Death of the Pharma Sales Rep?

bah humbugWe’re not feeling a whole load of Christmas cheer among the pharmaceutical industry this festive season.

First came the news that GSK is phasing out all payments to doctors and will no longer be bonusing their reps based on sales.  Now, a new study suggests the end of the road may be nigh for pharma sales reps.

According to a survey of nearly 3,000 physicians undertaken by CapGemini and QuantiaMD, when it comes to receiving clinical and medical info, reps rank last as a resource behind print, digital media and phone links.

  • 67% of physicians say digital media is their preferred source of information from drug-makers
  • 40%  believe digital media has the most relevant and personalized content
  • 52% believe sales reps will eventually become information coordinators
  • Only a paltry 20% say reps are their favorite source of information

no repsIn parallel, more health care providers are shifting toward larger, organized health systems, which make it more difficult for reps to reach physicians for visits. Sixty four  percent of those surveyed say they restrict rep visits and 31 % of physicians in organized health systems do not allow reps any access, due to corporate policies.

Newer and younger physicians are more likely to rebuff reps – as many as 80%  impose restrictions. 90% of new physicians are joining organized health systems right out of medical school.

Physicians today are in a time crunch, juggling more commitments than ever before and no longer have the time to dedicate to in-person meetings with pharmaceutical representatives. So the reliance on more digital channels comes as no surprise,” said Dan Malloy, Senior Vice President at Quantia. “This study supports what we’re already seeing from our 200,000 members–that a physician-centric, digital communication model is the most effective way for reaching and engaging doctors.”

On a more positive note, reps slightly edge out other resources when it comes to finding product info and patient education.

Hala Qanadilo, a principal in life sciences at CapGemini says, “While the more traditional face-to-face, in-office visits might decrease, the role of these representatives is projected to be as important as ever. Moving forward, they will need them to be the directors of multiple information sources, customizing their outreach so it is more personalized and physician-centric.”

How are you tackling the changing healthcare environment in these increasingly restrictive times?  We’d love to hear from anyone out there in Pharmaland.

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Compounding the Problem?

healthcare crisisHere’s a question to get you thinking this Friday morning.  What has been called the “worst public health crisis” in the US in decades?  Is it:

(a)  HIV

(b)  Obesity

(c)  Healthcare.gov

(d)  Heart Disease

(e)  None of the above

fungal meningitisWhile there’s no doubt options (a) through (d) challenge our healthcare system, the correct answer is in fact (e). What’s more, this public health crisis may have gone unnoticed by many. What we’re referring to is the fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there have 751 reported cases, including 64 deaths.

fungal meningitis case-counts-960px-2013-10-23Indeed, most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed and sickened people in 20 states.

Since then, the FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.

Now, after months of negotiating, the US Senate has finally passed legislation that was drafted in the wake of the scandal.  The Drug Quality and Security Bill will give the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Obama for his signature

The bill will create a new class of compounding pharmacies, as suggested by the FDA. The agency believes that traditional compounders – those who mix or alter ingredients for individual patients on an as-needed basis, should be distinguished from ‘non-traditional’ compounders – those that sell high volumes and ship out of state because these activities may pose a higher risk.

We know more from a barcode on a gallon of milk than we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death,” says US Senator Michael Bennet. “Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”

compoundingThe bill also creates a voluntary category for so-called office compounding of sterile medications. These operations would voluntarily register with the FDA and submit to GMP, or good manufacturing practices, compliance and pay fees in exchange for the right to ship product without a prescription. But there is no criteria concerning interstate shipping or the percentage of production involved.

The legislation “leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be,” says the National Community Pharmacists Association.

But not everyone agrees.

Rosa DeLauro, a Democratic Congresswoman from Connecticut, says the “voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA.”

NECC steroidsSimilarly, the International Academy of Compounding Pharmacists released a statement saying that “a voluntary category of outsourcing facilities is not the answer” and warned that another potentially deadly New England Compounding Center type of scandal could still occur.

Some health policy experts have even said they fear the new bill will make drugs, less, rather than more, safe.

Critics say that by giving compounding pharmacies the option whether or not to register with the Food and Drug Administration and adhere to stricter guidelines for testing, quality and sterility, does not go far enough.

It makes what is now illegal legal,” said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.

Carome said he opposes the bill because it allows large scale compounding without individual prescriptions and with no requirement to follow the strictest quality and sterility guidelines that drug manufacturers must adhere to.

It makes no sense to have two different tiers of drug manufacturers – one that has to meet all the manufacturing guidelines and one that only has to meet some of them. We believe in a level playing field.”

What do you think of this legislation?  Has it gone far enough?  We’d love to hear from you.

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Fluffy Therapy

animal-therapyThese days, therapy dogs and cats are often brought into health care facilities to help boost their health and happiness of people suffering from mental and physical illnesses or disabilities.

The results are often so amazing, they are almost inexplicable. I vividly remember, Laura, a patient from many years ago. She was a sweet old lady, who was deaf, dumb and blind and had recently been diagnosed with advanced breast cancer. Following surgery, in a strange hospital environment she seemed to be lost in her world of diminished senses, and appeared to be giving up. She wasn’t eating, or drinking. IV fluids were keeping her alive and diamorphine was keeping her pain free. Anticipating she didn’t have much longer to live, I called the next of kin listed in her records and spoke to her sister. The younger sibling, who lived half-way around the country, agreed to come but asked if she could bring Laura’s service dog. At the time, this was unheard of on a surgical unit and would certainly have been frowned upon by hospital authorities. Never one to follow the rules, and a self-confessed animal lover, I immediately agreed. I’d deal with the consequences later if need be.

DocTheDog041_t607A few days later, Grace arrived on the ward with Honey, a calm and happy Golden Labrador. Without any directions, Honey led Grace straight to Laura’s bed and laid her big head on her mistresses’ frail outstretched arm. Laura’s eyes opened, she sat up, and began talking to the dog.

This wasn’t a miracle in the conventional sense, the dog had not restored the power of speech, it turned out that Laura, while blind, could hear and speak perfectly well. However, separated from her faithful companion, she’d become profoundly depressed, and simply stopped communicating.

Honey stayed in the hospital for several weeks, barely leaving Laura’s bedside, until they were both ready to go home. During those weeks, other patients benefitted from Honey’s presence too. Even the medical and nursing staff even seemed to be cheerier as they went about their work.  So not a conventional miracle, but one of the closest things I’ve ever seen to one.

Did I get into trouble for harboring and concealing a canine?  Sure!  Would I do it again?  In a heartbeat!

Therapy animal programs are designed to promote improvement in human physical, social, emotional, or cognitive function, according to the American Veterinary Medical Association. Therapy can occur in a group setting or individually, and can benefit patient populations from the young to elderly, to those in hospitals, nursing homes, assisted-living homes and rehabilitation facilities.

RojocroppedSo, I was more than a little curious when I read that Providence Children’s Center in Oregon is employing two unique therapy animals to help patients smile: an alpaca named Napoleon, and a llama named Rojo.  The unique pair light up every room they enter at the hospital.

I never realized the power animals have to bring healing and joy to people like this,” said Kelly Schmidt, a social worker at the Children’s Center. “I truly believe they are given a purpose more than just entertainment.”

Rojo is an “old pro” at making children happier. From the day he was born in April of 2002, Rojo has enjoyed being around people of all ages. His owner, Lori Gregory, of Mtn Peaks Therapy Llamas and Alpacas in Vancouver, WA along with handler, Shannon Hendrickson, trained Rojo and entered him in local and state level fairs in the Public Relations and Handler Classes. While at the fair, a spectator observed Rojo’s exceptionally gentle temperament, and suggested that he become certified as a therapy animal. The rest, as they say, was history. Rojo even has his own Facebook page!

Gregory, just like the patients, feels a rush when she introduces her animals – which are often dressed in funny hats and other silly outfits – at hospitals and other medical facilities.  “When you realize that they have this amazing ability to create a natural response therapeutic-wise to get people to do things they normally wouldn’t do.”

napoleon alpacaHer stable also includes two other llamas and two more alpacas.  On its website, Mtn Peaks says its animals have made more than 650 therapeutic visits to patients since the organization was founded in 2007.  They add “Our Therapy Teams might take a walk with an adolescent struggling with difficult issues, or motivate a patient recovering from a stroke to reach farther, or calm a child with autism so that they can focus, and achieve new goals. By offering friendship and warm touch, our llamas help alleviate loneliness, lower blood pressure and reduce stress. Their presence brings a sense of normalcy to institutional settings.

therapy elephantIn researching this post, I also came across other unique therapy animals including miniature horses, elephants (which have been used in Thailand to help some children with autism), helper monkeys and animals with disabilities.

Have you worked with or been helped by therapy animals?  If so we’d love to hear from you and share your stories.

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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.

Prescriptions, Physicians, Patients and Payers: Let the battle commence!

Last week the FDA announced that it wants to remove obstacles to America’s most commonly used drug treatments.  If the Agency gets its way, some drugs used to control chronic conditions, such as high cholesterol, diabetes and asthma may soon be available without prescription.  But in doing so, they have reopened a  big can of worms. One that brings into question the very nature of health reforms, preventative medicine and improved access to healthcare.

Here’s the proposal: The FDA would create a new class of “safe use” drugs. While consumers would not need a prescription, they would still need to get clearance from a pharmacist or from specially designed websites to purchase them.

Battle lines are being drawn! With physicians on one side, and patients, pharmacists, pharma and payers on the other.

Doctors are most definitely not thrilled by the idea. Removing the prescription requirement for an inhaler refill, for example, doctors fear they would be taken out of the loop on everyday care decisions.

Insurers, on the other hand are embracing the move. They recognize that they could save big bucks if physician visits weren’t required for run-of-the-mill complaints and ongoing medication monitoring. They might even save on the costs of the drugs themselves because, depending upon how they’re classified, most health plans don’t pay for over-the-counter treatments.

Pharmacists see it as validation of their expertise and pivotal role in primary healthcare and the pharmaceutical industry, who has repeatedly asked for permission to sell such drugs over-the-counter, must surely be cautiously optimistic.

Even normally conservative regulators are supporting the move. “Greater over-the-counter and behind-the-counter access will lower costs and make healthcare more accessible to consumers,” former FDA commissioner Scott Gottlieb said via Twitter. “It’s a good idea, long overdue.”

Even so, the FDA will have a fight on its hands as it moves to turn its proposal into reality. The American Medical Association lambasted the idea in USA Today, saying that patients need guidance from doctors. The doctors’ association also points out that giving patients more control could complicate coordinating care, such as, tracking all the drugs a patient uses to prevent interactions.

But, as The Washington Post points out, FDA sees the doctor’s visit as a hindrance to care; some patients don’t seek treatment if they have to see a physician first. “Obviously, it’s much easier for you to go to your drug store and pick up an item than it is to make an appointment, take a prescription, drop it off and get it filled,” says Nancy Chockley, president of the National Institute for Health Care Management.

About 20% of prescriptions written in the United States currently go unfilled. Removing obstacles that keep Americans from managing their own health care is, according to one patient, namely me, a good thing.

The FDA contends, and I agree, that some consumers may not even go as far as getting a prescription because of the “cost and time required to visit a health-care practitioner.  Earlier this month, I stood in line at my local pharmacy for thirty minutes to pick up a refill prescription for blood pressure meds. On reaching the end of the line I was told that there was no prescription. The pharmacist called my doctor and the lack of prescription was confirmed. I called my doctor and was told I would need to make an appointment to have the prescription renewed. I pointed out that I had done that one month earlier and that nothing had changed regarding my health. I was then informed that it was a new policy to issue prescriptions on a month-by-month basis rather than provide automatic refills. Even when I pointed out that I have a chronic condition that I’m doing my best to manage and part of that management is the medicine I have been taking for years, they wouldn’t sway. No doctors visit, no prescription.  And the kicker, I couldn’t get an appointment to see my doctor for a week…meaning, I had to go 7 days without blood pressure meds, all so my doctor could better manage my care!

Practicing medication adherence is very hard when your doctor won’t give you medication…and leaves me wondering if this policy change had more to do with revenue generation than improving chronic disease management.

My personal experience aside, at the heart of this discussion is a fundamental disagreement over what role doctors play in managing patient care. The FDA proposal views a trip to the physician as a hindrance to care, whereas doctors see that visit as crucial, especially as chronic conditions become increasingly prevalent.

The FDA proposal is still in formative stages, meaning there’s still a lot of space for this debate to evolve. Where the discussion heads on this particular issue could end up guiding health policy on what role doctors play in managing patient care – and, at what point, the patient takes charge.

I, for one, can’t wait to see how it plays out, assuming of course that I’m not dead from uncontrolled hypertension!

Pills That Pack On Pounds

If you are one of those people who are overweight  and would love to blame something other than too much food or lack of exercise, this blog is for you.

According to the Harris County Hospital District’s Drug Information Center, weight gain or loss may not always be attributed to lifestyle. For some, it’s due to the medicines they’re taking.

Certain meds can cause significant weight changes. For example, weight-related side-effects are common in medicines taken by patients with diabetes, high-blood pressure and mental health conditions.

Those likely to experience weight increase include people taking steroids and women on birth control, while those taking antidepressants such as Prozac® and Wellbutrin® are likely to lose weight.

However, this does not mean you should immediately start making changes to your medication regimen. Drugs are weird. They do different things to different people and it’s often impossible to predict which people will have which side effects from which drugs.

Because of the stigma of weight gain, patients may tend to stop taking their medicines or decrease their dosage without talking to their physician,” says Ryan Roux, PharmD, chief pharmacy officer, Harris County Hospital District. “Doing this is a bad thing. It can affect your health in a number of negative ways.”

Instead, it’s important that you tell your physician about any weight changes and then reassess the drugs or dosages taken. The more you can become actively involved in your treatment and be informed about long-term medication use, the better.

Not sure if the meds you’re taking could be to blame?

SRxA’s Word on Health brings you a list of some common medications and their weight side effects listed both by brand and generic name:

Diabetes

Weight promoting

  • Actos® (pioglitazone)
  • Amaryl® (glimepiride)
  • Insulins

Weight loss or weight neutral

  • Byetta® (exenatide)
  • Januvia® (sitagliptin)
  • Symlin® (pramlintide)
  • Metformin
  • Precose® (acarbose)

Hypertension

Weight promoting

  • Lopressor ® (metoprolol)
  • Tenormin® (atenolol)
  • Inderal® (propranolol)
  • Norvasc® (amlodipine)
  • Clonidine

Antidepressants

Weight promoting

  • Paxil® (paroxetine)
  • Zoloft® (sertraline)
  • Amitripyline
  • Remeron® (mirtazapine)

Weight loss or weight neutral

  • Wellbutrin® (bupropion)
  • Prozac® (fluoxetine)

Antipsychotic

Weight promoting

  • Clozaril® (clozapine)
  • Zyprexa® (olanzapine)
  • Risperdal® (risperidone
  • Seroquel® (quetiapine)
  • Lithium
  • Valproic Acid
  • Carbamazepine

Antiepileptic Drugs

Weight promoting

  • Carbamazapine
  • Neurontin® (gabapentin)

Weight loss or weight neutral

  • Lamictal® (lamotrigine)
  • Topamax® (topiramate)
  • Zonegran® (zonisamide)

As always, we advise – for more information about the effects of medicines, consult your physician or pharmacist.

Pharma – Cracking Down on Crime

It’s rare in the pharmaceutical industry when a drop in numbers is a sign of good news. Unless it’s fewer side effects, most industry insiders cringe when they hear that this year’s figures are lower than last.

However, SRxA’s Word on Health brings you news of a downward trend that should please all but the most criminal elements of society.

A new report from Freightwatch International shows that the number of thefts of pharmaceuticals significantly declined over the past 12 months.  Not only were there fewer incidents, the average value of each theft was lower.  In total, there were 36 thefts involving shipments during 2011, compared to 49 in 2010. And the average value of lost shipments was $585,000, down dramatically from $3.78 million the year before. Trailer thefts accounted for approximately 90% of the heists. Deceptive pickups and burglaries from warehouses made up the remainder.

This was the first year on record that the pharmaceutical industry did not have the highest value per theft incident. That distinction went to the electronics industry, where the most targeted items were televisions, consumer electronics and cell phones.

Significantly, there were just two pharmaceutical thefts valued at more than $1 million last year. In previous years, the average loss per pharmaceutical theft averaged between $3.5 million and $4 million. Two years ago, medicines worth up to $75 million were stolen from an Eli Lilly distribution center in Connecticut after robbers broke in by cutting a hole in the roof.  That incident resulted in national headlines and prompted the drugmakers  to improve security efforts and tighten the supply chain. Organizations such as the Pharmaceutical Cargo Security Coalition are now dedicated to preventing the theft of medicines in transit.

Nevertheless, pharmaceutical supply chain issues remain a hot topic.

RxPatrol is an initiative designed to collect, collate, analyze and disseminate pharmacy theft intelligence to law enforcement agencies nationwide.

The FDA is also concerned about protecting consumers from the threat of stolen, counterfeit, and diverted prescription and over-the-counter medicines. Stolen products may put consumers at risk because they may not have been stored or handled properly or may have been tampered with while out of the normal supply chain.  An FDA website lists all thefts involving FDA-regulated products that have been stolen either from warehouses or tractor-trailers, and encourages the public to report any suspected criminal activity.

Earlier this month, the US Pharmacopeial Convention (USP) published its proposed general chapter on good distribution practices to ensure pharmaceutical supply chain integrity, for comment in advance of its upcoming workshop due to be held in May 2012.  The aim of the workshop will be to develop best practices to combat counterfeit active pharmaceutical ingredients, excipients, drug products and medical devices that are imported into the USA.

And that can only be a good thing. One of the most harrowing books I ever read was Dangerous Doses by investigative journalist Katherine Eban. In it she exposes a world of criminal activity and corruption and how an increasing number of Americans get counterfeit medicines instead of the real thing.

And while pharmaceutical thefts have not gone away, they are on the decline. For that we must be grateful this Monday morning.