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

Kenneth R. Baker, BS Pharm, JD

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?

Will requiring CQI by law actually reduce errors?

Depending upon the results of sometimes contentious negotiations, some pharmacies could be forced to stop filling Medicaid prescriptions. According to pharmacy leaders, this could mean that some pharmacies, particularly in rural and poorer urban areas, could go out of business.  

These new regulations, on the other hand, could result in a more just reimbursement rate and a fair professional pharmacist's fee, in recognition of the time, cost, and expertise involved in filling prescriptions for the patients who constitute an important part of pharmacy's patient base. 

In July 1965, President Lyndon B. Johnson signed a law that created the modern Medicaid and Medicare programs.

  These programs grew over the years and their importance to pharmacy practice expanded greatly. 

The Kaiser Family Foundation (KFF) reports that the United States spends $234 billion for prescription drugs annually.

  Prescriptions represent 10% of national spending on healthcare - one-third of the amount spent on hospitals and one-half of the cost of physician services. While the amount spent on prescription drugs has increased in the last decade, the "rate of increase in drug spending has declined each year except 2006," when Medicare Part D was implemented.

In 2009, pharmacies dispensed 3.9 billion prescriptions in the United States.

  Private insurance accounted for approximately 42% of prescription drug spending.

  Government's share was 37%, and out-of-pocket spending by patients was 21% of the total.

  Of the public money spent, approximately 25% was for Medicaid and 60% was for Medicare.

In most cases, pharmacies do not set prices for third-party prescriptions. In the case of Medicaid, they are set by CMS and the States, based upon government regulations. By and large, the reimbursements are presented to pharmacies on a "take it or leave it" basis.  

In 2006, CMS proposed a regulation that would set a method to determine the Average Manufacturer Price (AMP) and a federal upper limits (FUL) reimbursement rule for multiple source (generic) drugs.  

In response to these proposals, the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) filed a lawsuit in the U.S. District Court in Washington, D.C.

  The associations argued that the Social Security Act established definitions and required certain factors be used in calculating pharmacy fees, which they charged that CMS had violated. The suit requested that an injunction be issued, stopping the proposed rule from going into effect as proposed.

The suit was successful and a preliminary injunction was issued. The proposed rule was eventually withdrawn by CMS in November 2010.

Newest proposed rules for Medicaid pharmacy reimbursement

Another set of changes has now been proposed, establishing the amount pharmacists will be paid for Medicaid prescriptions. Some of these changes came in response, at least in part, to the points raised in the suit over the 2006 rules. These newest changes are being decided now, in a rule-making procedure scheduled to take effect next year.  

Recent changes to Medicaid's reimbursement rules raise many confusing questions. Drug Topics' senior legal columnist sets out to clarify some key points

Medicaid reimbursement

In setting up your pharmacy's CQI system, begin by defining medication error. To reduce the risk of such errors, you need to know what that means.  

For example, many pharmacists would argue that it is a medication error to correctly dispense a contraindicated drug. Others would cite the dispensing of a prescribed drug to a patient with a known allergy to the drug. Some would call it a medication error when a patient regularly takes more of a drug than is prescribed. These types of error I refer to as "drug-review errors."  

Since the mid-1990s, drug-review errors have been the fastest growing type of professional malpractice claims against pharmacists, as shown in the Pharmacists Mutual Claims Study. The latest published version of that study shows drug-review claims totaled almost 10 percent of all professional pharmacy liability claims received by Pharmacists Mutual Insurance Company in 2008. It would seem prudent  to design a CQI program to reduce this risk.  

An even broader definition of a medication error might include a drug prescribed when another drug would have been a better choice. The pharmacy might have filled the prescription for the drug specified by the prescriber, but the prescriber made a mistake. It could also include a floor nurse's administration error. Pharmacists are not the only clinicians who make mistakes. As part of our CQI program, which of these should be included in our definition of medication errors? 

Unless asked by the prescriber, a pharmacist is not likely to have a role in the risk-assessment decision that resulted in the inferior choice of drug. Nor would a pharmacist usually be involved in the floor nurse's mistake. A pharmacy CQI system cannot prevent all medication errors, so we do not want to expand our definition too broadly. As pharmacists we can be most effective when we look at those medication errors that we can influence. Our goal might be to reduce the risk of the medication errors we might be able to prevent. In a legal sense, then, we would include in our definition the mechanical dispensing error and go beyond that to include at least some drug-review errors.  

Is there more we might want to include? From a professional pharmacy perspective, is poor patient compliance a medication error that a pharmacist might influence? 

Compliance primarily involves a patient error. In designing our CQI program, we might consider reaching above the legal requirements and include ways to assist patients to overcome their own errors. From the patient's perspective, a medication error occurs when recovery is delayed because the patient took medication incorrectly, perhaps through misunderstanding what the prescriber and/or pharmacist said. A patient medication error also might be the result of the patient's attempt to save money because the prescribed drug is not on the insurance plan's formulary and the patient cannot afford it. Rather than asking to try a different drug with a lower co-payment, the patient might take one dose every third day instead of daily.  

Pharmacists cannot catch all patient-caused medication errors, but we may be able to anticipate some of them and design a CQI quality system that will intervene appropriately. Usually, this would be part of the drug review, quality check, or counseling part of the program.  

Legal duty defines, not our best, but our least obligation. Professional duties represent our ideals, what is done by the best of our profession. Viewed from this level, a medication error might include not just mistakes that we may be able to influence, but those of our patients that we may be able to reduce or at least influence.  

This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with pharmacy law in their states.

 is a pharmacist and an attorney with the Arizona law firm of Renaud Cook Drury Mesaros, PA. He consults in the areas of pharmacy error reduction and risk management and can be reached at 

When pharmacies are planning their quality assurance or continuous quality improvement plans, they need to determine whether their goals are strictly conformity with state and federal requirements, or something more.