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36 Cards in this Set
- Front
- Back
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Food and Drug Act of 1906
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prohibited interstate commerce in adulterated food, drinks, and drugs
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Sherley Amendment
1911 |
prohibited false claims about a drugs therapeutic effects
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Harrison Narcotic act
1914 |
controlled the distribution and usage of narcotics
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Food Drug and Cosmetic Act
(FDC) 1938 |
Required new drugs to prove safety before marketing
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Alberty Food Products vs. US
1950 |
the purpose for which a drug is being used must be indicated on its' labeling
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Durham-Humphrey Amendment
1951 |
ensured "caution: Federal law prohibits dispensing without a prescription" to be on all prescription bottles
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Federal Hazardous Substances Act
1960 |
required all hazardous materials be handled cautiously and disposed of in a easily recognizable container labeled "hazardous material"
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Kefauver-Harris Amendments
1962 |
ensured that manufacturers must prove effectiveness and safety of a drug before marketing
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Fair Packaging and Labeling Act
1966 |
required all consumer products in interstate to be labeled properly
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Poison Prevention Packaging Act |
required the use of child proof packaging on prescription drugs. - 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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Comprehensive Drug Abuse Prevention and Control Act- CSA 1970 |
DEA was formed. CS placed into schedules 1-5 based on abuse potential |
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Orphan Drug Act- 1983 |
Drugs for rare diseases such as Huntington's Disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States |
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Drug Price Competition and Patent Term Restoration Act (HATCH-WAXMAN Amendment)- 1984 |
Streamlines process for granting aproval of generic drugs. Give manufactures incentives to develop new drugs by giving patent extensions. Generic drug companied can rely of safety and efficacy findings of innovators drugs after patent expires |
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Food Drug and Admin ACT- 1988 |
FDA as an agency. Any adverse reactions and outcomes must be reported. |
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OBRA 1987 |
Revisions to medicaid conditions of participation reguarding long term care facilities and pharmacy |
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OBRA- Onibus Budget Reconciliation Act-1990 |
Pharmacist must attempt to offer counsel on all new perscriptions. -how to be taken -side effects -interactions, contradictions -storage -refill info etc |
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HIPPA- Health Insurance Portability and Accountability Act- 1996 |
rules reguarding privacy and security of patient health info. says who can access, distribute and recieve patient info. |
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Combat Methamphetamine act- 2006 |
limits purchase of pseudophedrine products to 3.6g per day or 9g per 30 days |
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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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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 |
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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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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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Schedule I-
have no medicinal use and have the highest abuse potential. |
- 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. |
- 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. |
- 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 |
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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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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Medicare Part A |
covers Inpatient services |
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Medicare Part B |
covers Outpatient services, including DME |
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Medicare part C |
Combinationof A&B in a managed care plan |
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Medicare Part D |
Covers Rx drugs and medical supplies for insulin administration |
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Type A flow hood |
Recirculate part of the air and exhausts into the room |
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B1 hood |
Exhausts majority air outside |
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B2 flow hood |
Exhausts all air outside |
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B 3 flow hood |
Recycles air and exhausts to the outside |
