Kenneth R. Baker, BS Pharm, JD

These articles are not intended as legal advice and should not be used as such. When a legal question arises, the pharmacist should consult with an attorney familiar with pharmacy law in his or her state.

Ken Baker is a pharmacist and an attorney. He tea

In February, the DEA Office of Diversion Control moved to revoke a Florida pharmacy’s certificate of registration, a decision that should make pharmacists take notice.

 This decision can educate pharmacists and technicians on what to do before the Feds enter the pharmacy.

Trinity Pharmacy II is a full-service family-owned independent pharmacy in Clearwater, FL, that specializes in compounding.

 In February 2018, the DEA Office of Diversion Control 

 proposing revocation of Trinity II’s DEA Certificate of Registration for its Clearwater location, alleging that the pharmacy’s “continued registration is inconsistent with the public interest.”

The DEA’s order set forth several reasons,

 saying that Trinity II failed to comply with 

 and dispensed controlled substances outside the usual course of pharmacy practice. The order alleged it ignored red flags and dispensed prescriptions without resolving those red flags. In addition, the DEA alleged the pharmacy, on at least one occasion, dispensed “a Schedule II controlled substance outside the usual course of professional practice . . . and in contravention of its corresponding responsibility.”

 in FDA Law Blog noting Trinity II was a “must-read” for any pharmacy registrant or their counsel.

 The DEA revoked one pharmacy controlled substance license in 2017, but by mid-2018, has revoked four, including Trinity II, he says.

Of particular note is the DEA’s discussion of the pharmacy’s 

, or knowledge of wrongdoing, often referred to as intent. In particular, the hearing officer looked at the concept of “willful blindness,” ignoring what was in plain sight.  

An important government witness was its pharmacy expert 

 A red flag is “a term that’s come to be used to give examples to pharmacies of things that might indicate or suggest that prescriptions were filled outside the usual course of pharmacy practice,” he said in testimony. A red flag could be indicative of abuse or misuse, over or under compliance, drug-drug interactions, or a “forged or altered prescription.”

More from the author: Refusal to Fill Prescriptions Under Conscience Clauses

Such issues would be reviewed and resolved by a pharmacist “before filling any prescription” as part of the “prospective drug use review,” the testimony states. The pharmacist’s resolution of these red flags “would be documented on the face of the prescription, on the rear of the prescription, or in the patient profile.” The standard of practice regarding such documentation is that it has to include a reason that makes sense to the average pharmacist and that the prescription is legitimate despite the red flag(s). In other words: “If it’s not written down, you didn’t do it.”

When I used to defend criminal cases, I occasionally hired a particularly good private detective. He had a favorite saying: “The faintest ink is sharper than the keenest memory.” 

Every pharmacist and technician should read the Trinity II decision.

 They should look closely at the discussion of red flags, the expert testimony about prospective drug review, and the need to document information surrounding red flags. The government has used this testimony repeatedly when charging pharmacists and pharmacies with illegally dispensing controlled substances. Do not overlook the need and concept of a pharmacist’s corresponding responsibility. If you fail to abide by these lessons, you may be charged with filling illegal prescriptions knowingly and with willful blindness. Protect yourself-document red flags and how you resolved them.

These articles are not intended as legal advice and should not be used as such. When a legal question arises the pharmacist should consult with an attorney familiar with pharmacy law in his or her state.

Trinity Pharmacy II, Decision and Order; 

https://www.federalregister.gov/documents/2018/02/20/2018-03294/trinity-pharmacy-ii-decision-and-order

https://www.yelp.com/biz/trinity-pharmacy-clearwater

http://www.fdalawblog.net/2018/06/dea-issues-decisions-in-pharmacy-cases/

Articles

Why pharmacists need to be paying attention to the Trinity II case and its consequences.

How to Protect Yourself from Red Flags

If a pharmacist is convinced that filling a prescription is not in the best interest of the patient, due to an allergy or contraindication, the pharmacist may be under a professional duty to refuse to fill, at least until he or she contacts the prescriber to resolve the question.

Similarly, if the pharmacist believes the prescription is illegal, the purported prescription is not legal and not a valid order. It may not be filled, at least until questions are resolved.

A more difficult question is raised if a pharmacist refuses to fill based upon his or her religious beliefs. In July 2002, a University of Wisconsin student requested a refill on her birth control prescription at her local pharmacy. The pharmacist on duty, Neil Noesen, RPh, refused to fill it, citing his religious beliefs. He also would not transfer the prescription or tell her where she could get it filled.

The student filed a complaint with the Wisconsin Board of Pharmacy. The board’s administrative law judge restricted Noesen’s license, finding that a pharmacist with a conscientious objection to dispensing a prescription must ensure there is an alternative mechanism for the patient to receive the medication, including informing the patient of their options to obtain their prescription.”

Noesen appealed the decision. The Court on appeal ruled, “Noesen had a right to refuse to provide birth control pills but not to refuse to transfer a valid prescription to another pharmacy.”

Related article: When valid prescriptions are refused

In 2012, the Washington State Pharmacy Quality Assurance Commission passed a regulation stating that all pharmacies “must stock and dispense emergency contraceptive drugs” regardless of religious or moral reasons. A federal court judge originally ruled the regulation violated the religious freedom of pharmacy owners, however a unanimous federal appeals court panel overruled this in 2015.

 The Court of Appeals decision was appealed to the United States Supreme Court. The Supreme Court refused to hear the case, leaving the appeals panel’s ruling as the final decision on the case.

Reports of pharmacies refusing to fill prescription for birth control or provide emergency contraceptives have arisen in 26 states, according to the National Women’s Law Center. Regulations allowing pharmacists to refuse to fill are in effect in at least seven states, while a similar number require pharmacists to fill the prescriptions.

 Pharmacy law is primarily a product of state law and Board of Pharmacy rules.

 published an article in January 2018 noting, “The Trump administration is making it easier for medical providers to object to procedures on religious grounds.” The author noted an HHS proposed rule that would require hospitals and doctor’s offices to post notices of protections against religious discrimination on their job applications and employee manuals, and it would allow HHS to enforce protections for religious medical providers.

The article noted, “The initiative doesn’t change the law. Rather, it strongly signals a change in the focus of the department’s Office of Civil Rights, which is responsible for investigating civil-rights violations in healthcare contexts.”  The head of the Office of Civil Rights has stated he hopes to increase enforcement of laws that protect workers from being forced to violate their consciences, according to the article.

Pharmacists must be familiar with their state regulations and new federal guidelines. 

1. McLean MR. A pharmacist refuses to fill a prescription for birth control: An ethics case study. 

2. Stormans Inc v Wiesman. Supreme Court of the United States. 

. National Women’s Law Center. Accessed on May 15, 2018.

4. Khazan  O:  When the religious doctor refuses to treat you.  

Pharmacists must know state and federal rules on their right to refuse to fill a prescription based on religious beliefs. 

Refusal to Fill Prescriptions Under Conscience Clauses

Pharmacists are scientists. They are trained in the science of pharmaceuticals-pharmacokinetics, pharmacology, and more.

As scientists, pharmacists are experts in drugs-the way drugs act; how, why, and when drugs should be taken; how to reduce the risks associated with the drugs they dispense; how to compound and mix drugs to make them more effective; and much more. 

The first job in pharmacy is to fill a prescription correctly as written by the prescriber. Common mistakes include typing the wrong information into the computer, selecting the wrong line in a dropdown list, pulling the wrong bottle from the shelf, or handing the prescription to the wrong person. These are mechanical errors, also known as “human errors.” According to the latest Pharmacists Mutual claims study,

 mechanical errors represent 83.8% of all claims reported to that insurance company since 1988. 

Compounding and miscellaneous professional claims make up 3.9% of claims in the study, while the remaining 12.3% are intellectual in nature, involving thought and knowledge.  These include HIPPA violations, failure to counsel, and improper prospective drug review. Today, intellectual claims are the fastest growing type of claims against pharmacists received by Pharmacists Mutual.   

Reducing mechanical mistakes and reducing filling errors is a priority for pharmacists. For the last several years, pharmacy has made great strides in this area. Today, virtually every hospital and community pharmacy has embraced a continuous quality improvement work flow designed to stop mechanical mistakes from being made or catching them before they reach the patient. Technology is also improving patient safety. Pharmacists and pharmacy technicians are using these systems and making strides in reducing the likelihood of a mistake, despite the ever-increasing number of prescriptions and drug orders they must process in less and less time.   

As robotics and other systems improve, the physical aspect of pharmacy dispensing is bound to change how pharmacists do their job, moving them away from mechanics to more intellectual aspects of pharmaceutical delivery. Doctors and nurses will struggle keep up with the avalanche of new drugs and biologicals coming in the next few years. Increasingly, they will rely on the drug expert-the pharmacist. But pharmacists cannot be content in their role as scientists. Practicing the “art” of pharmacy will be a large part of the future of pharmacy.   

The future of pharmacy practice will center around two skills pharmacists have or that they must improve upon. Pharmacists’ knowledge of drugs will become more important as the number and sophistication of newer, more formidable drugs and biologicals enter the market. The scientific knowledge pharmacists possess will become even more valuable.

Knowledge, however, is not enough. All the expertise pharmacists have is useless if they cannot communicate it to the patient, the prescriber, or the caregiver. The future of pharmacy is in the art of communications.

1. Pharmacists Mutual Insurance Company. Claims Study 2017, Available at 

These articles are not intended as legal advice and should not be used as such.  When a legal question arises, the pharmacist should consult with an attorney familiar with pharmacy law in his or her state.

As robotics and other systems improve, the physical aspect of pharmacy dispensing is bound to change how pharmacists do their job.

Two Crucial Skills Pharmacists Will Need to Succeed in the Future

The goal is admirable. While we will never eliminate medication errors in pharmacy, we must continue to reduce them to the smallest number possible. By passing laws requiring pharmacies to have a continuous quality improvement (CQI) program, the states believe they have taken an important step along this path. Merely passing laws, however, will do nothing.  

The board also needs to ask what makes the system one of continuous improvement. There must be a way of discovering mistakes and preventing them in the future. This requires a method of monitoring, using statistics, charts, and graphs that give real proof that the pharmacy's program is working. The board needs to say to the pharmacy, "Show me your evidence of success."  

In order to provide proof of CQI, the pharmacy's program should incorporate monitoring and statistical process controls (SPC). A monitoring program using statistics allows a pharmacy to calculate its success and correct its mistakes.  

Monitoring and SPC means recording not just errors that reach a patient, but all mistakes, including those often referred to as near-misses. When each mistake made in the pharmacy workflow is discovered and then recorded, corrections can be made to the process before errors reach a patient. To record and measure errors only is to look only at the tip of the iceberg. Underneath the tip lie all the mistakes, of which most - but not all - are usually caught. These mistakes (near-misses) make up the true story of how the workflow actually functions. The goal of a good quality system is not only to reduce the number of errors that reach a patient, but to reduce the mistakes/near-misses that lead to errors. Without a mistake earlier in the workflow, there will be no error. 

The board of pharmacy's role is the same as that of every pharmacist, to protect the public. It should not take a law or a board regulation to tell pharmacies they need to implement CQI systems to safeguard patients from pharmacy mistakes. If the board passes a regulation, however, the board needs to know that the programs are being used and they are working.  

It is counterproductive for inspectors to say, "Show me every error you have made and that you fixed all of them." This will eventually lead to mistakes being covered up and some errors not being reported.  

It is better if the pharmacy board inspector can ask for statistical proof showing that the system is improving. If a CQI system with SPC is made a part of a workflow and the staff is trained to use it, improvement will be inevitable. Statistics will show success. Collecting only errors records only failures.  

For a discussion of statistical process controls, see 

, Warholak, T.L. and Nau, D.P., editors, chapter 8, Statistical Process Control by Maczygemba, L.R. and Holdford, D.A.   

These articles are not intended as legal advice and should not be used as such. When a legal question arises, the pharmacist should consult with an attorney familiar with pharmacy law in his or her state.

 is a pharmacist and an attorney consulting in the areas of pharmacy error reduction, communication, and risk management. Mr. Baker is an attorney of counsel with the Arizona law firm of Renaud Cook Drury Mesaros, PA. Contact him by e-mail at 

Medication errors can't be completely eliminated, but can CQI programs keep them to a minimum?

Author | Kenneth R. Baker, BS Pharm, JD

Articles

How to Protect Yourself from Red Flags

Refusal to Fill Prescriptions Under Conscience Clauses

Two Crucial Skills Pharmacists Will Need to Succeed in the Future

Will requiring CQI by law actually reduce errors?