Glenmark Pharmaceuticals Recall (check your prescription bottles)

In February, the FDA found problems with cleaning and testing at the plant in Madhya Pradesh, India, which was the subject of a ProPublica investigation last year. The current recalls, listed in an FDA enforcement report last week, cover a wide range of commonly prescribed medicines, including ones that treat epilepsy, diabetes, multiple sclerosis, heart disease and high blood pressure, among other ailments. ​​A full list of the recalled medications is available here. An Indian Drugmaker, Investigated by ProPublica Last Year, Has Recalled Two Dozen Medications Sold to U.S. Patients https://www.propublica.org/article/glenmark-recalls-two-dozen-drugs

Time to bring the pharma supply chain back onshore.

Telehealth Company Cerebral Agrees to pay $3.7M fine (and found guilty of nothing)

Telehealth company Cerebral has agreed to pay a fine of more than $3.6 million for allegedly attempting to boost prescriptions of Adderall and other controlled substances, the Department of Justice and Drug Enforcement Administration said Monday. 

Regulators allege Cerebral’s initial visit metric didn’t consider medical literature or whether prescriptions would be clinically appropriate for patients. The company also used financial incentives to spur providers to meet prescribing metrics — and even considered disciplinary measures for those who hadn’t prescribed enough stimulants for ADHD patients, according to a press release.

https://www.healthcaredive.com/news/cerebral-controlled-substance-prescribing-fine-doj-dea/732108/

This company agreed to a fine it was unable to pay so the regulators deferred payment.

Huh?

Have you reviewed your HIPAA policies, training, and compliance lately?

Timothy A. Carney's avatarGableGotwals Insurance Law Update

HIPAA PRIVACY ENFORCEMENT ON THE RISE

In February 2009, as part of the economic stimulus legislation known as the American Recovery and Reinvestment Act, Congress enacted the Health Information Technology for Economic and Clinical Health Act (HITECH).  HITECH not only provided federal incentives for medical care providers to accelerate implementation of electronic health records systems, but also broadened the categories of those responsible for protecting the patient health information contained in those records and significantly increased the penalties for HIPAA violations.

The original HIPAA Privacy Rule finalized in 2002 applied only to “covered entities” such as health care providers, health plans, health care clearinghouses and later, sponsors of drug discount cards under Medicare. The Department of Health and Human Services Office for Civil Rights (OCR) is responsible for civil enforcement of HIPAA privacy regulations.  Under the original Privacy Rule, OCR lacked direct enforcement authority against the  “business associates” of covered…

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Thought for Today – 09.18.11

New Economic Perspectives: William Black: Why Nobody Went to Jail During the Credit Crisis

We have known for centuries, that if you don’t underwrite loans, or if you don’t underwrite insurance, you’ll get something called “adverse selection”.

This interview answers the question of why nobody went to jail for our recent financial crisis.

For this underwriter, it’s all about prudent underwriting and strong internal controls.

If Your Leg Breaks Stop Taking Biphosphonates

The highlighted bold is me.  I keep reading this FDA recommendation just to make sure I understand what they are trying to say.  I think the recommendation says the FDA found no cause and effect between the use of biphosphonates and leg fractures so keep taking your medication.  But if your leg breaks, your physician will instruct you to stop taking the medication she prescribed for you to help prevent bone loss and fractures.

I’m glad the FDA cleared up this issue, don’t you?

Safety Alerts for Human Medical Products > Bisphosphonates (Osteoporosis Drugs): Label Change – Atypical Fractures Update

BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.

RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. See the FDA Drug Safety Communication below for additional information.

FDA Warns Docs, Patients of Femoral Fracture Risk Linked to Some Bisphosphonates — AAFP News Now — American Academy of Family Physicians