What is pharmaceutical granulation?Pharmaceutical granulation is a process whereby granulated active ingredients (the drugs), are combined with excipient substances (additional inert powders). The binding of these powders creates medicines in tablet form. No tablet can consist of purely an active ingredient therefore extensive tests are carried out to find the perfect excipient to mix in. Just a small variation in the type or quantity of the excipient, can have a significant impact on how the drug works, along with the ability to distribute a tablet that is always exactly the same. Although the significant amount of trials carried out to test the excipient within each pill can be highly costly and time consuming, it is essential that the correct one is found. Once the perfect excipient is found, it will help the active ingredient to bond and evenly distribute itself around the body. It may also be flavoured to make the tablet more pleasant for the consumer. Coatings can also be used to improve the flavour of the tablet; these often contain sugar to create a sweet taste. The coating may also be designed to control where in the digestive system the active ingredient is released, this will ensure the most beneficial release of the drug.The process of pharmaceutical granulation is not the same for all tablets. There can be different problems depending on the density or particle size within tablets, along with other compatibility issues. Here the active ingredient may not blend with the excipient and segregation can occur. Tablets may cause problems when consumed or simply not work effectively where this has happened. It is therefore necessary to run tests to completely ensure that the particles are correctly bound and distributed with the ability to do so in large scale production. Sometimes segregation can be resolved by granulating the active ingredient alone in the first instance, and then granulating it alongside the excipient afterwards to form the tablet.Why is pharmaceutical granulation used?The most widespread form of medication used across the world is tablets; thus making the process of pharmaceutical granulation extremely commonly used and incredibly important. Tablets are used in the treatment of a huge quantity of illnesses and diseases. They are very convenient to carry around and can be consumed easily without any need for extra devices, possibly just a fluid to aid swallowing. This is a strong advantage over other medicines which may require a measuring spoon or syringe at least. Individuals that are required to take a number of pills each day are able to take tablets out of their original packaging and place them into portion boxes for each day, allowing them to be better managed and organised. Pharmaceutical granulation helps to create strong hard tablets which will not disintegrate into a fine powder and therefore can be managed and handled easily. The ability of the pill to avoid crumbling also ensures there is no loss of any active ingredient. This is highly important as it guarantees the consumer is receiving not only the same dosage each time, but also the correct dosage throughout their treatment. Furthermore hard, strong tablets can be snapped without any crumbling to enable individuals who perhaps prefer to swallow smaller parts at a time, to break the tablets in half.
Machinery used for pharmaceutical granulationPurchasing machinery for pharmaceutical granulation can be extremely expensive, particularly in the testing stage. Both Spheronization and Extrusion equipment will be required to perform the process which can be bulky and difficult to store. Fortunately there are a few options for new or smaller pharmaceutical companies carrying out trials to reduce both the cost and need for storage space. Some manufacturers provide the option of hiring the equipment, allowing pharmaceutical companies to pay a smaller fee and return the product after use. Alternatively small scale versions of the machines can be bought which are easier to store and cheaper to obtain. One of the leading providers of small scale speronization equipment is Caleva, their Spheronizer 380 is specifically designed for small scale trials and production. They also offer machine hire to those who only require the machinery for shorter periods of time or for those who are not ready to commit to full scale production.
Friday, October 31, 2014
Thursday, October 30, 2014
Do I Have Carpal Tunnel Syndrome? A New Treatment Option
Carpal tunnel syndrome is a very common condition affecting up to 7.8% of the working population. Symptoms include numbness to the thumb, index and middle finger as well as weakness and pain in the hand / wrist. Symptoms can also include pain radiating up to the shoulder and neck region. These symptoms usually worsen after strenuous or repetitive activity. They can also worsen with awkward hand positions such as driving a car, holding a phone, or while sleeping at night, which place increased pressure on the nerve. Certain conditions such as diabetes, rheumatoid arthritis and hypothyroidism also increase the amount of pressure within the carpal tunnel and subsequently increase the likelihood of developing carpal tunnel syndrome. Patients can also be genetically prone to developing this condition because they may be born with a smaller than usual tunnel which increases the risk of developing pressure on the nerve.This condition can lead to permanent nerve damage when left untreated. The nerve fibers can tolerate just so much pressure before the nerve cells permanently lose function. A physician can diagnose carpal tunnel syndrome with a proper history and exam. This diagnosis is then confirmed with either a nerve study, which can show the abnormal function or an ultrasound, which can show any possible areas of nerve compression.
Treatment includes conservative management with splints, anti inflammatory medications or steroids. These typically help with new or mild symptoms but are less effective as the condition progresses. It is not uncommon to hear of some initial relief with these treatment options then decreasing relief over time as these treatments lose effectiveness. Surgery for carpal tunnel syndrome has been improved considerably over the last decade. New minimally invasive procedures (endoscopic release) allow the release of pressure on the nerve causing the symptoms with minimal pain and significantly quicker recovery compared to traditional open procedures. These newer minimally invasive techniques do have increased risk and should be performed by experienced surgeons for the best outcome and least risk for injury. When these endoscopic procedures are performed with the proper equipment by experienced surgeons they allow the quickest return to normal function.Carpal tunnel syndrome is an extremely common condition, which produces symptoms of numbness, tingling, weakness in the hand and pain in the wrist. These symptoms can occur together or separately and can even radiate up the arm. This condition can be easily assessed and treated with excellent results by a hand surgeon before permanent nerve damage develops.
Treatment includes conservative management with splints, anti inflammatory medications or steroids. These typically help with new or mild symptoms but are less effective as the condition progresses. It is not uncommon to hear of some initial relief with these treatment options then decreasing relief over time as these treatments lose effectiveness. Surgery for carpal tunnel syndrome has been improved considerably over the last decade. New minimally invasive procedures (endoscopic release) allow the release of pressure on the nerve causing the symptoms with minimal pain and significantly quicker recovery compared to traditional open procedures. These newer minimally invasive techniques do have increased risk and should be performed by experienced surgeons for the best outcome and least risk for injury. When these endoscopic procedures are performed with the proper equipment by experienced surgeons they allow the quickest return to normal function.Carpal tunnel syndrome is an extremely common condition, which produces symptoms of numbness, tingling, weakness in the hand and pain in the wrist. These symptoms can occur together or separately and can even radiate up the arm. This condition can be easily assessed and treated with excellent results by a hand surgeon before permanent nerve damage develops.
Monday, October 27, 2014
For Patient Safety To Improve, These 3 Things Must Happen First
Over the years there have been many suggestions offered by people in the healthcare industry on how to improve patient safety, but whether or not hospitals or healthcare executives are actually listening it's hard to really tell.There are quite a few organizations that are dedicated to improving patient safety. The National Patient Safety Foundation (NPSF) has been around since 1997. Just recently the organization announced the creation of a program called the NPSF Patient Safety Coalition, which is a program to align stakeholders from across the continuum of care in a unifying mission to make healthcare safer for all.When you hear about studies such as the one conducted by Johns Hopkins Hospital in which researchers discovered that a surgeon in the U.S. leaves a foreign object in a patient's body at least 39 times per week and that wrong type of surgery is performed on a patient about 20 times per week, it does make you wonder if hospitals are truly making efforts to put patient safety first.So what exactly will it take to improve patient safety?We can talk about improving hospital systems or improving communication between healthcare professionals and providers, but there are a few things that need to be put in place if we are to ever truly experience change. These things are more about changing the attitude and mental paradigm of people working in the healthcare industry.
Acceptance of change - Everyone within an organization needs to be on the same page when it comes to making changes to the system. People have to recognize that improvement is necessary. Even having a few people who are not open to making changes can make it that more challenging for the organization as a whole to advance to another level of care.Commitment - Every single medical professional working within an organization must make the commitment to put patients first above all. Through monthly meetings, newsletter, or reminders posted in work areas, you can keep the idea of patient safety at the forefront of people's minds on a daily basis.Positive Daily Habits - It's been said that it takes about 21 days for change to take place, so positive actions and tasks have to be performed daily to turn them into a habit. Whether it's a new way of administering medication or a new way of interacting with patients, the focus has to be doing these tasks well and doing it with every patient.What are your thoughts about improving patient care? Are there any tips that you would add to this?
Acceptance of change - Everyone within an organization needs to be on the same page when it comes to making changes to the system. People have to recognize that improvement is necessary. Even having a few people who are not open to making changes can make it that more challenging for the organization as a whole to advance to another level of care.Commitment - Every single medical professional working within an organization must make the commitment to put patients first above all. Through monthly meetings, newsletter, or reminders posted in work areas, you can keep the idea of patient safety at the forefront of people's minds on a daily basis.Positive Daily Habits - It's been said that it takes about 21 days for change to take place, so positive actions and tasks have to be performed daily to turn them into a habit. Whether it's a new way of administering medication or a new way of interacting with patients, the focus has to be doing these tasks well and doing it with every patient.What are your thoughts about improving patient care? Are there any tips that you would add to this?
Saturday, October 25, 2014
How to Minimize Risk in Cold Chain Packaging
To ensure the best management of pharmaceuticals in terms of both manufacture and protection, companies have to aggressively follow all the right evaluation methods. Minimizing risks in cold chain processes is not just a strategy but also a need for companies to comply with all rules and regulations.Companies can follow best practices and guidelines, but considering every region's different shipment structures and carriers, it's a challenge for companies to follow them exactly because regulations are normally not region-specific but general, yet they are still very detailed.So how can a company meet their targets for both profit and safety? Here are few tips to ensure best packaging which fulfills the needs of the company, makes customers happy and also adheres to health and safety rules.What is your weakest link?It's extremely important for every pharmaceutical company to detect its weak areas, where it needs improvement. Do you deal with shipment preventions on a regular basis due to bad weathers or handle cold attitudes of cargo-handlers? Finding the weakest link in the entire logistics chain requires both time and resources. Therefore, you must consider the following to see if you are dealing with your weaknesses efficiently:a) Perform a gap analysis and document all the risky points.b) Manage the risk for each point in the entire logistics.c) Establish quality and validation system in a way that trains your employees and optimizes your carriersd) Carefully review everything mentioned above. Perform final security measures testing to see if all the previous steps are in place to reduce the risk.How effective is your packaging?Temperatures at the manufacturing plant and the destination are different, which can cause damage to liquids inside shipping vehicles and containers. The damage could also be caused by sudden flight delays or prolonged security inspections.To handle this problem, companies must ensure the following:a) Usage of specialized containers which meet expectations of green companies, have longer hold capability, are cost-effective and weigh less.b) The complete checking of packaging, for example; validate gel pack conditioning procedures, equipment usage during shipment, temperature qualifications, CQ/DQ/IQ/OQ/PQ)
Do you excessively opt for new, technologically advanced packaging?Using more of something is not always good - it can be fatal. Are you confident that your packaging has a perfect match with your distribution process and the product inside? Will it stand up to damage due to bad weather, or face other major or minor issues? If this is the case, then you must be spending a lot of money in using the right material, temperature and shipment weight. Is this excessive spending really necessary for the product, or is it over-engineering the packaging activities? Taking the right measures comes from knowledge, and knowledge is acquired through gathering data. Therefore, you must go through the following:a) Any research study which reveals the perfect temperature ranges for the biochemical and pharmaceuticals. (Conducted in your region of business operations)b) Any research study which has examined the impact of seasonal changes on productsc) Any research study which has examined the impact of packaging on productsd) Any technical reports which make perfect cost comparisons of all packaging options.Do you address changes in the environment and undertake training programs?In-house training programs are always beneficial if adopted pro-actively. The training programs should always be chosen with respect to the organization's specific shipping and receiving needs. These programs must focus on:a) Proper guidance on evaluation, screening and rejectionb) Assessment of packaging optionsc) Training on quality assurance and complete auditd) SOPs for pre-conditioning packaging (+2 to +8 C shipments)e) Proper training on industry guidelinesf) Complete information on supplier qualification for shipment projectsg) Usage of advanced equipments for temperature assessment and temperature controlled packaging solutions, training employees how to carry out such an assessment and deciding appropriate ranges.
Do you excessively opt for new, technologically advanced packaging?Using more of something is not always good - it can be fatal. Are you confident that your packaging has a perfect match with your distribution process and the product inside? Will it stand up to damage due to bad weather, or face other major or minor issues? If this is the case, then you must be spending a lot of money in using the right material, temperature and shipment weight. Is this excessive spending really necessary for the product, or is it over-engineering the packaging activities? Taking the right measures comes from knowledge, and knowledge is acquired through gathering data. Therefore, you must go through the following:a) Any research study which reveals the perfect temperature ranges for the biochemical and pharmaceuticals. (Conducted in your region of business operations)b) Any research study which has examined the impact of seasonal changes on productsc) Any research study which has examined the impact of packaging on productsd) Any technical reports which make perfect cost comparisons of all packaging options.Do you address changes in the environment and undertake training programs?In-house training programs are always beneficial if adopted pro-actively. The training programs should always be chosen with respect to the organization's specific shipping and receiving needs. These programs must focus on:a) Proper guidance on evaluation, screening and rejectionb) Assessment of packaging optionsc) Training on quality assurance and complete auditd) SOPs for pre-conditioning packaging (+2 to +8 C shipments)e) Proper training on industry guidelinesf) Complete information on supplier qualification for shipment projectsg) Usage of advanced equipments for temperature assessment and temperature controlled packaging solutions, training employees how to carry out such an assessment and deciding appropriate ranges.
Thursday, October 23, 2014
What's the Difference Between Food Allergies and Food Intolerances?
In practice over the past 10 years, the most common question related to food intolerances is "what is the difference between food allergies and food intolerances?"For me the answer brings me back to a research project and presentation on food intolerances that I completed during my residency at Bastyr University. Food allergies (as classically defined) are caused by IgE antibodies. Food intolerances are caused by IgG antibodies. Allow me to explain this science talk."Ig" is scientific shorthand for Immunoglobulin, which is another name for antibodies, the messengers of our immune system. The letters "E" and "G" are assigned to each antibody based on their unique characteristics. (Wouldn't it be fun to rename them something more descriptive?IgE antibodies work quickly and cause severe reactions, such as hives, swelling and anaphylaxis. When a person is exposed to a food or substance that causes such a reaction, emergency care is often needed. This is the classic "food allergy," such as to peanuts or shrimp, that are tested for by allergists with a skin prick test.IgG antibodies, on the other hand, work more slowly, taking even up to 72 hours to cause much more subtle or mysterious symptoms, as fatigue, sinus congestion, digestive upset and/or uncomfortable, yet non-emergency, symptoms throughout the body. Unfortunately, from my perspective, conventional medical care has not integrated IgG testing into the standard of care. That is why this may be the first you are hearing of it.While many people know about "lactose intolerance," what I am describing is much more broad based then an inability to digest the sugar in milk. I am talking about the immune system launching a full attack on the foods you are eating, which then leads to deterious effects in any number of areas of your body.The most common symptoms related to IgG food intolerances include: headaches, fatigue, constipation/diarrhea, eczema/psoriasis, urinary frequency/urgency, susceptibility to infections (anywhere in the body), anxiety/depression, and weight gain/loss. These symptoms can potentially cause, and be labeled as, much more serious conditions, such as autoimmunity, chronic fatigue syndrome and cancer, to name a few. The foods types that are most likely to be involved in this condition are: dairy, gluten (the protein in wheat products), eggs, and nuts.
While practicing in an allergy specialty clinic I started to notice that people who are intolerant ("sensitive" is another word used) to gluten tend to be intolerant to many other foods as well, such as certain fruits and vegetables, as well as the foods that are most common in their diet.This phenomenon is referred to as "Leaky Gut," or medically referred to as Intestinal Permeability. One way to think of it is as if the intestinal lining looks like a colander instead of bowl.As I originally learned during my undergraduate training, in a healthy digestive tract food particles must be fully digested and pass through the cells that line the intestine in order to get into the blood stream. In which case the immune system, which sits between the lining of the intestine and the blood vessels, is only exposed to nutrients, never actual food particles.In order for IgG antibodies to be created, the immune system must be exposed to food particles, which means that the intestinal lining has been compromised, allowing partially undigested food to get between the cells. Thus the sieve effect, called Leaky Gut.A frequent culprit in causing Leaky Gut is gluten, which explains why people who are intolerant to gluten are often intolerant to many other foods. In fact, most often the very foods that are coming down through their digestive tract frequently. (It's not unusual for people to eat the same foods over and over again.) Another common cause is too-frequent exposure to antibiotics and/or disruption of the balance of healthy bacteria in the intestines.So how can you tell if your immune system is attacking the foods you eat and wreaking havoc each time you have a meal?Thankfully a highly refined antibody testing device, known as ELISA testing, can be used to determine which antibodies, to which foods, are being produced in your bloodstream. And it only requires a few drops of blood to test for close to 100 foods. To order the test go to: http://dld.bz/cKnvy.With this test result you'll get answers and insights into what's going on within your body. And with the right guidance, you'll know exactly what to do with this information.
While practicing in an allergy specialty clinic I started to notice that people who are intolerant ("sensitive" is another word used) to gluten tend to be intolerant to many other foods as well, such as certain fruits and vegetables, as well as the foods that are most common in their diet.This phenomenon is referred to as "Leaky Gut," or medically referred to as Intestinal Permeability. One way to think of it is as if the intestinal lining looks like a colander instead of bowl.As I originally learned during my undergraduate training, in a healthy digestive tract food particles must be fully digested and pass through the cells that line the intestine in order to get into the blood stream. In which case the immune system, which sits between the lining of the intestine and the blood vessels, is only exposed to nutrients, never actual food particles.In order for IgG antibodies to be created, the immune system must be exposed to food particles, which means that the intestinal lining has been compromised, allowing partially undigested food to get between the cells. Thus the sieve effect, called Leaky Gut.A frequent culprit in causing Leaky Gut is gluten, which explains why people who are intolerant to gluten are often intolerant to many other foods. In fact, most often the very foods that are coming down through their digestive tract frequently. (It's not unusual for people to eat the same foods over and over again.) Another common cause is too-frequent exposure to antibiotics and/or disruption of the balance of healthy bacteria in the intestines.So how can you tell if your immune system is attacking the foods you eat and wreaking havoc each time you have a meal?Thankfully a highly refined antibody testing device, known as ELISA testing, can be used to determine which antibodies, to which foods, are being produced in your bloodstream. And it only requires a few drops of blood to test for close to 100 foods. To order the test go to: http://dld.bz/cKnvy.With this test result you'll get answers and insights into what's going on within your body. And with the right guidance, you'll know exactly what to do with this information.
Monday, October 20, 2014
Basic Guidelines for 2013 Anesthesia Billing and Coding
The proposed 2013 Medicare physician fee schedule contains a 27% pay cut for the top 10 anesthesia codes. Moreover, CMS has released the 2013 OIG work plan stating that Medicare Part B claims will be reviewed closely to determine whether they were supported in accordance with Medicare requirements. Also, the use of modifier "AA" will be scrutinized for Medicare requirements. This should prompt anesthesia groups to re-evaluate certain anesthesia care team scenarios.While the use of the AA modifier has been determined there are cases that occur in the anesthesia care team model that do warrant additional review. Clear cut billing guidelines do not exist for scenarios where a case starts as medically directed and ends as personally performed, or vice versa. These scenarios can present billing challenges as the existing modifiers of AA (personally performed by the MD), QK/QX (medical direction by the MD/medically directed CRNA) and QZ (services provided by a non-medically directed CRNA) do not fully describe these situations. In such cases, reimbursement is not impacted for groups that employ the CRNAs as the modifiers could affect the payment amount received by the physician group. Provider groups that encounter clinical scenarios which are not accurately described by the current modifiers available may consider seeking clarification from their MAC for clear guidance on appropriate billing procedures.
Lately, CPT 2013 updates have been making the rounds, but there were no new or deleted anesthesia codes. However, revisions have been made to 01991 and 01992 anesthesia billing codes with the description when block or injection is performed by a different physician or other qualified health care professional.Also, the term "other qualified health care professional" has been included to stress on the fact that CPT does not limit code reporting to specific specialties or providers; instead, scope of practice laws, regulations, contracts, and hospital policy/bylaws determine whether a provider is qualified to perform a service. The individual is also required to be qualified to perform services and independently report it. Clinical staff who do not report their services independently do not fall within the scope of this definition provided by CPT.ICD-9-CM codes are used in medical billing and coding to describe diseases, injuries, symptoms and conditions. 288.60 ICD-9 code is one of thousands of ICD-9-CM codes used in healthcare. Although ICD-9-CM and CPT codes are largely numeric, the only point of difference is that CPT describe medical procedures and services. 288.60 ICD-9 code is used to report Leukocytosis, unspecified and is a billable medical code that can be used to specify a diagnosis on a reimbursement claim.
Lately, CPT 2013 updates have been making the rounds, but there were no new or deleted anesthesia codes. However, revisions have been made to 01991 and 01992 anesthesia billing codes with the description when block or injection is performed by a different physician or other qualified health care professional.Also, the term "other qualified health care professional" has been included to stress on the fact that CPT does not limit code reporting to specific specialties or providers; instead, scope of practice laws, regulations, contracts, and hospital policy/bylaws determine whether a provider is qualified to perform a service. The individual is also required to be qualified to perform services and independently report it. Clinical staff who do not report their services independently do not fall within the scope of this definition provided by CPT.ICD-9-CM codes are used in medical billing and coding to describe diseases, injuries, symptoms and conditions. 288.60 ICD-9 code is one of thousands of ICD-9-CM codes used in healthcare. Although ICD-9-CM and CPT codes are largely numeric, the only point of difference is that CPT describe medical procedures and services. 288.60 ICD-9 code is used to report Leukocytosis, unspecified and is a billable medical code that can be used to specify a diagnosis on a reimbursement claim.
Saturday, October 18, 2014
Urologist Vs Nephrologist
What is the difference between a urologist and a nephrologist? No, it's not a setup for a joke: many are unsure about the difference between these two medical specialties. The confusion probably stems from the fact that both urologists and nephrologists deal with the kidneys, and the fields of urology and nephrology often overlap.A urologist specializes in treating all aspects of the urinary system. The urinary system includes ureters, urethra, bladder and adrenal glands, plus the prostate and testicles in men. Urologists perform surgery on the urinary tract and kidneys, and deal with urology conditions such as kidney stones, kidney blockages, kidney, bladder and prostate cancer, incontinence, low testosterone, erectile dysfunction etc. The medical field of urology is vast, and it overlaps not only with nephrology, but also with gynaecology, andrology, pediatric surgery, oncology, gastroenterology, and endocrinology.To become both a urologist or a nephrologist, one must complete undergraduate education and medical school, after which a future urologist completes an internship and residence raining in urology, passes a licensing examination and gets board-certified, while a nephrologist has a residence training in internal medicine, before completing a nephrology fellowship program. He can also become board-certified in nephrology.Urologists and nephrologists both work in hospitals and private practice. They may further specialize, for example in treating specific age groups: there are pediatric nephrologists as well as pediatric urologists. There are urologists who specialize in the male reproductive system, neurological disorders, reconstructive urologists, urological oncologists, laparoscopists, endourologists, female and pediatric urologists.
A nephrologist is a kidney specialist who studies chronic kidney disease, manages dialysis centers and programs, treats end stage renal disease, urinary tract infections, regulates uric acid counts as related to gout, electrolytes, and deals with diseases that can lead to kidney problems, like diabetes and high blood pressure. He recommends patients for kidney transplants. A nephrologist delivers nonsurgical treatments. Some of his patients may require surgery - which is performed by a urologist. A nephrologist is, however, responsible for the care of that patient before and after the surgery.Since the roles of a urologist and a nephrologist tend to overlap, urologists and nephrologists often work together to diagnose and treat patients. The cases when the treatment of a specific condition has both medical and surgical requirements are not rare: a patient may need a urologist, a nephrologist - or both. However, each of them is trained to deal with a specific type of problems.
A nephrologist is a kidney specialist who studies chronic kidney disease, manages dialysis centers and programs, treats end stage renal disease, urinary tract infections, regulates uric acid counts as related to gout, electrolytes, and deals with diseases that can lead to kidney problems, like diabetes and high blood pressure. He recommends patients for kidney transplants. A nephrologist delivers nonsurgical treatments. Some of his patients may require surgery - which is performed by a urologist. A nephrologist is, however, responsible for the care of that patient before and after the surgery.Since the roles of a urologist and a nephrologist tend to overlap, urologists and nephrologists often work together to diagnose and treat patients. The cases when the treatment of a specific condition has both medical and surgical requirements are not rare: a patient may need a urologist, a nephrologist - or both. However, each of them is trained to deal with a specific type of problems.
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