Friday, July 30, 2010

The Ministry of Health and Social Policy has posted on the network the presentations of the 5th Conference

Our readers will remember that the last June 3 and 4 was held in Madrid the 5th International Conference on Patient Safety, which has already been reviewed in this blog.

The Spanish Ministry of Health and Social Policy has posted on its Patient Safety Web Site, the presentations of that conference.

It is also an opportunity to visit -for those who have not yet done it- the specific Patient Safety Web which provides interesting and important contents.

Posted by Fernando Palacio
English version by Erika Céspedes

Wednesday, July 28, 2010

Again with blood glucose meters: Supplementary information

We recently echoed in this blog a warning from the Spanish Agency of Drugs and Health Care Products (AEMPS), referring to problems of interference in glucose meters.

Abbott Laboratories have corrected their test strips FreeStyle Lite, for not to interfere with certain medications at the time of measuring blood glucose in diabetic patients.

They have therefore changed the reactive enzyme, replacing PQQ-glucose-dehydrogensasa by glucose dehydrogenase-FAD, which is specific for the detection of glucose in blood.

To identify these new strips they have changed aspects of packaging and labeling, making it necessary to pay attention to these changes.

The Spanish Agency for Drugs and Health Care Products (AEMPS) has issued a supplementary information to the security note on possible errors in measurements of glucose in diabetic patients due to interference with certain treatments, which provides detailed information on laboratory changes.

See also in this blog:

Again with blood glucose meters

Beware with blood glucose meters

Posted by Juan José Jurado
English version of this post Jesús Moreno

Monday, July 26, 2010

3rd Seminar. Assessment of the observance of Hand Hygiene in a Primary Care area of Madrid

With the aim of bringing good practices to our daily work, we start a little series where we will bring to the blog the oral communications presented at the last 3rd Seminar for the Improvement of Patient Safety in Primary Care.

And we start with a polemical topic, hand hygiene.

We know that hand hygiene, as the WHO recommends, is a controversial topic in Primary Care, where the famous five stages do not find a proper insertion. To approximate us to reality the Training and Research Unit of the 4th Area of Madrid designed an observational study whose results were presented at the Seminar. Those results are very interesting because they show a low level of observance, even after risk of exposure to body fluids. Although the WHO recommendations are not enterely applicable in Primary Care, this study provides evidence that our reality, on hand hygiene, may be well below than acceptable. Both at Hospitals and Primary Care, it seems to be great opportunities to improve a behaviour that affects patient and professional safety.

The researchers have been Carmen Martín Madrazo, Juan Carlos Abanades Herranz, Asunción Cañada Dorado, Miguel Salinero Fort and Sonia Soto Diaz.

Tuesday, July 20, 2010

Manual of Patient Safety for nursing

Nurses play a vital role in improving the safety and quality of patient care, not only in health care facilities but also community-based care and the care performed by family members. That is why we echo a publication of 2008 of the Agency for Healthcare Research and Quality (AHQR) that may be useful for nurses to select techniques and interventions with proven effecacy.

The publication of 1 400 pages, is titled Patient Safety and Quality: An Evidence-Based Handbook for Nurses.

It is structured in the following sections:

- Patient Safety and Quality
- Evidence-Based Practice
- Patient-Centered Care
- Work Conditions and Work Environment
- Critical Opportunities for Patient Safety and Quality
- Tools

It is a complete, clear, scientific and practical book.

Hughes RG (ed.). Patient safety and quality: An evidence-based handbook for nurses. (Prepared with support from the Robert Wood Johnson Foundation). AHRQ Publication No. 08-0043. Rockville, MD: Agency for Healthcare Research and Quality, March 2008.

Contribution by Jesús Moreno, a nurse. Entrimo Health Center (Terrachan), Spain.
English version by Erika Céspedes

Wednesday, July 14, 2010

GSK hid the Rosiglitazone (Avandia) is associated with cardiovascular risk

The New York Times has published an article which alleged that GlaxoSmithKline (GSK) has withheld the results of a study, organized by the very multinational pharmaceutical company, which showed an increased cardiovascular risk in patients treated with rosiglitazone (Avandia).

Rosiglitazone, a drug used in the treatment of diabetes, is also marketed in the European Union, in combination with Metformin (Avandamet) and Glimepiride (Avaglim).

This study, conducted prior to the approval of the product, comparing rosiglitazone with pioglitazone, concluded not only that it was not superior for treatment, but also produced an increased cardiovascular risk. Although the results were clearly unfavorable to the drug of GSK, the laboratory not only did not published them but, according to company files, deliberately concealed them, stealing relevant information for the approval of the regulatory agencies.

Currently, the agencies responsible for authorization of medicines in USA (FDA) and the European Union (EMEA), are assessing the safety of Rosiglitazone, after the publication last year of two studies concluding that it increases the likelihood of suffering serious cardiovascular problems and even death.

That is, new trials agree in indicating cardiovascular risks identified previously by the manufacturer in 1999 and hidden from the authorities, patients and professionals. Meanwhile thousands of patients, only about 80,000 in Spain, are taking a drug that some studies indicate may increase the risk of suffering a cardiovascular event like heart attack, stroke and even death.

There is a fierce debate in the FDA over the decision to take on Avandia, in which the director of new drugs, John Jenkins has defended the retention of the drug on the market, and has even informed GSK managers about the internal deliberations of the agency.

Rosemary Johann-Liang, an former member of that department of the FDA, who was sanctioned for recommending to emphasis Avandia's cardiovascular warnings in its package information leaflets, has now joined the voices calling for a change in the leadership of the FDA.

+ Info on NYT Diabetes Drug Maker Hid Test Data, Files Indicate

See also in this blog: GSK recibe una reprimenda de la FDA por ocultar datos sobre su antidiabético Rosiglitazona (Avandia)

Posted by Jesús Palacio
English version by Jesús Moreno and Erika Céspedes

Thursday, July 8, 2010

The effects of on-screen, point of care computer reminders on processes and outcomes of care

A Cochrane review on on-screen computer reminders delivered to health professionals at the point of care, concludes that those ones produce only small to moderate improvements in both process and outcome of care.

Computer reminders are intended to help health care professionals to recall information that they may already know, but could forget easily when doing other activities of care. They also serve to support decisions, provide information or guidance in an accessible format at a particularly relevant. These reminders are able to address multiple topics, are automatic and come at the right time of care.

This Cochrane review found 28 studies that evaluated the effects of different on-screen reminders. The studies tested reminders to prescribe specific drugs, to warn about drug interactions, to provide vaccinations or to order tests.

The review found small to moderate benefits, that is, these reminders improved medical practice in a small percentage by measuring the results against the percentage of patients receiving care according to the reminder given to the professional (e.g. specific medication prescription, performance of a specific task such as sending to a medical specialist, etc.).

They also studied continuous process outcomes, for example, duration of treatment with antibiotics and various markers of disease or health status (e.g., mean blood pressure or cholesterol level). However, the results of improvement patients’ health also achieved small benefits.

Shojania KG, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care.. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD001096. DOI: 10.1002/14651858.CD001096.pub2

See also in this blog: ¿Se cancelan las alertas sobre medicamentos en la prescripción electrónica?

Posted by Guadalupe Olivera
English version by Erika Céspedes

Sunday, July 4, 2010

Again with blood glucose meters

To complete the warning published in the previous post on blood glucose meters, we have posted in sanoysalvo files a review made in the Area 6 of Madrid, which details issues such as reliability, calibration, interferences and frequent errors, that must be read by those who perform this type of techniques.

Click here to download the document.

Posted by Juan José Jurado and Fernando Palacio
English version by Jesús Moreno

Thursday, July 1, 2010

Beware with blood glucose meters

The Spanish Agency for Drugs and Health Care Products has issued a safety note on June 18 warning on the risk of possible errors in measurements of glucose obtained with some blood glucose meters using the enzyme as a reagent pyrroloquinoline quinone glucose dehydrogenase (GDH-PQQ ), interfering in these results some medications.

Meters that use this enzyme are Accu-Chek Sensor®, Accu-Chek Compact Plus®, Accu-Chek Compact®, Accu-Chek Aviva®, Accu-Chek Aviva Nano® , Accu-Chek Voicemate®, FreeStyle Lite® and Freestyle Freedom Lite®.

Drugs wich may interfere are Extraneal® , Orencia®, Octagamocta® and Adept® 4%.

This same warning has been published by the FDA in August 2009 (FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ * Glucose Monitoring Technology).

Both notes report that the use of these meters in patients undergoing treatment with outlined in the table medications, can produce abnormally high results detecting substances other than glucose that are generated from the administration of these drugs.

Worth noting that these drugs are not used routinely in primary care settings because the conditions for which are shown are monitoring, most of them specialized care. These patients are those undergoing peritoneal dialysis (Extraneal), patients with certain immune deficiencies situations or undergoing bone marrow transplantation (Octagamocta), patients with rheumatoid arthritis (Orencia), or patients undergoing abdominal surgery (Adept).

It is important therefore not to use these blood glucose meters in these patients.

With respect to the use of blood glucose meters, we also note that a valid result can come conditioned by other aspects of this process:

• Assessing the need for prior calibration of the meter.
• Improper storage of test strips.
• Ambient temperature.
• Insufficient blood volume.

Also, each meter has different methodologies for testing. Therefore, it is not advisable to make comparisons of results between different commercial laboratories.

Posted by Juan José Jurado
English version by Jesús Moreno