To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or 405-513-4236

Editorial: Looking Forward 2012, Part VII: DEA Harming Patients

This was received a week ago. (Used with permission.)

Dr. Allen, I thought you might find this interesting. The director of the Darlington County, SC EMS called me today. The EMS has run out of Morphine Sulfate Injection for use on the EMS's emergency vehicles. My drug wholesaler and the EMS's wholesalers do not expect to receive any commercial Morphine Injection for at least 45 days. I telephoned the DEA office in Columbia, SC to inquire as to how I needed to process a DEA 222 Form in order to provide compounded Morphine Injection for the EMS. The DEA official told me that she would get the needed information and call me back. She called back about an hour later and informed me that I could not legally compound for the EMS. I believe the EMS director told me he has four doses of morphine left. It is a sad state of affairs that a county EMS cannot obtain Morphine Injection for emergency use.

Best regards, Tenny Moss
Moss Pharmacy, Florence, SC

Law-abiding citizens suffer because of the consequences of those that break the law. Case-in-point: Cancer patients, accident victims, surgery patients, and others requiring pain management therapy suffer because of the DEA policies enacted to try to thwart the drug abuse problem in the U.S. Quotas, limits, etc. devised by the DEA on narcotic analgesics are often based on inaccurate or incorrectly used information resulting in patients not having access to their needed medications.

What would happen if VERY SEVERE/EXTREME penalties were inflicted very rapidly on those involved in abusing drugs, selling drugs to abusers, and others involved in these illegal activities? If severe penalties were rapidly imposed and even capital punishment in those appropriate cases, undoubtedly the situation would change. Today, however, the penalties imposed by the courts are so protracted and relatively mild compared to the damages they cause and the resultant suffering. Why do we accommodate the guilty and allow the victims/patients to suffer and die?

DEA has made the current policy AND THEY CAN CHANGE IT! But, as with so many bureaucrats, they hide behind sometimes arbitrary and shallow decisions to protect their jobs. I would think that things would be different if they were the patients in pain!


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

Impure Heparin Back
The FDA reports it found 14 additional Chinese companies supplying contaminated raw material to make heparin. The same companies supplied the materials in 2008 when a link was found between contaminated heparin marketed by Baxter International Inc. to some Chinese suppliers of the active ingredient used in heparin. The occurrence was linked to 80 deaths in U.S. patients and hundreds of allergic reactions.

Deborah Autor, an FDA deputy commissioner, said the agency doesn't have any evidence that the 14 companies are currently supplying contaminated raw materials. She further stated that the heparin supply is safe as heparin is one of the most protected drugs we have.
http://online.wsj.com/article/SB10001424052970203960804577239624228625522.html

Astra Selling Arimidex Straight to Patients
AstraZeneca (AZ) is selling Arimidex directly to U.S. patients, offering an option for people who want to pay for the brand instead of generic versions. The new program allows patients with a prescription to pay $40 a month for Arimidex to be mailed to their homes.

AZ started the program in response to the introduction of generics which became available in mid-2010. This move is similar to one by Pfizer which has offered delivery of brand versions of its Lipitor drug to patients after they lost U.S. patent protection.
http://www.chicagotribune.com/health/sns-rt-us-astrazeneca-arimidextre81f23a-20120216,0,7271059.story

(Editor's Note: Are AZ and Pfizer licensed with the individual state boards of pharmacy to fill prescriptions in the states where they are mailing the medication?)

McNeil Recalling Infants TYLENOL� Oral Suspension (1 oz. Grape) Due to Dosing Device
McNeil Consumer Healthcare is voluntarily recalling seven lots, approximately 574,000 bottles, of Infants' TYLENOL� Oral Suspension, 1 oz. Grape distributed nationwide. This voluntary recall is a precaution after receiving complaints from consumers who reported difficulty using the Infants' TYLENOL� SimpleMeasure� dosing system. The SimpleMeasure� includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or "flow restrictor," at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe. If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product.
http://www.fiercepharma.com/press_releases/mcneil-consumer-healthcare-announces-voluntary-nationwide-recall-infants-ty?utm_medium=nl&utm_source=internal

Canisters of Caffeine Set to Get FDA Review
FDA officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if it is legitimate to brand it as a dietary supplement. AeroShot consumers put one end of the canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly. Each grey-and-yellow plastic canister contains B vitamins, plus 100 milligrams of caffeine powder, about the equivalent of the caffeine in a large cup of coffee.
http://online.wsj.com/article/SB10001424052970204909104577233492700658520.html?mod=dist_smartbrief

Doxil Replacement Found
Patients with ovarian cancer and other deadly tumors will regain access to an important chemotherapy drug. Doxil has been in short supply since last June, and there are no generic versions of the drug. The FDA has worked out a deal to temporarily import a replacement drug, called Lipodox, from an Indian company, Sun Pharma Global, which exports the drug to other companies.
http://yourlife.usatoday.com/health/story/2012-02-20/New-source-found-for-cancer-drug-Doxil-in-short-supply/53181806/1

Washington State Can't Force Pharmacies To Sell Plan B
A federal judge has ruled that Washington state cannot force pharmacies to sell Plan B or other emergency contraceptives. U.S. District Judge Ronald Leighton heard closing arguments earlier this month in a lawsuit that claimed state rules violate the constitutional rights of pharmacists by requiring them to dispense the medication. The judge did not strike down the rules, but said simply that the way they were applied to the plaintiffs in this case was unconstitutional. The state can still try to enforce the law against other pharmacies
http://www.time.com/time/nation/article/0,8599,2107446,00.html

�that legitimate drug supplies are limited by our governmental agencies attempting to rein in the drug abuse problem? The overall drug abuse problem involves both legitimate pharmaceuticals as well as illegal drugs. This impacts pharmacists by limiting what we have for our patients and limiting what is sold as precursors (Pseudoephedrine) to make other drugs. Like it or not, you are involved or affected!

Drug Abuse
Drug abuse affects us all in some way or another. It is important to keep informed and to work with local law enforcement to help attack the problem.

The APhA Complete Review for Pharmacy
9th Edition
Gourley DR, Eoff III JC
American Pharmacists Association: Washington, DC.
996 Pages; 8 � x 11 softbound; $65.95

If you are reviewing for the NAPLEX or just reviewing your professional educational material, this book may be the answer. It has more than 40 chapters and 13 appendices covering all aspects of the pharmacy educational content. It also has three new chapters including Drug Information, Biostatistics, and Clinical Trial Design.

The chapters begin with reviews of pharmaceutical math, law, pharmaceutics, and the pharmaceutical sciences and then go into drug information, clinical research, and then covers the different areas in clinical practice, including oncology, seizure disorders, infectious disease, etc. Chapter 41 contains 2009-2011 drug updates, a nice chapter.

This volume contains over 900 practice exam questions and answers along with explanations reinforcing important learning points. The organization supports ease-of-use, and it can be valuable as either a resource or as a study guide. It is highly recommended.

The one who drives
When he's been drinking,
Depends on you
To do his thinking.
      Burma Shave

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

Lloyd's Remedies, Gray, Louisiana; Dr. Lloyd Duplantis, President; lloydrem@lloydsremedies.com; Re-accreditation for Sterile Compounding

Please join us in congratulating them for their achievement.

Newly Proposed Standards, Upcoming Workshop Focus on Supply Chain Integrity to Help Reduce Risks of Counterfeit or Mishandled Medicines
As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines have mounted. In an effort to encourage comprehensive public standards across the industry, the United States Pharmacopeial Convention (USP) is seeking feedback on a newly proposed set of recommended best practices that will help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with their quality intact. These are contained in USP General Chapter <1083> Good Distribution Practices-Supply Chain Integrity, and are the central focus of a workshop to be held May 22-23 (more information here: http://www.usp.org/meetings-courses/workshops/supply-chain-integrity-workshop). These standards are designed to be relevant to all members of the pharmaceutical supply chain, from suppliers to manufacturers to practitioners.

Hardwall Modular Clean Room for Sale
Class 100/ISO 5. Hepa filters and HVAC system included. Total foot print 26'x12'9''. Ante room 13'x12'9''. Sterile prep class 100 room 12'6''x11'2''. Set up for sterile prep on a workbench, under the hepa filters. No laminar flow hood required. Currently dismantled and in Denver area. $6,000 OBO, can ship. QualMed Pharmacy 303.790.8200

Wanted: Jaansun Capsule Machine
Fellow Compounders; I am looking for a used Jaansun capsule machine with plates. Either a 100 count or 300 count machine would interest me. Please contact me at one of the following: george@mullercbs.com or 985-264-2803 Thanks, George Muller, R.Ph.