Many of us do it, we take those pills that cost a fortune and we split them in half and then figure insurance will cover two month’s worth instead of one. The insurance company will save money, we have a lower co pay and fewer trips to the pharmacy, so why not? The editors at JAMA considered this “why not” and published an article about it in their Medical Letter on Drugs and Therapeutics.

A number of medications were tested and the amount of their active ingredient subsequent to cutting or breaking the tablet in half was measured. The studied medications included warfarin (an anticoagulant) and medications for hypertension, heart disease and depression (simvastin, metoprolol, lisinopril and citalopram). The good news was that the split pills were pretty much within the half dose range. The results with scored tablets were better than those with unscored tablets. The editors also cited a recent review that found that the use of split tablets did not seem to affect the clinical outcomes of patients with hypertension, hyperlipidemia (high cholesterol) or psychiatric disorders.

The article went on to state the obvious; that breaking the tablet in half is somewhat dependent on a patient’s visual acuity, strength, dexterity and cognitive ability. Clearly large, elongated tablets with deep score marks on both sides will be the easiest to split. (And just so you know…there is a tablet splitting device which you can buy at the pharmacy. I’ve actually used it, the only problem is taking a very small tablet and making sure it is cut exactly through the middle.) The article suggests that if patients want to split the tablets they do so one at a time so if one half is too small and under dosed, the next day the larger half will be taken and will compensate for the previous lower dose.

Obviously capsules should not be split, nor should tablets that are enteric-coated or extended- release. Also combination tablets in which the amount of one active ingredient changes from one size to the next, but the amount of the second does not, should not be split because that will impact the dosing. These include combination drugs that lower blood pressure and also control blood sugar (sitagliptin/simvastin also called Juvisync, linagliptin/metformin, codeine/acetaminophen, azilsartan/clorthalidone and amoxicillin/clavulanic acid) among others. (I sense that most of you reading this have looked away from this generic drug list…but I felt that in deference to the article and medical completeness I should include them.)

Bottom line: Tablet splitting probably does not have adverse clinical consequences and can reduce the cost to you and your insurance. (The pharmacy may not like this…but oh well.) This pill division is not appropriate for all drugs, nor for that matter all patients. If you do split the tablets, try to make sure that the halves are equal. And if the tablet is coated or comes with instructions not to chew or crush or if it contains a combination of medications, then take the whole tablet as prescribed.

Most of us have heard that men over 50 should consider taking daily aspirin in order to reduce their risk of a heart attack. This recommendation was primarily based on the Physicians Health Study which showed that in the healthy men that were followed, daily aspirin decreased the incidence of first heart attack by as much as 35%. This and other studies have shown, however that “preventative aspirin” has little effect on the risk of stroke in healthy men.

Do these studies apply to women. ..can we be considered “little men”? The answer of course is no… In order to make a gender appropriate recommendation, there must be gender appropriate studies! Only male physicians were included in the Physicians Health Study. But wait, we do have a large study that examined whether aspirin afforded heart attack prevention for healthy women: The Women’s Health Study (WHS) which was reported in 2005. A recent article in the North American Menopause Society Journal reminded physicians of the results of this study and was published under the headline “Practice Pearl”. I thought it would be helpful to review this “pearl” on this week’s website.

The WHS evaluated the benefits and risks of low-dose aspirin (100 mg on alternative days) for the prevention of heart attack, stroke and cardiovascular death among 39,876 initially healthy women age 45 and older who were followed for 10 years. The study demonstrated that aspirin significantly lowered the risk of stroke by 17% and the risk of ischemic stroke (caused by a clot in a cerebral artery which shuts off blood flow to a region of the brain) by 24% in these women. But aspirin DID NOT lower the risk of heart attack or cardiovascular death in healthy women under the age of 65. Moreover, aspirin increased bleeding risks. Gastrointestinal hemorrhage requiring transfusions were 40% more common with aspirin use and there was a 24% increase in the risk of hemorrhagic stroke. The study did show heart benefits for women, but only among those who were age 65 and older. Regular aspirin use was associated with a 26% reduction in the risk of major cardiovascular events, ischemic stroke (risk reduction, 30%) and heart attack (risk reduction, 34%).

These and other studies have definitely shown that aspirin prevents further adverse cardiac events in men and women who have coronary vascular disease, especially if they have had a heart attack. But for primary prevention of heart attack i.e. use of aspirin if you are heart healthy, the study we rely on indicates that women who are under 65 should not routinely take aspirin. Older women are likely to experience a net benefit from daily low dose aspirin unless they have bleeding or allergy contraindications. Most experts would recommended doses between 81-100 mg daily.

Bottom line: Do not routinely take aspirin if you are younger than 65 for coronary protection unless you have an elevated coronary risk, have been diagnosed with coronary artery disease, or have had a heart attack or ischemic stroke. Assess your risk with your physician…diabetes, a strong family history of heart disease, smoking, hypertension and obesity may all contribute to risk.

Last week, I had a somewhat animated discussion with an erudite friend who felt that science is so advanced that we don’t have to worry about resistant bacteria. I argued that we did. And although when it comes to bacterial attacks I really don’t want to be the one to say “I told you so”, an article in last week’s JAMA confirmed that I (and all of us) are right to be worried.

The article was titled “Report Reveals Scope of US Antibiotic Resistance Threat”. The author points out that although antibiotic resistance is well known to US clinicians, until now the true scope of the problem has been unclear and underestimated. A new report by the Centers for Disease Control and Prevention (CDC) provides clarity. They stated that more than 2 million people in the United States become infected every year with organisms that are resistant to antibiotics, and at least 23,000 die. They added that nearly 250,000 people acquire Clostridium difficile infections each year, a serious diarrheal illness that is not so much antibiotic resistant but rather is precipitated by antibiotic use.

The report listed at least eight different types of bacteria in the gut that have been found to be resistant to some or all of the most powerful antibiotics, as well as bacteria on the skin (Staphylococcus) and bacteria that inhabit the upper respiratory tract. The director of the CDC said in a recent press briefing that their report shows just the bare minimum and that they up to now that have only counted the infections that are resistant to antibiotics that occur in hospitals. They know however, that there are many more infections in nursing homes, dialysis units, long-term hospitals, assisted-living facilities and communities. The estimate is that hospital infections alone result in significant need for increased and prolonged care as well as loss of productivity and cost more than $50 billion a year! According to the FDA, more than 70% of the bacteria that cause hospital associated infections are now resistant to at least one type of antibiotic most commonly used to treat these infections.

One of the pathways that bacteria learn to become resistant is that genes jump from one organism to another. So, if one type of bacteria is resistant, it can teach others to have the same ability to shrug off antibiotic impact. Now that I’ve rung the bacteria alarm, I want to at least let you know that experts feel that we can try to do something about this. They have set a goal of at least preventing a worsening situation and perhaps improving the one that we currently have. They recommend developing and administering more immunizations, instituting infection prevention actions in healthcare settings, preparing and handling food more safely and being vigilant about hand washing. And to keep up with the natural process of antibiotic resistance that occurs as bacteria become resistant, researchers have to continue to develop new antibiotics. Despite this clear and present danger, the number of new FDA approved antibacterial drugs have been decreasing steadily since the 1980s. The federal government (which plays a very important role in our health) has passed “Generating Antibiotics Incentives Now Act” (GAIN) in 2012. It is (as usual) long and complicated but it essentially is trying to increase the commercial value of antibiotics by extending the length of time an approved drug is free from competition and simplifying the regulatory pathway for FDA approval of new antibiotics.

Perhaps one of the most important things we as physicians and you as patients need to realize is that antibiotics should be used appropriately and safely. Currently, up to half of antibiotic use in humans and much of antibiotic use in animals is absolutely unnecessary. So please remember this the next time you have a slight cough or sore throat and call your doctor to get an antibiotic prescription. There is a good chance that the antibiotic won’t help and moreover it can increase the chance of developing resistance to this and other “bugs” in your body and in the bodies of others.

Every once in a while you’ll see a “how awful” media story about a young woman who had a stroke or clot in her lungs that was ostensibly caused by oral contraceptive pills (OCPs). Lawyers are suing, OCP users are scared and I get lots of calls from concerned patients and parents. And then there are those ads that come on at night, often on non-network channels, that ask you to call a specific law firm if you have had “fill-in the blank” complications after taking Yaz or Yasmin or for that matter, any birth control pills. So although I have tried over the years to both reassure and address the pros and cons of birth-control pills to patients and concerned family members, unfounded and founded concerns remain. Hence I was delighted to see a new review in The Journal of Obstetrics and Gynecology titled ” Risk of Acute Thromboembolic Events With Oral Contraceptive Use”. The authors reviewed 6476 citations that reported on an association between exposure to oral contraception and outcomes of venous clots (thromboembolism), stroke and heart attack. They looked at every study’s design and quality as well the number of women who took OCPs and control women (who did not) and the number of years in which the women and controls were followed. In the end they found that 50 of the studies included the data that made them appropriate for their review.

Having given you ” the how they got to their conclusions”, I will skip the 7 dense pages of data and charts in the article… They found that there was a threefold increase in the odds of a venous thromboembolism diagnosis among current users of oral contraceptive pills compared to women who did not use OCPs. There was no evidence that the pills that had the progestin drosperinone ( found in Yaz, Yasmin and the generic equivalents) or other pills that had new second- generation progestins where associated with an increased risk of venous thromboembolism in many of the studies. Altogether, they did not find evidence for a difference in risk among the four types of progestins used in birth control pills. They also found a twofold increased risk of stroke from clot obstruction to cerebral vessels among current oral contraceptive pill users. But as they pointed out, the risk of a clot or stroke in pregnant and postpartum women is increased much more, threefold to eightfold that of non pregnant women. (In other words, a woman is far more likely to get a clot during pregnancy then she is using the pill to prevent pregnancy.) Additionally, there was no increase in heart attacks in women who took the pill when compared to women who did not.

The issue of whether OCPs that contain 20 ug of ethinyl estradiol or less (very low-dose pills) versus those that contain 35 ug (low dose pills) was not resolved because many of the studies did not distinguish between these two doses of birth control pills. The authors also pointed out that women who were high risk for clot formation because of heredity, obesity, previous clots or cardiovascular problems were less likely to get prescriptions for OCPs and hence the complication stats could be skewed.

So now when I’m asked, I can say yes, there is a slight increase in risk of clots with birth control pills but that risk of this complication is far greater during pregnancy. And I also want to remind women that birth control pills can regulate cycles, decrease cramps and heavy menstrual bleeding, treat acne, help overcome hormonal changes, reduce the risk of endometrial and ovarian cancer and of course prevent unwanted pregnancy. (But I should now add that there are other forms of contraception that are highly effective and for certain patients may be more appropriate, this is not an ad paid for by Ortho!)

The choice of OCP brand, amount of estrogen or type of progestin depends on a woman’s symptoms, side effects from previous use and her physician’s prescribing habits. This new analysis of multiple studies has shown that there is no difference between OCP types with regards to risk of thromboembolism. I hope the malpractice attorneys pay heed.

We’ve all been hearing more and more about HPV infections; that they cause cervical cancer, vaginal cancer, anal cancer, throat cancer, mouth cancer and venereal warts. I’ve written several articles about the need to immunize girls and boys with the HPV vaccine. The most common vaccine, Gardasil is given in 3 doses, it is a quadravalent vaccine, which means it gives immunity to 4 types of HPV (6,11,16 and 18). These are the ones that cause 70% of cervical cancers, many of the other above mentioned cancers as well as venereal warts. But alas, despite the multiple direct to consumer ads in the media, recommendations by most doctors and the studies in peer-reviewed journals, only one third of adolescents are currently being immunized.

We would certainly expect the prevalence of these infections to be significantly diminished in those whose parents had the clinical acumen to have their children immunized. But they represent just 30% of their peers. So it was pleasantly surprising to find that a study published online in the Journal of Infectious Diseases reported that the prevalence of infections with the human papilloma virus types included in the Gardasil vaccine dropped by almost 60% among females aged 14 to 19 years during the four-year period after the vaccine became available and was recommended. Dr. Thomas Frieden, the CDC director, said during a press conference held to announce the results of the study, that increasing the vaccination rate to 80% would prevent about 50,000 cases of cervical cancer among girls alive today. “We owe it to the next generation- our sisters, our daughters, our nieces and to protect them against cervical cancer.”

Just to remind you, a three dose series of the quarivalent HPV vaccine was recommended in 2006 by the CDC as a routine vaccination for females age 11 to 12 years and for females aged 13 to 26 years who had not been previously vaccinated. In 2011, the recommendation for the vaccine was expanded to include boys aged 11 and 12 years and for non vaccinated males up to 26 years. No data is yet available on the proportion of males who have been vaccinated and/or the impact of vaccination on their infection rates.

The nearly 60% drop in HPV infection is greater than expected but can be due to “herd immunity” from vaccination (nothing to do with animals, it means that those who got the vaccination were unable to infect those who did not).

Remember, HPV is the most common STD in United States. The estimate is that 14 million people becoming infected with HPV every year. According to the CDC, 79 million of the those who have become infected with HPV are in their late teens and early 20s. Every year, about 19,000 cancers in women are caused by HPV; most are cervical cancer. And of 8,000 cancers caused by HPV that occur in men in the United States, most of them are oropharyngeal (mouth and throat).

Wow, this vaccine can make a huge difference. It may be too late for many of us who are over the age of 26 but we certainly can make sure that the younger (and youngest) generation are vaccinated… Not to do so is malparenting!

I know this is the Fourth of July weekend and many of my patients and readers will be busy with family, barbecues and hopefully celebrating the independence of the fabulous country we live in. (And, of course, there are those wonderful sales!). But if you happen to be glancing at this website, I want to take this opportunity to indulge in a modicum of self-congratulation; a committee opinion from the American College of Obstetricians and Gynecologists was just released and it supports what I’ve been telling my patients for years; that hormone therapy does not increase coronary heart disease risk for healthy women who have recently become menopausal. What also makes this committee opinion novel is that it states that if a woman’s quality of life is diminished by menopausal symptoms past the age of 65, extended therapy may be considered. Let me repeat: The American College of Obstetricians and Gynecologists now recommends against routine discontinuation of systemic estrogen at age 65 for women who need HT to manage their vasomotor symptoms (hot flashes and night sweats).

So that’s the summary. And you can go back to your holiday celebrations. But if you want to read further here are some of the studies and facts that the committee used in its announcement:

Much of the controversy about the impact of hormone therapy (HT) on cardiovascular disease came out of the Women’ Health Initiative (WHI) and the Heart and Estrogen/progestin Study (HERS) which seemed to show an increase in heart attack and stroke in women who took hormone therapy. But more recent studies have cast doubt on some of the methodologies used. Many of the women who were in the those two studies were over the age of 63 when they started hormone therapy and already had underlying coronary heart disease, hence they had an underlying increased risk for developing heart attack and stroke, which perhaps was augmented by hormone therapy. But newer studies indicate that when hormone therapy is started at a younger age, in women aged 50 to 59, the opposite occurs. An important study used CT scans to examine the distribution of calcification (plaque) in the coronary arteries in 1064 women who were in that 50 to 59 year range. Those who took estrogen had calcium scores that were lower than women who took a placebo, moreover, those who stayed on estrogen for more than five years had a significant reduction of 40% in their calcification scores.

The committee also looked at other variables of hormone therapy that could affect cardiovascular disease. They stated that synthetic medroxyprogesterone acetate (Provera) causes constriction of blood vessels whereas natural progesterone causes the vessels to relax and therefore may have a positive effect on blood pressure. In addition, unlike synthetic progestins, natural progesterone causes little or no reduction in high density lipoprotein. (Remember, high density lipoprotein is the good cholesterol and works like a rotor router to protect vessels from plaque formation). The committee doesn’t go so far as to state that ET or HT improve cardiovascular outcomes, they simply state that the evidence is as yet insufficient. But they do say that recent evidence suggests that women in early menopause who are in good cardiovascular health are at low risk of adverse cardiovascular outcomes and should be considered candidates for estrogen therapy or combined estrogen and progesterone therapy for relief of their menopausal symptoms. And women over 65 should talk to their doctor. If their symptoms are persistent, it’s OK to consider continuing their hormone therapy.

My final summation: If you develop symptoms that make you miserable – start hormone therapy in the early years of menopause, there is no increased risk of CHD if you are healthy… and continuation beyond age 65 may be an appropriate option if your quality of life is significantly reduced by these symptoms. We still have to discuss risk- benefits (most specifically breast cancer risk…) There is no free lunch or hormone!

As women transition from their regular periods and reproductive stage of life to irregular periods, followed by their absence and menopause, we are likely to experience symptoms such as hot flashes and night sweats. And they are expected… But what we don’t expect is a decrease in our mental abilities or fine motor skills. (As I type this in my iPad, I am watching my fingers to see if they are doing the walking with diminished dexterity!). So I was somewhat alarmed by a recent article in the medical journal Menopause, which of course has a bright red cover. The authors come from the department of neurology at the University of Rochester and the department of psychiatry at The University of Illinois at Chicago. They followed 117 women between the ages of 40 and 60. The women were classified in 4 groups according to their menstrual histories:

  • Late reproductive stage; having subtle changes in menstrual flow, cycle length or both (34 women)
  • Early menopausal transition; persistent cycle irregularity, defined as a difference of 7 days or more at least twice during the previous 10 cycles (28 women).
  • Late menopausal stage; no period for 60 days or longer (41 women).
  • Early postmenopausal stage; the first 12 months after the final menstrual period. (This final menses is also given its own important initials… FMP. I do have to laugh at the acronyms we use in order to sound medical, by the way there were only 14 women in this group… Where have all the postmenopausal women gone?)

These women underwent a battery of psychophysiologic tests that assessed their working memory, verbal fluency, fine motor skills, visual spacial skills, and memory. They all answered questionnaires to help determine their degrees of depression, anxiety (and taking all these tests may have increased the latter), overall health and their menopausal symptoms (specifically hot flashes and sleep disturbances). The researchers then measures the blood levels of estrogen (estradiol) and FSH (Remember FSH is the hormone that is secreted by the pituitary to get the follicles in ovaries to develop and produce estrogen. If there is little or no estrogen, the pituitary works harder and puts out more FSH. The latter will always be high once we run out of follicles and can’t produce estrogen, i.e. menopause has occurred.)

Without going into excruciating detail, what the authors were trying to investigate is whether there was a direct correlation between levels of estradiol, FSH, depression, anxiety, hot flashes and sleep disturbances and cognitive function and whether this function got worse as women progressed through the stages of perimenopausal to menopause.

The results were as follows: Women in the first year of postmenopausal performed significantly worse than women in the late reproductive and late menopause transition on measures of verbal learning, verbal memory and motor function. And depression, anxiety, sleep disturbances as well as hot flashes did not predict cognitive performance.

Okay, this is all rather complicated, so let me come to the conclusion: according to this somewhat small study (and larger ones have not have been as thorough), cognitive function may vary across the menopausal transition, with early postmenopausal being a critical period during which subtle declines in attention/working memory, verbal learning, verbal memory, and fine motor speed and dexterity may occur. The authors (all women) postulated that this may be due to the fluctuating hormones during this transition rather than the total loss of estrogen production that will occur later.

Having brought your attention to this article, I would like to point out that women who were AFTER that first year of absent periods were not tested…they may have reestablished their cognitive ability. (I hope so, otherwise I and most of my friends are in trouble). And just one more comment.. women who took hormone therapy were not allowed in the study. It’s possible that the results would have been different had they been tested. Just a hormonal thought!

I have obsessively discussed the positive health aspects of the various forms of contraception in my newsletters over the past few years. (Clearly a part of my Planned Parenthood background!) I have also proclaimed gender health success when the Affordable Care Act (ACA) stated that after August 1, 2012, preventive health services recommended by the Institute of Medicine and endorsed by the Department of Health and Human Services would be covered by insurance companies. These services are meant to promote the development of a health system that sustains health rather than merely treats illness. The services include all FDA approved forms of contraception, the morning after pill as well as sterilization procedures. And women will now be afforded health mandated services for cervical cancer screening, screening for sexually transmitted infections, mammograms and maternity care. But as we all know, some religious organizations and private employers have demanded exemptions from providing contraception stating that this violates their religious beliefs. Many of us have been outraged. Our umbrage was beautifully voiced in a “viewpoint” article published in the May 15th Journal of JAMA. Three physicians from the Northwestern University Feinberg School of Medicine in Chicago, Illinois contributed to the article and I would like to share their arguments with you.

We all know that Bacchus was a man. Based on gender stereotypes, most of us assume that women are less likely to excessively imbibe alcohol then men. (For the sake of transparency, the Superbowl was playing while I wrote this and all that celebrated testosterone caused me to make that last statement). But not necessarily so… According to a recent CDC report in “Vital Signs,” more than 14 million US women binge drink about three times a month and consume an average of six drinks per binge. This number includes one in eight women and one in five high school girls! The report states that binge drinking is most common in young women, women who are white or Hispanic, and among women with household incomes of $75,000 or more. Oh…and half of all high school girls who drink alcohol report binge drinking.

A woman’s ability to metabolize alcohol differs significantly from that of a man. When we drink alcohol it is absorbed more quickly, deactivated by enzymes less efficiently, and gets to the brain faster. (Well, we always knew that our brains have rapid and superior circulation. ) We generally weigh less than men so we are also less likely to dilute the stuff. As a result, one drink for a women has the impact of two for a man.

The definition of binge drinking for a woman is consumption of four or more alcohol drinks on an occasion. And an occasion is considered to be 2 to 3 hours. Although binge drinking in high school or college can lead to a higher incidence of alcoholism in later life, most binge drinkers are non-alcoholics and not alcohol dependent. The CDC reports that drinking too much (which of course includes binge drinking) results in about 23,000 deaths in women and girls each year and increases the chances of breast cancer, heart disease, sexually-transmitted diseases, unintended pregnancy as well as other health problems. If a woman binge drinks while pregnant, she risks exposing her baby to high levels of alcohol during its development which can lead to miscarriage, low birth weight, sudden infant death syndrome (SIDS), attention deficit/hyperactivity disorder (ADHD), and fetal alcohol syndrome (facial disfigurement and mental deficiencies). This is where I’m supposed to say it’s not safe to drink alcohol any time during pregnancy.

Aside from giving warnings, the CDC and its Guide to Community Preventive Services recommend certain strategies for preventing excessive alcohol consumption.. These include:  

*Increasing alcohol taxes.

*Reducing the number and concentration of stores that sell alcohol in a given area.

*Continuing government controls over alcohol sales.

*Maintaining or reducing the days and hours of alcohol sales.

*Enhanced enforcement of laws prohibiting sales to minors.

*Electronic screening and counseling for excessive alcohol use.

I know some of this sounds excessive and may go against our sense of what the government should and should not do. (There are no blue laws in California, and according to that wonderful series Boardwalk Empire, prohibition doesn’t work!) To help avoid teenage binging, the best plan might be to make sure that our teens can’t get into our liquor closet and of course, maintain zero tolerance for alcohol use before, during and after school parties. And then we should listen to the anti-binge advice ourselves. Remember abstaining from that second and certainly the third drink may lessen our risk for breast cancer, heart disease, stupid behavior, and worse yet, the wrong sexual and reproductive decisions. We just don’t need that extra glass of wine, cocktail or beer to enjoy the game, the dinner or the party. The salute ” Le Chaim” (translated, for those of you who need it) to “To Life” need not be accompanied by 4 drinks…one is healthier and should suffice.

A quick personal note: I am traveling to Mozambique next week with several women to see the school we built through the LA Associates of Save the Children. I will be happy to share pictures and stories upon my return.

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The CDC, most medical journals, and mainstream media have been covering the disastrous infections caused by the contamination of the steroid that was distributed by a compounding pharmacy in New England. Three potentially contaminated lots of this steroid were used by physicians in epidurals, and joint injections in over 14,000 persons. They have, so far, caused stroke, meningitis, bone infections and in some instances death, in over 137 patients.

The initial detection of this serious contamination reads like a detective story. On September 18, 2012 the Tennessee Department of Health was alerted by an observant physician that a patient had a confirmed fungal infection (to be exact, Aspergillus fumigatus) diagnosed 46 days after epidural steroid injection. By September 27, an investigation carried out by the Tennessee Department, in collaboration with the CDC and the North Carolina Department of Health, had identified 8 more cases. All nine patients had received epidural steroid injections with preservative free methyl prednisone acetate solution (MPA) compounded at the New England Compounding in Framingham, Massachusetts. And as of October 10 (when last reported in JAMA) a multistage investigation by the CDC together with local health departments and the FDA have identified 137 cases and 12 deaths associated with this outbreak in 10 states. The invoices from the pharmacy showed that approximately 17,500 vials of MPA were distributed to 75 facilities in 23 states!  By October 6, the vials not already used were recalled. And as of October 10, health departments reported that 90% of patients exposed to the medication from one of the suspected infected lots of MPA had been contacted at least once.

The patients and their doctors have been advised that they should get tested if they develop neurological symptoms such as headache, neck rigidity, fever, nausea, unsteady gait or sensitivity to light…and if so a lumbar puncture should be done to check for the fungal infection. Those patients that had joint injections should notify their physician if they develop increasing pain, redness or swelling, in which case fluid should be aspirated from the affected joint for culture. This all sounds ominous and in fact it is! Right now it’s postulated that the incubation periods for infection range from 4 to 42 days, but the maximum incubation for this infection is not known. Treatment with high dose anti-fungal therapy for months may be necessary.

If anyone doubts the importance of the epidemiological sleuthing carried out by our health departments and the CDC…this should dissuade them. And additionally, there is the issue as to whether products from compounding pharmacies are indeed safe. In an article published on December 6 in The New England Journal of Medicine, the authors summarized the evidence for compounding safety…. First, they explain what these pharmacies do: “Pharmaceutical compounding refers to the combining, mixing, or altering of ingredients of a drug by a licensed pharmacist to produce a drug that is tailored to an individual patient’s medical needs on the basis of a valid prescription from a licensed medical practitioner.” They go on to state that ” there are few reliable data on the prevalence of compounding, but it has been estimated that 0.25% to more than 2% of dispensed  prescriptions in the United States are compounded drugs. Under certain conditions, compounding may serve an important public health benefit by providing access to the needs of individual patients when a commercially available product is unavailable; however, compounded drugs are not approved by the FDA and should not be confused with generic drugs all of which must be approved by the FDA before marketing. Compounded drugs are not reviewed and approved by the FDA; therefore, their safety, efficacy, quality and conformance with federal manufacturing standards have not been established…. The regulatory authority of the FDA over compounding pharmacies is different and more limited than is its authority over pharmaceutical manufacturers.”

 

Bottom line: Thank you to the FDA and CDC. Even though regulations can be burdensome and costly they are worth it; they protect the purity and sterility of our medications. And if I do prescribe a compounded medication, I tell the patient and request that she fill the prescription in a closely monitored pharmacy.

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