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A Pharmacist’s Corresponding Responsibility in Dispensing

A Pharmacist does not just throw pills from a large container into a small container for patient distribution.  No, while that might be a “traditional” idea, it does not capture the full responsibility borne by pharmacist.  A pharmacist licensed by California’s State Board of Pharmacy today has a much broader “gatekeeping” role; the pharmacist is responsible for reviewing a prescription to make sure it is valid, serves a legitimate medical purpose, and is not contra-indicated.  What does this mean?  For instance, there are individuals that seek to pass off fake or counterfeit prescriptions for narcotics, and the pharmacist must check to make sure that the patient is the right person, that the prescription is being written by an actual physician for that real person, that the prescription hasn’t been altered (for additional narcotics or refills, for instance), and, finally, that the prescription isn’t a cocktail for abuse.

In this expanded gatekeeper role, a pharmacist must be alert to see if any “red flags” present wave to signal a possible illegitimate prescription.  While a subjective standard, a pharmacist may want to err on the side of caution and refuse a prescription rather than face a Pharmacy Board inquiry.

So what are these “red flags” a pharmacist should look out for?

The pharmacist might look at a number of factors on the face of the prescription itself:

  1. Is the prescription written in ink, indelible pencil, typewritten, or electronic?
  2. Is each substance prescribed on a separate prescription?
  3. Is it manually signed?
  4. Is the prescribing practitioner’s name and address on the prescription?
  5. Is it dated with a recent date?
  6. Is the practitioner who signed the prescription authorized to prescribe this controlled substance?
  7. If electronic, has the prescription already been filled by another pharmacy?
  8. Is the drug name complete?
  9. Is the dosage or strength reasonable?
  10. Are there too many refills listed?
  11. Is the prescription written by a practitioner consistent with the practitioner’s area of specialty?

After an initial viewing of the prescription, a pharmacist may also want to look at the patient(s), and consider the patient relative to other members of the public:

  1. Are multiple patients sharing the same address and presenting on the same day?
  2. Are there multiple patients sharing the same diagnosis code from the same doctor?
  3. Are there multiple patients sharing the exact same substance (or combination of substances) and dosage from the same doctor?
  4. Is the patient paying in cash?
  5. Does the patient look nervous?
  6. Is the age of the patient consistent with the type of substance or dosage prescribed?
  7. Can the patient present valid photographic identification, such as a driver’s license, passport, or military identification?
  8. Does the patient live in the geographical area? (If not, is the patient “shopping” for narcotics?)

Finally, a pharmacist must look to the overlap of the prescription and the patient:

  1. Is the pharmacist aware of any allergies the patient has that would contra-indicate?
  2. Is the pharmacist aware of any other medications the patient is taking (perhaps prescribed by a different practitioner) that would contra-indicate?
  3. Does the prescription make logical sense for the patient and diagnosis?

 

 

 

A pharmacist at any point in the above may decide the prescription or patient raises too many “red flags” or “warning signs” and therefore, inquire further before dispensing.  To do this, a pharmacist may call and verify the prescription with the practitioner, may question the practitioner, or may independently evaluate the patient therapy (including using the CURES report system).  It is the pharmacist’s duty and obligation to exercise their professional judgement and corresponding responsibility in deciding whether or not to dispense the prescription.

A pharmacist may not simply defer to the prescribing practitioner!  Pharmacists must exercise their independent judgment to determine if a prescription was written for a legitimate medical purpose by a practitioner acting in that practitioner’s usual course and pattern of professional practice.

The Drug Enforcement Administration (“DEA”) published a decision that considers the scope of a pharmacist’s corresponding responsibility under the Code of Federal Regulations (21 CFR 1306.04(a)).  In East Main Street Pharmacy ((2010) 75 Fed. Reg. 66149), it was held that a pharmacist cannot fill a prescription for controlled substances if that pharmacist “either knows or has reason to know that prescription was not written for a legitimate medical purpose.”  In that case, the owner and sole pharmacist told DEA investigators “that it was ‘not [his] job to question a physician.’”  (Id.)  Even though the pharmacist had called the doctor who wrote the prescriptions to verify he existed, and called a local attorney to ask about the doctor’s reputation in the community, he did not call other pharmacies that he knew rejected the prescriptions and did not make any inquiries of the patients themselves or their individual therapies.  If the pharmacist determines that there is no legitimate medical purpose, “a pharmacist may not intentionally close his eyes” and ignore “the real purpose of the prescription.” (Id. at 66163, citations omitted.)

Similarly, in California, the Board of Pharmacy issued its first (and, as of this typing, only) precedential decision, 2013-01, In the Matter of the Accusation Against Pacifica Pharmacy; Thang Tran (August 2013), in which a pharmacist’s and pharmacy’s licenses were revoked and a significant cost recovery award was assessed, for failure to notice the “red flags” and instead prescribe a large quantity of controlled substances (opiates), in violation of California’s Health and Safety Code, section 11153, subdivision (a).  This Health and Safety Code section was repealed and added in 1982 to change prior language of “corresponding liability” to “corresponding responsibility” and follows a 1981 California Appellate case, Vermont & 110th Medical Arts Pharmacy v Board of Pharmacy (1981), 125 Cal.App.3d 19, in revoking the license of a pharmacy and one pharmacist, and suspending two other pharmacists, for filling vast numbers of prescriptions written by a small group of doctors in a short period of time for four popularly black-marketed narcotics to a variety of questionably named individuals at a variety of questionable addresses.  The court held that no one should have had to tell the pharmacists that what they were doing was wrong:  “A true professional does not have to be told such things.” (Id. at 26.)

This is not to say that a pharmacist should not fill narcotics prescriptions from a local pain management doctor who caters to hospice patients.  It will, however, be the pharmacist’s duty to take the steps to verify that the prescriptions, the patients, and the prescriber are valid and that the prescription serves a legitimate medical purpose.  Mindful that this area is very subjective and both the pharmacist’s and pharmacy’s license status could be in jeopardy, having policies (or checklists) and documenting the steps taken in certain situations may be the difference between a phone call of inquiry from the Pharmacy Board and an Administrative Accusation by them.

Simas & Associates has a long history of representing pharmacists, wholesalers, and other licenses in the industry. If you need guidance on your corresponding responsibility, please call us at 888-999-0008 or email at info@simasgovlaw.com.



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