Month: June 2017

Understanding the Clinical Research Process for Pharmaceutical Products

Clinical research is conducted around the world each and every day. This testing is completed for medications, medical equipment and products to identify their safety, effectiveness, benefits and adverse effects.

Pharmaceutical products have to go through very strict phases and stages to ensure that they are effective and safe. With diseases such as HIV, cancer, diabetes and more, scientists and researchers are constantly working on new medications to help slow and eliminate these disease, but this all has to be tested before it can be made available to the general public.

This all starts with the developmental stage. The developmental stage will identify how the medication is absorbed into the body, the potential benefits, dosage requirements and any side effects. These tests are only theoretical at this point and have not been tested on humans. It is what the research or scientist believes, but in order to have it FDA approved, it has a number of other steps and hoops to go through before it is considered safe for human consumption and can start making a positive difference to lives on a global scale.

Once the developmental stage is completed, the medication will enter the pre clinical research phase. This stage is often carried out in a laboratory using both in vitro and in vivo to learn more about the product, get a detailed overview and confirm it is safe for human testing. Any doubt in the products safety in humans will stop it going to the next stage of the clinical trial which is the human testing phase.

When the medication has effectively passed the pre clinical research stage, then it goes onto the clinical research phases, which comprise of four phases to identify if the product is safe, how effective it is, learn about side effects, risks and benefits.

Initially a specialist company or the pharmaceutical company will start choosing their participants to take part in the trial. This will include a number of factors including age, gender, medical history, health and more. They will also identify how many participants they need to ensure that they get a clear overview of the product to submit to the FDA. Participants can vary from forty or fifty participants to a couple of hundred participants.

Dosage and assessments will be determined and then the clinical research will enter trial one. Phase one usually lasts a couple of months, usually focusing on the products safety aspects, with only seventy percent of pharmaceutical products going onto phase two. Phase two can last up to two years, depending on it’s success, this focuses on the effectiveness of the product. Only around thirty three percent of products make it to phase three of the clinical research project.

Phase three is a long term process which can last up to four years. During this time the larger scale aspects of the medication is tested with participants being very closely monitored and supervised. This is to determine any benefits of the product, along with any adverse side effects. Everything has to be detailed and recorded to submit to the FDA for approval.

Only up to thirty percent of pharmaceutical products make it to the fourth and final stage. On completion of the fourth stage, documentation is collated and passed onto the FDA for consideration to be made available to the general public to improve quality of life and make a difference in lives on a global scale.

What Is Functional Medicine?

Functional medicine is an evolutionary practice that addresses the unique healthcare needs of those in the 21st century.

Rather than treating just the symptoms of any disease, functional medicine focuses on the underlying cause of disease by using an approach that focuses on the body’s systems and their primary functions. Practitioners work to engage the patient in a partnership that will lead to overall better health and wellness.

Functional medicine practitioners focus on the whole person, rather than just the isolated constellation of symptoms. This shifts medicine from traditional sick care to a more patient-centered approach. These practitioners spend a great deal of time with their patients and listen to histories, while also evaluating the environment, lifestyle, and genetic factors that may play a role in long-term health and the development of chronic disease. By doing it this way, practitioners offer their patients a unique experience in healthcare, which will lead to higher engagement and vitality for each individual.

Why is Functional Medicine Needed?

There are several reasons why functional medicine has become more and more popular in our culture. Some of these reasons include the following:

Current medical practice is aimed toward acute care (or sick care), the diagnosis and treatment of disease or trauma, and conditions that need urgent attention such as broken bones or appendicitis. Medicine is not focused on the wellness of a human body, but in the curing of an already sick one.

There is a drastic increase in the number of chronic disease diagnoses among those in our society. These diseases include heart disease, diabetes, mental illness, cancer, and autoimmune conditions like rheumatoid arthritis. Acute care medical approaches do not allow the ability to treat or prevent complex chronic diseases. This is generally because it does not account for the unique make-up of the individual or outside factors that could be playing a role, especially in the environment, which exposes us all to toxins. Lifestyle choices also play a primary role in overall health and may have a direct influence on the rise of chronic illness in our Western culture

There is a gaping chasm between the way doctors practice and the research in their selected fields. This gap is enormous, as much as 50 years, especially in the field of chronic disease.

Sadly, most modern day physicians are not trained to look for underlying causes of disease. They are not taught to look at treatment strategies such as diet, nutrition, and exercise that could improve illnesses in their patients.

Functional Medicine Differentiation

The origins, prevention, and treatment of chronic disease, especially, is of primary concern to a functional medicine practitioner. The principles of functional medicine that differentiate them from conservative approaches include the following:

Patient-centered healthcare: The whole patient is the primary focus. This practice promotes positive vitality beyond the absence of disease and promotes overall good health. By truly listening to patients’ stories and background, the functional medicine practitioner is able to guide the patient into self-discovery and then further tailor treatment to fit their individual needs.

Scientific and integrative healthcare approach: This is unique in itself. Doctors look for causes of illness by evaluating the web of interactions in the patient’s history, lifestyle, and physiology. Alone, the genetic makeup of a person can cause illness, so it is of primary concern to a functional medicine practitioner. Additionally, both external (social and physical environments) and internal (body, mind, and spirit) factors affect the body’s overall health as well.

Using best medical practices that are integrative: The practice brings together both alternative medicine practices, as well as traditional Western medical practices. They focus primarily on prevention through diet, nutrition, and exercise routines. They use the latest and best lab results and other diagnostic studies to assist in their diagnosis and treatment of each individual. They prescribe a combination of pharmaceutical medications, natural supplements, botanicals, detoxification programs, stress-management strategies, and therapeutic diets.

Mental Health Conditions Induced by Substance Abuse

A mental condition can be induced by a substance use disorder as much as a person with mental illness is likely to abuse any substance. Most of the times, it is difficult to ascertain which came first. The co-occurrence of a mental health condition along with a substance abuse problem is called dual diagnosis.

Here, we take a look at some of the mental disorders which can be induced by a substance use disorder:

    1. Substance-induced delirium: Also known as delirium tremens, it is a rapid onset of confusion that stems from alcohol withdrawal. Symptoms can last for a couple of days and the problem usually occurs when a person consumes excessive alcohol and tries to quit it abruptly. People often hear voices or see things that are illusionary and not felt by others. This suggests that while quitting alcohol, one should seek expert guidance to manage withdrawal.

    1. Substance-induced persisting dementia: The symptoms of a substance-induced persisting dementia are akin to those of normal dementia. The only difference is that it is caused by the abuse of substances. A person abusing substances may have trouble with memory, personality changes, and other physical or psychological problems, just like a regular dementia patient.

    1. Substance-induced psychotic disorder: Commonly known as toxic psychosis, it is a form of substance use disorder where the symptoms are ascribed to substance abuse. The toxins produced in the body as a result of the substance abuse affect the mind of an addict in such a manner that it results in psychotic disorder.

    1. Substance-induced anxiety disorder: Anxiety disorders can also be triggered by substance abuse and the symptoms can be equally ominous. It includes symptoms of a normal anxiety disorder, such as generalized anxiety disorder (GAD), obsessive-compulsive disorder (OCD), panic attacks or phobias. It may occur during the intoxication period or during withdrawals. Symptoms should not be taken lightly, considering the fact that they are induced by substance abuse. Repercussions of not getting treated on time could land someone in the soup.

    1. Substance-induced mood disorder: Many over-the-counter (OTC) prescription medicines and certain drugs are blamed for causing depression and other mood disorders. Reports of substance-induced mood disorder have been doing the rounds since the 1950s and are long known.

    1. Hallucinogen persisting perceptual disorder: Hallucinogen persisting perception disorder (HPPD) is a condition characterized by a continual presence of sensory disturbances. A person using hallucinogenic substances experiences persistent changes in his perception that are most commonly visual.

  1. Substance-induced sleep disorder: Substance abuse almost always causes sleep problems in addicts. Insomnia is a definite fallout of substance abuse. A person suffering from it has difficulty in sleeping or at times tends to oversleep. The variety of sleep disturbances is caused by abuse of substances.

The co-occurring disorders can be quite difficult to handle and treatment also becomes a bit of a challenge. A treatment cannot be effective unless both the conditions are addressed simultaneously. Merely treating one condition without addressing the other would not yield desired results. Hence, seeking help from the right treatment center at the earliest holds the key. c

A Brief Discussion on Types of Needles and Syringes

Needles and Syringes are among the most used medical apparatuses. In this article, we will be discussing about some of the most used types of these medical apparatus.

The most widely discussed classifications of syringes are non Luer Lok and Luer Lok syringes. This classification is made based on the kind of tip these units possess. The Luer-Lok syringes come equipped with tips that need needles that get twisted and locked into appropriate place. This design ensures that the needle doesn’t slip out of the syringe accidentally.

There’s another way of classifying syringes; this time we are classifying it based on the purpose it’s used for. The two most widely used types include insulin syringe and tuberculin syringe. The insulin syringes are significantly small in size and are capable of holding 0.3 to 1 ml of medication. They are usually calibrated in units instead of milliliters. The majority of the insulin syringes get calibrated up to hundred units. Another important characteristic of these syringes is that they are designed to allow seamless self-injection. They are mostly used for administering subcutaneous injections.

The other type i.e. tuberculin syringes are used to test patients for tuberculosis. The fluid in these syringes gets injected directly into the patient’s skin. Although these syringes are small in size, unlike the insulin syringes, they get calibrated in milliliters. The most prominent feature of the tuberculin syringes is their thin barrel that comes equipped with a pre-attached needle. These pieces are capable of accommodating 1 ml of medication. Here, it must be mentioned that in spite having a petite structure, they cannot be used for giving insulin.

Now, let us discuss about needles and their types. The majority of the needles available on the market currently have stainless steel body. They have a hollow structure and boast a miniature hole right at the middle. Their bodies are segregated into three main parts, the hub, the shaft and the bevel. The hub is the part that fits onto the syringe’s tip. The shaft of the needle is its long slender part. A needle’s bevel, on the other hand, is its slanted tip.

Needles are usually classified based on their diameter and length. Their length ranges between 0.5 inch and 3 inches. Their diameter gets measured in gauge. A 19 gauge needle is known to possess bigger diameter than a 25 gauge piece. This means the greater would be the gauge of a needle and smaller would be its diameter.

A needle must be of at least 7-gauge. The maximum limit, on the other hand, is 33-gauge. Doctors select gauge of a needle based on the density of the medication they are injecting. For instance, for extremely thick medications, doctors always use needles of smaller gauge. If the density is less, doctors tend to use needles of bigger gauge.