One of the many responsibilities of a compounding pharmacist is to solve problems. Problems may be clinical or pharmaceutical in nature. They may arise from a physician, a patient or from another pharmacy. Compounding pharmacists generally handle these problems using a similar approach somewhat analogous to the "Scientific Method."

The Scientific method generally involves about seven steps, as follows:

Question/Observation: What is the issue/question that has been presented and what issues are to be addressed?

Hypothesis: What is the general "prediction" or what alternatives are feasible?

Procedure: Design a response to confirm or disprove the prediction or each of the alternatives being considered.

Experiment: Carry out the response/experiment and obtain data.

Data Analysis: Organize and evaluate the data.

Conclusion: Was the prediction (hypothesis) correct? Was any alternative better than the others?

Presentation: Follow up with a consultation with the parties of interest with your conclusion(s).

It is interesting that although there are multiple steps in this process, an experienced professional will generally carry them out without thinking about them individually.

The problems compounding pharmacists address may involve therapeutics (e.g., drug selection, dosing, interactions), formulations (e.g., drug form, dosage form, route of application/administration, compliance), compounding procedures (e.g., API source, vehicles, stability, quality), and many, many others.

The "icing on the cake" is when the physician, nurse, patient, or family member follow up and let you know of the final results involving improved patient care.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Human Growth Hormones Use by Teens Increasing Sharply
America's teen's experimentation with human growth hormones (HGH) more than doubled in the past year, as more young people looked to drugs to boost their athletic performance and improve their looks. In a confidential 2013 survey of 3,705 high school students, 11% reported using synthetic HGH at least once—up from about 5% in the four preceding annual surveys. Teen use of steroids increased from 5% to 7% over the same period, the survey found. Of teen girls, 9% reported trying synthetic HGH; 12% of teen boys reported trying synthetic HGH.
http://hosted.ap.org/dynamic/stories/U/US_TEENS_DOPING?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2014-07-23-01-11-50

Whistleblowers in India to be Paid for Information on Counterfeit Drugs
To combat the counterfeiting problem, the Indian Ministry of Health & Family Welfare is willing to reward "whistleblowers" that pass along information leading to a seizure. And informers stand to reap a bounty up to 20% of the value of any drugs that are seized; this may also include government employees.

Counterfeit medicines are a global problem in the U.S. The FDA is increasing its oversight in India in hopes of cracking down on violators and, more importantly, to elevate industry practices. The agency is in the process of increasing its staff to 19 inspectors from 12 in order to keep watch over some 600 plants. However, the FDA is having trouble staffing its office there because of several recent departures (see next news item).
http://blogs.wsj.com/pharmalot/2014/07/18/india-to-pay-whistleblowers-for-info-on-counterfeit-drugs/

FDA Heads in India Departing
The FDA offices in India are now being run by Carl Sciacchitano, who is also the FDA's senior adviser for scientific international affairs. The agency is seeking a new leader for the unit following Altaf Lal's departure a year after taking the job. Atul Agrawal, the supervisory consumer safety officer, has also departed. Since the beginning of 2013, 25 plants in India have been added to the list of facilities banned from sending drugs to the U.S. Drugs U.S. patients get from India doubled to 12% in 2012 from 6% in 2008, making it the second-largest importer of drugs to the U.S. behind Canada.
http://www.bloomberg.com/news/2014-07-17/drive-to-add-fda-drug-police-in-india-delayed.html

Tasmania, Opium, and Genetic Engineering
Nearly a half-century of plant breeding, a gentle climate, and tight regulations have given Tasmania a stronghold on the production of opium. Tasmania (about the size of West Virginia) grows about 85% of the world's thebaine, an opium poppy extract used to make OxyContin and a family of similarly powerful prescription drugs that have transformed pain management over the last two decades. It produces all of the world's oripavine, which is used to treat heroin overdoses and shows promise in controlling other addictions. Tasmania also accounts for a quarter of the world's morphine and codeine.

The two manufacturers that dominate Tasmanian opium extract production are battling to diversify supply sources and alter the plant's genome to produce a stronger, more productive crop. The manufacturers, GlaxoSmithKline and Johnson & Johnson, provide narcotic alkaloids to their own painkiller units and to other companies worldwide, which have started demanding that the two giants act to ensure reliable supplies.
http://www.nytimes.com/2014/07/20/business/international/tasmania-big-supplier-to-drug-companies-faces-changes.html?_r=0

Clinical Trials: Many Study Results Remain Unpublished
Despite increasing requests for more published clinical trial results, many studies are not disclosed to the public, according to a new study. For example, nearly 30% of 400 randomly selected trials that were completed in 2008 had not been published in a medical journal or posted on the ClinicalTrials.gov four years later. Also, smaller trials that occur at the earlier stages of development and funded exclusively by the pharmaceutical industry (Phase II), were less likely to be published, according to the study in PLOS One.
http://blogs.wsj.com/pharmalot/2014/07/22/what-clinical-trials-many-study-results-remain-under-wraps/#

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Did You Know ...

�that a characteristic distinguishing the scientific method from other methods is that scientists seek to let reality speak for itself, supporting a theory when a theory's predictions are confirmed and challenging a theory when its predictions prove false?

Tip of the Week

Some "scientific" papers and presentations do not follow the scientific method very well. Also, they tend to become "opinion" papers, leaving science behind when it does not conform to previously held biases and beliefs.

Looking Back

Passing school zone,
Take it slow,
Let our little
Shavers grow!
     Burma Shave

Classifieds

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