Pharmacists’ Corresponding Responsibility

What is a pharmacist’s “corresponding responsibility”? Corresponding responsibility requires pharmacists to refuse dispensing prescriptions to people they know or have reason to know that the presented prescription 1) is a fake or illegal, 2) is written not based upon a valid medical reason, and 3) while properly secured is being consumed incorrectly or abusively. Pharmacists can lose their license for violating this corresponding responsibility!

The pain medication overdose epidemic stemming in part from properly secured medications dispensed to injured athletes of high school and college sports departments, and now society as a whole, has created huge pressure on state and federal authorities. Their secondary response (aside from prosecuting the prescription writing doctors) is to target the pharmacist and pharmacy dispensing the schedule II medication. Stripping pharmacists of their professional licenses (state and federal DEA dispensing authority) for violating their corresponding responsibility is the new battled ground in the war against drug addiction and dependence.

Federal and state prosecutors are bringing professional license disciplinary prosecutions against pharmacy owners and the pharmacists by claiming violations of their corresponding responsibility. Prosecutors seek to portray these pharmacists as mere conduits for bad doctors selling prescriptions. The process begins when a doctor is charged with selling prescriptions. Either set up and targeted in a sting or simply being caught by Federal DEA investigators, these doctors are typically criminal charged federally and go to jail. While the doctor’s license is emergently revoked during the pendency of their federal criminal prosecution, the DEA and the state pharmacy investigators turn their attention to the pharmacy which was filling (dispensing) that bad doctor’s prescriptions.  Mandatory monthly regulatory compliance audits of the same pharmacies, which pharmaceutical suppliers and health insurance prescription plans must conduct, corroborate the specific pharmacists who were filing the fake, fraudulent, or abusive prescriptions.

21 CFR §1306.04, Purpose of issue of prescription, the Code of Federal Regulations, CFR) states

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Pennsylvania’s Drug Act counterpart is 28 Pa. Code § 25.52, which states:

(a) A prescription for a controlled substance must be issued for a legitimate medical purpose by a licensed practitioner in the usual course of professional practice. The responsibility for proper prescribing of controlled substances is upon the practitioner but a corresponding responsibility rests with the pharmacist who dispenses the medication and interprets the directions of the prescriber to the patient.
(b) A prescription may not be issued by a practitioner to obtain controlled substances for use in his routine office practice nor for general dispensing to his patients.
(c) A prescription may not be issued for the dispensing of controlled substances listed in any schedule to a drug dependent person for the purpose of continuing his dependence upon such drugs, nor in the course of conducting an authorized clinical investigation in a narcotic dependency rehabilitation program.

What are pharmacists to look for in fake or fraudulent prescriptions? A list of red flags that present to a pharmacist reasons not to fill a prescription include:

1) Some patients, in an effort to obtain additional amounts of legitimately prescribed drugs, alter the practitioner’s prescription, to secure high drug amounts by:

a) providing a different call back number to verify the prescription,
b) calling in their own prescriptions and give their own telephone number as a call-back for confirmation, and
c) stealing legitimate prescription pads from practitioner’s offices and/or hospitals and prescriptions are written using fictitious patient names and addresses.

2) Suspicious activity includes any combination of :

a) different hand writing,
b) different color ink in the prescription,
c) cross outs or incorrect spelling of patient, doctor, or drug names,
d) incorrectly dosing in strength and quantity of controlled substances,
e) patients showing up with prescriptions of other people,
f) incorrect, old, or wrong addresses and telephone numbers,
g) photo copied prescriptions,
h) Prescriptions that look “too good” or too legible,
i) quantities, directions, or dosages differ from usual medical usage,
j) prescriptions that do not possess correct standard abbreviations,
k) prescriptions that present with textbook presentations, and
l) directions that are written in full with no abbreviations.

3) Prescriptions not written for a valid medical condition present as follows:

a) a prescriber writes significantly more prescriptions (or in larger quantities) compared to other practitioners in the area.
b) patients appear too frequently – not on a monthly basis;
c) prescribers who write prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time;
d) a number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician; and
e) people who are not regular patrons or residents of the community, show up with prescriptions from the same physician.

The manner and means of investigating what pharmacies and which pharmacists are failing perform their corresponding responsibility when dispensing schedule II prescriptions, for which doctors, patients, and drugs, is very easy. Historical reviews of drug company delivery records to pharmacists are now being conducted on bi-monthly. Drug manufacturers are routinely reporting to the state pharmacy board’s, DEA, and state attorney general narcotics enforcement officers suspect volume changes of schedule II narcotic orders, excessive increase in volume and ordering, and conducting their own investigation of doctors who are writing the prescription.

As a pharmacist, please call me to discuss allegations of your breach of your corresponding responsibility, how to defend it, and how we can protect your federal and state DEA dispensing licenses.

State Trooper Highway Automobile Dog Searches After the End of Traffic Investigation

This week the United States Supreme Court decided Rodriguez v.United States, 575 U.S. ___ (2015). The decision affirms a significant portion of Pennsylvania law in the area of extension of traffic stops beyond the initial motor vehicle code investigation. I have handled these cases in Cumberland, Lancaster, Montgomery, Bucks and Philadelphia Counties.

These cases routinely involve state troopers illegally extending basic traffic stop investigations into motor vehicle searches. These extended traffic stops discover illegal contraband leading to broader criminal charges. However, it is that extended search, based only upon a guess, hunch, or a simple illegal request to search, that is illegal.

Rodriguez v. United States rules illegal the extension of a traffic stop by calling in a dog sniff team without reasonable suspicion of criminal activity. The US Supreme Court previously stated that a dog sniff conducted during a lawful traffic stop does not violate the fourth amendment proscription unreasonable seizures. Rodriguez presents the question of whether the Fourth Amendment tolerates EXTERIOR dog sniffs after completion of a traffic stop, not during, when the time needed to handle the matter for such violation exceeds a reasonable time.

The Pennsylvania trial courts have addressed this scenario many times, leading a Chester County Judge to state, “there is a distasteful convergence of facts and circumstances … that test the bounds of credulity and requires the court’s candor in distinguishing between lawful police investigatory conduct and conduct proscribed by our Constitutions.” Commonwealth v. Parker, 2009 Pa. Dist. & Cnty. Dec. LEXIS 132 (2009)(Honorable Ronald C. Nagle, Chester County Court of Common Pleas). The Pennsylvania Supreme Court has consistently stated, “Where the purpose of an initial traffic stop has ended and a reasonable person would not have believed that he was free to leave, the law characterizes a subsequent round of questioning by the police as an investigative detention or arrest. In the absence of either reasonable suspicion to support the investigative detention or probable cause to support the arrest, the citizen is considered unlawfully detained.”

After police finish processing a traffic infraction, the determination of whether a continuing interdiction constitutes a mere encounter or a constitutional seizure centers upon whether an individual would objectively believe that he was free to end the encounter and refuse a request to answer questions. Commonwealth v. Kemp, 2008 PA Super 274, 961 A.2d 1247, 1253 (Pa. Super. 2008) citing Commonwealth v. Strickler, 757 A.2d 884 (Pa. 2000).

To determine whether interaction following a legal detention is a “mere encounter” or a detention, Pennsylvania courts analyze the totality of the circumstances including:

1) the presence or absence of police excesses; 2) whether there was physical contact; 3) whether police directed the citizen’s movements; 4) police demeanor and manner of expression; 5) the location of the interdiction; 6) the content of the questions and statements; 7) the existence and character of the initial investigative detention, including its degree of coerciveness; 8) the degree to which the transition between the traffic stop/investigative detention and the subsequent encounter can be viewed as seamless, . . . thus suggesting to a citizen that his movements may remain subject to police restraint; 9) the presence of an express admonition to the effect that the citizen-subject is free to depart is a potent, objective factor; and 10) whether the citizen has been informed that he is not required to consent to the search.

Commonwealth v. Moyer. Conferral of the ‘free-to-go’ advice is itself not a reason to forego a totality assessment’ and therefore does not constitute a controlling factor in assessing whether a person would actually credit a police indication that he was free to leave.”

In many of these cases, the police fabricate the basis for the late night car stop, picking some specious motor vehicle code violation. Allegations of traveling too closely, lane change without a blinker, a license plate lights out, obstructions from a rear view mirror, or illegal under car lights are typical deminimus traffic violations. Sometimes tickets are issued. More often than not, no warnings or violation is recorded.

After the individual is removed from the vehicle, basic cursory flashlight investigation and driver’s information computer checks are made. In many cases all is legal.  There is no evidence of criminal activity presented to justify either a consensual search or a request for a non-consensual search. Maybe two cell phones, a rental car, and a careful driver from out-of-state is present. Troopers routinely claim under oath that the person, wherever they are coming from, was traveling from a high drug area.

At this juncture, state troopers threaten dogs ripping apart vehicles. If this does not work, suggestions of long delays and “we will just get a warrant” followed by “we will then rip your car apart” are employed. These tactics are deployed to secure consent to search. It is when the search requests are denied, as in Rodriguez, that state troopers call in backup canine officers. Here the motorist must wait and is thus detained.

When the dogs arrive and conduct the exterior sniff, alerting to “contraband”,Troopers now claim reasonable suspicion to then enter the car for further searching. Rodriguez addresses the legality of this police tactic; extending an otherwise legal traffic stop that did not present reasonable suspicion of criminal activity, by requiring a motorist to wait for the canine sniff team for the exterior search which creates the only reasonable suspicion to then enter the car without consent.

It is now the law of the land that this is illegal. Rodriquez rules that the traffic stops become unlawful when prolonged beyond the time reasonably required to complete the mission of issuing a warning ticket. The seizure remains lawful only so long is unrelated inquiries do not measurably extend the duration of the traffic stop. The court ruled that a dog sniff, a measure aimed at detecting evidence of ordinary criminal wrongdoing, with out reasonable suspicion to do so extends illegally the duration of the traffic stop.

The Court squarely rejected the argument that an officer may incrementally prolonged a stop to conduct dog sniffs so long as the officer is reasonably diligent in pursuing the traffic related purpose of the stop. (The Court equated this to the officer earning bonus time to pursue an unrelated criminal investigation.) The magistrate’s finding that the detention for the dog sniff, which itself prolongs the traffic stop, was not independently supported by individualize suspicion, rendered illegal the extension of the traffic stop.

Call me to discuss your car investigation.

Good Moral Character? Moral Turpitude?

What is moral turpitude? What is good moral character? These questions arise in cases contesting a disciplinary action based upon a conviction of a misdemeanor or felony and in applications for reinstatement of a professional license after revocation. How does one prove that they are both a person of moral character and posses the moral turpitude that warrants either reinstatement or no disciplinary action?

Every licensing scheme possesses a provision allowing that licensing board to revoke or cancel a license when a licensee is found guilty of a felony charge or an felony or misdemeanor offense in conjunction with the practice of that license, or found guilty of conduct involving moral turpitude by court of competent jurisdiction or a jury. Moral turpitude is not defined in any of the licensing acts.  The Pennsylvania Supreme Court routinely defines moral turpitude to mean anything done knowingly contrary to justice, honesty, or good morals.  The terms good moral character and the lack of moral turpitude are used interchangeably to define each other in many cases.  ‘Fraud’ certainly has acquired a peculiar and appropriate meaning in the law. Black’s Law Dictionary 594 (5th ed. 1979) defines fraud as any kind of artifice employed by one person to deceive another.

In a March 2015 case, an individual convicted of 3rd degree murder, who served 10 years of a 10 year sentence, sought reinstatement of his podiatric license. He presented character witnesses, proof of some rehabilitative efforts, and efforts to maintain up-to-date on podiatric medicine continuing education requirements. The board rejected his application for reinstatement, concluding he had not presented sufficient evidence of rehabilitation and did not present sufficient remorse. Long v. Bureau of Prof’l & Occupational Affairs, 2015 Pa. Commw. LEXIS 130, (Pa. Commw. Ct. 2015).

Many cases state that the petitioner seeking reinstatement carries the burden of proof in establishing that they meet all of the licensure requirements for reinstatement. The pivotal issue on these types of cases, both for reinstatement and contesting disciplinary action, is what efforts were made by the licensee to rehabilitate their character such that they now or still possess good moral character to be trusted to hold a license at the time of reinstatement or disciplinary action. Garner v. Bureau of Prof’l & Occupational Affairs, 97 A.3d 437, 440, 2014 Pa. Commw. LEXIS 391, 5-7, 2014 WL 3734280 (Pa. Commw. Ct. 2014)

In reviewing the evidence a petitioner presents demonstrating good moral character, character witnesses, post jail release behavior, and the delay in time between criminal event and application for reinstatement are not enough. Proof of sufficient rehabilitation does not just include attending victim counseling, religious services, and paying restitution. Krichmar v. State Board of Vehicle Manufacturers, Dealers and Salespersons, 850 A.2d 861, 864 (Pa. Cmwlth. 2004), requires clear and credible expressions or evidence of remorse and corrective community action. Lack of remorse itself is a sufficient basis to deny reinstatement. Storch v. State Board of Vehicle Manufacturers, Dealers and Salespersons, 751 A.2d 263, 264 (Pa. Cmwlth. 2000).

Shallow and unimposing claims of entitlement to reinstatement that show little remorse for the victim of the crime will not carry the day. Licensing boards look for individuals to rehabilitate their character through established patterns of behavior that are honorable, trustworthy and consistent with the communities’ current ethical standards that show an absence of moral turpitude. The “determination of whether a crime involves moral turpitude turns on the elements of the crime, not on an independent examination of the details of the behavior underlying the crime.” Licensing boards will not re-litigate the facts underlying the criminal conviction.

Character witnesses must base their conclusions of an applicant’s credibility upon factual interaction and consensus amongst a large group of individuals. Bringing to a hearing just the respondent/applicant’s immediate social or family circle will not carry the day. Employment related job evaluations and supervisors and coworkers who may provide the Board with significant and weighty testimony about the applicant’s established pattern of honorable and trustworthy behavior consistent with current community ethical standards is a priority in the evidence presented.

Call me to discuss your disciplinary action or attempts at reinstatement of your professional license.

What Happens After Criminal Convictions

Criminal convictions of differing types affect your Pennsylvania professional license differently. If a licensee is found guilty, pleads guilty, or enrolls in the Pennsylvania’s ARD – pretrial diversion program, these criminal trial dispositions must be reported to your licensing board. If your guilty plea or conviction involves a felony Drug Act charge or relates to a Medicare/Medicare fraud from Pennsylvania or elsewhere, harsher disciplinary action my come quicker. Under either circumstance, the disciplinary process will soon commence.

All reported or discovered convictions (for any offense but especially DUI, forgery, credit card fraud, insurance fraud, or non-medical insurance fraud) generate petitions for discipline before the Pennsylvania Bureau of Hearings and Appeals. The actions seek to suspend, revoked, or discipline a license. Responding to these petitions in a timely and legally appropriate manner is the first step in insuring the professional maintains their professional life.

Once a licensee receives a petition for discipline (“A Rule to Show Cause”), they have thirty days from the date of receipt to file an Answer with the Prothonotary, sending a copy to the prosecutor. It is important for counsel to make only appropriate admissions to certain legal pleadings or allegations, raising affirmative defenses, and properly preserving objections to the evidence attached to the “Rule”. Once the “Rule” is timely responded to, meeting with counsel, organizing witnesses, and collecting exhibits to present both as an explanation of the criminal conviction and of who the professional is is the only way to properly preserve the licensee’s professional life.

Many cases address the type of mitigation evidence that can be presented. It is important to meet with counsel and corral witnesses, preparing them for what they can and can not say. Employment evaluations, continuing education credits, and character statements are also important documentary evidence that needs to be presented at these hearings. For the licensee, providing counsel with extensive and appropriate explanations of the criminal act, especially in case involving others (a conspiracy) is very important for these types of disciplinary hearings.

Case law discusses mitigation evidence appropriately presented in cases involving Medicare/Medicaid fraud and it’s Pennsylvania counterpart. It is appropriate in mandatory disciplinary cases to seek retroactive application of suspension time. Here, previously surrendering a license, long- term prosecutorial cooperation, and minimal participation in a larger conspiracy are issues that should be discussed with counsel so that such can be properly presented at the hearing. Letters from prosecutors regarding cooperation, motions filed in federal court, and transcripts of proceedings at a sentencing are all important documents that should be presented to any licensing board.

Please call me to discuss your criminal legal matter and any resulting disciplinary action currently being sought against your license.

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