Lawyer for Alabama Pharmacy Board Hearing – Call today to discuss your case – FDA Approves First Orally Dissolvable Methylphenidate Tablets for ADHD

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Lawyer for Alabama Pharmacy Board Hearing – Call today to discuss your case – FDA Approves First Orally Dissolvable Methylphenidate Tablets for ADHD – (866) 348-2889

Officials with the FDA have approved methylphenidate (Cotempla XR-ODT, Neos Therapeutics) extended-release orally disintegrating tablets. The tablets are indicated to treat attention-deficit/hyperactivity disorder (ADHD) in patients aged 6-17 years old.

The approval is based on data from a phase 3 clinical trial that supports the safety and efficacy of Cotempla XR-ODT. In the trial, treatment demonstrated a statistically significant improvement in ADHD symptoms compared to a placebo in children in a laboratory classroom. The drug’s effectiveness was indicated at 1 hour after the dose was received and lasted for 12 hours. No serious adverse events were reported.

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Lawyer for Alabama Pharmacy Board Hearing – Call today to discuss your case – After FDA approves second infliximab biosimilar, clinicians face decisions

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Lawyer for Alabama Pharmacy Board Hearing – Call today to discuss your case – After FDA approves second infliximab biosimilar, clinicians face decisions – (866) 348-2889

In April, FDA approved infliximab-abda (Renflexis, Samsung Bioepis), the second biosimilar for reference biologic infliximab (Remicade, Janssen) after biosimilar infliximab-dyyb (Inflectra, Pfizer). As with infliximab and infliximab-dyyb, infliximab-abda is approved for adult Crohn disease, pediatric Crohn disease, ulcerative colitis, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. How clinicians choose which agent to use may set the tone for future cases in which more than one biosimilar is approved for a biologic.

The infliximab agents are currently not interchangeable by FDA standards, as the agency released draft guidance on the requirements for that designation only last January. But the approval process for biosimilars should put health providers at ease when making clinical decisions, said James G. Stevenson, PharmD, FASHP, professor in the department of clinical pharmacy at University of Michigan College of Pharmacy in Ann Arbor.

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Alabama Pharmacy Board Defense Attorney – Pharmacist Hearing Upcoming? Call Today – Combining vitamin C with antibiotics destroys cancer stem cells

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Alabama Pharmacy Board Defense Attorney – Pharmacist Hearing Upcoming?  Call Today – Combining vitamin C with antibiotics destroys cancer stem cells

A combination of vitamin C and antibiotics could be key to killing cancer stem cells, a new study finds, paving the way for a strategy that could combat cancer recurrence and treatment resistance.

Researchers found that a therapy involving the antibiotic Doxycycline and ascorbic acid, or vitamin C, was up to 100 times more effective for killing cancer stem cells (CSCs) than 2-DG, a molecule currently being tested as an anti-cancer agent in clinical trials.

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Alabama Pharmacy Defense Attorney – Hearing Defense – Thirteen Individuals Illegally Diverted Oxycodone for Street Sale With Stolen Prescription Pad

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Alabama Pharmacy Defense Attorney – Hearing Defense – Thirteen Individuals Illegally Diverted Oxycodone for Street Sale With Stolen Prescription Pad – (866) 348-2889

Thirteen individuals affiliated with a prescription drug ring that illegally wrote and filled prescriptions for oxycodone and then sold them in Lehigh Valley, PA, were charged with conspiracy to acquire a controlled substance by fraud and related charges. The prescription pad was stolen from St Luke’s Orthopedic Specialists, of Fountain Hill, PA. Data from the Pennsylvania Department of Health’s Prescription Drug Monitoring Program was used to investigate the case and file these charges, indicates Pennsylvania Attorney General Josh Shapiro’s press release.

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Alabama Pharmacy Board Defense Attorney – Pharmacist Hearing Upcoming? Call Today – CDC Publishes Guide to Help Pharmacists Initiate CPAs With Prescribers

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Alabama Pharmacy Board Defense Attorney – Pharmacist Hearing Upcoming? Call Today – CDC Publishes Guide to Help Pharmacists Initiate CPAs With Prescribers – (866) 348-2889

Centers for Disease Control and Prevention (CDC) published a guide that provides pharmacists with information and resources to empower them to initiate collaborative practice agreements (CPAs) with collaborating prescribers. The guide, Advancing Team-Based Care Through Collaborative Practice Agreements: A Resource and Implementation Guide for Adding Pharmacists to the Care Team, contains a sample CPA and sample language that can be customized by pharmacists and prescribers using their specific state laws to create a CPA. Cardiovascular disease and hypertension were used as examples of disease states that can be managed using a CPA, but the concepts presented in the guide can also be applied to many other chronic conditions, treatments for acute illness, and preventive health measures.

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Alabama Pharmacist Defense Lawyer – Board of Pharmacy Matter Pending? We Can Help – NACDS and APhA Urge Trump Administration to Reject Broad Drug Importation Proposals and HHS Waiver Authority

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Alabama Pharmacist Defense Lawyer – Board of Pharmacy Matter Pending? We Can Help – NACDS and APhA Urge Trump Administration to Reject Broad Drug Importation Proposals and HHS Waiver Authority – (866) 348-2889

The National Association of Chain Drug Stores (NACDS) and the American Pharmacists Association (APhA) urge the Trump Administration to refrain from endorsing pending legislative proposals that would allow for broad personal and commercial importation of non-FDA-approved prescription drugs. In a letter, NACDS and APhA also ask the Secretary of Health and Human Services (HHS) to not exercise the waiver authority that allows the Secretary to waive the general prohibition against personal importation of prescription drugs.

The Drug Supply Chain Security Act (DSCSA), which requires the track and trace of prescription drugs from manufacturer to receipt by the dispenser, is undermined by drug importation, notes the letter. Importation proposals fail to align with track and trace requirements of the DSCSA in addition to other DSCSA requirements involving licensure of supply chain participants, verification and validation of drug products, and the handling of suspect and illegitimate products. The letter states, “broad importation and HHS waiver of importation prohibitions create loopholes within the DSCSA regulatory framework, easily allowing counterfeit drugs to slip into the United States supply chain.

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Lawyer for Alabama Pharmacy Board Hearing – Call today to discuss your case -Arizona Governor Declares Public Health Emergency Due to Opioid Overdose Epidemic

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Lawyer for Alabama Pharmacy Board Hearing – Call today to discuss your case -Arizona Governor Declares Public Health Emergency Due to Opioid Overdose Epidemic – (866) 348-2889

Arizona Governor Doug Ducey declared a public health emergency to address the increasing number of opioid deaths throughout the state. The declaration allows Arizona to coordinate public health efforts between state, local, and private-sector partners, and to utilize all of its public health resources, including distributing naloxone throughout the state. The declaration and enhanced surveillance advisory will provide for enhanced reporting of overdose deaths from doctors and hospitals.

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Alabama Pharmacy Board Defense Lawyer – Call Today – Former FBI Director Investigates Drug Importation Proposals and Their Effects on Law Enforcement

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Alabama Pharmacy Board Defense Lawyer – Call Today – Former FBI Director Investigates Drug Importation Proposals and Their Effects on Law Enforcement – (866) 348-2889

An investigation led by former Federal Bureau of Investigation (FBI) Director Louis J. Freeh found that Congressional drug importation proposals would increase the threat of illegitimate products entering the United States, worsen the opioid epidemic, and overburden law enforcement and government regulators. The report, Report on the Potential Impact of Drug Importation Proposals on U.S. Law Enforcement, focuses on the impact of drug importation on law enforcement’s ability to protect the US from substandard, adulterated, counterfeit, and diverted pharmaceuticals.

Current and former law enforcement officials from the FBI, Food and Drug Administration (FDA), Drug Enforcement Administration, as well as state and local law enforcement were interviewed as part of the investigation. The report includes recommendations to improve and enhance existing law enforcement capacity to prevent counterfeit drugs from entering the US drug supply, and ensure law enforcement has sufficient resources, expertise, and authority to protect the public health and integrity of the US drug supply. Additional information is provided in a press release.

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Alabama Pharmacy Defense Attorney – Hearing Defense – FIP Highlights Pharmacists’ Roles in Reducing Drug-Related Harm

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Alabama Pharmacy Defense Attorney – Hearing Defense – FIP Highlights Pharmacists’ Roles in Reducing Drug-Related Harm – (866) 348-2889

During the 70th World Health Assembly in Geneva, Switzerland, the International Pharmaceutical Federation (FIP) informed attendees about pharmacists’ efforts to reduce drug-related harm. FIP highlighted pharmacists’ contributions to needle exchange programs, opioid substitution therapy, promoting responsible use of medicines with high risk of addiction, and educational campaigns in Portugal, France, and the US. FIP requested to have pharmacists’ perspectives and experiences included in the World Health Organization mechanism for surveillance of psychoactive substances. Additional information is available in the FIP press release.

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Alabama Pharmacy Board Defense Attorney – Pharmacist Hearing Upcoming? Call Today – Mibelas 24 Fe Tablets and Professional Samples of BRILINTA Tablets Recalled

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Alabama Pharmacy Board Defense Attorney – Pharmacist Hearing Upcoming? Call Today – Mibelas 24 Fe Tablets and Professional Samples of BRILINTA Tablets Recalled – (866) 348-2889

Lupin Pharmaceuticals, Inc, of Baltimore, MD, has voluntarily recalled one lot of Mibelas™ 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) tablets. The affected product was distributed nationwide in the US to wholesalers, clinics, and retail pharmacies. The recalled lot number L600518 expires May 2018 and the National Drug Codes are 68180-911-11 (wallet of 28 tablets) and 68180-911-13 (carton of three wallets). As noted in the safety alert, a confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have four non-hormonal placebo tablets as opposed to the active tablets. To date, no adverse events have been reported.

AstraZeneca voluntarily recalled one lot of professional (physician) sample bottles containing eight tablets of BRILINTA® (ticagrelor) 90 mg tablets. The product was distributed to physicians in the US between March and April 2017. The recall affects lot number JB5047. As indicated in the safety alert, the recall follows a report that a professional sample bottle containing eight tablets of BRILINTA 90 mg also contained another medicine called ZURAMPIC® (lesinurad) 200 mg tablets, which is also manufactured by AstraZeneca. To date, AstraZeneca has not received any reports of adverse events related to this recall.

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