Editorial: Pharmaceuticals and the Internet

Just a brief digression from our series on Quality Assurance in Compounding. I would like to address the topic of pharmaceuticals and the Internet. The title is not "Pharmacy and the Internet" or "Pharmacists and the Internet" because pharmacists may not be involved. We are talking about "bulk pharmaceuticals" that can be purchased on the Internet without prescriptions by the lay public.

A few weeks ago, a purchase was made by an individual from home for Lidocaine USP from a source on the Internet. The container was labeled, shipped, and received as Lidocaine USP. Along with the container was a small "scoop" (tiny bottle with a screw cap) about 1 mL in size, with instructions to measure the scoop full of the lidocaine and incorporate the contents into a cream for a topical lidocaine cream. In addition, the instructions provided a procedure to mix the substance with pure water to make a lidocaine injection. An MSDS sheet was offered online but was not retrievable by the purchaser.

What's going here? Why can an individual just go on the Internet and order chemicals of unknown quality and composition (there was no Certificate of Analysis) along with instructions for "do-it-yourself" compounding?

Just a few questions:

1. Why is the news media not jumping all over this?
2. Why is the FDA not involved in surveillance of the material?
3. Why is a state board of pharmacy not involved in oversight about a substance mailed from South Carolina?
4. From where is the material purchased and how is it repackaged?
5. If the facility is not licensed to handle the material, how did they obtain it?

I believe there are many avenues to be explored by our federal agencies to take care of those that are blatantly breaking the law. However, the agencies continually complain of insufficient funds and personnel to take care of their charge responsibilities. Why, then, are they working in Congress to expand their authority and workload into patient information and compounding pharmacy when their staff cannot handle their current tasks satisfactorily?

Maybe more pharmaceutical issues should be executed at the state level with financial assistance provided to the states to assist in the activities that the FDA is attempting to assume in Congress. The states would welcome the funding and may be able to get the job accomplished economically and with dispatch as they are closer to those involved.


Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

USP is conducting a survey regarding compounded medications used in pediatric and geriatric patients to determine the most frequently compounded medications and how often these medications are requested. USP is interested in providing quality standards for compounded medications in order to assist those practitioners who provide this service to patients, and to ensure that the medications compounded are safe for patients and consumers.

Every respondent, who completes the survey and provides their name, address, and e-mail, will receive a $5.00 gift certificate to Starbucks. As a further incentive, the first 10 respondents will receive a free USP Pharmacists' Pharmacopeia (a $225.00 value). For more information see http://www.usp.org/hqi/pharmInfo/compoundingPharmSurvey.html

This Regulatory Update has been provided by the American Pharmacists Association.

Your Feedback is Needed: FDA to Hold a Public Hearing on Use of Medication Guides
June 12-13, 2007, the FDA's Center for Drug Evaluation and Research (CDER) will hold a public meeting to obtain feedback on the Medication Guide program. APhA is concerned with the growing number of Medication Guides and the logistics for handling them in the pharmacy and would appreciate your feedback as we develop our comments to the FDA...Provide your feedback to APhA at http://r.listpilot.net/c/aphanet/1c8vcw0/deee

NPI Application Reminder
While CMS is implementing a contingency plan that will allow acceptance of legacy provider numbers for most covered entities (including pharmacists) that will not meet the NPI deadline, the requirement to use the NPI remains. HIPAA covered entities, including pharmacists, are required to begin using the NPI by May 23, 2007. See if NCPDP has current NPI information for you or your pharmacy at http://r.listpilot.net/c/aphanet/1c8vcw0/de74 ...Apply for an NPI online at http://r.listpilot.net/c/aphanet/1c8vcw0/c6c0

This Regulatory Update has been provided by the American Society of Health-System Pharmacists.

J.D. Power and Associates Reports:
Pharmacy Staff Interaction with Customers Strongly Impacts Overall Satisfaction. See http://www.jdpower.com/corporate/news/releases/pressrelease.asp?ID=2007057

Need to know if a drug is in short supply? Go to the Drug Shortage Center at http://www.ashp.org/s_ashp/subindex2.asp?CID=480&DID=522

We have added 52 abstracts and citations on forskolin and andropause/menopause and other hormone-related topics related to aging to the CompoundingToday.com drug information database. See them at http://ComoundingToday.com/Articles/SearchResult.cfm?Batch=118 and http://ComoundingToday.com/Articles/SearchResult.cfm?Batch=117

Losing e-mails?
Anyone ever tell you they have been e-mailing you and you have not been responding? Check your spam filter. If someone is e-mailing you that is not on the "white list," then it will not come through. Check your spam e-mail for a few days or weeks to add newcomers onto your acceptable list so they will not be lost in cyberspace, wherever that is.