Pharmacovigilance - An Introduction

Posted by sleepyguy in Prescription Sleep Medicine on August 09th, 2009

Pharmacovigilance is the practice of maximizing the safety and benefit of drugs and minimizing the risks and adverse effects. Pharmacovigilance techniques are employed during trials and afterward once a product is on the market to monitor any adverse events and side effects in order to protect the public. Effective pharmacovigilance is a legal requirement of any pharmaceutical company and the penalties for failing to implement good pharmacovigilance practice are severe.

When a pharmaceutical company is granted a license to release a drug onto the market, the license is granted on the back of several phases of clinical trials where the drug will have been tested firstly on healthy volunteers and then on patients suffering from the condition that the drug is designed to treat. In many cases the drug will have been tested for extensive periods of time on thousands of people the intention being that as many of the adverse effects of the drug will have been spotted during the clinical trials.

The licensing authorities have a balancing act - on the one hand medicines must be as safe as possible, on the other hand they need to make sure that diseases are treated. In order to help achieve this balance there are procedures in place to ensure safety once a drug is on the market. This may be necessary if there are unforeseen long-term consequences of using the medicine or if the medicine interacts in unusual or unexpected ways with other medicines or if the medicine turns out to be less suitable for use in certain populations than was previously suspected - for example in the elderly or infirm. Also very rare and potentially serious side-effects may only be spotted after the drug has been taken by a much larger number of people than could have been on the trials.

In order to almost guarantee finding a side effect that occurs in 1 in 10 patients, you have to give the drug to 30 patients just to be sure of finding that effect. In order to almost guarantee finding an adverse effect that is extremely rare and only affects 1 in 10,000 patients, you need to give it to 30,000 patients. No clinical trial would ever be that extensive and therefore pharmacovigilance is the way to detect these rarer events.

Pharmacovigilance is the science of drug safety, a combination of pharmacoepidemiology and pharmacology it provides the tools to help assess risk vs benefit, to detect signals in data that point to an adverse event and to help assess the significance of these signals. You can read more about it in other articles on here or at the site for the Pharmacovigilance Information Service.

Taking Too Many Drugs - Polypharmacy

Posted by sleepyguy in Prescription Sleep Medicine on August 09th, 2009

Have you been a victim of having too many unnecessary drugs as part of your daily medication routine This article topic is near and dear to my heart because I have an aunt that was a victim of being prescribed too many drugs that she did not need. Also, I feel it is important to get this message across because polypharmacy is becoming a bigger problem for a lot of people.

Polypharmacy is the word used to describe a situation where:

1. a patient is prescribed too many drugs that are not needed.

2. a patient is taking too many forms of a drug.

3. even if medications are needed, the patient has to take a lot of pills every day - so many that the patient may get confused or overwhelmed.

What happened with my aunt was she ended up taking drugs to treat the side effects of the medications she had already been taking. Because her doctor prescribed the medications, she thought she absolutely had to take them all for the rest of her life. It was hard for her to grasp the fact that eventually some drugs are just not needed anymore. She found it very difficult on her mind and body to remove her prescription drugs from her daily routine - why else would the doctor prescribe them

The only reason she stopped taking most of her meds is because she eventually couldn’t afford them (that’s a whole other issue!) Her medication list had reached a total of 18 different drugs to be taken in one day - that number went down to only 4 medications when all was said and done. WHAT !!! Yup, that’s right….only 4 medications now and she feels so much better!

I repeatedly explained to her that all 18 medications were not needed and that she was reaching a danger zone, but she had an excuse as to why she needed them all. She agrees now that she was taking too many drugs.

There may be some people that do need 18 or more medications for medical reasons, but either way, be sure to go over your medication list with your doctor and pharmacist every so often in order to keep your drug list up-to-date - I see firsthand how patients are affected by being overmedicated.

Remember, drugs may be seen as powerful healers, but they can cause a lot of harm too. I think it’s important for patients to know that more drugs does not always mean better results.

A Natural Way to Treat Hypertension

Posted by sleepyguy in Prescription Sleep Medicine on August 09th, 2009

Hypertension or high blood pressure is a common health problem of older age groups and some younger adults. Hypertension varies depending on the age, height, weight, and gender.

Most physicians and doctors are recommending pharmaceutical medicines which are being sold in drug stores, as the means to treat hypertension. Many researchers and scientists are beginning to lean towards the natural ways as the means to treat hypertension. This is because of the unpleasant outcomes which may result when you continuously take pharmaceutical medicines.

In this busy stressful life, it is highly important for old and younger adults to have a systematic check of their blood pressure. High blood pressure can be controlled with natural remedies and changes in diet and lifestyle. Reducing your stress can also improve your general health, including your blood pressure. Adopting healthy lifestyle habits and diet habits prove to be an effective step in both preventing and controlling high blood pressure. Blood pressure medications can be added if lifestyle changes alone are not effective in controlling your high blood pressure.

Having hypertension is one indication that you are living an unhealthy lifestyle, and hence leading a healthy lifestyle can probably help you to control your blood pressure and lead a healthier and happier life. Hypertension is a disease that is typically easy to treat with natural means. There are a number of natural ways to treat hypertension. Most of the natural remedies used for treating hypertension are safe and effective. Researches found that hydrotherapy, special vegetarian diet, exercise, herbal tea, and adequate water have good effect in controlling hypertension.

Diet change is one natural way of treating hypertension. Consume either raw or cooked garlic to help in lowering hypertension. Garlic, which contains a compound called adenosine which functions both as a muscle relaxant and as an aid in vaso dilation, helps in dilating the muscles of blood vessels, thereby avoiding blood clots and lowering blood pressure. Eat high-potassium diet, such as bananas, potatoes, tomatoes, skimmed milk, oranges, watermelon, soya beans, almond and spinach, to help lower your blood pressure. Fruits and vegetables are best sources of vitamin C, potassium and soluble fiber, all of which have an effect in lowering blood pressure. Fishes which contains omega-3 fatty acids can be a good diet for people who are experiencing hypertension. Omega-3 fatty acids have the ability to dilate blood vessels and significantly lower blood pressure. Food rich in calcium regulates the heart’s muscle contraction, making it easier for managing blood pressure. Many people have successfully treated hypertension with apple cider vinegar. It is rich in so many vitamins and nutrients that are thought to be helpful in lowering hypertension. Hawthorne berries can also be used to treat hypertension.

Drinking lot of water and getting enough rest are holistic and natural way of treating hypertension, besides taking natural medications. Enough sleep, regular exercise and healthier lifestyle with recreation time can control your blood pressure. You can also control your hypertension through weight management, meditation and relaxation. All these natural health remedies rely on how you balance your diet, intake of supplements and your lifestyle, in order to control your high blood pressure.

Besides the above tips, you can refer a lot of web-sites which show the exact step-by-step formula of natural treatments for Hypertension.


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