IROs Help Determine Medical Necessity of Growth Hormone Therapy

  • Author: Health Informer
  • Filed under: Health News
  • Date: Apr 27,2009

Today the human growth hormone (HGH) industry approaches $2 billion a year. It claims benefits for enhancing athletic performance, anti-aging and stimulating growth. Unfortunately, many of these remain unproven says NAIRO, trade association of independent review organizations (IROs) whose members see daily requests from health plans asking about the medical necessity of growth hormone therapies (www.nairo.org).

Because of its dangers, the Food and Drug Administration (FDA) tightly controls HGH and prohibits doctors from prescribing it for any use the agency has not specifically approved. For example, if doctors prescribe the drug to enhance athletic performance or reverse aging they are breaking the law.

“There’s much confusion about growth hormone therapy, even among healthcare professionals,” said Joyce Muller, NAIRO president. “Health plans wanting to determine the approved uses and standard of care for the drug should consult an IRO.”

Limited Approval for Children

The FDA has approved HGH for children to treat rare genetic conditions, such as Prader-Willi Syndrome (PWS) or Pituitary Dwarfism where it has shown therapeutic benefits. In all cases, HGH treatment requires the assistance of a pediatric endocrinologist. Although it has some rare side effects, treatment with synthetic (recombinant) HGH is generally safe. FDA approved uses include idiopathic short stature, growth-hormone deficiency, and chronic kidney disease.

Anti-aging and Performance Enhancement Unproven

In 2002, the National Institute on Aging sponsored the most comprehensive single study on the anti-aging effects of HGH. It discovered marginal benefits and significant side effects. It warned that HGH should be limited “to controlled research studies” and not widely prescribed.

Despite professional sports outlawing HGH, the belief persists that it makes athletes stronger and faster. Nevertheless, there is insufficient scientific evidence to support this.

The FDA approves HGH in adults only for relatively rare diseases–adult growth hormone deficiency and the wasting syndrome of late stage AIDS. In these treatments, after diagnosing patients with extensive blood tests doctors must monitor them closely.

Unapproved used of HGH can lead to increased health problems including diabetes, heart problems, liver problems, kidney problems, cancer, or death. Moreover, purchasing HGH online is risky because of the possible lack of quality control by manufacturers not approved by the FDA that can result in contamination by other drugs or steroids. Additionally, HGH misuse and its related side effects can increase health plan administrative and litigation costs that cause consumer premiums to rise.

“Health plans should be cautious about approving HGH therapies,” Muller said. “Because HGH carries sanctions for indications not approved by the FDA, health plans must consider the medical necessity of each case carefully to protect themselves, their providers, and their members. IROs can help them determine whether there’s a real medical need.”

Source: NAIRO


Hospitals are cutting services and staff, while more patients are in need of assistance

Six out of ten hospitals nationally are seeing a greater proportion of patients without insurance coming through their emergency departments, according to a new survey from the American Hospital Association (AHA). At the same time, nearly half of hospitals reported they have cut staff. Recent employment information from the Bureau of Labor Statistics confirms that hospital employment is no longer growing and that the number of mass layoffs for hospitals reported in February was more than double what it was a year ago.

The majority of hospitals reported that fewer patients are seeking inpatient and elective services; however, many hospitals are seeing more patients covered by Medicaid and other public programs for those in need. Need for hospital-subsidized services such as clinics, screenings and outreach is increasing even as charitable contributions are down for many hospitals.

“Today’s findings signal what many of us in health care are concerned about: people put off care when they lose their job, which can complicate health care issues for many down the road,” said AHA President and CEO Rich Umbdenstock. “At the same time, the fact that hospitals are cutting staff challenges the notion that hospitals are recession-proof.”

The survey also found that the economy is affecting hospitals with nine in 10 hospitals making cutbacks to help weather the economic storm. At the same time, more than one in five hospitals reported reducing services their community depends on, such as behavioral health programs, post acute care, clinics and patient education.

“Community need for care remains high and in these tough times, communities turn to their local hospital,” Umbdenstock said. “Hospitals are walking a tightrope, trying to balance the growing needs of their communities with today’s economic challenges.”

Despite taking these steps, the majority of hospitals are seeing a moderate or significant decline in their financial health in 2009 versus the same period in 2008. Many hospitals are struggling to make ends meet with over 40 percent expecting losses in the first quarter of 2009, jeopardizing their mission of caring for their communities. The majority of hospitals reported that fewer patients are seeking inpatient hospital care or elective care, further shrinking the resources hospitals rely on to meet the health needs of their communities. Financial measures such as days cash on hand that are important to creditors are slipping. If key measures fall below a certain level, creditors can require immediate repayment of borrowed money.

Nearly all hospitals report that their ability to borrow funds to make improvements is getting worse or remains challenging. In a December survey, many hospitals reported that it was significantly more difficult or even impossible to access tax-exempt bonds and other sources of capital to make improvements. Nearly eight of 10 hospitals have stopped, postponed or scaled back projects such as facility upgrades as well as clinical and information technology planned or already in progress.

The survey, AHA’s second about the economic downturns impact on patients and communities hospitals serve, was sent to all 4,946 community hospitals in March.

1,078 responses were received, broadly representative of the universe of hospitals. A full copy of the report can be found at www.aha.org/economy. Video clips of hospital representatives sharing stories of how the economic downturn is affecting their patients and communities can be found on YouTube(TM) at www.youtube.com/AHAAnnualMeeting.

Source: American Hospital Association


Meningitis cases hit record low

  • Author: Health Informer
  • Filed under: Health News
  • Date: Apr 26,2009

Thousands of lives saved thanks to vaccine success

Cases of bacterial meningitis in children are at a record low thanks to NHS immunisation programmes, Health Secretary Alan Johnson announced

To coincide with World Meningitis Day, a new report by the Director of Immunisation, Professor David Salisbury, highlights the success of childhood vaccines against the three main strains of meningitis:

  • Since the Hib (Haemophilus influenzae type b) vaccine was introduced in 1992, cases of this disease, which can cause meningitis, have dropped by 99 per cent from about 800 cases a year to a record low of 12 cases last year in children under five.
  • Since the Meningitis C vaccine was introduced in 1999, deaths from the disease have fallen from as many as 79 to an average of less than one death a year.
  • In the two years since the pneumococcal vaccine was introduced, it is estimated that over 900 serious cases have been prevented, saving over 50 lives.

In the next three years, a vaccine against the last significant cause of bacterial meningitis, group B meningococcal disease, is a very real prospect. It means attempts to bring the disease most feared by parents to its knees could be in sight.

Meningitis and septicaemia can be difficult to spot in young children. The bacterial form of the diseases is fatal in one in ten cases and urgent treatment is required. Many of those who recover are left with long-term
conditions including hearing loss, brain damage, paralysis, and seizures.

Secretary of State for Health, Alan Johnson, said: “In just over 15 years, thanks to the NHS immunisation programme, cases of meningitis are at a record low. This is thanks to decades of research by scientists and dedication of NHS staff, and with the support of parents.

“The immunisation programme continues to improve and, last year, the first vaccine against cancer was introduced. All girls up to the age of 18 can now arm themselves against cervical cancer – saving up to 400 lives each year.

“When the NHS was established 60 years ago, everyone knew someone touched by childhood disease. Today, thankfully, people barely know what polio and rubella are.”

Department of Health Director of Immunisation, Professor David Salisbury, said: “I am pleased to submit this report, published during European Immunisation Week, which highlights the great strides the NHS continues to take towards not just treating patients but preventing ill-health.

“According to the World Health Organization, vaccination sits alongside clean water as the public health measure that’s had the biggest positive impact on the world’s health.

“Thanks to our immunisation programme, 1000s of children, young people and their families have been – and will continue to be spared the misery of meningitis, polio, measles, and even cervical cancer.”

The UK’s three leading meningitis charities – Meningitis Research Foundation, Meningitis Trust and Meningitis UK – are raising awareness about World Meningitis Day on April 25.

Sue Davie, speaking on behalf of the charities, said: “We see the devastating impact of meningitis on people every day. There are vaccines for some forms of bacterial meningitis which are part of the UK childhood immunisation programme, saving many lives since their introduction.

It is really encouraging that a Meningitis B vaccine is in the pipeline but we must remain vigilant for the signs and symptoms of the disease.”

Source: Department of Health UK


Electronic Pedigree Services Enable Small and Mid-Sized Drug Companies to Adopt “Smart” Drug Safety Technology

IBM and contract manufacturer and third party logistics provider Golden State Medical Supply (GSMS)  announced the two companies have worked together to help drug companies comply with stringent prescription drug pedigree regulations in advance of state and federal mandates.

Global counterfeit drug sales will grow at almost twice the rate of legitimate pharmaceutical commerce by 2010 according to estimates from the Center for Medicine in the Public Interest. The organization predicts that the counterfeiting business will generate $75 billion in revenues in 2010 – a 92 percent increase from 2005. California has lead the nation with landmark prescription drug regulations which aim to protect California consumers from these potentially lethal drugs.

Using IBM technology, GSMS is now able to act in accordance with California’s law which take effect in 2015, as well as new electronic pedigree regulations that are emerging in other states and countries. Having used IBM’s system in its own operations, GSMS is now offering pedigree compliance services to pharmaceutical manufacturers seeking a quick and proven way of addressing regulations taking effect in California and around the world.

The pioneering work with GSMS overcomes many of the previous obstacles to creating an effective electronic pedigree program faced by small to mid-size pharmaceutical companies. New improvements in technology, lower costs, as well as new industry standards for sharing and analyzing information are making it possible for drug companies of any size to ensure their drugs are authentic — while enabling the use of smart technology to track movement of drugs from the manufacturing floor to the pharmacy.

An electronic pedigree is an electronic record containing information on all the steps a pharmaceutical takes as it moves from the manufacturer, to wholesalers, and finally, to pharmacies or hospitals. California has mandated that these pedigrees be maintained in an interoperable electronic system so that all participants in the drug supply chain can access the electronic records.

“The pharmaceutical industry giants won’t have a problem complying with the California regulations, but many smaller players in the industry don’t have the resources to do it on their own,” said Jim Stroud, president and CEO, Golden State Medical Supply, Inc. “However, our company has been serializing at the saleable unit and RFID tagging at the case level since February of this year. The system IBM built for us will not only benefit GSMS, but also small and mid-sized drug manufacturers around the world.”

Serialized drug pedigree information is gathered by IBM’s WebSphere Premises Server software, and transmitted to IBM’s InfoSphere Traceability Server, which allows GSMS to manage and share information with trading partners to authenticate pharmaceuticals. The software is compliant with both GS1/EPCglobal’s Electronic Product Code Information Services (EPCIS) standard, and its Drug Pedigree Standard. In addition to using the IBM system for electronic pedigree, it can also address business needs such as chargeback resolution, targeted recall and expiration management.

“Now is the time for the pharmaceutical industry to inject technology into their operations to make the drugs we take safer,” said Katherine Holland, general manager, global life sciences, IBM. “The key to a smarter, safer drug supply is the use of a unique serial number on every bottle of medicine. Using IBM technology, GSMS can help drug manufacturers around the world address the growing threat of counterfeit drugs.”

Source: IBM


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