AEMPS: Information about the use of drugs in case of heat wave

As usual at this time, the Spanish Agency for Drugs and Health Care Products (AEMPS) has issued a safety communication giving information about the use of drugs in case of heat wave.

The Spanish Society of Family and Community Medicine (semFYC) also published in June 2009, in the section of its website aimed at population, its recommendations for preventing the effects of excessive heat.

SemFYC advise to exercise extreme caution with the most vulnerable people including the elderly, the chronically ill and bedridden, obese, young children, psychiatric patients and those who take certain medications.

"The drugs that physician should take into account include diuretics (to increase the amount of urine), antihistamines (allergy), anticholinergics (depression, Parkinson's, etc), beta blockers (hypertension), phenothiazines (mental disorders)."

"In any case, you should never remove or reduce the pharmacological treatment without the risk-benefit assessment."


Posted by Jesús Palacio
Englilsh version by Erika Céspedes

Pharmacotherapeutic follow-up DaderWeb

The journal Atención Primaria have published the overall results during the first year of initiation and piloting a new Primary Care database accessible from DaderWeb.

This web application arises from the need to optimize all data related to the program Dáder. The program was designed by the Research Group on Pharmaceutical Care, University of Granada, in 1999, and is currently being used in different countries by hundreds of pharmaceutical professionals in thousands of patients. It is based on obtaining the patient's pharmaceutical record in the community pharmacy and the personal pharmaceutical monitoring (SFT) by detecting, preventing and resolving drug-related problems on a continuous, systematic and documented way. It cooperates with the patient and all professionals of the Health System, in order to achieve concrete results that improve the quality of life of patients.

This first year of initiation and piloting is aimed to improve the organization of the information provided, to avoid loss of it, to optimize the processing of data and, ultimately, to enhance the quality of the information stored in it by:

a) Preparation of records and collection of information about its activity,

b) Location and access to updated information and quality,

c) Communication between professionals.

Among the registration documents available in DaderWeb we distinguish the pharmaceutical intervention sheet (HIF), which refer to a possible pharmaceutical care across countries and fields on the detection and intervention on negative results associated with the use of drugs (RNM).

Among their findings, only in the field of primary care in Spain, 234 HIF sent (a RNM for HIF) by 27 community pharmacies, 147 patients involved, with a mean age of 66 years (SD 11.8) and 59.4% of women. The 88.5% of the RNM was clinically manifested when detected.

The most frequent RNM were related to the ineffectiveness of drug therapy, supporting the need for closer monitoring of clinical outcomes of medications.

As most prevalent causes of failure were identified the neglect (17.9%) and the not appropriate dose, regime or duration of treatment (13.7%). In the 16% of cases they did not identify any cause and in a 36.9%, although there was a problem in the application process, it was not specify in the default list provided by the HIF3.

In the 35.9% of cases the pharmacist intervened independently through direct patient education to resolve the RNM. After measuring the appropriate clinical variables indicating, in each case, the development of RNM, these were resolved in the 81.2% of the times.

To systematize the SFT has made great strides thanks to the Dáder program. The evaluation of the quality of the prescription allows to detect any differences, points of improvement and to develop and design appropriate interventions to optimize outcomes in the health field. The Dáder, certainly, is a huge step that should appeal to all community pharmacists in improving the SFT and to build on its steps.

Sabater-Hernández D, Faus D, Fikri-Benbrahim N, García-Cárdenas V. Resultados globales de la base de datos del Programa Dáder de Seguimiento Farmacoterapéutico: 2008. Aten Primaria. 2010;42:297-8.


Contribution by M ª José Montero Fernández. Primary Care Pharmaceutical, Area 4, Madrid.
English version by Jesús Moreno

Held the First Congress of the Health Blogosphere

As announced on this blog, last Monday June 14 was held in Madrid the 1st Congress of the Health Blogosphere.

We presented there our blog Safe and Healthy. The presentation can be downloaded here. It is a summary on what it is and what can be found in safeandhealthypatient.org (the English version of sanoysalvo.es).

The conference was a success of participation and contents, that is why we must thank the organizers.


Posted by Jesús Palacio
English version by Jesús Moreno

What European population knows about the use of antibiotics. Eurobarometer 2010

Antimicrobial resistance is a threat to world public health. Recognizing this, the European Union (EU) has launched a Community strategy against antimicrobial resistance, which includes initiatives to promote its safe use and to combat misconceptions about antibiotics.

Thus, since 2008, the EU organizes an annual campaign to raise awareness on the proper use of antibiotics, coordinated by the European Centre for Disease Prevention and Control - ECDC. We have echoed these campaigns in this blog.

However, despite these and other initiatives, the results published in 2010 in the antimicrobial resistance Eurobarometer shows that citizens ignore issues such as when to take and what are antibiotics.

The study was conducted through a survey of 26 761 inhabitants of the EU member countries. A summary of the most relevant results are shown in the following presentation that compares the situation of our country (Spain) with the rest of Europe.

Conocimiento de la población europea con respecto al uso de antibióticos. Eurobarómetro 2010

View more presentations from Sano y Salvo.

As a conclusion, future campaigns on antibiotics should be more consistent and show that antibiotics are completely ineffective against viruses. The broadcasts on television that target the public in general are still valid, because they reach large numbers of people.

Citizens rely on their doctors to obtain adequate information regarding the use of antibiotics, so these professionals can and should participate actively in these campaigns.


Posted by Guadalupe Olivera
English version by Erika Céspedes

Versión en español de esta entrada

V International Conference on Patient Safety

Under the Spanish Presidency of the U.E. Madrid was held at the V International Conference on Patient Safety. Impeccable organization and excellent speakers at tables rather moderate.

A lot and very good. How to summarize? I chose to reflect what has impressed me most as a family doctor who has left these days its small and saturated query to continue learning to improve the safety of care patients receive.

I encourage the rest of the attendees to write their impressions on this blog from the same or from other points of view and thereby enrich my comment.

About infections associated with health care and antimicrobial resistance I noted: Over 50% of the Spanish adult population admitted having taken antibiotics in the last year (30% "with the flu").

Antibiotic consumption is associated with increased bacterial resistance which cause delays in the administration of effective treatments and therefore increase morbidity and mortality, prolonged hospital stay and high economic costs. Resistance increases with increased use. It is shown that less use increase complications in patients with infectious disease.
In Spain, 92% of antibiotics are acquired by prescription (in France 97%, with a European average of 95%).

Other data for comparison with the rest of Europe: we consume more broad-spectrum antibiotics and continues the upward trend in the prevalence of MRSA in our hospitals (the French show that this trend can be reversed).

Research on antibiotic therapy is virtually idle since the 60s (currently only a research compound against gram negative).

There is decrease in the supply of active ingredients while raising presentations. The EFG represent 43% of prescriptions.

What I can do?

Non-pharmacological interventions:

Prudent use of antibiotics: only when necessary, correct intervals and duration.

Optimization of empirical treatments. Prescribing based on evidence.

Help end the illegal practice of giving antibiotics without a prescription at the pharmacy (for example, not providing the same into the patient).

Ask to enhance research in antibiotics (eg, not favoring my requirements that the business is in selling so many drugs that do not represent steps)

Find information and training and quality transparent

Collaborate with health authorities in health education campaigns for proper use of antibiotics and other initiatives related to patient safety.

Regarding measures to be taken to prevent transmission of pathogens themselves that we use and abuse the most powerful tool to address infections associated with health care: hand hygiene. Compliance through this simple but effective measure is only 38% and fewer doctors that nurses meet.

I keep taking note of the representatives of our patients tell us they are in health care silence and concealment of errors, reactive actions to prevail against those aimed at preventing them.

We ask for proactive risk management, teamwork, improve communication with and among us, standardization of procedures based on best available knowledge to care "partnerships" with industry to establish and therefore we do not focus on the sophisticated technology in the pursuit of our interest but in the promotion of good practice and in them, our patients.

They in turn are considering what to do for health systems and better use of resources and effort to ask for and offer honesty, transparency and participation.

Already in the last speech heartened to hear that primary care matters a great deal, how to tell us so little!

But beyond the first moment of pride that we have to take rather this phrase as a warning: be so important in AP extent of the risk does not appear to be reaching for now strategies to achieve safer health care in the same So get to other levels of care.

I recommend to visit the website of the Linneaus project.

For my part I try, and this week in my small and saturated consultation, follow some concrete recommendations for action by his representative: Do not lose sight of the importance of good interaction with the patient to understand and follow my explanations, explanations should be improving day by day and manage my time so you can establish routines that allow me to advance the consultation of the patient if something can not go well and record, report, analyze and learn from the failures and errors.


Posted by Marian López Orive
English version by Jesús Moreno

The Gaal questionnaire, a tool to introduce the Safety Culture

We have uploaded to “sanoysalvo files" the spanish version of the questionnaire developed by Sander Gaal, to know the perception that the health professionals of the risks to patient safety.

It is a very interesting questionnaire that has two parts. The first presents 10 situations of everyday practice and the second presents 15 factors that can influence the safety of patients. The questionnaire requests the value from 1 (not committed / not increase the risk for patient safety) to 5 (patient safety is very committed / greatly increases the risk) each of the 25 items.

It is not a questionnaire to evaluate, since there are no right answers, but is useful for input to the subject. The discussion of each of the situations or the importance of risk factors can facilitate an introduction-based daily practice, the concepts related to patient safety.

This approach to how professionals value the risks is essential in order to improve the safety culture, for if the perception of risk is low will be more difficult to be aware of the problem.

+ info: Patient safety in primary care: a survey of general practitioners in The Netherlands.
Gaal S, Verstappen W, Wensing M.
BMC Health Serv Res. 2010 Jan 21;10:21.


Posted by Fernando Palacio
English version by Jesús Moreno

From Evidence-based Medicine to Marketing-based Medicine

A study published in the Journal of Bioethical Inquiry shows how pharmaceutical companies use business marketing strategies that serve to provide very flattering data, with respect to its products, in terms of efficacy and safety. In this way they get to influence the opinion of prescribers and clearly enhance their marketing interests.

The study uses several internal documents from the pharmaceutical industry and analyzes which strategies are used. Some of the most significant are the Suppression and spinning of negative data and the publication of their studies in journals of high reputation, using the name of well-known professionals who lend their names to change counterparts, whereas the real authors of the article corresponds to a 'ghost' hired by the company. The objective of this technique is to get scientific credibility among readers.

The authors present examples of strategies used in the field of mental health by different companies, transforming studies whose results show a lack of efficacy or questionable efficacy in an effective study.

Other strategies used serve to increase the indications for its products, especially in subclinical or borderline situations. It highlights how the industry segments the market according to the personal profile of the physicians, directing their efforts mainly towards those profiles that are more easily influenced.

The authors conclude that the impact of marketing-based medicine is a poorer health outcomes and increased costs, making it necessary to propose solutions that enable a transparent dissemination of studies conducted by pharmaceutical companies. Those solutions are the prospective registry of clinical trials and their results in public acces registries, public access to regulatory agency reports, as well as a more rigorous role of the editors of medical journals.

These behaviors are obviously hidden, making it difficult to know its extent. That raises the need to reform the system for development and approval of new treatments to enhance transparency and independence in the assessment of both their effectiveness and safety.

Full text: Spielmans GI, Parry PI. From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents. Journal of Bioethical Inquiry. 2007; 7:1(13-29)

See also Industria farmaceútica y promoción de medicamentos ¿todo vale?


Posted by Guadalupe Olivera
English version by Erika Céspedes

Drugs and driving

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) has posted on its website a new section of drugs and driving.

The packages of medicines that can produce effects that impair the ability to operate a car or a dangerous machine shall have the symbol illustrated here before 2011.

You can consult on this page which active ingredients have to use or not the symbol.

Posted by Jesús Palacio
English version by Erika Céspedes