Alaina Scott, Senior Editor

A second round of revised quality standards for heparin became effective recently, the U.S. Pharmacopeial (USP) Convention has announced. 

Working closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and other regulatory and scientific bodies, USP started initial revisions in 2008 after adverse reactions and deaths resulted from heparin intentionally adulterated with over-sulfated chondroitin sulfate (OSCS). 

OSCS is a less costly substance that can mimic the blood-thinning properties of heparin. The immediate public health crisis was addressed by the first stage of quality revisions released by USP in June of 2008, but a thorough modernization of the existing heparin monographs was needed to ensure the continuing quality of heparin. Those second stage tests and accompanying reference materials that enable manufacturers to compare their products to a proven standard were first announced by USP in February of 2009. 

Following a period of public comment, the standards are now enforceable in the United States by FDA. “It has been gratifying to see so many dedicated scientists and regulators collaborating successfully and in an expedited manner in the interest of protecting patients,” said Roger L. Williams, MD, chief executive officer of USP. 

As part of the second-stage revisions, USP has harmonized dosage measurement units with those established by the World Health Organization (WHO). This harmonization means a more uniform worldwide standard. To give manufacturers and practitioners the opportunity to fully understand the revisions, FDA and industry will conduct communications outreach to clinicians and hospitals. 

USP and FDA are now starting work on a third stage of revisions to the heparin standards, which will involve laboratory research designed to bring even greater sensitivity and precision to the tests and standards used to help ensure drug quality.

Articles

A second round of revised quality standards for heparin became effective recently, the U.S. Pharmacopeial (USP) Convention has announced.

Supply of heparin further secured

Independent pharmacies are seeing more competition each year as chain pharmacies pop up across the United States. Owners of independent pharmacies are focusing more every day on niche services as they strive to stand out to customers. 

Wholesalers and fellow pharmacists nominate candidates in the following categories: 

Marge McCoy, RPh, and Richard McCoy, RPh. 

Marge McCoy can spot a case of shingles yards away. She can tell when medication is not going to be enough to help her patients even before they know what's wrong with them. That professional vigilance and willingness to do whatever it takes to serve patient needs are the hallmarks of the services she and her husband provide day in and day out. 

The McCoys counsel every patient who comes into the pharmacy on a first visit to fill a prescription. It doesn't matter whether the patient has been taking the medication for 30 years, Marge said. She'll still counsel them. "I don't care whether they're a doctor. It's my job. I won't let them get away without it." 

Some pharmacies, she said, try to focus on getting customers in and out as quickly as possible and later brag about convenience. But Lopez Pharmacy tries to get away from the "fast-food medicine" mentality. The McCoys will take as much time with a patient as necessary. 

"I'm going to do whatever it takes to make sure my customers have the best outcomes," Marge said. She and her husband have delivered medications to senior citizens who are unable to travel and parts for durable medical equipment to patients' homes. 

But none of their other services match the care the McCoys give their patients. They know all of them by name and will accompany them, if necessary, to the clinic located behind the pharmacy. "Because we're on an island and medical care is a little bit unique, we're available 24 hours a day, seven days a week," Marge said. "Our doctor will call us at home if he needs something. Patients will call us at home or just stop by our house." 

Each year, pharmacists who offer special services are recognized by their peers and wholesalers through nominations for Drug Topics' annual Top Independent Pharmacists awards in categories pertaining to service, competition, crisis response, and merchandising/promotion. This year's awards honor pharmacists in Washington State, North Carolina, Illinois, and New York.

Superstars of community pharmacy

Business Roundtable’s Partnership for Disaster Response today released the findings of its 2009 Flu Season Survey, which provides data on how companies are preparing for H1N1 Influenza, flu season and their top concerns about the potential effects on employees, customers and business operations. 

The surveyors investigated the ways that businesses are preparing in light of the 2009 flu season and growing public anxiety around the resurgence of H1N1 Influenza. Following the outbreak of H1N1 Influenza in April, Business Roundtable’s Partnership for Disaster Response fielded a survey among its member companies which represent nearly 10 million employees and one-third of the U.S. economy - to provide the federal government with a snapshot of the private sector’s level of preparedness. 

“The results of our 2009 Flu Season Survey show that U.S. companies are taking the flu very seriously and making great efforts to prepare appropriately,” said Michael Dan, Chairman, President and CEO of The Brink’s Company and chair of Business Roundtable’s Partnership for Disaster Response “Additionally, we’re seeing that companies are using creative channels to communicate key information and updates to their employees, consulting trusted resources such as the CDC and WHO.” 

While the survey found that companies are making flu preparation efforts a top priority, many still had a number of concerns, specifically a desire for more information and clarity on the H1N1 vaccine, definitions of severity as they relate to the flu and the government’s plans should the flu become more widespread. 

During a conference call Wednesday morning, John Castellani, president of Business Roundtable said, “The top-line findings discussed today are a reminder of how it is incumbent on the business community to work together with the government and other key parties to protect the health and well-being of our employees, fellow citizens and the communities in which we live and work.” Other key findings of the survey included: 

Ninety-five percent of companies have business continuity and crisis plans in place that specifically address flu-related issues; 

Eighty-nine percent of the companies with business continuity and crisis plans either activated or updated the flu plans since April 2009 because of the H1N1 Influenza outbreak; 

Two-thirds of member companies said their number-one concern is the H1N1 Influenza vaccine; 

Thirty-five percent of respondents expressed a basic need for information about and clarity on the severity of a H1N1 outbreak as compared to seasonal flu.

Business Roundtable is working closely with the federal government to communicate important updates and to address the concerns of its member companies during the 2009 flu season.

Business Roundtable?s Partnership for Disaster Response today released the findings of its 2009 Flu Season Survey, which provides insights on how companies are preparing for H1N1 Influenza.

Business Roundtable's Partnership for Disaster Response releases survey results

The Food and Drug Administration (FDA) has announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks. 

REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission. The draft guidance for industry titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications” 

Provides FDA’s current thinking on the format and content that industry should use for submissions of proposed REMS * describes each potential element 

Includes preliminary information on the content of assessments and proposed modifications of approved REMS * describes REMS policies for certain regulatory situations 

Informs industry about who to contact within FDA about a REMS 

Indicates FDA Web sites where documents about approved REMS will be posted 

Provides an example of what an approved REMS might look like for a fictitious product. 

“With this new guidance, manufacturers will have a useful blueprint for how to develop these important safety strategies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. The draft guidance is available at www.fda.gov.

The FDA has announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies.