Search This Blog

Showing posts with label pharmacovigilance. Show all posts
Showing posts with label pharmacovigilance. Show all posts

Tuesday, 12 February 2019

Still time to submit an abstract for the EACPT Congress in Sweden: 29th June to 2nd July 2019

The next EACPT Congress will be held from 29th June to 2nd July in 2019 in Stockholm as a partnership between the EACPT and the Swedish Society for Pharmacology, Clinical Pharmacology and Therapeutics. 

The Congress will address Tomorrow’s Healthcare Challenges and will be held at the City Conference Centre – 5 minutes from Stockholm Central Station.

Abstract closing date extended to 14th March.

Register online 

The Congress Reception on the evening of Saturday 29th June, will be held at Stockholm City Hall, the venue of the Nobel Prize banquet.

The Keynote Opening Lecture will be given by the President at the Karolinska Institute, Professor Ole Petter Ottersen, on global health and clinical pharmacology.

Around 60 invited speakers are expected from throughout Europe and beyond. Congress keynote lectures, sessions and themes will include:
  • Advanced therapies
  • Chronic disease
  • Clinical pharmacologists versus computers
  • Closing the money gap
  • Drug regulation in the 2020’s
  • EACPT meets Asian Societies
  • EPHAR-EACPT joint symposium on personalised medicine
  • Ethics in clinical research
  • Global Health
  • How to become a clinical pharmacologist
  • How to measure drug exposure
  • How to measure drug use
  • How to perform a health economic study
  • Interprofessional exchange for better drug treatment
  • Misuse of medicines
  • Patient empowerment
  • Preparing tomorrow’s prescribers
  • Prescribing and deprescribing
  • Targeting small populations
  • The critically ill patient
  • Treating ageing populations
  • Treating cancer
  • Treating children
Major awards to be presented at the Stockholm Congress include the EACPT Lifetime Achievement Award and the biennial EACPT Scientific Award for best publication on a clinical pharmacology or therapeutic theme.

Opportunities for EACPT Associate Members include
* discounted registration fees for EACPT meetings
* networking with colleagues worldwide through the global EACPT network of Associate Members
* active involvement in EACPT Working Parties and other activities


Find out how to become an Associate Member of the EACPT

Future EACPT Congresses will be held in:
– 2021 Athens
– 2023 Rotterdam


The EACPT was founded in 1993 and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

Sunday, 2 November 2014

Helping to improve safety in the use of medicines in Sub-Saharan Africa.


Press Release: 00.00h Monday 3rd November 2014


Medicines have powerful effects to help patients. However medicines also have the potential to cause powerful harmful effects. Education on how to ensure safe and effective use of medicines is therefore vitally important for patients and health services.
An International Symposium on Medicines and Patient Safety is being held in Kigali, Rwanda at the College of Medicine and Health Sciences (CMHS) on Wednesday 5th November 2014, followed by an international videoconference on Prescribing Skills and on Pharmacovigilance on Thursday 6th November with contributors from the UK and the WHO. The meeting will include talks on medicines and communicable and non-communicable diseases by national and international clinical and policy experts from Rwanda, South Africa, USA and the UK.
The Symposium is being held in partnership with Pharmacology for Africa, a consortium of 8
Sub-Saharan countries supported by the International Union of Pharmacology, and led by Professor Douglas Oliver and Professor Christiaan Brink, from South Africa, both of whom will be speaking at the meeting.The 3 major themes of the symposium are: educating health professionals in safe and effective use of medicines; regulating drugs, including pharmacovigilance and quality of medicines, reducing harm from high risk medicines and in patients with high risk conditions.
Speakers will discuss ways to reduce risk from medicines for treating children and expectant mothers, preventing disorders of the heart and stroke, and for treating cancer, retroviral disease and kidney disease. There will also be round table discussions not only on prescribed medicines, but also on the risks of over-the-counter and traditional medicines.
Pharmacist Dr Kayumba said: “The Symposium is timely in building on strategy in Rwanda on pharmacovigilance and on developing our undergraduate and postgraduate educational systems for good practice in use of medicines.”
Physician Dr Musabeyezu added: “The Symposium will also provide important updates for doctors, pharmacists and nurses from Referrral and District Hospitals from throughout Rwanda on reducing risk of harm from high risk medicines often used for high risk diseases”. 
Clinical Pharmacologist Professor Singer noted: “Partnership with Pharmacology for Africa brings important opportunities to improve patient health and safety through engaging with a wide range of international experts in education, training, clinical practice and research aimed at best practice in use of medicines.
The symposium is supported by the World Health Organisation, Pharmacology for Africa, the International Union of Basic and Clinical Pharmacology, Partners in Health, the Rwanda Social Security Board and the University of Rwanda College of Medicine and Health Sciences

Information for Editors
For further information, including to arrange an interview with the organisers, and for a press pass to attend the symposium on 5th November 2014, email ISMPS@gmail.com





Friday, 22 August 2014

Benefits and risks of aspirin in the context of its anti-cancer potential

Aspirin has been reported to have the potential to prevent selected cancers of the digestive tract. Aspirin also reduces the risk of serious vascular diseases in patients already at higher risk of them. A team led by researchers from the University of London has published their assessment of the risks and benefits of aspirin by analysing previous reports of the effects of aspirin.

Aspirin is a powerful drug with powerful adverse effects, including bleeding into the digestive tract or brain, causing some forms of asthma, exacerbating gout and causing rare but serious complications in children under 16 years of age ...

See more on this in Spanish on the BBC World Service website.

Below is an English version of the BBC World Service report:

" Myth and reality of aspirin to prevent disease

Writing

BBC Mundo



Aspirin is one of the world's best selling drugs. More than two thousand years ago, Hippocrates, the Father of Medicine, discovered the active ingredient in aspirin, which he extracted from the willow plant, and used to soothe fevers and headaches.


But it was not until 1897 that the German Felix Hoffman developed the drug as such. More than a century later, aspirin, acetylsalicylic acid, is one of 10 generic best sellers in the world, with annual sales of about $ 1.7 billion.

Besides being a recognized analgesic, aspirin has gained ground as way to prevent certain diseases. Multiple studies have highlighted its benefits in preventing cardiovascular disease and various cancers.
However, taking aspirin regularly involves significant risks. BBC News spoke to several experts to discuss how and when it is advisable to take a dose of this medicine each day.

Cardiovascular Benefits

Taking a daily dose of aspirin is a method widely used to prevent cardiovascular disease in people who have had this disorder already.

Mike Knapton, associate medical director at the BHF, told the BBC that for people who have had heart attacks, angina, some types of stroke and diseases of the arteries, a low dose of aspirin a day can prevent the occurrence of new episodes. This practice is well established and several studies have demonstrated these benefits.

The reason is that aspirin inhibits platelet adhesion in blood vessels reducing blood clotting.  But research also points that the drug may not prevent cardiovascular events in healthy people.  Rather, "the risks of taking a daily dose of aspirin outweigh the benefits of taking it in the case of people who have never had this kind of disorders," said Dr. Mike Knapton.

Reduction of cancer

In recent years, several studies have also pointed to the benefits of the drug as a way to prevent certain types of cancer. Experts also point out that aspirin increases the risk of bleeding. In fact, Peter Elwood, a British expert who participated in the scientific team that first showed the benefits of this analgesic in cardiovascular disease states that "the future is aspirin in reducing certain types of cancer."

Recent research by Queen Mary University of London, argues that for people between 50 and 65 years, a dose of daily aspirin can significantly reduce the risk of developing colon, esophageal and stomach cancer.
"This study showed a 35% reduction in cases of colon cancer and 40% in the number of deaths from this disease," Julie Sharp, Director of the Health Information Department of the British charity Cancer Research UK told the BBC.

"In relation to stomach cancer and esophagus, a reduction of 30% in the number of cases and between 35% and 50% in deaths was recorded, "said the expert. The study recommends that people between 50 and 65 take a dose of 75 and 100 grams of aspirin for at least 5 years, preferably 10 years.

Significant risks

But some studies in the UK have indicated that in some cases, taking the drug may have more risks than benefits. One of the side effects of this drug is the possibility of internal bleeding, including brain. Experts agree that a daily dose of aspirin helps prevent cardiovascular problems in people who already suffer from these disorders.


As he explained to the BBC, Donald Singer, professor of clinical pharmacology in the department of medicine at Yale University in the United States, "as a result of its blood thinning effect, aspirin can cause bleeding, for example in people who have a stomach or intestinal ulcer, and in some cases it can also cause bleeding in the brain. "


Research from Queen Mary University of London recognizes these risks and stresses that in the case of persons 60 years of age who take a daily dose of aspirin for 10 years, the risk of bleeding in the digestive tract increased from 2.2% to 3.6%, and in a small proportion of these cases (5%), can lead to death. " It is important that in each patient assessment is done to establish who can take aspirin and who should not".



Julie Sharp, of the British charity Cancer Research UK said the risk increases significantly for people over 70 years.


But to what extent do the risks outweigh the benefits of aspirin?


Here is a point on which not all experts agree. "I have no doubt that the balance is in favor of taking aspirin for people over 50 years," Professor Peter Elwood told the BBC. He noted that, although the risk of bleeding is increased, there is no evidence aspirin is associated with fatal bleeding. "The evidence suggests that there is minor bleeding, but not fatal."


But a study from the University of London published in 2012 concluded that the medicine, taken daily, can do more harm than good to a healthy person.
Julie Sharp notes that precisely because it is not known with certainty who may suffer side effects, "it is important that in each case testing done to establish who should take aspirin and who is not."

Consult your doctor

The active ingredient of aspirin has been used to treat headaches for centuries. With so many studies highlighting the benefits of aspirin, thousands of people in several countries take the drug to prevent disease before presenting with any symptoms, something that according to Professor Donald Singer, a member of the British Pharmacology Society, can be very dangerous. "It's very important that people are aware of the risks and consult your physician" before taking long term aspirin treatment.

He explained that people who suffer from indigestion, or asthma, or who have gout or who are taking other drugs that inhibit blood clotting are at increased risks of the side effects of aspirin.


And that also applies to children under 16 years of age. "One might be tempted to give aspirin to a child, in the case of families with a history of colon cancer, such as prevention. But this is very dangerous because in the case of minors, a daily dose may cause liver damage."

It is also important not to take more than the dose of 75 mg, or a quarter of a standard dose of aspirin.


The benefits of aspirin to prevent disease in specific cases are well established, but experts insist that consulting a doctor is essential to reduce risks of adverse effects."









Wednesday, 5 June 2013

New EU black triangle scheme for medicinal products

There are several key stages in use of medicines and vaccines in clinical practice when reporting on clinical experience of side effects and suspected adverse effects is particularly important.

In addition to a duty to report any serious adverse effect, times to be particularly vigilant include when a medicine has just been launched; when indications for use are changed – ie new patient groups are exposed to the medicine; special patient populations for whom experience of a medicine may be limited – e.g. children; new combinations with the treatment, with which unexpected drug interactions may occur. 
The European Medicines Agency [EMA] notes these additional categories: “ it contains a new active substance authorised in the EU after 1 January 2011; it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), for which there is limited post-marketing experience; it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data); the company that markets the medicine is required to carry out additional studies, for instance, to provide more data on long-term use of the medicine or on a rare side effect seen during clinical trials.”

A Black Triangle logo has been used in the UK for many years “to signify medicines that are subject to intensive monitoring" [MHRA]. This inverted Black Triangle logo will now be used in all EU Member States, with a list of 'Black Triangle' medicines and vaccines agreed Europe-wide, the first version released in April 2013. The Black Triangle will start appearing in the package leaflets of medicines concerned from autumn 2013.
See more on the EMA website on the new European Union wide black triangle scheme for medicinal products and vaccines,
 indicating that they should be subject to additional monitoring and reporting by health professionals and patients.

Sunday, 11 November 2012

More news on the Geneva EACPT 2013 Congress

-->
Around 10 months to go until the European Association for Clinical Pharmacology & Therapeutics 11th International Congress to be held in beautiful Geneva 28-31 August 2013. The image is one of a series on the congress website showing the best of the city.

Abstract submission is now open for the next EACPT Congress,

Over 900 participants are expected to attend including health professionals, scientists, policy makers, biotechnology and pharmaceutical professionals and others with an interest in basic and clinical pharmacology, pharmacotherapy, drug discovery and development, regulatory affairs and related areas.

Key themes at the congress will range from bedside pharmacology for special patient groups to pharmacology & toxicology, and pharmacology and society. 

Specific topics will include advances in personalised diagnostics to improve the safety and effectiveness of medicines, updates on new biological approaches to ocular disease, therapeutics of cardiovascular, cancer and inflammatory disease, clinical trial design and regulation, and drug safety and toxicology.

See here for more on key themes of the Congress

EACPT Geneva 2013 Congress website  

The European Association for Clinical Pharmacology and Therapeutics (EACPT) has its origins in a working party in the early 1980s under the auspices of the World Health Organisation (WHO-Europe). 

The EACPT's next biennial congresses after Geneva 2013 are in Madrid 2015 and in Prague 2017. The EACPT also arranges summer schools, and other scientific and professional activities.

Thursday, 8 September 2011

Networks and personalized medicine for better drugs?


For more on this theme see 
- article with Andrew Marsh in the inaugural March 2012 issue of Health Policy and Technology
- article in the October 2011 issue of Public Service Review: Science and Technology Review 

For many individual patients treatments may not exist, may not be very effective, or may result in unpleasant adverse effects. How can prescribers improve drug selection andreduce the harmful effects of medicines? Are there better ways to develop drugs for patients who are difficult to treat?  And what can we do to improve poor adherence to medicines? These elements underpin ‘personalized medicine’, in current use the concept that by considering differences among patients in genetics, disease burden and other factors, more effective and safer drugs can be developed. Personalizing medicine is a path to better disease prevention and control where limited treatment options exist, such as for many cancers, resistant infections and dementia syndromes, and better drug development for new medical challenges. These concepts have in recent years attracted interest from the Royal Society, the Nuffield Council on Bioethics and cognate international institutions.
It is clear that there needs to be consistent investment and support from policy makers and regulators to develop and sustain the academic and industry pharmacology expertise and activity needed for the long-term success of a personalized medicine strategy, so that we can continue to be able to improve the health of the public and individual patients.
NICE is an international leader in developing evidence-based treatment guidelines. Its reports increasingly recognize the need to refine drug choice based on patient characteristics. For example, updated national hypertension guidelines released in August 2011 advise drug selection guided by age, gender, ethnicity, and monitoring, with treatment modified depending on clinical response. NICE also recognizes the need for research on ways, tailored to patient preference, to improve long-term adherence to drug treatment.
Pharmacologists are developing two complementary approaches aimed at achieving “precision medicine” in as many patients as possible: better drug discovery combined with high definition biomarkers for drug selection and monitoring. Network pharmacology brings together sophisticated databases of genetic mechanisms for disease, pharmacological pathways, candidate drugs, and population data describing important variants among individuals in drug handling and responsiveness.  These methods also allow ways to find previously unexpected “off-target” actions of existing or new drugs, which may accelerate discovery of new treatments for serious diseases.
Diagnostic methods are increasingly being used to improve drug selection for individual patients. For example growth tyrosine kinase receptors can be blocked using the biological agent imatinib to treat particular patterns of Philadelphia chromosome-positive chronic myeloid leukaemia, and rare gastro-intestinal tumours. Understanding genes and drugs that influence enzymes that modify drugs in the body, improves accuracy in defining patients who will not respond to a given medicine, or may develop adverse effects.  For example, to minimize risk of serious harm, pharmacogenetic testing is recommended for variability in a specific liver enzyme before deciding whether or not to prescribe the anti-HIV drug abacavir. This knowledge also allows better prediction of a patient’s risk of harm from interactions between treatments, based on recognition of medicines and other remedies that interfere with how drugs are cleared by the body. 



Monday, 15 August 2011

NICE guidance and treatment of Alzheimer's Disease

The following blog is based on a contribution to a Daily Telegraph article quoting from my Science and Media Centre response to new NICE draft guidance on Alzheimer's Disease.

'The proposal by NICE to extend its guidance to include access for 3 drugs (donepezil, galantamine and rivastigimine) to patients with much milder disease than previously eligible is excellent news for patients with Alzheimer's disease and their families. It is also very encouraging to have in the guidance a new treatment option (memantine) for patients with more severe disease. People with serious conditions such as Alzheimer's may naturally express concern about how long this has taken. However it is essential that health policy makers have convincing evidence both for effectiveness and risk before making a medicine available to people who could benefit. Consider the recent public concern about regulation of the diabetes drug rosiglitazone, for which an unexpected increase in cardiovascular risk appears to have occurred after it became widely available. It will still be very important to remain vigilant for possible unexpected risks of the Alzheimer's treatments, as these drugs will now be exposed to large numbers of people, who may also be medically more complex, and therefore more at risk of adverse effects, than in the clinical trials on which the NICE guidance has been based.'

There are many causes of dementia other than Alzheimer's. The following paper describes research on CADASIL, a genetic disorder for dementia: Hussain, MB, Singhal S, Markus HS, Singer DRJ. Abnormal vasoconstrictor responses to angiotensin II and noradrenaline in isolated small arteries from patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). Stroke 2004; 35:853-8.