pdr

Drug Resources Assignment -
This assignment is intended to acquaint you with drug information resources that you may refer to in the future when you want more information about a drug you or someone you care about is taking. Sometimes you just want a little general information on the drug and a resource designed for the average consumer may be good enough. But there may be some time in the future, perhaps when you or your child is experiencing some adverse reaction, when you really want to know every detail about the responsible drug. Then you should turn to one of the official, professional resources that include all the drug details the drug company had to establish with years of research before they could get FDA approval to sell their drug. All these details are summarized in the "FDA-approved" package information, which is available in a couple different places, depending on the brand name prescription drug that you are looking up. You must use 1 official "FDA-approved" source and 1 consumer-oriented source for this assignment.

Official "FDA-approved" sources
1) Recent drugs that are still under patent will usually be included in the official, professional (used by physicians and pharmacists) Physician's Desk Reference (PDR) - a big, heavy book about 5 inches thick, published annually to keep it up to date, with a red or blue cover. The library keeps the most recent edition in the Reference area of the library and an older edition at the Reserve Desk.
(Note: there are less complete "unofficial" versions of the PDR like PDR Family, PDR Health, or PDR for Nurses which should NOT be used as your "official" source (although these may be used as your second, more consumer-oriented reference. )
2) This same information is available in the official, manufacturer's package insert (tiny print, quite long) that you can request from your pharmacist. It is sometimes labeled "Prescribing Information" because it is the thorough information doctors may need when choosing to prescribe a particular drug for a particular patient. This is package insert NOT the brief info that the pharmacy prints off on its computer.
3) This official, package insert/FDA-approved product label info is also available for at least some drugs the DailyMed website: http://dailymed.nlm.nih.gov/dailymed/about.cfm?CFID=199472492&CFTOKEN=913858b572967ed8-CA33F970-E4A8-F440-05268A0ADBB1303B&jsessionid=8430dba8a25c1e62b2477a4b454820227870 If possible, after you find your drug on this site, click on "Full Table of Contents" to see the complete list of information available on this medication. You will need to llok at several sections of the info to complete the assignment.

Pick a brand name PRESCRIPTION drug of interest (could be something you or someone you care about has taken or may take, could be one of the types of drugs discussed this semester (stimulants, depressants, pain-relievers, drugs for psychological problems, steroids, etc.). You will need to find a specific brand name for the drug (even if you have used a generic form) because the generic companies don't provide detailed drug info on their products (remember, they did not do the drug research - the brand name companies did). You can find brand names in the Physician's Desk Reference or on the DailyMed site. If you cannot find any of the official, FDA-approved sources listed above for your drug, select another drug. Although the PDR or the package insert are not easy references to read (you may find you need to refer to a medical dictionary) these are THE professional references, best reflecting the drug research that the company had to do to get FDA approval. When you really need to know about a drug this is the place to go. I have one PDR on reserve in the basement of the library and the very most recent PDR is kept on the Reference Shelves of the library (RS 250 P5). Also look up your drug in another general but detailed reference on drugs geared more for consumer. Many of these consumer books are organized by generic name so be sure you know both the brand & generic name for your medication.You may also use a drug reference website as long as it provides extensive information on your drug. Please xerox/print at least the first page or two from your consumer reference.

From your OFFICIAL FDA-approved source, copy, paste and print the CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS SECTION as well as any "BOXED WARNINGS" from your drug's coverage in the PDR or attach the manufacturer's package insert, to prove you used an official source. You will have to read more of this source to answer the questions below, but you don't have to print it all. Failure to provide this proof of using the FDA- approved source will result in a loss of 25 pts (in addition to any points lost for other reasons).

To give you some sort of context, imagine this scenario (let's hope this is not a premonition about the future!): All medically or pharmaceutically trained personnel have been killed off by a nasty virus that swept through all healthcare facilities. Pharmacies still contain medications but there are no experts anymore - just the drug reference books. You have been put in charge of the medication you have selected. You must become "the expert" on that particular medicine by reading the reference books. You must be able to visually recognize your medicine in its different dosages (in some pharmacies the pills have been dumped out of their containers). You will responsible for who can have that medication and who cannot (someone else will be responsible for diagnosing their condition in the first place) . You must tell those you dispense the medicine to about the important side effects, precautions, warnings etc., what dose to take & how often. and so forth. You REALLY don't want any of your "patients" to have serious or dangerous side effects or die on you. Some of your patients, in fact, are people you love! So be reasonably careful and include the important info in your report.. For instance you will want to read your references carefully for any information on who should not use your medicine or who must use special caution if you decide that they can have the medicine. (e.g. what if they are pregnant? an infant or child? a substance abuser? elderly? taking other meds? operating heavy equipment or driving? nursing a baby? have a diagnosed health condition like heart trouble or kidney problems? etc.)

Looking Up Prescription Drugs (75 pts)

Do not try to answer on this sheet (you will need more space). Copy and paste to a word-processed file so you can enlarge the spaces as needed for your responses. Numbers by each question are approximate point values (some drugs have more uses, effects, important side effects, drug interactions etc. than others).

1. Brand name(2)

2. Generic name(s) of the active ingredient(s)(2):

3. Manufacturer(2):

4.. Clinical Pharmacology - What kind of drug is it? What is said about how it produces its effects?(2-4)

5. What is it used for ("indications & usage") (6):

6. If you have found your drug in the PDR, go to the photo guide towards the front of the book. Find the photos from your Manufacturer, then find your drug and use the photos to answer # 6 (2-6 points)
Drug's identifying appearance in its various dosages (see photo guide for color, shape, AND markings that allow identification of all brand name drugs by sight).
If you are using the package insert or online prescribing information, you will have to search online for close-up photos of the various dosage forms of your particular prescription drug to find this information.

7. Who shouldn't use it or who needs to be particularly cautious about use? (16)

This info may be under headings like CONTRAINDICATIONS, WARNINGS, or PRECAUTIONS. In the PDR particularly critical warnings are sometimes highlighted in a "black box" to make the warning stand out..

Statements, if any, concerning use of this med by:

A. Pregnant women?

B. Nursing women?

C. Children?

D. Elderly?

E. Those prone to substance abuse?

F. Those driving/operating machinery?

G. Those on other medication that would preclude the use of this drug?

H. Health conditions of particular concern that might make use dangerous?

8.a) What side effects are LIKELY to occur (common side effects)(5)?

b) What more serious adverse effects are possible in some people(5)?

9. Interactions with other drugs (4-10)

10. What happens if your take too much (Overdosage)*(4)

*some drugs won't say much about this because it is so uncommon

11. Usual dosage and administration schedule (6) (if your drug has more than one use, there may be different dosages for different purposes)

12. Other brands or other manufacturers available (if any) for same generic drug (2-6)?(look up the generic name in the index at the front of the PDR or on DailyMed) - what other drugs (if any) contain this generic ingredient?

13. About how many other drugs available for same use/purpose ______ (6) ( look in the PDR's Product Category Index and try to find the category or categories your drug would fall into. How many other drugs are there in that product category that might serve as alternatives to your medication? Daily Med lists some "Drug Class" categories, but not all. You could also check your consumer reference or our Julian text to figure out other drugs that might be prescribed for the same purpose. )

Give a few examples of other drugs used for the same purpose :

14. I also looked up this drug in the consumer reference (provide reference or URL:):

(Attach a copy of the first page or two of information your drug from this source to your assignment.) (4)

15. What additional or different information did it provide (if any)(4)?

16. Which reference did you prefer? Why? (4)

17. What was the most surprising thing that you learned about your drug (in either reference)? (2)