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Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults
Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults
Source: Morbidity and Mortality Weekly Report (CDC)
In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009 (1). Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men (MSM), including 3% in MSM who inject drugs. In January 2011, following publication of evidence of safety and efficacy of daily oral tenofovir disoproxil fumarate 300 mg (TDF)/emtricitabine 200 mg (FTC) (Truvada, Gilead Sciences) as antiretroviral preexposure prophylaxis (PrEP) to reduce the risk for HIV acquisition among MSM in the iPrEx trial, CDC issued interim guidance to make available information and important initial cautions on the use of PrEP in this population. Those recommendations remain valid for MSM, including MSM who also have sex with women (2). Since January 2011, data from studies of PrEP among heterosexual men and women have become available, and on July 16, 2012, the Food and Drug Administration (FDA) approved a label indication for reduction of risk for sexual acquisition of HIV infection among adults, including both heterosexuals and MSM.* This interim guidance includes consideration of the new information and addresses pregnancy and safety issues for heterosexually active adults at very high risk for sexual HIV acquisition that were not discussed in the previous interim guidance for the use of PrEP in MSM.
Update to CDC’s Sexually Transmitted Diseases Treatment Guidelines, 2010: Oral Cephalosporins No Longer a Recommended Treatment for Gonococcal Infections
Update to CDC’s Sexually Transmitted Diseases Treatment Guidelines, 2010: Oral Cephalosporins No Longer a Recommended Treatment for Gonococcal Infections
Source: Morbidity and Mortality Weekly Report (CDC)
Gonorrhea is a major cause of serious reproductive complications in women and can facilitate human immunodeficiency virus (HIV) transmission (1). Effective treatment is a cornerstone of U.S. gonorrhea control efforts, but treatment of gonorrhea has been complicated by the ability of Neisseria gonorrhoeae to develop antimicrobial resistance. This report, using data from CDC’s Gonococcal Isolate Surveillance Project (GISP), describes laboratory evidence of declining cefixime susceptibility among urethral N. gonorrhoeae isolates collected in the United States during 2006–2011 and updates CDC’s current recommendations for treatment of gonorrhea (2). Based on GISP data, CDC recommends combination therapy with ceftriaxone 250 mg intramuscularly and either azithromycin 1 g orally as a single dose or doxycycline 100 mg orally twice daily for 7 days as the most reliably effective treatment for uncomplicated gonorrhea. CDC no longer recommends cefixime at any dose as a first-line regimen for treatment of gonococcal infections. If cefixime is used as an alternative agent, then the patient should return in 1 week for a test-of-cure at the site of infection.
New From the GAO
New GAO Reports and Testimony
Source: Government Accountability Office
+ Reports
1. Influenza Pandemic: Agencies Report Progress in Plans to Protect Federal Workers but Oversight Could Be Improved. GAO-12-748, July 25.
http://www.gao.gov/products/GAO-12-748
Highlights – http://www.gao.gov/assets/600/592990.pdf
2. Medicare: CMS Needs an Approach and a Reliable Cost Estimate for Removing Social Security Numbers from Medicare Cards. GAO-12-831, August 1.
http://www.gao.gov/products/GAO-12-831
Highlights – http://www.gao.gov/assets/600/593216.pdf
3. Medicaid Expansion: States’ Implementation of the Patient Protection and Affordable Care Act. GAO-12-821, August 1.
http://www.gao.gov/products/GAO-12-821
4. Counter-Improvised Explosive Devices: Multiple DOD Organizations are Developing Numerous Initiatives. GAO-12-861R, August 1.
http://www.gao.gov/products/GAO-12-861R
5. Service-Disabled Veteran-Owned Small Business Program: Vulnerability to Fraud and Abuse Remains. GAO-12-697, August 1.
http://www.gao.gov/products/GAO-12-697
Highlights – http://www.gao.gov/assets/600/593237.pdf
6. Contingency Contracting: Agency Actions to Address Recommendations by the Commission on Wartime Contracting in Iraq and Afghanistan. GAO-12-854R, August 1.
http://www.gao.gov/products/GAO-12-854R
7. Ensuring Drug Quality in Global Health Programs. GAO-12-897R, August 1.
http://www.gao.gov/products/GAO-12-897R
+ Related Product
Survey on States’ Implementation of the Patient Protection and Affordable Care Act (GAO-12-944SP, August 2012), an E-supplement to GAO-12-821. GAO-12-944SP, August 1.
http://www.gao.gov/products/GAO-12-944SP
+ Testimony
1. Medicare: Action Needed to Remove Social Security Numbers from Medicare Cards, by Kathleen M. King, director, health care, and Daniel Bertoni, director, education, workforce, and income security issues, before the Subcommittees on Social Security and Health, House Committee on Ways and Means GAO-12-949T, August 1.
http://www.gao.gov/products/GAO-12-949T
Medicines for Treating Depression: A Review of the Research for Adults
Medicines for Treating Depression: A Review of the Research for Adults
Source: Agency for Healthcare Research and Quality
Antidepressants are only one kind of medicine used to treat depression. They are the most common medicine used for this condition. Your doctor may prescribe other types of medicines to treat depression. This summary will review only the research on antidepressants. It does not review research on non-medicine therapies. The research studies also did not look at patients with bipolar disorder, substance abuse, bulimia nervosa, or schizophrenia.
Trends in Anticonvulsants Utilization and Expenditures for the U.S. Civilian Noninstitutionalized Population, 1999 and 2009
Rising health care costs in general and prescribed medicine costs in particular continue to be a concern for U.S. policymakers and consumers of care. Analyzing down total prescription drug costs into therapeutic classes and subclasses provides decision makers and the public with an understanding of the costs and extent to which specific therapeutic classes and subclasses of drugs are contributing to the upturn in total costs. This Statistical Brief provides trends for one therapeutic subclass of prescribed drugs—anticonvulsants.This Brief presents trends in utilization and expenditures for outpatient prescription anticonvulsants for the years 1999 and 2009. The estimates are for the U.S. civilian noninstitutionalized population and are derived from the 1999 and 2009 Household Component of the Medical Expenditure Panel Survey (MEPS-HC). For outpatient prescription anticonvulsants, the Brief compares, for 1999 and 2009, the number of persons obtaining at least one prescription, total expenditures, and total number of prescriptions, as well as average annual cost per person and average drug cost.Only prescriptions purchased or obtained in an outpatient setting are included in these estimates. Prescription medicines administered in an inpatient setting or in a clinic or physician’s office are excluded. Expenditure estimates are presented in real dollars; estimates for 1999 were inflated to 2009 dollars based on the GDP Price Index (http://www.meps.ahrq.gov/mepsweb/about_meps/ Price_Index.shtml). All differences discussed in the text are statistically significant at the 0.05 level.
Medicare Could Be Paying Twice for Prescription Drugs for Beneficiaries in Hospice
Medicare Could Be Paying Twice for Prescription Drugs for Beneficiaries in Hospice
Source: U.S. Department of Health and Human Services, Office of Inspector General
During calendar year 2009, Medicare Part D paid for prescription analgesic, antinausea, laxative, and antianxiety drugs, as well as prescription drugs used to treat chronic obstructive pulmonary disease and amyotrophic lateral sclerosis, that likely should have been covered under the per diem payments made to hospice organizations. As a result, the Medicare program could be paying twice for prescription drugs for hospice beneficiaries: once under the Medicare Part A hospice per diem payments and again under Medicare Part D.
To be eligible for Medicare hospice care, a beneficiary must be entitled to Part A of Medicare and be certified as terminally ill (i.e., having a medical prognosis that life expectancy is 6 months or less if the disease runs its normal course). Under the Medicare Part D program, individuals entitled to benefits under Medicare Part A may obtain voluntary coverage for prescription drugs.
We recommended that CMS (1) educate sponsors, hospices, and pharmacies that it is inappropriate for Medicare Part D to pay for drugs related to hospice beneficiaries’ terminal illnesses; (2) perform oversight to ensure that Part D is not paying for drugs that Medicare has already covered under the per diem payments made to hospice organizations; and (3) require sponsors to develop controls that prevent Medicare Part D from paying for drugs that are already covered under the per diem payments. CMS concurred with our first and third recommendations but did not concur with our second recommendation.
Vital Signs: Risk for Overdose from Methadone Used for Pain Relief — United States, 1999–2010
Vital Signs: Risk for Overdose from Methadone Used for Pain Relief — United States, 1999–2010
Source: Morbidity and Mortality Weekly Report (CDC)
Background:
Vital statistics data suggest that the opioid pain reliever (OPR) methadone is involved in one third of OPR-related overdose deaths, but it accounts for only a few percent of OPR prescriptions.Methods:
CDC analyzed rates of fatal methadone overdoses and sales nationally during 1999–2010 and rates of overdose death for methadone compared with rates for other major opioids in 13 states for 2009.Results:
Methadone overdose deaths and sales rates in the United States peaked in 2007. In 2010, methadone accounted for between 4.5% and 18.5% of the opioids distributed by state. Methadone was involved in 31.4% of OPR deaths in the 13 states. It accounted for 39.8% of single-drug OPR deaths. The overdose death rate for methadone was significantly greater than that for other OPR for multidrug and single-drug deaths.Conclusions:
Methadone remains a drug that contributes disproportionately to the excessive number of opioid pain reliever overdoses and associated medical and societal costs.Implications for Public Health Practice:
Health-care providers who choose to prescribe methadone should have substantial experience with its use and follow consensus guidelines for appropriate opioid prescribing. Providers should use methadone as an analgesic only for conditions where benefit outweighs risk to patients and society. Methadone and other extended-release opioids should not be used for mild pain, acute pain, “breakthrough” pain, or on an as-needed basis. For chronic noncancer pain, methadone should not be considered a drug of first choice by prescribers or insurers.
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CRS — How FDA Approves Drugs and Regulates Their Safety and Effectiveness
How FDA Approves Drugs and Regulates Their Safety and Effectiveness (PDF)
Source: Congressional Research Service (via Federation of American Scientists)
The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers’ applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDA’s responsibilities regarding drug approval and regulation.
The progression to drug approval begins before FDA involvement. First, basic scientists work in the laboratory and with animals; second, a drug or biotechnology company develops a prototype drug. That company must seek and receive FDA approval, by way of an investigational new drug (IND) application, to test the product with human subjects. Those tests, called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in a new drug application (NDA). FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug’s proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug’s identify, strength, quality, and identity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and associated regulations detail the requirements at each step. FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, animal efficacy approval, fast track applications, and priority review.
Once a drug is on the U.S. market (following FDA approval of the NDA), FDA continues to address drug production, distribution, and use. Its activities, based on ensuring drug safety and effectiveness, address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, and directto-consumer advertising, all topics in which Congress has traditionally been interested.
FDA seeks to ensure product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs. FDA’s approval of an NDA includes the drug’s labeling; the agency may require changes once a drug is on the market based on new information. It also prohibits manufacturer promotion of uses that are not specified in the labeling. The FFDCA requires that manufacturers report to FDA adverse events related to its drugs; clinicians and other members of the public may report adverse events to FDA. The agency’s surveillance of drug-related problems, which had primarily focused on analyses of various adverse-event databases, is now expanding to more active uses of evolving computer technology and linking to other public and private information sources.
The FFDCA allows FDA to require a manufacturer to conduct postapproval studies of drugs. The law specifies when FDA must attach the requirement to the NDA approval and when FDA may issue the requirement after a drug is on the market. To manage exception risks of drugs, FDA may require patient or clinician guides and restrictions on distribution. The agency publicly disseminates information about drug safety and effectiveness; and regulates the industry promotion of products to clinicians and the public.
See also: FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective (PDF)
See also: FDA Regulation of Medical Devices (PDF)
See also: The FDA Medical Device User Fee Program (PDF)
New From the GAO
New GAO Reports
Source: Government Accountability Office
1. Prescription Drug Data: HHS Has Issued Health Privacy and Security Regulations but Needs to Improve Guidance and Oversight. GAO-12-605, June 22.
http://www.gao.gov/products/GAO-12-605
Highlights - http://www.gao.gov/assets/600/591808.pdf
2. Managing Critical Isotopes: DOE’s Isotope Program Needs Better Planning for Setting Prices and Managing Production Risks. GAO-12-591, May 23.
http://www.gao.gov/products/GAO-12-591
Highlights - http://www.gao.gov/assets/600/591064.pdf
Medicines as a Service: A New Commercial Model for Big Pharma in the Postblockbuster World
Medicines as a Service: A New Commercial Model for Big Pharma in the Postblockbuster World
Source: RAND Corporation
The past decade has not been kind to large pharmaceutical companies. Their share prices have been lagging the market after many years of outperforming it. Many had to undergo painful restructuring and workforce reductions because their traditional blockbuster model is becoming extinct. More and more top-selling drugs are being replaced by cheap generics, and developing new drugs is more difficult because fewer opportunities exist and more-costly research and development (R&D) productivity has declined. Although this diagnosis is not disputed, the best course of treatment is not clear. Companies have tried to stop the bleeding with the help of mergers and reorganizations and infused new blood by acquiring biotech companies or their innovative products or by diversifying into products other than prescription drugs. In this paper, the authors propose that the pharmaceutical industry can reconfigure its considerable resources to develop innovative and meaningful business models that are based on services that improve access and adherence to prescription drugs for chronic conditions. They argue that such innovation beyond drug development is consistent with the core capabilities of large pharmaceutical companies and has the potential to achieve profit levels similar to those of its traditional models. Their argument is based on the fact that, although effective medicines for most chronic conditions exist, access and adherence to medicines is far from what would be needed to achieve full treatment efficacy. Therefore, value can be created by getting and keeping more patients on their drugs, and innovative business models would allow pharmaceutical companies to capture that value.
Drugs of Last Resort? The Use of Polymyxins and Tigecycline at US Veterans Affairs Medical Centers, 2005–2010
Multidrug-resistant (MDR) and carbapenem-resistant (CR) Gram-negative pathogens are becoming increasingly prevalent around the globe. Polymyxins and tigecycline are among the few antibiotics available to treat infections with these bacteria but little is known about the frequency of their use. We therefore aimed to estimate the parenteral use of these two drugs in Veterans Affairs medical centers (VAMCs) and to describe the pathogens associated with their administration. For this purpose we retrospectively analyzed barcode medication administration data of parenteral administrations of polymyxins and tigecycline in 127 acute-care VAMCs between October 2005 and September 2010. Overall, polymyxin and tigecycline use were relatively low at 0.8 days of therapy (DOT)/1000 patient days (PD) and 1.6 DOT/1000PD, respectively. Use varied widely across facilities, but increased overall during the study period. Eight facilities accounted for three-quarters of all polymyxin use. The same statistic for tigecycline use was twenty-six VAMCs. There were 1,081 MDR or CR isolates during 747 hospitalizations associated with polymyxin use (1.4/hospitalization). For tigecycline these number were slightly lower: 671 MDR or CR isolates during 500 hospitalizations (1.3/hospitalization) (p = 0.06). An ecological correlation between the two antibiotics and combined CR and MDR Gram-negative isolates per 1000PD during the study period was also observed (Pearson’s correlation coefficient r = 0.55 polymyxin, r = 0.19 tigecycline). In summary, while polymyxin and tigecycline use is low in most VAMCs, there has been an increase over the study period. Polymyxin use in particular is associated with the presence of MDR Gram-negative pathogens and may be useful as a surveillance measure in the future.
Medicines to Help You: Depression
Lists the brands and generic names of various anti-depressants. Learn the side effects, who should not take them, and warning signs regarding harmful drug and food interactions.
Retail Pharmacies with Questionable Part D Billing
Retail Pharmacies with Questionable Part D Billing (PDF)
Source: U.S. Department of Health and Human Services, Office of Inspector General
WHY WE DID THIS STUDY
Under the Medicare Part D program, CMS contracts with private insurance companies, known as sponsors, to provide prescription drug coverage to beneficiaries who choose to enroll. In the 6 years since Part D began, OIG has issued several reports that found that Part D had limited safeguards in place.HOW WE DID THIS STUDY
We based this study on an analysis of prescription drug event records. Sponsors submit these records to CMS for each drug dispensed to beneficiaries enrolled in their plans. Each record contains information about the pharmacy, prescriber, beneficiary, and drug. We analyzed all of the records for drugs billed by retail pharmacies in 2009. We developed eight measures to describe Part D billing and to identify pharmacies with questionable billing.WHAT WE FOUND
Retail pharmacies each billed Part D an average of nearly $1 million for prescriptions in 2009. Over 2,600 of these pharmacies had questionable billing. These pharmacies had extremely high billing for at least one of the eight measures we developed. For example, many pharmacies billed extremely high dollar amounts or numbers of prescriptions per beneficiary or per prescriber. This could mean that a pharmacy is billing for drugs that are not medically necessary or were never provided to the beneficiary. Although some of this billing may be legitimate, pharmacies that bill for extremely high amounts warrant further scrutiny. The Miami, Los Angeles, and Detroit areas were the most likely to have pharmacies with questionable billing.WHAT WE RECOMMEND
Together, the findings of this report and prior OIG reports call for a strong response to improve Part D oversight. Therefore, we recommend that CMS: (1) strengthen the Medicare Drug Integrity Contractor’s monitoring of pharmacies and ability to identify pharmacies for further review, (2) provide additional guidance to sponsors on monitoring pharmacy billing, (3) require sponsors to refer potential fraud and abuse incidents that may warrant further investigation, (4) develop risk scores for pharmacies, (5) further strengthen its compliance plan audits, and (6) follow up on the pharmacies identified as having questionable billing. CMS concurred with four of the recommendations and partially concurred with the other two.
Postmenopausal osteoporosis management: A review of the evidence to inform the development of quality indicators
Postmenopausal osteoporosis management: A review of the evidence to inform the development of quality indicatorsSource: RAND Corporation
This report aims to inform the development of quality indicators for postmenopausal osteoporosis management through (a) assessing the evidence for screening and diagnosis of osteoporosis and related risk factors, and for prevention and treatment of osteoporosis and osteoporosis-related fractures; (b) describing current practice for managing postmenopausal osteoporosis in Europe; and (c) highlighting existing gaps in the evidence base and management practices in Europe. Analyses involved a comprehensive review of reviews regarding the screening and diagnosis of osteoporosis and related risk factors and the prevention and treatment of osteoporosis and osteoporosis-related fractures. While this identified a well developed evidence base on the effects of selected treatments on clinical outcomes of postmenopausal osteoporosis and associated fractures, and on the usefulness of selected simple risk factor assessment tools to identify postmenopausal women who would benefit from further diagnostic assessment, uncertainties remain regarding for example the optimal use of pharmacological interventions for preventive purposes and the effectiveness of population-based screening. We also carried out case study reviews of current practices for managing postmenopausal osteoporosis in England, France, Germany and Spain. We identify a need for the establishment of routine monitoring systems to enable better understanding of contemporary patterns and trends and identify care gaps in the management of postmenopausal osteoporosis and associated fractures. Such analyses are crucial to inform targeted strategies and policies to effectively address the burden of osteoporosis and associated fractures, which is sizable and set to increase across Europe. We set out considerations as a starting point for the further development of quality measures for postmenopausal osteoporosis in Europe.
Ethical and Scientific Issues in Studying the Safety of Approved Drugs
In any given month, an estimated 48 percent of Americans take at least one prescription drug. Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time, mainly because clinical trials conducted before approval may be too small or too short to detect all possible risks. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed.To help determine when it is appropriate to require a postmarketing study, which types of studies to require, how to best protect the rights and interests of patients who participate in research, and how to use research in making regulatory decisions, the FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM concludes that the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.
Documents Uncovered by Judicial Watch Raise Concerns About Use of Drug for Military Personnel
Documents Uncovered by Judicial Watch Raise Concerns About Use of Drug for Military Personnel
Source: Judicial Watch
Judicial Watch, the public interest group that that investigates and fights government corruption, announced today that it has uncovered documents from the Food and Drug Administration (FDA) detailing more than 2,000 episodes during the past 15 years in which people had serious adverse reactions caused by the anti-malaria drug, mefloquine hydrochloride, commonly known as Lariam®. Of 87 reported deaths associated with the drug, 39 were recorded as suicides and 12 were homicides.
The documents obtained by Judicial Watch pursuant to a March 26, 2012, request submitted to the FDA, include details from the agency’s Adverse Event Reporting System (AERS) identifying persons treated with mefloquine from November 4, 1997, through March 28, 2012, and the specific reported reactions to the drug. In addition to the reported deaths, reported reactions included hallucinations, panic attacks, depression, paranoia, anxiety, confusion, mental disorder, delusion, hemorrhaging, and numerous other serious disorders.
Long known for its severe neurological side effects, mefloquine was supposedly removed as the drug of choice in the treatment of malaria by the Department of Defense (DOD). In a September 2009 policy memorandum, the Defense Department stated that mefloquine was to be prescribed only in limited cases where other drugs, such as doxycycline and mallarone, were considered unlikely to be effective. Mefloquine was specifically prohibited in the treatment of patients with head injuries, and in particular, a TBI (traumatic brain injury). It is also contraindicated for patients with post-traumatic stress disorder.
Nonetheless, the documents obtained by Judicial Watch indicate clearly that mefloquine is still prescribed, even though its use has decreased since the September 2009 memorandum limiting its use was issued. In the field, medics apparently do not necessarily need to follow such policy recommendations by the U.S. Army and U.S. Central Command (CENTCOM).
What Every Clinician Should Know About Herb–Supplement–Drug Interactions
What Every Clinician Should Know About Herb–Supplement–Drug Interactions (PDF)
Source: Alternative and Complementary Therapies
Any items that a person takes orally on a supplemental basis–whether they be herbs, dietary supplements, other natural products, or functional foods such as energy drinks and nutritional bars–can interact with each other and with medications. We know that these interactions may have harmful or beneficial effects and can increase or potentiate lev- els of other therapeutics and/or decrease levels of other therapeutics. Dietary supplements can also interact with diagnostic test results and laboratory assays.
It is important to note that interactions caused by supplements can be hard to predict due to a lack of clinical research, compared to reactions caused by drugs, because many products are not standardized to specific ingredients or amounts, and herbal constituents may differ depending on what plant parts the constituents are derived from, for instance, petals, seeds, stems, roots, or leaves. Unlike a prescription drug, for which one can definitively draw the chemical structure graphically, measure it, weigh it, and see it under a microscope, this is more difficult when dealing with natural products.
We have all heard that “natural” does not equal “safe,” but this is really true. If something has a therapeutic action in a human body, this substance can also cause a reaction or an interaction. Supplements are not 100% receptor-specific to only have one effect and no other effects, and what might help one person might hurt another person, just like medications do.
But, remember that not all interactions are bad. Some interactions may be beneficial. An example is if one therapy in- creases the benefit of another or affects electrolyte levels or liver-function test results in a beneficial way. One therapeutic might interact with another in a good way in that it decreases a side-effect or allows a dose of another therapeutic to be lowered, and, therefore, a person experiences a lesser side-effect risk from both therapeutics. Also, a socioeconomic benefit may be, if one purchases or perhaps grows a natural ingredient in a garden, that might be more cost-effective than the alternatives. Purchasing without a prescription may keep insurance costs down over time.
I think it is critical that clinicians consider herbs and supplements as therapeutic options. But, whether we are trained about this in medical school or not, I feel that we have a professional responsibility to educate ourselves and our patients or consumers about the potential for various types of interactions.
See: Risks of Mixing Drugs and Herbal Supplements: What Doctors and Patients Need to Know (Science Daily)
Neonatal Abstinence Syndrome and Associated Health Care Expenditures
Neonatal Abstinence Syndrome and Associated Health Care Expenditures
Source: Journal of the American Medical Association
Context: Neonatal abstinence syndrome (NAS) is a postnatal drug withdrawal syndrome primarily caused by maternal opiate use. No national estimates are available for the incidence of maternal opiate use at the time of delivery or NAS.
Objectives: To determine the national incidence of NAS and antepartum maternal opiate use and to characterize trends in national health care expenditures associated with NAS between 2000 and 2009.
Design, Setting, and Patients: A retrospective, serial, cross-sectional analysis of a nationally representative sample of newborns with NAS. The Kids’ Inpatient Database (KID) was used to identify newborns with NAS by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code. The Nationwide Inpatient Sample (NIS) was used to identify mothers using diagnosis related groups for vaginal and cesarean deliveries. Clinical conditions were identified using ICD-9-CM diagnosis codes. NAS and maternal opiate use were described as an annual frequency per 1000 hospital births. Missing hospital charges (<5% of cases) were estimated using multiple imputation. Trends in health care utilization outcomes over time were evaluated using variance-weighted regression. All hospital charges were adjusted for inflation to 2009 US dollars.
Main Outcome Measures: Incidence of NAS and maternal opiate use, and related hospital charges.
Results: The separate years (2000, 2003, 2006, and 2009) of national discharge data included 2920 to 9674 unweighted discharges with NAS and 987 to 4563 unweighted discharges for mothers diagnosed with antepartum opiate use, within data sets including 784 191 to 1.1 million discharges for children (KID) and 816 554 to 879 910 discharges for all ages of delivering mothers (NIS). Between 2000 and 2009, the incidence of NAS among newborns increased from 1.20 (95% CI, 1.04-1.37) to 3.39 (95% CI, 3.12-3.67) per 1000 hospital births per year (P for trend < .001). Antepartum maternal opiate use also increased from 1.19 (95% CI, 1.01-1.35) to 5.63 (95% CI, 4.40-6.71) per 1000 hospital births per year (P for trend < .001). In 2009, newborns with NAS were more likely than all other hospital births to have low birthweight (19.1%; SE, 0.5%; vs 7.0%; SE, 0.2%), have respiratory complications (30.9%; SE, 0.7%; vs 8.9%; SE, 0.1%), and be covered by Medicaid (78.1%; SE, 0.8%; vs 45.5%; SE, 0.7%; all P < .001). Mean hospital charges for discharges with NAS increased from $39 400 (95% CI, $33 400-$45 400) in 2000 to $53 400 (95% CI, $49 000-$57 700) in 2009 (P for trend < .001). By 2009, 77.6% of charges for NAS were attributed to state Medicaid programs.
Conclusion: Between 2000 and 2009, a substantial increase in the incidence of NAS and maternal opiate use in the United States was observed, as well as hospital charges related to NAS.
See: About One Baby Born Each Hour Addicted to Opiate Drugs in U.S. (Science Daily)
Medicare Payments for Drugs Used To Treat Wet Age Related Macular Degeneration
WHY WE DID THIS STUDYWet age-related macular degeneration (AMD), a leading cause of vision loss in people aged 60 and older, affects millions of Americans. Lucentis is a Medicare Part B-covered drug approved by the Food and Drug Administration (FDA) for the treatment of wet AMD. Avastin is a Part B-covered drug approved by FDA for the treatment of various forms of cancer, but smaller doses of the drug are being used off-label to treat wet AMD. A dose of Avastin used to treat wet AMD costs a small fraction of the cost of a dose of Lucentis. CMS established a national Medicare payment amount for Lucentis; however, there is no national Medicare payment amount for Avastin when used to treat wet AMD in a physician’s-office setting. In 2010, combined Part B expenditures for Lucentis and Avastin totaled nearly $2 billion.HOW WE DID THIS STUDYUsing Medicare claims data, we selected 2 stratified random samples: 1 sample of 160 physicians who received Medicare payment for Lucentis and 1 sample of 160 physicians who received Medicare payment for Avastin. We sent electronic surveys asking physicians to provide the total dollar amount and quantity purchased of Lucentis and Avastin in the first quarter of 2010. We also asked physicians to describe the factors that they consider when choosing Avastin instead of Lucentis for the treatment of wet AMD. We compared physician acquisition costs to Medicare payment amounts obtained from CMS and Medicare contractors. Additionally, we analyzed Medicare contractor payment policies and the reasons physicians reported for administering Avastin instead of Lucentis.WHAT WE FOUNDIn the first quarter of 2010, physician acquisition costs for Lucentis and Avastin were 5 and 53 percent below the Medicare payment amount, respectively. Medicare contractors’ payment amounts for Avastin when used to treat wet AMD differed by as much as 28 percent, although payment policies were similar. Additionally, we found that the majority of physicians who administered Avastin to treat wet AMD reported the substantial cost difference compared to Lucentis as a primary factor in their decision.WHAT WE RECOMMENDWe recommend that CMS:
(1) Establish a national payment code for Avastin when used for the treatment of wet AMD and(2) Educate providers about the clinical and payment issues related to Lucentis and Avastin.
CMS did not concur with our first recommendation at this time but did concur with our second recommendation.
Primum non nocere: an evolutionary analysis of whether antidepressants do more harm than good
Antidepressant medications are the first-line treatment for people meeting current diagnostic criteria for major depressive disorder. Most antidepressants are designed to perturb the mechanisms that regulate the neurotransmitter serotonin – an evolutionarily ancient biochemical found in plants, animals, and fungi. Many adaptive processes evolved to be regulated by serotonin, including emotion, development, neuronal growth and death, platelet activation and the clotting process, attention, electrolyte balance, and reproduction. It is a principle of evolutionary medicine that the disruption of evolved adaptations will degrade biological functioning. Because serotonin regulates many adaptive processes, antidepressants could have many adverse health effects. For instance, while antidepressants are modestly effective in reducing depressive symptoms, they increase the brain’s susceptibility to future episodes after they have been discontinued. Contrary to a widely held belief in psychiatry, studies that purport to show that antidepressants promote neurogenesis are flawed because they all use a method that cannot, by itself, distinguish between neurogenesis and neuronal death. In fact, antidepressants cause neuronal damage and mature neurons to revert to an immature state, both of which may explain why antidepressants also cause neurons to undergo apoptosis (programmed death). Antidepressants can also cause developmental problems, they have adverse effects on sexual and romantic life, and they increase the risk of hyponatremia (low sodium in the blood plasma), bleeding, stroke, and death in the elderly. Our review supports the conclusion that antidepressants generally do more harm than good by disrupting a number of adaptive processes regulated by serotonin. However, there may be specific conditions for which their use is warranted (e.g., cancer, recovery from stroke). We conclude that altered informed consent practices and greater caution in the prescription of antidepressants are warranted.
See: Evidence shows that anti-depressants likely do more harm than good, researchers find (EurekAlert!)
