The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.
“Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries,” said FDA Commissioner Margaret A. Hamburg, M.D.
Millions of people are harmed every year by medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient’s condition.
Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm. Unintended exposure to prescription medications such as opioid drugs can cause harm, even death, in a single dose, if taken by someone other than the patient who was prescribed the medication.
“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”
More detailed information on the new program was contained in a report, titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines.” The report was released by Drs. Hamburg and Woodcock at FDA’s annual Science Writers Symposium at the agency’s White Oak Campus in Silver Spring, Md.
As outlined in the report, the FDA intends to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, cross-sector interventions for reducing harm from these problems, and the metrics for success will be developed.
The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.
To further advance the Safe Use Initiative, the FDA intends to hold a series of public meetings to gather feedback as the candidate list is being developed and will open a public docket to receive comments on the report and proposed candidate cases.
The agency also today made public new FDA guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons.
The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register today.
Accidental overdoses can be caused by dosage delivery devices that are unclear or are inconsistent with the labeled dosing instructions.
“This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Woodcock. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially for children.”
For more information: http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm
For vast numbers of people killed or injured by pharmaceutical drugs these initiatives amount to too little, too late. Hopefully we will see at least some worthwhile improvement in drug safety from these moves. However, since the FDA is completely responsible for approving all the harmful drugs, including all their labelling and required associated patient and prescriber information, it does appear to be a case of putting Dracula in charge of the Blood Bank.
The FDA is not an impartial regulator but part of the problematic process. Does it take its own culpability seriously? I don’t think so. As approver of these harmful drugs the FDA shares responsibility for the harms caused.
Tags: drug safety, FDA, medication dangers
The first ever World Pneumonia day is 2nd November 2009. This serves as a call to focus attention and take action to help prevent millions of avoidable deaths in children due to pneumonia. Is this important? Yes, indeed it is. Of the 9 million children aged under-5 who die each year, at least 1.2 million die from pneumonia. That is a terrible statistic.
The offending infectious organism is Streptococcus pneumoniae (or pneumococcus). The yearly death toll attributable to pneumococci in patients with AIDS and other immunocompromised states, elderly people, and those with comorbid illnesses is difficult to quantify, but probably exceeds the infant mortality rate. This bacterium continues to kill millions of people every year.
Naturally, the significant majority of infant deaths occur in less developed countries. In developed countries they tend to occur mainly among the underprivileged, for example, in Australia, in isolated Aboriginal populations. However, the problem exists at some level of incidence in all communities.
Health authorities with a global focus tend to be dominated by orthodox medical views. Within orthodoxy there is belief in the persistent myths that mass vaccination programs and widespread use of antibiotics are virtual panaceas. Why is this? I would suggest two main reasons. The first is that it reflects the status quo view of orthodoxy. It is what is taught to medical students and reinforced in (I have to say, paradigmatically bound and less-than-critical) medical literature and politically acceptable health policy. The second is related to the last point, it is simply easier (and therefore politically palatable) to ship off some vaccines and antibiotics than it is to do what really will improve the situation. The tragedy is that by doing what is really needed to reduce deaths from pneumonia, most other troubling diseases would also be addressed and we would make progress towards equity and justice.
So what is really needed? Improved housing, quality water supplies, improved nutrition and better public health measures including health education for public and personal hygiene. These require real commitment, infrastructure expenditure, ongoing monitoring and support. Furthermore, these things should be provided in a manner consistent with the principles of Primary Health Care and not as some grand paternalistic gesture.
On World Pneumonia Day a 6-year plan from WHO and UNICEF- the Global Action Plan for Prevention and Control of Pneumonia (GAPP) – will be announced. The plan aims to place children in an environment where they are at low risk of pneumonia, prevent them developing it, and treating those who contract it. Key interventions include exclusive breastfeeding in the first six months of life, use of vaccines, and management of the condition in clinics and, importantly, at the community level. The authors predict that successful implementation of GAPP could substantially reduce child pneumonia mortality.
Much of this is laudable and I wish those who implement it the greatest success. My main disappointment is the reliance on vaccination. For instance, consider the following graph, used by some to support the use of vaccination.
Original Source: Centers for Disease Control and Prevention. Invasive pneumococcal disease in children 5 years after conjugate vaccine introduction — eight states, 1998-2005. MMWR Morb Mortal Wkly Rep 2008;57: 144-48.
When I read that data summary I see a decline in the incidence of pneumonia that was well underway prior to the introduction of PCV-7 vaccine. I see no particular justification in the data to attribute the decline to the vaccine.
Neverthless, let us not debate this point now. Be aware of the efforts being made to reduce the deadly effects of pneumococcal disease, particularly in children, and please render whatever assistance you can.
My thanks to Dr Naveed Jafri for alerting me to this important announcement.
Tags: pneumonia
The November 2009 edition of The Health Gazette Ezine will be published on schedule, November 1st. The feature article this month examines the excellent work of Alessio Fasano, M.D., professor of pediatrics and physiology at the University of Maryland School of Medicine, and director of Pediatric Gastroenterology and Nutrition at the University of Maryland Hospital for Children, on haptoglobin 2 precursor and its role in celiac disease and other autoimmune disorders.
Dr Fasano’s work has described the pathophysiology of leaky gut syndrome. We now have a much better understanding of how large molecules, such as gluten for example, can pass through what should be a barrier in the intestinal wall. As He put it: “We now have a new way of looking at our cells. Our cells are not stacked together like bricks. They are a dynamic field, which is constantly in flux.”
The research has implications for conditions such as celiac (or coeliac) disease, insulin dependent diabetes, multiple sclerosis, rheumatoid arthritis, other autoimmune disorders and allergies and even cancer, all of which are related to an exaggerated production of pre-haptoglobin 2.
The November Ezine edition is also available in the subscriber’s archive.
Holistic approaches (really wholeistic) acknowledge the actual oneness of mind and body. Use of particularistic terms like “interaction” is therefore inappropriate, but it is a way of expressing how what we call mind and recognize as body actually do interact. One such view of the nature of this “interaction” was provided by scientific study recently published in the journal Psychotherapy and Psychosomatics.
The research explored what is behind the feeling of not being competent and involved use and detailed analysis of focussed psychological measurement scales. The published paper details: Cockram CA, Doros G, de Figueiredo JM: Diagnosis and Measurement of Subjective Incompetence: The Clinical Hallmark of Demoralization. Psychother Psychosom 2009;78:342-345 (DOI: 10.1159/000235737)
Technically, the article presents the development and application of a method to diagnose and measure subjective incompetence, the clinical hallmark of demoralization. The subjects (n = 112) were patients with cancer at a consultation clinic of a cancer center. They completed a questionnaire on general background information, the Brief Cope Scale, and a newly developed scale to measure subjective incompetence. The development and psychometric properties of this scale were studied. Data analysis included both univariate and bivariate statistical tests and an examination of the intercorrelations between the subjective incompetence scores and the scores on the Brief Cope Scale.
The scale for subjective incompetence was found to have adequate reliability and validity. The proposed scale will allow the investigators to determine if the distinction between depression and demoralization has practical implications and to what extent. Where it becomes particularly interesting holistically is that it will further clarify the role of demoralization in the etiology and pathogenesis of both physical illnesses and mental disorders.
The combined use of this scale with the existing criteria and scales for demoralization will highlight the role of subjective incompetence in converting what might have been a normal response to stress into an abnormal state requiring intervention.
Tags: cancer, demoralization, depression, psychology
It was previously thought that osteoporosis – a known complication of celiac disease – develops in celiac patients because they cannot properly absorb calcium and vitamin D from their diet. Both nutrients are essential for healthy bone development.
New research has revealed that people with celiac disease may develop osteoporosis because their immune system attacks their bone tissue.
It is the first time an autoimmune response – a condition whereby the body can attack itself – has been shown to cause damage to bones directly.
Researchers from the University of Edinburgh studied a protein called osteoprotegerin (OPG) in people with celiac disease – a digestive condition that affects significantly more people than was previously thought.
In healthy people, OPG plays a crucial role in maintaining bone health by controlling the rate at which bone tissue is removed.
The latest research shows that 20 per cent of celiac patients produce antibodies that attack the OPG protein and stop it working properly. This results in rapid bone destruction and severe osteoporosis.
The team found that this new form of osteoporosis did not respond to calcium and vitamin D supplements.
The research is published in the New England Journal of Medicine.
Professor Stuart Ralston, of the Institute of Genetics and Molecular Medicine at the University of Edinburgh, who led the team, said: “This is a very exciting step forward. Not only have we discovered a new reason to explain why osteoporosis occurs in celiac disease, but we have also found that it responds very well to drugs that prevent bone tissue removal. Testing for these antibodies could make a real and important difference to the lives of people with celiac disease by alerting us to the risk of osteoporosis and helping us find the correct treatment for them.”
Source: University of Edinburgh
Of course The Health Gazette does not advocate the use of drugs unless absolutely essential. It is important for people with celiac (aka coeliac) disease to avoid gluten in their diets. The best way to preserve bone tissue is to deactivate the disease by strict gluten avoidance and to eat a healthy diet, including supplements, and to obtain regular weight-bearing exercise.
Osteoporosis is a terrible condition and definitely one to be avoided. It is important for everyone who knows they have gluten intollerance to carefully avoid gluten. This is not easy for people who eat processed foods and junk food. It is worth learning how gluten is masked in common foods you may eat and to find safe alternatives.
Tags: celiac, coeliac, gluten, osteoporosis