P3 Law Quiz 1
true or false: firms that make biologicals are regulated by the FDA
False: Firms that make biologicals are regulated by the Center for Biologics Evaluation and Research.
If central fill is used, bot parties involved must keep compete and accurate records of drugs, devices, or biologics including
name of pharmacist filling or refilling name of pharmacy filling or refilling name of pharmacy dispensing
How many Basic Classes are there for Schedule I and II defined by the DEA?
10
Record retention federally
2 years
What are the basic classes of schedule I and II
4 narcotic 4 CNS stimulant 1 hallucinogen 1 depressant
How many schedules are there?
5
Record Retention in NE
5 years
When a nebraska community pharmacy that includes a controlled substance business is closed, how long must the documentation and record associated with this closure be retained?
5 years due to nebraska law only 2 years is required by federal law ** reference: law quiz 2 feb 2019
What are the records of disposition for destruction, theft, or loss of non-controlled and controlled substances?
ANY controlled substance - DEA form 106 non-controlled substance (of significant loss) - police report
Who, in the following list, may serve as the prescribers agent for purposes of transmitting a refill authorization? Please assume that each has the prescriber's permission (if allowed by NE) and select all that apply. a. the dental office manager b. podiatrist's twin sister c. the optometrist pool and lawn management contractor d. physician's golf caddie
All are true. Anyone can act as the prescriber agent if given prescriber permission to transmit information to the pharmacy. In Nebraska, there is not a requirement to have an employment relationship. ** reference: law quiz 2 feb 2019
The controlled substance act grants the united states attorney general authority to perform which of the following functions with regard to controlled substances? select all that apply A. Place the unscheduled drug into a schedule B. Place the scheduled drug into a different schedule C. Remove the drug from the scheduled status D. Place a drug in schedule I to avoid "imminent hazard to public safety
All are true. The United States attorney General can Place the unscheduled drug into a schedule Place the scheduled drug into a different schedule Remove the drug from the scheduled status Place a drug in schedule I to avoid "imminent hazard to public safety ** reference: law quiz 2 feb 2019
Your best friend is the PIC for the pharmacy down the street. She needs to acquire the thirty brand name ambien tablets from your pharmacy to complete the prescription. How do you legally handle this transaction? a. you have her send you a dea form 222 to order the 30 tabs from you b. you put a post it note on your stock bottle saying that she will return 30 tablets next week when her order comes in c. you complete an invoice for the drug, listing your pharmacy DEA number and her pharmacy DEA number and sell her the drug d. you fill out a DEA form 41 and send her the drugs e. you fill out a DEA 222 for the 30 tabs and sell them to her
C. you complete an invoice for the drug, listing your pharmacy DEA number and her pharmacy DEA number and sell her the drug ** reference: law quiz 2 feb 2019
what schedule is ephedrine in Nebraska
CIV
There is a reasonable probability that the product may cause serious health problems or death. Emergent situation involving removal from the market of a product in which the consequences are immediate or long-rang, life threatening, and involve a direct cause-effect relationship
Class I Drug Recall
The product may cause a temporary health problem, or posse only a slight threat of a serious nature
Class II recall
true or false: The FDA will not allow the manufacturing firm to take corrective action if found noncompliant with cGMP
FALSE: The FDA WILL ALLOW the firm to take corrective action, but has powerful tools if the firm does NOT take corrective action
in the event that an FDA inspection discovers significant, objectionable conditions relating to products and/or processes, this form is issued to make official notification, in writing, of the findings.
FDA Form 483
Nebraska Schedule I drugs (10 listed)
LSD heroin mescaline peyote psilocybin marijuana k2 or spice quaalude (methaqualone) more
When can a dispensed drug be returned to saleable inventory?
May be returned from a long term care facility to the pharmacy from which they were dispensed for credit or relabeling and resdispensing given that -no controlled substances -no rx or medical device restricted by FDA -decision rest solely with the pharmacist -must have been in control of the long-term care facility at all times -drug must be in original, unopened labelled container with tamper evident seal intact with an expiration date and lot number -tablets or capsules dispensed in a unit dose container impermeable to moisture and approved by the board
program gathers post-marketing (sometimes phase IV) safety concerns about medications. It was started in 1993 to identify adverse events and sentinel events.
MedWatch
How often are you required to take a written inventory?
NE- 1 year Federally - 2 years
Can you take returned controlled substances?
NO. The DEA prefers the use of mailers to properly return dispensed/sold controlled rxs
What are the records of disposition for returns or transfers of non-controlled and controlled substances?
Non-controlled - invoices CIII-V - invoices CII (and I) - DEA form 222
What are the records of receipt for non-controlled and controlled substances?
Non-controlled - invoices CIII-V - invoices CII (and I) - DEA form 222
found about halfway into lecture topic 13 and in canvas heart- drug lotion bottle - cosmetic paw- pet capsule and tablet - solid dosage forms
Not listed here, but review the product category icons found on a sample enforcement report
Which products can be reported under medwatch?
Rx OTC medical devices biologics - no vaccines (VAERS) speciality nutritional products such as dietary supplements, infant formula, medical food cosmetics
high abuse potential, no currently accepted medical use in the United States, lack of accepted safety for use even with medical supervision
Schedule I
True or false: you are the PIC at a pharmacy that has just had a fire, due to an electrical wiring problem. The "A" section of your drugs were severely damaged. You must fill out a DEA form 106 to report the loss of alprazolam to the DEA.
TRUE DEA form 106 is for the loss or theft of ANY controlled substance. DEA form 41 is for the intentional destruction of controlled substances.
May agents fax prescription orders with their signature?
The agent of the prescriber practitioner may additionally put the information, verbally received from the prescriber, into written form and transmit that in writing over the fax machine. This may be done either before or after oral communication with the pharmacist, HOWEVER there MUST BE ORAL COMMUNICATION WITH THE PHARMACIST before the medication can be dispensed.
true or false: if the identified, adulterated product is made outside of the United States, the FDA can issue Border Alert requiring US customs to block the products entry into the United States
True
Written document that states that the manufacturing firm has made product that is adulterated thus violating the Food, Drug, and Cosmetic Act. The FDA has authority to issue this after issuing the FDA form 483
Warning letter
When may a pharmacy accept the return of a controlled substance in schedule IV? a. When the drug is no longer needed by the patient b. when there has been a manufacturers recall of the drug asking patients to return the drug to the pharmacy c. when the drug is used to treat symptoms in cancer chemotherapy patients and the drug is sent to the cancer drug repository d. never, there is never a time when controlled substances may come back into the pharmacy
When there has been a manufacturer's recall of the drug asking patients to return the drug to the pharmacy A mailer should be given to patients with excess controlled substances. Cancer drug repositories do not include controlled substances. ** reference: law quiz 2 feb 2019
What is the calculated expiration date
Whichever will occur earlier -expiration date on the manufacturer's, packager's, or distributors container OR -one year from the date of repackaging
What is a sample?
a unit of drug intended NOT to be sold a sales promotion item for that product prescription only perhaps used as a starter pack to determine if the patients can take the drug
What can you report to medwatch?
any serious adverse event occurring with use of any medical product
What is the main difference between the immunosuppressant drug repository and the cancer drug repository?
cancer has a participant registry, while the immunosuppressant does not
What are the levels of hazard of a drug recall?
class I, II, III
the recalled product is unlikely to cause any adverse health reaction, but it violates and FDA labeling of manufacturing regulation
class II recall
Purpose of the Prescription Drug Marketing Act 1987
concern that the drugs were adulterated and misbranded due to diversion concern that public health and safety were threatened by a secondary distribution system for prescription drugs concern that therew as unfair competition
What are some of the major drug offenders to mechanical claims?
coumadin levothyroxine methotrexate is often mistaken but due to small population of users, not on top of list in study by pharmacist mutal
What is cGMP?
current good manufacturing practices that the FDA requires when a pharmacy engages in repackaging and relabeling drugs BEYOND the usual conduct of dispensing and selling those drugs in pharmacy practice settings
What are the exempted anabolic steroids
estratest estratest HS syntest DS syntest HS testoderm
What donated drugs cannot be accepted in a statutory repository program?
expired adulterated or misbranded unit dose packaging opened, unsealed, or tampered with drug no longer in original container drugs with storage requirements other than room temperature controlled substances
True or False: the only person who may complete a DEA 222 form is a pharmacist
false - anyone can ** reference: law quiz 2 feb 2019
true or false black boxed warnings are the most serious warning that can be placed on drug labeling
false: the FDA and DEA doesn't care what color box it is, BUT (any color) BOXED warnings are the most serious warning that can be placed on drug labeling
true or false: you are required to respond if you receive and FDA Form 483
false: you are not required or mandated to response, BUT IT IS PRUDENT YOU DO This allows you to tell the FDA what you are going to do to correct the identified problems immediately and what changes you are going to make to systems to assure that the root of the problem does not occur. If you do not respond, the FDA can make your life hell by issuing a warning letter
true or false: a pharmacist cannot be sued for filling a prescription correctly
false: a pharmacist CAN be sued for filling a prescription correctly
true or false: all CV are legend drugs
false: by federal law, not all CV are legend drugs. Some may be sold OTC according to federal law and do not have to be "legend". IN NEBRASKA, all CVs DO require a prescription
true or false: product seizures must be approved by the DEA
false: seizures must be approved by a US federal court judge
true or false: they caught the person who poisoned the tylenol capsules in 1982 in Chicago
false: they never caught the guy. dun dun DUN.
true or false: the FDA prohibits the restocking of return of unused prescription drugs to pharmacy stock
false? kind of a trick question Compliance Policy Guides from the FDA states "a pharmacist should not return drug products to his stock once they have been out of his possession." In reality, FDA does not care about legend drugs and does not specify what is considered out of a pharmacist possession. They only care about controlled substances. Their main concern is intent to resell (and make a profit). The FDA does not have a stance on what is considered outside of the pharmacist possession and encourages the states to define this.
What is considered a serious event?
fatality life-threatening event permanently disabling event that requires or prolongs hospitalization event that causes congenital anomaly event that requires intervention to prevent permanent impairment or damage
What controlled substances records may be kept at a central location?
given that the special agent in charge of the DEA was notified by mail, you may begin central recordkeeping 14 days after receipt of notice of the following: financial records shipping records including invoices and package slips
Repository Site must keep a perpetual inventory log book. What must be included? (9)
name of the cancer drug expiration date lot number quantity name of the person who accepted the drug from the donor name of the original patient date drug is dispensed name of new patient date of destruction if required
product whether produced directly or indirectly by extraction from substances of vegetable origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis of opium, opium poppy and poppy straw, coca leaves and opiates, a compound or manufactured salt or derivative, or any substance or compound that is chemically equivalent to or identical
narcotic
categories in schedule V
narcotics - mostly opiate in antidiarrheal or codeine in antitussive stimulant depressant
categories in schedule IV
narcotics in limited quantities depressants including minor tranquilizers stimulants
Can a retail pharmacy request prescription drug samples
no, the presence of any sample drug in a retail pharmacy shall be considered evidence that the sample was obtained illegally
What are common intellectual claim errors made in pharmacies?
non-bodily injury drug review counseling compounding others - drug admin, illegal use, child resistant caps
What are the records of disposition for (purposeful) destruction of non-controlled and controlled substances?
non-controlled: invoice/reverse distributor record CIII-V: invoice/reverse distributor record CII (and I): DEA form 222 or 41
What are the records of disposition for sales of non-controlled and controlled substances?
non-controlled: medical order controlled: medical order, invoice, DEA form 222 depending on who is buying OTC C-V: log book
How to report to medwatch?
online: www.fda.gov/medwatch fax phone mail
what are the general categories in schedule II
opium and various other narcotics amphetamines and other stimulants depressants (barbiturates) certain hallucinogens
What drugs may be accepted in a statutory repository program?
original, unopened, sealed and tamper evident packaging un-expired at time or donation not adulterated or misbranded drugs that are stored at room temperature only
Who may receive samples?
practitioners licensed to prescribe pharmacies of hospitals pharmacies of healthcare entities
What are the exceptions Ephedrine scheduling in nebraska
primatene tablets bronkaid dual action tablets pazo hemorrhoidal ointment **all are brand specific. generics would be scheduled
What schedule is codeine?
pure codeine (by itself) is schedule II depending on the quantity of codeine, it may also appear in schedule V
the PDMA prohibits
sale, purchase, trade, or the offer to sell purchase or trade any prescription drug that was purchased by a hospital, health care entity or charitable organization (at discount rates)
high potential for abuse, there is currently accepted medical use, but there are severe restrictions, abuse may lead to severe psychological or physical dependence
schedule II
potential for abuse is less than substances in schedules above it, there is currently accepted medical use in the United States, abuse of these substances may lead to low or moderate physical dependence or high psychological dependence
schedule III
The federal controlled substances act classifies anabolic steroids in which schedule?
schedule III ** reference: law quiz 2 feb 2019
low potential for abuse relative to substances in above schedules, there is currently accepted medical use in the US, abuse may lead to limited physical dependence or psychological dependence relative to class above (generally dependence has been shown in some studies or mfr requested for schedule)
schedule IV
schedule with currently accepted medical use, lowest potential for abuse, abuse may lead to limited physical dependence or physical dependence relative to class above, some of these may be sold OTC in specific states
schedule V
5 categories of CIII
stimulants depressants narcotics (paregoric) anabolic steroids hallucinogenic substances
what are the step in a recall
the manufacturer initiates the recall either bc they have identified the problem or because the FDA identified it for them the manufacturer notifies the FDA and sellers of the recall manufacturer develops a contigency plan the manufacturer destroys or reconditions recalled product the manufacturer send the FDA a final report
What does the notification of central record keeping must contain?
the nature of the records the exact location of where records will be kept name, address and type of DEA registration whether the records are manual or in a computer readable form
Effect of the Prescription Drug Marketing Act of 1987 (PDMA)
the sale, trade, purchase of prescription drug samples becomes illegal mandates storage, handling, and recordkeeping requirements for drug samples bans trafficking in or counterfeiting drug coupons prohibits hospitals from reselling pharmaceutical purchases to other business requires states to license drug wholesalers for prescription drug distribution bans the re-importation of prescription drugs
Recalls are voluntary. If you ignore the FDA, they may seize the product if:
there is an imminent public health threat that the drug manufacturer is NOT correcting on its own or the FDA is trying to get the attention of the firm that is not satisfactorily complying with FDA requirements
true or false: the controlled substances act refers specifically to "narcotic" and non-narcotic controlled substances
true
true or false: loss of prescription inventory or records due to theft or any other cause resulting from failure to secure the inventory or records are grounds of disciplinary action against the PIC of the pharmacy
true ** reference: law quiz 2 feb 2019
true or false: the issuance of written inspectional observation (ex: FDA form 483) is mandated by law
true the issuance of written inspectional observation (ex: FDA form 483) is mandated by law
true/false: The product is considered adulterated if cGMP are not followed
true: The product is considered adulterated if cGMP are not followed
true or false: your mom could be my doctor's special agent
true: a prescriber agent can be anyone who is working under the authority of a prescriber to communicate a prescription on behalf of the provider. In nebraska, there is not definitive definition and an employment relationship is NOT required. IF your mom was told by my doctor to call in sertraline 50 mg daily into my pharmacy under the doctors credential, that is a valid prescription.
true or false: a secretary or agent/employee of a practitioner may communicate a prescription to a pharmacist
true: agent/employee is a broad term and may indicate any person acting under the authority of the prescriber. A doctor's dog sitter or child could call in and read the prescription to a pharmacist if told to do so by a doctor. They may not make any clinical decisions or call in emergency C2 rxs
true or false: The product is considered adulterated if cGMP are not followed
true: cGMP are required if the activity is beyond usual and traditional course of pharmacy's business
true or false: the FDA does not have the authority to recall drugs
true: recalls are "voluntary" actions taken by firms to remove products from the market. The FDA may seize a product if a firm does not voluntarily recall a product that poses a threat to the public
true or false: prescriptions may be prepared by the practitioner's agent for that practitioner's signature
true: sometimes it is in your best interest that the doctor doesn't chicken scratch the rx
true or false: The FDA can temporarily suspend or permanently revoke a biologic product license to stop the distribution of product by a noncompliant cGMP firm
true: the FDA does not regulate the firms that make the biologics, BUT the US government requires that biologics themselves be licensed individually. The FDA does have the authority to temporarily suspend or permanently revoke this license stopping production and distribution from the non-compliant cGMP firm.
Penalties for not licensing a wholesaler with the state includes (but not limited)
up to 10 years in prison up to $25000 fine both FOR THE FIRST OFFENSE
What questions are best to ask every time a patient comes to your pharmacy to pick up a med? These provide best patient care and risk management
what did your doctor tell you this was for? what are your allergies? what other medications are you taking? what possible side effects did the doctor go over with you?
when can a person obtain a schedule 1 substance?
when properly registered, persons may use schedule I for research
What are common mechanical errors made in pharmacies?
wrong drug wrong strength wrong direction
Can drugs be returned and re-dispensed in Community Health Centers?
yes patient assistance drugs go to the community health center for a specific patient. If patient does not pick up med, med may be relabeled for another community health center patient.