Generic Colchicine for Gout May Soon be Available on Local Markets

ColchicGout, Colchicineine has been the gold standard drug for the treatment of acute gout flare ups for generations. It is used additionally when physicians institute uric acid lowering therapy with allopurinol to prevent an acute gouty attack that can accompany any change of our uric acid level. It has additional uses in the treatment of the very rare Mediterranean fever.

The drug was always generic and exceedingly inexpensive until 2010 when the FDA granted Takeda Pharmaceuticals copyright exclusivity production it put its version known as Colcrys through the rigorous testing and trials the FDA demands. Before Takeda engaged in the testing and evaluation of Colcrys, all of our colchicine in the USA was produced overseas in small generic factories that had no oversight or inspections by the Food and Drug Administration (FDA). As a reward for going through the oversight process to insure that our colchicine was safe and pure, Takeda Pharmaceuticals received an exclusive distribution right while the other foreign products were removed from the market. The cost of colchicine produced by Takaeda USA soared to $6-$10 per pill. This made a month’s supply too expensive for many users.

Last month, under encouragement from the FDA and consumer groups, Takeda Pharmaceuticals USA gave permission to Prasco Laboratories to distribute Colcrys as a generic product at a much lower cost. It will be sold under the Prasco name. As of 03/19/2015 it has not yet arrived in the South Palm Beach County Florida market but should be there shortly.

Study Reveals No Deterioration of Kidney Function …

NSAIDSAs we age and try and keep moving we notice the severe aches and pains from wear and tear and osteoarthritis that we feel at the start of a day. To relieve those feelings we often reach for the over the counter bottle of Advil ( ibuprofen) or Aleve ( naproxen sodium) knowing full well that the medication will help the aches and pains but may irritate our stomach or contribute to the downfall of our kidneys.

The problem and decision making in prescribing NSAIDs is even more critical in patients with Rheumatoid Arthritis. A recent scientific publication in the Annals of Rheumatic Disease 2015:74: 718-723 authored by B Moeller MD of the Unselspital-University Hospital, Bern, Switzerland looked at this question. They “found reassuring data regarding preserved renal function despite long-term NSAID use in Rheumatoid Arthritis (RA) patients.” Kidney function was followed on 4101 RA patients between 1996 and 2007. 2739 patients used NSAID while 136 2 patients did not.

They assessed and followed kidney function by the accepted methods of calculating the Glomerular Filtration Rate ( GFR). Their results revealed that there was no decline in kidney function in patients who had less than stage 4 Chronic Kidney Disease at the start of the study. They went on to recommend that if a patient’s eGFR or glomerular filtration rate was less than 30 ml per minute they should not take NSAIDs to treat their aches and pains from RA because of the high risk of these medications exacerbating their already compromised kidney function.

The study included medicine from two different classes of NSAIDs, both the “coxib” and “rofecoxib” class. With this data it is safe to say that individuals with arthritic aches and pains can take NSAIDs without fear of kidney deterioration as long as they do not already have severe chronic kidney disease.

Disagreement Over Optimal Nursing Staff Ratios Continues

NursesIn an ongoing disagreement, nursing unions and their supporters believe that the number of patients per nurse during inpatient hospital care is a major indicator of the quality of care provided in a hospital. The current argument involves staffing in critical care areas such as intensive care units where the norm has been a one nurse to one patient staffing ratio or at worst one nurse for two patients. The decision on number of patients per nurse is based on the severity and acuity of care required on the individual patient.

The state of Massachusetts passed a law mandating this staffing ratio in critical care areas as of September 2014. Hospital lobbying associations dispute the need to staff at this ratio. The state of Minnesota was supposedly conducting a research study to answer the question of the relationship between how many patients a nurse was caring for and quality but only one of the State’s 39 hospitals cooperated by providing support and data.

The ratio of nurses to patients in critical care areas and emergency areas is one question but the same question applies to care on the general medical and surgical floors. When I first started practicing in 1979 the ratio stood at four patients per nurse. That figure has ballooned to 5 – 8 patients per nurse today with the patient population being older, sicker and more complex. In those days the nurses worked an 8 hour shift. Today’s staffing schedules have nurses working fewer days but working 12 hour shifts. There are those experts who believe that most of the errors in care and medication that occur in a hospital setting occur in hours 9 – 12 on a nurse’s shift. The extra day off created by working the longer hours is well appreciate by staff on the 12 hour schedules, but is it as safe for patient’s as the eight hour shift?

As a practicing physician in a community hospital it is very clear to me that the quality of care provided in a hospital is directly related to the quality of the nursing service provided. Having quality and experienced doctors is important but not nearly as important as caring and experienced nurses. They are the eye s and ears of the medical staff when the doctor is not at the bedside. They are the ones who first become aware of a problem or recognize a change in the patient’s condition and have an opportunity to sound the warning. When they are asked to care for too many patients it limits their time and exposure to the patient’s clinical situation.

On a daily basis the public is bombarded with advertisements from hospitals and hospital systems touting the excellence of care they provide. How many patients think to ask about the number of patients per nurse? How many philanthropic individuals think about donating towards an extra nurse per shift instead of a bricks and mortar type donation like a piece of equipment or a room or object? The improvement in care with an extra nurse per shift may be far more significant than a remodeled waiting area in the emergency department.

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Adult Sore Throats

Throat, soreThis is the tail end of flu, cold and sore throat season. All my healthy adult patients are busy with business and social events and family visitors. None of us have time to be sick. At the first sign of a sore throat, runny nose and cough I am being asked to prescribe an antibiotic. In most cases adult sore throats are caused by viruses which do not respond to antibiotics. Not only are antibiotics ineffective but their side effects may make you as ill or worse than the illness you are attempting to treat. “I know my body and it always responds to a Z-Pack,” is a common phrase heard in local medical offices, walk in centers and emergency departments.

With this as a background it was interesting to see a publication in the Annals of Internal Medicine this month investigating the causes of a sore throat. Dr. Robert M. Centor, from the Department of Internal Medicine at the University of Alabama in Birmingham, performed throat swabs on 312 patients reporting a sore throat at a university health clinic and compared the results with the throat swabs of 180 healthy but similar students. Dr. Centor has developed a clinical algorithm and scale for determining when one should do a throat culture and when it is likely that the sore throat is due to Group A Streptococcus and requires antibiotics. Dr. Centor had the advantage of using polymerase chain reaction techniques to look for anaerobic mouth bacteria called fusobacterium necrophorum that normally resides in the mouth, can cause infection but is not detectable by routine and commercially available tests.

Dr. Centor found that 10% or less of adult sore throats are caused by bacteria specifically Strep throat. An accompanying editorial on the subject reminded physician readers that good old fashioned penicillin is still the drug of choice for a Strep throat with no resistance ever having been detected. They went on to say that an increasing percentage of Strep throats are resistant to a Z Pack so it should not be the drug of choice.

Dr. Centor in his scoring scale noted that if you didn’t have a cough, swollen or tender cervical lymph glands, a temperature > 100.4 and a tonsillar exudate, you probably didn’t need a throat swab for strep A. In adults, when a rapid Strep test was performed and it was negative there was little if any chance that a traditional throat culture would have a different result.

The message from this is that if you are an adult and have not been around young sick children then your sore throat is probably viral and does not need an antibiotic. If your temperature isn’t elevated and your glands aren’t swollen and your tonsils and throat don’t have a white coating then you probably do not have a bacterial strep sore throat either. Grab those lozenges, sucking candies, warm fluids and wait it out.

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Dr. Reznick is board certified in internal medicine and has practiced in Boca Raton and the surrounding communities since 1979. For information about his concierge practice, call 561.368.0191 or visit http://www.BocaConciergeDoc.com.

March Is Colon Cancer Awareness Month

Colon CancerColon Cancer is still the second leading cause of death from cancer in the United States despite numerous advances in screening and early detection. It is a disease that is found more commonly in black Americans with 46.7 cases per 100,000 individuals as compared to 38.9 cases per 100,000 individuals for Caucasian Americans. Death from colorectal cancer occurs in every 21.1 cases for African Americans and only 14.6 cases for white Americans.

Even with these dismal figures the cancer death rate from this disease has decreased by 22 percent over the last decade. We attribute this to increased awareness and increased screening.

All individuals should report a change in bowel habits to their doctor immediately. Blood stained stool is a cause for an immediate call to your physician. Generally at age 40 all adults should be having a digital rectal examination as part of a checkup. Stool occult blood slides or stool fecal immunoglobulin slides are used to screen for microscopic gastrointestinal tract bleeding. These tests involve placing a small smear of stool on a slide and submitting it to the lab where it is tested for microscopic blood loss. Usually a CBC or complete blood count is performed as well since gastrointestinal blood loss in small constant amounts usually produces a low blood count or anemia of the iron deficient variety.

Screening colonoscopies are recommended for all non-Black Americans at age 50. Due to the increased risk of colon cancer in Black Americans we recommend that they start screening colonoscopies at age 45. If you have a first degree relative who had colon cancer or precancerous polyps we ask that you start your screening at an age that is 10 years earlier than your relatives disease became apparent.

For those individuals unwilling to have a screening colonoscopy we can offer a CT Virtual Colonoscopy. The preparation is simpler than for a colonoscopy but the radiation dosage involved is equivalent to receiving ten years’ worth of chest x-rays all at once. If the virtual colonoscopy shows a polyp or a mass you will then need to undergo a traditional colonoscopy for biopsy and removal preceded by a traditional pre- colonoscopy bowel cleansing prep.

Cologuard is a new and attractive stool test that detects abnormal DNA associated with premalignant polyps and cancerous tumors. It is fairly new but readily available.

Numerous lifestyle choices can influence your development of colon cancer. Tobacco use is associated with an increased risk, as is drinking more than moderate alcohol. Red meat intake is associated with an increased risk of colon cancer with a 20% increase per 100 gram increase in red meat per day. Regular exercise and intake of high fiber food helps to decrease your risk of developing colon cancer.

March is colon cancer awareness month. Speak to your physician about your risk of developing this serious disease and ways to prevent it from developing. You can use the visit to establish your own personalized colon cancer screening surveillance schedule.

Tiny Sensors to Monitor Medicine Intake Internally

Ingestible SensorsProteus Digital Health is in the process of fine tuning small BB size sensors that you swallow. They are called ingestibles and are activated when they come in contact with saliva or gastric digestive juices. They send signals to monitors, the size of band aids, worn on your chest. From there the data is sent via your smartphone or computer to those health care professionals you designate to receive the data.

The data can include whether you actually took the medicine or not and have developed appropriate blood serum levels, while also monitoring blood sugar levels, blood chemistries and other vital signs. These devices are designed to assist our growing senior citizen population and their care givers up to date on whether you are actually following the prescribed therapies and are they effectively working.

Ingestible chips are now being fine-tuned and integrated with the British National Health Service and are not yet commercially available here in the USA. In development are tinier chips that will actually be in medication pills and send messages to us via our smart phones that it is time to take your pill. Once the pill has been taken it will record that data and serum levels. If you forget you have taken your medication and go to take a second dosage, it will alert you to the fact that you already have taken the medication. If you forget to take your medication a message will be sent to your cell phone or computer and or health care provider.

Some individuals wonder whether all this data is one more “big brother” invasion of personal privacy. With 10,000 baby boomers turning 65 every day and 90% suffering from at least one chronic illness requiring several medications, we will need to balance the benefits versus the risks in deciding if we wish to participate in these monitoring programs.

What Is In Those Supplements?

VitaminsThe Attorney General of the State of New York charged four national retailers on Monday, February 2nd  of selling dietary supplements that were “ fraudulent and in many cases contaminated with unlisted ingredients.” His office said they had run tests on popular store brands of herbal supplements at the retailers – Walgreens, Walmart, Target and GNC and found that out of five products tested, four contained none of supplements listed on the label. At GNC they found that five of six samples from its “Herbal Plus “brand were either “unrecognizable or a substance other than what they claimed to be.” They analyzed Ginkgo Biloba, St. John’s Wort, Ginseng, Echinacea, Saw Palmetto, Garlic and Valerian Root.

For many years now health care advocates have encouraged the Federal government to establish a safety monitoring system for the multibillion dollar vitamin, mineral, herb and supplement product market. Many health care providers question the safety and efficacy of these products to begin with since there are few if any well designed double blinded controlled studies which look at their overall risks and benefits. To now find out that the bottles do not even contain product raises further questions about their efficacy and safety. The American College of Nephrology has been trying to educate the public to the harmful contaminants they have found in many over the counter supplements leading to renal failure and problems in children. Most of these poisons and heavy metal contaminants however, came from products produced overseas.

The time to set up a Federal watchdog on these products is long overdue. The National Institute of Health Division of Alternative and Complimentary Medicine has always taken the position that if products results are positive and reproducible in legitimate studies then the product is not an alternative treatment. That feeling is still shared by me but it does require the product to be in the container you purchase free of harmful contaminants.

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