last thing for law lol- study guide Flashcards
Prescribe
- IPs need DEA and are authorized by state or exempt
- delegation of prescriptive authority
- those allowed to dispense CSs: RPh or pharmacist employed by registered pharmacy or institutional practioner
- Ancillary and IPs can dispense if their state allows
- Rx can only be given by IP who is authorized to by the state, is registered or exempt from registration under 21 CFR 1306.03
prescription
- medication order for ultimate user
- Rx does not include orders for medication dispensed for immediate administration (like hospital charts)
-prohibition for Rx for office use
DEA #
–Nine digits composed of letters and numbers
two alphabet letters followed by seven numbers
–Initially, the registration number started with the letter A.
All registration numbers starting with A have been assigned
DEA started with B now F, started G (?)
- Mid-level practitioners (and pharmacists) begin with M.
- Distributors begin with either P or R
- The second letter is usually, but not always, the first letter of the registrant’s last name
- The next six positions are a computer-generated number unique to the registrant
- The last and 9th position is a computer-calculated
To check the validity of a DEA registration number:
an RPh
–adds the first, third, and fifth digits
–adds the sum of the second, fourth, and sixth digits, multiplied by 2, to the first sum
–determines whether the rightmost digit of this sum corresponds with the ninth check digit
Disclaimer
– In reality, many forgers are familiar with the procedure to verify a DEA registration number and can invent a number that would be plausible.
–Therefore, pharmacists cannot rely solely on this check to determine the validity of a controlled substance prescription.
Issue of Rx
–Date of issuance required: no predating or postdating
– name and address of patient
–drug name
– drug strength
–dosage form
–quantity prescribed
–directions for use
–name, address, and registration number of practitioner & DEA #
–Before filing, must contain the written or typed name or initials of a dispensing pharmacist, the date dispensed, and the units or volume dispensed
– everything in permanent ink
–Corresponding responsibility of pharmacist and prescriber that a CS Rx complies with all requirements
correcting written Rx
For C-III, C-IV, and C-V Rxs:
– The pharmacist may add or change any information after consultation with the practitioner
cannot change:
- patient’s name
- name of CS (except generic substitution)
- prescriber’s signature
For C-II Rxs:
- corrections can be made if state law or policy permits.
Purpose of CS Prescription
- for a legitimate medical purpose in the usual course of professional practice.
- Corresponding responsibility upon the pharmacist
- Knowingly prescribing or dispensing a CS Rx not for a legitimate medical purpose violates the law.
- When suspicious a pharmacist should investigate.
- Legitimate medical purpose: acting in accordance with accepted standards of medical practice.
Examples of invalid prescriptions include:
- Narcotic Rxs for the purpose of maintaining or detoxifying an addict
- Rxs written for fictitious patients
- Rxs written without a good-faith medical examination
- Rxs written when there is no medical reason
- A facially valid Rx is not necessarily a valid Rx.
- Pharmacists will more likely face enforcement action in situations where there is blatant or glaring misconduct as opposed to isolated prescriptions.
CII Rules
Oral
Written
Fax
Emergency
Refills
Partial Fill
Retail
LTC
Unable to supply (?)
Multiple CII
Oral: can be given in emergency situations
Written: written and signed by a prescriber
Fax: faxed RPh serves as original for narcotic infusion, LTCFs, Hospice patients
Emergency: dispensed upon oral order
- immediate administration of CII is necessary for the proper treatment of the intended ultimate user;
- no alternative treatment is available, including administration of other CSs
- not possible for the prescriber to give a written Rx prior to the dispensing.
Refills: no refills without a new Rx
Partial Fill:
—- Retail:
- 2016 CARA Law permits that there can be a partial refill within 30 days of the Rx
- CARA also allows partial refills upon emergency Rx
LTC:
- can be given up to 60 days from the date of issuance if the record is kept
Unable to supply (?)
Multiple CII:
- Each Rx must be on a separate blank.
- The total quantity prescribed does not exceed 90-day supply.
- The practitioner determines a legitimate medical purpose to do this.
- The practitioner writes instructions on each Rx
- Multiple Rxs do not create undue risk of diversion.
- Permissible under state law
CIII, IV and V
III and IV
Refills 5
6 months
V do not apply to 5 monthly refills and 6-month expiration
Oral
Fax
Written
Refills
CIII, IV, and V
III and IV
–Refills 5
– 6 months
can get up to 5 refills within 6 months of the original Rx
- V does not apply to 5 refills and 6-month expiration
- refills cannot exceed the quantity originally authorized
Oral:
- for III & IV the practitioner may orally authorize additional refills if the original was written for less than five and authorization is recorded on hard copy or in an automated system.
Fax:
Written
–May be dispensed pursuant to written, faxed (considered original), electronic, or oral order (need to be reduced to writing)
look above for Refills
Label
Partial fill
II, III, IV, V
Pharmacy name and address
Serial Number
Name of patient
Name of drug
Directions for use and cautions
Aux Sticker II, III, and IV NOT V
Partial fill
allowed if
- recorded in the same manner as the refill
- The total quantity dispensed does not exceed the total prescribed.
- No dispensing after 6 months from the date of issuance
must have:
II, III, IV, V
Pharmacy name and address
Serial Number
Name of patient
Name of drug
Directions for use and cautions
Aux Sticker II, III, and IV NOT V
- The label must include the date of filling if a C-II drug
- date of initial filling if in another schedule.
- Refills should be labeled with both the date of initial filing and the date of dispensing.
- Labels must cautionary statement prohibiting the ultimate user from transferring the drug.
- Labeling requirements are not applicable if prescribed for administration to an institutionalized patient, provided that restrictions and requirements are met.
E-prescribing
prescriber requirements
pharmacy requirements
Prescribers must:
- Undergo identity proofing
- Digitally sign using two of three possible factors for authentication
- An agent can enter Rx information but cannot have access to authentication factors and sign.
Pharmacy requirements:
- The pharmacy or ASP must digitally sign,
- The pharmacy must archive the Rx.
- If Rx transmission fails, the regulation establishes that certain requirements must be followed.
- May make changes to Rx after receipt
- Must back up daily and keep records for two years
- All application systems must be approved by a third-party audit or certified by a DEA-approved entity.
Transfer of III, IV and V
CIII
- You cannot transfer a CII because they do not have refills
- CIII-V can be transferred once if state law allows and requirements are followed by both pharmacies
- Rx information sharing among pharmacies participating in common-electronic record systems is not subject to the transfer Rx requirements
Central Fill
- Pharmacies that fill Rxs for other retail pharmacies pursuant to a contractual arrangement
- May fill both new and refill Rxs
- Any Rx dispensed for another pharmacy must be transported to that pharmacy for furnishing to the patient.
- The label must indicate which pharmacy the drug was dispensed.
- Cannot accept Rxs directly from patients or practitioners or deliver Rx directly to patients or practitioners
- Corresponding responsibility doctrine applies to pharmacists at both facilities.
Internet Prescriptions
- Rogue internet pharmacy businesses are those that sell Rx medications to customers either without requiring Rxs or by issuing Rxs pursuant to online surveys.
- The Ryan Haight Act law valid Rx: issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient - online pharmacies must comply
- Although the act only applies to CS Rxs, most states consider any Rx not dispensed pursuant to a legitimate physician–patient relationship as invalid.
PDMP- State Electronic Drug Rx Monitoring Programs
- All states have a PDMP.
- Requires a pharmacy to electronically state a record of the CS Rx dispensed.
- Enables states to determine possible diversion and abuse situations
- Most PMPs allow or mandate practitioners to request patient-specific information.
- Many states share data between PDMPs.
Long-Term Care (LTC) Pharmacy
- Not registered with DEA
- DEA is concerned about excess supplies of CSs and so permits automated dispensing systems, partial filling, and voluntary collection receptacles by registered “collectors”
Record keeping
Time
Inventory requirements
Initial
Biennial
Exact count II and bottles greater than 1000
Best practice exact count of all
- Every registrant must keep a complete and accurate record of all CSs.
- Three types of records are involved:
Inventory
Drugs received
Drugs dispersed
Negligent recordkeeping is a violation of the CSA.
Time: every 2 years
Inventory requirements
Initial and Biennial - Prior to beginning business and subsequently every two years, an inventory must be conducted containing a complete and accurate record of all CSs “on hand” (in possession of or under the control of the registrant)
- Inventory may be taken at the beginning or end of the business day; records must be written, typed, or printed.
- Newly scheduled drugs must be inventoried on the date of scheduling.
- The exact count must be made of C-I or C-II drugs.
- The estimated count is permissible for other schedules unless the container holds more than 1,000 units.
Non-RX V- 279
Distributions from a Pharmacy to Another Practitioner
5% rule
The total number of dosage units distributed to another registrant must not exceed 5% of total units of CSs distributed and dispensed in one year.
Forms
41
222
106
41: disposal & destruction of CII from ultimate users and LTFCs
222: distributing CII
106: reporting a theft or loss of CII, notify DEA within 1 day of discovery of theft or loss
form 222
Copy 1
Copy 2
Copy 3
Partial fill 222 (?)
CSOS
Lost
Stolen
Each form is in triplicate titled Copy 1, Copy 2, Copy 3. just have 1 form now
Electronic CSOS can be used instead of 222, The purchaser can order any drug, The registrant must obtain a digital certificate for each DEA-registered location.
Power of Attorney (POA)
Required to allow person other than one who signed registration to execute Form 222
Lost or Stolen Forms
- the purchaser must execute another together with a statement noting the serial number of the lost form, the date of the lost form, and that the CSs were not received.
- Must maintain together Copy 3 of the second order form and lost order form with a statement
- The copy of the statement must be sent with Copies 1 and 2 to the supplier.
- If forms are stolen or lost other than in transmission, must notify DEA and provide serial #s of missing forms; if found, DEA must be notified immediately
Closed System
allows for controlled substances to be traced from initial manufacture to final dispensing to the patient.
created by federal controlled substance act
Schedules
Placement into one of five schedules depending on abuse potential and degree to which drug may cause physical or psychological dependence
Examples of CS
CI: hallucinogenics, some opiates, methaqualone, and unapproved GHB
CII: opium and many other opiates (including products containing hydrocodone); cocaine; stimulants such as amphetamine and methamphetamine; depressants such as amobarbital, glutethimide, secobarbital, and pentobarbital
CIII: stimulants, anabolic steroids, dronabinol, ketamine, paregoric, and GHB approved by the FDA
CIV: dextropropoxyphene; depressants such as alprazolam, chloral hydrate, barbital, benzodiazepines; stimulants such as diethylpropion, phentermine; tramadol
CV: antitussives containing codeine and antidiarrheals containing an opiate
Authority to schedule
- in the attorney general who requests a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS
- The recommendation of the secretary regarding scientific and medical issues is binding on AG, except when AG finds the drug must be placed in C-I to avoid an imminent hazard to public safety.
Manufacturer Labeling and Packaging
- Labels and labeling of commercial containers of controlled substances must contain the identification symbol of the schedule.
- The symbol must be prominently located.
Registration
Who needs to be registered
who is exempt
- Manufacturer - register annually
- Distributor - register annually
- Dispenser - register every 3 years
- reverse distributing
- conducting research
- conducting narcotic treatment programs
- conducting chemical analysis
- importing
- exporting
exemptions:
- agents or employees of registrants
- common carriers
- ultimate users
- prescribers
- dispensers in the service of the U.S. government
- law enforcement officers
separate registration
Each principal place of business where CSs are administered, dispensed, or stored requires a separate registration.
Application for Registration
what form do you use
- register before participating in an activity requiring registration
- Current registrants should receive a registration form approximately 65 days before expiration. A second notice will be sent electronically if required.
- The dispenser registration form is DEA Form 224 (used to register with the DEA), which is available online.
Transfer vs termination of registration
- Any modifications must be approved by the DEA.
- If the registrant dies or ceases legal existence, the DEA must be notified, and the registration is terminated.
- Registrations cannot be assigned or terminated without DEA approval.
Security requirements
Store CSs in a locked cabinet
Intersperse them throughout the other drugs to prevent a quick sweep
penalties for practitioners
Section842 establishes penalties for practitioners for not conforming to the requirements of the CSA, such as recordkeeping. The standard was changed from strict liability to negligence.
Pharmacy Inspection
Constitutional issues:
- The Fourth Amendment protects individuals from unreasonable searches and seizures.
- Requires the issuance of a search warrant based on probable cause
- The exclusionary rule provides that any evidence obtained in violations of the Fourth Amendment will not be admissible.
Administrative Inspection Warrant (AIW)
- No consent required
- Probable cause requirement
- Valid public interest
- Contrast to probable cause for search warrant (SW, which requires probable cause that you are doing something illegal)
- AIW created by Supreme Court as alternative to SW
- AIW may only be served during regular business hours.
Opioid Treatment Programs (OTPs)v
- Congress first authorized narcotic treatment programs (now OTPs) in 1974.
- Only LAAM, methadone (CII- a retail pharmacy can hold this for severe pain, cannot use for cough), buprenorphine, and buprenorphine containing products are authorized drugs for treatment of opioid addiction.
- Practitioners wanting to conduct maintenance or detox treatment must be registered by the DEA.
methadone:
- Used for severe pain outside of narcotic treatment programs
- Not legal to prescribe or dispense as an antitussive
- The APhA lawsuit established that the FDA could not restrict the distribution of methadone.
- Manufacturers voluntarily restricted 40 mg methadone tablets to OTPs. So, retail pharmacist usually have 5 or 10mgs
DATA
- Enacted in 2000 with the intent of allowing addicts to be treated for addiction in office-based settings (outside of OTPs)
The only permitted drugs are buprenorphine SL (Subutex) and buprenorphine-naloxone (Suboxone) tablets.
- Treatment must be by a “qualifying physician.”
- The qualifying physician may apply to treat up to 275 patients and must obtain a special DEA number (“X”).
- A recent amendment now allows mid-level prescribers to prescribe under DATA if state law allows.
Controlled Substance Registrant Protection Act
- a federal crime if robbery results in $500 or greater replacement cost of CSs, or person suffers “significant” injury, or interstate commerce is involved in the planning or execution of the crime.
- Penalties can result in up to 20 years of imprisonment, $25,000 fine, or both. If a weapon is used, the penalties are higher. If death results, the penalty is higher yet.
Chemical Diversion and Trafficking Act
regulate precursor chemicals, essential chemicals, tableting machines, and encapsulating machines by imposing record-keeping and import/export reporting requirements on transactions involving these materials.
Anabolic Steroids (CIII) Act of 2004
- Amends prior anabolic steroid (Testosterone etc) legislation enacted to prevent misuse in order to enhance athletic performance
- Maintains anabolic steroids as schedule III
- Adds several steroids to the act
- Provides for automatic scheduling of certain salts, esters, and ethers of anabolic steroids without the need to prove muscle growth
- Physicians and prescribers cannot give for athletic performance
Combat Meth Act
know the math for pseudoephedrine!
- Places restrictions on OTC drugs used to manufacture methamphetamine including pseudoephedrine
- The law limits sale to no more than 3.6 g of ephedrine, PSE, or PPA base to a single purchaser per day.
- No consumer may purchase more than 9 g within a 30-day period or 7.5 g within a 30-day period by mail order.
- The products must be stored behind the counter or in a locked cabinet where customers do not have direct access.
- Sales must be recorded with required information.
Limits pseudoephedrine age: no age requirement, each employee undergoes training that is certified to attorney general
pseudoephedrine is 30mgs
Know basic info: 3.6g per day
3.6 grams is 3600 mg
3600/30mg is 120 tablets
Ask about pseudoephedrine base not hydrochloride or sulfate
US Postal Laws
CSs may be mailed, provided they meet the packaging standards established by the U.S. Postal Service.
Can you mail drugs: yes
Can mail CII-CV drug
If you were not able to mail, there would be thing as mail order pharmacy
Lable must not say that there are drugs inside
FDCA
Federal Food, Drug, and Cosmetic Act (FDCA) is a set of United States (US) laws that authorize the Food and Drug Administration (FDA) to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics.
Durham Humphrey
explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC), oral refills
Food additive
manufacturers to provide safety assessments for all new food additives.
Color Additive
brought all colors, natural and synthetic, under the Food, Drug, and Cosmetic Act. Color additives may not be used to deceive consumers or to conceal blemishes or inferiorities in food products.
Kefauver Harris
required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects. required that evidence of effectiveness be based on adequate and well-controlled clinical studies conducted by qualified experts.
Medical Device
consolidated and expanded ex- isting Federal authority over medical devices into a system of regulating the safety and effectiveness of medical devices in proportion to the degree of risk that they pose.
Orphan Drug Act
a law passed by Congress in 1983 that incentivizes the development of drugs to treat rare diseases
