Stem Cell Research Secures Future Health

Stem cell research is one of the perfect solutions for child health. It has widened opportunities of saving millions of lives. The researchers had worked very hard in finding out the true benefits of umbilical cord blood. Today, they feel astonished because their research is a great hope for the patients who are suffering from Cancers, Blood disorders, bone marrow failure and other serious diseases.

As per the recent survey, it is said that baby's cord blood can heal more than 80 critical diseases and rejuvenate patients' life back. Is not it interesting? Undoubtedly, it has ignited a strong hope in the hearts of millions who has become the prey of deadly diseases. Seeing its positive and life-saving qualities, expecting parents are getting registered with the cord blood banks.

Why the stem cell research has captured the attention all over the world? The reason is very simple and creditable. Every year, millions of people die because of diabetes. And this new stem cell research has the potentiality to heal Diabetes. The public cord bank accepts the cord tissue from the donors who do not want to preserve their newborn baby's cord blood into any private cord blood companies.

Both the public and private banks strictly follow the standards set by the FDA and American Association of Blood banks. These banks do take care of hygiene and cleanliness for preserving these precious stem cells. After seeing its powerful results, more and more parents reserve their baby's stem cells and secure their future health along with family members' future health. Using the present-day medical laboratory technology, the lab technicians can reserve the umbilical cord blood for nearly 15 years in its natural conditions.

Parents feel privileged when they register their memberships with any of the cord blood banks in their cities or states. This is one of the best gifts any parents can give to their lovely children. It secures life against dangerous illness. Is there any parent who does not wish to secure his / her baby's health? Of course, becoming parents meaning seeing children growing healthy and happy.

The FDA approved banks secure the stem cells and return back to the families in the time of medical urgency. This saves health victim's life from serious illness and the family members can again see their fellow animals healthy & recovered.

Technology and a thorough research have made this possible for the whole of the humanity. What was regarded as the medical wastage is being used as the lifeguard. And the researchers are still optimistic about the future of stem cell research. They say that they will be able to treat more illnesses through baby's cord blood. So, it is important to store the natural stem cells at the time of delivery. It simply requires 25 minutes of time and the collection process is painless. It does not harm a mother and a newborn baby.

If you want to secure your baby's future health against deadly diseases like diabetes, cancers and others, you need to consult your gynecologists for authentic information.

{ Comments are closed }

Could Our Pets Infect Us With Ebola?

Just when you thought the Ebola Crisis could not get any worse. It does. Especially, if you happen to be an animal lover, like me. And I am sure there are plenty of people like me.

Health officials in Texas, are now being confronted with a second dilemma. What should be done with the pet dog, relating to the Texas hospital nurse who contracted Ebola from the patient she was nursing, who later died from the disease?

Not only did that nurse interact with other people and of course she was completely innocent to the fact that she had become infected. She also interacted with her pet dog, a King Charles spaniel. Needless to say health authorities have no idea if dogs can catch and spread Ebola in the same way humans can.

Health permissions claim that they are currently trying to find a place where they can monitor the dog, to see if it develops Ebola symptoms. The nurse's apartment has been thoroughly cleaned and disinfected. She was admitted to a hospital isolation unit and is reported to be in a stable condition. Texas authorities say her pet dog will be looked after. But to what extent that statement is a pet lover talking, or just a deliberate attempt by Texas authorities to avoid the torrent of criticism because of what occurred in Spain recently is anyone's guess.

Spain had a similar scenario to Texas. A Spanish nursing assistant also contracted Ebola from a patient. She too had a pet dog. And while the dog showed no signs of having the virus, Spanish authorities, who were clearly not animal lovers, decided it should be put to sleep. The decision caused a public uproar. Animal rights activists took to the streets to protest the decision in more than 20 cities across Spain. An online petition attracted more than 400 thousand signatures.

I have some sympathy for authorizations because this is a really tough call. According to the World Health Organization, Ebola is found in a number of animals like fruit bats, monkeys, apes, chimpanzees and pigs. One of the ways that humans get Ebola in Africa, is by eating bush meat infected with the virus.

A study from 2005, suggests there is a theoretical possibility that dogs can pass the disease on to humans, but nothing is confirmed and the only option health authorities have is to recommend exercising caution.

In 2001, an Ebola outbreak in the African country of Gabon, found traces of Ebola anti-bodies in dogs, which is a sign that they were infected at some point. But where and how they were infected, nobody can answer.

A University Professor in the UK, who is also an Ebola expert, said the wisest move would be to encompass that dogs do represent a risk to humans but the truthful answer is no-one can confirm it because no-one has connected the necessary research .

Ebola spreads through close body contact with someone infected with the disease. The virus is found in bodily fluids such as blood, vomit, faeces, urine or semen. There has to be an entry point for the infection to be transferred such as having sex, a cut, or touching the mouth, nose or eyes. That is why health workers must wear full protective suits when they come into contact with an infected patient. The most infectious veins are blood, faeces and vomit. But the virus can also be found in the saliva and sweat of patients who are extremely ill with Ebola.

The symptoms include, headache, muscle pain, diarrhoea, vomiting, stomach pain or unexplained bruising or bleeding.

But does it mean that by coming into contact with dog faeces or secretions from a pet, relating to a patient with Ebola, you will contract the disease? The answer is who knows?

The US Center For Disease Control and Prevention, is at pains to point out that there have been no reports of pets becoming sick or playing any kind of role in the transmission of Ebola to humans. The center is currently working with the American Veterinary Medical Association, and others, to help develop some guidelines to cover the US pet population.

Ebola has filled more than four thousand people. The number of cases is currently double that. There is evidence to suggest that Africa could reach more than a million Ebola cases by the end of the year. We need to fight this thing with everything we have got because potentially it threatens the entire world.

But it would be even more tragic and cruel and heartbreaking to discover that dogs and cats have a role to play in its transmission to humans. Clearly it is one more question we need to answer urgently.

{ Comments are closed }

Allergic Rhinitis and Its Treatment

SIGNS, SIGNS AND MANAGEMENT

Allergic rhinitis is a group of symptoms that occur when you breathe in an allergen- such as dust, animal dander, or pollen. This type of allergic rhinitis is commonly called hay fever, and may be seasonal allergy or non-seasonal (perennial).

SYMPTOMS

Symptoms that occur shortly after you come into contact with the substance you are allergic to may include:

• Itchy nose, mouth, eyes, throat, skin, or any area
• Diminished sense of smell
• Running nose (rhinorrhea)
• Sneezing
• Conjunctivitis with watty and itchy eyes.
• Blocked nose

Other symptoms that may develop later include:

• Clogged ears
• Dark circles under the eyes
• swelling under the eyes
• Headaches

DIAGNOSIS

This is established primarily from the history. Often the patient will present with the typical symptoms of nasal stuffiness associated with itching and sneezing. Much as these symptoms are often seasonal, and worse over spring, they occur in some patients throughout the year. There often is a family history of the disease, but in some cases the condition is de novo.

Physical examination also assists showing bogginess of the nasal tissues, excessive secretions and pallor of the inner lining. Skin tests are a definite form of investigation.

TREATMENT

LIFESTYLE AND AVOIDING ALLERGENS

Avoidance the pollens that cause your symptoms is very helpful. Although it is impossible to avoid all pollen, steps can be taken to reduce your exposure.Pets and grass are a major source of allergens. Exposure to a dusty environment can also be minimized.

MEDICATION

ANTIHISTAMINES

Antihistamines work well for treating allergy symptoms. Many antihistamines taken by mouth can be bought without a prescription.

• Some can cause sleepiness and should be taken at bedtime.
• They should also not be used during pregnancy.

CORTICOSTEROIDS

Nasal corticosteroid sprays are the most effective treatment for allergic rhinitis.
• They are also safe for children and adults.

ALLERGY SHOTS

Allergy shots (immunotherapy) are sometimes used but their long-term success is doubtful.

COMPLICATIONS

Untreated allergic rhinitis can have serious complications.

• Sinusitis is fairly common, and presents with persistent frontal headaches, green nasal discharge and fever. Untreated, this may lead to meningitis and brain abscesses.
• Ear infections are often encountered, and often present with an earache, deafness and a purulent discharge.
• Nasal polyps presenting with grape-like growths in the nose often cause persistent nasal obstruction that may require surgery.

PROGNOSIS

Most symptoms of allergic rhinitis can be controlled. Some people may outgrow an allergy as the immune system becomes less sensitive to the trigger.

{ Comments are closed }

Investing in Pharmacy Business in Uganda: Weep and Reap

Prior to putting pen to paper for this article I called up my mother. Shortly after exchanging Christmas holiday pleasantries, I quickly got down to business (she said she was playing Monopoly with the family and so needed to get back to Euston road), and asked her point blank:

“Is pharmacy business profitable?”

You see at one point of her entrepreneurial career she run a pharmacy and supported 7 children at the time. Drug names like Magnesium Tricilicate and Penicillin V therefore easily rolled off my tongue from early childhood. I therefore believed she would help me.

Her simple response (in my mother tongue):

“Yes, but the pharmacies are always playing cat and mouse with the permissions and you need to watch for the theft of the drugs.”

In her simple lay person terms, and without a pharmacy degree or formal training, she had laid out the key risk factors to look out for if you are to invest in this business.

Why invest in the pharmacy business in Uganda?

The title of the article highlights the double jeopardy of this sector.

Cat and mouse: Government vs hospitals, where are the drugs?

You cry (or weeep) for our beloved country because it would seem that many reports indicate that whereas the Government is constantly allocating money to hospitals for buying medication, when you get there the drugs in stock and you will have to buy them from somewhere else.

Ugandan hospitals appear to have there before been transitioned into diagnosing clinicians identifying underlying health issues of patients and then sending them out to look for medication. The doctors claim there are no drugs in stock. It's therefore common for patients in Uganda to go to government hospitals, receive diagnosis for their diseases and leave without even the basic medication of pain killers. The government claims that they send the medicine to the hospitals but the hospitals claim they never receive the drugs so the big question is where do the drugs go?

The pharmacy sector: More weeding.

According to the Pharmaceutical society of Uganda, the body is responsible for the sector, there are currently 465 qualified pharmacists, of which 70 are abroad, leaving about 395 practicing within the country.

With a population of approximately 34 million people, this represents a pharmacist to population ratio of 1: 88,000 which is way below the recommended World Health Organization (WHO) 1: 2,000 ratio.

The chronic shortage is being addressed by the pharmaceutical society in conjuction with universities to among others increase the number of pharmacists being trained but in the meantime, illegal pharmacies continue coming up, the cat and mouse games with National Drug Authority (NDA), the regulator , continue and mean while the population sufferers as a result of the imbalance.

This there before presents an opportunity to invest, and hence reap (whilst weeping for the sad state of affairs).

When I further analyzed the state of the pharmacy sector in Uganda, I noted a number of key aspects to consider:

1. Whilst many press report place the number of clinics in the country to over 10,000 there are only 414 registered pharmacies in Uganda (registered with the regulating body).

2. Of these 414 registered pharmacies, over 292 are located in Kampala, the capital and in the Central region. This is a huge imbalance considering Uganda's population is almost evenly distributed at 25% in all the four regions (Northern, Eastern, Western, and Central).

3. The opportunity is therefore to invest in a franchise or network of pharmacies that target the up country towns.

Prior to investing, there are however a few key considerations:

1. Drug license. You must have a license and your approved pharmacist must be regulated by the pharmaceutical society.

2. Retail business considerations. As any retail outlet, you must consider retail business risks such as location and stock controls (as my mother alluded to). Many drugs come in tablet or pill form and as such the quantities can be hard to monitor. It is there before important to first understand the drug classes (in Uganda, this is mostly class B and C) and then understand how to ensure proper controls are put in place.

3. Return on investment. From my estimates, the profitability from investing in this sector is a revenue of Shs. 187m and a Return on Investment (ROI) of only 0.87 months.

Final word

In a country characterized with limited availability of medicine in the government hospitals, more and more pharmacists and businessmen have seen an opportunity to open independent pharmacies. They do this because of the unsatisfied demand for medication by the patients who do not get it in the hospitals.

It is a business where we all weep for the state of our country, and then those who see the opportunity to help create change (while making money) reap (sometimes with little gnashing of teeth).

{ Comments are closed }

Online Homeopathy Medicine: Some Frequently Asked Questions!

Most of us know homeopathy as an alternative medicine that focuses on balancing the mind, body as well as spirit to stimulate the immune system from within and gradually cure the ailment. Unlike allopathic medicines, homeopathic doses sometimes take longer to show their effects in chronic cases. However, the largest advantage of using homeopathic medicines is that they do not cause any harmful side effects. After all, the entire focus is on activating the body's inherent ability for a long term cure rather than pumping chemicals as the temporary solution. In today's technically advanced era, even homeopathic medicines are available online. In fact, you can also interact with the homeopath and discuss your problem through online chatting portal available on several websites.

For those who are still unsure about the online homeopathic medicines, here is a list of five frequently asked questions:

What are the diseases cured by homeopathy?

A lot of us think that homeopathy is effective against small scale ailments like cold, fever, indigestion, etc. But, this is not entirely true. You will be surprised to know that there is homeopathic treatment for problems like psoriasis, sexual dysfunction, and a host of other diseases. Homeopathy is a complete science in itself that offers effective cures to several diseases including several chronic disorders.

Can I take homeopathic medicines while I am taking allopathic medicines?

Homeopathic medicines are targeted towards increasing the inherent immunity of the body. Unlike allopathic medicines, these sugar pills or dilutions do not have any side effects. Therefore, you can comfortably take homeopathic and allopathic medicines at the same time. However, make sure that you let your homeopath know about the medicines that you are taking prior to undergoing the treatment prescribed by him or her.

Is it safe?

We have already told you that homeopathic medicines do not cause any side effects that can harm the body. This in turn automatically makes them safe even when you have to consume them for longer durations. In fact, there are several parents who prefer to take their children to a homeopath even for the small ailments.

Can I afford it?

Homeopathy has always believed in providing affordable healthcare to the patient community across the globe. As opposed to the costy synthetic drugs, homeopathy is quite affordable.

How important is the doctor's advice?

While allopathic medicines are formulated on the basis of specific symptoms, homeopathic cures differ from person to person. Prior to prescribing your medicine, the homeopath will do a proper interaction to understand the patient's requirements and accordingly decide the course of treatment. Therefore, it is very important to follow the doctor's advice in homeopathic treatments.

{ Comments are closed }

Cure Your Back Pain and Make Your Life Simple

Back pain treatment has to be effective and should give the patient immediate relief as only a person who has suffered this at some point of his life will understand the degree of difficulty. The extent of suffering is such that it renders the patient practicable incapability of enjoying free movement without seeking help or assistance from others. Some experts recommend sleeping with a pillow under the knees and once you take adequate rest it is essential that you resume your activities as soon as possible as longer the period of rest the longer it will take to recover as the body will start getting used to comfort of your bed. Usually poor posture and muscle strain are among the most common reasons for back pain. However, back pain may also be the result of underlying health problems like osteoporosis or due to some forms of tumors. Modern medicine offers prescription medicines for treating the condition after careful diagnosis of the undering cause, but in Ayurveda there will be a personalized approach for each condition and the mode of treatment for each case varies. According to Ayurveda back pain occurs as a result of one of three errors that govern the balance within the human body and this condition aggravated because of the bone and muscle weakness either due to an internal malfunction that has been induced or due to external trauma. Sometimes the body responds to stress in the form of back pain and this is the reason the patients are requested to relax during the course of treatment.

Back pain treatment becomes a cause for concern when the patient feels that the pain returns every time he or she is accelerating too much and sometimes may render the patient unable to do daily chores. A majority of the body weight is pressurized on the lower back therefore in the case of overweight patients doctors generally advise them to lose weight as early as possible. There are cases when rest of over the counter drugs may not just do the trick of making the pain vanish and in such cases it is better to seek medical help as soon as possible. Most choose topical agents or ointments or even pain killers that have the capacity to reduce the sensation of pain but it is essential that if the pain returns an internal expert check-up is necessary. Modern day sedentary lifestyle and maintaining improper posture are often considered the villains and it is best that a makeover in the usual sitting, standing and sleeping positions are corrected. For a temporary relief there are various alternative therapeutic procedures but a long standing result should be the aim for any treatment opted. It is known that any slight change from the normal spinal curve can put pressure on the muscles and nerves. According to Ayurveda, back pain in the local areas of the lower back can be treated with internal and external treatment, but depends on various factors and the actual cause of the pain and with this the state of equilibrium within the body can be brought to balance .

{ Comments are closed }

Stress and Synergy Disruptors

My patient Carly was a 28-year-old woman who loved her job as a junior copywriter in a public relations firm. She had been putting in many late nights at work, averaging only four to six hours of sleep each night, working straight through lunch, and relying on pasta or cereal for dinner.

Carly was exhilarated by the challenge of this assignment and considered the extra effort well worth it, especially when she got a coveted promotion and a much-needed raise. Yet in the course of her marathon session, Carly had exposed her body to a number of synergy disruptors, minor but significant challenges to her system that included missed sleep, irregular meals, and a carb-heavy diet without sufficient protein.

If Carly had undergone just a single week of synergy disruptors, her otherwise healthy body would have quickly recovered, and I would never have seen her as a patient. In fact, like many of my patients, Carly frequently skipped meals, ate an imbalanced ratio of carbs and protein, and skimped on sleep. Over time, these synergy disruptors took their toll, and so when Carly came to my office, she reported a whole host of symptoms: acne, PMS, some unusually intense menstrual cramps, fatigue, a lack of sexual energy, recurrent urinary tract infections, constipation, and an extra 10 pounds that she just could not seem to shed.

I am stuck by how many people-both patients and groups-underestimate the potentially serious consequences of these seemingly minor synergy disruptors. Not giving our bodies the sleep and nutrition that they need can stress our adrenals, unbalance our carbohydrate metabolism, and set us up for an immune / digestive condition known as leaky gut, in which partially digested food leaks through intestinal walls.

As a result, we put ourselves at risk for adrenal dysfunction, blood sugar imbalance, and inflammation, an overreaction of the immune system that has been associated with many health issues, including heart disease, diabetes, and cancer.

I define as a synergy disruptor anything that interferes with the body's complex system of synergies and causes some portion of the body to compensate.

Typical synergy disruptors include:

* Insufficient or poor-quality sleep.
* Missed meals, too-large meals, or meals with the wrong balance between protein and carbohydrates (As a general rule, your plate should be made up roughly of 40-45 percent carbs, 40-45 percent protein, and 10-20 percent healthy fats).
* Foods that we do not tolerate well. Here's how to find out which foods are causing you issues.
* Excessive caffeine, alcohol, and sugar.
* Exposure to toxins, such as pesticides, pollutants, heavy metals, and exogenous hormones.

All of these synergy disruptors stress our adrenals and alter our cortisol levels either directly or indirectly, by causing leaky gut and / or unbalancing our carbohydrate metabolism. When we discount their importance, we miss a serious aspect of stress-and we miss a cruel opportunity to support our bodies.

Synergy disruptors can do damage both by themselves and through magnifying other life stressors. Understanding how they work, how we can avoid them, and how we can reverse their effects is a significant aspect of optimizing our health.

Minimize Synergy Disruptors by Feeding Yourself!

{ Comments are closed }

Biological Drugs Market – Highest Growth in North America 2020

As new breakthroughs are made in the biomedicine sector, growth is also anticipated in the biological drugs market. According to US-based market research firm Persistence Market Research, this market will report a 10% CAGR from 2014 through 2020, and will be worth USD 287.13 billion by 2020.

Segments within the global market

The global biological drugs market can be broadly classified as: vaccines, therapeutic protein, and mAb. The segment of the therapeutic proteins can be split into: Avonex, Enbrel, Neulasta, Lantus, NovoLog, Humalog, Aranesp, Rebif, Levemir, Epogen, Victoza, Neupogen, Betaseron, and Eylea. Similarly, the mAb segment can be divided into: Remicade, Humira, Rituxan, Herceptin, Avastin, and Lucentis. And, the segment for vaccines can be sub-segmented as: Cervarix, Gardasil, Varivax, Prevnar 13, and Fluzone.

Global market by geography

The market for biological drugs can be classified and studied on the basis of geographical regions. Thus, the market can be split into: North America, Europe, Asia Pacific, and Rest of the World. By market share, North America emerges as the dominant region. It is followed by Europe and Asia.

In North America, the global market is fueled by the growing use of such drugs for treating chronic diseases as well as diabetes and cancer. A case in point would be the American College of Rheumatology's recommendation of disease modifying antirheumatic drugs as well as biologic agents in treating rheumatoid arthritis in 2012. The American College of Rheumatology is an organization dedicated to advancing treatment options for rheumatic conditions through education and research.

In other markets such as Europe, the growth of the market can be attributed to a spike in the geriatric population. A report by the United Nations states that as of 2000, the olderly complied 23.2% of the total population of Germany. This percent could well scale to 33.2% by 2025. Glaucoma and macular degeneration are age-related disorders that create opportunities for the development of treatment options such as drugs.

Where are the investment dollars flowing?

A healthy portion of the total investments by biological drug makers is now being seen in Asian countries. The low manufacturing costs that prevail here, combined with growing transfer of pharmaceutical know-how from the West to the East, will support the growth of the market here. A recent example would be that of Swiss biotech company, Lonza, which invested a reported USD 350 million in two Asian locations – Singapore and India – to advance biological drug-related activities.

Growth drivers and restraints in the market

To a great degree, the worldwide market will also benefit from favorable government policies, leading to potentially higher investments. Within this market, two key emerging trends are that of Genetically Modified Organisms (GMOs) and anti-Vascular Endothelial Growth Factor (VEGF).

On the restraints front, the biggest challenge for companies will be the high costs associated with developing biological drugs. This challenge could have been compounded by the impending patent expiry of certain blockbuster drugs. Besides these impediments, there has been some speculation about adverse effects of injectable drugs.

Leading participants in the market are: GlaxoSmithKline plc., Pfizer Inc., Novartis AG, Abbott Laboratories, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck & Co., Inc., and others.

{ Comments are closed }

Everything That You Wanted to Know About Rotavirus

Rotavirus causes an acute gastroenteritis condition that is coupled with vomiting and diarrhea. The virus affects infections as well as young children. Rotavirus has got its name from the fact that the disease-causing virus resembles a wheel whenever put under a microscope. Thanks to the developments in medicine and technology, two vaccines have been successfully created to combat the disease.

Is rotavirus really a big problem?

Rotavirus infects intestinal tracts of under-fives. Children who are under the age of five can get the infection more than once, but the first time is usually the worst. When talking globally, the virus is responsible for two million hospitals as well as 500,000 deaths of under-fives on a yearly basis. The figures are abysmal and depressing. Adults as well as older children can also be infected by the virus, but the condition will be too mild.

How does rotavirus spread, anyway?

The disease, sadly, is highly contagious. The stool of an infected child has germs that are livable for a long duration. The germs can remain for a long duration upon contaminated surfaces, such as hands. A child can catch the disease by touching a contaminated object and putting it in mouth. The spread of the virus is a primary problem in daycare and hospitals as well. The disease can spread from child to child like wildfire.

Daycare workers also help in spreading of the disease. The childcare workers, sometimes, do not wash their hands after changing diapers, Ie the germs remain in the hands of the workers. And the workers feed other infants from the same unwashed hands. That is, by far, one of the most common causes of the disease.

What are the different symptoms of the disease?

• The intestinal infection in infections is characterized by watery diarrhea, vomiting, low-grade fever and abdominal pain as well.

• In most cases, bowel movements can occur close to 20 times per day. Such highly frequent bowel movements last up to nine days. That is a lot of water wastage from an infant's body, and it is dangerous.

• The chances of having dehydration through a rotavirus infection are thick. Having 20 bowel movements for nine days can cause severe dehydration in infections. The common signs of dehydration are deep breathing, tiredness, coldness of hands as well as feet, lack of tears and weakness.

The consequent rotavirus infection in an infant may not have dehydration as a symptom.

How to diagnose the disease?

The infant has to get admitted to a hospital. Most of the times, doctors and pediatrists test young children for Rotavirus A. The test involves examination of the injured child's stool. Such type of examination, by and large, is carried out with the help of immunoassay. The immunoassay helps measure the presence of a substance (proteins or virus) in the stool.

Rotavirus vaccine has arrived to help in combating from this malady. Each child should get a dose of the vaccine. The dosage value depends upon the brand of the vaccine. The vaccination program should be started when the child is two months old. The vaccine is available in liquid form only. A rotavirus vaccine is as important as a conjugate vaccine , and it should be included within a child's immunization schedule.

{ Comments are closed }

Issues in Medication Errors and What Can Be Done to Prevent Them

It's been said that many times that one of the main reasons why people sue for medical malpractice is lack of communication, but not too much has been said about medication errors.

According to an article in The New York Times, in 2008 medication errors had increased more than 50 percent with 1.9 million people becoming sick or injured from medication side effects, or they took or were given the wrong type or dose of medication.

So what is being done or what can be done to reduce these medication errors?

In 2004, the FDA implemented a new rule requiring bar codes on certain drug and biological product labels. Each patient is given a bar-coded identification wristband that transmits information to the hospital's computer. Before dispensing medications, nurses scan the wristband to pull up a patient's full name, social security number, and the exact medications the patient has been prescribed.

Another idea is to eliminate abbreviations and dosage expressions that can be misinterpreted. A study conducted by Bates DW, Cullen DJ, Laird N, et al. that was published in JAMA about medication prescribed discovered that more than 30% of all handwritten prescriptions had a mistake of some type that required deciphering and correcting by a pharmacist. For example, the number 1 error-prone medication is insulin in which the abbreviation “u” for units is often confused with the number 0. ISMP reports that these errors have been occurring for over 30 years.

Patients are often given the incorrect medication. There are thousands – if not hundreds of thousands – of medications on the market nowdays. It would be good to limit the look-alike and sound-like drug names, and confusing packaging. The pharmacy manager should develop a sound policy and procedure for the safe distribution medication and supplies to patients.

Reducing medication errors will take a major revamping of the system. Development of new policies and procedures does involve many departments from pharmacy to risk management, legal counsel, and upper level executives. Included in these new policies and procedures is taking a great deal of care and consideration in hiring personnel, evaluating their competency, and ensuring proper training so that tasks are performed impeccably.

A review of medication programs and quality improvement should be ongoing, and all personnel should be committed to the safe use and distribution of medicines.

These are just a few of the major issues and solutions when it comes to medication errors. What other things can you think of to help reduce mistakes?

{ Comments are closed }

Dangerous Diet Pill Ingredients

The vast majority of people know that a healthy balanced diet and exercise are the right way to lose weight, but for some struggling to lose weight they are turning to diet pills. There are a large variety of diet pills on the market such as over the counter and prescription pills. They generally suppress a person's appetite, block fat absorption or raising your metabolism or all three. Some of these pills may be OK on a temporary basis to jump start your weight loss journey, but some are downright dangerous.

I am listing below 5 bad ingredients to watch for and stay away from. This of course is not all the bad ingredients, but the worst of them and could even be life threatening. If you are thinking of getting diet pills just make sure these ingredients are not in them.

Ma Huang / Ephedra / ephedrin / pseudoephedrine
Ma huang, is a species of ephedra and often contains ephedrine and pseudoephedrine, which can affect the nervous system that results in high blood pressure, increased heart rate, irregular heart rhythm, heart attack, stroke or death. Ephedra has been kicked in the USA.

Bitter orange / synephrine
Bitter orange contains the chemical called synephrine, which is similar to ephedra that can cause increased heart rate, headaches, vomiting, insomnia, high blood pressure, fainting, heart attack and stroke.

Sibutramine
Sibutramine is a very powerful stimulant that my significantly increase the risk of heart attacks, arrhythmias or strokes, in addition to causing a long list of side effects. It was taken off the market in 2010. Several weight-loss drugs have been found to be illegally spiked with sibutramine.

Fenproporex
Fenproporex is a stimulant not approved for use in the USA; it is converted to amphetamine in the body and my cause heart arrhythmias and possibly even sudden death. It may also be addictive.

Phenolphthalein
Phenolphthalein is an ingredient that was found in some laxative products up until 1999, when the FDA determined that it was “not generally recognized as safe and effective.”

Please always consult your doctor before taking any pills or starting a new health and fitness program. One size does not fit all when it comes to our health and fitness. We are all unique individuals in every way, so what works for one person may not work for the next person. These types of pills are not good for anyone period!

{ Comments are closed }

Clinical Research Associate (CRA) – A Growing Career Path in Biotechnology / Pharmaceutical Industry

A clinical research associate (CRA) is a professional who oversees all aspects of clinical trial conduct. They oversee clinical trials to test drugs / medical devices / biologics / or in vitro diagnostics for their effectiveness, risks and benefits to ensure that they are safe to allow on to the market. CRAs are also known as clinical trial monitor or clinical monitor. A CRA may be involved in some or all stages of the clinical trial depending on the type of position and the employer a CRA work for.

Type of CRA

In-House CRAs

CRAs who work for a sponsor company are called in-house CRAs. An in-house CRA may be overseeing all aspect of clinical trial conduct, from planning to clinical study report (CSR) generation for submission to regulatory bodies. Below are some job functions of an in-house CRA.

· Designs study documents such as study designs, synopsis, site specific protocols, informed consent forms, case report forms, site study procedure manuals and project tools, monitoring plans, and tracking tools, clinical study reports, budget and contract negotiation.

· Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.

· Maintain frequent contact with and work effectively with investigators and coordinators.

· Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

· Review and resolve discrepancies in clinical data with clinical sites or through a contract research organization (CRO).

· Low amount of travel may be required (eg up to 25-30%).

Regional CRAs / Home-Based CRAs

CRAs who work independently from home are called regional CRAs or home-based CRAs. Regional or home-based usually do not handle planning and preparation of clinical trials. They generally handle the monitoring function and oversee trial conduct. Thus, they can work from home and they usually travel quite a bit more than their in-house CRA collections.

· Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.

· Maintain frequent contact with and work effectively with investigators and coordinators.

· Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

· Review and resolve discrepancies in clinical data with clinical sites.

· High amount of travel may be required (eg up to 75-80%).

CRAs Who Work For a CRO

CRAs who work for a contract research organization (CRO) can be either in-house CRA or monitoring CRA. They usually work out of a CRO's office. As the goal of the CRO is to provide full range clinical trial services to sponsor companies, CRAs who work for a CRO may be called upon to perform in-house or monitoring functions depending on the project and client's needs. One note to mention is that CRO is sensitive to the economic cycles. When the economy is good, CROs may hire a lot of CRAs to meet the higher numbers of clinical trial claims. When the economy is bad, CROs may turn around and lay off CRAs as work demand reduces. In addition, CRAs who work for a CRO are expected to work hard. They may be assigned to oversee multiple studies with high number of sites (> 10 sites). That being said, a CRA position at a CRO is usually a good way for a new CRA to gain experience. Another benefit in working at a CRO is getting exposure to a variety of therapeutic areas that may enhance a CRA's credential and career progress.

Education and Skills Needed

Education

Although there are no exact rules, general educational requirements for a CRA role is typically a bachelor of science (BS) or a bachelor of art (BA) degree in life sciences, medical sciences, or healthcare related field such as nursing. Advanced degree is not required, but can be helpful for career progress.

Skills

CRAs perform variety of functions relating to clinical trial. As different functions require different skill sets, below are some skills that can be helpful in a CRA's job performance:

· Excellent communication skills (both written and oral). This is important as CRAs work with clinical trial sites (Principal Investigator and staff), regulatory review boards, key opinion leaders (KOLs), and collections.

· Ability to motivate and train others. This goes along with the communication skills. CRAs will need to train and monitor the progress of clinical trial conduct at different clinical sites.

· Attention to details. CRAs will need to be able to see mistakes and identify incorrect trial data / results. The work also involves documentation and recording of information. Detail oriented skills is critical to the monitoring work to ensure that clinical trial results are recorded appropriately and are accurate based on source data on medical records.

· Problem solving skills. Unexpected events and issues often will come up through different phases of clinical trial. CRAs are the main contact for all the issues that may come up. Thus, CRAs should maintain flexibility and positive approach toward unexpected issues.

· Multi-tasking, time management, and organizational skills. Multi-tasking skills are essential as CRAs are often handle different tasks at the same time. Time management skills are the key to effective work schedule arrangement in order to avoid overload. Organizational skills will help CRAs when working with stringent record keeping and regulatory requirements from regulatory bodies that regulate clinical trials.

· Ability to travel. Although travel can vary depending on the type of position, CRAs are expected to travel to clinical sites as needed. Ability to handle travel both domestically and internationally is one of the skills needed for CRAs.

· Knowledge of good clinical practice (GCP) and FDA Code of Federal Regulations (21 CFR 11, 50, 56, 312, 812, 45 CFR 46). These are some of the documents that govern clinical trial conduct. Familiarity with these documents is essential. If you are new to the industry, they can be learned.

How to Get Into a CRA Role

It's not impossible to get into a CRA role straight out of college. Some sponsors and contract research organizations (CROs) may recruit recent graduates with the necessary exercises and skills. However, most employers will require some relevant prior experience for a CRA role.

Experience

Similar to many other career fields, experience is the key to obtaining a CRA position. My own career path started with a bachelor of science in engineering. I worked in an academic research lab for 6 years after college before switching to a clinical research coordinator (CRC) role at a hospital for 3 years. From there, I transitioned into a clinical research associate (CRA) role at a sponsor company, an in vitro diagnostic device manufacturer, for 3.5 years. I then progressed into my current position overseeing clinical trial management at a non-profit drug company. Switching job had helped me gain experience and pushed me to develop new skills. In addition, every new position was an increase in responsibilities, job title, and compensation.

What if you do not have prior experience?

This question came up when I switched my career path from working in an academic research lab to working in clinical research. It also came up again and again as I changed jobs into roles with greater responsibilities. The key to conquer new career path without prior experience are:

· Build on prior applicable skills and knowledge

· Willingness to work hard and start somewhere

These two factors were the reason that helped me transitioned into a clinical research coordinator (CRC) position in an emergency room setting at a hospital. I had applicable skills in science and research when I was in academic lab. The other factor was that I was willing to work at night and on the weekend. In addition, I had to push myself beyond my comfort zone. I was recruiting pediatric patients into clinical trials in emergency setting. Imagine yourself as a parent who brought a really sick child into an emergency room late at night, participating in clinical trial is probably not the first thing on your mind. This pushed me to work hard to succeed. I used the same approach to advance my career into a CRA role and into my current role as a manager.

Different pathways towards a CRA role

Similar to my career path, those without experience can get into clinical research at a lower level. These starting positions may be directly or indirectly applicable to clinical research industry. Once experience has been gained, a clinical research associate (CRA) position can be pursued using the applicable skills and knowledge acquired.

Directly applicable starting positions may include:

· Clinical research coordinator (CRC) role at a clinical site

· Clinical trials associate (CTA) role at a sponsor company

· Nursing role with patient care experience.

Indirectly applicable starting positions may include:

· Pharmacy or medical sales

· Clinical laboratory work

· Clinical data work

· Academic or pharmaceutical research

Clinical Research Training

Although experience is the key towards a CRA position, there are training programs that are offered through colleges and universities as well as online training courses that can help increase the chance for a candidate who looks to get into clinical research. These may include postgraduate degree and certificates in clinical research. The cost and time investment for these training programs should be considered carefully and compared to the pathways listed above for pros and cons. Training may also be done part-time while one work full time in one of the starting positions in clinical research. Specific curriculum will vary from institution to institution. Below are some general areas that a clinical research training program should cover:

· Clinical research ethic

· Clinical research practice

· Clinical trial design

· Clinical document writing (study design, protocol, informed consent, case report forms, etc.)

· Clinical trial monitoring and management

· Risk management

· Regulatory requirements

Career Development

Career progress can be different depending on company and business environment. However, with motivation and previous experience showing success in clinical research, one should be able to progress either within the same company or at another company. Below are different levels of CRA title that we can use as a rough guide in gauging CRA career progress:

CRA Title

· CRA I – starting level with 1-2 years of experience. CRA I may be working on different parts of clinical trial, such as setting up trial master files, document preparation, and site correspondence. Some supervision from more senior CRA may be needed to help guide CRA I on different clinical trial related functions.

· CRA II – mid level with 3-5 years of experience. CRA II should be working on all stages of clinical trial. Job function can range from clinical trial design and planning, protocol and form generation, site selection, monitoring, to clinical report generation. CRA II should be working independently with little or some supervision from more senior CRA.

· CRA III / Senior CRA / Lead CRA – senior level with 5 or more years of experience. CRA III, Sr. CRA, or Lead CRA should be able to perform any of the clinical trial tasks proficiently. They are also expected to supervise, train, and mentor more junior CRA.

Beyond A CRA Role

Many CRAs may choose to remain in CRA role as a career. Some CRAs may become consultants after gaining years of experience. Beyond a CRA role, career progress may include management role such as:

· Clinical trial or clinical affairs manager

· Senior clinical trial or clinical affairs manager

· Associate director of clinical research

· Director / vice president of clinical research

The sky is the limit for opportunities and career progress beyond a CRA role. One note is that advance degree (MD, Ph.D., MBA, etc.) may be advantageous as one progress higher in clinical research career.

{ Comments are closed }

Drug Development – The Process of Drug Discovery, Clinical Trial, and Post Marketing Surveillance

Drug development involve multiple stages. The process from start to finish can take lots of funding and time (many years). Large drug companies usually have multiple drug candidates that go through the development process at the same time. Out of the many, only a few will make it to regulatory approval and be sold to the public. This is the reason why new drug costs so much. The cost is to support this lengthy and costly process of drug development.

The process of drug development includes:

Drug Discovery
Pre-clinical testing
Clinical trials
Post market survey
Drug Discovery

Drug discovery is the process that new drug candidates are screened and selected. Thousand of potential small molecules, natural products, or extract are initially screened for desired therapeutic effects. For example, candidates for protease inhibitor should bind the protein protease with certain affinity, selectivity, potency, and metabolic stability. Oral stability and bioavailability should also be considered for the candidates to be made into a pill that can be swallowed. Once one or more top candidates are selected, the next step is to conduct pre-clinical testing to confirm safety, toxicity, pharmacokinetics and metabolism.

Pre-Clinical Testing

Prior to testing new drug candidate on human, intensive pre-clinical testing in animals must be done to ensure the safety of the new drug. Pre-clinical testing is also conducted to learn of any toxicity, metabolic profile, and pharmacokinetic of the new drug. Pharmacokinetic studies, commonly referred to as PK studies, are conducted to learn what happens to the new drug in a living organism, from the moment it enters the body to the moment it get eliminated through urine and stool. Pre-clinical testing also includes studying the biochemical and physiological effects of the drug on the body. This is called Pharmacodynamics or PD studies. PD studies aim to learn the mechanisms of drug action and the impact of drug concentration on the living organism. From PK and PD studies, appropriate doses and dosing schemes of the new drug can be determined.

The chemical makeup of the new drug is also studied in pre-clinical testing. This includes the solubility, stability, and formulation of the new drug in different forms (capsules, tablets, aerosol, injectable, and intravenous). This portion of chemical studies is known as Chemistry, Manufacturing and Control (CMC).

Clinical Trials

Once intensive pre-clinical testing showed promising results for the new drug candidate, the next step is to conduct clinical trial in human. In United States, prior to conducting clinical trial in human, an application to the FDA called Investigational New Drug (IND) application. Below is a link for FDA 21 CFR 312, the regulation that govern new drug candidate that requires IND. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312

If the sponsor or drug manufacturer does not receive any objection notice from the FDA within 30 days after IND application submission and the clinical trial has been approved by the IRB, the clinical trial can start.

Clinical trials in human are often done in phrases:

1. Clinical Trial Basics – Drug – Clinical Trial Phases

Phase 0 – Pharmacokinetics (PK) and Pharmacodynamics (PD)

This is first in human trial where pharmacokinetics (PK) and pharmacodynamics (PD) are studies. The number of subjects are usually very small (N = 10 to 15)

– Pharmacokinetics (PK) studies are done similar to the PK studies described in pre-clinical testing to understand what happens to the new drug from the moment it under human body to excretion. PK studies are done to learn what the body does to the new drug.

– Pharmacodynamics (PD) studies are opposed to the PK studies. PD studies are done to learn what the new drug does to the body.

Phase I – Safety

Phase I studies are often done in small number (N = 20 – 80) of healthy subject. The goal of this phase is to learn the safety of the new drug. To avoid further complication and symptoms from underlining disease, healthy subjects are enrolled into this phase. Exception to this includes oncology trials where actual disease patient may be used. Phase I studies are often done in a specialized facility or clinic where continuous monitoring of subjects can be done. These facilities or clinics are often called CPUs (Central Pharmacological Units). Side effects of the new drug are carefully recorded in phase I studies. In addition, phase I studies are often designed to test single (Single Ascending Dose) and multiple (Multiple Ascending Dose) dosage and dosing interval to learn the range where the new drug is safe in human.

Phase II – Efficacy (Proof of Concept)

Phase II studies are done in larger number of subjects (N = 100 – 200). The population for this phase is patient with the disease where the new drug is intended to treat. Study design for phase II studies usually compares the new drug against standard care treatment and / or placebo group. Placebo is an inert substance that has no medical effect (eg sugar pill). The goal of phase II studies is to test for efficacy of the new drug. Additional safety information is also usually collected. Phase II studies can be done in two stages, phase IIa to compared dosing and dose regiment and phase IIb to evaluate efficiency and safety. Sometimes, phase I and phase II are done in combination to evaluate efficiency and toxicity in order to save time and cost. Since phase II studies evaluate efficiency, this phase can be referred as “Proof of Concept.” Phase II usually determine the fate of the new drug; continue to phase III if shown efficiency vs. discontinue clinical testing if shown ineffective.

Phase III – Pivotal Studies

Phase III studies are designed to obtain large enough population to show statistical evidence of efficiency and safety of the new drug. Phase III studies are often done in large number of patients with the disease the new drug is intended to treat (N = 300 – 3000). Similar to phase II, new drug in phase III studies are being compared against standard care treatment and / or placebo group. Due to the large number of patients being evaluated, phase III studies are time consuming and costly. Similar to phase II, phase III studies can be done in stages; phase IIIa to evaluate efficacy and safety and phase IIIb to evaluate additional disease indication or additional marketing claims. Due to the evaluation of efficiency and safety in large population, phase IIIa are often called “Pivotal Study.” While not required in all cases, often 2 successful phase IIIa trials are needed to show efficiency and safety to obtain regulatory approval from major regulatory bodies such as the FDA in the US and EMA in European Union. Upon favorable results from these phase IIIa trials, sponsor or drug manufacturer may submit a New Drug Application (NDA) to the FDA or EMA for regulatory approval.

Phase IV – Post Marketing Surveillance

Phase IV studies are usually done after regulatory approval of the new drug. The goal of phase IV studies is to collect safety information in larger population (general population) and in longer time period (multiple years) than in phase I, II, and III trials. Phase IV studies are necessary to protect patient's safety after regulatory approval of new drug. As safety information are collected and reported to the oversees regulatory body, if serious side effects are found, the new drug may be restricted to certain use or it may be prohibited from being sold altogether.

{ Comments are closed }

“Gua Sha” to Relieve Muscle Soreness, Head Colds and PMS

The past few years has seen a steady rise in popularity of TCM (Traditional Chinese Medicine). You've probably know Chinese reflexology and acupuncture, but one healing practice you may never have heard of is called ” gua sha .” Sometimes called “coining” or “spooning” by Westerners, the process involves scrapping the surface of the skin in order to detoxify and refresh the body. Although still relatively unknown in the West, gua sha is quite popular in Asia since it's so easy, and the results are so quick and amazing.

Traditional Chinese Medicine believes that muscle soreness and other injuries are essentially blockages of both blood and qi . Whether you believe in the concept of qi or not, it's no mystery that when you suffer from muscle soreness, rubbing the area to increase blood flow will help relieve the pain. That's the basic idea. Gua sha starts with a warm bath or sauna, and then, after applying massage oils, your masseuse will run a special scrapping tool over the affected area (or, for home, use a simple spoon). The Chinese say this unblocks qi , and medical science explains this as an expulsion of metabolic waste built up in congested tissue and muscles. The scraping works like an extreme form of exfoliation, and will leave behind marks and redness – but do not worry, these will fade within a few days of the treatment.

So what exactly can Chinese gua sha help you with?

1) Tired Muscles

Anyone who's had a hard work out knows the dreaded feeling that sets in the next day – DOMS – or Delayed Onset Muscle Soreness. ESPecially when trying to get back in shape after a long break, the dreaded DOMS is almost inevitable by product of exercise. To counteract this extreme muscle soreness, follow a tough work out with plenty of stretching, water, and a session of gua sha – rid your body of all that lactic acid, and make room for new muscle to build! Gua sha is great for any kind of muscle soreness, stiffness, or fatigue.

2) Head colds

Upper respiratory illnesses afflict us all at one time or another – usually in the cold of winter – so what better way to treat a cold than with a hot bath or sauna followed by gua sha ? Your masseuse will run the scraping tool over your upper back, neck and shoulders to tie congestion and expel fluids built in your chest – and you'll experience the relief almost immediately afterwards!

3) PMS

Since gua sha is such an ideal treatment for sore muscles, it's also ideal for those monthly menstrual aches and pains. By following the principles of reflexology, your masseuse will scrape different parts of the body to relieve soreness in your lower abdomen.

To try the practice for yourself, contact your local acupuncturist, or buy a simple gua sha tool or use a spoon and try it for yourself at home.

{ Comments are closed }

About Private and Public Cord Blood Banking

It is important to understand the difference between public and private banks before opting for cord blood banking. There are three choices every expectant parent has:

  • Knowing the doctor to discord cord blood after the baby's birth
  • Storing it with a private bank
  • Donating it to a public cord blood bank

Private Banking:

In case of private cord blood stem cells banking, you will own the right to use your baby's stem cells. If he or she ever needs it in the future, there will not be any issues in using the cells for your child's therapeutic or transplantation treatment. It can also be used in the treatment of a sibling or blood relative, should there be a close match.

Private Banks charge a one-time processing fee and annual storage fee for conserving the cells cryogenically. An expert representative from such banks can come and collect your baby's umbilical cord blood anywhere you want them to.

Transplant-related complications reduce if you opt for private banking of cord blood. This is due to the incidence of Graft vs. Host Disease lowers if stem cells from a related donor are used. In such diseases, transplanted cells tend to react against the tissues and can be fatal for the recipient. Matching opportunity is 100% in private banking. With this type of banking, expectant parents can create opportunity for the use of baby's own cells and a family member's cells for cellular therapies in the future such as diabetes, heart attack and various other medical conditions.

Public Banking:

If you opt for public banking, you will have no rights over the use of your baby's cord blood stem cells. The donor does not have to pay any money for the procedure. The collection service has limited access which means public banks perform the collection procedure only at limited number of locations.

There are various reasons due to which access to one's cells in a public bank becomes extremely difficult. Around 70% of the donated cord blood at public banks is discarded as the criteria for processing and storage is not met. Due to this, the likelihood of a specific sample being available in a public bank is reduced to a great extent.

Cells are released from these types of banks only when a good match is identified with an unrelated recipient. This is also one of the major reasons due to which finding matching cells in such banks are next to impossible.

Compared to the immediate availability at private banks, search and match process at public banks takes weeks or even months. Obtaining matching cells is extremely difficult for patients from ethnic minorities or mixed ethnicity.

Blood found in a newborn of umbilical cord is a really good source of stem cells that contribute to the development of organs, tissues and systems in a human body. Parents who do not want to reserve their baby's stem cells should opt for public banking and help make a difference in someone else's life.

{ Comments are closed }