Help
Options
Didn't know it?
click below
click below
Knew it?
click below
click below
Don't Know
Remaining cards (0)
Know
retry
shuffle
restart
0:00
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.
Normal Size Small Size show me how
Normal Size Small Size show me how
Block One
Law and Chemistry
| Question | Answer |
|---|---|
| State Board of Pharmacy | 7 members, 6 Pharmacist and one general public 3 Year terms max 3 consecutive terms |
| Lisensure Requirements NV | 1. Be of good moral character 2. graduate accredited College of Pharmacy 3. Pass MPJE with at least a 75 4. Have 1500+ hours of experience |
| How long after original application for lisensure good for? | One year upon receipt of application. |
| Temporary License | Can get one for up to 6 months if new to NV A pharmacy can get one if they move, a perminint one will be issued following inspection |
| Display of Certificates, Licenses and Permits | Each must be prominantly displayed so that the general public can see it. Really should be displayed wherever you are working that day |
| Expiration of Certificates | Pharmacists expire Oct 31 of odd numbered years, PharmTechs and interns expire even numbered yrs on Oct 31 |
| How long do you have after moving or changing jobs let them know | within 10 days |
| What happens if you lose your license in another state? | NV will NOT allow you a licence aqui |
| PharmTech requirements | Issued a certificate of registration 18 or older highschool grad No felony or misdemeanor relating to sale or use of drugs No history of drug abuse Completed a training(another card) |
| Ways to become a PharmTech | Pharmtech in training program Registered tech in another state Completion of 1500hrs as a pharmtech in training completion of pharmtech program from military Completed another states approved by that state |
| Can you transfer a tech in training licence? | NO! Not even from one CVS to another CVS, you MUST reapply |
| Pharmtech duties | 1. Package and label (pharmacist must check) 2. Prepare, package and compund and label prescript for an order(final product must be checked) 3.Prepare bulk compounds Distribute routine orders, stock shelves in pharmacy and area of patient care |
| Pharmtech duties cont | 5. Maintain inventories of supplies of drug 6. Maintain pharmacy records 7.Ask physician to refill script 8. Transfer scripts w/in company 9. Enter inro into computer for new script inc dir for use |
| Pharm techs may NOT | Perform any action that requires a judgement decisoin or interpretion of drug or instructions Take a new script or chart orders via phone Distribute meds on chart or a script w/out verification from pharmacist. |
| Ratio of pharmacist to techs | 3:1 or better |
| After a tech fills a script whats the pharmd have to verify? | Selection and strength of drug Dosage form Labeling of the script both the techs and pharmd's initials are on label |
| Pharm Tech in service training | 12 hours every 2 years one hour of which must be law. Owner and pharmacy manager are responsible for getting this accomplished and taught. (Can't teach the law) |
| When is a 4:1 ratio ok ON TEST! | When a pharmacist is acting as a instructor he can supervise one add'll tech if that tech has 9 months in technician program AND has less than 240 pratical training hrs |
| Physician Assistants requirements to register w/ board | Can get application to prescribe or to prescribe and dispense controlled substances, poisons, dangerous drugs, and devices Must get approval from Pharmacy board and Medical board and must have a supervising physician |
| For what reason can a PA prescribe and despense drugs | Legit med purpose or when authorized by physician. Can't supply more than a 365 day supply except the 5yr birth control chip |
| How does a PA prescribe? | By written script or oral. Unless given permission by hospital rules and his form is on file in a hospital pharmacy the PA cannot order a script on the chart of a patient |
| Immunization by a Pharmacist/intern pharmacist | may adminsiter by intranasal, intramuscular or subcutaneous injustion within written protocol from physican. Must be certified with the Accreditation council for pharmacy education. cannot delegate to uncertified person. |
| Requirements to be able to give immunizations | maintain certification in basic cardiac life support and each yr b4 oct 31 complete 2hrs continuing ed about disease and immunizations |
| Immunization by Pharmacist records | Report necessary info in Immunization Info System estaablished by Department of Health and Human Services. All records must be kept for two yrs |
| Continuing education for pharmacists | Must complete 30 hours within the biennium following renewal period. 2yr grace period following school. one unit is in law Hours don't carry over |
| How many hours per month following the two year grace after school | 1.25 units per month. see group exercise for example |
| How long do you keep records of continuing education? | four years. must have certificats incase of audit |
| How often does each practitioner or pharmacy get to destroy controlled substances? | Once per a year...be sure to follow directions on destruction |
| What is the number of beds in a hospital that requires a full time pharmacy manager? | 100 or more |
| How many inmates require a correctional institution to have a full time pharmacy manager? | 1500 or more |
| if a hospital has less than 100 or a jail with less than 1500 then what do they need to have? | A part time pharmacy manager or a consultant |
| Who is allowed to withdraw meds after the full time pharmacist is gone? | A practitioner or a nurse |
| In a place with a full time pharmacy manager, how long does the pharmacist have to review the drugs that were taken after hours. | 72 hours it should be reviewed, and within 96 hours it should be done in person |
| In a place with a part time pharmacist or a consultant how long does the pharmacist have to review the drugs that have been taken out by a practitioner or a nurse? | Must be reviewed within 30 days, and in person within 90 days. |
| Where must the records of controlled substances be kept? | In a manner that they are readily retrievable. |
| What is a dangerous drug? | AKA legend drug |
| What do you use to sell C3-5 drugs to another pharmacy? | You must use a invoice |
| What do you use to sell C2 drugs to another pharmacy or practitioner | DEA form number 222, must show quantity of the substance distributed and the date that it was completed |
| How often can a Facilities for intermediate care and skilled nursing destroy C.S. | They can do it at least ONCE A MONTH |
| Stock of drugs and nursing home like places | Quantities can't exceed 20 units Drugs must be stored in unit doses not a whole bottle These are used for emergencies in treating patients |
| Surgical Centers for ambulatory patients | Must be licenced by the board and DEA to dispense cs They must have a pharmacist on staff who goes there once a month and trains |
| If a practitioner orders an entry in a patient's chart the chart must be signed w/in ___hours after the order is given | 48 |
| If your order drugs who can they be shipped to | TO YOU they can't go anywhere else except right to your pharmacy |
| Drive through pharmacies | Must be secure Readily accessable to pharmacy workers only Provide 2 way visual and auditory communication Computer must be in that part of the pharmacy |
| What must all workers in a pharmacy have on at all times | A ID that clearly identifies him by name and the classification of his registration |
| How many days to report fired or new place of work? | TEN |
| Meal period | Must be allowed 30 minutes in order to eat and take a break. Can't be interupted during this time unless they say it is ok. |
| Nuclear pharmacists require _________ | additional training |
| In order to send drugs into NV who has to be licenced? | The pharmacy must be licenced in NV, however the pharmacist can be licneced in any state |
| Mail order into nevada must contain what information on the script? | Must have a phone number that is toll-free and availabe at least 5days a week and 40hrs in a week. |
| Parenteral Solutions | IV's and TPN's |
| What kind of fume hoods are required to mix regular drugs? | A class 100 HEPA laminar airflow hood that is certified EVERY year |
| What kind of fume hoods are required to mix cytotoxic agents in a pharmacy? | Must have VERTICAL laminar airflow hood that is certified EVERY year |
| Limitations on practitioner dispensing | Can't charge for CS or drugs unless he obtains a certificate from the board and pays fee AND issues a written prescription |
| Patient Utilization Report | Allows a practitioner to log in and check a patients history prior to the dispension of Controlled substances |
| What must a written prescription contain? | 1.Name and sig of DR and his address 2. Classification of licence 3.Patient name, address 4. Name, strength, and quantity of drug 5.Symptom or purpose for script 6.Directions 7.Date |
| What must the label contain on any drug? | 1.The date 2.Name, address and prescription serial number of the practitioner(pharmacy) who filled it. 3.Name of prescribing dr&patient name 4.Number of dosage units 5.Symptom or purpose if on prescription 6.Specific directions 7.EXP date of meds (1 |
| What else does the label contain? | 8.Strength of the drug 9.generic name of the drug as written by practitioner |
| A practitioner is liable for any order for a prescription in which his agent oral transmists to a pharmacist | FACT |
| What is different about the records for refills on all scripts in NV? | They can't be kept electronicaly, they are kept in a bound book or on the back of the original script |
| How long can you fill a script for a CS | 6 months...1 year for dangerous drugs |
| Pharmacists Judgement rule on drugs | If someone has been on a drug for a long time and in your professional opinion they need that drug you can give them that drug in a few day supply. This is only used if you know patient well... |
| Rescission of authorization | At any time the practitioner who prescribed the script can take it away. Also any other practitioner the patient is seeing can take it away |
| When can you subsutitue a generic | If the Dr does not HANDWRITE "Dispense as written" on the script or oral tell you, or if its on a fax |
| What are the rules for substuting a generic | 1.less expensive 2.biologically equivelent 3.Same active ingredient, quantity and form of dosage 4. is of the same generic type as the drug that is prescribed |
| What if there are more than one generic drugs available | Then you dispense the least expensive equivelent to the script |
| What do you have to do w/ patient b4 substitute? | 1.Tell the person or their agent and tell them they have the right to refuse unless it is being paid for by Govt agency. |
| If you do substitute you must put what on bottle | Put the name of manufacturer of generic on script and put "substituted for... and then put trade name" |
| What can a clerk do? | Enter info into pharmacy computer except new scripts concerning the drug and directions Process sales Stock shelves Deliver meds to patent in areas of hospital where the patients are cared for |
| Who is responsible for everything that happens in a pharmacy | The pharmacist, pharmacy manager and the owner |
| When must patient counceling take place? | 1.that pharmacy has not dispensed that drug to that patient before 2.If you think it would be good 3.After looking at record you think saftey is a concern |
| What if you won't see the patient to give them their drugs | Then you send it in writting unless patient is at medical facility where there are authorized people to administer drugs |
| Can you keep patient councilling records electronically? | YES, keep it for two years |
| Do you need to advise on a refill if it has been filled at your pharmacy before? | NOPE |
| What kind of drug can not be prescribed electronicaly | CII |
| What must be included on a electronic prescription | 1.Registration number of pract. if it is for a controlled substance 2.Tele number of pract. 3.Time and date of transmission 4.Name of the pharmacy to which it is being sent *if it has all this it is considered a orginal script** |
| What does a pharmacist do upon receipt of a electronically submitted prescription | Prints a copy on good paper and keeps a copy of it for the next two years |
| Can you send a C2 script via fax | Not unless it is going to be compounded for direct admin. to patient, or for someone in a LTCF, or hospice patients |
| Can you call in CS? | C3-5 and non controll yes C2 only in emergency situations |
| Can you transfer a C2? | NO B/C there is no refill...you can transfer C3-5 once and non controlled can be transfered as long as there are refills remaining |
| Container rules | Must be child resistant unless: 1.Patient is 18 2.Specifically request container that is not childproof 3.signs a doc verifing they made the request |
| ID of CS prescription | must provide ID and you photocopy it; unless part of the drug is paid for via insurance, patient has had the same cs b4, the pharmacy is part of a health care facility |
| What happens if the retail pharmacy is closed and someone needs their meds? | The ER or surgical center can give a few day supply |
| How does NV stop internet pharmacy | If the Dr. is not licenced here Patient resides in a state different than Dr If it is to be paid for in full w/cash on fist visit |
| How to verify a prescription | Speak w/ pat. or Dr and establish that the script is real and the Dr. and pat. know eachother and record the name of Dr you talked to and the time and the date and time of the pat-Dr visit. Must have had person to person visit w/ Dr unless jail |
| Reasons a pharmacist can decline to fill a prescription | 1.He believes its unlawful 2.Script could hurt pat 3.Script is fraudulent 4.Script is not for ligit med purpose |
| Nurse practitioners requirements to register w/ board | Application to dispense controlled substances poisons dangerous drugs and devices, must send in copy of license and verification from St. Board of Nursing, and must have supervising physician |
| Nurse Practitioners authority to prescribe | Real reason, no more than a 365 day supply except birth controll. |
| Nurse practitioners dispense | Can't dispense more than a 30 day supply must be registered and have a physician they are under. |
| How long do you have to keep records | Two years and they must be readily available |
| Poison Control Center | Each pharmacy must have the phone number of the nearest Poison Controll Center posted in the pharmacy. |
| Rules on selling needles to people | 1.Diabetes and asthma 2.For use in injecting shots by a practitioner 3.Use in an ambulance or by firefighters 4.Injection of animals or chickens 5.Jewelers and hobbyists. 6. Funeral directors or embalmers 7.Med techs or research labs |
| When can you sell a nasal inhaler? | When you act in good faith for medicinal use in treatment of human illness |
| Who is considered a practitioner | 1.Physician, dentist, veterinarian or podiatric physician 2.Nurse pract. 3.Scientific investigator, pharmacy, hospital 4.Euthanasia tech 5.PA 6.Optometrist |
| Schedule of controlled substances | there are 5 schedules, drugs are placed within each schedule based upon its abuse potential and the accepted medical use |
| How long are records kept for and where | Records are kept for two years and they must be readily available in the pharmacy. |
| Directions for use on a controlled substance | Must say how many and how often you are to take the script. For a CS it is necessary to have more than just "take as directed" it must tell you how many and how often |
| If a doctor has 3 offices and at office A he prescribes only, office B stores prescribes and dispenses, and at office C he stores and prescribes. How many DEA#s does he need? | Two |
| If there are two docs praticing at one location how many DEA#'s are needed | They will each need their own DEA number |
| Where must CS be stored at in a Doc office? | In a locked storage area |
| What does a doc have to do prior to dispensing dangerous drugs or controlled substances from his office | He must write a prescription and offer the patient the option of filling at his location or taking it to another pharmacy |
| Can a doc dispense a CS for his own use? | Only in an emergency...the wierd part is it is up to his disgression on what a emergency is. |
| Can you take an order for a C2 over the phone? | Not unless it is a emergency. In an emergency situtition you take the order, write "authorization for emergency dispensing" and you dispence a small supply. The prescriber then has 72 hrs to get you a original script. |
| How do you order a C2 | A 222 form |
| How do you order a C3-5 | using an invoice |
| Can a practitioner issue a script to get CS to dispense to his patients? | NO |
| Can you fill a narcotic script to keep someone going who is dependent on them? | Not unless they are in a course of an authorized clinical investigation in a development of a program for rehabilitating addicts |
| What schedules can you fax? | III,IV, and V |
| What must be on label of a controlled substance? | Name n address of pract. and sig date, full name of patient w/ address. Name strength and # of drug, dir for use, DEA# and classification of licence |
| On a CS script, if the practitioner does not put his DEA #, then what do you do? | You must fill it in and initial. In this situtition you CANNOT put RA on it you MUST fill it in. |
| What can you fill in on a script for a CS if it is missing? | You can put patient address after obtaining positive id. pract. address, dea# |
| What can you change on a C2 after obtaining permission from pract | Strength prescribed and quantity. Dir for use. Date it was issued if it is obvious error. |
| What CANT a pharmacist change on a C2? | Patient name CS prescribed except for switch to generic Sig |
| What do you need to do if you change a script of a C2? | Obtain practs permission and then EM it and date and time it |
| When may a pharmacist dispense a C2? | Written script or a faxed script Emergency oral order (must get original w/in 72hrs) |
| Can a script with a C2 have other scripts on it? | YES it can have anything on it. Just make the a copy of it for each drug on it for filing |
| How long does a patient have to turn in a script for a C2? | 14 days after the day it is written they must validate it at a pharmacy. They have 6 months from the day it is written to have it filled |
| If a patient drops off a C2 w/in the 15 day period but does not have it filled. Can they come pick it up and take it somewhere else even though it is past the 15 days? | Yes they can, just have to get it filled w/in the 6 months of written day |
| What is unique if a C2 drug is prescribed but says "don't fill until______"? | It must be ALONE. If it is not alone you can't fill it, you could fill other order but not the C2. Also CANT exceed a 90 day supply! |
| A patient brings in a C2 for 30 pills and you only have 13 what do you do? | You can if the patient agrees give them the 13 pills and they can come back for the other 17 within 72 hours. If you can't get them w/in the 72 hours then patient forfits them. If this happens then you must notify the practitioner. |
| How long is a script valid for a LTCF or terminaly ill patient? | 60 days |
| What is a full refill? | The same amount as the orginal script. If it is for 30 and the patient comes and gets 15 then that is only 1/2 of a fill... |
| You just got hired to be manager of a pharmacy how long do you have to take invintory? | 48 hours and you must do it with the previous manager. After this date you must take an inventory AT LEAST every two years |
| How do you store C2-5 records? | In files with C2 seperate and the C3-5 marked controlled and then the non-controll. |
| A pharmacist must keep records in conn with any sale or replenishment of supplies of controlled substances to the holder of a permit for the operation of an ambulance, air ambulance or a vehicle of a fire fighting agency at the scene of a emergency. | FACT, you only have to have record of what they took, what they do with it they have to account for. |
| How much C5 over the counter can you sell in NV? | 60cc in 48 hours only by pharmacist to person 21 or older who furnishes appropriate id. The person puts name, address, controlled substance and amount, and date in book initialed by pharmacist |
| Paregoric rules | may sell for treatment of stomache or bowl. It must be mixed w/ 3oz of nonnarcotic medical prep and contain less than 1 oz of paregoric |
| How do you dispense cough syrup containing a controlled substance in schedule 5. | Must dispense for a valid legit med purpose. the pharmacist is incharge of ensuring that this is followed. |
| Can a salesman of a manufacturer or wholeseller of pharmaceuticals posess, transport or furnish C2 drugs? | NOPE |
| What form do you use to report loss or theft? | 106 w/in 10 days of discovery! |
| Methamphetamine | Product that is a precurser to meth means it contains ephedrine, pseudoephedrine or phenylpropanolamine or the salts, optimal isomers or salts of optical isomers of such chems and may be marketed lawfully in US |
| Where do you store any product that is a precursor to meth? | In a locked cases or cabinet or behind a counter so the public does not have direct access to it before a sale or transfer is made |
| Requirements for sale of meth: | 1.A retail distributor shall keep a logbook and record name of product, quantity of product, name and address of purchaser and date of sale or transfer. Must check buyers ID. Record kept 2 yrs |
| How much meth can you buy? | 3.6 grams per day max of 9 grams per month. This goes into a computer system so this should be the MAX one can get. |
| Pure food act of 1906 | Prohibited adulterating and misbranding of drugs |
| Food, Drug, and Cosmetic Act of 1938 | Regulates drug quality Requires new drugs be proven safe propr to being marketed Labels must contain "adequate dir for use" Warnings about habit forming properties |
| Durham-Humphrey Amendment of 1951 | No more "adequete dir for use". Two classes of drugs; OTC Rx. Authorizes oral scripts. Refills. FDA can switch Rx to OTC. Rx label must say "Caution:Fed law prohibits dispensing w/o script" |
| Medical Devices Amendment | Strengthened Saftey and efficacy requirements of medical devices |
| Orphan Drug Act of 1983 | Provides tax and licensing incentives for manufactures to develop market drugs for diseases that effect few people |
| Drug Price Competition and Patent-Term Restoration Act of 1984 | Streamlines the generic approval process while giving patent extensions to innovator drugs |
| The Prescription Drug Marketing Act of 1987 | Establishes sales restrictions and record keeping requirements for rx drug samples. Prohibits hospitals and other health care entities from reselling their drugs to other businesses. Requires state licensing of drug wholesalers |
| OBRA 90 | Primary goal to save $$ Drug Utilization Review Programs-3 componets 1.Screen rxs prior to dispensing 2.Patient counseling by pharmacist 3.Pharmacist documentation of relevant information |
| Dietary Supplement Health and Education Act of 1994 | Regulates dietary supplements |
| Hippa | Established to ensure security and privacy of patients medical records when electronicaly transmitted Congress initiated "privacy rule" to protect info called PHI Public Health Information |
| Food and Drug Administration Modernization Act of 1997 | Expedited availability of safe and effective drugs and devices. Fast tracks drugs for serious/lifethreatning disease. Establishes data base on clinical trials.Expands rights of manu to disseminate unlabeled use info and expands FDA auth on OTC's |
| How would you dispose of a C.S. when there are no directions given | Mix it with something undesireable like coffee grounds or cat litter and then throw it in the tarsh |
| What do you do when there is a theft of controlled substances? | Fill out a 106 and call the local police |
| CIII-V transfer rules | Can transfer it ONCE. if it is transfered from a walgreens to a walgreens it does not count as a tranfer |
| What are the rules to mail a CS | You have to ensure the package is safe and that there are no markings on the outside of the package that would indicate that mes were in there |
| CI storage | a securely locked substantially constructed cabinet |
| CII-V storage | a securely locked cabinet or distributed throughout the inventory so as to detor theft. If a individual practitioner has a CS it must be locked up at all times |
| How much CII can you get per a visit? | no more than a 90 day supply |
| Refill max | CII=0 CIII-IV=5 CV and Non Controlled=what ever |
| Partial filling | Have 72 hours to fill remaining order for a CII, after 72 hours the patient forfits the rest of the script and you have to let the prescriber know what happened |
| What constitutes a refill? | The same number of medications is dispensed as that which was orginally prescribed. |
| Fax prescription rules | II-fax and then bring orginal for pickup unless: Directly administered, LTCF, Hospice III-V: must have all content of reg script, and then it will count as the orginal |
| Emergency CII prescription | Limit the number supplied to a 2-3 day supply. The Dr. must send a written script w/in 72 hours of this happening |
| What is an emergency? | Immediate need is neceessary and proper, no other treatment available, Dr. can't provide a script at that moment |
| Prescription requirements | Name, date, phys sig, drug;name, dose, form, strength, quantity, directions for use, name, address and DEA #of a pract. |
| Schedule two...can it be handwritten? | Yes it MUST be, a 3-5 may be hand written or orally given |
| Copy 3 of an order form goes where? | The purchaser keeps that compy |
| Power of attorney | Indiv who signed most recent order form can authorize another person to execute the 222form. Can be revoked at any time by giver, does not need to be filed, needs two witnesses and must have a file in the pharmcy |
| Copy one of the order form goes... | send it to the supplier, who keeps it |
| Copy 2 of the orrder form goes | send it to the supplier who then will send it on to the DEA |
| What is needed to sign a 222 form? | Power of attorney |
| 2N | Narcodic level 2, remember this is still a controlled substance |
| DEA form 224 | Used to order C.S. for the first time, |
| Disposal of CS | Form 41. Contact DEA and they will tell you to do one of four things with the drug: transfer, deliver to dea, destroy in front of dea, and anything else they ask you to do with it. KEEP THE RECORC FOR TWO YEARS |
| MEDWatch | Medication reporting system. Health care professional can report adverse effects od drug, use errors, product quality errors. Must contain " call your doc for med advice about side effects..." |
| Current good manufacturing practice | Makes sure that a manufacturer is processing and packaging and holding are safe. If it is violated the drug is adulterated. FDA checks every two years. |
| Orange book | lists all bioequivaelents of a drug. if it starts w/ a it is good if it starts w/ b it is not equivalent |
| Recall process | manu is resp for calling seller, seller contacts consumer, pharm responsible for knowing whats been recalled, manu can do this w/o the FDA, and the FDA may also start it |
| Class III recall | not likely to cause any adverse health consq. |
| Class I recall | Reasonable possibility that the drug will cause serious adverse health conseq. or even death |
| Class II recall | use may cause temp but reversable advers medical consq. Possibility of a serious adverse health consq is remote |
| Labeling | is the packaging paper that comes w/it |
| Patient info program | if adverse efects are found the patient must be informed |
| What makes a drug misbranded | False or misleading, does not state name of bus/manu, not prominantly present, does not have dir for use, habit forming drugs must say so, brand name must be one generic, not packed/labeled to standards, sub to deteriorization but does not say so, bad dir |
| What is a label | it is on the physical container |
| Misbranding | primarly concerned w/ the representations made by the manufacturer concerning the drug or device |
| Adulteration no no's | Prep in unsanatary cond, does not follow GMP, Dang cont may leach, unsafe color additive, otc not in tamper proof cont, class 3 med device w/o pre market approval, new unsafe animal drug or animal feed w/ drug, varies from compendia |
| National drug code 3rd section | Packaging |
| Adulteration | concerned w/ physical condt of drugs or devices and the enviroments of their manu...(sterile, up to par factory?) |
| National drug code 2nd section | Product |
| National drug code 1st section | manufacturer or distributer (labeler) |
| OTC monograph | Reg specifing condition in which specific act ing and combo may be formulated in OTC drug product w/o prior fda approval. allows them to be sent right to market |
| Supplemental New Drug Application (SNDA) | For drug products that are approved that request a change to the formulation or written material about the product. Patent starts over. Must be improved, must show saftery and efficacy |
| new drug application | Takes 18-24 months. must prove safe and effective through studieS |
| Abbreviated New drug application (ANDA) | generic manufacturers submit ANDA when approved drug patent expires. does not rerquire submission of saftey and efficacy data but bioequivalence studies are required most of the time. MUCH easier and cheaper |
| Prescription Drug | A drug intended for man which: is habit forming, because of effects must be maintaned by pract. licneced by law to administer, is only leagal under supervision of pract. |
| OTC drugs | drugs recog by experts to be safe and effective for use. must follow good manu pratices, must contain "adequete dir for use (so that a 5th grader can read it) |
| Prescription drug aka | legend drug |
| Cosmetic | subst intended to be rubbed poured sprinkeld on or introduced into or otherwise applied to the human body or anypart thereof for cleaning, beautifing, promoting attractivness or alerting the apperance. DOES NOT include soap |
| Federal or state law...which do you follow? | More strict |
| Drug | Recog by us pharmacopa and their supliments, substance for use in diagnosis, cure mitigation tratment or prevention in man or animal. affect structure or fx of body inc substances intended for use as a comp of a substance |
| CII inventory requirements | Must have an actual physical count at all times |
| CIII-V inventory requirements | Must have an estimated count unless the bottle holds more than 1000 units and is opened, then you must have actual count |
| CS records must be kept for | two years at place of registration. Records and inventories of CIII must be kept seperatly from the CII's |
| CS inventory requirements | Initial: complete and accurate Biennial inventory after initial: every 2 years, dont send to DEA keep your records yourself for 2 years |
| DEA form 41 | destroy controlled substances |
| DEA form 222 | drugs recieved, order form |
| DEA form 106 | loss or theft |
| DEA # varrification | 7 digits 1+3+5 + 2(2+4+6)=equal last digit if it is a match it is good |
| DEA form 224 | initial registration order form |
| who is exempt from having a DEA # | warehouse worker, user, pharmacist, public heath service practioners, bureau or prisons, militarty service practioners |
| Distributing | moving a drug |
| Who needs a DEA# | Pharmacy: every pharmacy regardless of type, register as a dispenser Dr. as a dispenser (Pharmacist registers as a pharmacist) |
| Dispose | to deliver a controlled substance to an ultimate user or research |
| manufacturing | production prep propagation compounding or processing or a drug directly or indirectl. also inculdes packing and repackageing or relabelign |
| How often do manufacturers and distributers register w/ DEA | every year |
| how often do dispensers register w/ DEA | Every 2 years |
| Registration w/ DEA required by (TEST) | Manufacturing CS Distributing CS Dispensing CS Conduct research w/ I-V Conduct narcotic treatment w/ II-V Conduct chem analysis w/ I-V Importing I-V Exporting I-V |
| Schedule V | Low potential for abuse comapred to IV; abuse may lead to limited physical dep relative to IV |
| Schedule IV | low pot for abuse comared to III. may lead to limited physical dependence or phychological dependence relative to drugs from III |
| Schedule III | Has pot for abuse greater than I and II. Abuse may lead to moderate or low physical dependence or high phychological dependence |
| Schedule II | High pot for abuse. Abuse of drug or other substance may lead to severe physical or psychological dependence |
| Schedule I | NO Approved health use in US |
| Schedule Rules | U.S. Attorney general can put drug on schedule. manufacturer must label products w/ symbol id'ing the classification |
| Narcotic Controlled Substance | Still a CS don't let N fool you! a natural or synthetic opium or opiate and any derivative of poppy straw, coca leaves or cocaine |
| Controlled Substance | aka Scheduled drugs; are drugs that have potential for abuse and addiction |
| Controlled Substance Act | Goal: to be able to trace a CS from the time it is made to the time it is dispensed to the user. All this to prevent it from entering illegal rings |
| New drug development process | Pre clinical test-animals File investigation new drug application Clinical trials (3 levels) File new drug app; post marketing trials (FDA can take away at any time) |
| Phase I trail | healthy people get tested to see if it has adverse efects |
| Phae II trail | people with disease try it to see if it works to help w/ disease |
| Phase III trail | large scale clinical trial |
| Medicare/Medicaid fraud and abuse statute | prohibits knowingly making false statement of a materila fact in any application for benefit or payment. prevetns kickbacks Violaters will loose licence, 5yrs jail, 25k fine, or civil/felony charges |
| What are non polar molecules soluble in | Lipid |
| What are polar molecules soluble in | Water |
| Benzene polar or non polar | very non polar |
| C-C, C=C, C=-C polar or non polar | very non polar |
| R-O-R | Ether, pretty non polar |
| R-X | Alkyl halide, pretty non polar |
| Esters non polar or polar | pretty much in the middle R-C-OR with a =o on the C |
| Aldehydes/ketones; polar or non polar | right in the middle |
| Amides polar non polar | pretty polar |
| Alcohols polar or non | polar |
| Amines polar or non | very polar |
| carboxylic acid polar or non | very polar |
| Look @ functional groups | page 5 of chemistry review 9/1/11 |
| Heterocyclic Ring | A ring that contains more than one type of a atom at one of the vertices in the ring. It is always carbon and usually a O, N, or S. Most drugs contain at least one heterocyclic ring |
| Saturated | If there are no double bonds it is saturated |
| Unsaturated | if there are double bonds in a ring |
| Like disolves like | if a molecule is more water based it will disolve in water if it is more fat based it will disolve in a fat |
| Opposites attract | refers to charges, + and - attract one another while like charges repeal one another |
| Van der Waals forces | A intermolecular force that exists between almost all molecules, and is very weak. Happens when two molecules get near one another. Only about .5-1 kcal/mol |
| Hydrogen Bonding | Intermolecular. Very specific. Found between an hydrogen atom that is attached to an electronegative atom (F,O,N) and another electronegative atom. |
| What are drugs that form hydrogen bonding uaually soluble in? | WATER |
| Strength of the hydrogen bond, order | F-H...F O-H...O O-H...N N-H...O N-H...N |
| Ion pair interations | Not too strong in a solution (5kcal/mol) |
| Hydrophobic interactions | Dominant force in protein folding The non-polar(hydrophobic) parts try to get away from the water |
| Carbohydrates | One of the three major dietary components-generaly used as fuel |
| Lipids | One of the three dietary components, stored as fuel and makes up membrane bilayers |
| Proteins | One of theree major dietary componets, primarly is functional. DO NOT STORE extra |
| Nucleic acids | can be synthesized. monomers=nucleotides polymers=long chains of DNA and RNA STORE INFO |
| Steroids | role as hormones and strucural component. Made of 4 rings |
| Vitamins | two classes water soluble and lipid soluble help digest |
| Inorganic minerals | play variety of roles |
| What are the three biomolecule that are classified as macromolecules | Carbohydrates, Proteins, Steroids |
| Chemical terms | steroid, peptide, amino acid, fatty acid, ion |
| Functional terms | hormone, neurotransmitter, enzyme, receptor, channel, pump, ligand, electrolyte |
| Carbohydrates | The most abundant organic compound found in nature and represent the major dietary component |
| Carbohydrates monomers | Sugars |
| Carbohydrates oligomers | Disaccharides |
| What are the polymers of carbohydrates | 1.Glycogen-stored in animal cells 2.Starch-can be digested 3.Fiber-can't be digested |
| Where does the body store glycogen and why? | It stores it in the liver and muscle, as reserve glucose for energy |
| Lipids | NONPOLAR-insoluble in H2O |
| What are the majority of lipids found as | triglycerides that are stored in adipose tissue for use as fuel. |
| Omega nomenclature | Used for unsaturated fatty acids, to name it you just count until the first double bond and then call it Omega ___ |
| Can proteins polymerize? | Yes |
| Function of proteins | Mostly they are functional-serve as enzymes, receptors, hormones, muscle fibers, etc. |
| Do we store proteins | Not really, therefore there are no major storage forms. |
| Monomers of proteins | amino acids |
| Oligomers of proteins | peptides and oligopeptides |
| Polymers of proteins | proteins |
| Nucleic Acids | Serve primarly to store information they are not a major dietary component and they are not used as fuel |
| Monomer of a nucleic acid | sugar+base+phosphate |
| Polymers of nucleic acids | DNA and RNA |
| Nucleic Acids three big points | 1.Are monomers and con form polymers 2.Molecules of information 3.Monomers made of sugar+base+phosphate |
| Steroids | Are very non polar (hydrophobic) The major dietary steroid is choldsterol |
| Function of steroids | bile salts-aid in digestion of fats |
| Vitamins function | Required in the diet in small amounts in norder to maintain proper functioning of cells, can't synthesise |
| Two classes of vitamins | Water soluble and fat (lipid) soluble |
| What vitamins are water soluble | B and C |
| What vitamins are lipid soluble | A,D,E,K |
| Are all ions electrolytes | No |
| Are all electrolytes | Yes |
| What are considered to be ions | Na+, K+, Ca+ and Cl- |
| Do you take in more vitamins or carbs in one day? | CARBS! |
| Na+ in and out of cell | Out: 142mEq/L In: 14mEq/L |
| K+ in and out of cell | Out: 4mEq/L In: 140mEq/L |
| Ca++ in and out of cell | Out 3mEq/L In: <1mEq/L |
| Mg++ in and out of cell | Out: 2mEq/L In: 40mEq/L |
| Cl- in and out of cell | Out: 103mEq/L In: 4mEq/L |
| HCO3- in and out of cell | Out: 24mEq/L In: 10mEq/L |
| Phosphates in and out of cell | Out: 4mEq/L In: 85mEq/L |
| Amino acids in and out of cells | Out: 30mg/dL In: 200mg/dL |
| Proteins in and out of cell | Out: 5mEq/L In: 40mEq/L |
| Glucose in and out of cell | Out: 90mg/dL In : 14mg/dL |
| pH in and out of a cell | Out: 7.4 In: 7.0 |
| how much protein is stored? | IT IS NOT! |
| how much cholesterol do we really need? | NONE! our liver will produce enough as it is |
| What are equivelents used for? | To express concentrations of electrolyes. The total number of equivalents of cations and anions must be the same in a solution |
| Osmoles | Contribute to osmotic pressure. In a per mole basis the number of osmoles is the number of particles per a mole. |
| milli | 10-3 |
| Micro | 10-6 |
| nano | 10-9 |
| pico | 10-12 |
| Molarity(M) | mol/L |
| Molality | moles/kg solvent |
| Osmolarity | osmoles/L |
| Osmolality | osmoles/kg solvent |
| mEq/L | used for electrolytes |
| Osmoles easy | number of molecules in a solution |
| Equevelents made easy | Total + charges and total - charges (they are always equal) |
| Charge on Al | 2+ |
| Charge on Nh4 | + |
| Ca charge | 2+ |
| Mg charge | 2+ |
| K charge | + |
| Na charge | + |
| C2H3O2 charge | - |
| HCO3 charge | - |
| CO3 charge | 2- |
| Cl charge | - |
| C6H11O7 charge | - |
| C3H5O3 charge | - |
| PO4 charge | 3- |
| SO4 charge | 2- |
| K3PO4 Osmoles and eq | Os: 4 osmoles Eq 3 |
Created by:
km442
Popular Law sets