Pharmacists split on new mail-order regulations



To some observers, a new law to protect people who get their prescriptions by mail was a win for Georgia consumers.

To others, it’s superfluous regulation that will jack up the cost of those medications and do nothing more to safeguard them.

When the Georgia Board of Pharmacy adopted a controversial set of rules regulating mail-order drug shipments from out of state last month, it split the pharmacy industry.

Retail pharmacists in the state say it's only fair that the mail-order houses abide by the same rules they do and say that the rules will increase safety. Companies with mail-order pharmacy interests including CVS Health, RxDirect and Humana Pharmacy Solutions took issue with some of the regulations and wrote to the state board saying so.

But the board unanimously approved the regulations, saying in a statement that the rules “will better ensure that patients receive safe and effective prescription drugs …”

The governor-appointed, eight-member board is made up of seven licensed practicing pharmacists and one consumer who regulate pharmacists and pharmacies in Georgia.

Two of the new rules drew the most attention. One requires that the patient or patient’s representative sign for any controlled substances upon delivery. Those prescriptions can’t just be left unsecured in mailboxes or at the door. Not all prescription drugs will require a signature.

One home-delivery pharmacy wrote in a letter to the board that the signature requirement would delay prescription deliveries and substantially increase delivery costs.

Another regulation that drew opposition requires that packages containing temperature-sensitive medications such as antibiotics and insulin have a measurement device inside to alert consumers if the drugs have been exposed to temperatures that could affect their potency and stability.

Until legislation was approved last year, pharmacies not in the state didn’t need a license to ship drugs to Georgia, which became the 48th state to require licensing. So, there were no rules governing shipping.

Now, any out-of-state pharmacies that want to ship into Georgia must be registered with the board and comply with its rules. The new rules apply to pharmacies in Georgia that ship by mail as well.

Beth Stephens, health access program director at Georgia Watch, a consumer advocacy watchdog group, said, “There is a large benefit to consumers to regulate out-of-state pharmacies.”

Pharmacies that ship drugs from elsewhere into Georgia already are required to be licensed in their home state.

Just how much of a problem unregulated mail-order drug deliveries pose is unclear.

Some 15-16 million prescriptions for controlled substances were shipped into Georgia in 2013, Tanja Battle, executive director of the Georgia Board of Pharmacy, said, citing data from the Georgia Prescription Drug Monitoring Program, a statewide electronic database. That does not include prescriptions for all types of drugs shipped into the state, however.

Because there was no previous oversight, consumers could not file complaints with the board regarding out-of-state pharmacies. And no official data was collected on problems related to temperature control or medications left unattended after delivery.

Without regulation, board vice-chairman Laird Miller said it is possible that some dangerous drugs left in mailboxes or on doorsteps could be diverted to the streets.

The Georgia Pharmacy Association, a state pharmacists’ trade group, said it took no formal position on the new regulations. But, “We do believe that requiring signatures for certain addictive medications delivered via mail order is a reasonable precaution that protects the public health,” said Scott Brunner, executive vice president and CEO.

He said the board is only requiring out-of-state pharmacies to follow a “similar standard of care as that required of retail pharmacies in Georgia.” He added, “The new Georgia (regulations) are reasonably consistent with those previously adopted by 48 other states.”