The laws governing pharmacovigilance lay down strict instructions on what pharmaceutical companies must do in the event of detecting a serious adverse event, and indeed what constitutes a serious adverse event.

With these major demands on pharmaceutical companies, it is important for them to set up an appropriate pharmacovigilance system, and this causes a number of problems.

First of all, the regulations are often hard to interpret certainly when it comes down to the finer points.

Second of all, if you get it wrong, you can be subject to a pharmacovigilance inspection, and you may eventually have your marketing authorization revoked for a particular product.

So, there is an awful lot riding on having effective pharmacovigilance solutions to hand. As a pharmaceutical company, you basically have two choices: either do the whole lot in-house or outsource some or all of your pharmacovigilance operation.

There are pros and cons to both.

In-House Pharmacovigilance:

Pros - Inevitably, in-house wages will be lower than using qualified staff. In-house staff already know the company culture and systems and will adapt quickly to running and working in a pharmacovigilance department. Where you have marketing authorization for many products in many territories it makes sense to have dedicated staff to deal with drug safety where a smaller company might be better off outsourcing their pharmacovigilance operation.

Cons - You need specialist staff in pharmacovigilance. You can get training, but where and at what cost? You will need a pharmacovigilance database that is validated, not just a spreadsheet in Excel or some Web site the CEOs kid knocked up in Access.

Then there’s the training - pharmacovigilance training. Would you like your staff trained by academics who don’t really understand the industry? Or maybe they should be trained by former regulators who have never had to work in a pharmaceutical company so their knowledge is only theoretical? Or maybe you could have them trained by someone who used to work for a pharmaceutical company who will have no real idea about what the regulators are thinking.

Or possibly you could find someone who has experience of all three arenas who could train your staff, someone accepted as a registered presenter for Continuous Professional Development by the CPD Certification Service. Such people are out there but would be hard to find. When you look at the qualifications of the people doing the training at pharmacovigilance conferences and in-house, these are the sorts of factors that should influence your decision to attend - do the presenters have the right experience so that my staff and I will learn what we need to in these sessions?

Discussion of the requirements of the pharmacovigilance legislation in the European Union is continued on the Pharmacovigilance Information Service’s Web site with particular emphasis on Volume 9 of the rules governing medicinal products in the European Union,?which contains pharmacovigilance guidelines for medicinal products for both human and veterinary use. You can see the full text of Volume 9 here.

Even large pharmaceutical companies struggle to find suitable expertise in-house. Running a search in Google for “pharmacovigilance job” will show you just how desperate the shortage it. This shortage of talent brings consequent problems when they are inspected by the competent authorities, such inspections being an inevitable part of the pharmacovigilance process. The demands on medium and small companies are such that they can not comply economically in-house and must outsource parts or all of their pharmacovigilance and drug safety operations. They are then left trying to find a reliable pharmacovigilance resource that they can trust.

For small and medium-sized pharmaceutical companies the cost of running a pharmacovigilance system is prohibitive - they simply can’t afford to do it, however worthwhile and important it might be. For larger companies pharmacovigilance systems may be something that they would wish to outsource for reasons of efficiency. There are a number of contract organizations who can run your pharmacovigilance system for you. Again there are many factors to consider, cost being just one of them.

With an outsourced pharmacovigilance systems, the regulator will consider you liable for any problems rather than the company you contract to, so you will want to make sure that the staff are properly trained and fluent in the relevant languages that they will need, most predominantly English. They will be taking in reports from medical professionals and processing them, expediting them where necessary, adding them to the pharmacovigilance database, dealing with and liasing with medical professionals and regulatory bodies on your behalf and also taking calls and queries from members of the public. Remember, when any member of your company or the company acting on your behalf hears of a potentially serious adverse reaction, they have 15 days to get that report confirmed and submitted to the regulator. Outsourcing is a serious matter. Your marketing authorization depends on it. What steps are you taking to make sure that your pharmacovigilance outsourcing is validated and compliant? Is your qualified person available at all times when they need to be? Are they experienced in responding to queries from regulators?

There are many companies out there offering pharmacovigilance services but very few that have been set up as dedicated pharmacovigilance contract research organizations by some of the people who have been in the industry since the start. PrimeVigilance were established as a joint venture between Ergomed, a CRO, and Elliot Brown Consulting whose managing director was one of the authors of MedDRA the Medical Dictionary for Regulatory Authorities, now used worldwide by all regulators, pharmaceutical companies and most recently the WHO. A similar consultancy service is offered by Pietrek Associates. The other option is to go with one of the big CROs such as Parexel, but costs with companies such as this can be prohibitive.

Diabetics need to fight not ony the disease but also various complications that it brings allong. Diabetic neuropathy is one such complication that is caused by poor blood supply and nerve damage to a diabetic’s body. One such silent complication that attacks from within the body is diabetic autonomic neuropathy. Here are the symptoms and treatments for diabetic autonomic neuropathy.

Over a period of time, high blood glucose fluctuations can lead to nerve damage and impaired blood circulation, which can result in specific organs of the body getting impaired or damaged. There are 4 types of diabetic neuropathy, namely peripheral, focal, proximal and lastly autonomic neuropathy that can affect different functions and organs of the body. Diabetic autonomic neuropathy affects the nerves related to the functioning of the heart, lungs, digestion, perspiration, bladder, bowels, salivation and vision. It is very difficult to diagnose the onset of this type of neuropathy since there is no associated tingling, pain or numbness, which is usually found in other types of neuropathy. Another problem in catching the symptoms is that it is sometimes confused with other minor ailments such as an upset stomach, etc.

The symptoms depend on the organs that get affected with the onset of diabetic autonomic neuropathy. Hence patients could develop gastrointestinal problems such as nausea, heartburn, vomiting, which in turn can also cause blood sugar levels to fluctuate wildly. Other symptoms include urinary tract infections and incontinence in case the urinary bladder is affected. In case the disease affects the patient’s sexual organs, then it could cause erectile dysfunction or vaginal dryness depending on the sex of the patient. This disease can also affect the sweat glands thus leading to excessive sweating or even extremely dry skin, which again can open the way for skin infections. Patients that have diabetic autonomic neuropathy can also become victims of hypoglycemic unawareness or even suffer silent heart attacks, which could prove to be extremely dangerous.

While medications and surgery can be used to treat specific cases of diabetic autonomic neuropathy, antioxidants such as alpha lipoic acid too have shown positive results in trials in Europe. This treatment can be used on humans and select pets such as dogs and hamsters although cats cannot be treated due to a toxic reaction by this antioxidant with its liver. Patients should also consume enough liquids to keep their skin hydrated and should also go in for smaller, low-fat and low-fiber meals to improve digestion and regularize bladder movements. Adequate exercises to build up muscle tissue and burn excess fat along with a strict insulin monitoring and delivery schedule is a must for diabetics that need to avoid the onset of diabetic neuropathy. Diabetics should also take adequate care of their skin and also observe the physical condition of their hands and feet on a daily basis.

Diabetics should regularly check-in for check-ups and consult their doctor before making any changes to their diet or insulin delivery schedules. Each medicine or injection should also be cleared by their doctor. Any symptoms related to diabetic autonomic neuropathy should be followed up immediately instead of waiting until it becomes too late to reverse or arrest the effects.

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