Friday, December 27, 2013

What an Interesting State Administrative Law Exercise that I found on LSU website

STATE ADMINISTRATIVE LAW EXERCISE
Your client is young Dr. Ponthieu, a newly minted physician who has just opened up a practice in Baton Rouge. He specializes in elderly patient care and finds himself in somewhat of a financial bind. He is very concerned about his patients, most of whom are elderly and on fixed incomes. Many of them require prescriptions for extremely expensive drugs to keep their blood pressure, heart regulation and arthritis problems under control. He has tried calling some of the major drug companies to see if they would "adopt" some of his patients and provide them with low cost or free drugs but has not had a favorable response. Since he is still paying off student loans and in addition borrowed some $250,000 to set up his practice. Dr. Ponthieu would like to assist them by dispensing drugs directly from his office, rather than sending them to pharmacies with a prescription. He comes to you with two questions: 1) what are the rules for dispensing samples left with him by pharmaceutical representatives and 2) can he get permission to order and keep on hand enough of a drug supply to dispense needed drugs regularly from his office? He plans to sell them at cost plus a 10 percent markup. May he do this and if so, what does he need to do to comply with the regulations?


(My apologies to the only Dr. Ponthieu I know, who is my companion animals' vet and never dispenses drugs without authority!)
1.  With regard to question number 1: what entity regulates the dispensing of  sample drugs? Can the doctor charge for sample drugs? What entity regulates the administering of  drugs in his office? What is "dispensing" (as opposed to "administering")? Cite the relevant law or regulation for each of these questions.
2.  With regard to question number 2: what entity would give Dr. Ponthieu permission to dispense drugs as he wishes to do? Cite the law or regulation.
3.  Are there any bills pending in the Louisiana legislature that would address Dr. Ponthieu's concerns about prescription drug costs?  If so, find and cite them.
Dr. Ponthieu calls you with some additional questions. He would like pharmacists at the BuyRite Pharmacy, in which he plans to purchase a twenty-five percent interest, to compound some drugs for his elderly patients, particularly those who have trouble swallowing pills, and for his young patients who don't like the taste of some of the medication he prescribes. Can the pharmacists do as he wishes?
1.  What is "compounding a drug"? Find a general (non-legal) definition. Find a legal definition that a Louisiana court might cite. Find these definitions in at least two different sources (printed and online).
2.  Is compounding legal?  If so, to what extent? What entity regulates such drugs? What justifications are there for compounding drugs? What objections might there be? Find the regulations for compouding drugs in Louisiana. Are they consistent with the Supreme Court case (hint) you found? Remember to check for any  pending or recently passed regulations on compounding drugs in the appropriate database and print publication.
3.  May Dr. Ponthieu purchase the interest in the pharmacy? If so, does he have any  obligation (legal or otherwise) to disclose his interest to his patients?
4.  What board regulates pharmacists? Find its website. How can you find out whether a particular pharmacist is licensed to practice in Louisiana? Is Melissa A. Magee licensed to practice in this state? Where did she get her education and under what name? When does her license expire? Where does she currently work?

5.  Does the Louisiana Attorney General's office believe that physician-patient privilege covers pharmacy prescriptions? Where did you find this information? On what basis does the AG's office come to its conclusion? Does this lead you to further information that assists you in answering Dr. Ponthieu's question above about dispensing drugs?
quoted from here

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