As a health care provider, I am concerned with the epidemic represented by Meth-amphetamine; however I feel that these current efforts are misguided,and the problems requirea a reconfigureation of the fight against this difficult issue.
As I teach interns, the classification of legend drugs and the availability of OTC drugs are based on 2 concepts:
1) OTC drugs must meet the minimum requirement that they be safe and effective and be able to be used as directed without medical supervision. Any drug that does not meet these requirements is classified as (prescription only) a legend drug
2) The schedules are "controlled drugs" 1-5 the smaller the number, the greater the "potential for abuse" Many prescription cough syrups are a schedule 5, morphine is schedule 2 and "no legitimate medical use" i.e. cannabis and heroin are schedule 1.
That said, this legislation puts further requirements on pharmacies to preform law enforcement functions. In my 15 years of pharmacy practice, I've encountered alot of fraud. I've attempted to report on various occasions. There is NO enforcement agency (local, state, or federal) that is interested in dedicating resources to investigate and prosecute pharmaceutical diversion originating at the pharmacy counter. So the pharmacist becomes the enforcement agency by default. Like no child left behind, what are the resources backing up the pharmacist trying to do the right thing? NONE. So, when a pharmacist discovers that they've been duped, the only real world recourse is to deny further service to that individual, and he/she becomes some other pharmacist's problem.
This legislation would give another club to enforcement agencies to go after hard working pharmacists who try to do the right thing, but may have been lax with paperwork. Ask any pharmacist: it is outrageous the government and insurance industry mandated paperwork that we must already comply with (and for less and less reimbursement dollars.) What has been happening, and what will continue to happen is pharmacies will discontinue all sales of pseudoephedrine. I have done this already. The paperwork is too cumbersome to maintain.
When the enforcement agencies come to pharmacies, they are "looking for a way to nail you." This proposed legislation puts pressure on the providers to conform with even more documentation requirements. As I said, it simply makes pharmacies decide to not carry the product at all. Which quite frankly is a disservice to the general public.
Realistic legislation would do the right thing: reclassify the entity as a prescription item, perhaps even a Schedule 5. If lawmakers are concerned about abuse, it should carry the proper classification. As a result of making pseudophedrine prescription only, the insurance companies would be obligated to pay for it. But at least the effective drug would be available to the public. Where the road that these laws lead is non-availability. These legislative initiatives are ineffective Band-Aids that outsource enforcement to the wrong people.
I am also licensed in BC Canada. They, like many other countries, Canada has "pharmacist only" dispensing. It has a category of medications that are not "prescription only" but require review and dispensing by only a pharmacist. This would be the Logical intervening step. Plan B birth control, Pseudophedrine, NSAIDS, PPI's and many others carry risk to certain patients, but can be sold at the local Kwikie-Mart by a 16 year old. You have to be 21 to sell booze - why are drugs all or nothing? Either a doctor prescribes, and a pharmacist dispenses, OR a kid at the corner store sells it to you. There needs to be a middle ground for trained licensed pharmacists to dispense medication not widely available in bottles of 1000 at Costco.
Mickey Lim, RPh
