right side: DAW.
T/F MO Board of Pharmacy has no jurisdiction over outpatient pharmacies.
False. MO BOP has no jurisdiction over INPATIENT pharmacies.
If revoked, the Board may statutorily prohibit licensee from reapplying for a license for up to ___ years.
Seven years
When is MO pharmacist license renewed?
Every two years. On even numbered years.
How many CE hours are required per 2 year registration period for a pharmacist?
30 hours per 2 years
How long must a RPh maintain record of CE?
Must retain proof of CE x 2 renewal cycles (4 years)
You change employers. You must notify MO BOP within ___ days of taking your new position.
Within 15 days
T/F You may only serve as PIC at one pharmacy due to the time requirements of the position.
False. You may serve as PIC at more than one pharmacy.
T/F The BOP does not need to be notified when new PIC is selected.
False. BOP should be notified immediately. New PIC can serve immediately. Must submit change of PIC form to the Board.
T/F MO law requires 1 pharmacist for every 5 technicians working in a pharmacy.
False. MO has no tech limits. But, requires techs be under "direct supervision and responsibility" of pharmacist
T/F All pharmacies must have an alarm system and security cameras.
False. Must have "adequate security to deter theft" of drugs.
T/F RPh and tech licenses must be displayed in the pharmacy and be accompanied by a 2x2" photo.
False. Only RPh license requires photo.
T/F You may move your pharmacy to a new location as long as you notify the Board of this move within 7 days of the move.
False. To move locations you must submit a new location application. The new location must be approved and inspected prior to moving.
What three changes to the pharmacy are considered "remodeling" according to the Board?
1. change in CII storage; 2. changes to water or sewage connections; 3. changes to physical security of drugs
You are remodeling your pharmacy and temporarily working out a few trailers on the parking lot of your pharmacy. Are you required to submit a new location application to the Board?
Yes. Change of location application is required even for a temporary move to location outside the current pharmacy.
Are non-resident pharmacies required to have a MO pharmacy permit prior to shipping, mailing, or delivering drugs to MO?
Yes.
Out-of-business form must be filed with the Board within ____ days after pharmacy termination.
15 days
T/F Pharmacy owners are instructed to shred their MO pharmacy permit after submitting their out-of-business form to the Board.
False. MO pharmacy permit should be returned to the Board with the OOB form.
T/F In MO, electronic prescriptions are required to have two signature lines for the prescriber to indicate whether substitution is permissible.
False. Not required on electronic Rx. However, prescriber must indicate product selection.
T/F A podiatrist is not an authorized prescriber in the state of Missouri.
False. Podiatrist is authorized prescriber.
T/F An optometrist is an authorized prescriber in the state of Missouri.
True.
T/F APRN has prescriptive authority as long as he/she is in a collaborative practice with a physician's assistant.
False. APRN and PA must be in collaborative agreement with a physician.
T/F Per BNDD, out-of-state prescribers must comply with the rules of their home state.
True.
Describe prescribing authority of APRN with regards to schedule III drugs.
Limit on CII (hydrocodone only) and CIII opiate/narcotics: 5 day supply with no refills. All other CIII-V no limit.
Describe prescribing authority of PA with regards to schedule III drugs.
PA can only prescribe 5 day supply for ALL schedule III drugs and hydrocodone. No refills.
T/F Prescriber may use a stamp of his/her signature to authorize non-control prescriptions.
False. Rubber stamp is not allowed. For non-control, may sign manually or electronically.
T/F Bob asks you to transfer his script for Norco to another pharmacy. It's 10 days to soon to fill the Norco. In this scenario, BOP recommends that you not transfer the Rx until it is time to fill the medication. You must inform the patient of this.
False. An Rx MUST be transferred if the Rx is still valid and has authorized refills remaining. It is the responsibility of the dispensing pharmacy to decide whether to dispense the Rx.
T/F Patient counseling only needs to be offered on the first fill of an Rx.
False. Must be offered on new Rx and all refills.
Can a pharmacist flavor OTC Robitussin at the patient's request?
No. Flavoring of OTC products requires an Rx.
T/F Flavoring a prescription product is considered compounding and must be entered into the pharmacy's compounding log.
False. Flavoring is not compounding.
A compounding pharmacy must retain ____ for each bulk product used in compounding products.
Certificate of analysis
T/F Given the complexity of many drug names, the Board allows names of drugs to be abbreviated on the label of compounded products.
False. Must have the full name of each active ingredient on the label. May use auxiliary labels to fulfill this requirement.
For sterile compounding, how often must the hood be re-certified?
Every 6 months
How long must a pharmacy keep compounding records?
2 years
How long must a pharmacy keep CS prescriptions?
5 years
How long must a pharmacy keep drug invoices?
2 years
How long must a pharmacy keep the RPh logbook?
5 years
How long must a pharmacy keep immunization records?
2 years
How long must a pharmacy keep immunization protocol?
8 years after termination of protocol
How long must a pharmacy keep MTS protocol?
8 years after termination of protocol
How long must a pharmacy keep prescription orders for MT services?
7 years
How long must a pharmacy keep sterile compounding log?
2 years
Which vaccines may a pharmacist administer per protocol in MO?
Pneumonia, shingles, meningitis, Hep A, Hep B, Tdap, and influenza
How old must patient be to receive an immunization from a pharmacist?
12 years
What is required of a pharmacist before he/she can administer vaccinations?
Notification of intent filed with BOP, active RPh license, CPR certification, vaccine administration certification, protocol with MO physician
How often must a notification of intent for immunization be filed with the BOP?
Annually
What are the specific CE requirements for pharmacist giving immunizations?
2 hours of CE related to immunization submitted annually with Notice of Intent
How long is a immunization protocol with a physician good for?
1 year
What must pharmacist document for each immunization administered?
Patient name, address, and DOB; date, route, and site of administration; name, dose, manufacturer, lot number, and expiration date; name and address of PCP; RPh initials; and ADR (if applicable)
What are the specific CE requirements for a pharmacist registered to do MTS?
6 hours of CE related to MTS every 2 years
What is the minimum education required of a Missouri registered pharmacy technician?
No minimum education requirements at this time
What three things must a pharmacist have prior to performing MTS services?
1) An MTS certificate from the BOP
2) A protocol in place with a physician practicing in Missouri or a "medical staff committee" of a hospital
3) A patient-specific prescription order from the protocol physician to provide MTS services
How often must a MO technician renew his/her license?
Annually by May 31st
What is the definition of a drug?
1. Articles listed in USP or NF; 2. Articles other than food intended for diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body
What is misbranding?
Label is defaced or misleading; labeling is missing any of the required information (lot or expiration date); do not dispense
What is adulteration?
Fails to conform to compendial standards for purity, quality, or strength; has not been manufacturered under GMP standards; fails to be stored under USP standards
What legislation created Rx and OTC classes?
Durham-Humphrey Amendment
What legislation requires drugs have "adequate directions for use"?
Durham-Humphrey Amendment
What legislation requires manufacturer demonstrate efficacy of product before marketing?
Kefauver-Harris Amendment
What legislation gives FDA authority over Rx drug advertising?
Kefauver-Harris Amendment
What legislation requires GMP?
Kefauver-Harris Amendment
The ____ ____ Amendment gave FDA authority of medical devices.
Medical Device Amendment
What are the classes of devices?
Class I is low risk and subject to GMP. Class II is medium risk and subject to GMP plus performance standards. Class III is high risk and subject to FDA premarket approval process.
Orphan Drug Act allows for tax breaks and such for drugs used for rare diseases. Less than _____ people in the US are affected by the disease.
Less than 200,000
What did the Hatch-Waxman Amendment do?
How we handle approval of generic drugs (ANDA) and requires FDA publish Orange Book
Define pharmaceutical equivalent
Same active ingredient, dosage form, route, strength and/or concentration. MAY differ in shape, scoring, release mechanism, packaging, excipients, and expiration time.
Define pharmaceutical alternative
Same therapeutic moiety, but are DIFFERENT salts, esters, or complexes of that moiety, or are different dosage forms or strengths. Data are generally not available for the FDA to make determination of tablet to capsule bioequivalence.
Define therapeutic equivalents
PHARMACEUTICAL EQUIVALENTS that are expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
T/F A medication may not be legally prescribed by a physician for an off-label use.
False. Physicians may write for off-label use. Pharmacist can recommend off-label use to prescriber. Manufacturer cannot market these uses without data to support their claims.
What legislation prohibits retail pharmacies from having samples?
Prescription Drug Marketing Act
What legislation prohibits resale of drugs purchased at special prices by hospitals?
Prescription Drug Marketing Act
What legislation created the uniform nutrition label format?
Nutrition Labeling Education Act
What legislation limits the claims that can be made about supplements?
Dietary Supplement and Health Education Act (DSHEA). May not overstate structure/function and general well-being claims; doing so will result in being regulated like a drug.
What legislation created a fast track for drugs for "life threatening" diseases?
Food and Drug Administration Modernization Act
What legislation strengthened laws regarding compounding? (Compounds cannot be sold to other pharmacies, cannot be already available from consumer sources, or contain products that have been removed from the market)
Food and Drug Administration Modernization Act
What legislation authorized the consumer products safety commission to set standards form child-resistant containers?
Poison Prevention Packaging Act
Who sets the standards for child-resistant container requirements?
Consumer Products Safety Commission (CPSC)
Child-resistant containers are required for ____ prescription drugs and ____ OTC drugs
All Rx (with exceptions) and certain OTCs
Name Rx drugs that are not required to have CRC.
SL nitroglycerin, cholestyramine products, oral corticosteroid dose packs, aerosols for inhalation, OCs in memory packs
Name OTC drugs required to have CRC.
Most common: aspirin, acetaminophen, NSAIDs, any OTC that used to be Rx, iron, lidocaine
Can a prescriber make a blanket request that all patient's pill bottles be without CRC?
No.
Can a prescriber make a request on a particular Rx that patient's pill bottle not be CRC?
Yes. Prescribers can make this request on a Rx-by-Rx basis.
Can patient make a blanket request that all pill bottles be without CRC?
Yes.
T/F It is required by law for a pharmacist to document in writing that a patient requests no CRC.
False.
What does OBRA stand for?
Omnibus Budget Reconciliation Act
What were three duties assigned to pharmacists by OBRA?
1. Maintain patient profiles; 2. Screen therapy (DDI, contraindications, etc); 3. Offer to counsel
When during the new drug approval process does a manufacturer file an IND with the FDA?
After pre-clinical trials. IND should present data from pre-clinical trials and outlined proposed protocol for clinical trials.
When during the new drug approval process does a manufacture file a NDA with the FDA?
Submitted after phase III trial. This is what the FDA uses to decide if the drug should go on the market.
Which phase of clinical trials includes healthy individuals?
Phase I
Which phase of the trial is used to assess effectiveness and dosage in a small group of patients with the disease?
Phase II
What is a phase III trial?
Large scale trial used to compare effectiveness of the new drug versus standard therapy.
What does ANDA stand for? And what is it used for?
Abbreviated new drug application. Used to get generic drugs approved. Only requires PK and bioavailability data
What does SNDA stand for? And what is it used for?
Supplemental new drug application. Used after marketing if the manufacturer decides to change drugs synthesis, production procedure, packaging, or labeling.
How many classes of drug recalls are there? Which class is the worse and may result in death?
Three classes. Class I is the worst.
T/F Controlled substances may be put in a patient med-pak as long as the prescriber indicates it is okay.
False. CS cannot be put in the med-pak.
T/F Only prescription drugs are required to have an NDC number.
False. OTC and Rx drugs must have an NDC.
What is the format of a NDC number?
Manufacturer (5), drug (4), package size (2)
What letter in the DEA number is used to indicate a prescriber is permitted to prescribe Suboxone for an opioid addict?
X
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
What is the definition of covered entity?
CE includes any health plan, healthcare provider, or agency that processes health claims, and company that subcontracts with any of those covered by HIPAA
Who enforces HIPAA?
Office of Civil Rights
What does PHI stand for?
Protected health information
What is "use" of PHI?
the sharing, employment, application, utilization, examination, or analysis of PHI WITHIN a covered entity that maintains PHI or by a covered entity that possesses PHI
What is "disclosure" of PHI?
divulging PHI, in any form, media or manner, OUTSIDE the covered entity creating or possessing PHI
What are the permitted uses of PHI that do not require specific authorization from the patient?
Treatment, payment, or healthcare operations. Remember TPO.
What is the minimum necessary rule?
Only use minimum necessary when looking at PHI. Minimum necessary does not apply to TREATMENT.
What is NOPP?
Notice of Privacy Practices. It details permitted uses and disclosures of PHI. Patient should be given NOPP.
What are the five rights of an individual under HIPAA?
1. Right to Notice (regarding CE's privacy practices)
2. Right to Request Privacy Protections
3. Right to Access (their PHI)
4. Right to Request an Amendment (to PHI)
5. Right to Accounting (of certain disclosures of their PHI)
How long must you keep HIPAA related documents?
Six years
What are business associates (with regards to HIPAA)?
Anyone that uses or access PHI to provide services to or on behalf of a CE
What safeguards does HIPAA require a pharmacy have to protect PHI?
"Reasonable" safeguards. Must have administrative procedures, physical safeguards, and technical safeguards. Does not define specific requirements.
Name that schedule: alfentanil
CII
Name that schedule: amobarbital capsule
CII
Name that schedule: amphetamine
CII
Name that schedule: cocaine
CII
Name that schedule: fentanyl
CII
Name that schedule: hydrocodone
CII
Name that schedule: hydromorphone
CII
Name that schedule: meperidine
CII
Name that schedule: methadone
CII
Name that schedule: methamphetamine
CII
Name that schedule: methylphenidate
CII
Name that schedule: morphine
CII
Name that schedule: opium tincture
CII
Name that schedule: oxycodone
CII
Name that schedule: amobarbital suppository
CIII
Name that schedule: butalbital (Fiorinal)
CIII
Name that schedule: buprenorphine
CIII
Name that schedule: codeine combo (90mg or less/dose)
CIII
Name that schedule: dronabinol
CIII
Name that schedule: hydrocodone combo product
CII
Name that schedule: ketamine
CIII
Name that schedule: pentobarbital suppository
CIII
Name that schedule: testosterone
CIII
Name that schedule: thiopental
CIII
Name that schedule: alprazolam
CIV
Name that schedule: chlordiazepoxide
CIV
Name that schedule: clonazepam
CIV
Name that schedule: clorazepate
CIV
Name that schedule: diazepam
CIV
Name that schedule: lorazepam
CIV
Name that schedule: midazolam
CIV
Name that schedule: modafinil
CIV
Name that schedule: pentazocine
CIV
Name that schedule: phenobarbital
CIV
Name that schedule: phentermine
CIV
Name that schedule: zaleplon
CIV
Name that schedule: zolpidem
CIV
Name that schedule: codeine combo preparations 200mg/mL or less
CV
Name that schedule: diphenoxylate preparations
CV
What is negligence?
Failure to comply with the standard of care a reasonable person would exhibit, which failure is the actual or proximate cause of harm or damages to another
T/F Per HIPAA, research is considered "healthcare operations" and does not require authorization from a patient to use PHI.
False.
Adulteration and misbranding are originally addressed in what legislation?
Pure Food and Drug Act
What legislation recognizes USP-NF as official standard?
Pure Food and Drug Act
Name some GRAS devices that were grandfathered into the Medical Device Amendment.
Toothbrushes, canes, tongue compressors
How many years does a drug patent last in US?
17 years
What is the cap on number of years a patent can be extended per Watchman-Hatch Amendment?
5 year cap to compensate for FDA review process
What legislation requires manufacturers pay fees for FDA review?
Prescription Drug User Fee Act (PDUFA). Allowed FDA to higher more staff.
What legislation allows for fast track approval for drugs for "life threatening" diseases?
Food and Drug Administration Modernization Act (FDAMA)
Who gets to decide the proprietary (brand) name of a drug?
The manufacturer
Who gets to decide on the generic name of a drug?
United States Adopted Names Council (USANC)
What does the term "labeling" refer to?
Information printed on the label, outside of package of a drug product, and all other written, printed, or graphic matter either on the product, its container, its wrapper, or accompanying the product.
For a container to be considered child resistant, at least ___% of adults having been shown how can open in 5 minutes and not more than ___% of children less than 5 years old having been shown how can open within 5 minutes.
90% of adults; 20% of children
What drugs are you required to give the patient the package insert?
Patients receiving Accutane, statins, and estrogen or progesterone containing products
What is a negative formulary?
A list of drugs that CANNOT be generically substituted
What is a positive formulary?
A list of drugs that CAN be generically substituted
T/F Medicare is primarily funded by the state.
False. Medicare is federally funded.
T/F Medicaid is primarily funded by the state?
True.
Medicare brings minimum healthcare to which two groups of people?
Elderly > 65 years of age and certain disabled persons of any age
Medicare Part A provides ___ coverage
Hospital services
Medicare Part B provides ___ coverage
Physician services
Medicare Part D provides __ coverage
Rx drug coverage
Which Medicare Parts are elective and cost the patient money?
B, C, and D
Medicaid provides minimum healthcare to ____.
Indigent persons. Medically indigent (blind, disabled, or aged). Or financially indigent (no or low income and asset base)
What services does Medicaid cover?
Hospital services, physician services, diagnostics, SNF and home health, dental and optometric services, outpatient RX drugs
What are the three methods that a drug can switch from RX to OTC?
1. manufacturer requests switch via SNDA (only applies to requesting manufacturer not all products); 2. manufacturer can petition the FDA; 3. FDA can recommend the switch (applies to ALL bioequivalent products)
Who regulates advertising of OTC drugs?
Federal Trade Commission
T/F Schedule I controlled substances may not be prescribed, dispensed, administered, or researched.
False. DEA does allow use of Schedule I substances for research (with separate registration).
Name that schedule: propoxyphene
CIV
T/F All pharmacists must be registered with the DEA.
False. DEA does not register pharmacists only pharmacies.
Define "emergency" for emergency dispensing of CIIs.
Immediate administration is necessary for proper treatment AND alternative treatment is not available (including non-CII drugs) AND not possible to provide a written prescription at that time
What must be documented on an Rx for a terminally ill or LTCF patient each time the drug is partially dispensed?
Date of partial fill, quantity dispensed, remaining quantity, and dispensing pharmacist
T/F All refills on a (non-controlled) legend drug's Rx expire in 1 year from date of 1st dispense.
False. Expire one year from date written.
T/F The full quantity of a non-controlled prescription may be dispensed up to the day the Rx expires. Example: sertraline 50mg daily #90 2 refills. You may dispense 270 tablets on the first fill
True. Legally allowable. May be a problem for insurance.
How long can a pharmacy technician assist an RPh prior to being issued a certificate of registration?
90 days
What factors does the Attorney General consider when he schedules drugs?
actual or relative potential for abuse; state of current scientific knowledge regarding the drug or other substances; its history and current pattern of abuse; scope, duration, and significance of its abuse; what, if any risk, there is to public health; psychic or physical dependence potential; whether the substance is an immediate precursor of a substance already controlled
How often must manufacturers renew their registration with the FDA?
Annually before December 31
A tornado rips through your county. The area is declared a "disaster area". You are permitted to move your pharmacy to a mobile location to better serve your patients for a maximum of ___ months without applying for change of location with the MO BOP.
6 months
When you decide to operate your pharmacy from a mobile location due to a disaster two things must you report to the MO BOP?
Location of your mobile location and estimated time expected to be in the mobile location
A patient asks you to transfer their Rx to a different pharmacy. You have ___ day(s) to transfer the Rx upon request.
One day
What is the maximum expiration date on a drug that is pre-packed?
12 months or manufacturer expiration date. Whichever is first.
Pre-packed drugs must have a label affixed with minimum of what information?
Drug name and strength, manufacturer, lot number, and expiration date
What is the definition of "pre-packed" drug?
Any drug which has been removed from the original manufacturer's container and is placed in a dispensing container for other than immediate dispensing to a patient
You work in a LTC pharmacy. Mr. Smith's order for furosemide changed from 20mg take 1 tablet to 20mg take 2 tablets. The nurse from the nursing home calls you and asks that you send them a label with the new directions so the patient's medication card will have accurate directions. Can you send her a label with the correct directions?
No. If a label change is required, a pharmacist must personally affix the label to the container. Nurses at the facility may use "change of directions" stickers to indicate a change in directions.
T/F When a patient leaves a LTCF their prescription drug orders may be transferred to a retail pharmacy to ensure the patient has continuation of care.
False. Drug orders given at LTCF are not valid outside that LTCF.
What is a patient med-pak?
A package prepared by a pharmacist for a specific patient comprising one or more containers and containing two or more prescribed solid oral dosage forms
T/F Patient med-paks are exempt from the Poison Prevention Packaging Act.
False. The patient med pak, if it does not meet child-resistant standards, shall be placed in an outer package that does comply, or the necessary consent of the purchaser or physician to dispense in a container not intended to be child-resistant, shall be obtained.
How long must a pharmacy keep documentation regarding quality assurance of an automated dispensing system?
2 years.
Quality assurance documentation for an automated dispensing system should include at minimum...
1. Breach of security of the automated system; 2. Failure of the system to operate correctly along with the frequency of any failures and the necessary repairs completed; 3. Tests completed to measure the effectiveness and accuracy of the system every six (6) months and when- ever any upgrade or change is made to the system.
Name that schedule: lacosamide
CV
Name that schedule: pregabalin
CV
Which legislation prohibits adulteration or misbranding of foods and drugs?
Pure Food and Drug Act of 1906
Which legislation was urged by 107 accidental deaths caused by anti-freeze diethylene glycol poisoning?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires new drugs to be proven safe when used according to labeled directions?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires that medications include labels with adequate directions for use?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires that labels include warnings about habit-forming risk?
Food Drug and Cosmetic Act (FDCA) of 1938
Which drugs available at pharmacies today have not been evaluated for their safety?
Those in use before the FDCA of 1938, which have been "grandfathered" in
Which legislation distinguished legend from non-prescription drugs?
Durham-Humphrey Amendment of 1951
Which legislation provided for verbal orders and refills on prescriptions?
Durham-Humphrey Amendment of 1951
Which legislation was adopted as a result of public concern about thalidomide?
Kefauver-Harris Amendment of 1962
Which legislation is also referred to as the Drug Efficacy Amendment?
Kefauver-Harris Amendment of 1962
Which legislation required new drugs must be EFFECTIVE in addition to being safe?
Kefauver-Harris Amendment of 1962
Which legislation gave the FDA authority to regulate prescription drug advertisements?
Kefauver-Harris Amendment of 1962
Which legislation created Good Manufacturing Practice (GMP) requirements?
Kefauver-Harris Amendment of 1962
Which entity regulates OTC advertising?
Federal Trade Commission (FTC)
Which entity regulates legend drug advertising?
FDA
Which legislation provides tax and licensing incentives to manufacturers to develop drugs used to treat rare diseases?
Orphan Drug Act of 1983
What is another name for the Drug Price Competition and Patent-Term Restoration Act?
Hatch-Waxman Amendment
Which legislation provided a streamline approval process for generic drugs with the creation of the Amended New Drug Application (ANDA)?
Hatch-Waxman Amendment or Drug Price Competition and Patent-Term Restoration Act
Which legislation regulated prescription drug sample distribution?
Prescription Drug Marketing Act of 1987
Which legislation required federal licensing of wholesalers and prohibited resale of prescription drugs purchased by hospitals?
Prescription Drug Marketing Act of 1987
Which legislation expedites the approval of an Amended New Drug Application for serious or life-threatening conditions?
FDA Modernization Act of 1997
Which legislation draws the distinction between compounding (to be regulated by states) and manufacturing (federally regulated)?
FDA Modernization Act of 1997
Which legislation abbreviated the required "Caution: Federal law prohibits dispensing without a prescription" to "Rx only"?
FDA Modernization Act of 1997
Which legislation eliminated the need for certain substances to be labeled "Warning - May be habit forming"
FDA Modernization Act of 1997
Which legislation specifically prohibits manufacturers from disseminating information about unapproved uses for drugs?
FDA Modernization Act of 1997
What must a pharmaceutical manufacturer do to obtain an additional six months of market exclusivity? According to which legislation?
Pediatric studies. FDA Modernization Act of 1997
What are the four programs of the Medicare Prescription Drug Improvement and Modernization Act of 2003?
Medicare Parts A, B, C, and D
What does Medicare part A cover?
Hospitalization
What does Medicare part B cover?
Physician services
What does Medicare part C cover?
Managed care
What does Medicare part D cover?
Prescription drugs
What is the primary purpose of the Investigational New Drug Application (IND)?
To prove a new drug is safe for human trials
Which phase during clinical trials is intended to evaluate pharmacokinetics and toxicology of a new drug?
Phase I
Which phase during clinical trials evaluate efficacy, but also to help determine appropriate dosing, risk of ADRs, etc?
Phase II
Which phase during clinical trials are likely to be randomized double-blinded, placebo controlled trials?
Phase III
Under which circumstance may an IND be used to treat a disease?
Imminent life threatening stage of an illness for which there is presently no cure, or current drugs are inneffective
ANDA or SNDA: new indication
SNDA
ANDA or SNDA: new generic
ANDA
Which end of the chemical classification of drugs (type 1 to 6) refers to the most difference from existing drugs?
Type 1
What form a pharmacy should use to apply for DEA registration
DEA 224 either online or request paper app
*if pharmacy wants a copy, request it online
What form a pharmacy should use to renew pharmacy DEA registration?
DEA 224a
*can start renew 60 days prior to exp date
What form can a chain retail pharmacy use to renew DEA registration?
DEA 224b
Registration requirement regarding the sale of SCLP?
retails store just have to self-certify, don't need registration
wholesale distributor have to get a chemical distributor registration
"Closed door" pharmacies?
those pharmacies that sell quantities of SLCPs to institutions, including
long term care facilities, jails, and other institutional-type settings for non-patient specific use.
What form to use for DEA chemical distributor registration?
DEA 510
What form should the registered reverse distributor who will destroy the controlled substances is responsible for submitting?
a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances have been destroyed
Rules for employing a person has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered for cause
Not allowed to hire them unless applying for a waiver
What form pharmacy use to notify the DEA of theft, loss?
DEA Form 106 Report of Theft or Loss of Controlled Substances
What form pharmacy use to notify the DEA of breakage and spillage of CS?
DEA Form 41 (Registrants Inventory of Drugs Surrendered)
How long should record for CS should be kept for?
for at least two years for inspection and copying by duly authorized DEA officials
Should pharmacy submit initial and biennial inventory to DEA?
No - not required
Requirement by the DEA on a rx for CS?
patient's full name and address, and the practitioner's full name, address, and DEA registration number, drug name, strength, dosage form, quantity prescribed, directions for use, # of refills
Exceptions to the schedule II fax prescription
-Meds to be directly administered as IV, SQ, IM, intraspinal
-Pts in long term care facility
-Pts in hospice
Is there a deadline to refill a CS from the day of issuance per fed law?
No - it's only specific to state
What is the max total number of day supply for multiple CII rx?
90 days
What does pharmacist have to record on refills of a CS rx?
-Dispensing pharmacist initial
-Date refill
-Amt of drugs dispensed on the refill (if different than the full amt of the rx)
How many times can CIII-V be transferred?
Once unless it's chain stores
Exemption of the Ryan Haight Act for online pharmacies
if the pharmacy is limited to dispensing new and and refilling rx of CIII-V
Which form to use to prescribe and dispense methadone?
DEA-363
Limit quantity for ephedrine, pseudoephedrine and phenylpropylamine
9 gm per every 30 days (<7.5gm from carrier or postal mails) and 3.6gm a day
Exception of the log book requirement for ephedrine, pseudoephedrine and phenylpropylamine
does not apply to purchase of any individual of a single sale package that contain not more than 60 mg of pseudoephedrine
How many days to report lost/theft of scheduled listed chemical products?
15 days
T/F Under USP 800 a low volume HD producing facility does not have to locate its BSC or CACI in a negative pressure room
FALSE - was true under 797
Containment segregation compounding areas (C-SCA)are
separate negative pressure areas with at least 12 air exchanges per hour
HDs with these levels of risk may be prepared in a BSC or CACI within a C -CSA
low and moderate risk - but must have a BUD of NMT 12 hours
T/F under USP 800 HDs may be unpacked in either a neutral or negative pressure room
TRUE - no positive pressure rooms
Under the USP 800 an entity must maintain a ________list of HD drugs and ______ add additional drugs to the list
NIOSH, may
The entity's list of HD must be reviewed at least ________ and updated
yearly, whenever there is an addition to the NIOSH list
Antineoplastics on the HD list must remain in ________ so long as they are being manipulated prior to dispensing
containment
It is up to the entity to determine containment strategies for these HD drugs
non antineoplastics - entity must document these strategies
Understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and care environment
responsibilities of all who handle HDs
Access to areas where HDs are handled must be
restricted to authorized personnel
Areas where HDs are handled must be located
away from breakrooms, patient/visitor areas
Before the entrance to HD handling areas must be
signs prominently displayed denoting the area as hazardous
Four distinct areas that must be designated for HDs according to USP 800
1.) receipt and unpacking 2.) storage of HDs 3.) Nonsterile compounding (if preformed) and 4.) sterile compounding (if preformed)
Two areas in which HDs may NOT be unpacked
sterile compounding areas and positive pressure areas
Neoplastic HDs should be stored on shelves which are _______ and have _________
secured and have raised lips
Non-antineoplastic, reproductive risk only and final dosage forms of antineoplastic drugs may be stored with
other inventory
T/F sterile and nonsterile HDs may be stored together
TRUE
Those medications which may be stored in the negative pressure buffer room
sterile HDs - as long as the buffer room is 12 air changes per hour
Refrigerated antineoplastic HDs must be stored in
a dedicated refrigerator within a negative pressure area with 12 air exchanges per hour or in a containment segregated compounding area
If a refrigerator storing antineoplastic HDs is placed in a negative pressure buffer room it must be placed in the room such that
the compressor is adjacent to an exhaust system
Definition of containment primary engineering control under USP 800
C-PEC = a ventilated device meant to minimize worker and environmental exposure to HDs when directly handling HDs
Definition of containment secondary engineering control under USP 800
C-SEC = is the room in which the C-PEC is placed
Definition of supplemental engineering controls under USP 800
are adjunct controls to offer additional levels of protection - such as drug transfer devices
Sterile and non-sterile compounds of HDs must be prepared in
a C-PEC located within a C-SEC
The C-SEC must have these attributes to comply with USP 800
1.) Be externally vented through a HEPA filter 2.) Be physically separate from other preparation areas 3.) have negative pressure between 0.01 and 0.03 inches of water
A C-PEC must operate ___________ if it supplies the negative pressure or if it is used for __________ compounding
continuously, sterile
If a C-PEC must be powered down you must wait this amount of time prior to starting compounding again
the manufacturer specified recovery time
In the event of accidental eye/skin exposure access to a _________ and ___________is required within _________
a sink and emergency eye wash station with running hot/cold water within the C-SEC
The location of the sink and emergency eye wash stations within the C-SEC should not interfere with
ISO specifications
Non-sterile and sterile C-PECs can be located in the same room for HDs if
the non-sterile C-PEC is effective enough that ISO 7 environment is never compromised within the C-SEC in which they are located and at least 1 meter apart
Acceptable C-PECs for non-sterile compounding of HDs
1.) Class 1 or 2 BSCs 2.) containment ventilated enclosure (CVE), 3.) CACI
Acceptable C-PECS for sterile compounding of HDs
1.) Class 2 or 3 BSC or 2.) CACI
T/F it is ok to use a C-PEC to non-sterile compound and then use it to sterile compound as long as it is Class 2 BSC or CACI and it is disinfected and cleaned prior to compounding
TRUE
Surfaces within the C-SEC must be
smooth, seamless, and made of impervious surfaces - due to difficulty of cleaning HD contamination from surfaces
Venting for non-sterile vs sterile C-PECs
non-sterile may be vented to the outside (preferred) or through redundant HEPA filters in series vs sterile ONLY may be vented to the outside
Two inappropriate C-PECs for the compounding of sterile HDs
laminar airflow hoods and CAIs (CACIs are ok)
T/F a HD C-PEC can be used for non-HD compounding if the non-HD preparation is placed into a protective outer wrapper during removal from the C-PEC and is labeled to require PPE handling precautions
true
The C-PEC for sterile HD compounds may be located in
a ISO 7 buffer room - preferred OR a C-SCA
The ISO 7 buffer room for C-PECs doing sterile HD compounds must maintain a negative pressure of _____ inches of water relative to
0.2, all surrounding non-ISO classified areas
The ISO 7 buffer room for C-PECs doing sterile HD compounds must have a minimum of _____ air exchanges per hour
30
A hand sink must be placed in the ISO 7 buffer room for C-PECs within ______ of the door
1 meter
A line demarcation must be defined in the negative pressure area for the purpose of
garbing
Only regulation concerning supplemental engineering controls in USP 800
cannot replace a C-PEC
Environmental wipe sampling should be completed
as a baseline and q6mo
Areas that should have environmental wipe sampling
1.) inside the C-PEC, 2.) work areas near the C-PEC 3.) areas adjacent to the C-PEC 4.) patient administration areas
If measureable contamination is found it is the responsibility of the ________ _________ to
compounding supervisor:identify, document, and contain the cause of contamination
PPE required to compound HDs that are sterile and nonsterile
Gloves, gowns, head, hair, and shoe covers
Times that PPE are also required other than compounding
Receipt, storage, transport, administration, Deactivation/Decontamination/Cleaning/Disinfecting and spill control
Chemotherapy gloves must be _______ free
powder - contamination risk
Chemotherapy gloves must be changed
every 30 minutes or anytime a defect is detected
Gowns should be changed
according to manufacturer specs or in the absence of these, every 2-3 hours or after spills/splashes
When compounding sterile HDs these actions concerning shoe covers must be observed
wear 2 shoe covers to enter the buffer room and take one off before exiting it
Eye/face protection must be worn when
working with HDs outside of a C-PEC - especially when splashes are a concern
Used chemo gloves should be disposed of prior to
exiting the C-PEC if possible - and placed in a baggie to be disposed of prior to leaving the C-SEC if not
ALL personal protective equipment should be disposed of after HD compounding prior to
leaving the C-SEC
Personal HD training competencies must be reviewed and reassessed at least
yearly or every time new equipment is used or every time there is a change in policy
Time period to move HDs to the HD storage area upon arrival in the pharmacy
immediately - no delay
If a package containing HDs is damaged it should be opened
within the C-PEC designated for non-sterile compounding
Labeling requirement for the transport of HDs
must be labeled as HDs at all times during transport
The use of pneumatic tubes is not authorized for
liquid or antineoplastic HDs
The counting of HD drugs should be done using
dedicated equipment - ie dedicated counting trays and should not be placed in automated counting devices
Compounding equipment such as mortars, pestles etc for HD compounding should be
dedicated to HD compounding and NOT used for other compounds
When dispensing HDs, if the dosage form allows a _______ must be used
supplemental engineering control (such as syringe transfer devices) - to minimize contamination of the patient area
During cleaning of HD areas PPE must be worn including ____ pairs of chemotherapy gloves
2
Cleaning steps + definitions
1.) deactivating = render a compound inert 2.) decontamination = remove the residue 3.) cleaning = remove organic/inorganic material 4.) disinfect = remove microorganisms
To deactivate use
sodium hypochlorite OR and EPA-registered oxidizer
To decontaminate use
sterile alcohol, sterile water, peroxide, or sodium hypochlorite
To clean use
germicidal detergent + sterile water
To disinfect use
sterile alcohol or other EPA-registered disinfectant
All personnel who are potentially exposed to HDs must periodically go through
medical surveillance and should have baseline and periodic data on biological markers
FDCA Definition of "Drug"
1. Articles recognized by official compendia in the US (USP/NF)
2. And used for the diagnosis, cure, mitigation, treatment, or prevention of disease
3. And intended to affect the structure or any function of the body
4. In man or other animals
FDCA Definition of "Food"
Articles used for food or drink for man or other animals
FDCA Definition of "Device"
1. Instrument, implant, machine, or similar article
2. Intended to affect the structure or function of body
3. And which does not achieve principal intended purposes through chemical action (i.e. drug)
FDCA Definition of "Cosmetic"
1. Articles intended to be rubbed, poured, sprinkled, sprayed, or applied to body
2. For cleansing, promoting attractiveness
DSHEA Definition of "dietary supplement"
1. A product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following:
vitamin; mineral; herb/botanical; amino acid; dietary substance for use by humans to supplement the diet by increasing the total dietary intake; concentrate/metabolite/constituent/extract
Definition of a "label"
Written, printed, or graphic material upon the immediate container of any article (includes container or wrapper)
Definition of "labeling"
All labels AND other written/printed/graphic material upon any article or any of its containers or wrappers, or accompanying such article (i.e. package insert, box, etc)
Definition of misbranding (key points)
1. Label/labeling must not be false or misleading
2. Package must contain information on manufacturer, packer, or distributor
3. Must contain all statements required or approved by FDA
4. Prescription drugs must have established name ingredient prominently displayed
5. Can't be imitation of another drug or offered for sale under the name of another drug
6. Information regarding dosages that might be dangerous to health or unsafe
7. Information related to dangers of use in children
8. Special packaging requirements to prevent deterioration, etc.
9. Must meet conditions of the Poison Prevention Packaging Act and/or other laws regarding packaging
10. Pharmacist cannot dispense a Rx drug without a prescription
Definition of adulteration (key points)
1. Includes drugs that consist in whole or in part of filthy, putrid, or decomposed substances
2. Drugs prepared, packed or held in unsanitary conditions
3. Drug's container is composed of any substance which may contaminate the drug
4. Drugs prepared, packaged, processed or held under conditions that violate CGMPs
5. Drugs containing an unsafe color additive
6. Drugs that purport to be those recognized in official compendia but strength, quality or purity falls below the standards
7. Drugs mixed or packed to reduce quality or strengths
Definition of a "new drug"
1. Drugs NOT generally recognized by qualified experts as safe and effective for use under the conditions recommended in the labeling
2. Must be used for a "material" amount of time for indications in the labeling
3. FDA determination on new drugs considered final authority (not court decision)
4. Sometimes applies to existing drugs with different/new indications, formulations, etc.
5. Not allowed in interstate commerce unless approved by FDA
Definition of "Rx Drug"
1. Drug intended for use by man
2. Because of toxicity or other harmful effect, or the method of use, or the collateral measures necessary for its use is not safe except under the supervision of a practitioner licensed by law to administer such a drug
3. Must be dispensed via a written or oral Rx, promptly reduced to writing or a refill authorized by the practitioner
4. Drugs required to be dispensed by a pharmacy via a prescription is misbranded if it fails to bear the legend "Rx only"
What is being violated if a prescription medication fails to bear the legend "Rx only"?
Misbranding
What does FDCA stand for?
Federal Food, Drug and Cosmetic Act
Why are labeling provisions included in the FDCA?
1. To ensure that drugs are not misbranded
2. The label property indicates the content
Why are adulteration provisions included in the FDCA?
To ensure the drugs are manufactured under conditions that are not putrid, filthy, or impure
Why are interstate commerce provisions included in the FDCA?
1. To ensure that drugs are safe and clinically effective for purposes indicated in label
2. To ensure that only approved drugs can enter interstate commerce
To whom does the FDCA usually apply to most often?
Manufacturers and wholesalers (CGMPs)
What does CGMP stand for?
Current good manufacturing practices
When was FDCA initially enacted, and what was the catalyst for it's creation?
Enacted in 1938; Prompted by the sulfanilamide elixir tradegy of 1937
The provision that restricts pharmacies from receiving or distributing drug samples from manufacturers is contained in which law, and prohibits the sale of drug samples by hospitals or other heathcare entities?
FDCA
The provision that allows pharma manufacturers to provide off-label information to healthcare entities (i.e. pharmacists, prescribers, hospitals, third party payers) is contained in which law?
FDCA
At what point would a "cosmetic" become a "drug"?
If the manufacturing promotes the product for a therapeutic purpose (structure/function claims, treatment, diagnosis, mitigation, cure claims), despite product chemistry
What does DSHEA stand for and what year was this law enacted?
Dietary Supplement Health and Education Act of 1994
Are dietary supplements regulated more like foods or drugs under DSHEA?
Foods
T/F: The FDA permits certain health claims for supplements, as long as certain scientific agreement exists for claim.
True
Does the following statement violate dietary supplement structure/function claims under DSHEA: "Vitamins in orange juice have been determined by the American Heart Association to help prevent heart disease"
No, this statement does not violate the DSHEA because it is validated by science
What must be stated on the label of dietary supplements?
Statements have not been evaluated by the FDA and the product is not intended to diagnose, treat, cure, or prevent any disease.
Legally, can pharmacists recommend dietary supplements?
Yes, based on scientific and clinical information about the product
Who is Rx labeling directed towards? What must be contained in the package insert of Rx drugs?
Directed towards healthcare professionals; must contain adequate information for use in its labeling including:
1. legend
2. recommended and usual dosage
3. type of container used to dispense
4. name and address of manufacturer, packer, distributor
5. established name of drug
6. ingredients
7. inactive ingredients (IF not for PO use)
8. quantity (i.e. 100 mg and 100 tablets)
9. statement of usual dosage or reference to PI
10. lot number
11. expiration date
Who is OTC labeling directed towards? What must be contained in the labeling of OTC drugs?
Directed towards consumer/patients;
Must contain
1. Adequate directions for use (warnings to stop use, dosages, intended patient populations, route of administration, time of administration, etc)
2. Statement of identity of the product (established name of drug and category)
3. Name and address of manufacturer, packer, distributor
4. Net quantity of contents
5. Cautions and warnings needed to protect consumer
6. Drug facts panel (active ingredient, purpose, indications, warnings, directions, other information, inactive ingredients, phone number to call with questions/comments)
What 8 pieces of information must be contained on an OTC "drug facts" panel?
1. Active ingredient
2. Purpose
3. Uses and indications
4. Warnings
5. Directions
6. Other information
7. Inactive ingredients
8. Phone number to call with questions or comments
Describe "adequate directions for use" on OTC labeling
A layperson can safely use for purposes intended; conditions, purposes, uses, quantity to use, frequency of administration, duration of administration, time of administration in relation to meals or symptoms, route of administration, preparation if necessary for use, etc.
What is the prescription drug legend?
"Rx Only" which was recently amended from "Caution: Federal Law prohibits dispensing without a prescription"
When an expiration date only contains a month and year (i.e. 8/2016), what is the actual expiration date?
The last day of the month - i.e. 8/31/2016
What must be contained on a unit dose labeling of a Rx drug?
1. Name of drug
2. Quantity of active ingredient in each dosage unit
3. Expiration date
4. Lot or control number
5. Name of manufacturer
6. Any statements regarding special characteristics if required by a compendia
If unit dose was repackaged, which date should be used for the "beyond use" date on the repackaging label?
1 year OR expiration date on manufacturer's container (whichever is earlier)
What is the "beyond use" date in comparison to "expiration date"?
Beyond use: drug should not be used after this date, cannot exceed expiration date, date used on repackaged unit dose containers.
Expiration date: manufacturer's date that is expected to meet the requirements of USP
Legally, can a pharmacist give a professional package insert to a patient?
Yes! It's available online! However, it is designed for the healthcare professional, and the pharmacist should help the patient navigate and interpret the information that the patient is looking for.
When was the new format for professional package insert requirements adopted?
06/2006
What does "PI" stand for in regards to package labeling?
Professional Package Insert
T/F: Professional Package Inserts must accompany every prescription drug product and include essential scientific and medical information needed for safe and effective use of the drug by healthcare professionals.
True
What does "PPI" stand for in regards to package labeling?
Patient Package Insert
The FDA requires a patient package insert ("PPI") to accompany which 4 classes of medications?
1. Estrogens
2. DES (Diethylstilbestrol)
3. Oral contraceptives
4. Intrauterine contraceptive devices
What law is broken if a pharmacist fails to provide a patient package insert ("PPI") to a patient with her oral contraceptive?
Misbranding
What stipulations are required by the FDA regarding patient package insert ("PPI")?
1. Manufacturer must notify pharmacist to insert leaflet in each prescription dispensed
2. Leaflet must provide general information regarding the risks associated with use and potential adverse effects
How must institutions comply with the FDA requirements for patient package insert ("PPI")?
Provide leaflet to patient upon administration of first dose, and then once every 30 days
What agency approved medication guides or "MedGuide"?
FDA
What does REMS stand for?
Risk Evaluation and Mitigation System/Strategies
When are MedGuides required by the FDA?
For certain products posing a "serious and significant concern" other than estrogen-containing products if FDA founds
a. Pt labeling could help prevent serious adverse effects
b. Product has serious risks that patient could benefit from knowing
c. Pt adherence must be approved by FDA
What does CMI stand for in regards to drug labeling?
Consumer Medication Information
When was the REMS system enacted by Congress/implemented?
Approved by Congress in 2007, implemented in 2008
Why was the REMS program initiated?
To establish formal protocols to communicate information about safety and efficacy concerns with certain medications
Who develops and approves REMS programs?
Developed by manufacturer, approved by FDA
T/F: If a drug has a REMS program associated, a MedGuide is necessary.
False, many medications already approed for REMS have MedGuides as well
REMS must include at least one of the following elements designed to ensure safety of use
1. Practitioners must be certified or have training to prescribe medication
2. Pharmacies and other dispensers or those who administer must have special certification
3. Drug distribution is limited to only certain settings such as clinics or hospitals
4. Patients who receive the medication must receive special information regarding safe use, including required lab testing
5. Patients must be monitored when using medication
6. Patients must be enrolled in a registry to use drug
REMS was initially created because of this class of agents
Long acting opioid medications
Educating prescribers about proper pain management, patient selection, and improving patient awareness about how to use the agents safely is contained in what information?
REMS program for long acting and extended release opioid medications
Companies that provide patients with educational materials, including a Medication Guide, that use consumer friendly language to explain both safe usage and disposal is a provision of what act?
REMS program
T/F: Pharmacies must include an FDA mandated side effects statement for all dispensed Rx drugs, and it must be provided on the vial.
True - Must contain the statement: Call your doctor for medical advice about side effects. You may also report side effects to 800-FDA-1088.
False - can be on vial cap, CMI leaflet, or MedGuide also
What is the statement that must be included with all dispensed Rx drugs in regards to side effects?
Call your doctor for medical advice about side effects. You may also report side effects to 800-FDA-1088.
T/F: Some specific drug products have specific labeling requirements for their labeling.
True - examples: ipecac, isporoterenol
What agency determines if the information contained on the label and labeling of drugs is false or misleading, and ultimately approves the information?
FDA
T/F: Misbranding and adulteration laws are at the federal level
States ALSO have misbranding and adulteration laws
If a drug package does not contain information about the manufacturer, packer, or distributor, what law is being violated?
Misbranding under the FDCA
If a drug is an imitation of another drug or offered for sale under the name of another drug, what law is being violated?
Misbranding under FDCA
If a company forgets or fails to print all statements required or approved by the FDA, what law is being violated?
Misbranding under FDCA
T/F: A drug can be rendered BOTH misbranded and adulterated
True
If an OTC package insert fails to contain adequate directions for use, what law is being violated?
Misbranding under FDCA
If a drug package insert fails to meet conditions regarding packaging, which 2 laws are being violated?
Misbranding under FDCA; Poison Prevention Packaging Act
If a pharmacist dispenses an Rx drug without a prescription, what law is being violated?
Misbranding under FDCA
To whom do most adulteration provisions apply?
Manufacturers
When might a pharmacy be deemed a manufacturer?
If the pharmacy repackages or compounds medications for sale under certain conditions
Why were adulteration laws put in place?
To ensure that drugs are manufactured under conditions that are not PUTRID, FILTHY, OR IMPURE
T/F: A drug is not adulterated if the container was exposed to something putrid, so long as the container was sealed and the drug itself was not contaminated.
False! It would still be considered adulterated
T/F: A pure drug may be considered adulterated due to how it was prepared, packaged, or stored if it MAY HAVE been contaminated.
True
T/F: A pure drug may be considered adulterated if it was manufactured under conditions not conforming with GMP
True
T/F: A drug may be considered misbranding if it contains an unsafe color additive.
False - this is adulteration
T/F: Drugs that purport to be those recognized in official compendia but strength, quality or purity falls below the standards is considered misbranding
False - adulteration
T/F: A drug that is mixed or packed to reduce quality or strength is adulterated
True
T/F: A pharmacist can be found for adulteration of a product if it is not stored properly in the pharmacy (i.e. shelf instead of fridge)
True
T/F: A pharmacist can be found for misbranding of a product if they forgot to include PPI/MedGuide
True
How often are manufacturer's inspected for CGMP compliance?
every 2 years
Are manufacturer's required to be registered with the FDA for CGMP compliance?
Yes
Are pharmacies required to be registered with the FDA for CGMP compliance?
Not required, but could be inspected in some cases
What is the purpose of CGMP inspections by the FDA?
-Production and control procedures to ensure proper identity, strength, quality, and purity of drugs
-Identify deficiencies and provide follow-up for correction
T/F: The FDA can seize all adulterated drugs during a CGMP inspection.
True
T/F: The FDA can ask manufacturer's to recall drugs from the market if found to be misbranded or adulterated
True
What must the applicant provide to the FDA legally for a new drug to be approved?
-Reports of drug safety and efficacy
-Drug components and composition
-Methods, facilities, and controls used in manufacturing, processing, and packaging
-Samples of drugs
-Proposed labeling
What government agency controls prescription drug advertising?
FDA
What government agency controls OTC drug advertising?
Federal Trade Commission (FTC)
T/F: an individual can bring actions against a manufacturer for false/misleading advertisements.
True
What government agency/law controls pharmacy and pharmacist advertising?
Pharmacy Practice Acts
What legal restrictions apply to advertising by manufacturers to health care professionals?
Must be:
-True statements
-Provide information related to the drug name, active ingredients
-Summary of information regarding side effects, contraindications, clinical effectiveness
-Can't be false or misleading
-Must present "fair balance"
-Must reveal material facts
Advertising (as opposed to labeling) includes information in these 3 areas:
-Journals and periodicals
-Broadcast media
-Telephone communications
Labeling (as opposed to advertising) includes:
-Brochures, booklets, mailing pieces, price lists, references, provided by the manufacturer for use by healthcare professionals
-Information must include everything required by labeling
Advertising or labeling: a booklet provided in the mail for use by a healthcare professional
labeling
Advertising or labeling: a telephone communication to consumers
advertising
Definition of a "prescription drug"
-Intended for use by man
-Not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, because of toxicity, harmful effect, method of use, or collateral measures necessary for its use
T/F: a prescription drug must be dispensed via a written or oral prescription
True
T/F: An oral prescription must be promptly reduced to writing
True
T/F: An oral refill authorized by a practitioner must be written
False - can be oral and immediately reduced to writing by the pharmacist
T/F: a prescription drug is considered misbranded if it is dispensed without the legend "Rx only"
True
What qualifications must a mediation meet in order to be OTC?
Panel review as safe and effective for use by consumers without a prescription
What agency decides whether a drug is Rx or OTC?
FDA, based on panel review
How does an Rx drug become OTC?
Manufacturer must submit an application or petition for review
What are the new (2010) warnings for OTC APAP and NSAID products?
-All OTC APAP: risk of liver injury
-All NSAIDS: risk of stomach bleeding
-Peds: Caution parents against use of APAP and cough/cold products for children < 2 yo
T/F: drugs provided to residents of nursing homes and LTC facilities are considered dispensed to a patient
True
T/F: Dispensing generally relates to providing medications through a pharmacy for the person to take away with them for personal use
True
T/F: Physicians that inject or provide medications in their office is considered dispensing
False - considered administration - some states allow MD's to dispense drugs as well
T/F: Dispensing pharmacists/pharmacies can be exempt from extensive labeling requirements
True - IF labeling....
-Meets requirements of the state
-Is not false or misleading
-Packaging and labeling conform to official compendia standards
-Drugs packaged and labeled appropriately
-Drug is packaged in conformance with the Poison Prevention Packaging Act (when required)
T/F: A company can add any additional information on their prescription labeling to go above and beyond the minimum standards.
True
What are the 5 MINIMAL requirements under FDCA for a dispensed Rx label?
1. Name and address of pharmacy
2. Serial number and date of the Rx/fill
3. Name of prescriber
4. Name of patient
5. Directions for use and cautionary statements
**States may require more**
What is the PPPA? When was it enacted?
Poison Prevention Packaging Act of 1970
What is the PPPA designed to protect the public against?
-Protect children from accidental poisonings with household substances (including rx drugs)
What government agency has the authority to regulate, enforce and ensure compliance with the Poison Prevention Packaging Act of 1970?
Consumer Products Safety Commission (CPSC)
What are the requirements for packaging Rx and OTC drugs under the PPPA of 1970?
-Must have child resistant containers
-New bottle and cap with each prescription filled
Which facilities are exempt from the PPPA of 1970?
LTC facilities, institutional settings - if the facility personnel will administer the medications to the patients
T/F: Under the PPPA of 1970, a new vial must be used for each prescription filled
True - can reuse glass containers
What testing must a packaging system undergo in order to be determined "child resistant"?
-80% of children (under 5 yo) cannot open it
-90% of adults can open it
T/F: An OTC product marketed specifically for the elderly/disabled is exempt from PPPA requirements.
True - if there is proper notation that the packaging is not child-resistant
How many package sizes is a manufacturer allowed to make in non-PPPA/child resistant packages?
ONE
What is an example of a specific drug that is exempt from PPPA packaging requirements?
Sublingual nitroglycerine
Who may request non-child-resistant packaging for the patient?
-The physician
-The patient
T/F: requests for non-child-resistant packaging by the physician or patient must be in writing
False - not required to be in writing, but encouraged
The tylenol incident of 1982 (cyanide) led to the passage of what law?
Tamper Resistant packaging act
T/F: The PPPA requires products to have a tamper resistant seal
False - Tamper Resistant Packaging Act
What does "DQSA" law of 2013 stand for?
Drug Quality and Security Act
Which law contains important provisions relating to the oversight of compounding human drugs?
Drug Quality and Security Act of 2013
T/F: The DQSA of 2013 requires a compounder of sterile products to register as an "outsourcing facility"
False - not required
How does the DQSA of 2013 define an "outsourcing facility"?
-A facility at one geographic location/address that is engaged in the compounding of sterile drugs
-Has elected to register as an outsourcing facility
-Complies with all the requirements of section 503B
What event triggered the passage of DQSA of 2013?
Outbreak of fungal meningitis from products compounded and distributed by the New England Compounding Center (NECC) in 2012
What incentives exist for a compounding facility to register as an outsourcing facility under DQSA of 2013?
-Qualifies the facility for exemptions of the rigorous requirements of a manufacturer
What requirements must a registered outsourcing facility for compounding meet?
-Comply with CGMP
-Inspected by FDA according to a risk-based schedule
-Reporting AE
-Provide FDA with information about the products that they compound
Are USP <795> and <797> "law"?
No - unless a state has incorporated it into their laws
What provision on DQSA of 2013 provides an exemption for "traditional compounding" on a small scale at a local pharmacy?
503A
How would a local pharmacy qualify for "traditional compounding" and therefore exemption from DQSA under 503A?
-Drug is compounded for an individual patient based on receipt of a valid rx order
-Compounding is performed by a licensed pharmacist in a licensed pharmacy, or by a licensed physician
-Anticipatory compounding is permitted only in limited quantities, based on the history of receiving valid orders
-Complies with USP chapters
-Compounded using bulk drugs that are manufactured by a registered establishment
-Cannot use drugs that have been removed from the market
-Cannot compound regularly or in inordinate amounts of products that are commercially available
-May not distribute more than 5% of the total prescriptions dispensed or distributed by that pharmacy without a memorandum of understanding between their state and FDA
Under DQSA exemption 503A, can certified technicians and pharmacy interns compound prescriptions?
No
T/F: Pharmacies are exempt from registering as manufacturers under DQSA 503A if they do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail
True
What other activities (besides compounding) could place a pharmacy into the realm of being considered a manufacturer, wholesaler, repackager, distributor, outsourcing facility, etc.?
Repackaging of drugs, resale or distribution of products, etc.
Compounding non-prescription products
-Must be labeled according to FDA provisions of an OTC agent
-Cannot be prepared with any prescription ingredients
-FDA might intervene if significant health hazards occur in a pharmacy compounding on a regular basis
Reconsititution
Involves mixing drug products for use by a patient pursuant to manufacturer's instructions
Is reconstitution considered compounding?
No
What is "drug repackaging"?
-An FDA-registered facility that repackages drugs from manufacturers and places them into new packaging
-Often unit-of-use packaging or more convenient types
T/F: A new NDC is issued to a drug that has been repackaged.
True
What is the difference between repackaging and prepackaging?
Prepackaging is when a pharmacy packages drugs from manufacturer's container to a customized unit dose or other type of unique dispensing systems for direct patient use
What does NDC stand for?
National Drug Code
Which products must have an NDC?
-OTC drugs
-Rx drugs
How are NDC's used?
-To identify drugs
-To process claims by insurance companies
How many digits are in the original NDC system?
9
How many digits are in the new NDC system?
10
How are NDC's configured?
4-4-2 OR 5-3-2 OR 5-4-1
What is the first segment of the NDC number?
Labeler (manufacturer/repacker/distributor)
Who assigns the first segment of the NDC number that identifies the manufacturer?
the FDA
What is the second segment of the NDC number?
-Product code
-Strength
-Dosage form
What is the third segment of the NDC number?
-Package code
-Identifies package sizes and types
Why might an NDC contain 11 digits?
May see asterisk as a place holder for HIPAA
What is the difference between generic substitution and therapeutic substitution?
-Generic substitution: dispense generic when brand is written
-Therapeutic substitution: dispense different drug in same therapeutic class (i.e. prevacid vs prilosec)
What does the first letter in the orange book rating describe?
A = therapeutically equivalent
B = not equivalent
What does the second letter in the orange book rating describe?
other information...
What are the only 2 letters that an orange book rating with start with?
A or B
What does the orange book rating of "AB" mean?
Therapeutically equivalent
What does the orange book rating of "BA" mean?
NOT therapeutically equivalent
Legally, can a pharmacist fill an Rx for an off-label use?
Yes - use professional judgement
Legally, can a manufacturer promote a medication for an off-label use?
NO - only approved indications
Legally, can a manufacturer distribute peer-reviewed articles with information about unlabeled uses to PBMs/healthcare practitioners/govt agencies?
Yes - as long as the information is not influenced by the company
What are the 3 types of Drug Recalls?
Class I, Class II, Class III
T/F: A drug recall is an action taken by a firm to remove a product from the market
True
T/F: Recalls may be conducted on a firm's own initiative
True
T/F: Recalls are only by FDA order under statutory authority
False - can be conducted on a firm's own initiative, upon FDA request, or upon FDA order under statutory authority
What is a Class I recall?
-REASONABLE PROBABILITY that the product WILL CAUSE serious, adverse health consequences or death
What is a Class II recall?
-When a product MAY cause temporary or medically reversible adverse health consequences
-Probability of serious adverse consequence is remote
What is a Class III recall?
-When a product is NOT LIKELY to cause adverse health consequences
What does "CSA" stand for?
Controlled Substances Act
What does "DEA" stand for?
Drug Enforcement Administration
What is the pharmacist's responsibility under the Controlled Substances Act?
Corresponding responsibility - holds the pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of professional treatment
What is a pharmacists corresponding responsibility under the CSA?
Holds the pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of professional treatment
T/F: A pharmacist must be aware of potentially improperly prescribed medications and take measures to clarify or correct the problem under CSA
True
T/F: Pharmacists share a responsibility for solving the rx drug abuse and diversion problem
True
T/F: A pharmacist can be punished criminally if they fail to uphold their responsibilities under CSA
True
Why are controlled substances highly regulated in the US?
-Reduces the potential for diversion
-Regulates the manufacture, distribution, and dispensing of drugs that are identified as having a high potential for addiction and abuse
What is the "closed distribution system" for regulating controlled drugs in the US?
-Laws apply to entities and persons registered with the DEA may dispense, administer, manufacturer, purchase, sell, or otherwise acquire controlled substances
-Laws and regulations for every step in the system, from "cradle to grave"
Who classifies a drug as controlled?
The Attorney General of the United States, after consulting with the Department of HHS for a clinical and medical evaluation of the drug
What are the classes of controlled drugs?
Schedule I-V
T/F: If the department of HHS finds that a drug should not be controlled, the Attorney General must comply.
True - unless there is a finding of imminent hazard to the public safety
T/F: States have their own authority to place drugs into stricter categories that what the Attorney General recommends.
True - i.e. numerous states place Sudafed as CIII
Criteria for Schedule I drugs
-High potential for abuse
-No currently accepted medical use in the US
-Lack of accepted information on safety even under medical supervision
T/F: Researchers may legally conduct experiments with Schedule I drugs
True - if they register with the DEA
T/F: Even if a state passes a law to approve medical use of Schedule I drugs (i.e. Marijuana), the DEA could charge with violation of federal law.
True - if not recognized by CSA
Criteria for Schedule II drugs
-High potential for abuse
-Currently accepted medical treatment in the US or currently accepted medical use with severe restrictions
-Abuse can lead to severe physical or psychological dependence
What is the term to describe the switching of hydrocodone products from CIII to CII?
Rescheduling
What aren't states/people being prosecuted for violating the CSA with Marijuana?
The Obama administration does not want to use resources to investigate this, however illegal activity
Criteria for Schedule III drugs
-High potential for abuse, but less than CI and CII drugs
-Currently accepted medical use in the US
-Abuse may lead to moderate or low physical dependence or high psychological dependence
Schedule III drug codeine or dihydrocodeine may not contain more than ______ per __________
1.8 grams per 100 mL ; 90 mg per dosage unit
Schedule III drug dihydrocodeinone and ethylmorphine may not contain more than ______ per __________
300 mg per 100 mL ; 15 mg per dosage unit
Schedule III drug opium may not contain more than ______ per __________
500 mg per 100 mL ; 500 mg per 100 grams ; 25 mg per dosage unit
Schedule III drug morphine may not contain more than ______ per __________
50 mg per 100 mL ; 50 mg per 100 grams
Criteria for Schedule IV drugs
-Low potential for abuse (relative to CIII drugs)
-Current accepted medical use in the US
-Abuse may lead to limited physical dependence or psychological dependence (relative to CIII drugs)
Criteria for Schedule V drugs
-Low potential for abuse (relative to CIV drugs)
-Current accepted medical use in the US
-Abuse may lead to limited physical dependence or psychological dependence (relative to CIV drugs)
Can schedule V drugs be sold by a pharmacist without a prescription?
State laws - in NC? Yes
Schedule V drug codeine may not contain more than ______ per __________
200 mg per 100 mL ; 200 mg per 100 grams
Schedule V drug dihydrocodeine may not contain more than ______ per __________
100 mg per 100 mL or 100 grams
Schedule V drug difenoxin may not contain more than ______ per __________
0.5 mg per dosage unit
Schedule V drug atropine sulfate may not contain LESS than ______ per __________
25 mcg per dosage unit
Schedule V drug ethylmorphine may not contain more than ______ per __________
100 mg per 100 mL or 100 grams
Schedule V drug opium may not contain more than ______ per __________
100 mg per 100 mL or 100 grams
What happens if a schedule V drug opium (NMT 100 mg/100mL) exceeds the drug concentration allowed?
It will fall into schedule III
What does NMT stand for?
not contain more than
What happens if a schedule III drug codeine (NMT 1.8 grams/100mL) exceeds the drug concentration allowed?
It will fall into schedule II
What are the manufacturer labeling and packing requirements for controlled substances?
-Commercial containers must be labeled with designated schedule
-Symbol must be prominently located on label and must be clear and large enough to provide easy identification
In the "closed loop" distribution process of controlled substances, every entity must register with the DEA except:
Ultimate consumer
T/F: Every individual healthcare practitioner must be registered with the DEA in order to prescribe controlled substances
False - every employer or affiliated health care setting must be registered
T/F: Every employer or affiliated healthcare setting must be registered with the DEA in order to prescribe controlled substances
True
T/F: each entity must provide separate DEA for each site where it conducts business with controlled substances
True
T/F: Practitioners need multiple DEA registration numbers if they practice and write prescriptions at more than once site
False - only need one DEA number in each state
T/F: If a practitioner practices in more than once state, they will need DEA registration numbers in both states
True
Before a business can begin, what is required from the DEA?
Certificate of Registration
The DEA issues renewal notices ____ days prior to expiration
60 days
If a registrant must change their name or address of DEA registration, what process must they undergo?
Apply to DEA in writing to request changes
How long must new and old DEA certificates be maintained?
Until expiration. Never throw away an old one; keep it or return it.
What must occur with a DEA number when the death of a person, corporation or discontinuation of business occurs?
Notify the DEA and terminate the registration
T/F: The DEA must approve transfers or assignments of DEA numbers per a written request.
True
What must occur with a DEA number when a business closes/discontinues?
-Return the certificate of registration to DEA office in Washington, DC
-Return 222 Forms to DEA office in Washington, DC
-Notify state board
How often must manufacturers and distributors (wholesalers) register with the DEA?
Each year, at the end of the month assigned by DEA for that year
How often must pharmacies register with the DEA?
Once every 3 years, in the month assigned
How often must hospitals and clinics register with the DEA?
Once every 3 years, in the month assigned
How often must teaching institutions register with the DEA?
Once every 3 years, in the month assigned
Who is exempt from registering with the DEA?
-Agents/employees of the manufacturer, distributor, or dispense (pharmacists) when acting in the usual course of business
-Common or contract carriers, warehouse men (i.e. FedEx)
-Officials of armed forces, public health system, bureau or prisons (the organization is registered)
When might a prescriber prescribe controlled substances under the hospital's DEA number?
-In a hospital setting
-If dispensing, administering, and prescribing is in the usual course of professional practice
-If the practitioner is authorized by jurisdiction
-Hospital where he is employed assures that the individual can
-Acting within the scope of employment at the hospital
-Hospital maintains a list of internal codes, accessible upon request
What might an internal DEA code at a hospital look like?
Hospital DEA # - internal code
XXXXXXXXX - XXXX
Who most often uses hospital DEA with internal code to prescribe controlled substances?
- Medical residents
-Foreign MD's at the hospital
Legally, can a pharmacist fill a prescription for a controlled substance that is written by a foreign MD who uses a hospital DEA # with internal code?
Yes, as long as he has this agreement with the hospital and is authorized by jurisdiction
T/F: A pharmacist should contact the hospital for verification of DEA # and internal code, if they have any doubts in dispensing such a prescription.
True
What are the requirements for dispensers conducting research in regards to DEA numbers?
-Registered dispensers may conduct research without a separate registration for CII-CV
-Applicant must submit a protocol to DEA
What must be contained in a protocol for dispensers conducting research that is submitted to the DEA?
-Name and qualifications of the investigator
-Institutional affiliation
-Description of the project
-Copies of the IND
-Description of the security procedures used
What are the stricter requirements for online pharmacies?
-Must submit a separate registration to the DEA
-Must maintain records of online dispensing of controlled substances
What are the stricter requirements for prescribes who work with internet websites to provide consults?
-Must conduct at least one in-person evaluation for patients
T/F: Pharmacies not registered with the DEA as on-line pharmacies cannot fill prescriptions for controlled substances from prescribers associated with online pharmacies.
True - not knowingly
What penalties are associated with online pharmacists knowingly filling rx's for controlled substances from prescribers associated with online pharmacies?
Criminal and monetary penalties for both the pharmacist and the pharmacy
T/F: A manufacturer must be registered with the DEA for each class of controlled substance.
True
T/F: Pharmacies can manufacture and distribute narcotic substances to other practitioners without providing registration.
True - ONLY IF preparation is aqueous, oleaginous solution, or solid dosage form - and ONLY IF narcotic preparation does not exceed 20% of the complete product
T/F: A DEA registrant may deliver controlled substances to other DEA registrants (i.e. "can I buy it from you?").
True -IF the registrant is permitted to dispense and dosage units < 5% of total units of controlled substances dispensed/year
T/F: A DEA registrant may deliver CI or CII substances to other DEA registrants (i.e. "can I buy it from you?").
True
-IF the registrant is permitted to dispense, < 5% units/year
-Must use DEA Form 222
When distributing controlled substances among DEA registrants, what must be contained on the written record of transfer?
-Date of transaction
-Name, form, quantity of substance
-Name, address, registration number of the person making the distribution
-Name, address, registration number of the supplier or manufacturer
How must schedule I controlled substances be stored?
-Securely locked in a substantially constructed cabinet
How must CII-CV controlled substances be stored?
Either:
-Dispersed throughout inventory to prevention diversion or theft
-Stored in a securely locked and substantially constructed cabinet
T/F: Significant losses and all thefts of controlled substances must be reported in writing to the FDA.
False - DEA requires reporting in writing to the Field Office of the DEA
When must significant losses and thefts of controlled substances be reported in writing to the Field Office of the DEA?
Immediately upon discovery
What form use used to document significant losses and thefts of controlled substances to the DEA?
DEA Form 106
What factors should be considered when determining whether a loss of controlled substances was significant?
-Types and amounts of controlled substances lost or stolen
-Activities and individuals involved in the loss/theft
-Pattern of loss/stealing
-Local trends in the area of loss/stolen controlled substances
Who determines if a loss of controlled substances is significant?
YOU! The pharmacist!
T/F: DEA is allowed to enter premises of registrants where controlled substances and records are maintained
True
T/F: DEA is allowed to examine and copy any records relating to controlled substance distribution, prescribing, or dispensing
True
T/F: DEA is allowed to examine and copy any records relating to controlled substances, including financial records
False
T/F: DEA is allowed to inspect the premises of any registrants where controlled substances are maintained
True
T/F: DEA is allowed to inventory controlled substances at the site of registrants
True
T/F: DEA inspector must state the purpose for the inspection with a written notice to which the owner/PIC must consent
True
Definition of "dispensing" by the CSA/DEA
-Delivering a controlled substance to an ultimate user or research subject by order of a practitioner
-Includes prescribing and administration in compliance with packaging and labeling requirements
What information is required on a controlled substance prescription?
-Written in ink, indelible pencil or typed
-Dated and must be signed on the date when issued
-Patient's full name and address
-Prescriber's full name, address, DEA #
-Drug name, strength, dosage form, quantity, directions, refills authorized
-Manual signature of practitioner
Who is ultimately responsible for ensuring that the CS rx conforms to all state and federal requirements?
The practitioner is responsible, the pharmacist should always check before you file it
Who is exempt from DEA registration under CSA and can prescribe controlled substances?
-Public Health Service practitioners
-Federal Bureau of Prisons practitioners
-Military practitioners
T/F: Midlevel prescribers are registered and authorized by the DEA and state to administer, dispense, and prescribe controlled substances.
True
Which clause in the CSA is the main focus for disciplinary and criminal proceedings against practitioners?
Corresponding responsibility - To be valid, a rx for a CS must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of CS. In addition, a corresponding responsibility rests with the pharmacist who fills the prescription.
T/F: The quantity of drugs prescribed and frequency of rx filled are indications for fraud or improper prescribing.
False - not alone - patient could be being treated with opioids for pain management - patient could have drug tolerance/physical dependence as a result of chronic pain management
What criteria may indicate that a rx was not issued for a legitimate medical purpose?
-Prescriber write significantly more rx's or larger quantities compared to other prescribers
-Patient appears to be returning too frequently
-Prescriber writes rx's for antagonistic drugs (i.e. depressants and stimulants)
-Patient presents with rx's written in the names of other people
-A number of people appear within a short period of time, all bearing similar rx's from the same prescriber
-Numerous "strangers" suddenly show up with similar rx's from the same prescriber
T/F: A prescription issued NOT in the usual course of professional treatment is not a valid prescription within the meaning and intent of the CSA.
True
T/F: A pharmacist that fills a prescription that is knowingly not in the course of professional treatment or legitimate research shall be subject to the penalties provided for violations of the CSA
True
If a pharmacist fills an rx that is knowingly not in the course of professional treatment, who can be held responsible under the CSA?
-Pharmacist
-Prescriber/person issuing the rx
Who may communicate information to the pharmacy regarding dispensing of a controlled substance under CSA?
-Prescriber
-Employee or agent of the prescriber, who is under the direct control or supervision of the prescriber
-Nurse at an offsite location (i.e. LTC) IF they have an agreement with prescriber
Who (besides the prescriber himself) may prepare a prescription for a controlled substance under CSA?
-Secretary or agent of the prescriber who is under direct control or supervision of the prescriber
-Prescriber must sign after rx has been prepared
Which controlled substances can be transmitted electronically (as long as the DEA system requirements are met)?
CII - CV
What is the format of a DEA number?
2 letters - 7 numbers i.e. AB1234567
What is the first letter of a DEA number for a physician?
A or B or F or G
What is the first letter of a DEA number for a midlevel prescriber?
M
What is the first letter of a DEA number for a distributor?
P or R
What is the first letter of a DEA number for a certified practitioner prescribing suboxone for pain?
A or B or F or G (see: indication)
What is the first letter of a DEA number for a certified practitioner prescribing suboxone for opioid addiction?
X
What does the first letter of a DEA number indicate?
Level of prescribing ability
What does the second letter of a DEA number indicate?
1st letter of prescriber's last name (may be different if they've gotten married, etc) or company name
Legally, can pharmacy technicians assist the pharmacist in dispensing prescriptions for controlled substances?
Yes - if the state ph ermits
A CII rx must be an original, written prescription or electronic, and signed by the prescriber EXCEPT:
-Emergency situations
-Fax for home infusion/LTC/hospice patients
-Partial fills when a pharmacy cannot supply the entire rx amount
T/F: Under DEA, no quantity or time limit exists for dispensing CII's.
True
T/F: Under DEA, prescribers are allowed to issue multiple rx's in one visit, up to a 120 day supply
False - 90 day supply
T/F: Under DEA, prescriber must determine that there is no undue risk of diversion or abuse, before prescribing up to a 90 day supply of a CII.
True
T/F: The DEA permits emergency dispensing of oral CII prescriptions in retail pharmacies. What stipulations exist?
True
-Quantity prescribed is limited to the amount necessary to treat the patient for the emergency period
-Rx must be reduced to writing immediately by a pharmacist
-Rx must contain all necessary information (except signature)
What must the pharmacist due when receiving an oral CII prescription for an emergency situation?
-Make reasonable efforts to determine that the rx is valid
-Reduce the rx immediately to writing
-Use judgement regarding whether the rx is for emergency purposes
When must the prescriber provide the pharmacy with the original, signed, written rx for an emergency CII, after authorizing the emergency rx?
Federal law: within 7 days (postmarked)
What must be written on the original, signed, written rx for an emergency CII, in addition to meeting all CII requirements?
"Authorization for Emergency Dispensing" and date of oral order
What must the pharmacist do if a prescriber fails to deliver a written prescription within 7 days, after authorizing an oral emergency CII rx?
Pharmacist must notify the nearest DEA office
T/F: In the retail setting, a pharmacy cannot fill a CII rx received via fax
False - they can fill via fax - cannot dispense until they receive the original rx
In what situations may a retail pharmacy use a faxed CII rx as the original, and fill accordingly without ever receiving a hard copy original?
-Narcotic substance compounded by pharmacy for direct administration to patient by IV, IM, Q or intraspinal infusion
-LTC residents
-Hospice patients that have been certified by the Medicare program
How many times may a CII be refilled?
Never
Legally, can a pharmacy provide a partial quantity of a CII rx?
Yes - if they are unable to provide the entire quantity - must note on the face of the rx and fill the balance within 72 hours
When must a pharmacy provide the balance of a partial filled CII rx?
Within 72 hours
Legally, can a pharmacy provide a partial quantity of a CII rx if the patient cannot pay for the entire quantity of the CS?
Yes - must provide balance within 72 hours after the partial fill
T/F: To reduce waste associated with unused meds for terminally ill patients, a pharmacy legally can partially fill controlled substance rx's
True
If a pharmacy is partially filling controlled substance rx's for a terminally ill patient to reduce waste associated with unused meds, when must all of the medication be dispense / when does the prescription become terminated/expire?
Within 60 days
If a pharmacy is partially filling controlled substance rx's for a terminally ill patient to reduce waste associated with unused meds, what must be recorded ON THE FACE of the rx by the pharmacist?
-Information regarding the patient's residence in LTC facility
-Information regarding the patient's terminally ill condition
-For each fill: date, quantity dispensed, remaining quantity authorized, name of dispensing pharmacist
How many times may a CIII rx be refilled?
5 times within 6 months
Legally, can a CIII rx be partially filled?
Yes - as long as it meets requirements of refilling
- as long as total quantity dispensed does not exceed total quantity prescribed
How many times may a CIV rx be refilled?
5 times within 6 months
How many timese may a CV rx be refilled?
No limits
T/F: Restrictions on controlled substances do not apply to CV drugs under DEA requirements.
True
Legally, can a pharmacy mail controlled substances to the patient, at the patient's request?
Yes - if not outwardly dangerous - must be prepared and packaged properly
How must a package be properly prepared if a pharmacist is mailing a controlled substance to a patient, at the patient's request?
-Marked and sealed
-Labeled properly
-Plain outer container
-Nothing to indicate controlled substances inside the package
What items on a controlled substance rx is a pharmacist NEVER permitted to change?
-Patient's name
-Drug
-Prescriber's signature
Legally, can a pharmacist dispense a controlled substance without a prescription?
Yes - Only CV's
Legally, can a technician sell a prescription for a CV without a rx (i.e. cough syrup)?
Yes - but the pharmacist must prepare it and dispense it
Legally, who can purchase a prescription for a CV (i.e. cough syrup) without an rx?
-Must be 18 yo
-Must present proof of age
What is the maximum allowable amount of an opium CV that can be dispensed without an rx?
PER 48 HOURS:
-NMT 240 mL
-NMT 48 dosage units
What is the maximum allowable amount of a CV (i.e. cough syrup) that can be dispensed without an rx?
PER 48 HOURS:
-NMT 120 mL
-NMT 24 solid dosage units
What must be contained on the log book for CV controlled substances dispensed without an rx?
-Name of patient
-Address of patient
-Quantity sold
-Date of sale
-Initials of pharmacist
How long must the long book for CV controlled substances dispensed without an rx be maintained?
2 years from date of last transaction
Legally, a pharmacy can transfer CS rx information for refill purposes.
Only for CIII, CIV, and CV - can only transfer once
How many times can a pharmacy transfer a CIII rx for refill purposes?
Federal: once
How many times can a pharmacy transfer a CII rx for refill purposes?
Never! No refills allowed
How many times can a pharmacy transfer a CIV rx for refill purposes?
Federal: once
If a pharmacy shares electronic information in real-time online databases, how many times may it transfer refill information for controlled substances?
As many times as law permits
Legally, can a pharmacy student intern transfer a CS rx to another pharmacist?
No - must be two pharmacists
What must be written on the face of the rx when transferring a CS rx?
VOID
What must be written on the back of the rx when transferring a CS rx?
-Name, address, and DEA# of the pharmacy where the rx is being transferred
-Name of pharmacist receiving the info
-Date of transfer
-Your name (transferring pharmacist)
What information is required for the pharmacy RECEIVING a transferred CS rx?
-Face: write "transfer"
-Date of original rx
-Original number of refills authorized
-Date of original dispensing
-Number of refills remaining
-Dates and locations of previous refills
-Transferring pharmacy's name, address, DEA #, rx #
-Name of both pharmacists
How long must records of transferred CS rx's be kept?
2 years
T/F: Controlled substance E-Rx's from systems that do not comply with DEA rule are considered paper rx's
True - therefore doesn't contain a signature and not valid
What are the requirements of an E-rx system under the DEA E-Rx rule?
-Main prescriber's registration is clearly identified (in the case of mid-level practioners working under a provider)
-Accommodate suffixes for institutional prescribers under the institution's DEA #
-Must accommodate "do not fill before" instructions
-Must accommodate notes that allow for dispensing methadone outside of narcotic treatment programs
T/F: Only the pharmacy must have a DEA approved system to transmit CS rx's electronically
False - both the prescriber and the pharmacy
How can you verify if a prescriber or pharmacy has a DEA approved system to transmit CS rx's electronically?
-A list is posted in Federal Register
-NABP has announcements
What special labeling requirements do CII drugs contain?
Date of filling
What special labeling requirements do CIII drugs contain?
-Date of initial filling
-Date of refill
What special labeling requirements do CII-IV drugs contain?
-Pharmacy name and address
-Serial number/rx number
-Name of patient
-Name of prescriber
-Directions for use
-Cautionary statements
-Caution related to transfer
What caution related to transfer must be on the labeling of all CII-IV drug labels?
Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed
T/F: CS labeling requirements do not apply if drug is prescribed for administration to an institutionalized ultimate user
True - this is considered a medication order
If a prescriber's electronic system has not been approved by the DEA, and they send a CIII rx to your pharmacy, what must you do with the rx?
-Print it out
-Call and verify
-Take as an oral rx
If a prescriber's electronic system has not been approved by the DEA, and they send a CII rx to your pharmacy, what must you do with the rx?
-Rx is not valid because there is no "wet" signature
-Rx must be signed manually until systems are approved
If CS labeling requirements have been exempt (i.e. administration to an institutionalized patient), what are the NMT limitations on CII drugs?
NMT 7 day supply of CII dispensed at one time
If CS labeling requirements have been exempt (i.e. administration to an institutionalized patient), what are the NMT limitations on CIII drugs?
NMT (the lesser of) 34 day supply OR 100 dosage units
What does "ADS" stand for in regards to dispensing in LTC facilities?
Automated dispensing systems
Legally, are automated dispensing systems permitted in LTC facilities?
Yes
T/F: A pharmacy must separately register an automated dispensing system with the DEA and has to pay additional fees
False - does have to register separately, but does not have to pay any additional fees
T/F: Pharmacies that use ADS are exempt from the 5% restriction on transfer of CS inventory
True
T/F: If a pharmacy uses ADS in a LTC facility, it must follow all provisions for pharmacies, including e-prescribing
True
Which DEA form is used in the disposal and destruction of CS?
DEA Form 41
What must be listed on DEA Form 41 for disposal and destruction of CS?
For each drug that will be disposed/destroyed:
-Name of drug
-Content of container
-Date and method of destruction
-List of witnesses
Who are authorized witnesses on DEA Form 41 for the disposal or destruction of CS?
-Physicians
-Pharmacists
-Mid-level practitioners
-Nurses
-Law enforcement officers
After submitting a DEA Form 41, who will inform the registrant of proper disposal/destruction procedures?
the DEA
What are some varieties of proper disposal/destruction procedures of CS via DEA Form 41?
-Transfer to registrant authorized to possess the substance
-Delivery to DEA agent or nearest field officer
-Destroy in presence of DEA agent or other authorized person
-Transfer to registered distributor
-Other methods authorized by DEA
When must the DEA Form 41 be submitted?
2 weeks in advance
Where should all DEA Form 41 be sent?
To the DEA
What is the law that regulated CS disposal by the patient/ultimate user?
Secure and Responsible Drug Disposal Act of 2010 (aka Disposal Act)
Is CS disposal by the patient/ultimate user legal?
Yes, under the Secure and Responsible Drug Disposal Act of 2010 (aka Disposal Act)
What is the goal of the Secure and Responsible Drug Disposal Act of 2010 (aka Disposal Act)?
Encourage public and private entities to develop a variety of methods of collection and disposal in a secure, convenient, and responsible manner
As of 10/2014, who is allowed to collect pharmaceutical CS from ultimate users?
-Manufacturers
-Distributors
-Reverse distributors
-Narcotic treatment programs
-Hospitals/clinics with an on-site pharmacy
-Retail pharmacies
T/F: As of 10/2014, it is mandatory that retail pharmacies have an option to collect pharmaceutical CS from ultimate users.
False - it is optional
What options do participants have in offering to collect pharmaceutical CS from ultimate users?
-Administering a mail-back program
-Maintain collection receptacles
T/F: Legally, a retail pharmacy can maintain a CS collection receptacle at a LTC facility.
True
T/F: Legally, a hospital pharmacy can maintain a CS collection receptacle at a LTC facility.
True
Who must pay the fees associated with a CS drug take-back program?
The registrant (i.e. the pharmacy)
How often must opioid treatment programs become re-accredited and re-certified?
Q3 years
What form is used for opioid treatment programs to become re-accredited and re-certified?
DEA Form 363
What is the definition of "maintenance treatment" in an opioid treatment program?
Dosage levels in excess of 21 days
T/F: Legally, any pharmacy can dispense methadone for analgesic use.
True
T/F: Legally, any pharmacy can dispense methadone for opioid addiction use.
False
T/F: Legally, a pharmacy can dispense 40mg strength of methadone for purposes of pain management
True - however the healthcare team has a voluntary agreement not to use this dosage strength for pain (40 mg not approved for pain)
T/F: Only pharmacies involved with opioid treatment programs can dispense methadone for detoxification or maintenance of addiction
True
T/F: Physicians may administer a one-day supply of methadone outside of the opioid treatment program
True
T/F: Pharmacies may administer a one-day supply of methadone outside of the opioid treatment program
False
T/F: Legally, pharmacies can dispense CIII, IV and V opioids for the outpatient treatment of narcotic addiction
True - suboxone and subutex
T/F: Legally, prescribers can prescribe CIII, IV and V opioids for the outpatient treatment of narcotic addiction
True - suboxone and subutex
If a practitioner is treating patients in the outpatient setting for narcotic addiction, how many patients are they legally allowed to treat?
-30 patients during the first year
-Up to 100 patients in the subsequent years
Practitioners who treat narcotic addiction in the outpatient setting must have what type of DEA number to prescribe Subutex and Suboxone?
DATA-waived DEA # that begins with an "X"
What DEA form is required for physicians to register for authorization to prescribe Subutex and Suboxone to treat narcotic addiction in the outpatient setting?
DEA Form 363
Which two drugs have been approved for the treatment of narcotic addiction in the outpatient setting?
Suboxone, Subutex
T/F: On the face of all Suboxone rx's must contain the prescribers DEA #, starting with an "X"
False - Suboxone can be used to treat pain and in this setting, prescriber would not need DEA "X"
T/F: Central fill pharmacies are recognized by the DEA to package and deliver patient specific prescriptions to another pharmacy to help manage pharmacy's volume
True
How must central fill pharmacies register with the DEA?
DEA Form 224
T/F: Legally, central fill pharmacies can fill both new and refill rx's.
True
T/F: Legally, a central fill pharmacy can receive and fill an rx for a controlled substance, and then sends the rx directly to the patient.
False - cannot provide directly to patient or practitioner - must send it back to the originating pharmacy
Legally, which pharmacy must maintain records of CS filled by a central fill pharmacy?
Both pharmacies are responsible for the validity of the rx and both must maintain records - central fill pharmacy maintains a faxed copy of the original
Legally, can a pharmacy contract with a central fill pharmacy in a different state?
Yes - if both states allow central filling
T/F: Electronic transmission of CS Rx information from originating pharmacy to central fill pharmacy is permitted
True
To order or transfer a CI CS, what form must DEA registrants utilize?
DEA Form 222
To order or transfer a CII CS, what form must DEA registrants utilize?
DEA Form 222
Where does a pharmacy obtain DEA 222 Forms from?
-Originally: DEA headquarters office in Washington, DC
-Subsequent orders: DEA field office
When requesting DEA 222 Forms, what information must be included in the written request?
-Name of each registrant
-Address of each registrant
-DEA Registration number of each registrant
-Number of envelopes requested
-Signed and dated by the same person who signed the DEA registration application
How many carbon copies are on a DEA Form 222?
3 copies, triplicate form
What color is copy #1 of DEA Form 222?
Brown
What color is copy #2 of DEA Form 222?
Green
What color is copy #3 of DEA Form 222?
Blue
T/F: Each DEA form is numbered by the pharmacist when they receive the forms
False - numbered by the DEA
T/F: The DEA pre-prints DEA Form 222's with the name, address, DEA number, and schedules of CS that may be ordered or handled
True
Who maintains ultimate records of copy #1 of DEA Form 222?
The "supplier"
Who maintains ultimate records of copy #2 of DEA Form 222?
The DEA in Greensboro (field office)
Who maintains ultimate records of copy #3 of DEA Form 222?
The "purchaser" = pharmacy usually
Who completes all 3 copies of the DEA Form 222 simultaneously?
The purchaser = the pharmacy
How many total lines are on the DEA Form 222?
10 lines
Who MUST enter the NDC of a CS ordered using DEA Form 222?
The wholesaler/supplier. Pharmacist may, but wholesaler MUST.
Who enters the name and address of the supplier on the DEA Form 222?
The pharmacist
Who must sign and date the DEA Form 222 order?
The purchaser = the pharmacist
T/F: If a pharmacist makes an error on the DEA Form 222, they can cross it off and correct the error, as long as then initial the change.
False - errors may not be corrected - must fill out a new 222 Form
Who submits copies 1 and 2 of DEA Form 222, and retains copy 3?
The purchaser = the pharmacy
Who records the date of shipment on DEA Form 222?
Supplier
T/F: If a supplier cannot provide the entire quantity of CS requested on DEA Form 222, they can provide a partial shipment and supply the balance within 90 days.
False - must supply within 60 days
Who provides Copy #2 of DEA Form 222 to the DEA?
The supplier
What happens to a DEA Form 222 if the supplier cannot fulfill the order?
-Supplier must return copy #1 and copy #2 to the purchaser
-Supplier must provide the rationale for not filling the order
-Purchaser must maintain all 3 copies in its files
What happens to a DEA Form 222 if the order is illegible, incomplete, altered or erased, upon receipt by the supplier?
-Supplier must return copy #1 and copy #2 to the purchaser
-Supplier must provide the rationale for not filling the order
-Purchaser must maintain all 3 copies in its files
How long must executed DEA Form 222 records's be maintained by each entity?
Federal: For at least 2 years
(Check NC for longer)
(Check Medicaid/Medicare for longer)
If a pharmacy wants to RETURN a CI or CII using DEA Form 222, who retains which copy?
Copy 1 (brown): pharmacy is considered supplier
Copy 2 (green): DEA office in Greensboro
Copy 3 (blue): distributor
How does a pharmacy obtain a DEA Form 222 if they wish to return a CI or CII item to the manufacturer or distributor?
Pharmacy must notify the manufacturer/distributor and they will send the 222 form with the quantity and amounts recorded
What must happen if a DEA Form 222 is lost or stolen in transmission?
-Purchaser must execute a new 222 form
-Record on new order form the serial number of the lost form, date of loss, and fact that the CS were not recieved
-Purchaser maintains copy #3 of both new and lost forms together
-Serial numbers of stolen 222 forms must be reported to the DEA
What must happen if a supplier receives a DEA Form 222 that had thought to be lost or stolen in transmission, and a subsequent 222 has also been received?
-Supplier must mark original as "not accepted"
-Supplier must return original copy #1 and #2 to the purchaser
-Purchaser must retain all three copies together in their records
What is the name of the electronic equivalent to DEA Form 222?
CSOS
T/F: CSOS can be used to order CII's.
False
T/F: CSOS can be used to order CIII's
True
T/F: CSOS can be used to order CIV's
True
T/F: CSOS can be used to order non-controlled substances
True
T/F: CSOS can be used to order CV's
True
T/F: Paper DEA Form 222's can only be used to order CII's
True
T/F: Paper DEA Form 222's can be used to order CIII-V's
False
T/F: Paper DEA Form 222's can only be used to order non-controlled substances
False
T/F: A digital certificate is required to use CSOS for EACH location
True - required for each location with a DEA registration - each pharmacy will need their own
What law established outsourcing facilities?
Drug Quality and Security Act of 2013
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