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21 Cards in this Set

  • Front
  • Back
what are Prescription or Legend Drugs
considered potentially harmful if not used under the supervision of a licensed health care practitioner.
what are Non-prescription or Over the Counter Drugs
considered safe to use without medical supervision, but must contain adequate directions for use on their label.
what are controlled substances
agents that are tightly regulated due to their abuse potential, may be prescript or OTC
what are schedule I controlled substances?
i. High abuse potential, not accepted for medical use in the US.
ii. Severe potential for physical and psychological dependence.
iii. Examples: heroin, LSD
what are schedule II controlled substances
High abuse potential but accepted for medical use
Severe chance of tolerance and addiction
Exp: morphine oxycodone
what are schedule III controlled substances
i. Potential for abuse less than CI or CII, accepted for medical use in the US.
ii. Moderate to low potential for physical dependence, high potential for psychological dependence.
iii. Examples: Phenobarbital, ketamine, Tylenol with codeine
what are schedule IV controlled substance?
i. Potential for abuse low relative to CIII, used in US.
ii. Limited potential for physical and psychological dependence.
iii. Examples: benzodiazepines, chloral hydrate
what are schedule V controlled substance?
i. Potential for abuse low relative to CIV, used in US.
ii. Limited potential for physical and psychological dependence.
iii. Examples: Robitissin AC, Novahistine DH, Kaopectalin PG
Under Kentucky law, all prescriptions should contain the following elements:
i. Date written (DMY)
ii. Full name of the patient
iii. Name of the drug
iv. Strength of the drug
v. Dosage form of the drug
vi. Quantity prescribed, numerical and written (#30=thirty)
vii. Directions for use
i. Prescriber name, business address, telephone number, and original signature
ii. Provider licensure # and DEA #
what are some Additional required elements that must be on all prescriptions for controlled substances:
i. Practitioner must be registered with the DEA
ii. DEA number must be provided on every prescription
iii. Total numeric quantity to be dispensed must be written on the prescription
iv. Name and address of the patient must be provided
v. Use of state security prescription blank required
Non-prescription or over the counter drugs must contain
adequate directions for use on their label.
b. Codeine preparations may be sold OTC if they:
1) contain no more than 200mg of codeine or its salts in 100mL or 100 grams, 2) are present in combination with another medicinal product. They are limited to 120 mL per any individual within a 48 hour period and to individuals 18 years of age and older. They must be tracked via the exempt codeine registry.
Prescription specific rules for non-controlled legend drugs:
i. Valid for up to one year after the date of issue.
ii. No limitation as to the number of refills allowed but refills are valid only for the life of the prescription.
iii. May refill “as needed” (PRN).
iv. May be transmitted orally, electronically, or via facsimile.
v. Limitations on quantity may be imposed by insurance company.
d. Prescription specifics rules for CII prescriptions in KY:
i. NO refills allowed.
ii. Valid for up to 60 days after the date of issue.
iii. Must be written – oral prescriptions not allowed.
iv. Facsimile copies allowed if:
1. Long term care facility patient
2. Hospice patient
3. Narcotic parental to be compounded
4. Original, signed Rx must be presented to the pharmacy within 7 days
what are the Additional requirements if written by a nurse practitioner for writing CII prescritions in KY?
1. Limited to a 72 hour supply
2. Exception: NPs certified in psychiatric-mental health nursing who are providing services in a mental health facility may issue a prescription for a 30 day supply of psychostimulant meds.
3. Additional limitations may also exist for controlled substances with the greatest potential for abuse or diversion.
Prescription specifics rules for CIII-CV prescriptions in KY:
i. Valid for up to 6 months from date of issue.
ii. May refill up to 5 times within 6 months of the date of issue (not date of original fill).
iii. May be transmitted orally, electronically, or via facsimile.
iv. If faxed, the transmitting practitioner or their agent must write or stamp “FAXED” on the face of the original prescription, date and initial, and retain the original in the patient’s records.
v. Additional requirements for CIII prescriptions if written by a nurse practitioner:
1. Limited to a 30 day supply.
2. No refills allowed.
3. Additional limitations may also exist for controlled substances with the greatest potential for abuse or diversion.
what is pharaceutical equivalence?
same active ingredient, dosage form, route of administration, and strength.
what is bioequivalence
pharmaceutically equivalent products that display comparable bioavailability when studied under similar experimental conditions
what is therapeutic equivalence?
pharmaceutical and bioequivalent
In KY, generic substitution is mandatory if
i. Prescription is written for the brand name
ii. The generic is not listed on the nonequivalent drug product formulary
iii. The therapeutically-equivalent drug is in stock
iv. The therapeutically-equivalent drug is cheaper
v. The prescribing practitioner does not write “Do not substitute”
vi. The patient does not specify otherwise
who can prescribe legend and controlled drugs in KY
a. Physicians, veterinarians, dentists, and podiatrists can prescribe legend and controlled drugs (all schedules).
b. Optometrists can prescribe legend drugs and schedule III-V controlled substances only.
c. Advanced registered nurse practitioners can prescribe legend and controlled drugs of all schedules.
i. CII: limited to 72 hours
ii. CIII: limited to 30 days
d. Physician assistants can prescribe legend drugs only.