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May 7, 2010 Volume 7, Issue 19
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The Apothecary Shops: Opening for Compounding Laboratory Manager in Phoenix, AZ
 
Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.


Editorial: USP Compounding Resolution 8 Information

Note: This is a follow-up from last week's editorial where additional information on the USP Compounding resolution was presented. The resolution provides information and support for the work of the Pharmacy Compounding Expert Committee for the next 5-year cycle. Much of the following is from the USP "Report of the 2010 Resolutions Committee".

Resolution (Passed): USP should continue its commitment to standards for compounding, working with the compounding community and other stakeholders to develop and maintain optimal process and preparation standards and promote adoption of such standards by compounding professionals and regulatory authorities.

Further Information: The USP recognizes that compounded preparations remain an important part of good patient care. It is important that USP work with other organizations, practitioners and stakeholders so that patients continue to have access to safe and high-quality compounded medicines. Accordingly, USP should:

  • Work with all stakeholders to develop optimal systems and approaches in the US and elsewhere to assure that practitioners compound quality preparations for use by patients and consumers.
  • Continue to develop and update monographs for compounded preparations, working with compounding professionals and regulators to identify and prioritize needs for such monographs.
  • Consider improvements to its standards development processes and policies that will facilitate the development and maintenance of monographs.
  • Continue to develop and update standards for good compounding practices such as General Chapters <795> Pharmaceutical Compounding-Nonsterile Preparations and <797> Pharmaceutical Compounding-Sterile Preparations, and promote the adoption of these standards by state regulators and accrediting organizations.
  • Consider the needs of specialized areas of compounding, including veterinary compounding and the compounding of radiopharmaceuticals, and work with practitioners in these areas to develop standards that will respond to the unique issues and challenges faced by these segments of the compounding community.
  • Determine, based on stakeholder feedback, how USP can best provide a resource for compounding professionals and other healthcare practitioners that will be of optimal value and use.
  • Provide ongoing education and training to compounding practitioners to help them understand the role and value of USP standards.
  • Continue its support for the Pharmacy Compounding Accreditation Board, promoting the value of voluntary accreditation and helping to ensure the rigor of the accreditation process.


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

 
Other News

43 OTC Medicines for Infants and Children Recalled
Forty-three over-the-counter medicines made for infants and children-including liquid versions of Tylenol, Motrin, Zyrtec, and Benadryl-are being recalled by Johnson and Johnson/McNeil. This voluntary recall (announced by McNeil Consumer Healthcare), affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the U.S. and its territories and in nine other countries. A complete list of recalled products is on the following website: http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc

The FDA is advising parents and caregivers to stop using the affected products. The FDA said the plant's manufacturing process was "not in control," a term regulators used to describe flawed procedures that affect the composition of medicines. They also said that deficiencies have persisted for some time.

McNeil said: "Some of the products included in the recall may:

  1. Contain a higher concentration of active ingredient than is specified;
  2. Contain inactive ingredients that may not meet internal testing requirements; and
  3. Others may contain tiny particles.

The problems may affect 'purity, potency or quality'."

Generic versions of the affected medicines by other manufacturers are not affected by the recall and can be used in their place. (Editor's Note: If a shortage of the generics exists, then compounding may be an option�see below.)

This is at least the third major recall of Tylenol products by McNeil since 2008. In January, McNeil recalled 49 types of Tylenol products made for adults and two Tylenol products made for children. In 2008, McNeil recalled 21 types of children's and infant's Tylenol liquid products.
http://www.washingtonpost.com/wpdyn/content/article/2010/05/01/AR2010050103051.html

Desperate Americans are Illegally Buying Drugs Online from Canada
The high costs of prescription drugs have resulted in many Americans looking for other ways to afford their medications. For many, cheaper prescriptions are just a mouse click away. There is an estimated 1 million Americans each year who buy their medications online from Canada.

Even though buying medication online from other countries is illegal, a group representing Canadian online pharmacies is seeking to get the word out about safely buying their drugs over the Internet. Because prescription-drug costs in the U.S. are among the highest in the world, many Americans seek alternative sources for their medications (says the general manager of the Canadian International Pharmacy Association). The association states that it is important for people to know that buying drugs online from a source you can trust is an available alternative, especially for people on fixed incomes. This organization represents licensed retail pharmacies that sell drugs to both Canadian and U.S. citizens. Member pharmacies sell medications made by leading name-brand manufacturers at prices that are often considerably lower than their U.S. counterparts. The association also verifies that members meet necessary standards and requirements for safety.

As the Canadian group is working to create greater awareness of ordering drugs online from our northern neighbor, the FDA is warning consumers against it and reminding Americans that it is against the law. However, an FDA spokesperson says the FDA rarely enforces the law against those who are buying the drugs for personal use.

Some Internet sites may be bogus Canadian sites that aren't from Canada but originate in other countries, and these sites may sell drugs that are expired, counterfeit, or do not contain any or enough of the active ingredient it claims to have.
http://www.orlandosentinel.com/news/local/os-drugs-canada-online-20100502,0,2523797.story

 
Book Review

Stockley's Drug Interactions
Ninth edition
Baxter K, ed.
London, UK: Royal Pharmaceutical Society of Great Britain; 2010
Hardback; 1,700 pages; $250

This is the world's most comprehensive and authoritative reference book on drug interactions. It is based on published sources and is fully referenced. This latest edition has over 3,400 monographs, covers interactions between therapeutic drugs, proprietary medicines, herbal medicines, food, drinks, pesticides, and drugs of abuse.

The volume lists over 17,000 fully referenced drug interactions in a format designed for quick and easy access. Also included is a tailored thesaurus to enable selection of appropriate search terms. The set provides the ability to enter up to 12 drugs at a time and new and updated information is added quarterly (see next paragraph).

It is interesting (and a great bargain) that the publishers have created a unique package solution for purchase in the Americas for the price of $250.00 that includes the new 9th edition as described here, the new 2010 edition of the Pocket Companion, 1-year access to Stockley's Online at MedicinesComplete, and 1-year access to Stockley's Alerts Online at MedicinesComplete.

 
Did You Know...

�that there is a website available to confirm suppliers' registration/DUNS/FEI numbers with the FDA? It is located at: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

The only shortcoming is that the date(s) of inspections (if they occurred) are not provided.

 
Compounding Tip of the Week

Compounding Recalled OTC Drug Products

If your state allows over-the-counter compounding and the children's medications that have been recalled are not available as generics or other brands, then compounding may be an alternative to meet your patients' needs.

If your state does not allow over-the-counter compounding, then physicians may prescribe the necessary medications to be compounded.

Just a reminder, the beyond-use dates for these preparations will generally be 14 days when stored in a refrigerator, unless other documented stability information is available or the exact formula used by the manufacturer is available (including excipients). Many companies have great vehicles that can be used where one needs only to add the active drugs. (See the advertisers on www.ijpc.com, www.CompoundingToday.com, and in the International Journal of Pharmaceutical Compounding.)

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