The MedSafe Compliance Corner

The Food and Drug Administration today announced the publication of a Request for Applications for grants to support the development of new animal drugs intended for minor species or minor uses in major species. (Major species are horses, dogs, cats, cattle, pigs, turkeys and chickens.)

• Cloud Computing Guidance Issued by NIST
• Drugmaker User Fee Passes Senate
• FDA Announces NARMS Strategic Plan 2012-2016
• FEMA Provides Emergency Alerts to Public Through Cell Phones
• Breach of Health Care Information at Boston Children’s Hospital

On July 13^th, Connecticut Governor Dannel Malloy signed into law an important bill aimed at protecting healthcare workers from workplace violence. Titled “An Act Concerning Workplace Violence Prevention and Response in Health Care Settings,” it became effective on July 1, 2011. 

 On April 19, 2011, the Obama Administration released a comprehensive action plan designed to address the national prescription drug abuse epidemic while protecting the delivery of effective pain-management. There are several Federal agencies cooperating with the endeavor, including the Departments of Justice, Health and Human Services, Veterans Affairs, the Department of Defense and the Food and Drug Administration (FDA).

 In 2007, OSHA had issued a final rule regarding personal protective equipment (PPE), titled "Employer Payment for Personal Protective Equipment," which became effective on February 13, 2008. In February, 2011, OSHA issued a new directive for OSHA enforcement personnel titled "Enforcement Guidance for Personal Protective Equipment in General Industry," to assist personnel when performing facility inspections. The recent instruction provides enforcement guidance and clarifies that employers must pay for PPE required to comply with OSHA standards, except in the limited cases specified in the standards.  

The Department of Justice announced on March 14 that the long-awaited new Americans with Disabilities Act (ADA) Final Rules are effective as of March 15, 2010. The Rules affect Title II (state and local governments) and Title III (Public Accommodations). "Public Accommodations" includes clinics, doctor's and dentist's offices, emergency preparedness shelters, pharmacies, stores, restaurants-- essentially any business establishment open to the public.

Allergies among animal handlers are a frequent and common occurrence.  One of the more serious problems caused by a work-related allergy is occupational asthma.  Both the National Institute for Occupational Safety and Health (NIOSH) and OSHA have expressed concerns about the number of animal handlers affected by this disease.  According to the Centers for Disease Control and Prevention (CDC), the number of all asthma sufferers is growing at an alarming rate---it has more than doubled over the last 20 years.  According to the American Academy of Asthma, Allergy and Immunology (AAAAI), it is estimated that over 10 million people now suffer from the allergic type of asthma, with another 10 million affected by non-allergic asthma.

 For the more than 385,000 healthcare personnel (and untold numbers of other professionals), who experience needlesticks and other sharps-related injuries each year, a new, recently published study has some encouraging news. The study compared the actual safety outcomes of active vs. passive safety engineered devices, and the results show that passive devices outweigh active devices in effectiveness, providing a good reason to upgrade to this type of instrument.

Finally, Congress has passed, and the President has signed, an amendment to the Controlled Substances Act called the Secure and Responsible Drug Disposal Act. The law will give users a method to safely dispose of unwanted or expired prescription drugs—including controlled substances.

According to OSHA and NIOSH, animal handlers, including veterinarians and veterinary technicians, have an increased risk of developing occupational asthma from exposure to allergens such as animal dander, scales, fur, body wastes, and saliva.