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Editorial: To Verify or to Validate�that is the Question!

The question of the use of the term "verify" and "verification" has come up many times over the past decade as it relates to both USP <795> and <797>; it is explained in <1163>. Throughout these compounding chapters, the term "verify" and "verification" are used as opposed to "validate" and "validation"; the latter two terms are used for the manufacturing industry and are required of those companies that are under Good Manufacturing Practices (GMPs). Compounders, however, utilize the standards of the USP and the terms verification and verify are used. Just what is the difference? Let's look at some definitions from the past and the present.

Verification/Verify
�to prove true; to confirm; to show to be true; to confirm or establish the authenticity of evidence; verifying = proving to be true; confirming; establishing as authentic [American Dictionary of the English Language (1828)]

�a confirmation of the truth of a theory or fact; to prove the truth of by the presentation of evidence or testimony; substantiate; to determine or test the truth or accuracy of, as by comparison, investigation, or reference: conduct experiments to verify a hypothesis [The American Heritage Dictionary (Second College Edition - 1982)]

�to confirm or substantiate in law by oath; to establish the truth, accuracy, or reality of <verify the claim>.
http://www.merriam-webster.com/dictionary/verify (2012)

Validation/Validate
...having sufficient strength or force; founded in truth; that can be supported; not weak or defective; having legal strength or force; executed with proper formalities; strong; powerful; that quality of a thing which renders it supportable in law or equity; as the validity of a will; the validity of a claim or of a title [American Dictionary of the English Language (1828)]

�to declare or make legally valid; to substantiate; well grounded, solid; producing the desired results; efficacious; valid methods. Legally sound and effective; incontestable [The American Heritage Dictionary (Second College Edition - 1982)]

�to make legally valid; ratify; to grant official sanction to by marking; to confirm the validity of; to support or corroborate on a sound or authoritative basis <experiments designed to validate the hypothesis>; to recognize, establish, or illustrate the worthiness or legitimacy of <validate his concerns>.
http://www.merriam-webster.com/dictionary/validate (2012)

In USP <1163> Quality Assurance in Pharmaceutical Compounding, the section on "Verification" states that:

Verification involves authoritatively signed assurance and documentation that a process, procedure, or piece of equipment is functioning properly and producing the expected results. The act of verification of a compounding procedure involves checking to ensure the calculations, weighing and measuring, order of mixing and compounding techniques and equipment were appropriate and accurately performed. The quality of ingredients should be verified upon receipt (e.g., Certificate of Analysis, manufacturer's label on commercial products, etc.). Verification may require outside laboratory testing when in-house capabilities are not adequate. Equipment verification methods are sometimes available from manufacturers of the specific equipment or can be developed in-house. The responsibility for assuring that equipment performance is verified, including work completed by contractors, resides with the compounder.

Validation as required by GMPs is more rigorous, time-consuming, and beyond the scope of compounding pharmacies; however, verification is achievable, adequate, and reliable.


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

Pharmacist Activist
The Pharmacist Activist is featuring an editorial supporting compounding. See the link below to read the editorial and to sign up for a free subscription.
http://www.pharmacistactivist.com/

Makena Compounding Under Scrutiny after NECC
Makena (originally at a $1,500-a-dose-price) alarmed state and private sector insurance officials, and as the FDA-approved drug has been made for years by pharmacies at $20 to $40 per dose, it gives more women access to the treatment. Federal officials have been sympathetic to cost arguments and have allowed the pharmacies to continue making the drug. This drug has been compounded for decades before Makena was approved. KV, which did not develop the drug, purchased legal rights to it from another firm for nearly $200 million and obtained market exclusivity for seven years; it just assumed state Medicaid programs and private insurers would automatically cover the FDA-approved version and that it would soon recoup its investment.

There is little debate over whether the compounded or manufactured drugs are similarly effective—assuming they contain proper ingredients at the correct concentration and are made under sterile conditions. However, as the investigation of NECC demonstrates, potency and purity problems have arisen with pharmacy-made drugs and oversight of pharmacies is inconsistent.
http://www.kaiserhealthnews.org/stories/2012/october/31/compounded-pregnancy-drugs.aspx?referrer=search

Ivermectin Head Lice Lotion; Safe and Effective
Sklice wiped out head lice in a single application in a study that suggests the drug may offer a better approach than existing medications, researchers said. (Editor's note: Actually compounding pharmacists have known this for years!) Just one day after treatment, 95% of those in the Sklice group were lice free compared with 31% given a placebo, according to company funded-studies that helped gain the drug's U.S. approval earlier this year.
http://www.bloomberg.com/news/2012-10-31/sanofi-worm-pill-kills-resistant-head-lice-as-a-lotion.html

British Medical Journal to Require More Details on Drug Trials
Beginning in January, the British Medical Journal (BMJ) will no longer publish the results of clinical trials unless drug companies and researchers agree to provide detailed study data when requested. This action is meant to induce pharmaceutical companies to reveal their data collected in researching new drugs, very little of which is ever made public. Critics complain that the drugs are presented in the best possible light and do not permit independent researchers to evaluate the data.
http://www.nytimes.com/2012/11/01/business/british-medical-journal-to-require-detailed-clinical-trial-data.html

Majority of Online Pharmacies are Questionable Operations
According to a report just issued by NABP entitled "Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: October 2012," about 97% of online pharmacies operate "out of compliance with pharmacy laws and practice standards in the U.S. For the report, it analyzed more than 10,000 sites, and concluded that it was important for members of the international pharmacy community to protect patients worldwide from the potential dangers of illegal online drug sellers, noting that the illegal sites provide a way to sell counterfeit drugs.
http://drugstorenews.com/article/vast-majority-online-pharmacies-are-fly-night-operations-report-finds

Mental Decline May be Helped by Daily Low-dose Aspirin
Aspirin 81 mg (low-dose aspirin) that millions take to help prevent heart attacks and strokes may also help slow down age-related mental decline, a new study suggests. The study involved almost 700 Swedish women aged 70 to 92, most of whom had heart disease. The women that took low-dose aspirin every day to prevent a heart attack showed a less pronounced slide in mental functioning after five years than their counterparts who did not take aspirin. The study showed that tests of memory, verbal fluency, and other mental capabilities showed some loss of brain power, but the decline was significantly less and occurred at a slower pace among the women who received aspirin continuously or even for a period of time compared to those who never took it. Sixty-six of the women taking the drug for all five years even saw some of their scores improve, the researchers said. The low-dose aspirin utilized was between 75 and 160 milligrams.
http://consumer.healthday.com/Article.asp?AID=670053

Generics to Be Further Scrutinized
The FDA is looking at the way generic companies make extended-release drugs after it found one failed to work as well as its brand-name counterpart. This activity is a rare departure for the agency, which for years has insisted that generic drugs are just as effective as their brand-name versions.

The drug precipitating this was bupropion 300-mg that was manufactured by Impax Laboratories and was intended to mimic the popular antidepressant Wellbutrin XL. However, soon after it was introduced in 2006, patients who switched to it from Wellbutrin began complaining that their depression had returned. Impax and Teva Pharmaceuticals, which marketed the drug, have stopped selling the 300-milligram dose.
http://www.nytimes.com/2012/11/01/business/fda-increases-scrutiny-of-some-generic-drugs.html?_r=0&adxnnl=1&adxnnlx=1351789686-VycyFtuqghOWk4yyyDQnww

Greece Fights Drug Shortages by Suspending Exports
As the Greek government battles a shortage of many medicines, it has suspended all drug exports in the wake of a fresh round of price cuts. The move addresses a major crisis that has been brewing for more than two years, following a series of Greek price cuts aimed at reducing healthcare costs. The governmental cuts have made Greece a prime resource for wholesalers to buy cheap products for re-export.

This so-called "parallel trade" in drugs is allowed under European Union rules protecting the free movement of goods. A quarter or more of all medicines shipped to Greece now are being re-exported to higher priced markets like Germany and the strains have reached the breaking point. This move is designed to save some 300 million euros ($390 million) on off-patent drugs.
http://www.reuters.com/article/2012/10/24/greece-pharmaceuticals-idUSL5E8LO8O720121024

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Social and Cognitive Pharmacy: Theory and Case Studies
Donyai P.
October 2012; Paperback; 248 pages; $49.99

This is a practical handbook for learning, teaching, and applying sociology and psychology to pharmacy practice. It is aimed at undergraduate and graduate students and academics. It discusses and explains the relationship between the principles, methodologies, and theories of the social and behavioral sciences and their application to pharmacy practice. It contains 15 case studies and a glossary and uses an outcomes-based approach to the subject. It is a book that is easy to use and understand.

�that the U.S. presidential election of 1788-1789 was the first presidential election in the U.S. and the only election to ever take place in a year that is not a multiple of four? It took place following the ratification of the U. S. Constitution in 1788. George Washington was elected for the first of his two terms as president, and John Adams became the first vice-president.

Don't forget to cast an informed vote on the candidates of your choice!

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