1902

• Diptheria antitoxin contaminated with live tetanus bacilli
• Biologics Control Act
• 1906
• Pure Food and Drug Act
• Strength and Purity
• Prohibited fodo and drugs that were adultered or misbranded
• Did not require manufactures to list the ingredients or directions for use on the product label
• All marketed drugs were available without a prescription
• 1938
• Sulfanilamide (diethylene glycol)
• Food Drug and Cosmetic Act
• Safety
• 1951
• Durham-Humphrey Admendment
• Distinguished between OTC and prescription
• 1959
• Chloramphenicol-Gray baby syndrome
• 1962
• Thalidomide-amendments to the Food Drug Cosmetic Act
• Safety and efficacy
• 1970
• Comprehensive Drug Abuse Prevention and Control Act
• Controlled Substances-agents tightly regulated due to their abuse potential
• May be prescription or OTC
• Title II Controlled Aubstance Act-regulated the manufacture and distribution of narcotics, stimulants, depression, hallucinogens, anabolic steroids, and chemicals used in the illcit production of controleld substances
• Categorized all controlled substances into schedules
• Established additional regulatory requirments

• Schedule I
• High Abuse Potential
• No Accepted Medical use in US
• Severe physical and psychological dependence
• LSD, Heroin
• Schedule II
• High Abuse potential
• Accepted Medical use in US
• Severe physical and psychological dependence
• methylphenidate, cocaine, morphine
• Schedule III
• Abuse potential less than CI or CII
• Accepted medical use in US
• Moderate to low physical dependence
• High psychological dependence
• phenobarbital, ketamine, Tylenol with codeine
• Schedule IV
• Abuse potential low compated to CIII
• Accepted medical use in US
• Limited physical and psychological dependence
• benzodiazepines, chloral hydrate
• Schedule V
• Low abuse potential relative to CIV
• Accepted medical use in US
• Limited physical and psychological dependence
• Robitissin AC, Novahistine DH, Kaopectain PG

• Soma (carisoprodol)-CIV
• Nubain (nalbuphine)-CIV
• Federal law classifies Talwin (pentazocine) as CVI but KY classifies as CIII

Exempt Codein Preparations

Class V

• Codeine preparations may be sold OTC if:
• Contains no more than 200mg of codeine or its salts in 100ml in 100gms
• Are present in combo with another medicinal product
• Limited to 120 ml per any individual within a 48 hour period and to individuals 18 years of age and older
• Must be tracked via exempt codein registry

• Term "prescription" is generally limited to use in the outpatient setting
• Inpateints
• Drug prescribing occurs via use of a specific page of the patients medical record called the order sheet or CPOE
  Required elements of a prescription often do not apply to the inpatient medical order
• However general priciples or prescriptions writing and federal/state drug classification and scheduing apply

• Practitioners-physicians, veterinarians, dentists, podiatrists can prescribe legend and controlled drugs.  All schedules
• Advanced Registered Nurse Practioners (ARNP)
• Legend and Controlled all schedules
• CII-limited to 72 hrs
• CIII-limited to 30 days
• Physician Assistants-Legend drugs only, no controlled substances

Written

Fax

Verbal

Electronic

Date Written-Day, month, year

Full name of the patient

Name of the drug

Strength of the drug

Dosage form of the drug

Quantity prescribed (#30=thirty)

Directions for use

Prescriber name, business address, telephone number and original signature

Provider licensure # and DEA #

• For ALL controlled substance prescriptions (CII-CV)
• Practitioner must be registered with DEA
  DEA number must be provided on EVERY prescription
• The total numeric quantity to be dispensed must be written on the prescription
• Name and Address of the patient must be provided
• Use of state security prescription blank required

• Required since Jan 1, 1999
• Latent repetitive void pattern in pantone green that appears if photocopies
• Watermark on back constistening of words " Kentucky Security Prescription"
• Opaque "Rx" symbol in the upper right hang corner that disappears if lightened
• Six (6) pre-printed quantity check-off boxes
• May contain logo in upper left hand corner
• No advertising or pre-printed drug names
• Only 1 prescription allowed per blank

Non-controlled legend drugs

Prescription Specifics

• Valid for up to one year after the date of issue
• No limitation as to the number of refills allowed but refills are valid only for the life of the prescription
• May refill as need: PRN
• May be transmitted orally, electronically, or fax
• Limitations on quantity may be imposed by insurnace company

Controlled Substances

Prescription Specifics

Class II

• No refills allowed
• Valid for 60 days after date of issue
• Must be written. Oral prescriptions are NOT allowed
• Fax prescriptions are allowed if:
• Long term care facility patient
• Hospice patient
• Narcotic parental to be compounded
• Original signed Rx to pharmacy within 7 days
• Additional requirments if issued by nurse practioners
• Limited to a 72 hr supply
• Exception: NP's 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 medications
• Additional limitations may also exist for controlled substances with the greatest potential for abuse or diversion

Controlled Substances

Prescription Specifics

Class III-Class V

• Valid for up to 6 months from date of issue
• May refill up to 5 times within 6 months of the date of issue
• May be transmistted electronically, orally, or fax
• If faxed the transmitting practitioner or their agent must write FAXED on the face of the original prescription and retain it in the pateints medical record
• Additional requirments for C III prescriptions issued by nurse practioners
• No refills allowed
• Additional limitations may also exist for controlled substances with the greatest potential for abuse diversion

• Generic Name: non-proprietary name given to a chemical entity by the United States Adopted Names (USAN) Council
• Brand or Trade Name: the proprietary or registered trademark name selected by the innovator pharmaceutical company who hold the patent on the drug
• Generic manufacturers may seek approval of a generic medication following patent expiration of the innovator product
• The generic manufacturer must submit and Abbreviated New Drug Application (ANDA) to the FDA for approval
• As part of the ANDA process the generic cmpd undergoes an equivalence evaluation

• Pharmaceutical equivalence-same acitve ingredient, same dosage form, same route of adminstration, same strength
• Bioequivalence-pharmaceutically equivalent products that display comparable bioavailbility when studied under similar experimental conditions
• Therapeutic Equivalence: pharmaceutical and bioequivalent
• Rated "A"-Therapeutically equivalent
• Rated "B"-Not therapeutically equivalent
• Published in the Approved Drug Products with Therapeutic Equivalence Evaluations

• Prepared by the KY board of pharmacy
• Includes drugs for which there are no equivalent drug products which should not be interchanged by pharmacists
• List all generic drugs which the FDA has determined to be therapeutically nonequivalent
• Includes:
• Digitalis
• Glycosides
• Anti-epileptics
• Anti-arrhythmics
• Estrogen
• warfarin
• theophylline
• thyroid hormones

• In the commonwealth of KY generic substitution is mandatory if:
• prescription is written for the brand name
• Not listed on the nonequivalent drug product formulary
• Therapeutically equivalent drug is in stock
• Therapeutically equivalent drug is cheaper
• Prescribing practioner does not write "Do Not Substitute" on the face of the prescription
• Patient does not specify otherwise

• Be familiar with the medication you are prescribing
• Indications, dosage forms, appropriate dose
• Include the therapeutic indications on the written prescriptions
• Ask pateints about other medications including OTC and herbal medications
• Provide specific directions
• Use separete prescription blanks for each drug
• Be aware of look alike sound alike drug names

• Inappropriate use of abbreviations acronyms and symbols continues to be a major source of medication errors
• Illegibility of prescriptions also contributes to misinterpretation of standard abbreviations
• Whenever possible the use of abbreviations should be avoided and directions clearly written out
• Joint Commission on the Accrediation of Health Care Organizations and the Institute for Safe Medication Practices
• Do not use list
• Do not use trailing zeros
• Always use leading zeros

• If there is an error or the order is written incorrectly it must be completely rewritten with the order titled "Clarification oder"
• Crossing out an order and writting the correction above the error could cause the order to be missed
• Orders are timed, signed, taken off and scanned sequentially; therefore they must not be altered once written

Patient Name

Patient Weight

Date

Time

Name of Drug, dose, formulation, route, frequency

Indication must be in chart

PRN must be in order

Medications-no abbreviations

Signature/Mnemonic

• Write legibly
• Space out words and numbers to avoid confusion
• Write complete prescriptions
• Avoid abbreviations if possible
• If the dose you order is outside the normal range it is wise to justify that
• When in doubt ask to verify
• Educate that patient and family