question
1a) When was the Food and Drug Act passed(pfda)?
1b) what did the act require?
1b) what did the act require?
answer
1a) 1906
1b) all food and drugs meet a standard of purity and strength
1b) all food and drugs meet a standard of purity and strength
question
2a) when was the harrison narcotic act passed?
2b) what did the act require?
2b) what did the act require?
answer
2a) 1914
2b) regulated drugs that produced or sustain physical or psychological dependence. the importation,sale, manufacture, and use of: opium, marijuana, synthetic agents, derivatives
2b) regulated drugs that produced or sustain physical or psychological dependence. the importation,sale, manufacture, and use of: opium, marijuana, synthetic agents, derivatives
question
3a) when was the federal food, drug and cosmetic act passed(ffdca)?
3b) what did the act require?
3b) what did the act require?
answer
3a) 1938
3b) manufactures of drugs and cosmetics must prove that their products are safe and all medical devices must be proven effective.
this gave the fda limited authority to remove products from the marketplace if they are found to be ineffective or unsafe.
3b) manufactures of drugs and cosmetics must prove that their products are safe and all medical devices must be proven effective.
this gave the fda limited authority to remove products from the marketplace if they are found to be ineffective or unsafe.
question
4a) when was the durham-humphrey act passed?
4b) what did the act require?
4b) what did the act require?
answer
4a) 1951
4b) supplemental to the federal food,drug, and cosmetic act.
4b) supplemental to the federal food,drug, and cosmetic act.
question
5a) when was the kefauver-harris act passed?
5b) what did the act require?
5b) what did the act require?
answer
5a) 1962
5b) drug manufactures to prove safety and effectiveness to fda before approval given for marketing
5b) drug manufactures to prove safety and effectiveness to fda before approval given for marketing
question
6a)when was the poison prevention act passed?
6b) what did the act require?
6b) what did the act require?
answer
6a) 1970
6b) pharmacists to use child proof packaging
6b) pharmacists to use child proof packaging
question
7a) when was the controlled substances act passed?
7b) what was the act's purpose?
7b) what was the act's purpose?
answer
7a) 1970
7b) classified drugs based on their potential for abuse: schedule 1, 11, 1V, and V
7b) classified drugs based on their potential for abuse: schedule 1, 11, 1V, and V
question
8a) when was the prescription drug marketing act(pmda) was passed?
8b) what is the act's purpose?
8b) what is the act's purpose?
answer
8a) 1987
8b) pmda is part of the fdc act, enacted to address certain prescription drug-marketing practices that have contributed to the diversion of drugs into a secondary gray market
8b) pmda is part of the fdc act, enacted to address certain prescription drug-marketing practices that have contributed to the diversion of drugs into a secondary gray market
question
when was the obra-90 act passed?
what was the act's purpose?
what was the act's purpose?
answer
9a) 1990
9b) pharmacists to offer counseling to medicaid patients regarding medications
9b) pharmacists to offer counseling to medicaid patients regarding medications
question
10a)when anabolic steroids control act passed?
10b) what is the act's purpose?
10b) what is the act's purpose?
answer
10a) 1990
10b) places " any drug hormonal substance chemically and pharmacologically related to testosterone" under regulatory provisions of the controlled substance act
10b) places " any drug hormonal substance chemically and pharmacologically related to testosterone" under regulatory provisions of the controlled substance act
question
11a) when was the health insurance portability and accountability act(hipaa) passed?
11b) what was the laws purpose?
11b) what was the laws purpose?
answer
11a) 1996
11b) first comprehensive regulation designed to safegaurd the privacy of protected health information(phi)
11b) first comprehensive regulation designed to safegaurd the privacy of protected health information(phi)
question
when was the fda modernization act was passed?
what was the act's purpose?
what was the act's purpose?
answer
12a) 1997
12b) to enable the FDA to reduce the average time required for a drug review from 30 months to 15 months.
12b) to enable the FDA to reduce the average time required for a drug review from 30 months to 15 months.
question
13a)when was the medicare prescription drug improvement and modernization act(mma) passed?
13b) what was the act's purpose?
13b) what was the act's purpose?
answer
13a) 2003
13b) produced the largest overhaul of medicare in the public health programs history
13b) produced the largest overhaul of medicare in the public health programs history
question
14a)when was the combat methamphetamine epidemic act passed?
14b) what was act's purpose?
14b) what was act's purpose?
answer
14a) 2005
14b) to regulate retail over-the-counter sales of EPH, PSE, and PPA products which are common ingredients found in cold and allergy products.
14b) to regulate retail over-the-counter sales of EPH, PSE, and PPA products which are common ingredients found in cold and allergy products.
question
15a) when was the patient safety and quality improvement act was passed?
15b) what was the act's purpose?
15b) what was the act's purpose?
answer
15a) 2005
15b) goal was to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.
15b) goal was to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.
question
what does the red "c" on the bottom of the prescription bottle mean?
answer
Federal law requires the red "c" be placed on prescriptions of schedule 111, 1V, and V controlled substances
question
all of the following pertain to schedule 1 drugs:
answer
- high abuse potential
- no accepted medical use in the united states
- only legal use for investigational purposes
- no accepted medical use in the united states
- only legal use for investigational purposes
question
examples of schedule 1 drugs:
answer
- heroin
- hallucinogenic substances
- opiate derivatives
- hallucinogenic substances
- opiate derivatives
question
all of the following pertain to schedule 2 drugs:
answer
-high abuse potential
- accepted medical use
- prescriptions are not refillable without a new script
- partial filling(Pharmacists are required to record # of units dispensed and dispense remainder of meds in 72hrs. If the remainder cannot be dispensed to the patient within 72hrs further quantities cannot be dispensed and the physician must be notified.
-partial filling cont(patients in a long term care facility or who are medically diagnosed as terminally ill in a hospice setting, prescription is valid 60 days from the date the prescription is written.
- rph must record that the patient is in a ltc facility or is terminally ill. rph must also record date, quantity dispensed, and quantity remaining. rph's intials or signature must be on the back of rx.
- physical inventory evry two years, within four days of the anniversary date, must be performed.
- 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.
- distribution records for inpatient and outpatient must be kept.
- all schedule 11 drugs must be locked in a cabinet or distributed throughout general stock.
-dea regulations require the date, # of items received to be on the dea 222 form.
- accepted medical use
- prescriptions are not refillable without a new script
- partial filling(Pharmacists are required to record # of units dispensed and dispense remainder of meds in 72hrs. If the remainder cannot be dispensed to the patient within 72hrs further quantities cannot be dispensed and the physician must be notified.
-partial filling cont(patients in a long term care facility or who are medically diagnosed as terminally ill in a hospice setting, prescription is valid 60 days from the date the prescription is written.
- rph must record that the patient is in a ltc facility or is terminally ill. rph must also record date, quantity dispensed, and quantity remaining. rph's intials or signature must be on the back of rx.
- physical inventory evry two years, within four days of the anniversary date, must be performed.
- 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.
- distribution records for inpatient and outpatient must be kept.
- all schedule 11 drugs must be locked in a cabinet or distributed throughout general stock.
-dea regulations require the date, # of items received to be on the dea 222 form.
question
side effects of schedule 11 drugs
answer
- severe psychological effects
- physiological dependency
- physiological dependency
question
emergency rules for schedule 11 drugs(prescriptions may be called into a pharmacy via phone call if the following criteria is met:
answer
1) Immediate administration required for proper treatment
2) there are no appropriate alternatives available, including a non-schedule 11 controlled substance
3) prescribing physicians aren't able to provide a written script
4) pharmacy must receive a hard copy of script from prescriber within 7days.
2) there are no appropriate alternatives available, including a non-schedule 11 controlled substance
3) prescribing physicians aren't able to provide a written script
4) pharmacy must receive a hard copy of script from prescriber within 7days.
question
In the event of theft of schedule 11 drugs what is required?
answer
The pharmacy is required to nofity the dea. EX: morphine, methylphenidate, methadone, and hydromorphone. As of 10/6/14 DEA requires all hydrocodone products become schedule 11 controlled substance. ex: norco, vicoproten, lortab, lorcet, vicodin.
question
all of the following pertain to schedule 111 drugs:
answer
- less potential for abuse/dependence than schedule 11
- rx may be refilled up to 5 times in 6 months from the date the rx is first issued * only if refills are authorized by a doctor
- rx may be refilled up to 5 times in 6 months from the date the rx is first issued * only if refills are authorized by a doctor
question
schedule 111 drugs partial filling:
answer
rph must: record quantity dispensed, place intials on the face of the initial order or on the back of the refill.
- must be done within 6months of date on original rx
- must be done within 6months of date on original rx
question
schedule 111 drug ex:
answer
acetamin w codine, fioricet w codiene, phentermine
question
Schedule 1V drugs
answer
less potential for abuse than schedule three ex benzodicezepines and meprobamate. rules for dispensing schedule 1V drugs are the same as schedule 111.
question
Schedule V drugs
answer
- less potential for abuse than 111 and Iv drugs
- may be sold over the counter if certain criteria is met: must be sold by a rph
- no more than 240ml in liquid form or 48 solid dosage units of opium-containing substances may be dispensed in a 48hr period.
- rph must have bound book for record-keeping that contains: name of purchaser, date of sale, pharmacists intials
- no refill limitations on schedule V drugs, refills must be dispensed in good faith based on professional judgement of pharmacist and physician
- may be sold over the counter if certain criteria is met: must be sold by a rph
- no more than 240ml in liquid form or 48 solid dosage units of opium-containing substances may be dispensed in a 48hr period.
- rph must have bound book for record-keeping that contains: name of purchaser, date of sale, pharmacists intials
- no refill limitations on schedule V drugs, refills must be dispensed in good faith based on professional judgement of pharmacist and physician
question
Rules for controlled substances
answer
- every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received,stored, distributed,dispenced, or otherwise disposed of.
- the records are required to provide accountability of all controlled substances. starts with manufacturing process, to dispensing pharmacy and to the patient. potential for diversion is reduced using this closed system.
- records that must be maintained for a pharmacy are: executed and unexecuted official order forms(dea form222) or electronic equivalent. power of attorney authorization to sign order forms.
- receipts/invoices for schedules 111,1V, and V.
- all inventory records of controlled substances including the intial and biennial inventories dated as of beginning or close of business
- records of controlled substances distributed : * sales to other registrants
* returns to vendors
* distributions to reverse distributors
- records of controlled substances dispensed: prescriptions schedule V logbook
- reports of theft or significant loss, DEA Form 106(if applicable)
- inventory of drugs surrendered for disposal DEA Form 41(if applicable)
- records that must be maintained for a pharmacy: dea registration ceriticate self-certificate and logbook( or electronic equivalent) as required under the cmea of 2005
- the records are required to provide accountability of all controlled substances. starts with manufacturing process, to dispensing pharmacy and to the patient. potential for diversion is reduced using this closed system.
- records that must be maintained for a pharmacy are: executed and unexecuted official order forms(dea form222) or electronic equivalent. power of attorney authorization to sign order forms.
- receipts/invoices for schedules 111,1V, and V.
- all inventory records of controlled substances including the intial and biennial inventories dated as of beginning or close of business
- records of controlled substances distributed : * sales to other registrants
* returns to vendors
* distributions to reverse distributors
- records of controlled substances dispensed: prescriptions schedule V logbook
- reports of theft or significant loss, DEA Form 106(if applicable)
- inventory of drugs surrendered for disposal DEA Form 41(if applicable)
- records that must be maintained for a pharmacy: dea registration ceriticate self-certificate and logbook( or electronic equivalent) as required under the cmea of 2005
question
rules for filling of presriptions for controlled substances- two basic methods:
answer
1) utilize three seperate files:
- legend
-schedule 111-V
- schedule 11
* files should be maintained seperately with no mixing of rx.
2) utilize two seperate files: legend, schedule 111-V(stamped with red "C".
- schedule 11 only
- legend
-schedule 111-V
- schedule 11
* files should be maintained seperately with no mixing of rx.
2) utilize two seperate files: legend, schedule 111-V(stamped with red "C".
- schedule 11 only
question
electronic prescription records:
answer
if a prescription is created, signed, transmitted and received electronically , all records related related to that prescription must be maintained electronically.
- must be maintained electronically for 2 years from date of creation/receipt.
- this requirement shall not pre-empt any longer period of retention that may be required now or in the future by any federal or state law/regulation applicable to pharmacists/pharmacies.
- records regarding controlled substances must be readily retrievable.
- must be easily readable or made into a readable format.
- electronic prescription records for controlled substances shall be maintained in an application that meets the requirements of 21 c.f.r 1311.
- computer may be located at another location, but records must be readily retrievable at the registered location if requested by dea or other law enforcement agents.
- electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an administration or other law enforcement agent at registered location.
- records must be sortable by prescriber name, patient name, drug dispensed, and date filled.
- must be maintained electronically for 2 years from date of creation/receipt.
- this requirement shall not pre-empt any longer period of retention that may be required now or in the future by any federal or state law/regulation applicable to pharmacists/pharmacies.
- records regarding controlled substances must be readily retrievable.
- must be easily readable or made into a readable format.
- electronic prescription records for controlled substances shall be maintained in an application that meets the requirements of 21 c.f.r 1311.
- computer may be located at another location, but records must be readily retrievable at the registered location if requested by dea or other law enforcement agents.
- electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an administration or other law enforcement agent at registered location.
- records must be sortable by prescriber name, patient name, drug dispensed, and date filled.
question
Disposal of Unwanted Controlled Substances
answer
- return to supplier with order form dea 222
- send to reverse distributor with dea form 222 or
- receive permission from dea to destroy onsite and use dea form 41- inventory of drugs surrendered.
- pharmacies are required to keep records for two years
- all prescriptions must be readibly available
- not required that prescription records be maintained on-site, but must be easily accessible.
- send to reverse distributor with dea form 222 or
- receive permission from dea to destroy onsite and use dea form 41- inventory of drugs surrendered.
- pharmacies are required to keep records for two years
- all prescriptions must be readibly available
- not required that prescription records be maintained on-site, but must be easily accessible.
question
when the state and federal law differ which one do you use?
answer
always use the stricter of the two
question
DEA # verification method
answer
ex Dr. john doe, MD.
dea #: AD0865937
first- add together the 1st,3rd,& 5th digits.
second- add together the 2nd,4th,& 6th digits, multiply the sum by 2.
third- add the result of step one and two together.
* the last digit of this sum should correspond w the ninth digit of the dea registration #.
- the two letter identifyer at the beginning of the dea designates: the 'A'(1st letter) identifies the type of prescriber
- the 'D'(2nd letter) identifies the first letter of the last name.
- prescriber dea # is needed for all outpatient prescriptions for controlled substances.
dea #: AD0865937
first- add together the 1st,3rd,& 5th digits.
second- add together the 2nd,4th,& 6th digits, multiply the sum by 2.
third- add the result of step one and two together.
* the last digit of this sum should correspond w the ninth digit of the dea registration #.
- the two letter identifyer at the beginning of the dea designates: the 'A'(1st letter) identifies the type of prescriber
- the 'D'(2nd letter) identifies the first letter of the last name.
- prescriber dea # is needed for all outpatient prescriptions for controlled substances.
question
investigational drugs
answer
- go through 4 controlled phases of testing before being released to the general public.
phase 1- drug is introduced for human use
phase 11- tests to establish the effectiveness and safety of the drug are performed.
* limited trials and close monitoring of patients are done.
phase 111- trials of effectiveness and indications are done.
* more precise definitions of adverse affects are studied.
phase 1V- post marketing trials and long-term use is done.
No control groups are used during this phase of testing.
after use during investigational testing, any remaining drugs should be returned to the person or persons responsible for the drug.
phase 1- drug is introduced for human use
phase 11- tests to establish the effectiveness and safety of the drug are performed.
* limited trials and close monitoring of patients are done.
phase 111- trials of effectiveness and indications are done.
* more precise definitions of adverse affects are studied.
phase 1V- post marketing trials and long-term use is done.
No control groups are used during this phase of testing.
after use during investigational testing, any remaining drugs should be returned to the person or persons responsible for the drug.
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