The new European pharmacovigilance legislation is the biggest regulatory change to how the industry develops human medicine since 1995. Through our intense industry research Health Network Communications has put together a conference which will summarise all the new sets of guidelines for the conduct of pharmacovigilance in the EU from July 2012.

Overcome the challenges you will face by meeting with the top senior safety executives from all the major pharma in Europe. Download your brochure now for the World Drug Safety Congress Europe 2012 conference and learn how to gain a competitive edge in the market!

Speakers include; Dr Ennis Lee, Johnson & Johnson, Dr Craig Hartford, Pfizer, Dr Vicki Edwards, Abbott, Mick Foy, MHRA, Dr Ralph Nies, Astellas, Dr Gro Laier, Novo Nordisk, Dr Ute Hoeffner, Novartis and many more!

I have been re-reviewing the drug safety survey results which have again proved interesting reading. Its a great way for us to keep up with what is happening in the industry as it allows safety colleagues to anonymously provide insight (and have a grumble) about the challenges of working in this sector. This survey shows clear patterns from the respondents as to where they see the biggest challenges/bottlenecks/hurdles in drug safety.

I have found that if you ask someone who works in the drug safety sector what challenges face them on a day to day basis, the list can be endless, whether they are strategic level challenges in the way management approach and prioritise safety, or day to day struggles stemming from man power and time lines. There are many hurdles in the industry but I wanted to highlight what our feedback is showing is one of the most significant.

I asked survey respondents to rate (from highly critical to not important) a number of drug safety factors on how they see their affect on the industry. The factors were quite broad in their scope but addressed safety throughout the lifecycle of a drug, from pre clinical, clinical through to post clinical themes as well as infrastructure and operational hurdles.

The feedback leant towards post marketing safety as the stage that presents most hurdles. Specifically risk management and communication (73% of respondents selected these as highly relevant), post authorisation safety (76%) and the stand out challenge was signal detection and reporting (82%). These elements of pharmacovgilance are where the size and scope of managing the data and responding to it get significantly bigger so its understandable that this is at the forefront of the industry’s mind. Do you agree with this feedback or is there an alternative area of drug safety that you feel is more of a significant challenge on a day to day basis?

Respondent break down:

54% pharma, 15% biotech, 27% CRO, remaining government, NGO, Re gulatory agencies.

 Reinerio A. Deza, MD, Head Global Pharmacovigilance, Cubist Pharmaceuticals spoke at the World Drug Safety Congress Americas last month on Risk Communication. He explained the purpose of risk communication as providing information regarding the positive and negative effects of a product to the intended user.

He then went on to describes the process that takes place from identification through to implementation and communication to the regulatory authorities and the healthcare professionals.

Deza believes the most effective risk communication must be of a high standard but understandable, available to the correct audience providing them with the information to make an informed decision. The information available needs to include the potential effects that could take place, both positive and negative, the likelihood of these taking place and ways to reduce this. Effective risk communication must be scientific, based on fact, transparent and updateable when necessary.

Challenges to effective risk management include not knowing what prior knowledge people have about the product, variations in individuals and competing information from other sources such as media.

The Institute of Medicines, the evidence-based advisory committee for policymakers, health professionals, the private sector, and the public has released a press release with advice for the improved oversight of drug safety of marketed medicines by the FDA.Drug safety is critical throughout the lifecycle of a drug but the increasing size, time length and diversity of the patient pool when a drug hits authorisation can throw some unexpected adverse events up. The IOM recommendations are for a more systematic and transparent process to collect, assess and respond to data about the benefit risk profile of a drug in the post marketing stage. This is already required through a number of documents but these recommendations suggest a more accessible format in a single document. The aim of this would be to demonstrate FDA’s commitment to improving transparency for better public access. The recommendations are:

• FDA should create a benefit and risk assessment and management plan for each drug 

• This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market

• The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product’s use, as well as benefit and risk assessments specific to these questions

• It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions 

This week an FDA report, "Advances in FDA’s Safety Program for Marketed Drugs", has highlighted the resources, both time and money, that the agency are dedicating to drugs that are on the market and available to the American public.

"Advances in FDA’s Safety Program for Marketed Drugs" details the new tools they have in place to ensure that once a drug is released no harm is caused to patients through side effects and negative reactions. The report shows the same amount of money is spent on post marketed drugs as pre-approval drugs. This is a response to previous suggestions that the FDA is inadequate at monitoring drug safety once a drug is on the market.

The FDA claims innovative tools such as Sentinel enable them to be ahead of the game when it comes to reporting, monitoring, analysing and reacting to issues raised.

What is the biggest change that you are seeing in pharma’s drug safety strategies at the moment?

The continuing shift from submission of individual case reports to aggregate analysis, signal detection and risk management. The implementation of these new processes has required the development of new methodologies and tools as well as greater cooperation between drug safety and other business functions.

What are the key challenges that pharma faces in effective benefit/risk communication?

There are several significant challenges for Pharmacovigilance functions. First, the analysis of benefit is not a topic generally undertaken by safety organizations. Thus there is a need to build a greater level of cooperation with clinical teams to develop and maintain robust benefit analyses. Then, there needs to be the development of generally accepted tools and methodologies for collecting and communicating information about benefit and risk both to regulators and the health care professionals. Finally, there also needs to be validated measures, taking into account both benefit and risk, that can be used for treatment decision making as well as for product approvals.

Well its been a busy few days for all involved in World Drug Safety Congress Americas this week in Boston. There have been some great presentations and interesting discussion on developments in pharmacovigilance, clinical safety and risk management.

A great way to gage how the industry is performing and what it is finding challenging is to listen to the questions and discussions in the conference room.

So what’s been discussed over the past week? Here are some of the key topics that people in the room have spoken about:

• INDUSTRY CHALLENGE: The current lack of participation by physicians in the debates on benefit-risk

• PATIENT BENEFIT RISK: When patients want certain drugs which improve quality of life but may have certain risks (eg. 1 in 10000), these are therefore considered risky by regulators. Why should they be denied these products?

• TRANSPARENCY: Should drug safety information be made transparent? Eg. What happens in some very rare vaccine cases

• TECHNOLOGY:  Rational use of tools – more focus on new drugs, new indications and new populations – and how can technology help this?

• SPECIAL POULATIONS: The risk benefit profile for pregnant patients – where the only risk can be to the developing baby

• SIGNAL DETECTION: Identifying signals on an ongoing basis for PSUR updates and the problems particularly with high volume drugs

• EU LEGISLATION CHALLENGE: After all the buzz on ‘harmonisation’ in drug safety, the new EU legislation is considered by some to only demonstrate the major problems with this. The legislation was driven by lawyers and politicians, who some suggested don’t understand the difficulties in its implementation –i.e. waves of modules being published – how is a team meant to plan a strategy when only parts come out at a time!! In saying that the modules are considered to be well written and clear.

• EU LEGISLATION BENEFITS: The positives from the new EU legislation is definitely the single point of reporting to Eudravigilance. Regulations dictate that member states can not impose additional reporting requirements on MAH.

In depth review of the new European pharmacovigilance legislation

Operational implications for integration of the new European pharmacovigilance legislation for pharma

The new PSUR: key amendments following the EU pharmacovigilance legislation changes

Implementation of DSURs in Europe and with it the new developments placed on pharmacovigilance in the approval of new medicinal products

Expectations of Health Authorities from the strengthening of the QPPV role

Transparency in the EU

Safety data management STREAM

Drug safety in patient groups and product case studies STREAM

Application of data mining techniques in pharmacovigilance

Gathering and processing safety signals

Benefit risk in the changing PV environment

The operational challenges for implementing benefit risk

Roundtable: Challenges of effective stakeholder benefit-risk communication

Plus many more! If these topics are of interest don’t miss the full programme with speakers- coming soon!

Michael Forstner is already confirmed to speak at the 2012 event and I very much look forward to hearing his update on industry best proactive in risk management.

What is the biggest change that you are seeing in pharma’s drug safety strategies at the moment?

The new EU PV legislation brings (amongst other challenges) the task to constantly evaluate the real-world benefit-risk balance of a drug, meaning that pharma will have to evaluate their risk management strategies based on the real world use of their drugs, including off-label uses outside of the labelled indications and/or outside the intended patient populations. This will require a much more pro-active approach to risk management (or actually: benefit-risk management), processes will have to be adapted and key audiences inside and outside the companies will have to understand the different needs. The second big change that will have to be implemented is the need to appropriately evaluate the effectiveness of risk management activities; based on discussions with colleagues from the industry and regulatory authorities, I am not convinced that we (collectively) have a good idea on how to best achieve this, how to integrate this activity in safety RM, and how to plan for actions that follow the evaluations.

What are the key challenges that pharma faces in effective benefit/risk communication?

Benefit and Risk mean different things to different audiences and decision making on the personal BR balance is a process that ultimately every patient has to perform (with the aid of their physician and – in some cases – their families or other affected persons). Pharma has to work with regulators and payers on a framework to communicate the BR balance in a non-paternalistic way to patients to enable them to make their own decision on whether or not they are willing to accept the risks that come with the benefits of a particular drug. For that purpose, we have to provide them with unbiased, yet interpreted data that are comprehensible in the same way as a PIL. The biggest challenge there is to overcome the functional innumeracy of a large proportion of the general populace that exceeds functional illiteracy by far, i.e., finding representations of numbers and probabilities that are intuitively comprehensible for non-statisticians. Naturally, these types of data representation must be agreeable to regulators as well and must be designed in a way to minimize the risk of liability litigation.

Want to hear more from Michael Forstner? Why not register for the World Drug Safety Congress Americas- taking place in 2 weeks time. See our website for more information.