The tension between the duty of pharmacists to serve the health needs of patients and the duty to be "gatekeepers" to prevent drug diversion creates an environment that leads some to conclude that controlled substances are "bad" and that selling them only leads to legal entanglement. That mindset is especially prevalent with regard to the so-called "exempt narcotics" in the Schedule 5 category of cough syrup. It is not uncommon for pharmacists to either refuse to sell or even carry these nonprescription medications out of fear that they may be prosecuted or lose their licenses to practice. This attitude is most unfortunate, because the products are useful and effective when used in proper circumstances. However, there have been enough cases involving allegations against pharmacists for unlawful sales that reluctance to provide the medications is understandable.
A new case1 may be helpful in bringing prosecutors who think pharmacists should not sell these drugs under any circumstances back to reality. If that happens, pharmacists should be able to feel more more secure legally and professionally when they do decide to sell these codeine-based products at the request of patients.
A Toledo, Ohio, pharmacy was inspected by the Board of Pharmacy agents on August 5, 1996. The agents inspected and seized the pharmacy's exempt narcotics book, in which the pharmacy recorded the sales of nonprescription Schedule 5 medications.
State regulations2 require that before a sale of drugs in this category can be sold, a pharmacist must require the purchaser to provide identification, including proof that he or she is over age 18 and establish a legitimate medical need for the preparation. The pharmacy must maintain a bound record book of exempt sales in which is entered the name and address of the purchaser, the type and quantity of the substance sold, the date and initials of the dispensing pharmacist. The pharmacy is not permitted to sell an additional amount of the medication to the same purchaser within a 48-hour period.
After analyzing the exempt narcotic book, the board of inspectors concluded that the pharmacy sold excessive quantities of the drugs to certain individuals and violated the 48-hour rule on numerous occasions. The Board of Pharmacy instituted administrative proceedings to revoke the licenses of the pharmacy and its pharmacist owner. It also initiated criminal charges against the pharmacist. In May 1997, the Lucus County Grand Jury handed down a 100-count felony indictment charging the pharmacist with 80 counts of drug trafficking and 20 counts of violating the 48-hour rule.
The pharmacist pled not guilty on all charges and asked the trial court judge to dismiss the 80 counts of drug trafficking. He claimed that under Ohio law, a pharmacist who sells exempt narcotics in his professional capacity cannot be charged with this crime. The judge agreed and, in June 1998, dismissed those claims.
The State appealed that action and the Ohio Court of Appeals reversed, finding that there are circumstances when pharmacists could be found guilty of drug trafficking.3 It based its decision on an earlier case in which a physician was found guilty of drug trafficking for issuing controlled substances prescriptions in exchange for sexual relations. In that case, the physician was found to have violated a medical board regulation pertaining to the details of the proper prescribing of controlled substances. The appellate court reasoned that violation of this regulation could provide a basis for charging a violation of the drug trafficking statute. Applying that precedent to this case, the court remanded the case back to the trial court with instructions to reinstate the original charges.
Before trying the case, the state withdrew some of the charges for lack of evidence. The court also dismissed some individual counts. By the time the case went to the jury, 35 counts of drug trafficking and three counts of violation of the 48-hour rule were left. The jury acquitted the pharmacist on the 48-hour rule allegations but convicted him on all drug trafficking charges. The pharmacist was sentenced to one year in jail and imposed a $52,500 fine. The judge suspended the prison sentence pending the pharmacist's satisfactory completion of a 5-year term of probation.
This time around, the pharmacist was exonerated. The Appeals Court noted that the statute on which the criminal charges were based specifically excludes pharmacists from prosecution when selling medicinal quantities of exempt narcotics. It found that its earlier ruling finding that pharmacists could be guilty of the crime was "correct in general terms, but misleading in view of the evidence presented at trial." That evidence suggested that the pharmacist violated the Board of Pharmacy regulation requiring the pharmacist make a "good faith" determination that the purchaser of exempt narcotics has demonstrated a legitimate medical need for the medication. The criminal statute excluding pharmacists from prosecution does not reference that regulation and does not impose a "good faith" requirement before application of the exemption. The Appeals Court noted that the trial court judge "unfortunately" read the first appellate decision as implying that the jury had to be instructed that the regulatory "good faith" requirement was an element of the statutory crime that the pharmacist was charged with violating. Because of this error, the drug trafficking charges should have been dismissed (as they originally were) and the conviction was vacated.
Over five years have elapsed since the investigation of this pharmacist began. He has been subjected to a roller coaster ride of emotions that have cost him a great deal of time, money, professional status and humiliation. Before the trial started, the drug trafficking charges were dismissed. That would be a cause for celebration. But a year later, the Court of Appeals reinstated the charges. That had to be a great disappointment. Then the trial comes along. But the pharmacist is successful in paring down the vast majority of allegations against him. Only three of the 20 claims that he violated the 48-hour rule remained and the jury found him not guilty of any of these charges. Forty-five of the original 80 drug trafficking charges were dropped. There had to be a large measure of comfort in these events. But then came the conviction, sentence and fine on the remaining 35 counts, another cause for certain depression. Then along comes the Court of Appeals a couple years later saying the trial court judge was right all along--the pharmacist is not guilty of these crimes after all. With the zeal displayed by the prosecutors so far, it would not be surprising if the pharmacist withholds his glee, at least until time for an appeal to the Ohio Supreme Court runs out.
Is this possibly a travesty of justice? Most pharmacists would likely think so. Here is a prosecution that has unquestionably ruined this pharmacist's livelihood and professional reputation. And to what end? After years of pursuing this pharmacist and spending tens if not hundreds of thousands of taxpayer dollars, are the people of Ohio any better off? Is pharmacy any better off? The state has nothing to show for its efforts unless a ruined life is considered some kind of victory.
Of course, there will be the skeptics out there who believe that this pharmacist must have done something wrong or he would not have been investigated in the first place. This kind of negative thinking would support the notion that the pharmacist scooted on a technicality. Before giving these skeptics their due, look at the facts that gave rise to this saga. Four years' worth of pharmacy records were reviewed by the Board's inspectors. In those approximately 1,450 days, the inspectors found surface evidence of 80 instances of alleged wrongdoing, including what appears to be 20 instances of violating the 48-hour rule. That translates to one violation every 18 days or so. And that is the worst-case scenario. By the time this case gets to trial, the prosecutors are only going to have 35 charges of improper sales left, and three of those are for violating the 48-hour rule; and the evidence is not enough to convince the jury on any of these latter charges. This would mean the pharmacist made a wrongful exempt narcotic sale every 40 days on average. Maybe it is being too gratuitous but this does not look like the source of any major drug diversion ring. But wait, there is more. Look at the evidence that was presented to the jury. The best the prosecutors could show is that the pharmacist failed to make a good-faith determination on each of the 35 instances charged that the purchaser was buying the cough syrup to treat a legitimate medical condition. Probably the pharmacist could not show his good faith because he did not even remember making the sales. One exempt narcotic sale every 40 days or even every 18 days would not rise to the level of consciousness, let alone be remembered three or four years later by most pharmacists.
The biggest problem with this case is what it will stand for in the minds of many pharmacists. At some point in time this case crossed over the line between prosecution of a crime and became persecution of an individual. The intimidation factor will no doubt ring loud and clear. Look what can happen if the government thinks you are doing something wrong, even when you are not. The ultimate vindication of the pharmacist pales in comparison to what he had to go through to clear his name. The real shame is that those pharmacists who have been reluctant to sell or stock Schedule 5 cough syrups will likely strengthen their resolve after reading this story. That is the saddest part, because patients who could benefit from the proper use of these drugs will have the option foreclosed.
The real lesson of this case should be much different. The pharmacist won. Yes, he paid a big price but he had the fortitude to keep fighting until he was successful. The rule of law, whether Board of Pharmacy members, their inspectors, the police, or anyone else with enforcement authority, like it or not, is that pharmacists have the right to sell Schedule 5 cough syrups and that activity cannot be criminalized by some twisted reading of the statutes. Maybe this pharmacist did do something wrong. Maybe he was selling excessive amounts of the medications. Even if that were true, it should not be called drug trafficking.
It took the Ohio Court of Appeals two grabs at the ring before getting it right but they did, finally. Although they did not say it explicitly, they almost apologized for erring the first time around. It is amazing that these judges were even candid enough to admit their earlier opinion and holding was "misleading." The hardest part of interpreting this is trying to determine what they mean now. In the first case, when they wrote that there are circumstances under which pharmacists can be found guilty of drug trafficking (without describing what those circumstances might be), did they not mean what they said? Or did they change their minds? Or maybe they just believed the evidence was so undeniably weak that it made the idea of charging this pharmacist with drug trafficking look ludicrous. It really does not matter; the outcome is still sloppy. It should have never gone this far. It hurts everyone. Pharmacists will continue to be intimidated. Worse, fewer patients will be given the option of using these medications.
1. Ohio v. Hutton, Slip Op No L-00-1285 (February 22, 2002), 2002 Ohio App Lexis 753. 2. Ohio Adm. Code 4729-11-09. 3. Ohio v. Hutton, Slip Op No L-98-1199 (December, 1998) 1998 Ohio App Lexis 5886.