Every day in April, people across the U.S. make a special effort to celebrate the tremendous generosity of those who have saved lives by becoming organ, tissue, marrow, and blood donors and to encourage more Americans to follow their fine example.

Facts about organ, tissue and eye donation

• As of January 2010, more than 105,000 people are currently awaiting a life-saving organ transplant in the U.S.
• Each organ donor can save up to 8 lives, and each tissue donor can enhance the quality of life for up to 50 people!
• The gift of life is ageless – anyone can sign up to donate life, at any age.
• No medical condition prevents you from signing up on the donor registry – the medical criteria at the time of donation will determine what is transplantable.
• Cornea transplants have been successful for more than 100 years!
• Organ transplants have been successful for more than 50 years!

So take the time to register your decision to be an organ and tissue donor, ensuring that your desire to give this gift is officially recorded. The priceless treasure that you may someday give will be the gifts of life, sight, and mobility to another.

Minerva has an Organ/Tissue Donation Emergency Card.

Minerva Health Manager includes an option for you to indicate your wishes for Organ/Tissue Donations and to print out an Organ/Tissue Donation Emergency Card to store in your wallet next to your driver’s license and Minerva Flash Drive. Having your long-term intentions made known to your family and caregivers is one of the most important healthcare preparations you can make.

Minerva Health Manager is the most comprehensive personal health record software solution for you to use in the safety of your home. Keep track of your complete health history including, medical alerts, allergies, pregnancies, diagnoses, lab tests, x-rays, medications, and much more. Carry your Minerva flash drive with you wherever you go to provide access to the complete health history for you and your family for office visits or in case of an emergency. Minerva Health Technologies supports Donate Life Month by offering a 15% discount on Minerva Personal Health Record Software by using PromoCode ‘DonateLife2012′.

For more information about Minerva or the Free Trial Version, visit www.MyMinerva.com.

National Donate Life Month is sponsored by The Division of Transplantation (DoT), within the Department of Health and Human Services, Health Resources and Services Administration’s Healthcare Systems Bureau.

Minerva is a registered trademark of Minerva Health Technologies Inc.

http://www.northjersey.com/news/national/DRUG0311.html
SATURDAY, MARCH 10, 2012 LAST UPDATED: SUNDAY MARCH 11, 2012, 9:22 AM

BY BARBARA WILLIAMS
STAFF WRITER
THE RECORD

Dan Schiavello shouldn’t be alive.

His doctors expected his Stage 4 cancer to kill him long ago. He’s survived because of a chemotherapy drug that has attacked the tumors in his body, shrinking most and even eliminating some.

But now, that drug is no longer being made.

He has been scrambling to find Doxil, the medication that has been his lifeline the last five years. He spends hours every day on the phone and on his computer searching for a dose and has traveled hundreds of miles for an infusion. He has found himself in a world where people are willing to put a price on his survival, like the pharmacist who offered to sell him a dose from a secret stockpile for $14,000 in cash.

“Withholding this drug from me is giving me a death sentence,” said Schiavello, 58, who suffers from muscle cancer.

His quest to find Doxil is just one example of how a national prescription drug shortage that has been building for over a year is jeopardizing lives.

A record 267 drugs were in short supply or completely unavailable in 2011, affecting 550,000 patients nationwide. The shortage includes antibiotics, anesthetics, drugs for cancer treatment and heart conditions, along with intravenous nutrition therapy. Even Valium has been scarce. The problem is continuing despite attempts by the federal government to speed up production of crucial drugs.

“It’s a big problem for us — many of these drugs are the backbone of treatment for malignancies,” said Dr. Thomas Rakowski, an oncologist at The Valley Hospital in Ridgewood. “Patients are being jeopardized as if this is a Third World country.”

This is the story about how the drug shortage has turned a Saddle River father into a scavenger. For Schiavello, finding his next dose is a full-time job.

“I have to do it to stay alive,” he said.

Treated since 2007

Schiavello’s health problems began when he found a lump in his leg in 2001. His doctor wasn’t concerned. When it continued to grow, he had the tumor removed two years later. Again, he was told it was nothing to worry about.

By January 2006, errant cells from the tumor had metastasized to his lungs. He was diagnosed with Stage 4 leiomyosarcoma, a smooth-muscle cancer. His lungs were riddled with tumors.

His prognosis was chilling.

“They told him he wouldn’t see five years,” said Schiavello’s wife, Arlene.

In 2007, he started Doxil, a chemotherapy drug from Johnson & Johnson that is more commonly given to patients with ovarian cancer, leukemia or AIDS-related Kaposi’s sarcoma. The drug’s formulation allows it to remain in the body longer to fight cancer cells, but it doesn’t trigger the typical side effects associated with chemotherapy drugs, like hair loss and nausea.

The change in Schiavello was remarkable: Doxil shrunk the tumors in his lungs 90 percent — both in size and number.

He’s already lived a year longer than the specialists expected.

He needs a dose every six weeks. For as long as he hopes to live. “It’s like insulin to a diabetic,” Schiavello said.

But on Aug. 30, his oncologist called him to say the infusion he was scheduled to receive two days later wasn’t available.

The only factory that made the drug, Ben Venue Laboratories, had been experiencing a series of production problems for months and had received numerous citations by the Food and Drug Administration for quality and sterility issues. The Ohio factory, which had been supplying the drug to J&J, would soon shut down.

Not highly profitable

Doxil is a drug that is complicated to make but brings in little in the way of profit, like many of the drugs that are in short supply. That means there is little incentive for factories to renovate to prevent manufacturing problems or for others to jump in and take over production if a factory falters.

“If a drug was making lots more money, the company would invest more,” said Dr. Ezekiel Emanuel, chairman of the medical ethics department at the University of Pennsylvania. “If you’re not making a lot of profit, are you going to throw everything you have to get the line back up? The incentive isn’t there.”

J&J told doctors not to start any new patients on Doxil. It started a waiting list for the drug, Doxil CARES.

The waiting list required physicians to submit a patient’s medical history and health status. But J&J refused to tell patients where they were on the list — and if or when they would receive another dose. The company is deciding who gets the medication and sends it to medical centers or physicians earmarked for specific patients. J&J has requested that all unused medication be returned, said Lisa Vaga, a spokeswoman for the company, which is headquartered in New Brunswick.

Schiavello’s oncologist put him on the waiting list, but Schiavello said he could get no answers from J&J about when he could get the drug.

“They can get all this health information on me but refuse to tell me whether I can get another dose?” Schiavello said. “I’m supposed to make life-and-death decisions in a vacuum — with no information to base them on?”

Vaga said the company won’t discuss individual patients or its reasoning for not telling patients how much Doxil they can expect.

“Patients on the wait list were allocated product as additional supplies became available, consecutively in the order their enrollment forms were submitted and verified,” Vaga said.

Schiavello scrambled for other options.

He discovered what has become known as the “gray market” — hospitals, medical offices and infusion centers that are licensed to dispense the drug but aren’t following J&J’s new distribution rules.

He had contacts in the field as a Columbia University alumni and a biomedical engineer who founded Minerva Health Technologies Inc., a local firm that develops healthcare software products. His contacts helped put him in touch with top oncologists and medical centers across the country that have supplies of Doxil. Schiavello is the first to acknowledge that another patient without his background would probably be dead by now.

Finds four doses

His search led him to Dr. Howard Bruckner, from Bruckner Oncology at the Eastchester Center for Cancer carein the Bronx. He gave him one precious dose.

“He’s had an exceptionally long remission. As an oncologist, I felt it was appropriate to maintain that,” Bruckner said.

“I never saw the request to send it [his supply of Doxil] back to J&J, but even if I did, I would have ignored it,” Bruckner said. “I had such a small amount that it wouldn’t have made a huge difference to a number of patients, but it will make a difference to one patient like Dan.”

Since September, Schiavello has received four infusions from sites in other states. He doesn’t want to disclose the locations because he doesn’t want to create a problem for his suppliers.

Every time he receives his life-saving medication, his search begins again for the next dose.

He’s found that some people are trying to profit from their leftover Doxil. A pharmacist at a large medical center offered to sell Schiavello a dose for $14,000 cash, thousands more than the medication is worth. Schiavello turned him down.

“Even if I could afford to pay that every month, there’s no way of knowing what kind of shape the drug is in. What if it’s been sitting in that pharmacist’s car trunk — it needs to be kept refrigerated,” Schiavello said. “And who’s to say what’s really in that vial? You have no idea who you’re dealing with when you go through channels like that.”

So far, all Schiavello’s doses have been paid by his insurance company, even those he’s obtained outside his own doctor’s care.

“The doctors and sites giving me the infusion aren’t making money on this,” Schiavello said. “It’s all perfectly legal — it’s just not what Johnson & Johnson wants.”

Dr. Harry Harper, Schiavello’s oncologist at Hackensack, said he is disheartened about the scarcity of such an essential drug.

“The alternative [to Doxil] is not guaranteed to work as well, and the side effects of other drugs are much more toxic,” Harper said. “It’s very frustrating to have a protocol that you’ve been following and want to continue but have an outside force disrupting the process.”

Initially, 4,400 patients enrolled in Doxil CARES. By the end of January, the list had decreased to 500, Vaga said. The company recently found a factory willing to make the drug, though production has not begun.

“We’re doing everything we can to get Doxil to patients and expect to have it available by the end of the year,” Vaga said.

Calls for action

Vaga told The Record that J&J now has enough inventory for seven doses per patient, which is a typical full course of treatment.

But scores of patients can be found on online chat rooms and blogs begging for someone to help them find a dose. There’s even a logo for the cause: “Got Doxil?” Schiavello said that when he asked how many doses he will receive, the company would only promise him one.

When the stories of these patients were pointed out to J&J by The Record, the company would only reiterate that it has an adequate supply. The company has posted a statement on its website: “Supply is now available and sufficient to meet the needs of all current Doxil patients.”

Schiavello said this is just a clever spin to mask a tragedy.

“You know what that means — that patients have either died or switched to less effective drugs,” he said.

Meanwhile, public pressure has mounted on the FDA to do something about the crisis. Recently, the agency announced that an alternative drug, Lipodox, can be temporarily imported from an Indian company, Sun Pharma Global.

But it is not an FDA-approved medication and, in fact, the FDA refuses to say whether it is bio-equivalent to Doxil. The agency has no plans to test the drug, and it will not be covered by Medicare or most private insurers.

“I’m only going to use Lipodox as a last resort because I just don’t know what it will do,” Schiavello said.

Another potential alternative drug has problems of a different kind. Michael Dwyer, a former New Jersey resident with a small pharmaceutical company in San Antonio, has been working on a generic form of Doxil. Azaya Therapeutics should be ready to start clinical trials in a couple of months, Dwyer said.

But a major hurdle stands in the way: Doxil must be used in studies to compare the new drug’s efficiency, and J&J said it has no Doxil available for such studies.

“I wouldn’t want to take Doxil away from patients who need it so I can do research,” Dwyer said. “But we are working with the FDA to get our product out there. It’s a very unique situation to not have the brand-name drug to test a generic.”

If its drug is approved, Azaya could get about 375 doses to market in 30 days, he said. His 11-employee company could continue that pace but would need 8 to 12 months to produce larger amounts, Dwyer said.

The dire shortage of life-saving drugs has raised ethical issues about whether companies that are the sole supplier of a critical drug can just cease production.

“The drug shortage is very frightening,” said Dr. Donna McNamara, co-chief of gynecologic oncology at Hackensack University Medical Center’s John Theurer Cancer Center.

“It’s unfair to patients,” she said. “We want to give optimal care and that means using optimal drugs.”

The Schiavello family is incredulous that the shortage may cost the husband and father of two his life.

“People diagnosed with these serious illnesses shouldn’t have to also fight just to get the drugs they need,” Schiavello said. “This is so scary, and I’m so angry about this whole thing — not just for me but for all the other patients out there.”

As the shortage drags on, the terror the Schiavellos experienced when he was diagnosed has returned.

His wife is back to waking often with a bone-deep fear.

“I’m so afraid I’m going to have to make the decision on whether to remove him from life support,” Arlene Schiavello said. “You never think of things like this unless you’re dealing with a terminal illness.

“And now that he doesn’t know whether he’ll be able to get the drug that’s saving his life, I’m thinking more often about it. He’s the father of my children, and the man that I love, and I don’t want to live without him.”

Email: williamsb@northjersey.com

Related stories:

Family faced loss of treatments for child’s cancer

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Minerva encourages you to share these articles to help increase awareness about the drug shortage crisis and help save lives!

Minerva is a registered trademark of Minerva Health Technologies Inc.

In the United States, the most common type of heart disease is coronary artery disease (CAD), which can lead to a heart attack. You are at higher risk of heart disease if you are:

• A woman age 55 or older
• A man age 45 or older
• Or a person with a family history of early heart disease

You can greatly reduce your risk for CAD through lifestyle changes and, in some cases, medication. Controlling and preventing risk factors is also important for people who already have heart disease. Start by planning heart healthy activities during the month of February:

• Watch your weight.
• Quit smoking and stay away from secondhand smoke.
• Control your cholesterol and blood pressure.
• If you drink alcohol, drink only in moderation.
• Get active and eat healthy.
• Talk to your doctor about taking aspirin every day if you are a man over the age of 45 or a woman or a woman past menopause.
• Manage stress.

But don’t stop there – stay healthy and active all year long!

It is also important to maintain your own personal health records so you and your doctors can have access to your most current medical records.

Minerva Health Manager is the most comprehensive personal health record software solution for you to use in the safety of your home. Keep track of your complete health history including, medical alerts, allergies, pregnancies, diagnoses, lab tests, x-rays, medications, and much more. Carry your Minerva flash drive with you wherever you go to provide access to the complete health history for you and your family for office visits or in case of an emergency. During American Heart Month you can save 10% on Minerva Personal Health Record Software by using PromoCode ‘RED2012′.

For more information about Minerva or the Free Trial Version, visit www.MyMinerva.com.
healthfinder.gov is sponsored by the National Health Information Center.
American Heart Month is sponsored by The American Heart Association.

Minerva is a registered trademark of Minerva Health Technologies Inc.

Why Minerva Health Manager?

Minerva Health Manager, is the most comprehensive personal health record software solution to use in the privacy of your home. With Minerva, you can keep track of your complete health history – from detailed information on your health conditions, medications, allergies, immunizations, and insurance to storing your test results, diagnoses, treatments, and contents of your official advance directive. No other software program provides 35 separate health topics:

• Advance Directive Copies
• Advance Directive Summary
• Allergies
• Current Residence
• Devices and Aids
• Diagnoses
• Diagnostic Imaging
• Diagnostic Procedures
• Diagnostic Tests
• Diet and Exercise
• Emergency Contacts
• Exams and Office Visits
• Genetic Tests
• Healthcare Providers
• Healthcare Proxy
• Inpatient/Outpatient Visits
• Insurance Providers
• Lab Tests
• Lifestyle
• Living Will
• Menses
• Nonprescription Products
• Non-Surgical Procedures
• Organ/Tissue Donations
• Past Residences
• Personal Profile
• Physical Measurements
• Pregnancy
• Prescription Drugs
• Screenings
• Stress Level
• Surgical Procedures
• Symptoms
• Vaccinations
• Vital Signs

Personal and Family Health Records

With Minerva you create separate Minerva Health Records for your spouse or partner, as well as each of your parents, and children – whether adopted or biological. Imagine the convenience of entering your entire family medical records in one software program. And whatever a family member enters into his or her own personal health record will be reflected in the rest of the family’s individual health records, automatically.

Do You Carry Your Health History Everywhere You Go?

With Minerva you can carry the complete health history for you and your family, which can be used for Emergencies and Healthcare visits, whether you are at home, on vacation, in school, or traveling for business. Just use the Minerva Flash Drive or the Minerva PHR Viewer, our free mobile app to view your Emergency Health Records on the iPhone, IPad, and Android devices.

Minerva Health Manager – Safely Managed at Home, Not on the Internet

With Minerva, you maintain all of your health records on your computer at home – NOT on the Internet.

Minerva Supports the Importance of Health Screenings as Reported by USA Today

To help you take control of your health, you can save 20% on Minerva’s Personal Health Record Software by using PromoCode ‘USATODAY‘ before February 29, 2012. For more information about Minerva or a Free Trial Version, visit www.MyMinerva.com.

Minerva is a registered trademark of Minerva Health Technologies Inc.

Google Health Users are choosing Minerva Health Manager

Fortunately, Google Health users need to look no further than the Minerva Health Manager, the most comprehensive personal health record software solution to use in the privacy of your home. With Minerva, you can keep track of your complete health history – from detailed information on your health conditions, medications, allergies, immunizations, and insurance to storing your test results, diagnoses, treatments, and contents of your official advance directive. No other software program provides 35 separate health topics:

• Advance Directive Copies
• Advance Directive Summary
• Allergies
• Current Residence
• Devices and Aids
• Diagnoses
• Diagnostic Imaging
• Diagnostic Procedures
• Diagnostic Tests
• Diet and Exercise
• Emergency Contacts
• Exams and Office Visits
• Genetic Tests
• Healthcare Providers
• Healthcare Proxy
• Inpatient/Outpatient Visits
• Insurance Providers
• Lab Tests
• Lifestyle
• Living Will
• Menses
• Nonprescription Products
• Non-Surgical Procedures
• Organ/Tissue Donations
• Past Residences
• Personal Profile
• Physical Measurements
• Pregnancy
• Prescription Drugs
• Screenings
• Stress Level
• Surgical Procedures
• Symptoms
• Vaccinations
• Vital Signs

Personal and Family Health Records

With Minerva you create separate Minerva Health Records for your spouse or partner, as well as each of your parents, and children – whether adopted or biological. Imagine the convenience of entering your entire family medical records in one software program. And whatever a family member enters into his or her own personal health record will be reflected in the rest of the family’s individual health records, automatically.

Do You Carry Your Health History Everywhere You Go?

With Minerva you can carry the complete health history for you and your family, which can be used for Emergencies and Healthcare visits, whether you are at home, on vacation, in school, or traveling for business. Just use the Minerva Flash Drive or the Minerva PHR Viewer, our free mobile app to view your Emergency Health Records on the iPhone, IPad, and Android devices.

Minerva Import Options for Google Health users

If you want to keep using the data you have stored in Google Health, Google strongly recommends that you take action before the end of the year. Go to the Google Health site and log in with your Google account to download your information and close your Google Health account. For more information on the download process, see the Google help center article at http://www.google.com/support/health/bin/answer.py?hl=en&answer=1347989.

Google Health users can import their health data into Minerva several ways. The simplest way is to download your Google Health record in PDF format and attach the file to one or more health topic entries or health journal entries in Minerva Health Manager.

Another option is to enter the data directly into Minerva. This allows you to enter your Google Health data into the appropriate Minerva health topic, which will more accurately record your data since Minerva has many more discrete health topics as Google Health.

You can also contact Technical Support to inquire about our customized Import Service.

Minerva Health Manager – Safely Managed at Home, Not on the Internet

With Minerva, you maintain all of your health records on your computer at home – NOT on the Internet.

For more information about Minerva or a Free Trial Version, visit www.MyMinerva.com.

Minerva is a registered trademark of Minerva Health Technologies Inc.

In addition to supporting local business, you can get a one-time $25 statement credit from American Express® when you use your registered or linked American Express® Card on Small Business Saturday to make a purchase of $25 or more at a small business.

Minerva Health Manager

The Minerva Health Manager personal health record software products are available for Small Business Saturday. Just go to the Minerva website and charge at least $25 on your registered Amex card to get a $25 statement credit. That’s like getting the Minerva Personal Edition for less than $5, or the Family Edition for less than $35! You must register with American Express before making your purchase.

Minerva Health Manager is the most comprehensive personal health record software solution for you to use in the safety of your home – NOT on the Internet. Keep track of your complete health history including, medical alerts, allergies, diagnoses, lab tests, x-rays, medications, and much more. Carry your Minerva Flash Drive with you wherever you go to provide access to the complete health history for you and your family in case of an emergency. You can also use the Minerva PHR Viewer, an app to view your Emergency Health Records on your iPhone, iPad, and Android devices.

For more information about Small Business Saturday and how to register, visit facebook.com/SmallBusinessSaturday. The $25 statement credit associated with Small Business Saturday is the sole responsibility of American Express.

For more information about Minerva or a Free Trial Version, visit www.MyMinerva.com.

Minerva is a registered trademark of Minerva Health Technologies Inc.

Don’t forget to “Like” and recommend us on facebook at facebook.com/MinervaHealthManager.

Whether individuals and their family members are relatively healthy and going for a routine doctor’s visit, or managing a chronic condition and receiving extensive treatment, many want to be actively involved in their healthcare experience. Minerva Health Manager helps them securely manage their individual health history, without the use of the Internet; from detailed information on medical alerts, emergency contacts, health conditions, medications, allergies, immunizations, and insurance, to storing test results, treatments, and contents of their official advance directives. 

And best of all, Minerva personal health records can be portable, so Healthcare Providers and Agents can have immediate access to their patient’s most current medical records – wherever, whenever, without the use of the Internet. 

“Unfortunately, you can’t always rely on our healthcare system to have access to critical health information for accurate diagnoses or treatments. Anyone who has been in an emergency room likely has nightmares of all of the paperwork and chaos,” said Dan Schiavello, President, of Minerva Health Technologies. “With Minerva, you can have all of your health information stored on a lightweight wristband or tiny flash drive—smaller than a house key — available in emergencies and for routine doctor visits.”

With a complete health history carried on their Minerva Wristband or Slimline Flash Drive, stored on a mobile device such as an iPad, iPhone or Android, or even as a printed report, they will be in a better position to receive the very best healthcare for themselves and their family members.  

The Minerva personal health record software solution is comprehensive and easy to use, and it is surprisingly affordable for such a powerful software tool. Watch the 3-minute Video Tour to learn how Minerva can help save lives. You can also download the free Trial and the Minerva PHR Viewer, a free app for your mobile device.

Lots To Live For, Inc. offers products to combat unpleasant and uncomfortable side effects of chemotherapy and radiation treatment.  Importantly, Lots To Live For, Inc. sells items to help heal and soothe radiation burns.  In addition they provide helpful cancer skin care products for sensitive and compromised skin, and hair care products to reduce and prevent hair loss. Lots To Live For, Inc offers thoughtful and appreciated cancer gifts and compassionate service.  Now through the partnership with Minerva, Lots To Live For, Inc. also offers patients a way to organize, coordinate, store, and carry their important medical records. 

Follow Minerva on Facebook at www.facebook.com/MinervaHealthManager.

For more information about Minerva, please visit MyMinerva.com.

There are plenty of ways you can become involved in American Diabetes Month and the Stop Diabetes movement.  For starters, see if you are at low, medium or high risk for type 2 diabetes by taking this simple test. You should become familiar with the symptoms of Type I Diabetes and Type II Diabetes, realizing that many people with type 2 diabetes have no symptoms.  You can also follow the Stop Diabetes blog to learn more.

Whether you have Diabetes or not, it is important for you to maintain your own personal health records so you and your doctors can have access to your most current medical records – wherever, whenever. Minerva Health Manager is the most comprehensive personal health record software solution for you to use in the safety of your home. Keep track of your complete health history including, medical alerts, allergies, diagnoses, lab tests, x-rays, medications, and much more. Carry your Minerva flash drive with you wherever you go to provide access to the complete health history for you and your family in case of an emergency. You can also use the Minerva PHR Viewer, an app to view your Emergency Health Records on your iPhone, iPad, and Android devices. Internet access is not required.

Every 17 seconds, someone is diagnosed with diabetes. Discover ways to create awareness among your friends and family during American Diabetes Month by visiting stopdiabetes.com, or by calling 1-800-DIABETES.

For more information about Minerva, visit www.MyMinerva.com.
Minerva is a registered trademark of Minerva Health Technologies Inc.

A: Cancer patients and their caregivers see firsthand the problems we have in our healthcare system, not the least of which is how we transfer information from place to place. Patients, in transition from active cancer care to more routine follow-up in community settings, are particularly vulnerable when diagnostic and treatment data doesn’t flow easily from oncologists to primary care professionals.

Patients are beginning to recognize that they are caught in the middle of the muddle. A recent survey commissioned by the Center to Advance Palliative Care and supported by the American Cancer Society asked consumers what their biggest concerns were for patients with serious illnesses. A top issue was that doctors might not talk to and share information with each other—and these results aren’t surprising. Patients are letting it be known that from their perspective their care has become disjointed and uncoordinated as they move from place to place and doctor to doctor. The challenges are increasing as the ways in which we deliver care are morphing into new and more challenging systems.

Much of this was supposed to be addressed by expanding the influence of electronic medical records. Although there has been progress, it has been slow in coming. We still need widely accepted standards that allow different computer systems to use the same data—that way, test results could be easily available wherever the patient receives care, and scans wouldn’t have to be repeated. And, although the process of health information exchange is gaining traction, it may be some time before networks that will move patient information from one place to another, just like an ATM network, are up and running.

Until we arrive at that magical day when our treatment information follows us to where we get our health care, you must be your own advocate. Know your disease, know your treatment, and know what your healthcare team wants you to do and when you should do it. Keep copies of important records and even CDs of scans. (Blogger’s comment: Better yet, consider using Minerva Health Manager, a personal health record (PHR) software solution that allows you to manage and store your medical and health history in one easy place – on your computer. Take control of your health records starting today.) If you don’t understand something, speak up and ask questions. No one is going to look out for you more than you do for yourself.

Please visit curetoday.com to read the original post by Len Lichtenfeld, MD, deputy chief medical officer for the American Cancer Society, dated September 14, 2011.

For more information about Minerva, please visit our website, www.MyMinerva.com, take the Video Tour, or download the Free Trial.

Minerva is a registered trademark of Minerva Health Technologies Inc.

An Associated Press review of industry reports and interviews with nearly two dozen experts found at least 15 deaths in the past 15 months blamed on the shortages, either because the right drug wasn’t available or because of dosing errors or other problems in administering or preparing alternative medications.

The shortages, mainly involving widely-used generic injected drugs that ordinarily are cheap, have been delaying surgeries and cancer treatments, leaving patients in unnecessary pain and forcing hospitals to give less effective treatments. That’s resulted in complications and longer hospital stays.

Just over half of the 549 U.S. hospitals responding to a survey this summer by the Institute for Safe Medication Practices, a patient safety group, said they had purchased one or more prescription drugs from so-called “gray market vendors”- companies other than their normal wholesalers. Most also said they’ve had to do so more often of late, and 7 percent reported side effects or other problems.

Hospital pharmacists “are really looking at this as a crisis. They are scrambling to find drugs,” said Joseph Hill of the American Society of Health-System Pharmacists.

A hearing on the issue was held on Friday before the health subcommittee of the House Energy and Commerce Committee (click on the link to watch the archived webcast or read the testimony). The Food and Drug Administration is holding a meeting Monday with medical and consumer groups, researchers and industry representatives to discuss the shortages and strategies to fight them.

The FDA says the primary cause of the shortages is production shutdowns because of manufacturing problems, such as contamination and metal particles that get into medicine.

Other reasons include:

• Companies abandoning the injected generic drug market because the profit margins are slim. Producing these sterile medicines is far more complicated and expensive than stamping out pills, and it can take about three weeks to produce a batch. Making things worse, companies don’t have to notify customers or the FDA that they’ve stopped making a medicine. That means neither FDA nor competitors can try to fill the gap.
• Only a half-dozen companies make the vast majority of injected generics. Even if other companies wanted to begin making a generic drug in short supply, they’re discouraged by the lengthy, expensive process of setting up new manufacturing lines and getting FDA approval.
• Theft of prescription drugs from warehouses or during shipment.
• Secondary, “gray market” vendors who buy scarce drugs from small regional wholesalers, pharmacies or other sources and then market them to hospitals, often at many times the normal price. These sellers may not be licensed, authorized distributors.

Hospitals that buy scarce medicines from the “gray market” are taking a gamble.

The drugs may be stolen and hospitals can’t always tell whether a medicine was properly refrigerated – as required for many injectable drugs – or whether it’s past the expiration date, said Michael R. Cohen, a pharmacist and president of the institute. Either way, the active ingredient might have degraded and the drug might not work well or could harm the patient, he said.

Cohen attributes at least 15 recent deaths to drug shortages based on reports by medical personnel, but says many deaths and injuries go unreported.

In the worst known case, Alabama’s public health department this spring reported nine deaths and 10 patients harmed due to bacterial contamination of a hand-mixed batch of liquid nutrition given via feeding tubes because the sterile pre-mixed liquid wasn’t available.

So far this year, 210 drugs have been added to the list of drugs in short supply, one less than the total for all of last year, according to the University of Utah Drug Information Service, which tracks the shortages. That’s triple the roughly 70 a year from 2003 to 2006, when shortages began to climb steadily. Click on the link to see the FDA’s current list of IV drug shortages.

“The shortages aren’t resolving. They’re piling up on top of existing ones,” said Erin Fox, a pharmacist who manages the service. She said at least 55 drugs from shortages before this year are still unavailable or scarce.

The average price markup on drugs sold by secondary distributors was 650 percent, according to an Aug. 16 report by the Premier Healthcare Alliance, a group that helps U.S. hospitals and other health providers improve their patient care and finances. The report is based on an analysis of 636 unsolicited sales offers that were faxed and emailed to hospitals from secondary distributors in April and May.

Virtually every offer was for at least double the normal price, the survey found. The drugs with the highest markups were for critically ill patients needing anesthesia or other medicines for surgery or for emergency care, cancer, infectious diseases and pain management.

In an extreme case, one vendor was offering a generic drug for dangerously high blood pressure, normally priced at $25.90 per dose, for $1,200.

So far, hospitals have been absorbing the extra costs, but they’ll soon have to start passing them on to insurers and patients, according to the American Hospital Association.

Hospitals sometimes have to cave in to save patients, according to Cohen and several hospital pharmacy directors.

The FDA says it must uphold quality standards but also works hard to prevent shortages.

“When FDA detects a contaminant, whether it be shards of glass or metal particles or an infectious agent, we have to take action to protect the public,” said Dr. Peter Lurie, a senior adviser in the FDA commissioner’s office.

When the agency orders a production shutdown, it urges other manufacturers to boost their output and expedites any approvals needed, said Valerie Jensen, associate director of FDA’s drug shortage program. When raw materials used to make drugs are in short supply, the FDA tries to find new sources.

The agency averted 38 shortages last year, Jensen added.

Legislation pending in the House and Senate would increase penalties for drug thefts from warehouses and tractor-trailers. Another proposal, which has bipartisan support, would require drug manufacturers anticipating a shortage to immediately notify the FDA.

Sen. Amy Klobuchar, D.-Minn., the primary sponsor of the Senate version of the notification bill, said other solutions being considered include better tracking of medicine shipments, mandatory accreditation of distributors, stockpiling of key drugs and allowing routine imports of prescription drugs from countries such as Canada.

Distributors that supply about 90 percent of prescription drugs to hospitals buy direct from drug manufacturers and deliver only to customers with appropriate licenses, said John Parker, a spokesman for the Healthcare Distribution Management Association. He said HDMA members don’t participate in the “gray market” but would not comment further.

The pitches hospitals get from the secondary distributors generally say they have small batches of specific drugs that are hard or impossible to find. “Are you enjoying this crazy ‘roller coaster ride’ of pharmaceutical shortages? … I utilize over 60 vendors to locate and procure needed pharmaceuticals to assist when you have shortage needs,” one reads.

Several distributors who sent hospitals solicitations for scarce drugs didn’t return calls from the AP. One representative said he wasn’t authorized to discuss the issue.

One company, Novis Pharmaceuticals, defended the higher prices, saying secondary distributors have to charge far more because they don’t get the big rebates manufacturers give primary distributors. They also have high costs to locate and transport batches of scarce drugs, although the company, which mainly distributes blood plasma, would not disclose its profit margin.

It’s illegal for companies to create a monopoly or collude to create a medicine shortage and raise prices, and there’s no evidence of that. There’s no federal law against price-gouging on prescription drugs, according to the FDA, but it does urge pharmacists to report cases to its Office of Criminal Investigation. An agency spokeswoman said she could not discuss whether any cases are being investigated.

The top three wholesalers say they try to alleviate problems by working with drug manufacturers, updating hospitals on shortages and rationing scarce supplies by giving their regular hospital customers a portion of their normal order. McKesson Corp. and Cardinal Health Inc. say they halt sales to any smaller distributors found to be diverting drugs or otherwise breaking rules. AmerisourceBergen Corp. does background checks on customers.

The hospital association and other groups urge hospitals not to buy from unaccredited vendors, to insist on documentation of the drug’s source if they must, and to report price gouging to state authorities. But only three states – Kentucky, Maine and Texas -have price-gouging laws that specifically cover medicines.

“Something has to be done here,” said pharmacist Michael O’Neal, head of drug procurement for Vanderbilt University Medical Center in Nashville, which has had to purchase medicines from secondary suppliers about 70 times the past two years.

“This is unethical,”he said. “We’re talking about people’s lives.”

Portions of this article were reprinted from the CBS Early Show as reported by the (AP) TRENTON, N.J. on September 23, 2011 6:33 AM.

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