Pharma Under Fire for Fair Balance Failings

Uh oh! Seems like the Pharma industry is in trouble again.

Research published in the Journal of General Internal Medicine suggests that family physicians receive “little or no information” about adverse effects associated with medicines in the majority of drug promotions made by sales representatives.

In the study, 255 family doctors from urban practices in the US [Sacrameto], France [Tolouse] and Canada [Montreal and Vancouver] answered questionnaires following visits from sales representatives.  The primary outcome measure was “minimally adequate safety information” (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).

The findings showed that sales representatives did not provide any information about common or serious side effects, or identify the patients who should not be using the drug, in 59% of the promotions. In Canada, no potential side effects were mentioned for 66% of promoted products, according to the results.

The researchers also indicated that although 57% of the promoted drugs carried boxed warnings from the FDA or Health Canada, serious adverse events were only discussed in about 6% of the sales pitches.

Félicitations to the French reps who provided information on harm for 61% of the promotions, compared to only 34% in Canada and 39% in the US.

Despite this lack of “fair balance” overall, the doctors considered the quality of the scientific information to be good or excellent for 54% of the promotions and indicated that they would be willing to prescribe the drugs 64% of the time.

“Laws in all three countries require sales representatives to provide information on harm as well as benefits,” says lead author Barbara Mintzes, Assistant Professor at the University of British Colombia. “But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion.”

Despite widespread belief by physicians to the contrary, the information provided by pharmaceutical sales representatives has been shown to influence prescribing. Greater exposure to promotion is associated with higher prescribing volume and costs.  And while regulations in all three countries require sales representatives to provide information on the risks as well as the benefits of their drugs, there are differences.  It’s interesting, to correlate the above results with the fact that that France has the strictest information standards, whereas Canada relies on industry self-regulation.

However, across all three countries, the results of this study would appear to question if current approaches are adequate to protect patient health.

The Pharma Industry should take note.  Time to clean up your act before the Government and Regulatory Authorities do it for you.

Ugly Shades of Gray

Ever thought you were paying too much for your meds?

A new report just released by the US House Committee on Oversight and Government Reform’s entitled  “Shining Light on the Gray Market” has examined the how’s and why’s of this.

The House staff investigation examined a group of companies that buy and sell prescription drugs used by hospitals and other health care providers. As SRxA’s Word on Health has previously reported, over the past several years there have been a growing number of supply shortages of prescription drugs. Operating outside of authorized distribution networks, “gray market” companies take advantage of these shortages to charge exorbitant prices for drugs used to treat cancer and other life-threatening conditions.

These companies’ questionable business practices put patients at risk and cost the US health care system hundreds of millions of dollars each year.

Here’s how it works. During drug shortages, hospitals find themselves unable to buy drugs from their normal trading partners – usually one of the three large national “primary” distributors, AmerisourceBergen, Cardinal Health, or McKesson.

At the same time, hospitals are deluged by sales solicitations from gray market companies offering to sell the same drugs for prices that are often hundreds of times higher than normal.  Not surprisingly, hospital pharmacists want to know why the hospitals can’t get these products but the ‘scalpers’ can.

The drug pedigree documents reviewed in the investigation show that some short-supply injectable drugs do not reach health care providers through the manufacturer-wholesaler distributor-dispenser chain.  Instead, these drugs leak into gray market distribution networks, in which a number of different companies – some doing business as pharmacies and some as distributors – buy and resell the drugs to each other before one of them finally sells the drugs to a hospital or other health care facility.

And this is not happening at nights, in dark alleys.  In 69% of the 300 drug distribution chains reviewed, prescription drugs leaked into the gray market through pharmacies. Instead of dispensing the drugs in accordance with their professional duties and state laws, these pharmacies re-sold the drugs to gray market wholesalers. Some pharmacies sold their entire inventories into the gray market. The wholesalers in turn sold the drugs, usually at significant markups, to other gray market companies.

As the drugs pass through these gray market distribution chains, they are significantly marked up, sometimes to prices that are hundreds of times higher than the prices that hospitals and other health care providers normally pay. The markups in these chains often bear no relation to the companies’ cost of purchasing, shipping, or storing the drugs. Instead, they reflect an intent to take advantage of the acute demand for short supply drugs.

In the example above, each company in the chain marked up the meds, even if they never took physical custody of them. The hospital that purchased the drug ended up paying $600 per vial for a drug that a pharmacy had purchased for $7 per vial.

Hospitals say they have no choice but to pay exorbitant prices for short-supply drugs because they need to take care of their patients.

Carmen Catizone, executive director of the National Association of Boards of Pharmacy has called for federal legislation to control pharmacies that are re-selling drugs on the gray market.

“We need to take some steps to remove pharmacies’ ability to act as wholesalers, in the way that they are. The end point of these transactions should be to patients and not to wholesalers,” Catizone said.

While some of the pharmacies that are selling drugs on the gray market are not necessarily doing anything illegal, according to Catizone it is a moral and ethical issue. “There are provisions in state laws in which pharmacies can wholesale up to 5% of their product. The intent was that, if you have a situation where a pharmacy runs short on a product, they can buy it from another pharmacy or wholesaler for that patient. They are violating the intent of those laws, morally and ethically.”

Well said, Mr. Catizone, well said.

Prescription Abandonment

You get sick, you go to the doctor, he or she writes you a prescription for some pills, you take it to the pharmacy and then…   Logic would suggest that the next steps would be that you pick up the prescription, take the medicine and get better.

Well, not always.  According to a new study published in the Annals of Internal Medicine almost 2% of these prescriptions are never picked up.

Using databases from a large retail pharmacy chain and a pharmacy benefits manager, researchers examined factors associated with prescription abandonment over a 3-month period.

Unsurprisingly, drugs with high copayments are the most likely to go unclaimed.  Prescriptions with copayments of $40 to $50 and prescriptions costing more than $50 were 3.40 times and 4.68 times more likely, respectively, to be abandoned than prescriptions with no copayment.

In addition, electronic prescriptions were 1.6 times more likely than non-electronic prescriptions to be left behind, and new prescriptions were almost three times more likely to be abandoned than previously filled prescriptions.

Interestingly, young adults were more likely than older patients to abandon their prescriptions, while opiates and anti-platelet agents were the least likely to be left behind.

Although the accompanying editorial called the low rate of abandonment “reassuring,” they suggest that physicians “remain mindful that costs are an important barrier to adherence and should aim to prescribe or recommend less expensive alternatives whenever feasible.”

SRxA’s Advisors can help pharmaceutical companies increase medication compliance and implement programs to lower the consumer cost of prescription drugs. Contact us today for more information.