What to do if things go wrong: a guide for junior doctors

This National Patient Safety Agency's booklet is a guide for junior doctors to manage a patient safety incident.

It is organized in 6 sections.

First, a description of a personal experience of having a medical incident. Second, to document the incident in the patient’s medical records and to inform consultant and/or supervisor. Third, to communicate the incident to the patient, family and caregivers and apologise to all. Fourth, to report the incident in a local reporting system. Fifth, the guide enhance that junior doctors, on the frontline of care, are vital in the identification of learning from reporting. Finally, an algorithm is presented to deal with the complaints process in England.

Every section is introduced by an incident description from a relevant medical doctor in England.

It is easy to read and a good example to adapt in every country as a guide to promote good answers to incidents in practice for junior doctors.

Medical error. What to do if things go wrong: a guide for junior doctors


Posted by Pilar Astier
English version by Pilar Astier

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

Increased reporting of medication errors in a Healthcare Area

Virginia Greciano, of the Area 2 of Madrid, presented an interesting oral communication on medication error reporting, which is summarized below.

Given the necessity to extend definitively the culture of reporting medication errors (ME) and facing an increasing number of targets by the organization, the Functional Unit for Health Risks Management (FUHRM) proposed the Pharmacy Department to develop strategies to promote reporting.

Managers designed a training session on ME for healthcare centers in the Area 2. This session was directed at doctors, pediatricians and nursing, and other non-healthcare professionals. The main objective was to deepen the concept of ME and its differentiation from other adverse events. The content was also aimed at promoting reporting by simple steps, as well as illustrating the session with useful information and examples.

There were a few support messages based on 4 basic principles:

1. Curiosity: about any circumstance that cause surprise about a drug or pharmaceutical product at any time.

2. No doubt: "at the dilemma of whether it is an ME, an adverse reaction or other event, report it. An excess of notification does not hurt anybody and do so could get a risk to the patient ".

3. No blame: the ME is a part of the sanitary work. Reporting is anonymous, encourages a culture of risk and helps us grow as healthcare professionals.

4. Avoid bureaucracy: do not let papers paralyze you. To report a ME, just publicize it and ask for collaboration.

The results of the sessions were very interesting in terms of number of people attending and the number of notifications that have been received later. In less than six months reported a number of EM sufficient to achieve the goal of the year, reaching 42% report a higher than agreed. At the end of 2009, we were the third AP Management goal percentage and fourth in number of notifications.

Having identified the improvement areas and made the balance in the FUHRM, various measures have been proposed to maintain this line of work in the future.

To view the full presentation click here


Posted by Fernando Palacio
English version by Erika Céspedes

Patient Safety 2010 Eurobarometer

The supplement on Patient Safety, of the newsletter of the National Health System’s Quality Agency, announces the publication of the Patient Safety 2010 Eurobarometer.

It is a very complete report, with 107 pages, containing the results of 26,663 questionnaires in the 27 EU countries.

Nosocomial infections are the adverse effects perceived as most frequent, followed by misdiagnosis and problems with medication.

When people are asked about the risk of having an adverse effect in the hospital, Greeks express the greatest mistrust, measured at 83%. The EU average stands at 50% and in the case of Spain, by 35%.

When the question refers to the risk in Primary Care, Greeks repeats the worst result, 78%. The EU average is 46% and 32% in Spain.

It is surprising that, despite the different kind of care, there is little difference between the estimation by the citizens of suffering harm in the hospital (35%) or primary care (32%).

Those are good results for Spain in terms of public confidence in the NHS, which compels us to continue working to not disappoint it.


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

Europe removes drugs containing rosiglitazone (Avandia®, Avandamet® and Avaglim®)

Finally, rosiglitazone (Avandia®) is no longer available in Europe.

In a previous post we discussed an article of The New York Times, which might help to explain why the FDA refuses its full withdrawal, although rosiglitazone is not better than pioglitazone, but causes more cardiovascular problems.

Yesterday, El País reported extensively on the ban, until Glaxo can "identify the group of patients in which the drug benefit exceeds the risks".

Avandia® sold 920 million Euros last year, and had arrived in 2006 to more than 2000 million. The question is: If the alert was given, and there are equally effective alternative medications, and safer, why was it still prescribed?

+ Info: - Spanish Agency for Drugs and Health Care Products (AEMPS):

Patient information note on the suspension of marketing of drugs containing rosiglitazone (Avandia ®, Avandamet ®, Avaglim ®)

Communication for professionals

- European Medicines Agency (EMA):

Press release: European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim

Questions and answers on the suspension of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)


- In this blog:

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

GSK recibe una reprimenda de la FDA por ocultar datos sobre su antidiabético rosiglitazona (Avandia) (GSK receives a rebuke from the FDA for hiding data on its antidiabetic rosiglitazone Avandia)


Posted by Fernando Palacio
English version by Erika Céspedes

MedlinePlus: Talking with your doctor

This website presents, in the section "Health News", some advices for patients to prepare for consultation with their doctors so the patient can participate actively in the care process.

The objective of these tips is the patient to reflect about the importance of his participation, from the position of a formed patient, in the healthcare process. The patient should organize information about his disease to be transmitted to the doctor during the visit. He must also raise the questions necessary to understand their disease: what is happening, what is the evolution and how will be the treatment and the follow-up. After the consultation the patient should not have doubts about the information transmitted by the doctor.

In the news you will find links to other documents of interest for patients, related to the medical consultation:

• Be an active member of your health care team (Food and Drug Administration)
• How to talk to your child's Doctor (Nemours Foundation)
• Tips for talking to your Doctor (American Academy of Family Physicians)

The column on the right contains links to topics of interest: Patient Safety, Patient Rights...


Posted by Lola Martín
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

Seminar of the Spanish Society of Preventive Medicine, Public Health and Hygiene: Patient safety, a shared commitment, a general interest

The next September 17 will take place in Alicante a Seminar of the Spanish Society of Preventive Medicine, Public Health and Hygiene (Sociedad Española de Medicina Preventiva, Salud Pública e Higiene), in which also participates the Spanish Society for Quality Healthcare (Sociedad Española de Calidad Asistencial, SECA) and the Spanish Association of Health Risks Management and Patient Safety (Asociación Española de Gestión de Riesgos Sanitarios y Seguridad del Paciente, AEGRIS).

Their slogan: "Patient safety, a shared commitment, a general interest”.

Some of the most committed to patient safety will participate, including our colleague Carlos Aibar, who manages a workshop.

It is useful to review the programme and participants and, if you can go, the registration is free, in order of application.


+Info on this web page


Posted by Safe and Healthy
English version by Erika Céspedes

Improving quality of antibiotics’ prescription in primary care: a qualitative evaluation of combined training intervention

BMC Family Practice publishes this paper focused on an intervention designed to change primary healthcare professionals’ antibiotic prescription habits.

The educational STAR program (Stemming the Tide of Antibiotic Resistance) has the aims of improving antibiotics’ prescription and to increase the awareness of the problem of antibiotic resistance among primary care physicians.

STAR program is composed of five main parts, complemented by a forum in the web about the course (part 6), and a reinforcement session (part 7) given approximately six months after completing the main program of the course.

Parts 1 and 2 include an online-introduction to antibiotic resistance and prescription. Participants present their own points of view on the subject. Clinical cases are also presented to discuss as well as some of most recent scientific evidence (graphics and abstracts). The objective of these two first parts is to raise clinicians’ awareness on how they treat common infections in everyday practice.

Part 3 consists of a practical seminar, where attendants meet in presence of a STAR instructor who contributes to the discussion about their prescription habits and data on resistances, collected from samples offered by professionals during the five to ten years previous to the study.

Part 4 presents online videos reflecting clinical settings or patient simulations to show key communication skills to employ in practice, useful for better understanding patients’ attitudes, expectations and worries.

In part 5 physicians are asked to describe three examples of their own clinical experience and to think them over, in order to consolidate the achieved knowledge.

The program’s effectiveness was evaluated in a randomized controlled study in which 244 primary care physicians and nurses took part. This text shows part of the study’s evaluation.

Evaluation was performed by a partly structuralized telephone interview, with digital data registration, to a 31 participants sample, by means of analysis of contents.

The majority of subjects reported higher awareness of antibiotic resistance, greater self confidence to reduce antibiotics’ prescription and at least some change in practice and attitude towards antibiotics’ prescription. Reported changes in practice included adoption of some policy to decrease prescription of antibiotics. Many physicians also reported their increased interest in patients’ expectances that contributes to improve the relationship between patient and physician.

The parts of the intervention that showed greatest influence to change professional’s behaviour were the update of available evidence, the simple and effective communication skills presented on online videos, and self reporting of antibiotic prescription data, combined with showing local resistance data.

Participants considered this educational intervention acceptable, necessary and feasible, obtaining a great impact and positive changes in attitudes and in clinical practice as a result of participation in STAR educational program.


Bekkers MJ, Simpson SA, Dunstan F, Hood K, Hare M, Evans J, et al. Enhancing the quality of antibiotic prescribing in primary care: qualitative evaluation of a blended learning intervention. BMC Fam Pract. 2010;11:34.





Posted by Lola Martín
English version by Erika Céspedes

3rd Seminar. Medication errors with vaccines: improving with the professionals

Problem description:

The objective of the 2009 program-contract in our area on medication errors reporting was to report at least 109 errors, which means a 5% of the expected in an area like ours.

The total in 2009 was 192 errors reported. The 26% of these was related to vaccine administration.

Analysis of causes:

A working group is formed with 12 professionals involved in immunization and motivated on patient safety: a pediatrician, nurses and immunization managers. Members of the risk unit of the area coordinate the group.

The group performs an analysis of causes of vaccine-reported errors.

Professionals: lack of training, unclear labeling, bad registration on patient's medical records, bad anamnesis, more than one professional to vaccinate a patient.

Organizational: lack of information in the admission of new professionals and substitutes, neither clear labels nor clear information on vaccine refrigerators, no registration of the vial opening date, failure to follow protocols and institutional advices.

Agents and resources: Errors in OMI drug list, frequent changes in laboratory supplier, multi-dose vaccines, different vaccines with similar labeling, prescribing information in other language, small print on the packaging.

Improvement actions:

Elaboration of an informative brochure and poster on the most common mistakes with vaccines.

The brochure will be given to new professionals and substitutes who will work with vaccines at their welcome, and there will be named a manager for this task in each facility.

The poster will be located in all offices at the primary care facility.

Rearrangement of vaccines in the refrigerator by age of administration.

Development of visible reminders in the refrigerator on the identification and proper placement of vaccines.

Results:

We improve the involvement of professionals in the security ambit.

A professional group makes improvement proposals, which will facilitate its acceptance.

We will assess the impact of these measures with the report of the errors with vaccines throughout 2010.

Presentation by María Dolores Martínez Patiño, UFGRS of the 5th Area of Madrid.

+ Info: http://seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20030.pdf


Posted by Fernando Palacio
English version by Erika Céspedes

3rd seminar. Safety incident with the defibrillator gel in health centers. Root cause analysis

Problem description:

There are CPR training courses at primary care facilities in the 5th Primary Care area of Madrid. In reviewing the crash cart, the teacher finds in some facilities the presence of an alcohol gel bottle next to the defibrillator.

The gels for manual defibrillator must be alcohol free, because its use could burn patients.

Analysis of causes:

Professional causes: ignorance, not reviewing the composition of the gel, the defibrillator’s instruction manual and the provision of the crash cart, the coexistence of a semi-automated defibrillator that does not need gel.

Organizational causes: inexistence of a crash cart manager, rotative reviewing among the professionals, not separating the ultrasound gels (for ultrasonography and physical therapy) with alcohol.

Agents and resources: the trading house that provides the gel submits to the competitive acquisition a container identified with a sticker "for ECG and defibrillator”, but brought an alcohol gel, with the sticker "gel for ultrasound".

Working conditions: In some cases, the sonographic instrument and the crash cart are in the same room, and gels are exchanged.

Improvement actions:

Verification the competitive acquisition of the correct gel. Sample: the bottle says "ECG and defibrillator", without alcohol. Current product says "ultrasound transmission gel”, containing alcohol.

Appointment with the trading house, to clarify the supply of a product other than awarded.

Reporting the incident by fax, internal mail and e-mail to all professional; publishing on the website; notifying that there is defibrillator gel available in crash carts.

Sending the centers a correct gel container with a newsletter.

Edition of the book "Quality assurance in the use of health material and apparatus".
That includes a specific section on use and maintenance of defibrillators.

Although no damage has occurred, it is crucial the deployment of measures to prevent it in the future.

Oral presentation by Mercedes Martínez

+ Info: http://seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20029.pdf


Posted by Fernando Palacio
English version by Erika Céspedes

3rd Seminar. Adverse effects detection, a way of sensitizing the professionals to Patient Safety

The interest and promotion of Patient Safety (PS) by National and International agencies in health services, motivated us to make this report with the following objectives:

• To assess the sensitization on PS through educational workshops, measured by the statement of adverse effects (AE) in all teaching units of the autonomous community of Galicia

• To study the frequency, severity and characteristics of the AE reported

The method was developed in two phases. Initially all Teaching Units of Family and Community Medicine of Galicia (senior residents and their tutors) were invited to participate. In the first phase there had place training workshops on PS concepts, types, error analysis and knowledge of the questionary APEAS1. In a second phase the professionals registered the AEs for 15 days, in their daily activities according the APEAS methodology.

During the registration period, 9,024 patients participated in 27 primary care facility. The prevalence of AE was 15.37 ‰: (5.97 ‰ incidents and 9.40 ‰ adverse effects), of which 76.7% were mild, 17.5% moderate and 5.8% severe. The 72% of the AEs were considered avoidable.

The 36.2% of cases the causal factors of the AE were related to medication, 34.2% with communication, and 25.6% to management, followed by other causes.

When we studied the origin of the AEs we found that 65% of them occurred at a primary care facility, 20% at specialized care, 4% at emergency departments, 3% at pharmacy offices and the remaining 8% at "others" as herbalist shops or private practice.

With regard to the care the patient received as a result of the AE, in the 63% the health care was not affected, in a 26% the AE was solved at primary care, the 10% required further consultation or a specialized care and the 1% required hospitalization.

Most professionals have reported at least one AE and its characteristics are similar to those published on other papers.

Reporting AE, with a previous training, may be a useful tool to assess the sensitization to PS, and teaching units, a resource in the development of a culture of PS.

Presented by Clara González-Formoso; M ª Victoria Martín Miguel; Antonio Rial Boubeta; Jose Luis Delgado Martín; M ª José Fernández Domínguez; José Luis Ramil Hermida; Fernando Isidro Lago Deibe; Ana Clavería Fontán; Margarita Pérez García.


+ Info: http://seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20048.pdf


Posted by Fernando Palacio
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

3rd Seminar. A project to systematize the communication in drugs administration at emergency situations

The Primary Care Management of Talavera de la Reina presented many presentations at the Seminar. In this one, they comment a very important topic, the risk of error in drugs administration at emergency situations.

Raised the issue, they developed a protocol on this subject that was presented with a video in all healthcare facilities.

The main author is Belen de La Hija.


+ Info: http://seguridadpaciente.com/Jornadas10/comunicaciones/Resumen% 20014.pdf


Posted by Belen de La Hija and 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

Interview with Pilar Vicente García, nurse, member of the Spanish Association of Latex Allergy

Latex allergy, although currently very common, is still little known. According some studies, in Spain a 2% of the general population has developed it and in risk groups the number may reach a 15%. Once it appears, any area of a person’s life is involved because, where there is no latex?

We interviewed Pilar Vicente García, a member of the Spanish Association of Latex Allergy (Asociación Española de Alérgicos al Látex), and nurse.

S. & H.: Do you think that health professionals are sensitized or trained in this problem?

P.V.G.: Although the situation has improved in the last two or three years, much remains to be done. Nowadays there are many health professionals that do not know what to do when a latex allergic person arrives to their offices o divisions.

What aspects should be improved?

Basically, two things: information and training. It is a disease partially unknown for many health care professionals.

Could you give us some examples?

Well, one would be when a professional see us with elastic underclothes, and says: "Come on, you are allergic to latex and you wear latex elastic!". It is a very uncomfortable comment for the patient. The first thing you think is that they do not believe you are allergic to latex. Fortunately, patients are increasingly trained in patient safety. Then, as calmly as you can, you explain that there are clothes with synthetic materials elastics that do not harm us.

Another example would be the administration of a drug that comes in a glass vial and has a rubber plug; you instinctively ask "the plug is of natural latex?". Answers may be very different... "but I will not touch the plug" or "so I remove the plug and you're done". And there is an answer more and more frequent "I am going to ask, I will make sure". In the first two cases the patient has to explain that the liquid may contain latex proteins and, even though you remove the plug or not touch it, it can cause a reaction. So what occurs is an estrangement between the professional and the patient that does not benefit either party. The third answer may start a rapport with the professional who shows more interest for the problem and investigates whether the plug is natural or synthetic latex. This situation really benefits both parts.

Another situation that causes surprise is when you explain that there are foods that, having proteins similar to those of natural latex, can cause reactions similar to those caused by latex itself. This is what we call “latex-fruit syndrome", since tropical fruits are the most concerned: kiwi, pineapple, banana... but also tomatoes, oranges, melons...

So, no latex-allergic people can eat these foods?

No, according to reports only the 50% of those latex-allergic people develop the “latex-fruit syndrome", and not to all fruits, but the truth is that when the reaction to any of these foods appears, the list often starts to grow.

In addition to training and information, as you mentioned at the beginning, what could be done to improve the situation?

We think that it would be desirable that health care professionals invite patients to their meetings, seminars, etc. and give them the opportunity to explain their day-to-day routine, the obstacles they have to overcome because of their latex allergy, their feelings in relation to health care situations. It is not about confronting or criticizing; it is about intercommunicating and listening to each other, it is about gradually changing the current culture.

Patients know that health care professionals and we have a common goal, our safety, patient safety. Strangely we both walk toward that goal but in parallel and with and askance look, and so, we will never meet. We must learn to walk together, side by side.

What would you emphasize of the actions of your organization, the Spanish Association of Latex Allergy?

The spread of the disease has been very important. We have carried out a number of seminars in different regions specifically directed at health professionals, many of which had recognized health interest. Accurate information has been given to all patients allergic to latex. We have conducted studies in which realization we had always the support of the Ministry of Health and Social Policy, the professionals from different disciplines such as chemists, engineers, biochemists, dermatologists, allergists, etc. and the different areas such as universities, hospitals, nursing schools, research centres in biotechnology, etc.

You may see all this on the Association’s website, www.alergialatex.com. The studies mentioned can be downloaded for free from the Web.

Thank you very much for thinking of us and giving the latex-allergic people the opportunity of being present in the Safe and Healthy blog, which is very interesting.

Thank you very much for your attention.


Interview by Clara Formoso for Safe and Healthy
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

Interview with Miguel Angel Máñez. Can we sell better the safety culture?

We met Miguel Angel Máñez at the Security Master developed by the Spanish Ministry of Health and Social Policy and the Miguel Hernández University. We felt he provided a new –and very necessary- point of view respecting safety culture. That is why we asked to interview him and he has kindly answered.

Miguel Angel Máñez is an economist. He is currently the Deputy Manager of Economic and Human resources of the Alicante-Sant Joan Health Department. He is the author of Salud con Cosas, a blog on healthcare management, since 2007. His areas of interest are leadership and clinical governance, innovation, social marketing applied to healthcare organizations, health 2.0 and change management. He has participated in courses and seminars on Internet and health, healthcare management and marketing; and he has also written articles in various media on these topics.

- S & H: Why, if we all agree on the "primun non nocere", in the ethical principle of nonmaleficence, are there difficulties for health professionals to take on the problems on patient safety?

- M. A. M.: The custom and culture of each organization play an important role in how professionals behave. To generate a behaviour change is complex in humans and that is why incentives or rewards are often used to make this change not only fast but also durable. However, in the healthcare environment, the incentives associated with the implementation of a new culture based on patient safety are not very effective (in the case of economic incentives) and difficult to apply (the non-economic).

A clear comparison is the behaviour change in business environment, since to get a consumer buy a product is to create a purchase impulse that can produce positive results in just three minutes, but to change behaviour is something very long.

Finally, in the case of patient safety, the benefits are invisible to the professional, as they directly affect third parties, making the change difficult.

And counting on it, from your point of view, what are the strategies to succeed in introducing this culture? How can we “sell” it?

First, we must show that there is a direct benefit for the professional. Without demonstrating that the change creates value for both professionals and their activities, we can not move forward. Social marketing techniques seek to modify behaviour based on an exchange, analyzing the attitudes of members of the organization to the proposed behaviour, and providing each professional skills and motivation both necessary to understand he can make that change.

We have to dissociate the "sale" of that culture of the monetary concept of the term "sale." Economic incentives only work in the short-run and, indeed, any change brought whit an economic incentive disappears when the incentive disappears. The design of incentives should be conducted in a manner that achieves a long-term change, appealing to professional values, beliefs and their abilities to overcome obstacles.

Moreover, a new culture implies that we must know exactly how the professionals of the organization are in order to detect the leaders, innovators and "early adopters" (in Rogers’s terminology) who are going to serve as engine and example. In addition, managers must act according to the new culture, to keep the professional look at their own bosses trying to implement a new way of doing things that they do not follow.

Finally, we need a consistent and innovative training base: workshops in the workplace, courses, training for managers of each unit, reminders, etc. Any support material is welcome, but also the originality and innovation will be appreciated to reach the professional’s attention.

Finally, what role do patients play in this topic?

The patient plays a central role, because if healthcare organizations seek to generate a cultural change aimed at the improvement in security, is because it has been shown that there is improvement in patient care: more quality, more safety. Perhaps we have gone through a culture of wellness and safety time for the professional, sometimes forgetting, in the process design, that the ultimate objective of health services is to provide a range of patient cares.

One way that lately has been used to achieve these changes in the culture we are discussing is to use the patient as a means of transmitting the professional the need to make things differently. Within the National Health Service (NHS) it has been much criticized, as there are professionals very reluctant to the idea of a patient requiring them to perform a task one way or another, but it is usually very effective. In fact, we are conducting in our center a project in social marketing and hand washing aimed to relate each type of marketing strategy with a change in professional’s behaviour.

Thank you very much for talking to us. Now it is time to reflect on what we have expressed and to work, more focused, to keep trying to create that culture of safety.

Thank you very much


+ Info: a very interesting link, his class in the Patient Safety Master of the Spanish Ministry of Health and Social Policy and the Miguel Hernández University, where Miguel Angel Máñez develops some of the ideas reviewed in the interview.


Posted by Safe and Healthy
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

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

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

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

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

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

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