October 21, 2011

CONVENTION

Pharmacists' Contributions to Patient Care Recognized During American Pharmacists Month—October is American Pharmacists Month, and USP supports the work of pharmacists through its quality standards for the medicines they use every day in their care for patients.  Pharmacy schools and associations, a close ally to USP in its public health mission, comprise 35% of USP's Convention membership. The American Pharmacists Association (APhA) has launched the "Know Your MEDICINE, Know Your PHARMACIST" campaign and provides resources to promote the professions contribution, including a compelling video and a downloadable Personal Medication Record.         

Last Call to Register for AAPS 25th Anniversary Reception at USP Headquarters—It's not too late to RSVP for next week's reception at USP headquarters in celebration of the American Association of Pharmaceutical Scientists (AAPS) 25th Year Anniversary.

Reception details:
Wednesday, October 26, 2011
5:30 p.m. to 7:30 p.m.
USP Headquarters Meetings Center
12601 Twinbrook Parkway
Rockville, MD 20852

Transportation will be provided from L Street entrance of the DC Convention Center.  Look for the USP sign.

HEADQUARTERS

Biologics & Biotechnology Symposium Podcasts—Podcast interviews with speakers at the recent USP Biologics and Biotechnology Science and Standards Symposium are available at http://pharmtech.findpharma.com/.

Register for December Aerosols-Inhalation and Nasal Drug Products Workshop—On December 12-13, 2011, USP will host an Aerosols–Inhalation and Nasal Drug Products Workshop, a forum for inhalation drug manufacturers, the FDA, and pharmacopeias to discuss the current challenges in inhalation and nasal drug products. This is your opportunity to influence USP's future direction on establishing standards for product analysis, particle size measurements, and content uniformity. The workshop will also provide an opportunity to discuss a new proposed General Chapter on the quality of inhalation and nasal drug products and its potential impact on inhalation product testing.  Industry and regulatory affairs professionals are encouraged to attend - register by November 12 for Early Bird Discounts.

Free Webinar for Healthcare Practitioners on CDC Investigation of a Bacterial Outbreak and USP Standards for Sterile Compounding—The outcomes of a recent investigation into a bacterial outbreak in compounded total parenteral nutritions (TPNs) is the focus of a the free public health webinar –  Compounding Total Parenteral Nutrition Preparations: A 2011 Investigation of a Bacterial Outbreak – presented by the Centers for Disease Control and Prevention (CDC) and USP. The webinar discusses the factors that resulted in the contamination of compounded TPNs, causing an outbreak of Serratia marcescens in adult patients. The CDC provides a review of its investigation and the breaches identified, and USP reviews the official standards for sterile compounding. 

USP Awards Fellowships to Graduate and Post-Doctorate Researchers—USP congratulates the winners of $150,000 in research funds under its 2011-2012 Fellowship Program. The program offers up to three years of funding to advance quality standards related to small molecule drugs, biologics and biotechnology, excipeints, food ingredients, and dietary supplements, and to support the work of early-career scientists in these fields.  Recipients of the 2011-2012 Fellowships are:

  • Kaho Kwok, Ph.D. (Purdue University College of Pharmacy, Department of Industrial and Physical Pharmacy) - $50,000 Research Fellowship. Research area: Detection of counterfeit medicines through excipient characterization by Raman spectroscopy and multivariate curve resolution.
  • Tariq Moujtahid (Ph.D. candidate, New Jersey Institute of Technology, Department of Chemical, Biological and Pharmaceutical Engineering) - $50,000 Research Fellowship.  Research area: Experimental and numerical determination of the efffect of vessel geometry on the hydrodynamics and dissolution profiles of solid dosage forms in the USP Dissolution Testing Apparatus 2.
  • Brian Krieg (Ph.D. candidate, University of Michigan, College of Pharmacy, Department of Pharmaceutical Sciences) - $25,000 Fellowship.  Research area: Identification of buffer systems that accurately simulate physiologically relevant bicarbonate buffers of the intestinal tract.
  • Ting Wang (Ph.D. candidate, University of Maryland at Baltimore, School of Pharmacy) - $25,000 Fellowship. Research area: Developing the scientific basis for the application of spectroscopic and chemometric methods for excipeint identification and adulteration detection.

INTERNATIONAL

USP Agreements with Brazilian Organizations Focus on the Quality of Medicines and Foods and Support Information Exchange—USP has signed agreements with key Brazilian regulatory, industry, and academic organizations to collaborate on improving the quality of medicines and foods and promote information exchange. In an agreement with Brazil’s National Agency of Sanitary Surveillance (ANVISA, a USP Convention Member), USP and ANVISA committed to develop joint education programs for professionals involved in formulating and using pharmacopeial monograph standards. An agreement with the University of São Paulo School of Pharmaceutical Sciences and the renewal of a Memorandum of Understanding with the São Paulo State Pharmaceutical Manufacturers Association (Sindusfarma, a USP Convention Observer) share the following goals:

  • To increase awareness of the quality, safety, and efficacy of medicines and foods;
  • Promomote cooperation to improve the quality of medicines and foods;
  • Improve the exchange of scientific and technical information; and
  • Facilitate the harmonization of pharmacopeial standards. 

USP and Russian Ministry Pledge Cooperation to Improve Medicine Quality—USP CEO Dr. Roger Williams  and Dr. V.I. Skvortsova, deputy minister from the Ministry of Healthcare and Social Development of the Russian Federation, signed a Memorandum of Understanding formalizing a mutual commitment to improve the quality of medicines for citizens of the U.S. and the Russian Federation. The MOU cites potential collaboration in several areas: exchanging information and taking action in emergency situations when accidental contamination or intentional aduleration of medicines and ingredients occurs; scientific and executive staff exchanges and training programs; joint scientific meetings; promoting pharmacopeial harmonization and the application of modern laboratory standards and measurement principles.

USP-USAID Collaboration Sees Progress in 10-Year Fight Against Malaria—After ten years, partners are seeing progress in their fight against malaria in the Amazon Basin. U.S. Agency for International Development’s Amazon Malaria Initiative (AMI) and the Amazon Network for the Surveillance of Antimalarial Drug Resistance of the Pan American Health Organization have played a significant role in a 52% decrease in malaria cases and 69% decrease in malaria deaths for the entire region. USP, through the Promoting the Quality of Medicines (PQM) Program (and its predecessor Drug Quality and Information Program), has worked closely with countries participating in AMI to ensure the quality of malaria medicines by providing technical assistance to stakeholders in Bolivia, Brazil, Colombia, Ecuador, Guatemala, Guyana, Jamaica, Panama, Peru, and Suriname. PQM, which is supported by USAID, has helped to develop medicine quality monitoring programs and strengthened testing capability and quality management systems of the Official Medicines Control Laboratories. PQM looks forward to a strong, continued partnership with AMI.