Showing posts with label Pharmacovigilance. Show all posts
Showing posts with label Pharmacovigilance. Show all posts

Friday, 12 June 2015

HEALING COMMUNICATION: THE "NEED TO HAVE" IN PHARMACOVIGILANCE




Pharmacovigilance communication: What are the public expectations? How should it look like? And what are the challenges?

Many might agree that we are living in an environment full of misleading, unreliable and inaccurate information. The internet, the fastest growing technology in our society, has been driven by the public’s hunger for fast, cheap communication. The modern patient appears to their medical practitioner with an internet diagnosis and treatment plan, obtained from a website with inaccurate or highly biased information. The internet provides an unparalleled opportunity to revolutionize medical education. The need for accurate, reliable and good quality information available on websites has become essential. With public forums and social media constant and immediate access to information, is no longer a “good to have” but a “need to have”.

There are a diverse number of tools used by the EU network to communicate with the public, some of those are the following;

•Direct healthcare professional communication (DHPC)
•Documents in lay language, e.g. Q&A
•Press communication
•Inter-authority communication
•Public enquiries
•Bulletins and newsletters
•Others, e.g. scientific journals etc.


Experts agree that is essential to involve all the players in a dialogue in order to achieve greater effectiveness in communicating drug safety issues through higher understanding of themselves and others. Building trust and a climate of openness is a fundamental key to competent communication. In a secretive environment, information would never be perceived as credible.

One of the main channels of communication are the Patient Information Leaflets (PILs). If the PIL looks attractive but still retains the use of poor language or the widespread use of technical terminology, again the opportunity to communicate with the patient will be lost. Clear language is already a legal requirement for PILs, as well as information being comprehensible and easily legible. The Queen Elizabeth Hospital Birmingham (QEHB) puts all the patient information leaflets and factsheets available for the public in their website giving easy access for anyone to approach the information.

There are several challenges surrounding communication in PV. Currently, package leaflets must present a set of information in a particular order. However, frequently they do not meet the needs of patients. In particular, there is a need for larger flexibility in the way information for each medicine is presented

We can conclude that in a world stuffed with information, advertising and communication of all kinds, there are three essential principles to remember:

1. Is extremely difficult to get and hold anyone’s attention, clear, direct messages are a must.

2. One-way communication is no communication: Receiving significant feedback requires at least as much skill as preparing the initial communication. The communication cycle must be completed.

3. One-time communication is no communication: repetition is what makes a difference with preoccupied human beings.

For each audience and target group, we must identify the various channels through which they may be reached and use several of them, the more personalized the information is, the better.

Monday, 18 May 2015

HOW CAN PHARMA INDUSTRY ENTER DIGITAL WORLD?





















It is undeniable that the internet has become an essential part of everyday life. People are constantly looking for knowledge, ideas and opportunities online. It is a waste not to exploit the potential of this rich source of all information under the sun, especially social media.

Unfortunately, unlike like most industries, Pharma does not enjoy communicating with its consumers on the internet. Communication with the public can create sensitive situations, such as dealing with exposed adverse events; that most drug makers want to avoid. However, the internet is a large pool of information no businessman wants to overlook. Pharma wants to join social network!

In recent years, it is common that patients go to the internet to ask for their illness, symptoms, recommendation of remedies and even drug usage. In a broad healthcare context, it is important to be well prepared and react decisively.

How is Pharma going to do that?

Brand managers want to benefit from social media, yet they lack of understanding of their patients and target consumers. The most asked questions must be where, what and how.
  •          Where do doctors and patients discuss medicines?
  •          What is the appealing content that most readers look for?
  •          How do we communicate without triggering unwanted discussions?


Healthcare professionals have the answers. They often discuss drugs, policy, treatments and brands in their own community. Communication with healthcare professionals does not bring up troubles. Once drug companies have access to needed information, they can see what is relevant without conducting time-consuming traditional research. Finding out what your patients discuss, need and concern; you can produce the most relevant and valuable content possible.

Appropriate use of social media proves to drive better Pharma outcomes, such as well educated patients, better drug safety reports and evaluation, smooth communication among patients, healthcare professionals and regulators, better PR, and even improved public health. However, many more questions should be addressed, until social media finally becomes Pharma’s comfort zone. 

Wednesday, 6 May 2015

OUTSOURCING IN PHARMACEUTICAL INDUSTRY 101



In recent years, global pharmaceutical industry have been facing a number of financial challenges. This situation encourages drug companies to pursue a more efficient and cost-effective way to operate their business. Outsourcing is believed to be the solution for global pharma companies, and has become a trend in low-cost growing markets, such as India and China.


Most emerging markets are attractive to global drug companies, since they possess a large talent pool with competitive knowledge and skills, yet only cost a reasonable wage compared to Western labor. Additionally, outsourcing to developing countries helps to market the medicines and widen the companies’ target customers.

It is a great challenge to successfully manage the outsourcing relationship and create value. To achieve this goal, global drug companies are constantly looking for partnership with desired local organizations in developing region, where high-cost research and production can be done for a much lower cost. The idea is to have global drug companies as technology and market providers, while outsource partners create innovative products. Outsourcing solves the financial challenges and allows pharma firms to exploit the potential of the latest technologies.

Despite outsourcing to developing countries, Pharma companies still need to fulfill their home countries’ demands and standards. They are rapidly investing and building their development facilities in those countries. Therefore, partner countries also benefit from this outsourcing relationship and are gradually rising as potential competitors. For instance, China and India have become prominent actors in global pharmaceutical outsourcing area.  The two countries possess different features and characteristics, yet both provide high quality service at low cost, which is extremely attractive to major Pharma firms.


Outsourcing has proved to be a successful and efficient way to operate research, production and marketing. Nowadays most big Pharma companies have been outsourcing to emerging markets, especially in Asia. Therefore, it is proper to state that outsourcing is playing a significant role to move the whole pharmaceutical industry forward. 

Thursday, 23 April 2015

COMMUNICATION: CHALLENGES IN PHARMACOVIGILANCE


It has been well recognized that effective communication is the core of successful pharmacovigilance. The purpose of interactions among healthcare professionals, patients, regulators and pharmacovigilance experts is to manage risks with medicine and prevent patient harm. Although communication is not a new issue, there is an urgent need of ideas with which to practice it appropriately and experiment new methods.

Why is it urgent? Adverse drug reaction (ADR) can be life threatening and is in fact a leading cause of morbidity and mortality. The lack of information and communication has been discussed and seen as a challenge for pharmacovigilance professionals. It is common for people to ask for advice and remedies from websites and social media in today’s world. Although most people have access to information, not many really understand what they are reading or get the knowledge they are looking for, since not all content on the Internet is validated.

Patients are concerned about their lack of understanding, and want their medical risks to be taken seriously; while healthcare professionals tend to prefer benefits to risks of medicines.  The difference in perceptions can and should only be eliminated by two-way communication. This requires surveys and research on patients for an extended period. Additionally, it would be beneficial for patients to have longer and more detailed consultations; however, it will be more expensive and put pressure on healthcare professionals.  

Communication between healthcare professionals, regulators and the public is also challenging. The public often demands information and transparency, while decision makers’ priority is benefit-risk balance. Since experts and regulators fear the public drug scare, or failed vaccination programme, it is understandable that they are reluctant to explain to mass media all the risks and possible harms that medicines may cause. 

Successful communication achieves advocacy. Failure can create social problem and damage public trust in government, which is difficult to rebuild. For these reasons communication in pharmacovigilance is a challenging task that should be focused on and carefully practiced by health authorities.