Pharmacy Law

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FDA - Federal, Drug, and Cosmetic Act

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-protects the public health
-label requirements for safe consumer us of OTC products
-prohibits sale of "adulterated" or "misbranded" foods and drugs.

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adulterated

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-presence of any decomposed substance.
-packaging under unsanitary conditions or if the product's strength or purity is different from what is indicated on the label.

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misbranding

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-when the label is false or misleading or when proper warnings and directions are absent.
-if the label does not have the name and place of business of the manufacturer
-fails to carry a "Warning - May be habit forming." if it is habit forming.

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NDA - New Drug Application

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-when the drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before being commercially available.

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Durham-Humphrey Amendment

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-separates drugs into two catergories: LEGEND AND NON-LEGEND (OTC)
-Also called the "Prescription Drug Amendment"
-Allows verbal new prescriptions to be called in over the phone and allows refill okays to be done over the phone.

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Legend

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Requires a prescription because the person requires supervision of a physician. The stock bottle is not required to have directions of use but must have on the bottle label, "Caution: Federal law prohibits dispensing without a prescription."

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Non-legend

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Requires that all products to have directions of use. Does not require a prescription.

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Kefauver-Harris Amendment

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-Label requirements for manufacturers and dispenser to the patients
-Regulates proper drug advertising and package inserts issued by the manufacturer
Requires manufacturers to: 1) register annually 2) be inspected every 2 years 3) report any drug reactions
-Requires all medication on the U.S. market to be pure, safe, and effective.

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PPI'S - Patient Package Inserts

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-Regulated by the FDA
- Must supply a PPI to patients receiving the following medications:
* Oral contraceptives
* Estrogen
* Progestin
* Isotretinoin (Accutane)
* Intrauterine devices
* Inhalers

Information on the PPI:
-indications for use
-contraindications (when/what it interacts with)
-warnings (extreme side effects)
-precautions (less severe side effects)
- dose (how much to take and how often)

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Occupational and Safety Act of 1970

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-ensures a safe and healthful workplace for employees by reducing hazards in the workplace. Audit shows compliance.
-gave rise to Occupational Safety and Health Administration (OSHA)
*ensures job safety standards and an injury reporting system for job-related injuries or illnesses.
-all pharmacies should:
* post a phone number to poison control
* have a reference guide for toxicities
* must have Material Safety Data Sheets (MSDS) for any "hazardous materials in pharmacy
The impact on pharmacy: air contaminants, flammable/combustible liquids, and eye/skin protection.

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Poison Prevention Packaging Act

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- enacted to reduce accidental poisonings in children.
- requires pharmacies to use child resistant containers (and most OTCs)
* defined as: difficult for 80% of children under 5 yrs. to open and allows 90% of adults to open.
-prohibits re-use of child resistant containers (because the wear and tear of normal use may decrease the effectiveness).

**Exceptions to this legislation:
- medications used as medical emergencies such as nitroglycerin sublingual tablets for chest pain
- written requests from Drs or patients (i.e. arthritic patients cannot open bottles)
- OTC medications must be labeled "package not child resistant" if it is not child resistant.
- betamethasone, mebendazole, methylprednisolone (<85 mg), Oral Contraceptives, Pancrelipase, cholestyramine

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Poison Log

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Log must include:
- date of sale
- name of address of purchaser
- name and quantity of poison dispensed
- reason for purchase
- full name of dispenser

Poison substances must be labeled with:
- complete name of poison
- the word "POISON" boldly imprinted on the label
- place of business of the seller
- proper directions of use

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All pharmacies should be well stocked with "Syrup of Ipecac" and "Activated Charcoal"

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Does of syrup of Ipecac is 15 ml (1 tablespoon)

Activated Charcoal works by absorbing the poison in the body and eliminating it. A person cannot take both or the charcoal absorbs the Ipecac and will not work to either absorb the poison or make the person vomit

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Controlled Substance Act of 1970 (CSA)

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regulates use and distributes drugs with high abuse potential and/or addiction into one of five schedules (CI-CV)

The CSA is enforced and regulated by the DEA

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Schedule I

- have no medicinal use and have the highest abuse potential.

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- crack cocaine
- crystal methamphetamine
- ecstasy
- hashish
- heroin
- LSD
- marijuana
- mescaline
- PCP
- peyote

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Schedule II

- have medicinal use but still have a very high abuse potential

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-amphetamine or dextroamphetamine (Adderall)
- codeine (Codeine)
- cocaine (Cocaine)
- meperidine (Demerol)
- dextroamphetamine (Dexedrine)
- hydromorphone (Dilaudid)
- methadone (Dolophine)
- fentanyl (Duragesic)
- morphine (MS Contin)
- oxycodone (Oxycontin)
- APAP + oxycodone (Percocet)
- ASA + oxycodone (Percodan)
- methylphenidate (Ritalin)
- secobarbital (Seconal)

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Schedule III

- have medicinal use but still have a high abuse potential but not as high as II's.

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- hydrocodone + APAP (Vicodin, Lortab)
- codeine + APAP (Tylenol with Codeine)
- ASA + codeine (Empirin #3)
- hydrocodone (Hycodan)
- ibuprofen + hydrocodone (Vicoprofen)
- chlorpheniramine + hydrocodone (Tussionex)
- carisoprodol + codeine (Soma with codeine)
- hydrocodone + guaifensin (Hycotuss)

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Schedule IV

- have medicinal use and still have an abuse potential but not as high as III's.

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- lorazepam (Ativan)
- flurazepam (Dalmane)
- propoxyphene + APAP (Darvocet N)
- alprazolam (Xanax)
- diazepam (Valium)
- clorazepate (Tranxene)
- pentazocine-naloxone (Talwin NX)
- pentazocine (Talwin)
- temazepam (Restoril)
- clonazepam (Klonopin)
- triazolam (Halcion)
- phentermine (Fastin)

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Schedule V

- medical use
- lowest abuse potential of the five

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ex. Lomotil and Robitussin AC

If the state wishes, it may permit C-V's to be dispensed without a prescription if the following standards are met:
- person is 21 years or older
- drug is sold by the pharmacist
- log of sale must be kept in a logbook containing:
* name, address, and full signature of purchaser
* date and time of sale
* name, strength, and quantity of drug sold
* full signature of R.PH.
- no more than 120ml or 120 gm of drug sold in 4 days

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Controlled Substances

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- Each pharmacy must make a complete inventory of controlled substances every 2 years and kept for two years.
- Each medication label on a control medication should state, "Caution, Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
*Do not cover with an auxiliary label.*

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DEA # is 2 letters and 7 numbers

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- 1st number is either A or B (Residents usually are M)
- 2nd letter is the first letter of the Dr.s last name

1. add the 1st, 3rd, and 5th number.
2. add the 2nd, 4th, and 6th number and multiply it by 2
3. add line 1) and line 2) together
4. last digit of the sum total and last digit of the DEA match

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Refilling Controlled Substances

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-Control II's are not refillable
* Patient must have a new written prescription each time from the doctor
- Control III and IV
* no more than 5 times in a 6 month period
* oral prescriptions are allowed over the phone with the Dr. responsible to provide a written "cover" prescription.
- Control V
* recorded in the Schedule V log book if state allows no prescription
* or no more than 5 times in 6 months

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Limitations of Pharmacy Technician Duties:

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- varies by state
- Fedral law: may perform all functions of pharmacy practice under the direction of the pharmacist except:
1) pharmacy technician shall not receive oral prescriptions over the phone
2) shall not exercise professional judgement in any matter of pharmacy practice
3) can not transfer prescriptions

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Drug Recalls:

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A drug is recalled if it was improperly made of labeled and causes severe adverse reaction.

3 classes of drug recalls.

- Class I - where exposure to the product will cause severe health problems/death
- Class II - here exposure to the product may cause temporary (meaning reversible) adverse health hazard.
- Class III - where exposure to the product is not likely to cause adverse health hazards

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Federal vs. State Law

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Think of it as Federal law is more laid back and State law is very strict.

State law can be stricter than Federal law but not more laid back than Federal law.
ALWAYS follow the more strict law if the two differ.

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Repackaging of medications

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1) Labeling:
- generic names of drug
- strength
- dosage form
- manufacturer and lot number
- expiration date after repackaging
- repacked medication is 50% of expiration date on stock bottle to max of 1 year.

2) Repackaging Log - documentation
- reviewed by R. Ph
- date of repackaging
- name of drug
- manufacturer
- exp. date of manufacturer and lot #
- quantity repacked
- R.Ph. initials or signature

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OBRA 90 - Omnibus Reconciliation Act of 1990

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-Directed toward the pharmacist but the pharmacist cannot do this without the help of the technician.
-Improves quality of drug therapy and saves health care costs.

Counseling must include:
- name and description of medication
- dosage form, dose, route of administration and duration of therapy
- special directions/precautions
- side effects and ways to prevent
- techniques for self-monitoring
- storage
- refill information
-action to take if missed a dose

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Drug Use Evaluation

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- ensures medications are used safely, effectively, and appropriately.
- required by JCAHO - Joint Commission on Accreditation of Health Care Organizations

JCAHO is quality control. This organization makes sure the procedures and end product meet standards. They help prevent errors by enforcing log books and inspections.

Pharmacy Technicians roles are to review patient charts, computer reports, prepare DUE reports

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Adverse Drug Reaction (ADR)

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Any undesirable or unexpected event that requires stopping a drug, modifying the does, prolonging hospitalization, or providing supportive treatment.

Type A ADR
- expected from the known properties of the medication
- most ADRs are Type A
- unlikely life-threatening

Type B ADR
- infrequent and not predictable allergic reactions
- may cause cancer and birth defects
- serious and life-threatening

Pharmacy Technician roles: identifying, documenting, analyzing and reporting ADR to the FDA