Association News

• Vice-President Magaly Rodriguez deBittner, reporting on the P3 Program, announced that McCormick and W.R. Grace had joined the program. Negotiations are ongoing with Constellation Energy and CareFirst.
• Chair Hoai An Truong, speaking for the Professional Development Committee, announced the collaborative practice training on writing protocols, went well on Saturday, February 2, at the School of Pharmacy with 12 participants.
• Thirty-five participants had registered for the 20 hour CE medication therapy management program on March 1. The program will be repeated at the ASCP meeting in Rocky Gap on August 7.

Around the State

• Final pharmacy tech regulations went into effect on January 28. None will be checked until July 28. The Board is accepting applications for PTCB certified and grandfathered techs at this time. All will have to have criminal background checks.
• Notice of proposed action was given by the Board on the adoption of new regulations for wholesale drug distributors to comply with the requirements of Senate Bill 759.

Resolved Resolution
The Maryland Board of Physicians Newsletter urged prescribers to use specific directions when writing prescriptions, rather than write "Take as directed." Information about a Resolution from the MPhA June 2007 Convention was sent to the physician group explaining the problems that can be caused when pharmacists and patients do not have specific written directions. The article in their Newsletter pointed out the increased chance of errors when directions are not spelled out. They even reported that the full directions may be needed to satisfy insurance companies. The article specified that written directions are a supplement to, not a substitute for, physician oral communication with the patient.

Teva in Maryland

Caffeine Jolt!
Toxtidbits, the Maryland Poison Center's monthly information letter, pointed out the serious side effects that have been seen with doses of caffeine larger than one gram in adults: tremor, seizures, tachycardia, dysrhythmia, diuresis, hypokalemia and metabolic acidoses. Coffee has 60-180 mg per 5 oz. cup, so one 20 oz. cup of a strong coffee is over 70% of the way to the one gram figure. Tea, on the average, contains half or less of the amount of caffeine as coffee. Energy drinks contain less caffeine than coffee-most being 40-70 mg per 8 oz., requiring at least 14 bottles to hit the one gram mark. If a patient presents themselves soon after an overdose of caffeine, activated charcoal is the proper treatment. A study in the Journal of Obstetrics and Gynecology, finds that women who consume 200 mg or more of caffeine a day may double their risk of miscarriage.

Shooter Sentenced
A Frederick, Maryland man has been sentenced to serve 20 years in prison for shooting a CVS pharmacist during an attempted robbery. The shooting occurred at the drive-thru window in April, 2007 and wounded the pharmacist. The felon, fled without getting any cash or drugs after the shooting and was soon apprehended.

Other News

Anti-epileptic Meds
The FDA alerted health care professionals to the increased risk of suicidal thoughts and behaviors in patients taking anti-epileptics to treat epilepsy, bipolar disorder, migraine headaches and other conditions. Suicidal thoughts were double in the test patients taking these drugs over those taking placebo. 0.43 percent of those taking the drugs showed suicidal tendencies, and 0.22 percent in the placebo group. 27,863 patient were in the drug treatment group in the experiment, and 16,029 were given placebos. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks, with results generally consistent among all products. New information will be developed for the labeling, and FDA suggests that patients on these drugs be observed carefully for signs of suicidal tendencies.

Vytorin Vs. Simvastatin
The FDA issued an Early Communication regarding their ongoing review of Vytorin (ezetimibe and simvastatin, Merck), Zetia (ezetimibe, Schering Plough) and simvastatin (brand name Zocor, Merck) alone. The companies said that preliminary results of the study demonstrated no significant differences between the two branded products and simvastatin. FDA said it would take about six months after receiving the final results for them to review it, and suggested that anyone concerned contact their physician.

Similar Drug Names
The USP has compiled a list of 3,170 pairs of names of drugs that look or sound alike, nearly double the 1,750 pairs that the publication identified in 2004. The advent of many more generic products is the cause of a large part of the increase. Some of the most common confusing names: Clonidine, Colchicine and Klonopin; oxycontin, oxandrin, oxybutynin, oxytocin and oxycodone; Zantac, Zocor and Zyrtec. Other names cited as easy to mixup, especially when the prescription is taken orally by phone: Seroquel and Ferro-Sequel; Fosamax and Topamax; Lamictal and Lamisil. In many cases, asking for the diagnosis helps prevent errors- such as Lamisil-take daily for fungal infection.

Stay with One Pharmacy!
U.S. News & World Report magazine featured an article in the February 8, 2008 edition titled: "Prescription Drugs: How to Avoid Heath Ledger's Fate." The actor died from an interaction of prescription medications, having taken oxycodone, hydrocodone, doxylamine, temazepam, diazepam and alprazolam. Had he obtained all these medications from the same pharmacy the pharmacist would have checked with the physicians who prescribed them.

Superbugs
Evidence shows that the drug-resistant "superbugs" that have been spread widely in day care centers, schools, locker rooms and prisons in the U.S. stem from one rapidly evolving bacterium, which has been tentatively named USA300. Scientists anticipate that new USA300 derivatives will emerge within the next several years and will have a wide range of disease-causing potential. Most drug-resistant staph infections cause soft-tissue infections such as boils that are readily treatable, but a skin infection can become a deadly pneumonia or blood or bone infection in a matter of days if the patient does not get the right drugs. The problem has spread rapidly from the traditional hospital setting, seeding an epidemic in the wider community.

Botox Reactions
Public Citizen, the consumer advocacy group founded by Ralph Nader, has asked the FDA to require Allergan to write to doctors warning them that botulinum toxins (Botox) have resulted in "hospitalizations and deaths." Hundreds of mild and severely adverse reactions to the treatments have been reported since the late 1990s in Europe and the U.S. However, Allergan disputes that the 2004 death of a woman who had received the treatment for cosmetic purposes was due to Botox. The Company said that she died from complications associated with staphylococcus pneumonia, not from a Botox treatment received seven weeks earlier. FDA originally said that the reactions may be related to overdosing, and later stated that adverse effects were found patients using the drugs for FDA-approved and non-approved usages.

• Merck received another "not approvable" letter from the FDA for permission to switch Mevacor (lovastatin) 20mg to OTC status.
• Wal-Mart is moving into the pharmacy-benefit area, initiating a pilot program to help select employers.
• "The Clinic at Wal-Mart" is the new name for the medical clinics that will be in 400 of their stores by 2010.
• All generic companies have stopped distribution of Extended Release Oxycodone tablets, leaving only Purdue Pharma's OxyContin available. The last of their patents does not expire until April 2013.
• The Circuit Court for Baltimore City granted Wyeth's motion for summary judgment in a case of an alleged vaccine injury from an exposure to thimerosal-containing vaccines causing a man to become autistic.
• A U.S. federal audit of the FDA said the agency is decades behind and too understaffed to monitor imported foods and drugs.
• Baby shampoos, lotions and powders may expose infants to phthalates, a chemical that has been linked to possible reproductive problems. The possibility is controversial at this point.
• Amgen/Wyeth are transitioning Enbel (etanercept) from drop-ship order to standard wholesaler distribution.
• A European study shows that being obese or even just overweight increases the risk of developing up to a dozen types of cancer.
• The American Heart Association recommends stopping all NSAIDs except aspirin in post-heart attack patients.

• The New York Times gave media coverage to the New England Journal of Medicine (NEJM) article published in January citing Prozac and Lilly as high-profile examples of how the drug industry purportedly suppresses negative clinical trial data. Lilly claims the that Times article was inaccurate related to Prozac and that the NEJM article did not identify a single Prozac story as unpublished. Lilly also claimed that two Cymbalta studies listed in an appendix to the original article as unpublished, had indeed been published in peer-reviewed journals.
• The online pharmacy Medications4Less and its Canadian partner Ultra Care Pharmacy will have to pay $115,000 to settle a lawsuit that New Jersey filed against them. The two pharmacies were charged with dispensing medications ordered by a fake doctor and one whose license had been suspended, and for importing drugs in violation of FDA regulations. As part of the settlement, they have to stop filling prescriptions for New Jersey residents.
• CVS Caremark Corp reported that their fourth-quarter 2007 profits nearly doubled with the acquisition of Caremark. Earnings for the period, after preferred dividends were $811.2 million, or 55 cents per share compared with $413.9 million or 40 cents per share in the same period the previous year. Retail pharmacy sales were $11.64 billion, while pharmacy services revenue was $11.61 billion.
• John Rossi, pharmacist owner of Lowen's Pharmacy in Brooklyn committed suicide amid a probe into on-line steroid and hGH sales at the pharmacy. The investigation is part of the expansion of the Signature Pharmacy, of Orlando, Florida case. Eight million dollars worth of raw hGH was found during a raid on the pharmacy.
• A key strain of circulating influenza viruses discovered in New York State is carrying a mutation that makes it resistant to Tamiflu. Experts say that only a small percentage of viruses are affected and that the current influenza vaccine still provides protection and is still the preferred method of prevention. About 3.8% of a sampling of 237 specimens from patients nationwide this winter showed mutant viruses. However, in Japan, where Tamiflu is very widely used, no resistance to the treatment has been seen.
• The U.S. FDA did not inspect a Chinese manufacturing plant before allowing it to ship the active ingredient in heparin to a Baxter-owned plant in New Jersey where the drug is finished. This plant could be the source of a potentially deadly allergic reaction experienced by hundreds of U.S. patients infused with the blood thinner. An inspection now is being prepared, several years after the product has been shipped by a U.S. supplier that owns the plant near Shanghai.
• A state owned Chinese pharmaceutical company that exports to dozens of countries including the U.S. is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed by contaminated leukemia drugs. Regulators accused the manufacturer of a cover-up and closed the factory that produced them. The drug maker, Shanghai Hualian, is the sole supplier to the U.S. of the abortion pill, mifepristone, known as RU-486, made in a different factory near the closed building.
• CVS employs about 41,000 pharmacy technicians and about 20,000 pharmacists nationwide. Walgreens has about 39,000 technicians and more than 24,000 pharmacists. Nearly 26,000 of Walgreens' technicians are certified, with the chain subsidizing test fees and giving raises to technicians who pass. CVS says about 12,000 of its technicians are certified and that the chain pays for study guides and registration fees. Technicians average salary is about $23,000 a year, while many pharmacists make over $100,000 a year, according to a USA Today article.
• According to government figures, U.S. consumers spent $199 billion in 2005 on prescription medicines. Of this $36 billion was spent on drugs to lower blood sugar, reduce cholesterol or treat other metabolic problems; $33 billion was spent on drugs to reduce high blood pressure and treat heart conditions; $26 billion was spent on CNS drugs, including pain killers, sleep aids and attention disorder products; anti-depressants and antipsychotic drugs sold for a total of $17 billion, and GI drugs, including antacids and laxatives, cost consumers $15 billion.
• According to a Drug Topics Survey, Lipitor again was the best selling prescription drug by number of units in 2007 in the U.S. despite a drop of 11.5% from the previous year, probably due to the emergence of generic simvastatin. Lipitor outsold the number two drug by about 2-1, with 54,122,000 being sold compared to #2 singular at 27,255,000. The rest of the top ten sellers by units were Lexapro, Nexium, Synthroid, Plavix, Toprol XL, Prevacid, Vytorin, and Advair Diskus. In the generic listing, Hydrocodone/APAP easily outsold #2 Lisinopril, 117,200,000 units to 61,704,000. Rounding out the top ten generics were Amoxicillin, Levothyroxine, Hydrochlorthiazide, Azithromycin, Atenolol, Simvastatin, alprazolam, and Furosemide Oral.
• A widespread switch to electronic prescriptions could save the government $29 billion on prescription drug costs over a ten year period, according to one industry estimate. The savings would mainly come from the use of more generic if the program used by physicians offers generic and other less expensive alternates when a drug is inputted. Ford Motors said it saved $3 million last year after buying electronic prescribing software for physicians in its employee health network. The use of generic drugs rose to 70% from 55%. Their program offers generic alternates to the physician when inputting a drug. Physicians in the group get an annual bonus for prescribing more generic. Currently only about six percent of U.S. physicians use this software. In some European countries physicians receive government subsidies to purchase the equipment.
• The Food and Drug Administration has an open continuous announcement for Pharmacists positions in the agency.
  The announcement is: Announcement #FDA-TRC-Z-2007-0081.
  The web link is: www.usajobs.opm.gov