Americans have seen an insidious trend for more and more drugs to be sold over the counter (OTC). Sometimes, the only difference between the OTC drugs and prescription drugs is the dosage. For instance, Motrin is sold OTC at 200 mg. Prescription doses are 800 mg. However, it doesn’t take an active imagination to know that we could take 4 Motrin OTC of 200 mg to have the same dose as provided by our physicians.
A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Here are the main differences between OTC drugs and prescription drugs.
Prescription drugs are:
• Prescribed by a doctor
• Bought at a pharmacy
• Prescribed for and intended to be used by one person
• Regulated by FDA through the New Drug Application (NDA) process. This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.
OTC drugs are:
• Drugs that do NOT require a doctor's prescription
• Bought off-the-shelf in stores
• Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."
OTC drugs have been of concern to physicians and other health care providers. Consumers are unaware of potentially dangerous drug-drug interaction. They are also unaware as to the symptoms which require further diagnostic testing, prior to self-medicating oneself. Delay in diagnosis could be deadly for some people.
Yet, the FDA is considering a practice which currently happens in several countries in Europe. More drugs will be made available OTC; however, a pharmacist must be consulted prior to purchase. While most pharmacists now have a doctorate in pharmacy, and certainly have the intelligence necessary to implement this regulation safely; the question remains how it would work in the real world.
Several physicians have spoken up and stated they can no envision this practice currently being performed in many of our retail pharmacists, such as at Long’s or Walgreen’s. Currently, these pharmacists don’t have the time, motivation, or reward system for basic counseling which they currently are responsible, let alone extending their authority and responsibility for additional over the counter medications. Physicians also state that they currently have problems getting their patients to identify all the medications they are taking, and their associated dosages, during an office visit. It is hard to imagine, anyone taking all of their current drugs and supplements into Walmart’s, so the pharmacist could review.
In summary, the question remains do Americans have sufficient knowledge to purchase potent and dangerous medications, any of which may have an adverse interaction with a current drug. The answer, in the opinion of experts, is no.
Sources
Federal Drug Administration: 2007
http://www.fda.gov/cder/info/consumer_otc.htm
Med Page Today: October 4, 2007
http://www.medpagetoday.com/ProductAlert/Prescriptions/dh/6876
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