Editorial: Use Most Current Information

It is doubtful that anyone would rely on the dated information in their 1965 Physicians Desk Reference to respond to a question from a physician about a current drug when there is more up-to-date information available for our use.

Over the past 25 years, there have been many publications involving formulations for compounding that have been published for use by pharmacists all over the world. At the time of printing, the data was up-to-date and ready for use. However, "time marches on" and new data is presented that is meant to replace old data.

This Editor has published thousands of formulations over the years; many other individuals and companies have also published thousands of formulations over the years. The intent is to always have the most recent information available when a formula is published, and it is intended to be used until replaced by new formulations or information.

The beyond-use-dates (BUD) published back in the 1980s, 1990s, etc. are now replaced by the USP standards (USP Chapters <795> and <797>) or documented stability studies, and the earlier BUD estimates should not be used, unless documented by stability studies, etc.

The reason this is being brought up is that telephone calls are being received from pharmacists indicating, as an example, that they have different copies of a formulation for XYZ in PLO gel and that one of the formulations has a BUD of 30 days (published in 2008) and another of 6 months (published in 1990s). The caller's question is, can they can use the longest BUD published in the 1990s? The answer is obviously no�the more recent one is to be used (with a BUD of 30 days).

This becomes an issue when a pharmacy wishes to provide a 60- or 90-day supply of a medication at one time to a patient. In this situation, the 30-day supply is all that can be provided to a patient. It is realized that company policies may require a 90-day supply but that cannot be done with compounded medications with shorter BUDs. Quality and patient safety take precedence over a facility's policy that may need to be changed.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Pentylene glycol (1,5-pentanediol; pentamethylene glycol; 1,5-dihydroxypentane; HOCH₂CH₂CH₂CH₂CH₂OH, C₅H₁₂O₂, MW 104.15) is used as an emulsifier, solvent, and as a plasticizer. It has a density of 0.995 g/mL at 25�C, a melting point of -18�C, and a boiling point of 242�C. It is miscible with water. Pentylene glycol is used in a number of cosmetic products, including moisturizers, anti-aging products, sunscreen moisturizers, sunless tanning products, lip gloss, around-the-eye creams, facial cleansers, masks, and foundations. In pharmaceutical compounding, it is used as an emulsifier, solvent, and wetting agent.

Medical Talks by Drug Firms Halted
Pharmaceutical industry employees will not be allowed to make medical education presentations later this year at the American Heart Association's (AHA) Annual Scientific Sessions. The policy was established by a national organization that accredits the heart association's continuing medical education programs as well as the programs of other medical organizations.

The AHA is taking the action because of a relatively new interpretation on a policy of the Accreditation Council for Continuing Medical Education. The goal of continuing medical education programs should be fairness and balance; however, too often when industry employees present, it is part of a strategic marketing plan. The rule also will affect the upcoming Endocrine Society meeting later this month.
http://pharmalive.com/news/index.cfm?articleID=711836&categoryid=9&newsletter=1

Tougher Rules for Outsourcing Drug Manufacturing to be Proposed by the FDA
Stronger regulations for pharmaceutical companies that outsource manufacturing will be proposed by the FDA, putting more responsibility on the companies to ensure the purity and safety of products made by contractors.

The FDA's Brian Hasselbalch said the agency may soon require companies to conduct on-site audits at outside contract manufacturing facilities. Currently, a company may review data about the quality controls, manufacturing analyses, and product testing submitted by its contractor without performing a hands-on inspection.

The agency wants to hold sponsor companies more accountable for flaws in manufacturing processes of outside contractors both in the U.S. and abroad, and for certifying that contractors have followed FDA drug-making standards.
http://online.wsj.com/article/SB10001424052748704324304575307421660792654.html?mod=dist_smartbrief

WHO, PHARMA Interests and the H1N1 Flu
The head of the World Health Organization strongly rejected suggestions that her decisions about swine flu were influenced by advisers' links to pharmaceutical companies. "At no time, not for one second, did commercial interests enter my decision-making," WHO Director-General Margaret Chan said. She also dismissed claims that the global health body had stirred unnecessary public fear over the pandemic.

The way that WHO handled the outbreak is being reviewed by a 29-member expert panel that will report its findings next year. Critics say many of the panelists are also WHO advisers and government employees and could whitewash any failures. Scientists who advised Chan on the threat posed by swine flu have never been identified, and WHO said they will only be released once the pandemic is declared over.

A report by the Council of Europe said the public health guidelines by WHO, European Union (EU) agencies, and national governments led to a "waste of large sums of public money and unjustified scares and fears about the health risks faced by the European public." The report by the EU's human rights watchdog said decisions about the outbreak were poorly explained and not sufficiently transparent.
http://pharmalive.com/news/index.cfm?articleID=709907&categoryid=9&newsletter=1

Avandia Safety Attacked
U.S. Medicare patients who took GlaxoSmithKline's diabetes drug Avandia may have suffered as many as 48,000 heart attacks, strokes, and other problems. The time period studied included between 1999 and 2009. The FDA says these could have been averted had they taken a different drug.

The FDA is scheduled to review the drug's safety in a meeting next month; it will be argued that Avandia should be withdrawn from the market. Glaxo defends Avandia's safety and opposes withdrawal. Past FDA reviews have allowed the drug to stay on the market because, among other things, it has been shown to lower blood-glucose levels in patients.

FDA officials confirmed the authenticity of the study in which Dr. Graham and colleagues from the FDA and Centers for Medicare and Medicaid Services retrospectively examined the medical records of 227,000 patients 65 and older. Extrapolating the results to all the people 65 and older who used Avandia from 1999 through 2009, the researchers estimated that about 48,000 elderly patients experienced serious cardiovascular harm or death as a result of using rosiglitazone instead of pioglitazone.

The researchers conclude that there is no rationale for the drug's continued availability on the market or its use by prescribing physicians or patients. Glaxo states that results from six clinical trials have shown that Avandia "does not increase the overall risk of heart attack, stroke or death."
http://online.wsj.com/article/SB10001424052748704312104575299051830930546.html?mod=dist_smartbrief

FDA: $32,000 Worth of Honey Seized in Philadelphia
Honey valued at more than $32,000 was seized from a distribution center in Philadelphia by the FDA because it contained a potentially dangerous antibiotic. The 64 drums of bee's honey had been imported from China. The FDA says tests showed the honey contained chloramphenicol, which is not approved for use in food, animal feed, or food-producing animals in the U.S.
http://www.newsobserver.com/2010/06/10/526094/fda-32k-worth-of-honey-seized.html

�that IACP's Compounders on Capitol Hill 2010 starts this weekend and continues through next Tuesday?

The Latest Info

Use only the latest, documented data and information in your daily pharmacy compounding practice.