Medication Disposal

Overdose deaths from the misuse of prescription drugs has reached epidemic proportions in our country. The diversion of pharmaceutical controlled substances is the root of this epidemic and we can take steps to prevent it. Statistics reveal the majority of all people who use pharmaceutical controlled substances for non-medical reasons get the drugs from friends or family for free. Sometimes the abuse is an unknown condition and prescriptions are voluntarily shared to address claims of pain or the prescriptions are accepted as the result of theft. One critical step in preventing this diversion is for consumers and legitimate end users to properly dispose of their unused, unwanted or expired pharmaceutical controlled substances. Consumers are urged to do their part and properly dispose of unused medications to prevent theft or other diversion of their prescriptions into the hands of addicts.

Programs have been implemented to encourage Americans to properly dispose of medications that pose a serious safety hazard if left in their residential medicine cabinet. The best and safest method of disposing of pharmaceuticals is for consumers to deliver their unwanted medications to an authorized collection site. This can be done at a sponsored schedule prescription “Take-Back” event or any time at a Drug Enforcement Administration (DEA) authorized collection site. The number of available drop off locations increased after DEA amended the Secure and Responsible Drug Disposal Act of 2010 and expanded the options available to collect controlled substances from ultimate users for the purpose of disposal. The public may find authorized collectors in their communities by calling the DEA Office of Diversion Control's Registration Call Center at 1-800-882-9539.

Two of the largest pharmacy chains in our country, CVS and Walgreens, have recently launched programs to allow consumers to return their unwanted medicines for safe disposal. In 2013, CVS launched its CVS / Pharmacy Medication Disposal for Safer Communities Program, a federal grant initiative. As part of this program, the company distributes drug collection bins to police departments and municipalities so they can set up environmentally responsible local drug disposal programs. (1) Walgreens plans to install safe medication disposal kiosks in more than 500 drugstores in 39 states and Washington , DC, primarily at locations open 24 hours. (2)

Healthcare providers and other DEA Registrants can learn how to properly dispose of unused controlled substances by viewing DEA's disposal regulations at the DEA Diversion website or at the Federal Governments Regulations website. The Final Rule of the Secure and Responsible Drug Disposal Act of 2010 authorizes certain DEA registrants (manufacturers, distributors, reverse distributors, narcotic treatment programs, retail pharmacies, and hospitals / clinics with an on-site pharmacy) to modify their registration with the DEA to become authorized collectors. All collectors may operate a collection receptacle at their registered location, and collectors without an on-site means of destruction may operate a mail-back program. Retail pharmacies and hospitals / clinics with an on-site pharmacy may also operate collection receptacles at long-term care facilities. (3)

DEA will conduct its 11th National Prescription Drug Take-Back Initiative (NTBI) on April 30th, 2016 from 10am to 2pm. Collection sites will not accept any dangerous, hazardous, or non-compliant items such as medical sharps and needles (eg, insulin syringes), or compressed cylinders or aerosols (eg, asthma inhalers). To find the collection site near you, visit the DEA website, click on the “Got Drugs” icon and enter your zip code. During DEA's last NTBI held on September 26, 2015, DEA and 3,800 other participating law enforcement agencies collected over 350 tons of unwanted prescriptions that could have otherwise been diverted into the hands of addicts.

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The Possible Risks When Your Pain Doctor Prescribes Medication

There are many people who never experience a headache or muscle ache at some point. And for those, we often turn to an over-the-counter medication for relief. However, when the pain is chronic and severe, such as that experienced from arthritis, cancer, an injury or another issue, we seek help from a pain doctor.

The doctor will often prescribe a stronger medication such as a prescription opioid, which is a form of narcotics. Opioids are known to have side effects, some more serious than others. And if you are on other prescription medications, it can pose even more possible issues.

Your pain doctor may prescribe opioids to be taken around-the-clock to manage your chronic pain. In some cases, depending on the patient, their pain and other medications that may be taking, opioids may prescribe to take “as needed” for times when the pain “breaks through” the other pain medication. Breakthrough pain is when pain flares up, disregarding of the round-the-clock pain medication.

What You Need To Tell Your Doctor

When your pain doctor prescribes opioid pain medications, you should advise them the following:

· How your pain responds to the medication

· If you are experiencing any side effects

· If you have other medical conditions that may increase any side effect risk

How Opioid Drugs Work

These drugs work using your brain, spinal cord and other parts of your body. They will bind the opioid receptors in your brain, spinal cord, etc. to reduce the number of pain messages that you brain receives. This, in turn, reduces the feelings of pain you experience.

Opioids Are not Friendly

While moderate to severe pain can be treated by opioids, they are not friends with many all medications, especially pain medicines. Some opioid drugs are:

· Codeine

· Fentanyl

· Hydrocodone

· Hydrocodone / acetaminophen

· Hydromorphone

· Meperidine

· Methadone

· Morphine

· Oxycodone

· Oxycodone and acetaminophen

· Oxycodone and naloxone

Most of the opioid medications that a pain doctor prescribes can be taken orally. Some of these must be taken by injection and there are some that are available in a patch now.

Should you feels as if the medications that you're taking are having adverse reactions, never change how you take them or quit taking them before consulting with your doctor. You can always expect some type of reaction, but when they are causing you more problems than they are helping, your doctor will need to make some changes.

To just quit a medication totally on your own is dangerous and could cause a severe problem. If it is time for you to quit taking opioids, the doctor will have a process of weaning you slowly.

Side Effects To Expect

As we've stated earlier, you can expect to have some kind of side effect when taking opioids. This is why you need to have open communication with your pain doctor so that they can monitor and adjust as needed. Some of the side effects are:

· Constipation

· Drowsiness

· Nausea

Always keep in mind that you should never consume alcohol while taking opioids. The combination can be dangerous and even deadly. Before you start taking any herbal or OTC medication in addition to what you're already taking, consult with your pain doctor .

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Homeopathy As Alternative Medicine – Holistic Approach to Treatment

Homeopathy is an alternative medicine system pioneered and developed by a German physician, Samuel Hahnemann, around the end of the 18th century. It is a science of acknowledging the wholeness of a person, not just the ailments or problems- but the mind, body, spirit, soul and psychology of a person affected when there is illness present. The science does not alienate the disease from the person; rather the focus is laid on the origin, progress, impacts, and effects of the sickness on the individual. Homeopathic medicines, or 'remedies' being very different from the allopathic or over the counter ones, stimulate the body's self-regulating mechanisms to initiate the healing process.

This philosophy believes that when a person is attacked by illness, it not only affects his physical body but the totality of him, ie the whole person is sick: body, mind, and spirit. The body manifests symptoms of illness but it is not the origin of the illness. The origin of illness usually lies in an imbalance of forces residing within an individual. The symptoms expressed by the body, mind, and spirit are the manifestation of that imbalance. When an appropriate homeopathic remedy is provided to match the symptoms of illness, the balance of the vital living forces is maintained. When the healing begin, the symptoms begin to disappear.

Homeopathy has been formed on the powerful and central blocks of principles that are its founding platform. These principals have proven their substance, sustaining for over 200 years, treating sickness of most kinds.

The first principle of homeopathy is likes cure likes – Homoeo means similar, and pathos means suffering, this is the code on which the theory was named on. It states that a substance that can create an illness in a healthy person can be used to obtain a healing response in someone presenting with a similar disease. Every person shows symptoms of the illness in the form of changes in the body / mind / spirit. Some of these symptoms are common to that particular illness, others maybe the attributes of that person. A homeopathic practitioner would match the symptoms of the remedy to the symptoms of the person, with special focus to those symptoms which are unique to the individual.

The second principle of homeopathy is The Single Remedy – According to this one one homeopathic remedy should be given at one time. It saves one from accounting for the working of several medicines at one time. Not just that, it also allows one to ascertain the complete effect of the given medicine. It safeguards from the unpredictability and ambiguity of practices and remedies of alternative medicine.

The third principle of homeopathy is The Minimum Dosage – The principle that only 'the minimum dose' should be employed is based upon the understanding that the Minimum single dose stimulus of the medicine triggers the intrinsic healing response. Following this principle, we give only enough medicine to initiate this healing response. This response then carries on, driven by the body's need to maintain health and balance.

The fourth principle of homeopathy is The Potentized Remedy – The dilution process that converges any natural substance to a homeopathic remedy is called potentizing. The concept of potentizing is the process by which natural substances become harmless as well as more effective as remedies. The process transforms a substance from the material state into the energetic state.

Homeopathic remedies have been known to work for more than centuries now. Today it has gotten its fair share of criticism and praise, and stands as a popular and effective way of treatment. People who have not had any success with allopathic or other forms of drugs have well invested their faith in it. Placebo or not, this form of alternative medicine has managed to stay in the world with more than million success stories.

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Health Benefits Of Camphor

Every time we hear about camphor the first thing comes in everyone's mind is that this is an important ingredient used in Indian houses for religious ceremonies. In general, it is a waxy, flammable product with a strong odor. You can use this product in various ways like in religious ceremonies, in the form of essential oil, as a room freshener or in many other ways.

This is well-known for spreading positivity because it has a strong healing power. It is made from the wood of the camphor tree. Apart from this, it also has some health benefits which are lesser known and is as follows.

Digestive problem: If you or any of your known one suffering from the gas or a digestion problem so nothing is much better than the camphor. It helps you to get relief from a digestive problem like diarrhea, gastroenteritis.

Inflammation: It has vast anti-inflammatory properties which make it useful in various ointments or oils. You can apply camphor oil on the affected area and it will reduce the pain, itching or swelling as well. It helps to get relief from a pimple and acne as well. But one of the important things to consider is that never put camphor directly on your wounds because it becomes poisonous after meeting with your blood so always uses it with the guidance of experts.

Improve blood circulation: It works effectively in stimulating and improving blood circulation which is good for your heart and health as well. This will help to stay your heart health and keeps your body absolutely fit and fine.

Nerve disorders: It is scientifically proven that camphor is an effective treatment for nervous disorders, epilepsy and muscular contraction. So you can take camphor to get relief from these problems, but only after consulting a doctor.

Stimulate hormones: One of the major benefits of camphor is that it works as an effective hormone stimulator that helps in increasing libido as well as sex drive.

From above, now you may know its health benefits, but one thing to always keep in mind is that never apply camphor directly on your skin always dilute it with olive oil, coconut oil or almond oil otherwise, it may be dangerous. Another important thing to remember while using camphor is that never ever applies or uses it without taking the advice of a doctor. This is a beneficial product if you use it with caution.

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Big Pharma’s Role in America’s Prescription Drug Abuse Epidemic

Count the amount of pharmaceutical advertisements you see, hear or read each day. Big Pharma, a term used to collectively identify all pharmaceutical manufacturing companies, sells a large portion of their budget on advertising their products. Some people are surprised to learn that the United States and New Zealand are the only two countries in the world that allow direct consumer advertising for pharmaceuticals. With 3.5 billion drugs or more prescribed each year, Americans buy more drugs per person than any other country. The availability and variety of drugs provided and marketed by Big Pharma is definitely a contributing factor to America's prescription drug abuse epidemic.

This may pose another question of why pharmaceutical marketing is allowed in the United States. The answer is the mighty dollar. While a large portion of their budget goes to advertising, another large portion of Big Pharma's budget is spent lobbying on Capitol Hill. Whether it is to promote a new drug, to obtain FDA approval, or to sway Congress to approve increases in drug prices, the fund which could be better absent on safety and quality control is instead applied in the political arena. The likelihood of the advertising ever stopping is low because there is too much financially backed political influence. Recommendations to cease direct consumer advertising for pharmaceuticals can not seem to gain any transaction.

Should blame for our prescription pill epidemic be placed solely on advertising by Big Pharma? Of course not. There are a host of other factors contributing to the epidemic. However, financial gain, for the street level dealer to the lobbyist on Capitol Hill, is arguably the most influential factor resulting in America's prescription drug abuse problem. For the first time in history, the global pharmaceutical industry is expected to reach over a trillion dollars in sales this year. Why would they stop advertising with those types of profits?

Furthermore, it sees our culture has evolved to believe the answer to every ailment is to take a pill for a cure. We want fast food, fast cars, fast phones, fast computers, and fast fixes to our problems. We want to swallow a pill to fix our bodies because it is easier and quicker. While a true and legitimate need for pharmaceuticals exists, the fact remains that they are over prescribed in the US To illustrate, the most astounding statistic is the quantity of hydrocodone sold in the United States in 2010 was enough to medicate every single adult in America for a month.

Free enterprise drives our culture. However, when profits become more important than human welfare, change has to come. Americans are vulnerable because we believe pharmaceuticals are the only answer. What happened to maintaining a healthy lifestyle? How many success stories have been printed about unhealthy or obese individuals taking several daily medications abruptly having no need for those medications after changing their lifestyles, losing weight and reaching a healthy body mass index? Why do not more people spend time each day to practice yoga or meditation to reduce stress? Because it only takes 3 seconds to swallow a Xanax.

Unfortunately, Americans seem to want the easy solution and Big Pharma is well aware and more than eager to provide. We want to maintain our unhealthy lifestyle because it is easier and it conforms to our existing habits. If something goes wrong, we believe there is a solution to any ailment in a pill. Sometimes we should pay more attention to daily habits that cause ailments, like tobacco use, alcohol consumption, overeating, pollution, and lack of exercise. To address what ails us may require some time and new choices in how we live. If we want a sustainable healthy future, we need to fix our bad habits instead of always looking for the best and newer pill.

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Amazing Facts Which You Should Know About Essential Oils

Do you know what essential oil is? And how it is good for your health? Do not need to be confused, here's the answer to all your questions. Essential oil is in general term the pure and natural water of the popular herb. Because of its antibacterial, antifungal, or antioxidant properties, this oil is really helpful to get relief from several health issues including asthma, nausea, depression, mental fatigue, migraine, sinus, muscle pains, period of pain, toothache or many other diseases.

In simple words, you can say that these oils are extremely helpful in many ways than any other commercial products. Following are a few facts you might not have known till now.

  • These are not technically oils because they do not contain fatty acids, which actually the real identity of the oil
  • Most of the people do not know that this oil can really help to deeply clean your body from inside and improve your immune system and blood circulation as well
  • It's a fact that in the 17th century if you use herbs for a medical cure, then you were hung as a witch
  • Most of the people do not know that these are generally described by their sweeten smell or scent
  • This oil is really helpful to get relief for the patient who is suffering from anxiety, bad dreams, and to retain youthful looks
  • This oil can not be patented
  • The bitter orange tree is the world's only tree that can produce three different types of essential oils, is not interesting
  • The massive plant helps to produce a small amount of oil, but it totally depends on the plant we use for this. For example 100 pounds of lavender use to produce only 1 pound while it takes over 4000 pounds of rose petals to produce the same amount
  • It's actually a fact that aroma of floral essential oils can help alleviate emotional stress including depression
  • There are only 21 plant families which help to produce essential oils
  • Yes, it's true, that the exact components of all the essential oils are still not known
  • These are minuscule in molecular size, which means they are easily absorbed by the skin

This oil is actually a product which has the capability to fulfill all your needs in the best possible way. So what are you waiting for? Go and buy it today from trusted or reliable essential oil manufacturers, suppliers and exporters. It is easily available in the worldwide market at a reasonable rate.

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The Best Ways to Get Discount Prescriptions

Let's face it: medication can be pricey. Regardless of whether or not you have insurance, the price of prescriptions can present a tremendous financial burden on an individual (or family) when the time comes that it's needed. Fortunately, there are options to help you save, and, extremely, to help keep more money in your pocket. Here are the best ways to get discount prescriptions.

1. Discount Drug Cards

Chances are if you've done any amount of research on discount prescriptions, you've probably stumbled upon the phrase “drug cards.” This incredibly popular means to access drugs at an affordable price should be at the top of the list for anyone looking to save money. Drug cards are simple and can be acquainted with little to no effort. Simply locate a program of your choice, such as drugs.com or discountrrugnetwork.com. Then, create an account to begin accessing all the great benefits of the programs, including, but not limited to, more affordable medications from brand names to generics at up to 40 percent off.

2. Pharmacy Saving Clubs

Yet another option to obtain discount prescriptions for the financial savvy consumer, or even the uninsured, is the pharmacy savings club. You can typically find them at your local independent pharmacy retailers as well as big box chains that also have pharmacies. Pharmacy savings clubs are pretty simple to use, much like the drug cards. Customers can sign up at participating retailers, with or without insurance, by paying a nominal fee of as little as $ 10 and then go on to enjoy significant savings on their prescriptions. Some savings clubs afford members the opportunity to receive additional savings on other items sold at the retailers. For example, at some pharmacies, additional savings can include savings on immunizations, store products, and over-the-counter medications. So, that's definitely a win-win.

3. Pharmaceutical Company Websites and Assistance Programs

Who does not love a freebie? Believe it or not, pharmaceutical companies and assistance programs (yes, they do exist) actually give away millions of dollars of prescriptions every single year. This gives consumers like you and me the opportunity to capitalize on freebies, extremely saving us a bundle. Aside from going to the manufacturer's website, which is a great place to start, another good source for freebies is the website for Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA will not only link you to your drug manufacturer, but it will also provide you with access to the near 500 assistance programs that can potentially provide you with a freebie. When you log on to the PhRMA website, there is a “get prescription help” button right on the home page so you can not miss it.

There's always a way to save, even when it comes to getting access to your medication. Whether you have insurance or not, there are quite a few viable options that could potentially save you hundreds of dollars this year.

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Select an Experienced Proteomics Company for Absolute Quantification

If your business requires you to procure high quality Custom AQUA Peptides, then you have to rely on an integrated CRO setup that delivers an exhaustive range of drug improvement services. It is pertinent that you choose a service provider that enjoys a significant experience and expertise in the fields of organic chemistry, genomics, biochemistry, systems biology, preclinical and clinical studies, molecular biology, bioinformatics, and structural biology, amongst certain others. With a full range of services at your disposal, you can benefit from several of the proteome-related researchers undertaken by your preferred setup in order to identify single protein for their use in uncomprehensive proteomic studies.

Choose a top cadre company that is renamed to have one of the most advanced proteomics boards in the global frontier. With a specialized company by your side, you could be assured of the quality of inputs embodied in the process of absolute quantification, through a full-fledged range of staffed scientists that are well versed with the avenue of proteomics. As such, these experienced professionals can render you with full support services relating to identification and quantification, characterization, protein separation, analysis of protein post-translational phase of modification, and processes featured with high throughput and super-sensitivity.

It is a well-known fact that in the intensive world of science, proteomics is equivalent to genomics. While in genomics, the process focuses on the full range of how a genome is structured. In proteomics, the processes involved therein complement the structures and functionalities of proteins. As proteome tasks can vary frequently from cell to cell and vary with the passage of time, these are recognized as the more complicated jobs. These tasks are time consuming, as they involve research and intensive analysis. If your business requires an analysis of Isotope Labeled AQUA Internal Standard Peptide, then you bought to select a top-notch proteomics company that houses thoroughbred specialists, who are skilled and experienced in handling hard-to-analyze samples that include cerebral-spinal fluid, serum, and plasma membrane. Choose a service provider that can help you in studying several protein-protein interactions and protein post-translational modifications. A pedigree service provider can also present your business with foolproof project counseling, along with several variants of optimal services fulfilling your needs. More so, with a specialty provider of proteomics, you can procure all product offerings and services from it, at the lowest cost level in the entire industry.

The study of Isotope Labeled AQUA Internal Standard Peptide belongs to the arena of targeted proteomics. The process of absolute quantification of proteins approach permits complete quantification of proteins in biological testers. The process finds its basis on the principle of the isotope labeled internal standard that is implemented classically for absolute quantification through bulk spectrometry. A native peptide is analyzed in subsequent to numerous standards to signify the protein for quantifying. An AQUA peptide is essentially a synthetic peptide conforming to the designated native peptide with one isotope labeled (13C, 15N, 2D) amino acid. The process is complex and has to be endeaken by a professional company specializing in proteomics studies.

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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 does not 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 administrating subcutaneous injections.

The other type ie 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 predominant 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 stated that in spite having a petite structure, they can not be used for giving insulin.

Now, let us discuss about problems 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 larger 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 a gauge of a needle based on the density of the medication that 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 larger gauge.

His store boasts huge collections of medical supplies used in hospitals including surgical equipment, hospital beds, wheel chairs, etc.

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What You Should Know About Conditions for Accelerated FDA Approval of New Drugs

The FDA has an accelerated approval mechanism for new drugs. Is accelerated FDA approval a good thing? Probably Yes. This mechanism of approval was put into place to help patients who suffer from certain serious diseases.

As the phrase suggests accelerated FDA approval involves a faster approval than for non-accelerated approvals. To get an accelerated approval sponsors must submit their application to the FDA. Before an application is accepted for approval, two major regulatory tests are described below are applicable.

THE DRUG HAD TO TARGET SERIOUS CONDITIONS

What is a serious condition? If you are a patient almost every disease would be a serious condition. The FDA has clarified this in a guidance document.

This is a disease or condition which has significant impacts on a person's day-to-day ability to function or even die.

Clinical judgment has to be made in determining whether a disease is serious or not.

The judgment is based on the impact of the disease on factors such as the patients' survival and day-to-day functioning. In addition an assessment is made on the likelihood that the disease will progress to a more severe condition if no treatment is provided.

There are other three pathways for expedited approval of NDA which require establishment of serious condition. They include fast track, breakthrough therapy and priority review.

All diseases that are life threatening qualify as serious illnesses but not necessarily for accelerated FDA approval as we will see later. Some will qualify for fast track, breakthrough therapy and priority review but not for accelerated approval.

THE DRUG HAD TO BE FOR AN UNMET MEDICAL NEED

The term “unmet t Medical Need” is used to refer to a medical condition that does not have adequate treatment or diagnosis. It may be for treatment of cancer or a method for better and faster diagnosis of a serious illness. The application of the term “unmet medical need” could be quite broad.

The term “unmet medical need” could have been used where there is no available appropriate treatment to the patients. Sometimes a new therapy may be available but unmet medical need may still exist such as when the new decreases the symptoms but not the serious outcome such as progressive disability or progress of the illness.

WHAT THE SPONSOR SHOULD DO

Because many sponsors may want to use accelerated FDA approval, certain pre-qualification criteria has been put into place.

As the accelerated FDA approval application is based on surrogate endpoints. Sponsors should ordinarily discuss with the FDA of the intention to request for accelerated approval.

The request would help the sponsor to choose the best surrogate endpoints during the clinical trials. Surrogate endpoints are endpoints other than clinical endpoints which take longer to determine for diseases that take long to show a clinical endpoint.

For example it may take long to show that a drug prolongs life. Prolongation of life is a clinical endpoint. Decrease in the blood in viral load such as in HIV would be a surrogate endpoint.

Surrogate endpoints include laboratory measurements and images among others. The use of clinical endpoints is however required in the confirmatory clinical trial reports.

By the time this application is being submitted the sponsor should be in a position to discuss the confirmatory clinical trials which should be in progress.

Without evidence of these confirmatory trials the FDA may be related to approve the requested accelerated FDA approval. The risk to patients is exposure to expensive drugs which may offer no clinical benefits. The sponsor must provide evidence for commitment to complete the pending confirmatory trials.

Does Canada have a similar program to accelerated FDA approval? The Canadian equivalence is called priority review.

In this program the sponsor is encouraged to request for priority review status early. The sponsor will get a notice of compliance status with conditions after the application when the only data available is from surrogate end-points.

The target review period is 200 days. Just as in USA, the sponsor has to submit confirmatory clinical trial data for full compliance without conditions.

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Preventive Medicine Failure: The Flint Michigan Example

The crucial role of preventive medication is usually not quite noticeable until there is a costly blatant failure as previously exemplified at Flint Michigan. The dangerous effect of lead poisoning on modern society is so well recognized that homes and public water supply systems built in the US in the last two decades have been totally free of lead pipes.

Older homes and public water supply systems have either been repiped or destroyed for obvious safety reasons. Cities that are unable to identify all their old lead pipe connections use corrosion control to protect inner lining of city water pipes. When these basic preventive measures (Kemper, Alex et al., 2007) were overlooked in Flint Michigan, a huge water crisis quickly developed.

Flint City had been buying healthy Huron Lake water treated at Detroit water plants for over fifty years prior to 2013. But in 2013 the city voted to switch over to a cheaper water pipeline being built to Lake Huron. This caused Detroit City to abruptly cancel their water supply contract leaving Flint without water supply.

On April 25, 2014, in a desperate move to maintain water supply to 100, 000 Flint citizens Darnell Earley, an emergency city manager, appointed by Governor Rick Snyder, decided (Reissman, DB et al., 2001) to switch their water supply to the corrosive Flint river water, without corrosion control and against expert warning. Experts had recommended a short term contract renewal with Detroit City to by Flint City the time it needed for lead pipe replacement and corrosion control, at an estimated cost of 1.5 million dollars. But that recommendation was overtaken by even

Soon after the switch Flint households started reporting fowl odor from their own tap water, along with brown discoloration. The local DEQ tested and confirmed E. Coli in Flint watersystem. Chlorine was introduced into the water system to clear the bacteria, and citizens were reassured that the city water safe. By January 2015, a toxic level of chlorine byproducts, Total Trihalomethanes (TTHM) was reported in the Flint water system.

Between April and June 4014, Flint residents started reporting deeper browning of their tap water, hair loss, and neurological symptoms in their kids. The DEQ tested samples of Flint City water and said it met federal standards of <5 parts per million of lead (Handler, Phoebe, etal, 2016). It even went as far as reporting to EPA that Flint City was in their use of erosion control, which was not true.

Flint citizens became suspicious of their DEQ, and started conducting their own water testing and blood testing for lead (Carty Denise C. et al., 2016). The found toxic levels of lead in their tap water. Dr. Mona Hanna-Attisha a pediatrician at Hurley Medical Center, also discovered a rise in the number of school kids with high blood lead from 2.9% – 4.9% since the switch in April 2014. So they invited an expert, Dr. Edwards, a city water lead control advocate, from Virginia Tech to come and test their tap water samples. He confirmed toxic levels of lead in the water samples and notified the city council

In less than three months the toxic Flint river water had badly eroded the interior lining of the all underground lead pipes delivering water to Flint City. Lead began leaching into the water city water system and turning the water progressively brown.

Media pressure from Dr Edward's EPA report and The Rachel Maddow Show reports on MSNBC lead to the declaration of public health emergency in Flint City by Governor Rick Snyder on Ocober16, 2015. Even with the declaration of a disaster, Governor Rick Snyder would probably not reach out to the federal government for disaster relief fund, until presidential candidate Hillary Clinton called him out on MSNBC.

Flint citizens, who are predominately blacks, took to the streets in protest against Governor Snyder, accusing him of racism. In an affect to contain the situation, the state government has now put the pediatrician who blew the whistle in charge of the Flint water crisis disaster control committee. But the citizens are still calling for the resignation of Governor Schnider.

Of all the complications of lead poisoning (Hou Shunngxing et al., 2016; Korfmacher.Katerina S., et al., 2016), the one that will cost Michigan State the most is the brain damage in school kids (Finkelstein, Myra et al. , 2016). Those kids with low IQ and learning disorder will not only be a loss, but also a financial burden to the state economy for decades to come. Compare that to a couple of million dollars that would have contained the Michigan river leaching in the first place. This is a good example of what preventive medicine should not be in the 21st century.

References:

Kemper, Alex R., Rebecca L. Uren, and Sharon R. Hudson. “Childhood Lead Poisoning Prevention Activities Within Michigan Local Public Health Departments.” Public Health Reports 122.1 (2007): 88-92. Print.

Hou, Shuangxing et al. “A Clinical Study of the Effects of Lead Poisoning on the Intelligence and Neurobehavioral Abilities of Children.” Theoretical Biology & Medical Modeling 10 (2013): 13. PMC. Web. 1 Feb. 2016.

Korfmacher, Katrina S., and Michael L. Hanley. “Are Local Laws the Key to Ending Childhood Lead Poisoning?” Journal of health politics, policy and law 38.4 (2013): 757-813. PMC. Web. 1 Feb. 2016.

Carty, Denise C. et al. “Racism, Health Status, and Birth Outcomes: Results of a Participatory Community-Based Intervention and Health Survey.” Journal of Urban Healthâッ¯: Bulletin of the New York Academy of Medicine 88.1 (2011): 84-97. PMC. Web. 1 Feb. 2016.

Finkelstein, Myra E. et al. “Lead Poisoning and the Deceptive Recovery of the Critically Endangered California Condor.” Proceedings of the National Academy of Sciences of the United States of America 109.28 (2012): 11449-11454.PMC. Web. 1 Feb. 2016.

Reissman, DB et al. “Use of Geographic Information System Technology to Aid Health Department Decision Making about Childhood Lead Poisoning Prevention Activities.” Environmental Health Perspectives 109.1 (2001): 89-94. Print.

Handler, Phoebe, and Daniel Brabander. “Increased Incidence and Altered Risk Demographics of Childhood Lead Poisoning: Predicting the Impacts of the CDC's 5 μg / dL Reference Value in Massachusetts (USA).” International Journal of Environmental Research and Public Health 9.11 (2012): 3934-3942. PMC. Web. 1 Feb. 2016.

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The Benefits of Purchasing Discount Drugs and What to Look for in Providers

Companies that provide discount drugs are a godsend to many people. Here is some information on how they work, why these businesses are able to offer such cheap medicines, and how to be well informed as you do research into which distributor is right for you.

How They Work

Many distributors of discount drugs are able to offer safe, FDA-approved medications to customers at vastly lower prices than they would find at pharmacies because the regulations in other countries are different. They legally acquire generic (and brand-name) drugs from nations which health law systems allow different pills into the market faster than those of the US, and they can then sell these drugs to American consumers at low costs, sometimes as much as 80% off the typical price.

These companies carry all sorts of much-needed prescription drugs, such as medicines for blood pressure, thyroid issues, mental health problems, diabetes, and more. When consumers take the time to seek out a trustworthy discount service, they not only cut their costs exorbitantly, but they also do away with the long lines and hassle of pharmacies. What's more, some pharmacies can be unreliable and lack quality customer service. Affordable medicine companies can provide a convenient and viable alternative.

What to Look For

Obviously, the most important things to make sure of are that the company you choose offers the particular medicine you need and that it only provides FDA-approved, top-quality products. Some of these are brand-name pills, but many are generic medicines that work equally well, as long as they are approved.

Choose a provider who has an established reputation and staff members who are experienced in dealing with clients and medicine. Only accept top-tier customer service. Health care is a personal, complicated matter. Every case is different, and when your well-being is at stake, you have to make sure you are dealing with people who can offer you nuanced advice for your particular situation and medical history.

A good way to research the company's reputation is to read reviews and testimonials from other customers. In addition, look for businesses that have the confidence to offer official guarantees.

Once you know you're getting the best quality product and service available, then consider the price. All discount drugs save money, but some companies offer better deals than others. The best ones have comprehensive systems staffed by well-trained employees to research and utilize the entire world market. These businesses are able to offer their customers the best deals.

Convenience is a factor as well. Often, these services have patients email or fax their prescriptions, after which the company sends the medication directly to the patent's door. This saves on the stress and wait-time factor of going to a pharmacy. Consider turnaround time as well; you do not want to have to rely on a prescription that will take a whole month to be delivered. You want a company that offers timely and reliable service.

Health comes first. Keeping this information in mind, do some research to see if a company offering discount drugs could be the right fit for you to help you and your family save money on valuable medicine.

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Cultural Competence Does Not Equal Color Blindness

Health care disparities and quality of care for ethnic groups are well documented. The National Healthcare Disparities Report (NHDR) published by the US Department of Health and Human Services provides thought-provoking examples about how health providers relate to ethnic groups. The evidence suggests that providers are not helpful to non-Whites, were less responsive, administrated less medication, provided incomplete discharge instructions and communicated poorly. This data indicates that there are differences in how providers deliver health care services in response to the color of a patient's skin. Furthermore, the NHDR documented that racial and ethnic minorities often receive poorer quality of care and face more barriers in seeking care including preventive care, acute treatment, or chronic disease management, than do non-Hispanic White patients. This mindset is indeed serious when it impacts the quality of care of racial, ethnic and socio-economic groups in the US In fact, this is so serious that the US Department of Health and Human Services released an Action Plan to Reduce Racial and Ethnic Disparities with the idea that it is possible to have a nation free of health care disparities.

What are the reasons for health disparities? Let's review what health disparity means. These are the differences in health outcomes that are closely linked with social, economic, and environmental disadvantage often driven by the social conditions in which individuals live, learn, work and play. This Action Plan documents the fact that numerous studies reveal that individuals, families and communities that have systematically experienced social and economic disadvantage face greater obstacles to optimal health. One main reason includes lack of health insurance. Another factor is the lack of cultural competency of health care providers. Millions of patients have limited English proficiency and therefore, the patient-provider relationship is often strained from a general lack of understanding. National efforts to reduce health disparities have been established by the National Institute of Health (NIH) and Center for Disease Control and Prevention (CDC) with programs that focus on the health of minority groups in a culturally competent manner and that truly address racial diversity. However, this effort, national in scope and seemingly comprehensive is not embroidered by all. A new strategy in dealing with these cultural issues is color blindness, which seems contradictory to facing the issues. It appears to deny we are a diverse society and looks the other way on racial discrimination.

Color blindness has become a central strategy for addressing racial diversity in many settings with the idea that it will result in racial equality. The idea is that color blindness will reduce racial distinctions and then limit the potential for bias. This strategy compounds the problem in that individuals can be blind to racial discrimination and consequentially impair the intervention rather than enhance it. One could argue that individual sensitivity to racial differences is hindered as a result. If one is color blind, then they can not see when discrimination occurs. It would appear that this strategy would only contribute to health care disparity since the provider may not be in tune with what is really occurring with the patient. A study revealed that color blindness does not reduce bias, it only adjusts the lens of perception to the bias. There is nothing wrong with accepting that we are different. It may even be refreshing to embrace our cultural differences and treat each other as unique individuals. There is nothing wrong with diversity; in fact, it is the fabric that makes our nation culturally rich. First, we need to accept that we can become a culturally competent nation. Would not this be helpful to the minority patient?

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An Exploit of the Pros and Cons of Vaccination

The world shrinks daily as more and more people gain access to social media. The concept of six degrees of separation can easily adjusted to three degrees of separation. We are in constant contact with people more now than the late 18th and 19th century. Therefore, the spread of disease can wipe out an entire city in months if not weeks. Consequently, the advent of parents to vaccinating their children appears counterproductive and at times willful.

Regrettably, there exist controversial regarding immunization. Many regularly connect Autism to vaccination even when several reputable medical experts debunked the report done on such a connection. Yet with established medical documentation that there is no actual connection to Autism and custody, mainstream media continue to link these two separate terms. The repeated exposure to inaccurate reporting mislead many parents into believing that vaccinating their child will cause Autism.

As the world shrinks and the degree gets smaller and with a review of historical black plague, vaccine becomes a necessary precaution. The recent scare of Ebola should be sufficient motivation to implement and improve the administration of vaccines. Modern day medical research has exceeded medical expectation however, research can not guarantee good health or long life. There are side effects for most manufactured drugs, but that should not prevent the use.

Parents are the first line defense for their children. Sometimes the defense gets foggy by misrepresentation and fear. Subsequently, with modern access to the internet and library resources parents can do their own research. Parents can take the bull by the horn. Proactive parents look into what is true, and what is false. They realize the importance of understanding all the consequences of custody and non-custody for their children. The information is out there Unfortunately, misinformation is also available. Parents must use differentiation and commonsense as they navigate through the vast array of medical information to make the best medical decisions. This can men taking the time to evaluate the pros and cons of immunization.

A healthy productive child is important to every parent. While the agreement on how best to accomplish this is froth with controversies, uncertainty, and fear it is imperative to keep options available. The individual child requires individual care and for some that may mean no vaccine for others a few, and for many more the regular dose. Read the article and unforgettable what will be best for your child.

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Outdoor Treatment for SAD Time Blues

Sad feelings come and go following bad news, disappointments, financial losses, rejections, health failures, job losses, relationship failures, etc. But when we get SAD during the fall and winter months, we are diagnosed with seasonal affective disorder or SAD Time Blues. This is one of the six recognized types of clinical depression, differenting mainly in its timing. It has been associated with the sudden switch from longer summer days to shorter fall and winter days in temperate regions of the world.

Day light entering the eyes helps the hypothalamus in the brain to maintain the normal sleep – wake cycle or circadian rhythm. The light stimulates the pituitary, and pineal glands to release hormones that stimulate the ascending reticulated activating system (ARAS) to keep us awake. The same light normally suppresses the release of serotonin from the enterochromaffine cells of the raffle nuclei of the brain. Thus with sudden drop of light supply during the fall and winter months, the blood level of serotonin increases dramatically causing increased sleepiness, tiredness, irritability and extremely depression. Severe depression may lead to suicidal thoughts and suicide attempts, which also generally increase during the winter months.

Like other major depressions, SAD may present with, sadness and irritability, loss of interest in previously exciting activities, feeling of helplessness, social isolation, excessive sleep, increased appetite and weight gain. The diagnosis is mostly clinical and therapeutic. Hormonal assays are mainly used to confirm the diagnosis and track clinical progress. With or without treatment, seasonal affective disorders tend to improve by the sunset of spring season. This is what differentiates it from the other five forms of major depression.

Treatment modalities include, light therapy, cognitive therapy and antidepressants (when severe). Light therapy substitutes 10,000 Lux light for day light for the short fall in normal day light (Danilenko KVV et al.). Cognitive therapy helps patients to actively substitute optimism for hopelessness, social involvement for social withdrawal, and thoughts of living for suicidal thoughts (Melrose Sherri, 2015). Both light therapy and cognitive therapy have been shown to be effective in the treatment of SAD (Rohan, KJ et al, 2015). But patients treated with cognitive therapy have also been shown to have lower recurrence rate in consequent seasons because they have thought through their conditions and adopted positive interpretations (Sitnikov L. et al., 2013).

Social integration or outdoor treatment has the advantage of combining light therapy and cognitive therapy. 'Outdoor' here is relative to a patient's seclusion environment. Since most social environments like the halls tend to be well lit up, the SAD patient gets complementary light while socializing. The outdoor patient also sees how other people are coping with shorter days and finds hope for making it through another winter. Seeing less privileged people in the community actively pursuing to survive also helps the SAD patient to switch from death wish to life wish. Volunteering in social recreational activities away from their homes may, therefore, be the easiest way for patients to take advantage of the outdoor Treatment for SAD.

References:

Danilenko, KV, and IA Ivanova. “Dawn simulation Vs. bright light in seasonal affective disorder: Treatment effects and subjective preference.” Journal of affective disorders 180 (2015): 87-89.

Melrose, Sherri. “Seasonal affective disorder: an overview of assessment and treatment approaches.” Depression research and treatment 2015 (2015).

Rohan, KJ, et al. “Randomized Trial of Cognitive-Behavioral Therapy Versus Light Therapy for Seasonal Affective Disorder: Acute Outcomes.” The American journal of psychiatry (2015): appiajp, 201514101293.

Sitnikov L, Rohan K. J, Evans M, Mahon J. N, Nillni YI “Winter depression recurrence one year after cognitive-behavioral therapy, light therapy, or combination treatment.” Behavior Res Ther. 2013 Dec; 51 (12): 872-81. doi: 10.1016 / j.brat.2013.09.010. Epub 2013 Oct 17. PMID: 24211338

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