Pharmacy law ‘doesn’t match’ industry technology, say healthcare lawyers
Pharmacy law “doesn’t match” the technological developments in pharmacy, leaving “grey areas” for pharmacists, healthcare law firm Charles Russell has warned.
Charles Russell associate Noel Wardle criticised current legislation for not adapting to innovations such as remote dispensing machines, collection points and pharmacy websites. “The legislation just doesn’t match what people would like to do with their pharmacies,” he explained.
Mr Wardle said this left “grey areas” in pharmacy law. He referred to the current laws on supervision, which do not take into account possible modern methods of supervising through remote devices.
“The legal definition of supervision is ‘in a position to intervene’ but this has a very different meaning in 2011 than it did when the law was created,” he said. Mr Wardle said this created confusion over the legal position of devices such as remote dispensing machines, where pharmacists communicate with patients by telephone.
He added that he felt these machines contradicted pharmacies’ NHS Terms of service, which say that services must only be provided on registered pharmacy premises.
Remote collection points were also cited as a source of confusion, because of discrepancies between the relevant legislation and guidance. Although it is legal for collection points to operate outside pharmacy premises, Royal Pharmaceutical Society guidance stipulates that remote collection points should only operate in remote areas after consultation locally.
Mr Wardle warned the wider introduction of remote machinery would have considerable legal implications for the sector.
He was speaking at a Charles Russell conference on pharmacy law, held in London on February 2.
Tennessee legislators introduce legislation to help fight meth production
Senator Mae Beavers (R – Mount Juliet) and Representative Debra Maggart (R – Hendersonville) introduced legislation [SB 325/HB 234] today that calls for the adoption of a statewide, industry-funded electronic tracking system, called NPLEx (the National Precursor Log Exchange), to monitor and stop illicit purchases of over-the-counter cold and allergy products containing pseudoephedrine (PSE), an ingredient sometimes used to illegally manufacture methamphetamine. The bill provides an alternative, less-intrusive solution to the prescription-only bill (HB 181) introduced last week.
“This kind of government intrusion in our lives is not the solution we need to attack the meth problem in Tennessee,” Sen. Beavers, the bill’s sponsor in the Senate said. “We should not punish the tens of thousands of innocent Tennesseans who need this over-the-counter medication to get at the criminals who are using the drug illegally to produce meth when there is another approach which is very effective. Our legislation offers a proven, effective, non-governmental solution to the problem, without pushing up the cost of the medication on consumers by requiring them to visit a physician to obtain a prescription.”
There is currently no mechanism in place in Tennessee to block illegal sales in real time, as many pharmacies and retailers rely on handwritten, paper logbooks to track purchases. As a result, criminals have learned to circumvent the current system. SB 325/HB 234 would provide a secure, interconnected electronic logbook that allows pharmacists and retailers to refuse an illegal sale based on purchases made elsewhere in the state or beyond its borders. Most importantly, SB 325/HB 234 preserves access to the PSE medicines consumers rely on and trust for cold and allergy relief.
“For all law-abiding Tennesseans, the experience of buying cold and allergy medicines containing pseudoephedrine at the local pharmacy will not change,” Rep. Maggart, the bill’s sponsor in the House of Representatives said. “However, for those looking to purchase more than their legal limit, this system will immediately deny the sale, and law enforcement will possess a powerful tool to track down these individuals when they attempt to do so.”
In the four states that have fully implemented e-tracking technology, nearly 40,000 grams of illegal PSE sales per month are blocked. The system, which provides local law enforcement officials with precise data on who is attempting to buy illegal amounts of PSE, also helps law enforcement find meth labs.
“NPLEx is effective because it prevents the illegal sale of pseudoephedrine from ever happening in the first place,” Carlos Gutierrez, a state government relations consultant at the Consumer Healthcare Products Association said. “Electronic blocking technology gives law enforcement the ability to identify meth cooks, not only in Tennessee, but across state lines and in real time.”
The leading manufacturers of over-the-counter medicines containing PSE, represented by the Consumer Healthcare Products Association, are working closely with state legislators and law enforcement to help implement NPLEx technology to pharmacies and retailers in Tennessee free of charge.
SB 325/HB 234 is supported by the Tennessee Pharmacists Association, the Asthma and Allergy Foundation of America, and the Tennessee Chamber of Commerce & Industry. If passed into law, SB 325/HB 234 would make Tennessee the 13th state to pass legislation requiring a statewide e-tracking system to block illegal sales of medicines containing PSE. The NPLEx system would be fully integrated into Tennessee pharmacy systems by January 1, 2012.