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

Proton pump inhibitors and risk of fracture

The FDA has issued a note, both for professionals and patients, reporting the revision of the prescription of the proton pump inhibitors to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine.

This information is based on the review of seven epidemiological studies that suggested that the increased risk of such fractures may depend on the dose, duration of the treatment or both.

At present, there is uncertainty about the magnitude of this risk. So, when prescribing PPIs, healthcare professionals should consider a lower dose or shorter duration of treatment, when required.

+ Info: Press release by the FDA

The widespread use of PPIs requires to take into account this risk, especially when deciding the appropriateness of the initiation or maintenance treatment of the treatment with these drugs.

There are several reliable publications on the appropriate of PPIs, for example, this synthetic and clear note of the Dirección General de Farmacia del Servicio Canario de Salud.


Posted by Guadalupe Olivera and Jesús Palacio
English version by Erika Céspedes

The relationship between patient safety culture and the implementation of organizational patient safety defences at emergency departments

VAN NOORD I, DE BRUIJNE MC, TWISK JWR

Int J Qual Health Care 22: 162–169 [PMID: 20382661]

Objective: The objective of this study was to investigate the association between 11 patient safety culture dimensions and the implementation of 7 organizational patient safety defences: a resident orientation program, the training, the skills assessment of residents, the presence of protocols, the review of patient records, the structured monitoring and the review of radiodiagnostics results.

Design: Data were gathered within a cross-sectional, retrospective survey. Setting: Emergency departments (EDs) in the Netherlands. Participants: Thirty-three EDs of non-academic hospitals, which belong to the clientele of Dutch largest medical liability insurer. Main outcome measures: Implementation of the separate organizational patient safety defences (0 = insufficient/sufficient, 1 = good).

Results: Analyses showed that several culture dimensions were negatively or positively associated with the implementation of the patient safety defences. A culture in which hospital handoffs and transitions were perceived adequate was related to less frequent implementation of four of seven organizational patient safety defences, whereas a culture with well-perceived hospital management support for patient safety predicted more frequent implementation of four of seven organizational patient safety defences: the structured monitoring, the review of radiodiagnostics results, the resident orientation program and the review of patient records. The perception of a hospital management supporting patient safety was associated with more frequent application of four of the seven organizational defences for patient safety: the presence of protocols, the review of radiodiagnostics results, the resident orientation program and the review of patient records.

Conclusions: Results suggest that well-perceived culture dimensions might inhibit improvements by lack of a sense of urgency as well as facilitate improvements by inducing feelings of support for organizational changes and improvements. The influence of patient safety culture appeared to be not always as straightforward as it seems to be in advance.

Although the study took place at the emergency departments, we comment it because it poses a design that may be of interest in primary care to investigate the relationship between the culture of patient safety and the effective implementation of organizational defences that assure it.


Posted by José Angel Maderuelo
English version by Erika Céspedes

The nursing organization, access to training and motivation are key to safety in hospitals.

The next day May 21 will be held in Madrid, at the Carlos III Health Institute, the symposium "Nurse staffing and its Impact on Patient Safety: towards a Better forecast of human resources in nursing needs", organized by Investen. During this event will be the study RN4CAST that although referred to hospitals, is worth seeing
for the uniqueness of your starting point: studies of Linda Aiken.

In 2002 and 2003, Aiken released his studies (see links at the bottom) on the so-called "magnetic hospitals,"those who attract the best medical and nursing professionals. They showed that nursing human resources influence the quality of the results of these hospitals, in aspects such as mortality or neglect of patient calls, in addition to its own welfare of nurses. Since then the concern for proper management of nursing resources and the design of planning models needs of these resources has been increasing. It should be noted that the results of Aiken were adjusted for other resources, such as doctor / beds or others.

In this sense, the project is underway Forecasting Registered Nurse (RN4CAST) that aims to collect data from 15,000 nurses and 10,000 patients in 330 hospitals in 11 countries participating in the study. Data are being collected from the environment and human resource nurses through the hospital and the nurses themselves.

These data will be associated with patient outcomes, which will be drawn from the records afterthe high standard of patients.

Data collection will take place in acute general hospitals and in them the majority of working nurses are responsible for the greatest number of medical errors and the biggest share of health spending.

The project is coordinated by the Center for Health Services and Nursing Research of the Katholieke Universiteit Leuven, Belgium, together with the Center for Health Outcomes and Policy Research at the University of Pennsylvania (USA) as vice-coordinator.

Participating countries are Belgium, Finland, Germany, Greece, Ireland, Poland, Spain, Sweden, Switzerland,Netherlands, UK, U.S. and three international cooperation partners (Botswana, China, and South Africa).

In Spain, the project is coordinated by the Instituto de Salud Carlos III, through INVESTEN.

With the results of the project will support the creation of standards for human resource planning in nursing.

It would be interesting that studies be undertaken similar to this one focusing on the area of primary care,which allow us to explore in an objective manner, what is the influence of staffing ratios on patient safety.


Aiken, LH, Clarke SP, Sloane DM, (2002) Hospital staffing, organization, and quality of care: cross-national Findings Nurs. Outlook, 50.187-194
Aiken, LH, Clarke SP, Cheung RB, Sloane, DM, Silber JH (2003) Educational Levels of hospital nurses and surgical patient mortality. JAMA, 290.1617-1623


Posted by Juan José Jurado
English version by Jesús Moreno

A more ambitious pharmacovigilance

A year ago we mentioned in this blog the Palmarès Prescrire 2008.
Again, in the Palmarès 2009, the main categories “Pilule d'Or” and “Tableau d'honneur” were not awarded. These categories are attributed to new drugs that would constitute a breakthrough for the treatment of certain diseases, because of its efficacy or its lower incidence or severity of adverse effects.

The announcement of the results took place in Paris in January 2010 and was preceded by a panel discussion about adverse effects of drugs.Joan-Ramon Laporte, Director of the Catalan Institute of Pharmacology, participated as speaker. Prescrire has published his interesting speech.

Laporte highlights the magnitude and severity of adverse effects of drugs that are one of the leading causes of morbidity and mortality in developed countries and, therefore, the key role of Pharmacovigilance for Public Health.

This pharmacovigilance depends heavily on spontaneous reporting of adverse reactions by health professionals. But this notifications are necessary but not sufficient, because they depend on the motivation of professionals and the training, knowledge and participation in reporting systems.

The professionals would notify fundamentally the rare and new events because these ones call their attention. More proactive pharmacovigilance strategies would carry out observational studies and meta-analysis to let us know the effects of drugs usually used in the treatment of common diseases. This has happened with substances such as NSAIDS, SSRIs, neuroleptics in dementia, ezetimibe, glitazones, bisphosphonates, etc.

In regard to health professionals, Laporte also argues that the prevention of adverse effects requires a more rational prescribing, and so an independent, continuing and qualified education.

Regarding the role of health authorities we want to note the demand for new drugs that demonstrate to bring a therapeutic progress, to be more effective or safer than the reference drugs, to get their marketing.

The authorities should act with full independence and require transparency to pharmaceutical firms.

It is truly interesting to read the data and reflections of Laporte on the European Commission's proposals in pharmacovigilance that seems to be elaborated to ensure the health of the products instead of citizen´s health.


Posted by Marian López Orive
English version by Erika Céspedes

1st Congress of the Health Blogosphere: Madrid, June 14, 2010

The next June 14, 2010, the Instituto Carlos III, Madrid, will take place the 1st Congress of the Health Blogosphere, in wich veteran and expert bloggers are participating.

I quote below the reason for the call, in organizers words.

See you there.

"Why?

Knowledge has gone from the conferences and books to computer screens. Internet is the natural way of searching for professionals and users of the National Health System. To analyze the status of the health blogosphere and the initiatives in information exchange is getting more and more important. The Hispanic health blogosphere is very active and dynamic. The blogs, magazines and digital forums, live together with initiatives with high impact in the training of professionals and patients. This Congress aims to value the health blogosphere as a source of organized knowledge and as a key in a modern health system. The First Congress of the Health Blogosphere in Spain also intends to build an active discussion group integrated by the major health bloggers, soy they can work synergistically. This conference intends to be the first of a couple of meetings and actions to provide an integrative field for all users and players of the health blogosphere. The Congress will also serve to share ideas, tools and initiatives through a market of blogs and web initiatives with free acces. "


Posted by Jesús Palacio
English version by Erika Céspedes

Report on Quality Plan for the National Health System 2006-2010

The Ministerio de Sanidad y Política Social of Spain has published the report of the activities 2006 - 2010 and the guidelines for this year.

Regarding patient safety -three of the 68 pages of the report- the highlight is the development of a normative reform proposal to allow non-punitive reporting of adverse events, an indispensable item for an effective notification system. We have discussed the last report on this subject in a previous post.

In a few words, these are the planned actions:
-To improve information and training of professionals in Patient Safety.
-To develop a normative reform proposal allowing non-punitive reporting of adverse events.
-To design and trial a notification system of incidents and adverse events.
-To identify and validate a set of key indicators of patient safety to evaluate the strategy.
-To promote projects to boost and evaluate safe practices in the NHS at all levels, in collaboration with the autonomic governments and scientific societies.
-To improve the understanding of adverse events in health-care facilities.
-To strengthen the participation of patients and citizens in the Patient Safety Strategy.


Posted by Fernando Palacio
English version by Erika Céspedes

5th May, World Hand Hygiene Day

As we reported in this blog, today, 5 May 2010, the World Health Organization (WHO) announces the second global annual day of hand hygiene in health-care facilities and our blog joins this iniciative also for the second consecutive year (see post of 5 May 2009).

This year the World Alliance for Patient Safety´s new proposals include the participation in a global survey on or around 5 May by observing the adherence to this good practice in the Moment 1 (before touching a patient) and performing a structural self-assessment to analyze the promotion and practice of hand hygiene in each health institution.

Webinars will also take place.

The Ministerio de Sanidad y Política Social of Spain has developed an outreach letter to health professionals through the Coordination Group of the Hand Hygiene Program. All information is also on their website.

Our group adapted the recommendations of the WHO for Primary Health Care (see here) and we have discussed this subject in the blog (all posts can be found inserting “manos” in the web searcher engine on the right column).

This year we offer a new resource for professionals: a video that shows in a nice way that even a child can wash his hands properly. In the film two children wash their hands with the technique proposed by the WHO, quickly and effectively. This technique is similar for alcohol-based handrubs, even faster because you don´t need to rinse or dry your hands.

The video can be used both for activities directed at professionals and for health education and activities for children or general population. This video can be used without permission, but we would appreciate if the reference is cited. If used for health professionals, we suggest combining it with this video fragment from the WHO recorded in a health center, showing the proper technique for that setting. The one we presents here can be shown entirely, so you can see that the rubbing technique proposed by the WHO is very easy to learn and to practice: it´s child's play.

SAVE LIVES: Clean your hands


Posted by Marisa Torijano, Jesús Palacio and Lola Martín
English version by Erika Céspedes

Welcome to the English version of Sano y Salvo

Sano y Salvo is currently the only website focused on patient safety in primary care. We receive visits from all over the world, which has made us consider the publication of our contents in English.

So we have created the blog safeanhealthypatient.org, in which we will publish the translation of sanoysalvo.es posts.

Publication at this site of the spanish originals will not be exhaustive or synchronous. We will publish the translation of new posts and, as we can, some of the older posts.

Sano y Salvo is currently a collection of the most relevant items published about patient safety in primary care, both at the national (Spain) and international level. Our web searcher engine and the links on the right column allow anyone to find relevant contents and interesting experiences to improve patient safety in primary care.

Now we also consider making these material worldwide available, in English.


Posted by Jesus Palacio, editor of sanoysalvo.es and Erika Céspedes, manager of the English version published in safeandhealthypatient.org