Category:

The Cynical Pharmacist lays it on the line..

• Back in the day - Not long ago, pharmacists were respected. We went out of our way to help people in every imaginable situation…What is the upshot of all this kindness today? Patients berate and complain about us unless or until we accede to their every demand.
• Think about what you’re doing…If a prescriber forgets anything on a prescription, what do pharmacists do? We call.
• Whose job is it?...What do we do? What should we do?...What happens when I send prescriptions back with a patient?
• Do the rules apply?...prescribers as well as pharmacists. I believe that both groups of people have to read, understand, and follow the same set of rules…Somehow it has become our job to fill in the blanks for the prescribers…How about a big fat “no”?
• Who ends up on the hook?...But what about the poor patients? Don’t put them in the middle of a pissing contest between you and the prescriber. It’s not their fault their prescriber was in a hurry/forgot/is a moron.”
• Stand up for pharmacy…I’ve done it. It’s amazing how quickly physician offices change their tune when facing legal repercussions.
• Just stop…we are great complainers. We also shy away from conflict. Patients yell at and abuse us all day long and we complain — after they’ve gone…Stop permitting abuse.

Better yet…just send them back.

Yet another sign of trouble for Valeant Pharmaceuticals has emerged. The beleaguered drug maker already faces congressional hearings into its pricing practices. Now, one of its bread-and-butter product lines may not ring the register as often as before…Fewer dermatologists are prescribing Valeant medicines…The change constitutes more fallout from a scandal involving the drug maker’s relationship with a mail-order pharmacy known as Philidor Rx Services. Valeant reportedly hid its ties to the pharmacy in order to inappropriately boost prescriptions and insurance reimbursements...68 percent are writing fewer prescriptions for Valeant’s dermatology products and a similar percentage expect they will not prescribe Valeant drugs in coming months.

Researchers from the University of Columbia, University of North Carolina, and Wake Forest University presented a 3D printer software that creates pills for patients. The software calculates the medicine's dosage based on the patient's medical and biological data…a prototype software that creates customized pills for patients. The software uses algorithms that enables it to adjust medical dosages based on patient information like weight, race, liver and kidney functions…In a trial run, the researchers created patient profiles that resulted in different dosages of 80 total pills printed. The pills ranged from 124 mg to 373 mg, which were dosages with high accuracy with little inconsistency.

Food and Drug Administration…unveiled amended guidance on the liver warnings that must be contained in labels of some over-the-counter drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours… helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirheumatic OTC drugs would be able to change liver warnings when the product’s directions for use result in a maximum daily dose of acetaminophen that is less than 4,000 mg for adults… FDA says that the optional statement, “for this product,” from the original warning is intended to help consumers understand that the maximum number of daily dosage units for a product might not reflect the maximum daily dose of acetaminophen… in certain circumstances, despite this optional statement, the wording might be interpreted as indicating that severe liver damage is associated with a total daily dose of acetaminophen that is less than 4,000 mg, which “is not the intent of the regulation.”

Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDT) – tests that are designed, manufactured and used in a single laboratory…But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients...LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results...FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT...the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients…FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.

Hussein “Sam” Arwada also admitted to defrauding the health care system of $2.3 million…physician who practiced in Warren, Michigan, was sentenced to 84 months in prison today for writing prescriptions for oxycodone and other controlled medications without medical justification, and for health care fraud…he conspired with James Lyons, a patient “marketer,” and others, to write prescriptions for 80,000 doses of oxycodone, and other controlled medications. The prescriptions were written in the names of people who were brought to him by Lyons and other marketers, for no legitimate medical purpose. The marketers then bought the pills from the “patients” and re-sold them to street dealers. Awada then used the patient data...to submit bills to Medicare and Blue Cross Blue Shield for services that were either never performed or were medically unjustified. Awada caused these same patients to receive monthly x-rays, and other invasive tests, which were medically unnecessary but helped to conceal his fraud.

...the largest U.S. managers of private prescription drug benefits have cut off at least eight pharmacies that work closely with drugmakers, intensifying scrutiny of a system that helps inflate drug prices…The terminations come from payers who together manage drug benefits for more than 100 million Americans…Express Scripts, the nation's largest pharmacy benefits manager, has changed the algorithms it uses in its audits to find pharmacies focused heavily on one drug manufacturer and has cut ties with half a dozen such pharmacies...Independent pharmacies and their drugmaker partners counter that Express Scripts, CVS and OptumRx together control more than two-thirds of the market through their own mail-order operations. The specialty pharmacies say that the benefit managers are trying to curb the explosive growth of smaller, independent players.

Global spending on medicines will reach $1.4 trillion in 2020, driven by increased healthcare access in emerging markets and high-priced new drugs for cancer and other diseases…That is up from about $1.07 trillion this year, representing a compound annual growth rate of 4 to 7 percent over the next five years…Some 225 new drugs will come to market over the next five years, about a third aimed at cancer, as well as medicines for rare diseases, which can carry ultra-high price tags, and treatments for autoimmune diseases and heart disease…cost will be partially offset by patent expirations expected to reduce spending on branded medicines by $178 billion, including $41 billion from biologic drugs as cheaper biosimilars become more widely adopted…Developed markets will still account for the lion's share of global spending, about 63 percent, due to higher prices and access to the newest, most expensive treatments.

American Medical Association is calling for a ban on advertising prescription drugs and medical devices directly to consumers. The move…is largely symbolic, because any ban would have to be authorized by Congress…The new AMA policy comes after years of complaints by physicians…some ads too often encourage patients to seek medicines unnecessarily. They also resent the pressure the ads place on them to write prescriptions out of concern patients will switch physicians…Another rationale for the ban, however, is the rising cost of drugs…many of the ads aimed directly at consumers promote more expensive medicines…the Pharmaceutical Research and Manufacturers of America…“Providing scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer pharmaceutical advertising...“Beyond increasing patient awareness of disease and available treatments, DTC advertising has been found to…encourages patients to visit their doctors’ offices for important doctor-patient conversations about health that might otherwise not take place.”...

We interview Kim Kersten – Board of Director member of the American Pharmacy Purchasing Alliance (APPA). (podcast 20:56)