evaluate the pros and cons of FDA regulation of the pharmaceutical industry

WHAT IS RETAIL MEDICINE, AND SHOULD IT BE OF CONCERN TO HEALTH CARE MANAGERS AND LEADERS IN FOR-PROFIT AND NOT-FOR-PROFIT ENVIRONMENTS?

Discussion 1:
The drug I chose to discuss is smoking cessation Zyban.  This is an FDA approval drug that is targeted for adults who are having a difficult time breaking the habit of smoking cigarettes.  The patient will need to see a doctor who will perform a physical and speak to the patient encouraging them to continue on the medication to become a non-smoker.  The doctor will write prescription and the patient pharmacy will fill it.  The cost of prescription is often covered by the patient insurance due to society behavior toward smoking and the health benefits when you stop.   The development of smoking cessation products was introduced in the late 90’s due to the overwhelming campaign to curb smoking because of the adverse health problems associated with nicotine. The most commonly observed adverse events consistently associated with the use of Zyban are dry mouth and insomnia (FDA 101: Smoking Cessation Products, 2015).
In addition to warnings about changes in behavior, hostility, agitation, depression and suicidal thoughts or actions while taking this drug, the medication guide for Zyban cites other adverse events and risks related to this product, including seizures, high blood pressure, and allergic reactions. Because Zyban contains the same active ingredient as the antidepressant Wellbutrin (bupropion), users and potential users are urged to talk to their health care professional about risks of treatment with antidepressant medicines (FDA 101: Smoking Cessation Products) .
This product is on the Med Watch list (FDA) due to the multiple warnings and symptom users may experience.  Patients who receive a prescription for this product are 18 years and older.  This product cannot be prescribed for children (FDA 101: Smoking Cessation Products).
I am an ex-smoker (18) years ago, and it took me three tries going cold turkey.   I am not sure I would have been courageous to try this drug.  The symptoms I experienced included irritation and an increased appetite for food which gave me 70lbs more of body weight.  But the benefits I received; to be able to have better lungs and breathing cleaner air was worth the 6 months it took me to break this habit.
References
FDA 101: Smoking Cessation Products. (2015). Retrieved from http://www.fda.gov/forconsumers/consumerupdates/ucm198176.htm website:
Discussion 2:
This discussion is a research activity in which you will evaluate the pros and cons of FDA regulation of the pharmaceutical industry. To meet the requirements of this discussion activity, you may consider the topic from either of the following perspectives: 1) a specific drug and its impact on patients or on costs.
For this week, I choose to look into the use of FDA regulations in regards to aromatherapy products. In our household, I try to do as much natural or essential oils as possible for illness and aliments. The job of the FDA is to put into place what a product is intended for as far as use and abuse goes. This is linked to labeling and advertising of the product as well.
Some pros of having on FDA rating for essential oils is the safety factor. In other words, when you use a product, you are told what to do with it and what should be expected along with possible side effects. This gives the consumer a safety net of sorts. It helps put trust in a product when you see those three special letters on the package or box.
A con can be it makes the world of generic products very difficult to break through. For those people that can’t afford the real deal or main market product, they could use the off brand for the same purpose. But you are taking a risk with that brand without the FDA approval. It may not work as well or you may have to use more of the product than you would with the name brand. Both of these can impact the consumer through cost, risk and what is needed or desired.
Reference:
U.S. Food and Drug Administration, Protecting and Promoting Your Health. Aromatherapy. Retrieved from:

 

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