US Court Sentences Canadian Pharmacy Owner for Selling Counterfeit Prescription Drugs to Health Care Providers – Drug for nerve pain boosts high for opioid abusers.

3Aabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

US Court Sentences Canadian Pharmacy Owner for Selling Counterfeit Prescription Drugs to Health Care Providers – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Kristjan Thorkelson, a resident of Manitoba, Canada, and a number of Canadian companies associated with Thorkelson, including Canada Drugs, Rockley Ventures, and River East Supplies, admitted to selling misbranded and counterfeit prescription drugs throughout the US. The US District Court in Montana sentenced Thorkelson individually to pay a fine of $250,000 and to serve five years of probation with the first six months in home confinement. The Canadian companies were sentenced to forfeit $29,000,000 of the proceeds from their illegal scheme, to pay a fine of $5,000,000, and to serve five years of probation. In addition, Thorkelson and the associated companies were ordered to permanently cease their illegal operations, surrender to the US all domain names and websites from their businesses, and cooperate with the DOJ and Food and Drug Administration (FDA) in any further criminal investigations.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Leave a comment

GAO Recommends US Agencies Develop Performance Metrics to Gauge Effectiveness of Efforts to Combat Synthetic Opioid Threat – APhA submits compounding comments to FDA.

4Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

GAO Recommends US Agencies Develop Performance Metrics to Gauge Effectiveness of Efforts to Combat Synthetic Opioid Threat – APhA submits compounding comments to FDA. – (866) 348-2889.

Many United States agencies’ documented that opioid response strategies lack outcome-oriented performance measures, indicates a new report by the US Government Accountability Office (GAO). Without specific outcome-oriented performance measures, federal agencies will not be able to truly assess whether their respective investments and efforts are helping them to limit the availability of and better respond to the synthetic opioid threat, states the GAO report Illicit Opioids: While Greater Attention Given to Combating Synthetic Opioids, Agencies Need to Better Assess their Efforts.

In response to a request from members of Congress to review US agency efforts to combat illicit synthetic opioids, GAO reviewed documents that described agencies’ international coordination efforts, domestic opioid reduction strategies and prevention and treatment approaches, and interviewed international and federal agency officials engaged in drug control policy. GAO also interviewed state and local law enforcement and public health officials in seven states that were selected in part for their high rates of overdose deaths.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

US Court Sentences Canadian Pharmacy Owner for Selling Counterfeit Prescription Drugs to Health Care Providers – Drug for nerve pain boosts high for opioid abusers.

5Aabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

US Court Sentences Canadian Pharmacy Owner for Selling Counterfeit Prescription Drugs to Health Care Providers – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Kristjan Thorkelson, a resident of Manitoba, Canada, and a number of Canadian companies associated with Thorkelson, including Canada Drugs, Rockley Ventures, and River East Supplies, admitted to selling misbranded and counterfeit prescription drugs throughout the US. The US District Court in Montana sentenced Thorkelson individually to pay a fine of $250,000 and to serve five years of probation with the first six months in home confinement. The Canadian companies were sentenced to forfeit $29,000,000 of the proceeds from their illegal scheme, to pay a fine of $5,000,000, and to serve five years of probation. In addition, Thorkelson and the associated companies were ordered to permanently cease their illegal operations, surrender to the US all domain names and websites from their businesses, and cooperate with the DOJ and Food and Drug Administration (FDA) in any further criminal investigations.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

GAO Recommends US Agencies Develop Performance Metrics to Gauge Effectiveness of Efforts to Combat Synthetic Opioid Threat – APhA submits compounding comments to FDA.

6Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

GAO Recommends US Agencies Develop Performance Metrics to Gauge Effectiveness of Efforts to Combat Synthetic Opioid Threat – APhA submits compounding comments to FDA. – (866) 348-2889.

Many United States agencies’ documented that opioid response strategies lack outcome-oriented performance measures, indicates a new report by the US Government Accountability Office (GAO). Without specific outcome-oriented performance measures, federal agencies will not be able to truly assess whether their respective investments and efforts are helping them to limit the availability of and better respond to the synthetic opioid threat, states the GAO report Illicit Opioids: While Greater Attention Given to Combating Synthetic Opioids, Agencies Need to Better Assess their Efforts.

In response to a request from members of Congress to review US agency efforts to combat illicit synthetic opioids, GAO reviewed documents that described agencies’ international coordination efforts, domestic opioid reduction strategies and prevention and treatment approaches, and interviewed international and federal agency officials engaged in drug control policy. GAO also interviewed state and local law enforcement and public health officials in seven states that were selected in part for their high rates of overdose deaths.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

Upcoming Webinar Focuses on Requirements for Pharmacists Under DSCSA – Drug for nerve pain boosts high for opioid abusers.

7Aabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

Upcoming Webinar Focuses on Requirements for Pharmacists Under DSCSA – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is presenting a series of continuing education webinars targeted toward students and health care providers who wish to learn more about FDA and drug regulation. The webinars are presented by FDA staff and will allow participants to interact with staff in a question-and-answer format.

The next webinar, “FDA Drug Topics: Protecting Patients – Pharmacists Requirements under the Drug Supply Chain Security Act,” will be held May 8, 2018, at 1 PM (EDT). This webinar will provide an overview of key requirements for dispensers (primarily pharmacies) under the Drug Supply Chain Security Act (DSCSA), review current and future dispenser responsibilities under the law, and highlight FDA resources available to dispensers to educate themselves further on the latest DSCSA implementation.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

FDA to Hold Third Public Workshop on Medical Gas Regulation, Requests Comments – APhA submits compounding comments to FDA.

29960_pharmacyboard_standard_081816Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

FDA to Hold Third Public Workshop on Medical Gas Regulation, Requests Comments – APhA submits compounding comments to FDA. – (866) 348-2889.

Food and Drug Administration (FDA) is holding a public workshop on medical gas regulation on May 11, 2018. To be held at FDA’s White Oak Campus, participants may attend the “Medical Gas Regulation: Workshop III” in person or via live webcast. This workshop will provide an opportunity for medical gas manufacturers and any other interested members of the public to provide input on potential areas of federal drug regulation that should be revised with respect to medical gases. In addition, this workshop is intended to build on discussions from the previous two workshops, as well as written comments submitted to the docket.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

DEA and 48 Attorneys General Agree to Share Prescription Drug Information – Drug for nerve pain boosts high for opioid abusers.

14676_graphic_standard_062716Aabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

DEA and 48 Attorneys General Agree to Share Prescription Drug Information – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Drug Enforcement Administration (DEA) has reached an agreement with 48 Attorneys General from 46 states, Puerto Rico, and the District of Columbia, to share prescription drug information with one another to aid investigations. DEA will provide the Attorneys General with data from DEA’s Automation of Reports and Consolidated Orders System related to transaction reports from manufacturers and distributors of prescription drugs. The states will provide their own information, often from prescription drug monitoring programs (PDMPs) to DEA.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

National Poll on Healthy Aging Offers Older Adults’ Perspectives on Medical Marijuana to Control Pain – APhA submits compounding comments to FDA.

16321_pharmacyboard_standard_080416Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

National Poll on Healthy Aging Offers Older Adults’ Perspectives on Medical Marijuana to Control Pain – APhA submits compounding comments to FDA. – (866) 348-2889.

One out of five older adults who are between 50-80 years old reported that their primary health care provider has asked whether they use marijuana, according to the University of Michigan National Poll on Healthy Aging. In October 2017, a national sample of older adults were surveyed about marijuana use for medical purposes, its perceived benefits, perception of how marijuana compares to prescription pain medicine, and support for marijuana-related policies.

Older adults appear to be open to asking about medical marijuana if they have a serious health condition that might respond to marijuana. When asked whether they would ask their health care provider about medical marijuana if they had a serious health condition that might respond well to marijuana use, 44% of respondents said definitely yes, 26% said probably yes, 13% said they would not ask, and 17% said they do not know if they would ask.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

National Prevention Week Raises Awareness on Substance Abuse Before End of School Year – Drug for nerve pain boosts high for opioid abusers.

16511-pharmacy-board-standard-041216Aabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

National Prevention Week Raises Awareness on Substance Abuse Before End of School Year – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Adolescents and full-time college students most often abuse substances for the first time during June or July, according to data from the SAMHSA National Survey on Drug Use and Health. Each year during the third week of May, SAMHSA observes National Prevention Week to raise awareness about the importance of substance abuse prevention and positive mental health before summer break begins. The 2018 National Prevention Week, themed “Action Today. Healthier Tomorrow,” will be held May 13 to 19.

National Prevention Week will address the prevention of prescription and opioid drug misuse on Wednesday, May 16. NABP’s AWARXE® Prescription Drug Safety Program has information on preventing medication abuse and provides several educational resources on how to use, store, and dispose of medication safely.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off

DEA Responds to Concerns About Potential Shortages and Production Capabilities of Certain Injectable Drug Products – APhA submits compounding comments to FDA.

5Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

DEA Responds to Concerns About Potential Shortages and Production Capabilities of Certain Injectable Drug Products – APhA submits compounding comments to FDA. – (866) 348-2889.

To prevent any pharmaceutical drug shortage that negatively impacts patients, DEA is working closely with FDA, drug manufacturers, wholesale distributors, and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl.

As indicated in a DEA news release, the largest US manufacturer of these injectable products has slowed production at one of their manufacturing facilities to perform necessary and required upgrades. As a result, this company voluntarily surrendered a portion of their quota allotment and DEA reallocated these amounts to three DEA-registered manufacturers of FDA-approved injectable products in accordance with DEA regulations. DEA indicates that an increase in DEA procurement quotas to various manufacturers alone cannot prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products.

CLICK HERE FOR CONTINUE READING

Posted in Pharmacist | Tagged , , , | Comments Off