4. Prescription Writing Flashcards
I. Definition: A ____ or verbal order for medication to be used for the diagnosis, prevention or treatment of a specific patient’s disease by a licensed physician, dentist, podiatrist or veterinarian. It is a ____ document for which the prescriber and pharmacist are both responsible; therefore, when it is given verbally the pharmacist should immediately commit it to ____.
written
legal
writing
II. Laws governing the writing and dispensing of prescriptions
A. 1938 - Federal, Drug and Cosmetic Act
- Manufacturers must provide the FDA with evidence of drug safety in the form of an ____ (New Drug Application).
- Required companies selling OTC drugs to furnish the purchaser with information necessary for the drug’s ____ use.
Before ____ there were no regulations in this country for dispensing drugs, showing they work or they are safe. This was the first reg where manufacturers had to provide evidence in the form of an NDA. These days an NDA can be 1200 pages – show human and animal safety data. What do they have to submit before starting to study the drug in ppl? An ____ (Investigational New Drug application) – has preclinical data (animal data, cell culture data, molecular monitoring) and if it looks good FDA accepts IND and they can start studying it in people.
NDA
safe and effective
1938
IND
II. Laws governing the writing and dispensing of prescriptions
B. 1951 - Durham/Humphrey Amendment to the Food, Drug and Cosmetic Act of 1938
- Resolved the issue of which drugs could be sold ____ and which drugs required a ____ by a licensed health professional.
- The ____ was given the responsibility of determining this.
What we started having in early 1980s was a lot of Rx (prescription) to OTC switches. A lot of stuff became available over the counter @ lower doses (e.g. ibuprofen (Advil, Motrin) which until 1981 or 82 was only prescription). Any tablet that is 400, 600, 800 is now by prescription. The uses are also different – worried about ppl spraining ankle and self-medicating. The stuff has to work and be really safe. But OTC Advil package insert says “no more than 400 mg in a single dose, no more than 1200 mg/day, no more than 10 days use”. But under your guidance (and you would write this in the chart) they can use up to ____ mg Advil (but this is now prescription ibuprofen and side effect profile is more intense @ higher dose) T
OTC
prescription
FDA
2400
II. Laws governing the writing and dispensing of prescriptions
C. 1962 - Kefauver/Harris Amendment to the 1938 Act.
- Prompted by the ____ tragedies in Europe from 1960-1962. A sedative/hypnotic released in Europe in the 1950s, it was commonly used by pregnant women to relieve the nausea of “____”. Severe teratogenic defects occurred in the infants born to these women including ____ (seal limb), absence of external ears and cranial nerve dysfunction. Retrospective studies determined that phocomelia was caused when women ingested this drug from 24-29 days after conception.
Turns out in ____ it did NOT show teratogenicity but it did in higher animal species. High incidence (30- 40%) of women had babies born with birth defects like phocomelia, cleft palate, mental retardation. FDA said hey now you have to do teratogenicity testing on all new drugs. They also did discover a critical period of when it had to be taken (within ____ weeks of CONCEPTION) but a lot of ppl don’t even know they’re pregnant yet then! This act required additional testing @ animal and clinical level for toxicity effects.
thalidomide morning sickness phocomelia mice 3-4
II. Laws governing the writing and dispensing of prescriptions
- This act set more rigorous standards of animal and clinical testing of new drugs including the necessity for thorough (at least at the animal level) testing of potential fetal toxicity.
Question about drugs before the act + Ans: the FDA has been going back on drugs marketed before 1962 (about 14,000 of them) and they’re going back asking them to show they are safe and that they work. One fell in Elliot’s lap: ____, which is in the clinic in yellow canisters.
cetacaine
- Cetacaine® topical ____ is an example of a drug marketed (in 1960) before this amendment. FDA now wants fetal toxicity studies in animals (which were recently completed in rats and rabbits and some rigorous clinical trials of efficacy and safety (especially with respect to drug’s effect on ____ levels). BAD for Cetylite Inc BUT VERY GOOD FOR ELLIOT. We have already done two of those clinical studies. Now I’m going to make you read one of the papers and test you on it! As Dr Mitchell would say, “LOVELY”.
anesthetic spray
methemoglobin
- Locals are easily absorbed through ____ membranes. One of the components in it is Benzocaine (a strong oxidizing drug, in OD can produce ____ where Fe2+ -> Fe3+ which doesn’t carry oxygen well and also doesn’t let go easily and the person turns blue). Also now want safety and efficacy data; go to Elliot. “That’s lovely, as Claire would say”.
- He got two grants for this and was published a few years ago with Steve Wang (lol) and found that if you use the max recommended dose (you can measure methemoglobin in the blood btw: if you took his blood rn it would be 0.5% met and 99.5% reduced. You start turning blue when met > 10%) met levels did NOT ____.
- Second study is on Canvas: they used experimental pain and said ok you’re a two-component product, show us you’re better than one component alone.
- Turns out that tetracaine-benzocaine formulation DID produce more profound ____ and more prolonged gingival anesthesia than benzocaine alone. Used pinprick pain intensity and heat pain threshold. He flexed his $30k device for the temp thing. Its cut off is like 50 ̊F which is less than a cup of coffee so he can’t actually fry gingiva. Also flexed $325,000 of grant money that the school took 35% of it lol
- “The papers in canvas I want you to read it then when we have the review session we can discuss”
mucous
methemoglobemia
change
gingival anesthesia
D. 1970 - Drug Abuse Prevention and Control Act
- Regulated by the DEA (Drug Enforcement Agency). Divided drugs with abuse potential (narcotics, amphetamines, barbiturates and these day’s anabolic steroids) into five schedules based on the drug’s potential for ____, their medical ____ and the degree to which they may lead to physical and/or psychological ____.
abuse
usefulness
dependence
Schedule I
____ abuse potential
No accepted medical ____
May lead to severe ____
Examples:
____, LSD, ____, methaqualone
high
use
dependence
heroin
marijuana
Schedule II
____ abuse potential
____ medical use
May lead to severe ____
Examples:
____, cocaine, ____, methadone, ____, codeine alone, oxycodone or hydrocodone alone or combined with acetaminophen or ibuprofen
high
accepted
dependence
amphetamines
dronabinol
morphine
Schedule III
Abuse potential less than ____
____ medical use
Moderate ____ liability
Examples:
Mixtures of ____ with
aspirin or acetaminophen, ____, stanozolol (a Rafael Palmero favorite)
I or II
accepted
dependence
codeine
oxymetholone
Schedule IV
Abuse potential less than ____
____ medical use
____ dependence liability
Examples:
____ including diazepam, chlordiazepoxide and triazolam, phenobarbital, pentazocine, tramadol (Ultram® and Ultracet®), ____
IV
accepted
low to moderate
benzodiazepines
chloral hydrate
Schedule V
Abuse potential less than ____
____ medical use
____ dependence liability
Examples:
Cough preparations containing small amounts of ____ or similar narcotics.
IV
accepted
limited
codeine
III. Drug Names
A. Generic name (non-proprietary name) - A name given to a drug by the United Adopted Names Council. A drug has only ____ generic name (ie, ibuprofen).
– ibuprofen has another generic name -> ____ in Europe *EXCEPTION
B. Trade name (proprietary name) - A name given to a drug product by the ____ for promotional purposes. A single generic drug may have ____ trade names. (ie, Motrin, Advil, Nuprin etc)
one
manufacturer
many
paracetamol
- Metoprolol (Lopressor) is a ____ beta blocker (and usually doesn’t cause airway tightening); lowers blood pressure.
- Prazosin (Minipres) is an ____ and vasodilates well: lowers blood pressure. Prazosin also used in ____ (vasodilators).
- Amitriptyline (Elavil) is used to elevate ____, for depression, but also for chronic pain @ low doses for ____ pain and also improves sleep patterns. A lot of antidepressants are mildly sedating.
- Atorvastatin (Lipitor) is used for high ____ (think lipids) btw this is #2 or #3 selling drugs in the U.S. #1 is an ____ inhibitor. Up until 2014 the #1 selling drug in the U.S. was acetaminophen + hydrocodone.
cardioselective alpha blocker congestive heart failure mood TMJ cholesterol ACE
