The PharmaCertify™ Team

Polish up your tiara and grab your glass slippers – it’s National Princess Week!  The princesses among us here at the News Week in Review are looking forward to a weekend of lavish luxuries, but first we must tend to our responsibilities about the castle. So cue the royal trumpeters…by royal proclamation, we proudly present the News Week in Review.

Following last week’s publication of a study showing 11% of Canadian prescriptions are written off-label, the Globe and Mail published an editorial calling for Health Canada to track off-label use of drugs. Citing information from the study that only one in five of drugs prescribed off-label has any scientific evidence to support its use, the publication asserted that patients and doctors need more education about the use of certain medications. They have called for the creation of a computerized system listing drugs and the conditions they are effective in treating.

Over in England, where they have real princesses, off-label prescribing could be sent to the dungeon. The General Medicines Council (GMC) has changed plans to ease the restrictions on off-label prescribing. Currently GPs may prescribe a drug off-label if it better serves the patient’s needs over the licensed drug. The GMC is reviewing whether the current restriction is in conflict with a European law.

Apparently, a certain princess doesn’t need quite as much help from Prince Charming these days. Typically, the federal government (Prince Charming) does the heavy lifting when it comes to investigating and prosecuting pharmaceutical companies for violations of healthcare law and regulations. However, the state of Oregon (our princess) recently struck its own settlement with Pfizer over false and misleading advertising of Zyvox. The settlement requires Pfizer pay the state just over $3M, not promote Zyvox in a false and misleading manner, disclose various payments and transfers of value, and post Zyvox clinical trial results to ClincalTrials.gov. Oregon participated in the government’s investigation of Pfizer over off-label promotion of Zyvox and Bextra. Will more princesses follow Oregon’s lead?

Is the clock about to strike midnight on the Massachusetts gift ban to doctors? Consumer groups certainly hope not, and say that if current effort to repeal the gift ban is successful, it will cost the state $750M (that is one expensive pumpkin!) in increased drug costs over the next ten years.  The repeal would also allow pharma companies to provide prescription coupons to consumers. Opponents say this would drive consumers to use more expensive drugs when cheaper generics are available, costing the state and consumers more in the long run. Supporters say the coupons offer patients more options, and help toward what can be expensive co-pays for drugs that are on that patient’s insurance company formulary.

Sometimes riding off into the Sun(shine)set isn’t always the path to your “happily ever after.” At least that’s the way doctors are feeling about the payment disclosures required by the Sunshine Act. A Massachusetts nurse practitioner who serves on a pharmaceutical company’s speakers bureau says participating in the programs is a catch-22. She is passionate about teaching other healthcare professionals, but she is concerned that patients may think she is “on the take” because of the payments. The NP says she and most healthcare professionals who speak on behalf of pharma companies simply want to help patients by educating their peers, but she understands that some are in it for the money. Physician groups and pharma are concerned that the regulations, as currently written, do not clearly explain the nature of the payments. A representative of PhRMA says patients need to understand that just because their doctor has received a payment from a pharma company, it does not mean the doctor “has been compromised.”

And so we close this proclamation of compliance-related industry news for the week. Our fairy godmother is standing by, with our chariot at the ready, so we bid you all a weekend filled with a little sparkle and a lot of magic. Bippity, boppity, bye!