- FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines (fda.gov)Clozapine Dispensing Requirements Changed (pharmacytimes.com)
Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about…severe neutropenia…There are two parts to the changes in the requirements for treating patients with clozapine. First, we have clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, we approved a new, shared risk evaluation and mitigation strategy called the Clozapine REMS Program…
- IACP Submits Comments on FDA’s Underestimated Time & Cost Burden of Reporting 503B Adverse Events (iacprx.org)IACPodcast 19 - FDA Guidance on 503B Facilities (iacp.site-ym.com)
International Academy of Compounding Pharmacists submitted comments on the Food & Drug Administration's underestimated time and cost burden of reporting adverse events by 503B outsourcing facilities.
- FDA Endorses Safety Device for Kids’ Liquid Medications (medpagetoday.com)How safe is your baby’s medicine bottle? (consumerreports.org)
Flow restrictor on bottle necks helps prevent children from overdosing..Food and Drug Administration has endorsed the use of a safety device for bottles of children's medication containing liquid acetaminophen,…Called a flow restrictor, the device fits into the top of a bottle to prevent kids from inadvertently squeezing or sucking out too much liquid..
- Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015–16 Influenza Season (cdc.gov)
This report updates the 2014 recommendations of the Advisory Committee on Immunization Practices regarding the use of seasonal influenza vaccines. Updated information for the 2015–16 season includes
- antigenic composition of U.S. seasonal influenza vaccines;
- information on influenza vaccine products expected to be available for the 2015–16 season;
- an updated algorithm for determining the appropriate number of doses for children aged 6 months through 8 years; and
- recommendations for the use of live attenuated influenza vaccine and inactivated influenza vaccine when either is available,…
- Another tool helping developers navigate the difficult road to approval of drugs for rare diseases (blogs.fda.gov)Rare Diseases: Common Issues in Drug Development Guidance for Industry (fda.gov)
...there are roughly 30 million Americans who suffer from a rare disease. And sadly, about 50% are children.. FDA…recently released a new resource for drug developers — a draft guidance document — designed to help them navigate the difficult and unique challenges of developing and bringing to market…drugs to treat rare diseases...document is intended to encourage drug developers to think early on in the process about all aspects of their program — and encourages careful planning which includes a foundation in strong science. Drug developers for rare diseases are often pioneers…this guidance as another important resource to help support their efforts.
- Pharmacy Board releases revised guidelines for pharmacists (pharmacyboard.gov.au)
Pharmacy Board of Australia (the Board) has released revised guidelines that provide guidance to the profession on a range of issues.
Pharmacists are urged to read the revised guidelines published today:
- Guidelines for dispensing of medicines
- Guidelines on practice-specific issues,
- Guideline 1 Reference texts for pharmacists
- Guidelines on dose administration aids and staged supply of dispensed medicines, and
- Guidelines for proprietor pharmacists.
- FDA issues vaccine guide for parents (drugstorenews.com)Vaccines for Children - A Guide for Parents and Caregivers (fda.gov)
Food and Drug Administration has issued a new guide for parents about vaccinating their children. The online guide includes information about the benefits and risks of vaccination, the types of vaccines children routinely receive as well as a section with questions that parents are asking about vaccination.
- Manufacturers: The Government Wants to Use 340B to Oversee and Publish Your Specialty Channel Strategy (drugchannels.net)340B Drug Pricing Program Omnibus Guidance (federalregister.gov)
Attention, proles! ...Health Resources and Services Administration has released its long-awaited Omnibus Guidance for the 340B Drug Pricing Program…guidance brings some much-needed clarity to the definition of an eligible patient...duplicate discounts…diversion…covered entities audit and monitor contract pharmacies…Unfortunately, HRSA has granted itself intrusive oversight for what it calls "limited distribution plans." Under the guise of auditing manufacturer compliance,…is asserting novel and impractical review and approval authority over manufacturers' channel strategies… every manufacturer is expected to have its channel strategies reviewed and then published…Watch out!
- NICE antimicrobial stewardship: right drug, dose, and time? (thelancet.com)Antimicrobial stewardship: systems and processes for effective antimicrobial medicine use (nice.org.uk)
National Institute for Health and Care Excellence in the UK released its first guideline on antimicrobial stewardship,..is aimed at all health and social care practitioners (hospital and care home staff, general practitioners, dentists, podiatrists, pharmacists, and community nurses), commissioning and provider organizations, and users,..main recommendations are designed to promote and monitor sensible antimicrobial use through stewardship teams to review prescribing and resistance data and to provide feedback, education, and training to prescribers.
- FDA Issues Guidance on Outsourcing Registration (pharmtech.com)
FDA released guidance… directed at companies that are considering registering with the agency as an outsourcing facility under…the Federal Food, Drug, and Cosmetic Act… guidance is in response to questions the agency received from companies about which activities (e.g., drug compounding) would require a company to register as an outsourcing facility and, therefore, be subject to registration fees…