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Editorial: United States Pharmacopeia 101, Part X

This is the tenth and final installment in the series on the United States Pharmacopeia-National Formulary. In this part, we will discuss the United States Pharmacopeia (USP) General Chapters.

The "General Chapters" information has developed over the years as follows:

As one can tell, the current section and numbering system was implemented in 1980 with USP 20.

In the General Notices section of USP 35-NF 30, we find the following:

4.20. General Chapters

Each general chapter is assigned a number that appears in angle brackets adjacent to the chapter name (e.g., Chromatography <621>). General chapters may contain the following:

Descriptions of tests and procedures for application through individual monographs,

• Descriptions and specifications of conditions and practices for pharmaceutical compounding,
• General information for the interpretation of the compendial requirements,
• Descriptions of general pharmaceutical storage, dispensing, and packaging practices, or
• General guidance to manufacturers of official substances or official products.

When a general chapter is referenced in a monograph, acceptance criteria may be presented after a colon. Some chapters may serve as introductory overviews of a test or of analytical techniques. They may reference other general chapters that contain techniques, details of the procedures, and, at times, acceptance criteria.

The organization of the current General Chapters is as follows:

As mentioned previously, chapters numbered less than <1000> are enforceable and those greater than <1000> are informational. General Chapters may be revised at any time so it is important to keep up-to-date on those chapters that directly impact your practice. In addition to USP <795>, <797>, and <1163>, there are several other chapters that directly impact pharmacy practice. It is generally up to the individual state boards of pharmacy as to the use of the General Chapters in the individual states.


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

Extending Expiration Dates on Drugs in Short Supply
"The drug shortage is affecting everybody," says John Hammond, a field representative with the Southern Nevada Health District with over 20 years' experience in emergency response. "We're trying desperately to extend the stock that we have...and there are other medications that can be used in place of these medications, but in our realm, it's hard to shift gears quickly."

Last month, the Southern Nevada Health District medical advisory board, which coordinates and oversees emergency services for the area, decided to answer the drug shortage problem by extending the shelf-life of drugs by decree.

Southern Nevada paramedics are allowed to use a select group of drugs (e.g., dopamine, morphine, magnesium sulfate, etomidate) for at least six months after the printed expiration date, and, upon review, for another six months after that.
http://www.lasvegassun.com/news/2012/may/27/300-drugs-short-supply-southern-nevada-officials-w/

States Cracking Down on "Doctor Shopping"
When a new patient presents into a doctor's office in some states now complaining of pain and asking for a specific drug without talking about other symptoms, a red flag is raised. The first thing often said is that they are in horrible pain and they need pain medicine and proceed to tell you what works for them.

Kentucky physicians can now check a state database to see if a patient is "doctor shopping" for narcotics. Kentucky is a hot spot where nearly 1,000 people in the state died from prescription drug overdoses in 2010, or about three a day, ranking it among the top states for such deaths.

State databases are designed to address the problem and to alert prescribers that someone may be abusing drugs or diverting them for illegal sale. Forty-three states now have databases to keep track of who is getting prescriptions for narcotics. Pharmacists can enter prescriptions for controlled substances into the database so prescribers can see if patients are getting prescriptions from multiple locations.
http://www.reuters.com/article/2012/05/31/us-usa-drugs-prescription-idUSBRE84U00D20120531

"No More Drugs If Over 700 Days Behind" Policy by Roche for Spanish, Portuguese Clinics/Hospitals
Roche has tightened its credit and collection policy for hospitals in Spain and Portugal, requiring clinics furthest behind to pay down debts before they can get more drugs on credit, and may do the same in Italy. This policy applies to a dozen Spanish hospitals and 23 hospitals in Portugal (which is about a quarter of Portuguese hospitals). In Spain, this situation means that Roche will not supply drugs to hospitals that are more than 700 days behind on payments.
http://www.bloomberg.com/news/2012-05-28/roche-limits-drug-billing-credit-for-spanish-portuguese-clinics.html

Fake Adderall Subject of FDA Warning
Counterfeit Adderall is for sale on rogue websites according to the FDA. The counterfeits, which look like the 30-mg product that has been in short supply, could pose a health risk to patients because they are made from ingredients used in pain medicines, including acetaminophen and tramadol. However, the FDA hasn't received any reports of harm to date.
http://online.wsj.com/article/SB10001424052702303807404577434761685243018.html?mod=dist_smartbrief

Baxa Corporation "Abacus Total Parenteral Nutrition (TPN) Calculation Software" Recall
A Class I Recall has been issued for the Abacus TPN Calculation Software as it can cause potential dosing errors. A number of errors have been reported by Abacus software users as a result of ordering salt-based parenteral nutrition ingredients on an ion-based ordering template.

The software is designed and intended to allow the ordering of electrolytes in only one of two ways: (1) as a salt (such as calcium gluconate 10%) or (2) as an elemental ion (such as calcium). However, if a dosage is entered into the system based on one method, when the template is configured for the other method, a dosing error can occur.

The affected catalogue numbers include:

• 8300-0045: Abacus Calculator Only (Abacus CE)
• 8300-0046: Abacus Single-Work Station (Abacus SE)
• 8300-0047: Abacus Multi-Work Station (Abacus ME)

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