Importation of Medicines via the Internet

Is it legal to order prescription pharmaceuticals over the internet? If not, your shipment could be seized at the border by US Customs and you could receive an alarming letter.

In the United States, the FDA has given guidelines for review of the personal importation of pharmacuetical products. They will generally be allowed on a doctor's prescription being for personal use only and no more than a 3 months supply.

FDA personnel are responsible for monitoring mail importations. If a customs officer examines a parcel, he/she is to set is aside if it appears to contain a drug, biologic, or device that the FDA has specifically requested to be held.

Additional issues arise when the pharmaceutical in question is a controlled substance, such as Valium, and falls under the jurisdiction of the US Drug Enforcement Administration.

Can an individual legally order drugs using the internet without seeing a doctor? No.

Federal law requires that "A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" (21 CFR 1306.04(a)). In other words, there must be a bona fide doctor/patient relationship.

Four elements indicate a legitimate doctor/patient relationship: 1.) patient has a medical complaint; 2.) medical history has been taken; 3.) physical examination has been performed; and 4.) some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.

A patient completing a questionnaire that is then reviewed by a physician hired by or working on behalf of an internet pharmacy does not establish a doctor/patient relationship.

In addition, providing false material information to obtain controlled substances could be considered obtaining a controlled substance by fraud and deceit, which is subject to Federal and State penalties. Illegal importation of controlled substances is a felony that may result in imprisonment and fines (21 U.S.C. 960).

Steve to Participate in MEDI Conference

I will be attending a round table at the MEDI medical device conference at the Marriott in Hartford, CT on September 9, 2008. I was asked to review what I consider to be the 10 most important documents for the conduct of a successful investigational medical device clinical trial.

My topics will include the clinical trial agreement, investigator agreement/FDA form 1572, indemnification, reimbursement for adverse events, the informed consent form, delegation of responsibilities, etc. The presentation will be useful to clinical monitors, sponsor and site management, and clinical trial vendors.

For more information, go to MEDI2008.com.

Thanks!

Steve

Increase in personal medical costs

There was an article in the Washington Post last week reporting that more than 2 in 5 adults in the 19-64 age group reported problems paying medical bills or had accumulated medical debt in 2007, compared to 1 in 3 in 2005. We all know about the plight of the uninsured. What is alarming about this new statistic is that 61% of those with medical debt or bill problems in this survey had health insurance.

I've recently seen an increase in the rise of individuals coming to me with problems having their insurance cover major medical bills that, IMO, are unquestionable as to the medical necessity. This is occurring among clients who are insured by the most reputable insurance companies. It is difficult to pay health insurance premiums AND out of pocket expenses at the same time.

You can review this survey at http://www.commonwealthfund.org/. The survey defines four problems with access to health care due to money or poor coverage: 1.) failure to fill a prescription, 2.) not seeing a specialist when needed, 3.) skipping a medical test, treatment or follow-up, and/or 4.) refraining from seeing a practitioner when a problem exists.

These problems are no longer relegated to the poor and the uninsured. The percentage of people with the above problems has approximately doubled among those with middle income ($40.000-59,999/year) and those with incomes of more than 60K per year.

Steve