Oregon Implements New Drug Storage Rules for Pharmacies: Will Your State Be Next?

Posted in: Pharmacy
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Like many State Boards of Pharmacy across the United States, the Oregon State Board has limited rules on the storage of drugs. But that’s about to change

Beginning January 1, 2016, pharmacies throughout Oregon will face new, stricter requirements surrounding the proper storage of drugs, cold storage monitoring and drug vaccine storage.

Here’s a of Oregon’s new rules:

  • A pharmacy must store all drugs at the proper temperature according to manufacturer’s published guidelines.
  • For pharmacies that store vaccines: A system of continuous temperature monitoring with automated data logging and physical confirmation must be utilized. Documentation of the temperature of each active storage unit must be logged at least twice daily, data must be downloaded weekly, and system validations must be conducted quarterly.
  • All drug refrigeration systems must be measured continuously and documented either manually twice daily to include minimum, maximum and current temperatures or with an automated system capable of creating a producible history of temperature readings.
  • A pharmacy must adhere to a monitoring plan, which includes, but is not limited to . . . maintenance of records of temperature logs for a minimum of three years.

According to the Oregon State Board’s meeting minutes on the topic, the new rules are . The Board’s compliance director, Gary Miner,
indicated that some of the Centers for Disease Control and Prevention’s (CDC) guidelines were incorporated into the draft rules.

To deliver safer, more effective services to patients, it seems likely that other State Boards of Pharmacy may follow suit.

Many Oregon pharmacies scrambling to prepare for new compliance requirements—as well as forward-thinking pharmacies across the country—are halting their manual temperature monitoring processes in favor of automated solutions. That’s because manual monitoring systems—which can result in missed checks, inaccurate readings and incomplete documentation—create increased risks to both compliance and patient safety. Manual monitoring can also reduce a pharmacy’s profitability. Indeed, it increases the chances for inventory loss and is a tedious and time-consuming use of a pharmacy’s skilled human resources.

Today’s top automated environmental monitoring solutions offer a range of features—from continuous monitoring and preventative alerting to meticulous reporting and documentation tools—which can help pharmacies ensure compliance, even in the face of tightening drug storage requirements.

November 13, 2015
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