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Editorial: Possible Answers to Some Questions
"My formula is correct, my equipment is calibrated and verified, my documentation is complete and everything checks out�but my analytical test results show my potency is not correct."
Ever been there? It appears that this pharmacist was doing everything properly. However, there is a potential source of error that has crept into pharmacy over the past 50 or 60 years, the fact that 100% of a drug molecule may not be active drug, and herein lies the problem.
Most compounding pharmacists are aware of this fact, but for those who may not be, we will briefly discuss it. In some cases, the dosing of a drug is calculated on the "free base" or "free acid" form and in some cases it may be the "salt form" or the "ester form". The drug or excipients substance may also be a hydrated or anhydrous form, it may be a dilution or a concentrate, it may be a "potency-designated" substance (some antibiotics and biologicals), or some other factor may be involved.
The first in a series of articles discussing this concern began with IJPC's July/August 2010 issue, and that article discussed salts and provided examples where problems can occur. For example, each milligram of fentanyl equals 1.57 mg of fentanyl citrate, a major difference between the salt and the base, and the drug is dosed on the base form.
Each article in this series also includes tables of the substances/dosage forms and confirms if the doing is based on the acid, base, salt, ester, or other consideration. The schedule for this series of articles is as follows: salts (July/Aug 2010), esters (Sep/Oct 2010), dilutions/concentrates/others (Nov/Dec 2010), potency-designated drugs (Jan/Feb 2011), inorganic salts (Mar/Apr 2011), and complex molecules (May/Jun 2011).
Yes, those days of sitting in the Medicinal Chemistry classes are valuable, as they can directly impact, through these issues, the proper medication dose for the patient. This can also help explain, in some instances, unexpected results from the analytical laboratory.
One last thing, the reason this situation has developed over the last 50 to 60 years is because there is not a "standard" method of dosing. One will see USP dosage form monographs based on all these and one will see commercially manufactured drug products based on all these. It is a REAL problem! Let me encourage all to read this series.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
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Personalized Medicine Market Projected to Grow 11% Annually
Many healthcare industry experts believe that personalized medicine will eventually become the standard of care in the U.S. This is discussed in a report entitled "Personalized Medicine & Orphan Drugs Review and Outlook 2010" by PharmaLive'. The Report describes the personalized medicine and orphan drug sectors, companies involved, as well as the drugs, technologies and business strategies that are driving growth.
Personalized medicine represents a growing change in the healthcare paradigm intended to move drug development from a treatment-concentrated approach to one that is more geared toward early detection and prevention. It is anticipated to significantly reduce the potential side effects of therapeutic medicines and improve point-of-care diagnostics. One important component of personalized medicine includes the orphan drugs.
http://pharmalive.com/news/index.cfm?articleID=728207&categoryid=43
A decrease in the usage of Prescription Proton Pump Inhibitors (Rx PPIs) due to a recent FDA safety review is projected
A recent study projects a decrease in the usage of Rx PPIs due to a recent FDA safety review. The study reports that 61% of physicians will change how they advise patients.
The FDA announced earlier this year that OTC PPIs include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
http://pharmalive.com/news/index.cfm?articleID=728331&categoryid=43
Appendix A of NIOSH Alert Adds 21 'Hazardous' Drugs
The sample list of drugs that should be considered as "hazardous", also known as Appendix A, now has 157 drugs that employers of healthcare workers should consider for a work-site hazard communication program. Appendix A is a part of the NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The Alert is available at:
http://www.cdc.gov/niosh/docs/2010-167/pdfs/2010-167.pdf
"Following the Money" is Difficult in Medical Journal Articles as Industry Ties Go Undisclosed
Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year. This is according to a study published online Sept. 13 in the Archives of Internal Medicine. "The study compared major payments to consultants by orthopedic device companies with financial disclosures the consultants later made in medical journal articles, and found them lacking in public transparency."
The study goes on to state that forty-one doctors accepted a total of $114 million in 2007, in amounts of $1 million to $8 million but half of the articles published by the doctors in the following year made no mention of corporate payments. This lack of disclosure appears to flout professional and medical journal standards requiring that doctors reveal any potential conflicts of interest that might influence their research or expert analysis.
The journals' lax enforcement of disclosure policies probably reflects the fact that journals, too, are dependent on industry support. In response to this criticism, The International Committee of Medical Journal Editors has proposed better disclosure policies in the last two years. However, each journal sets its own policy, and critics say many of them have still not gone far enough.
http://www.nytimes.com/2010/09/14/business/14devices.html?_r=1
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