Hot off the press for November 7, 2005

November 7, 2005

• Most see triptans not safe as OTCs
• FDA mandates digital Rx label submissions
• OTC pain medications can cause serious stomach problems
• Rx recall news may negatively impact drug trials
• AstraZeneca proposes mandatory FDA review of DTC ads
• Walgreens Home Care to acquire Home Pharmacy of California
• Salus Corp. recalls shampoo caps
• Consumers Union to FDA: DTC reforms needed
• Quigley, NCOA to educate seniors on safe OTC use
• R.Ph.s protest TennCare Rx cuts
• FDA approves Trileptal as adjunctive therapy
• Kaletra tablets get FDA nod
• NPI supports pertussis vaccination in adults
• ACIP recommends universal hepatitis A vaccination for children
• Coalition opposes monopoly protections for brand drugmakers
• CDC study supports aggressive initiative to combat diabetes
• Medicare beneficiaries get one free Rx plan change
• Preliminary vaccination priorities for bird flu announced
• CIGNA launches depression management program
• Florida Medicaid to curb benefits
• CHEC to focus on medicine safety
• Walgreens opens its 5,000th store
• NQF publishes report on home healthcare performance standards

Most see triptans not safe as OTCs
Should triptans go over the counter so patients can relieve their migraines more easily? Drug Topics posted this Instant Poll question on its Web site in October. Out of almost 300 people who responded to the survey, eight out of 10 respondents said it's not safe for triptans to switch from Rx to OTC; only 16% said it's a good idea. Another 3% said let's wait and see what England, which is now considering this application, does first. Finally, 1% said they don't know whether converting these migraine-relieving drugs to nonprescription status is a sound idea. Back to top

FDA mandates digital Rx label submissions
The FDA has required drug companies to submit digital versions of Rx labels that the agency will use to create a public on-line database. The electronic format will make it easier for pharmacists, other healthcare providers, and the public to access and search Rx products in a new DailyMed ( www.fda.gov/medwatch/safety/2005/safety05.htm#Caps. Back to top

Consumers Union to FDA: DTC reforms needed
Consumers Union has outlined major reforms to direct-to-consumer (DTC) prescription drug advertising for an FDA panel that is examining the issue. Consumers Union is calling for a moratorium on new drug ads for up to three years, preapproval of ads to ensure that they accurately convey the benefits as well as the risks, and monetary penalties to help enforce truth-in-advertising laws. To read the complete comments, visit www.ncoa.org. Back to top

R.Ph.s protest TennCare Rx cuts
Pharmacists have joined physicians to protest new TennCare rules requiring step therapy for patients with severe mental illness. Patients must first be prescribed an antipsychotic on the state formulary, which must be used for four weeks. If it doesn't work, the physician must prescribe another formulary antipsychotic for a month. Nonformulary drugs must have prior authorization. There is concern that the rule puts unstable patients at risk of hospitalization or suicide. Back to top

FDA approves Trileptal as adjunctive therapy
Novartis Pharmaceuticals has received the green light for Trileptal (oxcarbazepine) tablets and oral suspension as adjunctive therapy (use in combination with other antiepileptic drugs) in the treatment of partial seizures in children as young as two years old. Trileptal is already indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children four years of age and older with epilepsy. Back to top

Kaletra tablets get FDA nod
Abbott has received FDA approval for a new tablet formulation of its HIV protease inhibitor Kaletra (lopinavir/ritonavir), which will allow adult patients to take fewer pills with or without food as part of their regimen. Additionally, there will be no refrigeration requirements for the tablets. These benefits were not available with the old Kaletra capsules. The standard daily doses of new Kaletra tablets and capsules provide similar drug levels in the blood, according to Abbott. The AIDS Healthcare Foundation criticized Abbott for initiating a 7.9% price increase for this new version of the AIDS drug. AHF said the price hike exceeds the rate of inflation. Back to top

NPI supports pertussis vaccination in adults
The National Partnership for Immunization (NPI) supports the decision of the CDC Advisory Committee on Immunization Practices (ACIP) recommending that the Tdap (tetanus-diphtheria-acellular pertussis) booster vaccine be given routinely to all adults instead of the Td (tetanus-diphtheria) booster previously recommended. The committee also recommended that all adults who anticipate having close contact with infants receive a Tdap booster. Back to top

ACIP recommends universal hepatitis A vaccination for children
The Advisory Committee on Immunization Practices (ACIP) has unanimously recommended universal hepatitis A vaccination for all children in a single age cohort between 12 to 35 months, with catch-up vaccination through the preschool years. The National Partnership for Immunization, a nonprofit organization, applauded the unanimous decision, stating, "Hepatitis A is one of the most commonly reported vaccine-preventable diseases in the country. We believe universal hepatitis A vaccination for children is an effective strategy to reduce disease incidence and applaud the committee's decision." Back to top

Coalition opposes monopoly protections for brand drugmakers
The Coalition for a Competitive Pharmaceutical Market (CCPM) has asked the Senate to reject provisions included in biodefense legislation that would extend drug monopolies for brand-name drug manufacturers. CCPM warned that the provisions would dramatically increase Rx drug costs for the Medicare and Medicaid programs as well as for consumers in private plans. CCPM released a copy of a letter it sent to every U.S. Senator and announced a new round of advertising to increase awareness about the harmful consequences of the market exclusivity provisions. CCPM is a broad-based coalition comprising organizations representing the nation's employers, health insurers, chain drugstores, generic drugmakers, and PBMs. Separately, the Generic Pharmaceutical Association urged the Senate Committee on Health, Education, Labor, and Pensions to keep its promise to craft a bipartisan biodefense bill that ensures healthcare costs for consumers are not exacerbated by needless brand product monopoly extensions. Back to top

CDC study supports aggressive initiative to combat diabetes
A new study conducted by CDC reveals that diabetes has risen 14% in the past two years. Data from the study estimate that 20.8 million Americans, 7% of the U.S. population, have diabetes. That's up from 18.2 million in 2003. Nearly a third of these individuals are undiagnosed. Back to top

Medicare beneficiaries get one free Rx plan change
Medicare beneficiaries who sign up for a Part D Rx drug plan will be allowed to change their Rx plan provider one time before May 15, according to a CMS spokesman. For example, if Mrs. Smith signs up for a drug plan in December but then finds out that her drugs are not covered, she will have until May 15 to switch to another Rx plan. After 2006, beneficiaries will be allowed to switch plans only during the annual Nov. 15-Dec. 31 enrollment period. The one-time-switch provision does not apply to beneficiaries eligible for both Medicare and Medicaid. Those dual eligibles will be able to switch Rx plans every month. Back to top

Preliminary vaccination priorities for bird flu announced
If an avian flu pandemic develops, top priority for whatever vaccine is available goes to the military, with healthcare professionals with direct patient care responsibilities and their support staff next in line. The preliminary plan was released at the American Academy of Family Physicians Scientific Assembly in San Francisco. Avian flu priorities were part of an update on 2006 adult vaccination recommendations from CDC provided by Jon Temte, M.D., AAFP's liaison to CDC's Advisory Committee on Immunization Practices. Following health professionals on the priority list are those over 64 years old with at least one high-risk condition and those aged two to 64 with two high-risk conditions, household contacts of the first two groups, pandemic responders, others over the age of 64, critical infrastructure support workers, government healthcare decision-makers and mortuary workers, and the rest of the population. Separately, the FDA said it has formed a Rapid Response Team to ensure that antivirals will be available to the public expeditiously in the event of a pandemic. Back to top

CIGNA launches depression management program
CIGNA will launch its Well Aware Depression Management program in January. The program will integrate the company's expertise in behavioral health and pharmacy with medical management to help identify plan members with depression and give them appropriate care. The program features proactive intervention based on medical, behavioral, and pharmacy data along with personalized coaching from behavioral health professionals. It will also identify and intervene to help avoid drug interactions and ensure appropriate pharmacy management of antidepressants. Studies have shown that an integrated treatment approach that includes early identification and intervention improves outcomes in depressed patients, said Keith Dixon, Ph.D., president of CIGNA Behavioral Health. Back to top

Florida Medicaid to curb benefits
The secretary of HHS has given Florida permission to set a ceiling on spending for many of the state's 2.2 million Medicaid beneficiaries. The dollar amount will be based on the beneficiary's medical condition and historic use of health care. Pregnant women and children under the age of 21 will be exempt from the limits. Beneficiaries will choose a Medicaid managed care plan or be assigned to one by the state. They can also opt out of Medicaid and get subsidies to help them purchase employer-sponsored insurance. Back to top

CHEC to focus on medicine safety
The Consumer Health Education Center (CHEC), a new resource dedicated to improving public health through safe OTC use, has launched its inaugural program, Doctor in the House. The program is a national campaign recognizing women as the main healthcare decision-makers in the household and empowering them with information about OTC safety. CHEC was established by the Consumer Healthcare Products Association. For more information, visit www.qualityforum.org. Back to top