Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
193 Cards in this Set
- Front
- Back
All records of controlled substances must be maintained for how long?
|
2 years (federal)
5 years (state) |
|
To obtain a DEA registration, which form must be submitted?
|
DEA Form-224
|
|
What form must a pharmacy complete to report a theft or loss of controlled substances?
|
DEA Form-106
|
|
Controlled substance inventories should be maintained and readily retrievable for at least how long?
|
1) 2 years (federal)
2) 5 years (utah) |
|
What form must a pharmacy complete in order to destroy controlled substances?
|
DEA Form-41
|
|
1)What is the daily sales limit of ephedrine, pseudoephedrine, or phenylpropanolamine for each purchaser?
2) No more than __ grams of these products can be purchased by a single person during a 30 day period |
1) 3.6 grams
2) 9 grams (Federal limit) |
|
Records involving the transfer or destruction of controlled substances must be kept readily available for how long?
|
2 years (federal)
5 years (state) |
|
How many times may a C-III or IV prescription be refilled?
|
Up to 5 times within six months after the date of issue
|
|
For an inventory of C-III, IV, and V substances, when is an actual physical count necessary?
|
When a container contains more than 1,000 dosage units
(Federal) |
|
What concentration of a codeine preparation would be considered a C-V substance?
|
No more than 200 mg/100 ml or 100gm
(Federal) |
|
"CAUTION: Federal law prohibits the transfer of this drug to any person..." must be printed the labels of which controlled substances?
|
C-II, III, & IV
(Federal) |
|
To obtain a DEA Chemical Distributer registration, which form should be submitted?
|
DEA Form-510
|
|
When may a faxed C-II prescription be considered a "written prescription"?
|
1) Patient is undergoing home infusion/IV pain therapy
2) Patient is in a long term care facility 3) Patient is in hospice care |
|
"The total number of dosage units of controlled substances distributed by a pharmacy may not exceed __% of all controlled substances dispensed by the pharmacy during a calendar year."
|
5%
(Federal) |
|
What are the 4 basic elements of negligence?
|
1) Duty - a legal obligation to conform to a specific standard of conduct for protection of another individual against an unreasonable risk of injury
2) Breach - a violation of that legal obligation by the defendant 3) Causation - the breach is the actual and promiate cause of the plantifs injury 4) Damage |
|
What law required safety testing for medications
|
Food Drug and Cosmetic Act (1938)
Prompted by elixir of sulfanilamade required "warning, may be habit forming" on narcotics and hypnotics |
|
What law legalized oral prescriptions and refills
|
Durham-Humphrey Amendment to the FDCA (1951)
|
|
What law required drugs to be tested for efficacy?
|
Kefauver-Harris Amendment (1962)
Manufactures now required to provide safety and efficacy. Also allowed for inspection of manufacturing facilities (GMP). Established advertising procedures (prescription FDA), OTC (FTC)) DESI group |
|
What law created the Drug Enforcement Agency
|
Controlled Substance Act (1970)
Scheduling of drugs and other substances |
|
What law required that all prescriptions be subject to special packaging requirements?
|
Poison Prevention Packaging Act (1970)
|
|
Can a physician make a blanket request to not place a patients prescription in a child-resistant container?
|
No
|
|
Can a patient make a blanket request to not place their medication in a child-resistant container?
|
Yes
|
|
Whats a class I medical device?
|
Relatively low potential for causing harm - premarket testing is not necessary
e.g., scissors, forceps, hemostats, needles |
|
What is a class II medical device?
|
Safety and efficacy must be evaluated by specific standards.
e.g., hearing aids, sunlamps, tampons, thermometers |
|
What is a class III medical device?
|
Devices that are usually life-supporting systems.
e.g., indwelling catheters, neuromuscular stimulators, pacemakers |
|
What law essentially deregulated the herbal remedies industry
|
Drug Supplement and Health Education Act (DSHEA) - 1984
Cannot claim they diagnose, cure, mitigate, treat or prevent diseases |
|
What does the Food and Drug Administration Modernization Act do?
|
"Rx only" replaces warning
improve efficiency incentive for pediatric clin studies pharm cmpnding regulations |
|
What is considered biequivalence?
|
within 80-125% of the reference drugs Cmax and AUC.
Same pharmaceutical agent, and the same dosage form |
|
Adulterated vs. Misbranded
Which one is primarily concerned with the physical condition of the drug or device and the enviornment of their manufacture |
Adulterated
Prohibited in interstate commerce |
|
Adulterated vs. Misbranded
Which one is primarily concerned with the representations made by the manufacturer concerning the drug or device |
Misbranded
|
|
Aldulterated vs. Misbranded
A drug does not bear generic generic name in type not less than 1/2 the size of the trade or brand name |
Misbranded
|
|
Adulterated vs. Misbranded
Which one does label and labeling discrepencies fall under |
Misbranded
|
|
Aldulterated vs. Misbranded
Which one does a drug that does not conform to an official compendium fall under? |
Adulterated
|
|
Adulterated vs. Misbranded
Insulin or antibiotic drug which is not batch certified |
Misbranded
|
|
Who has the authority to schedule a drug?
|
Attorney General
|
|
What massive law included an indirect approach by the federal government to regulate the pharmacy profession and health care industry?
What are the 3 main components? |
Omnibus Budget Reconciliation Act (1990) - OBRA 90
1) Rebate programs 2) Demonstration projects 3) DUR programs Intent was to promote cost savings and better fiscal management in government sponsored health care |
|
Which law protected health information?
Who is in charge of enforcing this law? |
Health Insurance Portability Accountabilit Act (HIPPA)
Department of Justice - Office of Civil Rights |
|
What law prohibits knowingly making false statements of a material fact in any application for a benefit or payment?
|
Medicare/Medicaid Fraud and Abuse Act
|
|
Who is in charge of enforcing the Medicare and Medicaid Fraud and Abuse Statute preventing kickbacks and refund checks on medicaid patients?
|
Attorney General's office and Medicaid Fraud Control Units (MFCUs)
May punish pharmacy and/or pharmacist |
|
True or False
Manufacturers of controlled substances must label commercial containers of their products with a symbol identifying the classification? |
True
Typically C-I, C-II, C-III, C-IV, or C-V |
|
Narcotic schedule III agents may not contain more than:
|
1) 1.8 grams of codeine or dihydrocodeine per 100 ml or not more than 90 mg per dosage unit
2) 300 mg of dihydrocodeine or ethylmorphine per 100 ml or 15 mg per dosage unit 3) 500 mg of opium per 100 ml or not more than 25 mg per dosage unit 4) 50 mg of morphine per 100 ml |
|
Do pharmacists need a registration to manufacture or distribute any controlled substance or list 1 chemical?
|
No, we dispense, not manufacture or distribute.
|
|
Do pharmacists need to register with the DEA via a 224 form in order to dispense controlled substances?
|
No - the pharmacy must be registered and we are exempted from this because we are an employee acting in the usual course of our employment
|
|
How often must pharmacy registrations be renewed with the DEA?
When should the pharmacy expect to receive a renewal application? |
Every 3 years
45 days prior to the registration expiring |
|
Does each place of business have to be registered with the DEA?
|
Yes
|
|
What must a pharmacy do to change an address?
|
A new DEA certificate reflecting the new address must be obtained. A request for modification of the registration should be sent to the DEA before the effective date of the move.
|
|
What form is required for a renewal of a DEA registration?
|
224a
|
|
Corporations that own or operate a chain of pharmacies may submit a single _________ Form that does what?
|
a DEA Form-224b
This is an affadavit for renewal of retail/chain pharmacy registration. |
|
Who has the right to suspend or revoke a DEA registration?
|
The Attorney General
|
|
What 4 things must be done if terminating a registration?
|
1) Any registrant who discontinues his/her business or transfers it to another person must notify the nearest DEA registration field office IN WRITING before terminating the pharmacy's registration
2) Send the DEA the certificate of registration and any unused 222 forms 3) Write or stamp VOID across the face of each order form. The DEA should also be notified of where and how the C.S. were transferred and where the records will be stored 4) Records involving C.S. must be kept available for 2 years (federal) |
|
What 2 things must be done if transferring a business
|
1) Notify the DEA field office at least 14 days before the date of the proposed transfer
2) On the day of the C.S. transfer, a complete controlled substance inventory must be taken and a copy of the inventory must be included in the records of BOTH the person transferring the business and the person acquiring the business |
|
What are the 2 ways to dispose of controlled substances?
|
1) Transfer controlled substances to another pharmacy via a DEA Form-222 (C-I and C-II only). Document the transfer of C-III through V in writing.
2) Destruction of controlled substances (Form 41) |
|
Who may a pharmacy transfer controlled substances to?
|
1) To another pharmacy
2) To another supplier or manufacturer 3) To a reverse distributor (DEA Form-222 needed from distributor) |
|
How may a pharmacy destroy controlled substances?
|
First contact the nearest DEA Field Office
1) Once-a-year DEA Authorization for Destruction - DEA Form-41 2) Obtain an authorized member of a state law enforcement authority or regulatory agency to witness the destruction (Send in a DEA Form-41 after) 3) Reverse Distributor 4) "Blanket Authorization" for destruction - hospitals |
|
What must be done in order for a reverse distributor to destroy controlled substances from your pharmacy?
|
They must issue a DEA Form-222 to the pharmacy for C-IIs, then they will fill out a DEA Form-41 after the drugs have been destroyed.
|
|
What must be done for the Once-a-year DEA authorization for destruction of controlled substances?
|
1)A DEA Form-41 must be filled out listing all drugs that will be destroyed.
2) Pharmacy must prepare a letter outlining the drugs, date, and method of destruction, along with the names of at least 2 MLP who will witness the destruction. 3) After destruction, the pharmacy needs to send in the signed DEA Form-41 into the DEA |
|
What are the 2 options for keeping controlled substances in a pharmacy?
|
1) in a locked cabinet
2) Dispersed throughout the pharmacy along with the non-controlled substances State law requires an alarm system - not federal. |
|
Can an employee with a felony relating to a controlled substance be hired as a pharmacist?
|
Yes (Federal) - the pharmacy must request the DEA for an employment waiver.
Sorta (State) - DOPL has option to grant individual a pharmacists licence and NOT a CS licence. |
|
What must be done if controlled substances are found to be missing or stolen?
|
1) Contact the nearest DEA Field Office
2) Notify the local police 3) Complete a DEA Form-106 listing the name, address, DEA number, date of theft, name and # of local police, type of theft, listing of C.S. missing |
|
When may the federal government investigate thefts or robberies.
|
1) above $500
2) someone is killed or suffers significant bodily damage 3) interstate or foreign commerce is involved |
|
What are the 3 options for precription record keeping?
|
1) A file for C-II, C-III-V, non controlled
2) A file for C-II, and a file for all others with C-III through V having a red C stamp. 3) A file for C-II through V (schedule III - V must have a red C stamp), then a non-control file. (Utah does NOT allow for #3) |
|
How often must a pharmacy take a controlled substance inventory (federal)?
|
Biennial inventory (every 2 years)
no need to submit to DEA An actual physical count of all C-IIs has to be done. C-III through V can be estimated unless the container holds > 1000 pills |
|
What form is used to order more 222 forms?
|
222a form
|
|
How many order forms does each 222 form contain?
|
Each book contains seven sets of forms. Each pharmacy may have up to 6 books. Max of 42 forms in the pharmacy
|
|
What must a pharmacist do to complete a 222 order form?
|
fill in the # of packages, the size of the package, and the name of the item. When the items are recieved, the RPh must document on the purchaser's copy (copy 3) the actual # of packages received and the date received.
|
|
Power of Attorney to Sign an Official Order Form
|
Any registered pharmacy may authorize one or more individuals (do not have to be Rphs) to obtain and execute the forms.
The POA must be signed by the same person who signed the most recent application for registration. |
|
What must be done upon discovering the loss or theft of unused order forms?
|
You must immediately report the loss to the nearest DEA diversion field office and report the serial numbers.
|
|
According to federal law, how long does a patient have to fill a C-II?
|
Indefinitely (some interpret as 1 year). The RPh must determine that the prescription is still needed by the patient.
(This is obviously different in Utah) |
|
Emergency C-II prescriptions
|
1) May only fill for 72 hours
2) Immediately reduced to writing by the pharmacist 3) Pharmacist must make a reasonable effort to determine that the phone authorization came from a valid practitioner. 3) Within 7 days the M.D. must furnish the pharmacist a written, signed prescription. The prescription must have written on its face "Authorization for Emergency Dispensing". The pharmacist must notify the nearest DEA office if this does not happen, if the RPh fails to do this he/she will not longer be able to dispense without a written Rx. |
|
Can a pharmacy provide a partial fill for a C-II prescription?
|
Yes - if the pharmacy is unable to fill the entire quantity. The RPh must write the quantity supplies on the front of the prescription.
The remaining quantity may be dispensed within 72 hours of the first partial dispensing. |
|
What are the 4 elements necessary for a doctor/patient relationship?
|
1) A patient has a medical compaint
2) A medical history has been taken 3) A physical exam has been performed 4) Some logical connection exists between the medical compaint, medical history, physical exam, and the drug prescribed |
|
Narcotic treatment program registered with DEA can only handle the narcotic substances applied for on what form?
|
DEA Form-363
|
|
Can you mail a controlled substance?
|
Yes - has to meet U.S. Postal Service Mailing Requirements for Controlled Substances.
Cannot be superficially identified. Inner contents are labeled to show the name and address of pharmacy. CANNOT GO OUT OF CONTRY |
|
When does the logbook for the combat methamephetamine epidemic act not apply?
|
The logbook does not apply to any purchase by an individual of a single sales package that contains less than 60 mg of PSE.
The logbook requires photo ID |
|
How many members are on the board of pharmacy?
|
Seven
5 pharmacists, one technician, and one lay person. R.Phs and tech need to have practiced continuously for at least three years in the state, and at least 5 years overall. |
|
How long does a license last before it expires?
|
2 years
September 30 on odd years |
|
How long must you maintain your CE information?
|
4 years after your licensed has been renewed.
|
|
What is the shortest duration for which a license may be suspended?
|
A minimum period of 90 days
|
|
Diversion committees consist of how many professionals within the same or similar occupation?
|
At least 3
|
|
How many times may a licensee be eligible for the diversion program?
|
Only once for the same or similar offense.
|
|
Whats the maximum term of a diversion agreement?
|
Maximum of 5 years
|
|
Does a diversion offense remain on a pharmacist's record if he/she successfully completes the diversion program as stipulated by the board?
|
No - its as if it had never happened
|
|
Can DOPL inspect a pharmacy whenever they want?
|
Nope - it has to be within regular business hours and they must present ID, describe the nature of the visit, provide upon request the authority of the division to conduct the search, and then they may view the license(s)
|
|
What is a class A pharmacy?
Does it require a pharmacist-in-charge? |
A retail pharmacy
Yes - must have a PIC |
|
How many hours must a pharmacist who is applying for licensure by endorsement have?
|
A minimum of 2000 hours in 4 years immediately preceeding application in Utah.
|
|
How many hours of supervised practice must a pharmacist applicant have to be eligible for licensure?
|
1500 total hours
|
|
How many hours in each setting are required by DOPL for an applicant to be considered for a Pharmacist licence.
|
120 in community pharmacy
120 in institutional pharmacy and 120 in any clinical setting |
|
What is required to be a preceptor?
|
An active license
1 years of experience Provide supervision to only 2 interns during a working shift |
|
How many hours of CE are required?
|
30 total hours
|
|
How many hours of live CE are required?
|
12
|
|
How many hours of CE are required for Drug therapy and patient management?
|
15
|
|
How many hours of CE are required to be on law or ethics?
|
1
|
|
Within what time frame must you contact DOPL when changing your address?
|
10 days
Considered unprofessional conduct |
|
How many techs and interns can a pharmacist supervise at any given time?
|
Unlimited technicians (pharmacists discretion) and 2 intern
|
|
What 8 items must a label contain?
|
1) pharmacy info (name, etc)
2) Rx # 3) fill date or last dispensing date 4) patient name 5) presciber 6) directions for use 7) medication info (name, strength, etc) 8) beyond use date |
|
Whats the minimum notice a pharmacy can give to DOPL before it closes?
|
14 days
PIC must write a letter to DOPL within 10 days of closing |
|
State law dictates a CS inventory be taken how often?
|
Annually
|
|
Unprofessional vs. Unlawful conduct
Not offering counseling |
Unprofessional
|
|
May a pharmacist refill a controlled susbtance prescription if the patient is out of refills?
If so, what must be done? |
Yes - other than C-II substanceas
A pharmacist may exercise his/her professional judgment to refill a prescription, provided: 1) Failure to refill might result in an interruption of a regimen or create patient suffering 2) RPh made a reasonable effort to contact the practitioner, this effort must be documented 3) Quantity does not exceed a 72 hour supply 4) inform the patient that this refill is being provided without authorization 5) Pharmacist informs the M.D. 6) Maintains a record of the emergency fill. |
|
What references must a pharmacy have readily available and retrievable to personnel?
|
1) DOPL Act
2) General rules of DOPL 3) Pharmacy practice act 4) Utah Pharmacy Practice Act Rules 5) Utah Controlled Substance Act 6) Utah Controlled Substance Act Rules 7) USP DI Drug Reference Guides 8) Orange Book 9) any other reference needed to perform practice dictated by the usual course of business (All of these can be bookmarked on a computer terminal) |
|
Can a physician write a controlled substance with a sig of UD?
|
Nope - must be something like QID UD
|
|
How many times may a CIII or C-IV be filled?
|
May be filled only within 6 months of issuance, and may not be refilled more than 5 times.
|
|
How long is a C-V good for?
|
12 months
|
|
When does a C-II expire?
|
after 30 days
|
|
True or False
Each Rx for a controlled substance may have other controlled substances on it, but not non-controlled substances? |
False
Each Rx for a CS may contain only 1 controlled substance and may not contain any other legend drugs. |
|
When an M.D. writes for three C-II prescriptions that are for the same medication, what must be included on the 2nd and 3rd Rx?
|
The date of issuance and the date for dispensing.
Unless there is a valid medical reason, the date for dispensing may not be < 30 days from the dispensing date of the previous prescription. |
|
Can a M.D. prescribe a controlled substance for a minor without notifying the parental unit?
|
No - unless it is an emergency
|
|
Are M.D.'s allowed to write for a C-II or C-III for weight loss?
|
No
|
|
What must be done for a C-II emergency prescription?
|
1) Cannot exceed 72 hours
2) M.D. has examined the patient w/i 30 days 3) A written prescription is delivered to the pharmacist within 7 days 4) A reasonable effort to ensure that the M.D. is licensed to prescribe a C.S. |
|
Which of the following may a support personnel not help with?
a) Stocking b) Cashiering c) Billing d) Filing hardcopies e) Counting and filling prescriptions |
e) Counting and filling prescriptions
|
|
Unlawful vs. Unprofessional
Knowingly preventing or refusing to permit any authorized agent to conduct an inspection |
Unlawful
|
|
Unlawful vs. Unprofessional
Failing to deliver the license, permit, etc to the division upon demand |
Unlawful
|
|
Unlawful vs. Unprofessional
Conducting business under the name which contains “drugstore” , “apothecary”, “pharmacy”, etc. unless the place is a licensed pharmacy |
Unlawful
|
|
Unlawful vs. Unprofessional
Buying, selling any drug which bears the name “sample”, “not for resale”, “for investigational use only |
Unlawful
|
|
Unlawful vs. Unprofessional
Using to his own advantages or revealing to anyone other than the division or BOP, any information acquired under authority of this chapter or concerning any method of process which is a trade secret |
Unlawful
|
|
Unlawful vs. Unprofessional
Requiring any employed pharmacist, intern, etc. to engage in conduct in violation of this chapter |
Unlawful
|
|
Unlawful vs. Unprofessional
Being in possession of a Rx-only drug for any unlawful purpose |
Unlawful
|
|
Unlawful vs. Unprofessional
Willfully deceiving the division, the board, or agents regarding compliance with this chapter |
Unprofessional
|
|
Unlawful vs. Unprofessional
Paying rebates to practitioners or other providers |
Unprofessional
|
|
Unlawful vs. Unprofessional
Misbranding or adulteration of any drug |
Unprofessional
|
|
Unlawful vs. Unprofessional
Dispensing of any outdated, misbranded, or adultered drug |
Unprofessional
|
|
Unlawful vs. Unprofessional
Engaging in the sale or purchase of drugs that are samples |
BOTH
|
|
Unlawful vs. Unprofessional
Accepting back and redistributing of any unused drug after it has left the premises of the pharmacy unless the drug is in a unit pack or the manufacturer’s sealed container |
Unprofessional
|
|
Unlawful vs. Unprofessional
Violating the Fed and Utah CSA |
Unprofessional - probably both?
|
|
Unlawful vs. Unprofessional
Disclosing confidential patient information in violation of HIPAA |
Unprofessional
|
|
Unlawful vs. Unprofessional
Engaging in practice of pharmacy without a licensed pharmacist designated as pharmacist in charge |
Unprofessional
|
|
Unlawful vs. Unprofessional
Preparing as a pharmacist or intern, a prescription drug for sale to another pharmacist or pharmacy |
Unprofessional
|
|
Unlawful vs. Unprofessional
Obtaining a passing score on licensing exam or application by fraud, forgery, or deception or omission |
Unlawful
|
|
Unlawful vs. Unprofessional
Practicing through gross imcompetence, and gross negligence |
Unprofessional
|
|
Unlawful vs. Unprofessional
Violating any statue, rule or order regulating the pharmacy profession |
Unprofessional
|
|
A pharmacist may accept back and redistribute any unused drug after it has left the pharmacy if:
|
a. The drug was prescribed to a patient in an nursing care facility, LTCF, state prison, county jail, or state hospital
b. The drug was stored under the supervision of a licensed health care provider according to the manufacturer recommendations c. The drug is in a unit pack or manufacturer’s sealed container d. The drug was returned to the original dispensing pharmacy e. The drug was initially dispensed by a licensed pharmacist or intern f. Accepting back and redistribution of the drug complies with the FDC Act and CSA |
|
Whats the punishment for unlawful practice?
|
Class A Misdemeanor
|
|
Unlawful vs. Unprofessional
Failing to provide DOPL with a current mailing address within 10 business days following the change of address |
Unprofessional
|
|
Unlawful vs. Unprofessional
Practicing pharmacy with the inappropriate pharmacist to intern ratio |
Unprofessional
|
|
FDA Recall
Class I |
Worst case
serious ADR death |
|
FDA Recall
Class II |
Medium
temporary or reverisble damage remote chance of ADR |
|
FDA REcall
Class III |
Low
not likely ADR |
|
Food and Drug Cosmetic Act (1906)
|
SAFETY
Narc "may be habit forming" expand definition of misbrand/adulteration |
|
Durham-Humphrey (1951)
|
ORAL ORDER
allowed doctor dispensing for administration "caution: federal law prohibits dispensing without a prescription" |
|
Kefauver-Harris (1962)
|
EFFICACY
standards for GMP (good mfg practices) advertising - FDA:RX FTC:OTC new drug approval process |
|
Control Substance Act (1970)
|
created DEA
scheduleing of drugs resigrations |
|
Poison Prevention Packaging Act (1970)
|
child-resistant
no more than 20% of kids <5 yo can open in <10 min |
|
Harrison Narcotic Act (1914)
|
Manufacturing and distributing limits on opium
|
|
Medical Device Act (1976)
|
Brought devices under the perview of the FDA
|
|
Orphan Drug Act (1983)
|
Provided special incentive for drug manufactures to create treatments for rare diseases
|
|
Drug Price Competition and Patent Term Restoration Act (1984)
(aka Hatch/Waxman) |
Created the ANDA, allowing for cheaper/quicker releases of generic drugs
|
|
Prescription Drug user Fee Act (1992)
(aka PDUFA) |
Required higher fees for drug manufactures when getting drugs approved
Sped up the NDA approval process |
|
Dietary Supplements & Health Education Act (1994)
(DSHEA) |
Dietary Supps and Herbal crap cannot claim to "diagnose, cure, mitigate, treat, or prevent disease"
|
|
Food and Drug Modernization Act (1997)
|
"Rx only" replaces warning
improve efficiency incentive for pediatric clin studies pharm cmpnding regulations |
|
Class A Pharmacy
|
Retail
|
|
Class B Pharmacy
|
Institutional
hospital, clinic, closed door, nuclear, branch, pharm admin, sterile product |
|
Class C Pharmacy
|
mfg, productions, wholesale, distribution of drugs and devices
|
|
Class D Pharmacy
|
non- residential (mail order)
|
|
Class E Pharmacy
|
"Other" classification of pharmacies
(animal euthanasia, research facilities) |
|
DEA Form 41
|
DESTRUCTION
notify DEA and send copy keep records 5 years |
|
DEA Form 224
|
New Pharmacy Registration
|
|
DEA Form 224a
How often? |
Renewal pharmacy registration
Every 3 year Receive renewal form 45 day prior to exp |
|
DEA Form 510
|
DEA Chemical Distributor Registration
|
|
DEA Form 224b
|
Renewal chain pharmacies
|
|
DEA Form 222
|
Ordering or Transfering CII
Copy 1 is retained by the DISTRIBUTOR Copy 2 is sent to the FDA Copy 3 is retained by the PURCHASER |
|
DEA Form 222a
|
Ordering more 222 forms
limit of 6 books with 7 forms each (42 MAX) |
|
DEA Form 106
|
report theft or loss of CS
notify DEA w/in 1 day of discovery notify DOPL (send copy) includes shipping losses notify local police and get case # |
|
DEA Form 363
|
narcotic treatment program
|
|
Inventory Requirement (Federal)
CII? CIII-V? |
CII: actual count
CIII-V: estimate okay unless container is >1000 units and has been opened |
|
Inventory Requirement (State)
|
1. Annually
2. Kept for 5 years 3. CI & CII records kept separate from CIII - V |
|
Prescription Transfers
Who to who? Keep record how long? |
Pharmacist to pharmacist (or intern)
5 years keep records Must void rx and write "void" on original |
|
How to record a transfered Rx (5 reqs)
|
1. Date of issue, first and last fill
2. Original rx # 3. Original refills and amt remaining 4. Name, address of sending pharmacy 5. Name of both pharmacists/interns |
|
Additional Reqs for E-Scripts (4 reqs)
|
1. time and date transmitted
2. name of intended pharmacy 3. deemed original rx 4. record kept for 5 years *e-script presented physically by pt can NOT be filled* |
|
Prescription requirements
|
Doctor Info (Name, address, phone, DEA if controlled)
Patient Info (Name, address, DOB if controlled) Date of issuance Drug Info (Name, quantity, directions) Doc Signature |
|
Label requirements
|
Pharmacy Info (Name, address, phone)
Rx Number Date filled/dispensed PT name Doc name Drug info (Name, strength, quantity) Directions (and caution statements if necessary) Expiration date (Federal LAW!!!) |
|
Generic Sub allowed if
|
1. PT requests or consents
2. A/B rated in orange book 3. Pharmacist/intern counsels pt on use and expected response 4. Not DAW rx |
|
Drug samples okay to dispense by doc if...
|
1. not CII, benzo, opioid
2. in original mfg container 3. marked as sample on container OR marked in pt chart sample was given (name and quantity) 4. 30 day sup limit on controls 5. free of charge to pt |
|
Patient counseling by pharmacist should include
|
1. Name and description of drug
2. form, ROA, dose, duration of therapy 3. indication and expected action 4. special directions 5. common, serious ADR 6. self-monitoring 7. storage 8. missed dose 9. expiration date/BUD |
|
Schedule I
|
1. no medical use
2. can NOT be prescribed or dispensed 3. for research/lab/analysis only heroin, marijuana, mathaqualone, LSD, etc |
|
Schedule II
|
1. medical use
2. high abuse potential 3. severe pysch or physical dependence cocaine, fentanyl, secobarbital, hydrocodone, poppy, coca leaves, amobarbital, pentobarbital, phencyclidine, oxycodone, others |
|
Schedule III
|
1. medical use
2. less abuse potential than CII 3. high psych, moderate-low physical dependence anabolic steroids, ketamine, hydrocodone combos, dronabinaol, amobarbital, benzphetamine, chlorphentermine, buprenorphine, <1.8 g codeine/100ml (or 90mg per unit) <1.8 g dihydroco/100ml (or 90mg per unit) <300 mg dyhydro/100ml (or 15mg per unit) <300 mg ethylmorphine/100ml (or 15 mg/unit) |
|
Schedule IV
|
1. Medical use
2. less abuse potential than CIII 3. limited psych or physical dependence soma (carisoprodol), lunesta (eszopiclone), sonata (zaleplon), benzo's, nuvigil, provigil (modafinil), fenfluamine, phenteramine, sibutramine |
|
Schedule V
|
1. medical use
2. low abuse 3. limited psych or physical dependence lomotil, phenergan with codeine, pyrovalerone <200mg codeine/100ml or g (Cheratussin, Pediacof) <100mg hydrocodone/100ml or g (Cophene-s) <100mg ethylmorphine/100ml or g <2.5 mg diphenoxylate and 25mg atropine per unit (lomotil) |
|
DEA Number Check
|
two letters and 7 #'s
first letter ID's registrant - A,B,F: hospital, clinic, practitioner, pharmacy, teaching institution - M: midlevel practioner (PA, NP, OD, APN, CNP, - P, R: mfg, distrib, research, analytical, importer/exporter -X: DATA doc AB1111119 1st + 3rd + 5th = 3 2nd + 4th+ 6th = 3 x 2 = 6 3+6 = 9 (last number of DEA) |
|
CII Requirements (Utah)
|
1. no refills
2. 30 day sup 3. exp 30 days from date written 4. can NOT be filled after 30 days from last dispense date if separately indicated from issue date 5. may not contain another rx |
|
CII Multiple RX requirements (Utah)
|
1. limit 3 rx's
2. limit 30 days each 3. date of issue and date to be filled on 2nd and 3rd 4. can NOT dispense sooner than 30 days from date last filled |
|
CIII-IV rx requirements
|
1. 6 month expiration from date of issue
2. only refill 5 times 3. can NOT contain another rx |
|
CV rx requirements
|
1. rx in utah
2. 1 year expiration from date of issue 3. refills as doc directs 4. can NOT contain another rx |
|
True or False
Control rx must contain specific sig for use |
True
cannot just be UD |
|
Emergency verbal CII okay if...
|
1. Limit 72 hour sup
2. cover to follow in 7 days 3. report to dea if no cover, or else pharmacist cannot accept oral CII orders 4. prescriber-pt relationship (seen w/in last 30 days) |
|
Partial CII okay if
|
1. can NOT supply full quantity
2. must dispense remaining in 72 hours 3. pharmacist notes quantity given on front of rx 4. contact prescriber if can't supply in 72 hours - need new rx now |
|
Partial CIII-V okay if
|
1. noted dispensed quantity and initials back of rx
2. may not exceed total amt auth on rx 3. may not be filled after 6 months from issue |
|
What can NOT be changed on a CII
|
Any names or dates:
Any names (Drug name, PT name, Doc name/signature) Any dates (date written, "to be filled" date)...PT's DOB is ok to change. |
|
CS Database
Pharmacist submits how often? |
Weekly
Electronically |
|
CS Database
Cover page should include |
1. Pharmacy name
2. NABP# 3. Period of time of submission 4. Date prepared 5. Date Submitted 6. Number of rx's 7. RPh signature |
|
CS Database
For each rx info submitted: |
1. Name of doctor, pharmacy, RPh
2. Date issued and filled 3. Name of patient 4. Their form of ID and ID number 5. Name of drug, strength, quantity, directions |
|
CS Database
Who has access? |
1. pharmacist (NOT intern)
2. doc (may designate 3 ppl) 3. mental health therapist 4. DOPL investicational staff 5. DOPL and health dept authorized to analyze CS rx's 6. ultimate user with DOPL approval ***3rd degree felony if access illegally*** |
|
True or False
It is unlawful or unprofessional to prescribe or dispense for "the partner of ____". |
True and false.
It is ok to dispense for a partner if the medication is used to treat an STD. |