Grand Challenges: Integrating Mental Health Care into the Non-Communicable Disease Agenda

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Citation: Ngo VK, Rubinstein A, Ganju V, Kanellis P, Loza N, et al. (2013) Grand Challenges: Integrating Mental Health Care into the Non-Communicable Disease Agenda. PLoS Med 10(5): e1001443. doi:10.1371/journal.pmed.1001443
Published: May 14, 2013

Summary Points

• Non-communicable chronic diseases (NCD) and mental disorders each constitute a large portion of the worldwide health care burden, and they often occur together.
• Collaborative care models, where NCD care and mental health care are integrated and provided in the primary care setting, are effective for patients, strengthen health care service systems, and reduce costs.
• Using lay health workers to supplement the services provided by mental health specialists, physicians, and nurses can extend services to more patients, but raises challenges related to training and coordination.
• Implementation of collaborative care models and scale up of successful models will be enhanced by tapping local knowledge of social, political, cultural, and health system nuances.
• Collaborative care approaches that integrate services for NCD and mental health conditions require investments in human resources, services, and additional research.
• This is the third in a series of five articles providing a global perspective on integrating mental health.

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Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillator

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component

Affected Models include:

• Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E
• CardioVive 92532, 92533
• CardioLife 9200G and 9231
• GE Responder and Responder Pro
• Nihon-Kohden AEDs 

AUDIENCE: Emergency Medicine, Cardiology, Risk Manager

ISSUE: FDA notified healthcare professionals and medical care organizations of the Class 1 recall of the listed AEDs which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy, causing serious adverse health consequences, including death. The unit’s self test may not detect the failure or impending failure of the component.

BACKGROUND: These products are used for emergency treatment of victims showing symptoms of sudden cardiac arrest who are unresponsive and not breathing. These AEDs were manufactured and distributed from July 1, 2011 through December 30, 2011.

RECOMMENDATION: Affected customers are advised to contact the firm to arrange for delivery of shipping materials for an immediate return of their AEDs for repair. The affected devices will receive a hardware correction, and the same serial number device will be returned to the customer in most cases.

Read the MedWatch safety alert, including links to the Recal Notice and Letter, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm294538.htm

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Call to action on selling sickness: final statement

 Source: Call to action on selling sickness
 
The Selling Sickness conference of February, 2013 was designed to be part of a global progressive and activist health movement. A CALL TO ACTION statement can help unify professionals, researchers, activists, scholars, caregivers, advocates and all citizens alarmed by disease-mongering.
The statement below was shaped by many contributors and discussed at “Selling Sickness, 2013: People before Profits” in Washington, DC, In February, 2013.

CALL TO ACTION ON SELLING SICKNESS

Washington, DC

We come together as researchers, health care professionals, activists, advocates, patients, caregivers and citizens deeply troubled about the growing corruption of medical science and health care.
We demand an end to industry-promoted disease-mongering that manipulates health concerns and causes harm through practices that medicalise normal life and deceive professionals and the public.
Commercial imperatives are being allowed to corrupt clinical, research and marketing practices which now include hiding data, inflating diagnostic categories, unnecessary screening and treatment, deceptive marketing, faulty and biased research and publishing, inadequate oversight, a neglect of social factors and injustices, and uncritical, unbalanced reporting.
We are alarmed at how undergraduate and post-graduate professional education are based on untrustworthy “science” designed to expand markets rather than impart valid knowledge or improve individual or public health.
Hazardous practices and distorted science harm patients, waste public resources, create illness and health anxiety, hoodwink the public, corrupt knowledge, corrode professionalism, and expose everyone to unnecessary, costly and dangerous tests and treatments.
Recognizing that we all will enact this commitment differently, we pledge our support to a new movement of alliances and actions to ensure that:

• a clear firewall is created between industry/commercial influence, on the one hand, and, on the other, the regulators of drugs and devices as well as the developers and authors of clinical practice guidelines;
• direct-to-consumer advertising of prescription drugs and medical devices is much more tightly regulated or, if possible, is prohibited and effective surveillance programs created;
• drugs, diagnostic tests, and devices are tested, approved, reported and marketed solely with the goal of ensuring patient safety, scientific integrity and individual and public health;
• drugs and devices are tested against appropriate controls, usually the current best treatment, in appropriate populations;
• unsafe or ineffective marketed products are quickly identified, their harms and inadequacies are widely publicized, and they are removed from use;
• all clinical trials are registered and access to all raw clinical trial data is made available for independent analyses at least at the time of approval, but preferably before approval;
• the patent system for medicines is reformed so commercial benefit does not overshadow real clinical benefits for patients;
• patients and health care consumers are fully informed about and involved in individual health decisions, as well as in research priorities, research design, and regulatory policy;
• human subjects participating in clinical trials are adequately protected by ethical review boards that are functioning properly, accurate and complete informed consent, and the provision of full compensation for any harms;
• journalists, whose job it must be to independently vet claims made by third parties, realize the harm that is done when news stories disseminate disease-mongering sales and promotion messages in an unchallenged, unverified manner;
• health care regulations, health professional training, and clinical practice guidelines acknowledge and make allowance for marginalized and vulnerable groups who may be more susceptible to harms and exploitation;
• the usually less profitable non-pharmaceutical treatments and therapies, as well as disease prevention and community-centered interventions, are raised in research and publishing priority to levels comparable to drug and device therapies.

These reforms will substantially improve public health and safety in a complex world of escalating technologies and communications media, and will save money, thereby lessening pressure on individual and public budgets and private health insurance programs.
We believe the urgent threat to human health from disease-mongering requires the united and creative action of citizens and professionals.
We pledge ourselves to act, individually and collectively, to distribute and to implement the measures outlined in this statement and encourage continuing outreach to interested others.

PLEASE SIGN THE STATEMENT TO INDICATE YOUR ENDORSEMENT. 

JOIN OUR GLOBAL MOVEMENT!

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The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

AUDIENCE: Pharmacy, Healthcare Professionals, Patients
ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.
BACKGROUND:  The FDA is basing this warning on a recent inspection of The Compounding Shop. The investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop’s sterile drug products.
RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products. Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.

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Safety Patients : Reumofan

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Reumofan Plus: Recall - Undeclared Drug Ingredient AUDIENCE: Consumer, Health Professional, Emergency Medicine ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. An FDA laboratory analysis of Reumofan Plus found that it contains Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery. The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant. FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product. RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.

La FDA emite una nueva advertencia de seguridad sobre Reumofan Plus y Reumofan Plus Premium

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA en inglés) emitió hoy una nueva advertencia a los consumidores sobre los posibles riesgos de dos productos etiquetados como complementos alimentarios naturales para tratar la artritis, el dolor muscular, la osteoporosis, el cáncer de los huesos y otras afecciones. Los productos, Reumofan Plus y Reumofan Plus Premium, contienen varios ingredientes farmacéuticos activos potencialmente peligrosos que no están indicados en las etiquetas de los productos.
La FDA ha recibido docenas de reportes de eventos adversos, incluyendo muerte y derrames cerebrales asociados con el uso de Reumofan Plus desde que la agencia emitió su primera advertencia sobre el producto el 1 de junio de 2012. Otros reportes incluyen daños al hígado, sangrado grave, empeoramiento repentino del control de la glucosa (azúcar), aumento de peso, hinchazón, calambres en las piernas y síndrome de abstinencia de los corticosteroides, así como supresión adrenal.
Los consumidores que estén tomando estos productos o que hayan dejado recientemente de tomar Reumofan Plus o Reumofan Plus Premium deben consultar inmediatamente a un profesional del cuidado de la salud. Los consumidores no deben comprar ni comenzar a usar estos productos.
Los análisis de laboratorios continuos de la FDA de Reumofan Plus han encontrado que este producto contiene ingredientes que se usan en medicamentos recetados:
dexametasona – un corticosteroide, usado comúnmente para tratar las afecciones inflamatorias, que pueden afectar la capacidad natural del cuerpo para combatir infecciones y causar niveles altos de azúcar en la sangre, lesiones de los huesos y músculos y problemas psiquiátricos. La dexametasona también puede causar supresión adrenal cuando se toma durante un período de tiempo prolongado o en dosis altas. La descontinuación repentinamente de los corticosteroides después de haber sido usados por un largo período de tiempo o en altas dosis puede resultar en el síndrome de abstinencia de los corticosteroides que incluye cansancio, náuseas, presión arterial baja, niveles bajos de azúcar en la sangre, fiebre, mareos y dolor muscular y en las coyunturas.
diclofenaco de sodio - un medicamento antiinflamatorio no esteroide (NSAID, por su sigla en inglés) que puede causar un riesgo mayor de eventos cardiovasculares, tales como ataques al corazón y derrames cerebrales, así como complicaciones gastrointestinales graves adversas que incluyen sangrado, ulceración y perforación fatal del estómago y los intestinos.
metocarbamol - un relajante muscular que puede causar adormecimiento, mareos, baja presión arterial y afectar las habilidades mentales o físicas para realizar actividades, tales como conducir un automóvil u operar maquinaria.
Un análisis aparte de laboratorio de la FDA del Reumofan Plus Premium encontró que contiene dos de los ingredientes indicados arriba, diclofenaco de sodio y metocarbamol.
Reumofan Plus y Reumofan Plus Premium están etiquetados en español. Sin embargo, también pudieran existir versiones de estos productos con etiquetas en inglés.
Los productos son fabricados en México por Riger Naturals y se venden en los EE.UU. en algunas tiendas, mercados de pulgas y en varios sitios Web populares.
Los ingredientes ocultos de la droga Reumofan Plus y Reumofan Plus Premium pueden causar reacciones adversas graves al ser combinados con otros medicamentos. Se les exhorta a los profesionales del cuidado de la salud a que les pregunten a sus pacientes sobre el uso del Reumofan Plus, Reumofan Plus Premium y otros productos similares etiquetados como complementos alimentarios naturales cuando los pacientes presentan síntomas sin explicación que indican toxicidad con un medicamento antiinflamatorio no esteroide o NSAID, cambios psiquiátricos o el uso o descontinuación abrupta de los corticosteroides.

 

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