HOW SAFE IS THE MEDICINE/EQUIPMENT IN YOUR HEALTH CARE PROVIDER’S HANDS?

December 18, 2014

You’ve taken the time to research the medical procedure you need to have. Your Doctor comes highly recommended. You take your medicine as prescribed. You and your health care provider wash hands until everyone’s knuckles are raw. Still – a horrible infection or other serious problem occurs. What could have happened? Unfortunately, there is an entire group of pharmaceutical and medical equipment manufacturers and distributors that are “silent partners” in your health care. They must comply with government regulations for cleanliness and sterilization. When they fail, it isn’t one person that’s affected its large numbers of people who have ingested, injected and otherwise used these products who suffer injury.

Most recently, Federal prosecutors charged 14 people in a 2012 meningitis outbreak that killed 64 people nationwide in what they called, “the largest criminal case ever brought in the U.S. over contaminated medicine.” The co-founders of New England Compounding Center (NECC) are accused of using expired ingredients and failing to follow standards for cleanliness at the now-closed plant. NECC manufactured steroids used for injection into the backs and spines of people suffering from back pain.

According to the Federal indictment, mold and bacteria were in the air and on workers’ gloved fingertips. Pharmacists at NECC were accused of failing to test drugs for purity before sending them to hospitals and pain clinics. More than 750 people in 20 states became ill after getting steroid injections, about half of them with a rare fungal form of meningitis, the remainder with joint or spinal infections. Sixty-four died. U.S. Attorney Carmen Ortiz said NECC was “filthy” and failed to comply with even basic health standards, and employees knew it. “Production and profit were prioritized over safety,” she said.

Think this is an isolated outrage? Tragically, no. Savvy investigators were able to do some medical detective work in the NECC case and find the culprit. Other times, the manufacturer will report to the FDA/CDC (either voluntarily or because they have been ‘encouraged’ to do so) of safety concerns for a medical product. If you take a moment to look at the “MedWatch Safety Alerts” on the CDC website you will see a variety of concerns about medicines and products. (see, below for the alerts posted only since this past July)

In response to the recent NECC disaster, last year Congress increased federal oversight of compounding pharmacies like NECC, who custom-mix medications in bulk and supply them directly to hospitals and doctors. Vigilance is the key in fighting against unsafe practices and those companies who would sacrifice safety for lower cost and higher profits.

MedWatch Safety Alerts – August through November 2014

Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall – Potential Mold Contamination UPDATED 12/02/2014. Recall classified as Class I. Possibility of fungal infection should patients come in contact with mold. Originally posted 11/14/2014

Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall – May Produce Incorrect Results Using these recalled devices may cause ineffective patient treatment. Posted 12/02/2014

CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction – Connector Compatibility Issue with Philips FR3 and FRx Defibrillator Units May result in a delay in therapy. Posted 11/26/2014

Slim-Vie: Public Notification – Undeclared Drug Ingredient Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 11/26/2014

Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication – Case of Rare Brain Infection PML Reported Symptoms of PML may include: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation. The progression of deficits can lead to severe disability or death. Posted 11/25/2014

Black Storm: Public Notification – Undeclared Drug Ingredient Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Posted 11/24/2014

Super Extreme Accelerator: Public Notification – Undeclared Drug Ingredient Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 11/24/2014

Bee Thin: Public Notification – Undeclared Drug Ingredient Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 11/24/2014

Bee Slim: Public Notification – Undeclared Drug Ingredient Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 11/24/2014

Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall – Complaints of Empty Capsules Risk of missed dose(s) resulting in no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening. Posted 11/24/2014

Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication – Use Discouraged Due to Increased Risk in Women With Uterine Fibroids UPDATED 11/24/2014. New Boxed Warning and Contraindications recommended by FDA. Originally posted 04/17/2014

Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall – Mislabeled Overpouch Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences. Posted 11/21/2014

Forever Beautiful Bee Pollen by REFA Enterprises: Recall – Undeclared Drug Ingredients Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke Posted 11/20/2014

Intravia Containers by Baxter: Recall – Particulate Matter UPDATED 11/20/2014. Recall Classified as Class I. Particles may irritate patient’s veins, cause pain, worsen a previous infection, cause allergic reactions, block blood vessels, and cause death. Originally posted 10/25/2014

Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall – Power Failure May Occur Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, or death. Posted 11/19/2014

ABC Dophilus Powder by Solgar, Inc: Recall – Risk of Infection The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems. Posted 11/17/2014

October 2014 Safety Labeling Changes includes 37 products with revisions to Prescribing Information. Posted 11/17/2014

Long-term Antiplatelet Therapy: Safety Announcement – Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Posted 11/16/2014

Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall – Potential Mold Contamination UPDATED 12/02/2014. Recall classified as Class I. Possibility of fungal infection should patients come in contact with mold. Originally posted 11/14/2014

Mayhem: Public Notification – Undeclared Drug Ingredients Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems. Posted 11/14/2014

Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall – Software Issue May Stop Ventilator Ventilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death. Posted 11/07/2014

GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall – Power Supply May Not Deliver Enough Electricity Use of recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems…

V26 Slimming Coffee: Public Notification – Undeclared Drug Ingredient Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 11/05/2014

10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall – May Contain Incorrect Concentration of Formalin Use of this defective Formalin may prevent or delay diagnoses and treatment decisions. Posted 10/31/2014

Ginseng Kianpi Pil: Public Notification – Undeclared Drug Ingredients Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications. Posted 10/31/2014

Baby Wipes by Nutek Disposables, Inc.: Recall – May Contain Bacteria Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia. Posted 10/27/2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall – Particulate Matter Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.Posted 10/17/2014

Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall – Packaging Mix-Up Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening. Posted 10/22/2014

Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall – Possible Salmonella Contamination Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014

September 2014 Safety Labeling Changes includes 55 products with revisions to Prescribing Information. Posted 10/16/2014

LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall – Potential for Leakage A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events. Posted 10/15/2014

Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert – Electrodes Will Not Connect with Philips FR3 or FRx AED units The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death. Posted 10/12/2014

Sit and Slim II: Public Notification – Hidden Drug Ingredients FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications. Posted 10/10/2014

Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall – Lack of Sterility Assurance Patients in Oregon and Washington may be at risk of serious infections which may be life threatening. Posted 10/10/2014

ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall – Delivers Higher Flow Rate than Intended Use of the affected product may cause serious adverse health consequences, including death. Posted 10/10/2014

CareFusion EnVe and ReVel Ventilators: Class 1 Recall – Power Connection Failure Ventilator shut-off from power failures may lead to serious patient injury or death. Posted 10/10/2014

Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall – Uncontrolled Storage During Transit One lot may have experienced temperature excursions during shipment. Posted 10/08/2014

SAM Junctional Tourniquet Accessory (Axilla) Strap – SAM Medical Products: Recall – Potential Clip Failure Product failure could cause a potential delay in controlling axilla hemorrhage. Posted 10/08/2014

Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall – Circuit Ends May Crack or Break Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately. Posted 10/07/2014

Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall – Incorrect Labeling The labeled expiration date is longer than the known stability of the product. Posted 10/06/2014

Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement – Risk of Lead Poisoning Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. Posted 09/26/2014

Xolair (omalizumab): Drug Safety Communication – Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events FDA approves label changes after review of a five year safety study. Posted 09/26/2014

Potassium Chloride Injection (Baxter): Recall – Shipping Carton Mislabeling Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. Posted 09/17/2014

Playtex Nurser Deluxe Double Electric Breast Pump: Recall – Potential for Electric Shock UPDATED 09/16/2014. One AC/DC power adapter production lot added to recall. Originally posted 03/19/2014

August 2014 Safety Labeling Changes includes 32 products with revisions to Prescribing Information.

Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall – Particulate Matter Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response. Posted 09/12/2014

Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert – Lack of Sterility Assurance UPDATED 09/09/2014. FDA has issued a formal request to Downing Labs for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. Originally Posted 07/19/2014

Pharmacy Creations Certain Products: Recall – Potential Non-Sterility Compromised sterility of a product may lead to risk for infection. Posted 09/06/2014

CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall – Risk of Loop to Separate From Shaft UPDATED 09/04/2014. Classified as Class I Recall. Originally posted 08/20/2014

Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall – Lack of Assurance of Sterility Compromised sterility of a compounded preparation may lead to risk for infection. Posted 09/02/2014

Dermatend Original and Dermatend Ultra: Recall – Safety Concerns Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer. Posted 09/02/2014

RegeneSlim Appetite Control Capsules: Recall – Presence Of DMAA UPDATED 09/02/2014. Voluntary nationwide recall expanded. Originally posted 08/07/2014

DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall – May Reverse Directions After Surgery Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device. Posted 08/28/2014

Sterile Convenience Surgical Packs by Customed, Inc.: Recall – Potential Loss of Sterility UPDATED 11/25/2014. New lots added to recall. Originally posted 08/26/2014

Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall – Possibility of Mold Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death. Posted 08/22/2014

CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall – Risk of Loop to Separate From Shaft UPDATED 09/04/2014. Classified as Class I Recall. Originally posted 08/20/2014

Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall – Sheath May Fracture During Use Fragments of the sheath could possibly block blood vessels. Posted 08/19/2014

Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall – Presence of Particulate Matter Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome. Posted 08/15/2014