Infections, oral anticoagulant therapy, cotrimoxazole and ciprofloxacin

The newsletter on Patient Safety of the Ministry’s Quality Agency has published a new edition with articles of great interest. Among them, one published in Archives of Internal Medicine that associate the increased occurrence of upper gastrointestinal (UGI) tract hemorrhage in patients undergoing oral anticoagulant therapy with warfarin, if they are prescribed cotrimoxazole or ciprofloxacin, for a lower urinary tract infection (UTI), for example.

The researchers conducted a population-based, nested case-control study. Cases were hospitalized with UGI tract hemorrhage. For each case, we selected up to 10 age- and sex-matched control subjects. We calculated adjusted odds ratios (aORs) for exposure to cotrimoxazole, amoxicillin trihydrate, ampicillin trihydrate, ciprofloxacin hydrochloride, nitrofurantoin, and norfloxacin within 14 days before the UGI tract hemorrhage.Cases were patients taking warfarin and who were hospitalized with UGI tract hemorrhage. 2151 cases and 21434 controls were identified (10 for each). Researchers investigated whether the patients had taken in the days before cotrimoxazole, amoxicillin or ampicillin, ciprofloxacin, nitrofurantoin and norfloxacin (antibiotic commonly used to treat UTIs). Cotrimoxazole was even associated with increased risk of UGI hemorrhage, with an OR of 3.84. It also occurred with ciprofloxacin, with an OR of 1.94. Amoxicillin, ampicillin, nitrofurantoin and norfloxacin were not associated with an increased risk.

Although cotrimoxazole is rarely used in Spain at present, ciprofloxacin is usually prescribed. This article provides guidelines for a safer –and more rational- treatment of the UTIs or other location.

Fischer HD, Juurlink DN, Mamdani MM, Kopp A, Laupacis A. Hemorrhage during warfarin therapy associated with cotrimoxazole and other urinary tract anti-infective agents: a population-based study. Arch Intern Med 2010; 170 (7):617-21. [PMID: 20386005].


Posted by Fernando Palacio
English version by Erika Céspedes

Detection of potential interactions by the electronic medical record: A new approach to improve patient safety

The European Journal of General Practice has published the article: Prevalence and typology of potential drug interactions occurring in primary care patients. Authors: López-Picazo JJ, Ruiz JC, Sanchez JF, Ariza A, Aguilera B, Lazarus D, Sanz GR.

The objective of this article is to determine the prevalence and type of potential drug interactions in primary care patients.

It is very interesting because its content is directly related to medical errors and their consequences, adverse effects and drug interactions in primary care. This field has a huge impact on the global patient safety due to the high number of visits, the level of prescription and other factors such as pluripathology.

The authors start from the difficulty of identifying and confirming the actual prevalence of drug interactions, to propose a preventive approach. It is acting on potential drug interactions identified by the electronic medical records (and confirmed by prescription -recipes used-), according to the evidence available, and using software that identifies patients likely to suffer these potential interactions. All this would be completed by a warning system, related to the medical record, that, in real time, allows the family physician identify the potential interaction, and with the automatic proposal of safe therapeutic alternatives. Every active ingredient that each patient can be taking simultaneously is analyzed.

The study confirms the existence of a serious safety problem for patients, because 1 in 20 Spanish citizens is subject to the risk of drug interaction. And, more important, with a high rate of serious or high risk interactions.

At the time of analysis 29.4% of the population took medication. Of these patients, 73.9% took more than one drug and, therefore, was at risk of interactions; more than a half of the potential interactions could be clinically important. However, the percentage of interactions observed is usual in the literature.

There are more interactions among people with chronic conditions, the elderly, females and polymedicated patients. The active ingredients most frequently involved were hydrochlorothiazide, ibuprofen and acenocumarol. Respect to interactions that should be avoided, the most common are combinations with omeprazole, acenocumarol and diazepam.

This approach and the results of this study provide us valuable information and, most of all, a new simple and practical approach, which should not be wasted by the professionals or the institutions involved, for the benefit of our patients.


Edited by José Saura Llamas
English version by Erika Céspedes

Learning from the successes. Safety Meeting’ 10

The Observatory for Patient Safety, of the Quality Agency of Andalusia, has organized this conference on 23 September in Seville.

There will have place roundtables with suggestive titles such as "Improving safety is simple", "Improving safety takes 2 minutes" or "Report of successes".

On the other hand they will project the safe practice experiences sent before 15 September.

The Observatory organized with our group the 2nd Seminar for Patient Safety, held in Granada in 2009, so we know their good job. Therefore we encourage you to go to Seville.

The program and registration are available on this webpage.


Posted by Fernando Palacio
English version by Erika Céspedes

The quality, security and content of telephone and face-to-face consultations: a comparative study

Telephone consulting is increasingly used to improve access to care and optimise resources. However, there remains a debate about how such consultations differ from face-to-face consultations in terms of content, quality and safety. To investigate this, a comparison of family doctors' telephone and face-to-face consultations was conducted.

106 audio-recordings, from 19 doctors in nine practices, of telephone and face-to-face consultations, stratified at doctor level, were compared using:

- The Roter Interaction Analysis Scale (RIAS), measuring the content

- The OPTION, that observes patient involvement in decision making

- A modified scale based on the Royal College of General Practitioners (RCGP) consultation assessment instrument, measuring quality and safety

- Patient satisfaction and training (empowerment) were measured using validated instruments.

Telephone consultations were shorter: 4.6 minutes, on average, compared to 9.7 minutes of the face-to-face ones.

The study concludes that although telephone consultations are convenient and judged satisfactory by patients and doctors, they may compromise patient safety more than face-to-face consultations and further research is required to elucidate this.

Telephone consultations are more suited to follow-up and management of chronic diseases than for acute management.

McKinstry B, Hammersley V, Burton C, Pinnock H, Elton R, Dowell J, et al. The quality, safety and content of telephone and face-to-face Consultations: a comparative study. Qual Saf Health Care. 2010 Aug; 19 (4) :298-303.


Posted by Lola Martín
English version by Erika Céspedes

Organisational readiness: exploring the preconditions for success in organisation-wide patient safety improvement programmes

Does any organization can implement a patient safety improvement programme?

What does it need to succeed? What results can be expected?

Quality and Safety in Health Care has published this original research outlining some answers.

UK researchers examined the perceptions of organizational readiness and its relation to the impact of the Safer Patients Initiative (SPI), a national initiative of the Health Foundation to address the patient safety improvement.

To learn about this perceptions they used a mixed-methods design, involving a survey and semistructured interviews with a sample of the improvement groups (consisting of senior executive leads, the principal SPI programme coordinator and the operational leads in each of the SPI clinical work areas) of the four organizations taking part in the first phase of SPI.

They obtained a response rate of 90% and 34 leaders participated in the interviews.

The questionnaire included items on perceptions of readiness in the following aspects:

1. Culture and attitudes toward quality and safety
2. Systems and infrastructure
3. Resource availability, measured on a scale from 1 (low preparation) to 6 (high preparation)

Further, it wondered about organizational stability, measured on a scale from 1 (stable) to 6 (turbulent).

It also asked for a specific score using a scale of 3 (significant strength) to -3 (significant weakness), of 15 factors such as financial resources, medical support, support from nurses, support from managers, etc.

The interviews contained open questions about the preconditions of the organization (culture, history of improvement, quality of information systems and measurement procedures, financial stability...) and the preparatory factors of the initiative (framework for program management, team's initial selection, clinician’s participation, communication and training before deployment...).

For the entire sample, culture and attitudes were better rated than systems and infrastructure and also than availability of resources. Everybody said that their previous history of improvement was important to take the initiative and all also experienced difficulties with the information and assessment systems’ capacity. The importance of the financial balance and the outcome was particularly important for executives.

With respect to specific factors, most were considered strengths but, while managers’ and nursing’s initial support was rated as good, medical initial support was rated worse (it was considered a weakness).

Personal interviews revealed that it is worth reflecting on the influence of the conditions at the beginning of the program. This reflection process gives the organization a valuable learning.

The highest score has the overall perception of preparation in an organization; the greatest impact presents the initiative on quality and security performance, greater sustainability of its benefits and greater success in its deployment in that organization, being leadership style an important factor in this preparation.

So this study, though preliminary, would suggest that prior to start these programmes, organizations would benefit from an assessment of their readiness with time spent in the preparation of its infrastructure, processes and culture. Furthermore, a better knowledge of these preconditions, that mark an organization as qualified to undertake the improvement work, would allow managers to set realistic expectations about the results of safety campaigns.

Burnett S, Benn J, Pinto A, Parand A, Iskander S, Vincent C. Organisational readiness: exploring the preconditions for success in organisation-wide patient safety improvement programmes. Qual Saf Health Care 2010;19:313-317


Posted by Marisa Torijano
English version by Erika Céspedes

3rd Seminar. Involving professionals in patient safety

Cristina Cedrún of the Primary Care Area 5 of Madrid, presented the interventions undertaken to improve reporting of incidents.

These interventions achieved the declaration of a 76% above the proposed objective.

The information and involvement were again the key.

The authors are: Cedrún Lastra, C; Martínez Patiño, M.D; Piédrola Martínez, M.


+ Info: http://seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20028.pdf

Several posts on reporting adverse events have been published in this blog. Those can be accessed by typing in the search box on the right column the word “notification”.


Posted by Fernando Palacio
English version by Erika Céspedes

A brief synopsis on Patient Safety, WHO/Europe 2010

A brief synopsis on Patient Safety, WHO/Europe 2010.

“This document provides a simplified and non-exhaustive synopsis of the major international patient safety initiatives – past and present – undertaken in the WHO European Region. While patient safety is a complex issue spanning numerous public health and health-care domains, this document adopts a generic understanding of the subject in respect to avoidable harm.

As such, most of the patient safety interventions chosen for this document have a general and cross-cutting character and do not include the many complementary and dedicated actions developed at various levels of the health system and beyond. Moreover, as patient safety is constantly developing better ways to respond to health, economic, social and environmental challenges, the document is to be seen as a 'snapshot' of the current state of affairs in the WHO European Region, and as a work in progress”.

We can find in this document contents related to taxonomy, legislation, initiatives and consensus on safety in the WHO European region, and the list of initiatives related to patient safety, arranged chronologically from 2004 until this moment.

+Info: A brief synopsis on Patient Safety, WHO/Europe 2010 (pdf file)


Posted by Lola Martín
English version by Erika Céspedes

3rd Seminar. Design and implementation of a protocol on users’ unequivocal identification in primary care

The topic of the unequivocal identification of patients was also present at the Seminar, through this presentation of the Guadalquivir Sanitary District, Córdoba. The authors are Hervás Vargas, A. and Gutierrez Sequera, J.L., who summarize their work thus:

Problem Description: In the provision of health care, the identification of patients involves risks that may result in misdiagnosis, testing, surgery or giving medications or blood products to wrong patients.

Proposal for improvement: The Strategy for Patient Safety of the Andalusian Autonomous Government includes among its objectives the unequivocal identification of citizens that contact with the Andalusian Public Health System and says explicitly that all citizens treated in primary care must be unequivocally identified by at least two data, one of them, the Unique Andalusian Health Record Number (NUHSA). Therefore, we have developed a protocol which aims to establish a policy for secure identification of patients that lets identify reliably the patient as the person to whom the treatment, care or service is focused and, in turn, relate the treatment, care or services with that patient.

Strategy: The scope of our work covers all health services that integrate the eight Clinical Management Units of our Health District: primary care centres, emergency departments, domiciliary care, critical care units, minor surgery, etc., and so to all health and non health professionals who have direct care contact at any time with the patient.

The following tools will be used for diffusion:
1. Sessions/Workshops for health and non health professionals.
2. Brochure for the Citizen Advice Service Professionals.
3. Publication of the document on safety and unequivocal identification of patients in local magazines, aimed at citizens.
4. Publication of the document on safety and unequivocal identification of patients, aimed at professionals in newsletters.

+ Info: http://seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20020.pdf


Posted by Fernando Palacio
English version by Erika Céspedes

Time to listen: a review of the methods to solicit patient reports of adverse events

As patient participation is a relatively new addition to patient safety reporting systems, the techniques that are most successful and efficient are not yet known.

The journal Quality & Safety in Heath Care has published this literature review on reporting systems used by patients: populations, contact methods, verification, reporting, incentives, incident rates and reporting terminology.

Two databases were searched: PubMed and MEDLINE (English publications only), obtaining finally 17 publications for review. Of these publications, four focused on Primary Care (PC), and one included both primary and hospital care.

PC patient reporting studies used a combination of methods to collect patient reports: telephone recruitment with a follow up in-person interview, patient’s choice of reporting method (online, written or telephone reporting) and telephone survey. The terminology used to ask the patient about the events has also been variable.

Adverse events were corroborated only in three publications, none of PC. The incidence of nosocomial infections, pressure ulcers and drug-related events reported by patients was shown to be comparable to rates documented by healthcare providers in hospitals and to rates reported in patient safety literature.

The incidence rate for adverse events across settings and populations varied considerably, ranging from less than 0.1 to 5.8 per patient. The results are not comparable. The same happens with the classification of reports.

Thus, the variability found among the publications reviewed is extensive in terms of healthcare settings, method of reporting, time span, terminology, criteria for assessment and response rates, which makes establishing definitive conclusions impossible. It seems that higher response rates are achieved with open questions and solicitation techniques based exclusively on personal experiences by interview. Further research is required to determine the optimal language, method, format and tool for patient reporting. The utility of the incentives should also be studied.

In short, the participation of patients in reporting adverse events is a very interesting field, which represents a valuable new perspective to improve their security, but is soon to offer final conclusions. Further research is required to reach its implementation and to achieve its potential benefits.


A King, J Daniels, J Lim, et al. Time to listen: a review of Methods to request patient reports of adverse events. Qual Saf Health Care 2010 19: 148-157


Posted by Marisa Torijano
English version by Erika Céspedes

3rd Seminar. Safe practices presented by the Functional Unit of Health Risks Management, 4th Area of Madrid

The Functional Unit of Health Risks Management of the 4th Area of Madrid presented the safe practices identified in the last four years.

They define a safe practice as "an action, according to the evidence and knowledge available, to avoid or reduce health risks or adverse effects. It may respond to a particular health care situation or may be useful and/or generalizable to other facilities because of their potential impact on patient safety, frequency or importance. "

In their presentation there is a list of safe practices that are widespread. It is a very interesting list for those who want to implement them in their area of influence.

The authors are Asunción Cañada Dorado, Inmaculada García Ferradal, Carmen García Cubero, Sergio Serrablo Requejo, María Antonia Sánchez Márquez y María José Montero Fernández.

+ Info: http://www.seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20059.pdf

See also in this blog: Entrevista a Asunción Cañada a propósito de las Unidades Funcionales de Gestión de Riesgos Sanitarios (Interview with Asunción Cañada about the Functional Units of Health Risks Management)


Posted by Fernando Palacio
English version by Erika Céspedes

Atención Primaria Editorial: semFYC adapts the WHO recommendations on hand hygiene for Primary Care

The journal Atención Primaria publishes in its last number an editorial with the title: La Sociedad Española de Medicina Familiar y Comunitaria adapta las recomendaciones sobre higiene de las manos de la Organización Mundial de la Salud para atención primaria (The Spanish Society of Family and Community Medicine adapts the World Health Organization recommendations on hand hygiene for Primary Care).

The editorial is about why and how the semFYC’s Patient Safety Group, which manages this blog, made recommendations on that subject as well as a summary of its contents.

The full text of the Recommendations on hand hygiene for Primary Health Care workers and for Health Services in Spain can be downloaded here (html) and here (pdf)


Palacio J, Aibar C, Marec R. La Sociedad Española de Medicina Familiar y Comunitaria adapta las recomendaciones sobre higiene de las manos de la Organización Mundial de la Salud para atención primaria (The Spanish Society of Family and Community Medicine recommendations on adapting the hand hygiene of the World Health Organization for Primary Care). Aten Primaria. 2010; 42:401-2.


Posted by Safe and Healthy
English version by Erika Céspedes

3rd Seminar. Assessment of the Registration System of falls in nursing home residents and identification of improvement strategies

This oral presentation was considered the best of its work group (they chose the best presentation in each work group).

This presentation studies the falls in elderly residents of nursing homes in the Granada Sanitary District, and has three main objectives:


1. To determine the incidence of falls in nursing home residents.

2. To perform an analysis of the most common causes of falls.

3. To categorize the identified improvement areas to plan intervention strategies.

4. To assess the impact of the registration system in the professionals.


The results are very interesting. Among them, for example:

- One thousand and two patients of the total of 3142 had one or more falls in a period of less than three years.

- About 12% of the patients who fell went to the Emergency, and 3% of the total was hospitalized.

An ambitious and very well described project, on a topic often overlooked. The first author is Eugenio Vera.


+ Info http://seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20032.pdf


See also in this blog:

Evaluación multifactorial del riesgo en la prevención de caídas y lesiones en atención primaria y urgencias destinadas a personas mayores (Multifactorial risk assessment in the prevention of falls and injuries in primary care and emergency care for elderly).


Los programas de ejercicio son efectivos para la prevención de las caídas en ancianos (Exercise programs are effective in preventing falls in elderly).


Posted by Fernando Palacio
English version by Erika Céspedes

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

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.

+ Info: Summary of the Communication Evaluación del cumplimiento de higiene de manos en un Área de Atención Primaria de Madrid (Assessment of the observance of Hand Hygiene in a Primary Care area of Madrid)

See also in this blog: Recomendaciones sobre higiene de las manos en Atención Primaria (Recommendations on Hand Hygiene in Primary Care)


Posted by Fernando Palacio
English version by Erika Céspedes

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

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

Side effects of statin treatment in England and Wales

British Medical Journal published an analysis of the effects (benefits / risks) or unintentional side of statin therapy, registered in health centers in England and Wales. Includes the calculation of the NNT (number needed to treat to benefit) and the NNH (number needed to risk of adverse effects).

Cardiovascular disease is the leading cause of premature death in developed countries. Numerous published scientific papers recommending the use of statins to reduce cardiovascular risk among high-risk patients. Thus, statins have become one of the most prescribed drugs in primary care, and is likely to go to continue to increase their prescription. Side effects of these treatments, particularly those that appear over time are an underdeveloped area of research so far. However, having this information enables more informed decisions with a risk/ benefit balance shared with our patients.

The results presented in this research are from a prospective cohort study (six years) on a electronic medical records of patients whose information is dumped into a research database as many British health centers. We identified those patients treated with statins, at least one year, aged between 30 and 84 years.

Clinically relevant outcomes sought were: acute renal failure, venous thromboembolism, Parkinson's disease, dementia, rheumatoid arthritis, cataracts, osteoporotic fractures, common cancers (stomach, colon, esophagus, lung, kidney, breast, prostate, melanoma) impaired liver function moderate / severe in patients without prior liver involvement, myopathy moderate / severe or rhabdomyolysis.

The study could not confirm the potential protective effect of statins in reducing the risk of developing Parkinson's disease, pulmonary embolism, rheumatoid arthritis, osteoporotic fractures, and dementia. The authors acknowledge that the study has potential uncontrolled confounding biases. In connection with the development of cancers, it is confirmed that there is no clear link between taking statins and common cancers, except for esophageal cancer in which there is a risk reduction, and in the colon that appears pravastatin ruvastatina protective effect and increases the risk.

Confirm an adverse effect of class in relation to the occurrence of myopathy, liver dysfunction, acute renal failure and cataract.

These risks persist throughout the treatment time and were mostly in the first year of treatment. After stopping treatment, the risk of cataract, esophagus cancer, kidney failure and liver dysfunction at initial returns to age within one to three years.

As main contribution, the study provides the national estimate of the number of expected additional adverse effects associated with statin therapy per 10,000 populations, if all patients with high cardiovascular risk (15% and 20% risk of QRISK2) received statin therapy. We summarize the highlights in the following table.

	QRISK2 score >20%: risk at 5 years without treatment	NNH o NNT [IC 95%] (*)	No cases prevented / at risk per 10,000 patients [95%]
Potential damage in women
Acute renal failure	0.0041	434(284-783)	23(13-35)
Cataracts	0.1089	33(28-38)	307 (260-355)
Liver disfunction	0.0140	136 (109-175)	74 (57-91)
Myopathy	0.0020	259(186-375)	39 (27-54)
Potential damage in men
Acute renal failure	0.0047	346 (245-539)	29 (19-41)
Cataracts	0.0630	52 (44-63)	191 (158-225)
Liver disfunction	0.0133	142 (115-180)	71 (56-87)
Myopathy	0.0021	91 (74-112)	110 (90-134)
Benefits in women
Cardiovascular disease	0.1184	-37 (-64­_-27)	-271 (-374_-157)
Esophageal cancer	0.0025	-1266 (-3460_-850)	-8 (-12_-3)
Benefits in men
Cardiovascular disease	0.1326	-33 (-57_-24)	-301 (-417_-174)
Esophageal cancer	0.0042	-1082 (-2807_-711)	-9 (-14_-4)

(*) No negative indicate number needed to treat or cases prevented. No. positive indicate number needed to harm or cases are extra

Julia Hippisley-Cox and Carol Coupland.Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database
BMJ 2010;340:c2197, doi: 10.1136/bmj.c2197 (Published 20 May 2010)

See also: High doses of simvastatin and risk of muscular and renal impairment


Posted by Pilar Astier
English version by Jesús Moreno