To help pharmacies meet the legislatively mandated goal of providing useful written consumer medication information (CMI) to patients by 2006, the FDA has issued a draft guidance. The guidance gives recommendations not only on what drug information should be provided to consumers, but also in what sequence, type size, etc. If pharmacies' voluntary CMI efforts fail to meet FDA standards by next year, the agency could resort to a mandatory approach. For more information, refer to the May 26 Federal Register or click on www.fda.gov/cder/guidance/index.htm.
FDA offers guide to patient package inserts To help pharmacies meet the legislatively mandated goal of providing useful written consumer medication information (CMI) to patients by 2006, the FDA has issued a draft guidance. The guidance gives recommendations not only on what drug information should be provided to consumers, but also in what sequence, type size, etc. If pharmacies' voluntary CMI efforts fail to meet FDA standards by next year, the agency could resort to a mandatory approach. For more information, refer to the May 26 Federal Register or click on http://www.fda.gov/cder/guidance/index.htm.
Tracking system launched to combat drug counterfeiting SupplyScape Corp. and Unisys Corp. unveiled a pilot program designed to help safeguard the flow of prescription medicines from the manufacturer to the pharmacy. The goal is to establish a national standardized tracking system that would increase consumer safety and reduce drugmakers' growing losses from fraud. The pilot project, an electronic drug pedigree, is a certificate of authenticity detailing a drug's movement through the supply chain. The initial pilot will track the distribution of one of Purdue Pharma's analgesic products from the manufacturing facility to wholesaler H. D. Smith. The system will incorporate radio frequency identification or bar codes to match each medication container with its corresponding pedigree.
CVS severs ties to secondary wholesalers CVS, the nation's largest retail pharmacy chain, reported that it would no longer purchase pharmaceuticals from wholesalers that trade in the secondary drug market. It will purchase pharmaceuticals only directly from manufacturers or from wholesalers that certify they are not trading in the secondary market. CVS noted that when the company is unable to receive those assurances, those wholesalers' contracts would not be renewed.
FDA warns against DXM abuse The public is being warned by the FDA about potential harm from the abuse of dextromethorphan (DXM), a synthetically produced ingredient found in many OTC cough and cold remedies. The agency is working with other health and law enforcement authorities to address this issue following the deaths of five teenagers that may be associated with the consumption of powdered DXM sold in capsules. Abuse of DXM can cause brain damage, seizure, loss of consciousness, and irregular heartbeat. DXM abuse is not a new phenomenon, but it has developed into a new trend, which involves the sale of pure DXM in powered form. This pure DXM is often encapsulated by the dealer and offered for street use. Additional information can be found at http://www.family.samhsa.gov/get/otcdrugs.aspx.
North Dakota regulates PBMs North Dakota's Gov. John Hoeven signed into law a bill regulating the pharmacy benefit management industry. The law includes PBM disclosure and transparency requirements, an any-willing- provider provision, and a study of PBM practices. The new law was applauded by NCPA, which worked with the North Dakota Pharmacists Association to secure passage of the legislation.
DEA allows LTC automated dispensing As of June 13, DEA will, where permitted by state law, allow retail pharmacies to install automated dispensing systems in long-term care (LTC) facilities. Pharmacies installing automated devices will be required to have a separate DEA registration for each LTC facility, but they will not be charged a fee for each location. Automated devices will reduce drug waste, costs, labor, and medication errors, according to DEA, which published its final notice in the May 13 Federal Register.