Real World Evidence Europe 2015

Jun 3, 2015 - Jun 4, 2015, Amsterdam

Equip your company for real partnerships with payers and HTAs

Successful Pharmacovigilance: Harnessing Relationships between Stakeholders

What makes pharmacovigilance effective and efficient is the trust between the different parties and stakeholders.

Dr. Eszter Teleki, Group Director at Bristol-Myers Squibb Pharma EEIG

Maintaining the safety and quality of drugs was traditionally the sole responsibility of the pharmaceutical companies manufacturing the drugs and the drug regulation agencies authorizing and approving them for use. Today, there are many more key players required for successful pharmacovigilance.

The key stakeholders

As the world’s population increases and emerging markets in developing countries are also increasing the demand for medicine, the intrusion of counterfeit drugs has burgeoned as well.  It is now recognized that the safety of medicines is the responsibility of all stakeholders - the pharmaceutical companies, the government drug regulation agencies, healthcare professionals (HCPs), and patients. As clinical research and development of drugs is becoming increasingly regulated, contract research organizations (CROs) and sites (that is, clinics, hospitals, and communities where clinical trials are conducted) and even customs administrations, are now also considered stakeholders.

Each of these key stakeholders has a fundamental role to play in pharmacovigilance:

  • The pharmaceutical industries provide the financial capital for clinical research in discovering, developing, and trialing drugs.
  • Contract research organizations are increasingly taking on the research work for pharmaceutical companies.Traditionally, CROs merely conducted the different phases of clinical drug trials, but increasingly, CROs themselves also now conduct research to discover new drugs as pharmaceutical companies outsource more research jobs to CROs.
  • Drug regulation agencies review the data from clinical trials and conduct investigations as to the safety and therapeutic claims of drugs developed by pharmaceutical companies.
  • Healthcare professionals prescribe the drugs to their patients and report any adverse drug reactions (ADRs) they might observe in their practice. 
  • Patients participate in clinical trials when drugs are being developed; and after drugs have been approved and authorized for sale and use, patients provide feedback as to their experiences of taking the drugs.
  • Healthcare sites provide the venue and the eased ability for screening of patients as participants in drug trials, for collection of data, and for administration of the drugs during clinical trials.
  • Customs administrations and law enforcement agencies protect the intellectual property of the pharmaceutical companies by ensuring that counterfeit drugs are taken off the market and don’t compete with legitimate drugs.  By seizing counterfeit drugs, they are also protecting the general public from the health hazards posed by the counterfeit drugs to those who use them.

Together, these stakeholders uphold the integrity and quality of the drugs that the public consumes. The question that arises now is, with so many stakeholders involved how can pharmacovigilance remain efficient in ensuring the safety of drugs?

Maintaining relationships: the key to more effective pharmacovigilance

During the 8th Conference on Pharmacovigilance, the issue of more effectual pharmacovigilance was explored. In a panel discussion facilitated by Dr. Eszter Teleki, Group Director at Bristol-Myers Squibb Pharma EEIG, the importance of cooperation and collaboration was underscored - to make the relationships between stakeholders work and also to make pharmacovigilance more effective. The importance of involving patients more in pharmacovigilance efforts was also stressed

It was suggested that the level of collaboration and cooperation between stakeholders must start with “shared understandings” and “realistic expectations of communication,” especially in forming practical policies and in resolving problems. 

So, how can shared understandings and expectations of communication be applied in practical terms in order to formulate policies and resolve problems?

1.      Data pooling

Pharmaceutical companies and CROs need to effectively communicate regarding the data they collect.  Even during the clinical trial phases, much data is available that serves as signals to risks of potential ADRs. The CROs can already use data from clinical trials to hypothesize likely ADRs that may develop and recommend ways in which the risks can be managed.

Data pooling can also benefit individual drug companies as it will drive research costs down.  Researching a question which has been researched by someone else will not only prove a costly proposition, but it also wastes time. Data pooling and sharing can help re-focus research efforts and identify new areas of research.

In this regard, the views and descriptions of patients who participate in clinical trials are valuable as their descriptions include the impact of the effects of the drugs on their quality of life. In turn, patients’ views as to their experiences may determine new “off-label” uses for drugs.

A recent example of data pooling in practice is the collaboration of ten companies working to identify promising drug targets for Alzheimer’s disease, lupus and diabetes treatments. This initiative was led by the US National Institute of Health in Bethesda, Maryland, as part of wider efforts to help the pharma industry accelerate the development of new drugs.

2.      Data sharing

Most research and development data is proprietary and is usually kept confidential.  However, once a drug has been authorized, the information must be made available to patients, HCPs, and law enforcement agencies.  In the first place, HCPs must understand how the newly authorized drug works and what benefits it can give to patients.  This information can also help them recognize ADRs in their patients.

Furthermore, patients need to have access to information about the results of clinical trials, and they need to have access to the patient information provided pre-trial. This is to ensure that they are informed as to the potential risks that taking the drug might pose to them.  When patients have access to data that is significant to them, they become active partners and not passive subjects in clinical trials.

Lastly, law enforcement agencies need access to drug information so that they can use it to evaluate if the drugs passing through their jurisdiction are counterfeit or legitimate. Law enforcement agencies aren’t experts in detecting counterfeit drugs.  They need information that is readily available to use as a basis for evaluating the quality of the drugs they are inspecting. They also need information as to unique characteristics of packaging and labeling and pictures so that they can judge for themselves if the medicines in front of them are identical to the medicines that the legitimate manufacturers are selling.

3.      Reporting of ADRs

Not all ADRs are reported by HCPs because they often don’thaveenough information about a drug to detect if a patient’s presenting symptoms are ADRs. They may also feel that treating an ADR is their job but not preventing ADRs, hence, they don’t see the value of reporting them. Therefore, there clearly needs to be some assistance provided to increasing the self-efficacy of HCPs to report ADRs and to recognize their responsibility to do so.

A more patient-centered approach to clinical trials is also required. Patients can be an invaluable source of information and data about ADRs, especially if they are trained and educated not only to observe possible ADRs, but also to self-measure and self-manage when ADRs do occur.

In 1991, it was estimated that the cost of developing drugs was $318 million USD.  Today, the cost of developing a new drug has ballooned to $1.3 billion USD.  It is in the interest of all stakeholders to cooperate and collaborate not only to reduce the cost of developing new drugs because this translates into the availability of more affordable drugs, but also because reducing the cost of legitimate drugs will lower the demand for counterfeit drugs, which are always sold at a fraction of the price of legitimate drugs.

The internet is a convenient way of increasing the accessibility of information, for pooling it and disseminating it to stakeholders who need the information in order to make decisions that can save lives. Better information translates into better education for all stakeholders which will make the surveillance of the safety of drugs in the market more efficient, less time-consuming, and less costly.

Protocols, policies, laws, contracts, and consent forms are full of words; but what makes pharmacovigilance effective and efficient, is the trust between the different parties and stakeholders. Thus, it is in everyone’s best interest to effectively communicate and collaborate.

Real World Evidence Europe 2015

Jun 3, 2015 - Jun 4, 2015, Amsterdam

Equip your company for real partnerships with payers and HTAs