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Editorial: "Inordinate amounts"; What does it mean?

This week, we will discuss "inordinate amounts" as it relates to "total prescription orders." It is important for pharmacists to know how these phrases will be used in order to prepare for compliance. These phrases appear in the 503a Guidance at the following locations:

Line 135: The licensed pharmacist or licensed physician does not compound regularly or in inordinate amounts any drug products that are essentially copies of commercially available drug products.

Line 144: The drug product is compounded in a State that has entered into a memorandum of understanding (MOU) with FDA that addresses the distribution of inordinate amounts of compounded drug products interstate�

Line 199: �states that FDA, in consultation with the National Association of Boards of Pharmacy (NABP) will develop a standard MOU for use between FDA and the States that will address the interstate distribution of inordinate amounts of compounded drug products�

Associated with this is the phrase "total prescription orders" found on lines 150 and 209 referring to those that are "dispensed or distributed."

What does "inordinate amounts" mean? A number of considerations and options are reasonable to consider.

1. Is it different for different types of pharmacies?
   1. If full prescription services, is it based on all prescriptions?
   2. If compounding only, these pharmacies would be penalized.
      
      
2. Is it a dollar amount?
   1. Is it based on cost of ingredients or selling price?
   2. Is it what is paid by the consumer or third-party or government reimbursement?
   3. Can discounts be deducted?
   4. Can overages, spoilages, and losses be deducted?
   5. If a third-party audit results in funds being paid back to the auditing company, can this be deducted?
      
      
3. Is it based on a number of units? If so:
   1. Is a 30-mL vial 1 unit or 30 units?
   2. Is a 1-mL ampule counted the same as a single 30-mL multiple-dose vial?
   3. Is a single prescription for 100 capsules counted as 100 units or 1 unit?
   4. Is a 30 gram tube 1 unit or 60 units if dose is 0.5 gram each time?
   5. Is a pint counted as 1 unit but four 4-ounce bottles counted as 4 units?
   6. Does this mean that if an original prescription has 5 refills, then all 6 can be counted as "1" unit but if delivered individually, it counts as "6" units?
      
      
4. Once a pharmacy has reached its "limit," does this mean its patients are cut off from receiving their specific medications from this pharmacy?

As is evident, there are many considerations to be addressed in defining "inordinate amounts."


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

The 1st edition of a book titled Compounding Guide for Ophthalmic Preparations (2013) published by the American Pharmacists Association contains errors on pages 74, 76, 162, 165, 166, 167, and 171. To request a pdf showing corrected versions of those pages, you may send a request to aphabooks@aphanet.org. A new edition will be published in the fall of this year.

Medicine Shortage in Europe
The European Association of Hospital Pharmacists (EAHP) has launched its 2014 survey on medicine shortages in Europe. The survey covers the prevalence of shortages, types of shortages, and length of shortages; it also investigates the impact that shortages have on patient care and the operation of hospital pharmacy services. In the 2013 survey, 99% of hospital pharmacists reported it as a problem; 63% said it is a weekly or daily occurrence; and 73% reported the problem is getting worse.
For more info email: info@eahp.eu

Unease Grows Among U.S. Doctors Over Drug Quality in India
U.S. physicians are becoming concerned about the quality of generic drugs supplied by drug manufacturers in India resulting from the flurry of recalls and import bans by the FDA. India supplies about 40% of generic and over-the-counter drugs used in the U.S., making it the second-biggest provider following Canada. The FDA, citing quality-control problems ranging from data manipulation to sanitation, has banned the importation of products from Ranbaxy Laboratories Ltd., Wockhardt Ltd., and Sun Pharmaceutical Industries Ltd. It should be noted that many U.S. manufacturers and those in other countries have also been cited by the FDA.
http://www.reuters.com/article/2014/03/18/us-usa-india-genericdrugs-insight-idUSBREA2H06Y20140318

Walgreens Has Privacy Questions Raised
Walgreens has remodeled over 600 of its 8,200 stores in a push to become a bigger player in the healthcare system. However, the DHHS Office for Civil Rights, which enforces federal patient privacy laws, is investigating whether these new "Well Experience" stores are creating environments where private medical data gets compromised. The investigation began as a result of a complaint filed last fall by Change to Win Retail Initiatives. The organization stated it made 100 visits to Walgreen stores, observing them for a total of 32 hours. They allege widespread patient privacy violations, such as medical histories left visible on desks or prescription drugs left unattended.
http://online.wsj.com/news/articles/SB100014240527023040263045794494512
45815432?KEYWORDS=walgreens&mg=reno64-wsj

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PCAB is proud to announce the accreditation of the following pharmacies:

Doubek Pharmacy, Inc., Alsip, Illinois; Carolyn Wikstrom, PharmD, carolyn.w@doubekmedical.com. Initial Accreditation for Nonsterile Compounding

McMahan Pharmacy Services, Inc., Goldthwaite, Texas; Haverde Warner, RPh, mcmahan@centex.net. Initial Accreditation for Nonsterile Compounding

Total Care Medical, Inc., DBA Topical RX Pharmacy, Tallahassee, Florida; Jenna Mills, JennaM@topicalrxpharmacy.com. Initial Accreditation for Nonsterile Compounding

Premier Custom Pharmacy, Palm Beach Gardens, Florida; Tracy Christian, RPh, BPharm, tracy@premiercustomrx.com. Initial Accreditation for Nonsterile Compounding