pharmacy law
can issue unlimited prescriptions at one time for the same drug as long as it does not exceed a (90) days supply. give examples
(3) prescriptions for Oxycontin, cannot post-date or pre-date prescriptions. Must have the current date, the other two will have notes for 'do not fill' dates until 30 day period has passed; must have directions on all the prescriptions
how to calculate a DEA #
9 digit number: consists of letters and numbers the first letter indicate full prescriptive authority. A,B OR F-FULL LEVEL M-MID LEVEL Second letter is the first letter of their last name: Holland="H" add 1st+3rd+5th numbers=A add (2nd+4th+6th)X2=B then add "A" + "B"=CD and the "D" number should correspond to the last number of DEA #.
Schedule IV Controlled Substances Substances in this schedule have a low potential for abuse relative to substances in schedule III. NAME SOME EXAMPLES:
An example of a schedule IV narcotic is propoxyphene (Darvon® and Darvocet-N 100®). Other schedule IV substances include: alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).
WHAT IS A Scheduled Listed Chemical Product (SLCP)?
Scheduled Listed Chemical Product (SLCP) An SLCP is defined as a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug.
TRUE OR FALSE. Residents, Interns, Physicians etc. can work under the hospital's DEA number
TRUE
TRUE OR FALSE. You have to conduct an initial inventory prior to opening a new pharmacy. (all controlled substances on hand) subsequent inventories will be conducted every two years thereafter.
TRUE
TRUE or FALSE. All SLCPs must be stored behind the counter or, if in an area where the public has access, in a locked cabinet.
TRUE
You can be denied/suspend/revoke DEA registration if you:
convicted of a felony related to controlled substances, etc.
Renewal of registration for controlled substances, you must you what form? and how often?
every (3) years with form 224a
Emergency situations requirements:
1. quantity prescribed and dispensed must be limited to the emergency situation. 2. Must immediately reduce it to writing 3. your written must contain all of the required fields the regular controlled substances have, minus the signature 4. reasonable means to verify the doctor's orders 5. The prescriber must(mail) provide the pharmacist with an actual prescription within (7) days of the 'phone in'. 5. must include the date of the 'phone in' and the emergency purpose on the new script from the MD
How do you transfer scheduled drugs ?
1.)To transfer schedule II substances, the receiving registrant must issue an official order form (DEA Form 222) or an electronic equivalent to the registrant transferring the drugs. 2.)The transfer of schedules III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances.
Schedule I Controlled Substances Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision. NAME SOME EXAMPLES:
1.heroin 2. lysergic acid diethylamide (LSD) 3.marijuana (cannabis) 4.peyote 5. methaqualone 6.3,4-methylenedioxymethamphetamine ("ecstasy").
Transfer regarding scheduled drugs:
CAN ONLY TRANSFER THE CONTROLLED SUBSTANCE Rx ONCE WITH TWO DIFFERENT COMPANIES BUT THE SAME COMPANY MORE THAN ONCE. CII: MUST USE DEA FORM 222; CIII-CV: The transfer of schedules III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances.
Recording keeping regarding scheduled drugs:
CII: 2 years CIII-CV: 2 years
Phoned In regarding scheduled drugs:
CII: No bc you must have a hard copy(written, NO fax). [exceptions are I. emergency situations; II. faxed can be accepted provided the pt population is appropriate (home infusion, residents of LTC or hospice pts); III. If the drug is being partially filled] CIII-CV: yes, must immediately transcribe the prescription
Time restrictions to fill regarding scheduled drugs:
CII: No time restriction (excluding. quantity restriction of 90) CIII-CV: Yes; (6) months
Partial refills regarding scheduled drugs:
CII: Yes but certain requirements must be met(I. unable to supply the entire quantity (out of stock, pt cannot afford,or need to verify the legitimacy of the prescription) must complete the partial fill within 72 hours. If you cannot then the pt cannot get the remainder of the quantity. CIII-CV: Yes but unlimited provided that the total quantity dispensed does not exceed the total quantity prescribed.
Refills regarding scheduled drugs:
CII: Zero; prohibited CIII-V: (5) times within six months; refer to state law for CV drugs can be different
Inventory filing records regarding scheduled drugs(ex. DEA form 222 or the electronic order form used to purchase :
CII: must be separate CIII-V: a.) separate from all other records or b.) contained with other records as long as they are readily retrievable
Prescription filing regarding scheduled drugs:
CII: must be separate CIII-V: a.) separate from all other records or b.) contained with other records as long as they are readily retrievable
Security requirements regarding scheduled drugs:
CII: safe or dispersed in the open(but to prevent diversion) CIII-CV: dispersed on the general safe or locked in a safe
What drugs to do you need an "exact count" for? What drugs can you estimate the count?
Exact count for C2 Estimation-C3-C5 unless the vial/bottle size is greater than #1000
Schedule V Controlled Substances Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. These are generally used for antitussive, antidiarrheal, and analgesic purposes. NAME SOME EXAMPLES:
Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC® and Phenergan with Codeine®).
NAME SOME EXAMPLES OF NON-NARCOTICS SCHEDULE II:
Examples of schedule II stimulants include: 1. amphetamine (Dexedrine®, Adderall®) 2. methamphetamine (Desoxyn®) 3. methylphenidate (Ritalin®) Other schedule II substances include: cocaine, amobarbital, glutethimide, and pentobarbital.
Schedule III Controlled Substances Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. NAME SOME EXAMPLES OF NARCOTIC SCHEDULE III
Examples of schedule III narcotics include combination products containing less than 15 milligrams of and products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with codeine®). Also included are buprenorphine products (Suboxone® and Subutex®) used to treat opioid addiction.
NAME SOME EXAMPLES OF NON-NARCOTIC SCHEDULE III:
Examples of schedule III non-narcotics include benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin®).
Schedule II Controlled Substances Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence. NAME SOME EXAMPLES OF NARCOTIC SCHEDULE II
Examples of single entity schedule II narcotics include morphine and opium. Other schedule II narcotic substances and their common name brand products include: 1. hydromorphone (Dilaudid®) 2. methadone (Dolophine®) 3. meperidine (Demerol®) 4. oxycodone (OxyContin®) 5. fentanyl (Sublimaze® or Duragesic®). 6. hydrocodone per dosage unit (Vicodin®)
TRUE or FALSE. All schedule drugs must be kept in a locked container at all times in the pharmacy per DEA regulations
FALSE. May be in a locked cabinet or dispersed among non-controlled pharmaceuticals
use what form to order scheduled II drugs?
Form DEA 222(must complete for each distribution, purchase or transfer of any C2 drug)
Definition of an emergency situation:
It is necessary for the proper treatment for that patient and no other appropriate alternatives available to treat the patient during that emergency dept.
How do we get from the manufacturer to the patient? MANUFACTURER--->DISTRIBUTOR--->PHARMACIST--->PATIENT
Manufacturer has to be registered with the FDA, the pharmacy has to be registered with the DEA if it contains controlled substances; w/o the DEA certification the pharmacist will be able to only handle non-controlled
The law decreed that FDA would review all types of medical devices existing in 1976 and by regulation place them in Class I, II or III. Class I devices would be subject to various general postmarket controls (e.g., establishment registration, device listing, good manufacturing practice, or GMP). Class II devices would be subject to FDA established performance standards and general postmarket controls. . Class III would need premarket application ("PMA") approval or a completed product development protocol ("PDP") and would adhere to general postmarket controls.
Medical Device Amendment of 1972
Inventory count regarding scheduled drugs:
Must take the inventory at the opening of a business or at the close of business(at the end of the day). Then every (2) years thereafter. CII: exact count CIII-CV: estimation unless the stock bottle contains more than 1000 pills then you must do an exact count.
Law explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC). The bill requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, "Caution: Federal law prohibits dispensing without a prescription." Until this law, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should therefore be used only under a doctor's supervision. Legend drugs can only be dispensed with direct medical supervision whereas OTC drugs can be purchased and used without a prescription. This law also legalized verbal transmission of prescriptions and provided for the legal right of a pharmacist to refill prescriptions as indicated in a provider's initial prescription.
The Durham-Humphrey Amendment This amendment was co-sponsored by then Senator (and later Vice President) Hubert H. Humphrey Jr., who was a pharmacist in South Dakota before beginning his political career.[1] The other sponsor of this amendment was Carl Durham, a pharmacist representing North Carolina in the House of Representatives.
a law passed in the United States designed to facilitate the development and commercialization of drugs to treat rare diseases, termed orphan drugs. Orphan drug designation does not indicate that the therapeutic is either safe and effective or legal to manufacture and market in the United States.
The Orphan Drug Act of 1983
was the first of a series of significant consumer protection laws enacted by the Federal Government in the 20th century. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.
The Pure Food and Drug Act of 1906
A set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C),
We as individual pharmacists do not have to register with the DEA to dispense controlled substances from our pharmacy. Who does?
The stores. ex Walgreens, CVS, Walmart Every pharmacy have their own DEA number
The CSA is a closed system of distribution meaning every step that the drug goes through is accounted. What is the purpose?
To try to prevent diversion
Newly Scheduled Controlled Substance Inventory
When a drug not previously listed as a controlled substance is scheduled or a drug is rescheduled, the drug must be inventoried as of the effective date of scheduling or change in scheduling.
red flags
paying with cash, excessive quantities, certain combinations that dont go together, :ex The holy trinity
the corresponding responsibility doctrine
pharmacist must only dispense valid controlled substances prescriptions. must look out for 'red flags' . you can lose your license
DEA form 224
submit to the DEA to register to be able to handle controlled substances
