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Helpful MCN Healthcare Resources
The US Food and Drug Administration (FDA) has issued a drug safety communication about Methylphenidate ADHD Medications including Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. Methylphenidate products are central nervous system (CNS) stimulants used to treat attention deficit hyperactivity disorder (ADHD).
Based on a recent review of methylphenidate products, the FDA has updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. If not treated right away, priapism can lead to permanent damage to the penis. Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection. Another ADHD drug, Strattera (atomoxetine), has also been associated with priapism in children, teens, and adults.
Priapism appears to be more common in patients taking atomoxetine than in those taking methylphenidate products; however, because of limitations in available information, FDA does not know how often priapism occurs in patients taking either type of product.
Healthcare professionals should talk to male patients and their caregivers to make sure they know the signs and symptoms of priapism and stress the need for immediate medical treatment should it occur. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs. Encourage your patients to read the Medication Guide they receive with every filled prescription. Use caution when considering switching patients from methylphenidate to atomoxetine. Patients should not stop taking a methylphenidate product without first discussing it with your health care professional.
See the FDA Drug Safety Communication for additional information, including a Data Summary.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at the link below.
CDC Issues Health Advisory about Recognizing, Managing, and Reporting Chikungunya Virus Infections in Travelers Returning from the Caribbean
The Centers for Disease Control and Prevention (CDC) has issued a Health Advisory about recognizing, managing and reporting Chikungunya Virus Infections in travelers returning from the Caribbean. On December 7, 2013, the World Health Organization (WHO) reported the first local (autochthonous) transmission of chikungunya virus in the Americas. As of December 12th, 10 cases of chikungunya have been confirmed in patients who reside on the French side of St. Martin in the Caribbean. Laboratory testing is pending on additional suspected cases. Onset of illness for confirmed cases was between October 15 and December 4. At this time, there are no reports of other suspected chikungunya cases outside St. Martin. However, further spread to other countries in the region is possible.
Chikungunya virus infection should be considered in patients with acute onset of fever and polyarthralgia, especially those who have recently traveled to the Caribbean. Healthcare providers are encouraged to report suspected chikungunya cases to their state or local health department to facilitate diagnosis and to mitigate the risk of local transmission.
Chikungunya virus is a mosquito-borne alphavirus transmitted primarily by Aedes aegypti and Aedes albopictus mosquitoes. Humans are the primary reservoir during epidemics. Outbreaks have been documented in Africa, Southern Europe, Southeast Asia, the Indian subcontinent, and islands in the Indian and Pacific Oceans. Prior to the cases on St. Martin, the only chikungunya cases identified in the Americas were in travelers returning from endemic areas.
A majority of people infected with chikungunya virus become symptomatic. The incubation period is typically 3-7 days (range, 2-12 days). The most common clinical findings are acute onset of fever and polyarthralgia. Joint pains are often severe and debilitating. Other symptoms may include headache, myalgia, arthritis, or rash. Persons at risk for more severe disease include neonates (aged <1 month) exposed intrapartum, older adults (e.g., > 65 years), and persons with underlying medical conditions (e.g., hypertension, diabetes, or cardiovascular disease).
Diagnosis: Chikungunya virus infection should be considered in patients with acute onset of fever and polyarthralgia who recently returned from the Caribbean. Laboratory diagnosis is generally accomplished by testing serum to detect virus, viral nucleic acid, or virus-specific immunoglobulin M (IgM) and neutralizing antibodies. During the first week of illness, chikungunya virus infection can often be diagnosed by using viral culture or nucleic acid amplification on serum.
Treatment: No specific antiviral treatment is available for chikungunya fever. Treatment is generally palliative and can include rest, fluids, and use of analgesics and antipyretics. Because of similar geographic distribution and symptoms, patients with suspected chikungunya virus infections also should be evaluated and managed for possible dengue virus infection. People infected with chikungunya or dengue virus should be protected from further mosquito exposure during the first few days of illness to prevent other mosquitoes from becoming infected and reduce the risk of local transmission.
Recommendations for Health Care Providers and Public Health Practitioners:
- Chikungunya virus infection should be considered in patients with acute onset of fever and polyarthralgia, especially those who have recently traveled to the Caribbean.
- Healthcare providers are encouraged to report suspected chikungunya cases to their state or local health department to facilitate diagnosis and to mitigate the risk of local transmission.
- Health departments should perform surveillance for chikungunya cases in returning travelers and be aware of the risk of possible local transmission in areas where Aedes species mosquitoes are currently active.
- State health departments are encouraged to report laboratory-confirmed chikungunya virus infections to ArboNET, the national surveillance system for arthropod-borne viruses.
Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles
Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. On Nov. 12, 2013, Alexion announced that the two lots were found to contain visible particles. (Soliris (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-01, Lot number: 10010A and 10001-1). At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level.
The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immunogenicity and thromboembolic events. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As previously stated, Alexion does not anticipate any interruption to patient supply of Soliris.
The product is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare disorders. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product was last shipped on Nov. 1, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level. Soliris (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-01, Lot number: 10010A and 10001-1.
Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately by calling 1-888-SOLIRIS (888-765-4747).
Alexion will replace any recalled vials of Soliris. Unaffected lot numbers can continue to be used according to the instructions for use. Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747.
Featured Policy Library Manuals
MCN Healthcare’s HIPAA Guidelines Policy and Procedure Manual provides policies and procedures addressing the HIPAA Privacy Rule, the HIPAA Security Rule, Notification of Breach of Protected Health Information (HITECH), and Transactions and Code Sets as mandated by the federal government. Policies and procedures include the changes covered in the Omnibus Final Rule, January 2013.Read more »
The Medical Office Policy and Procedure Manual is cross referenced to Joint Commission standards for Ambulatory Care and Primary Care Medical Homes and NCQA standards for Patient Centered Medical Homes. This manual includes policies that meet OSHA requirements for safety and infection control, Human Resources policies and Medical Office Compliance Plan and much more!Read more »
Be sure your organization is in compliance with Joint Commission’s National Patient Safety Goals with MCN's quick, easy-to-use and proven reference guide that addresses each NPSG and associated Elements of Performance. This comprehensive resource tool includes over 140 policies, procedures, forms and implementation tools. Includes policies and procedures for the NEW NPSG.06.01.01!Read more »