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Physicians are responsible for prescribing and dispensing. Pharmacists have a corresponding responsibility to fill those prescriptions appropriately.
All around the U.S. and in Indiana, prescription drug abuse is front and center for healthcare professionals. In 2013, Indiana was ranked 7th in the nation for the number of tablets of hydrocodone dispensed, and the United States is number one in the world for utilizing the most hydrocodone-over 79,700 kilograms vs. the UK at second, utilizing only 200 kilograms per year.1 Many other controlled substances are being abused nationally as well-oxycodone and benzodiazepines to name a few.
One of the obvious methods to deter prescription drug abuse and a legal obligation both for prescribers and pharmacists is to ensure Controlled Substances are being issued for a legitimate medical purpose as required by the Controlled Substances Act. 21 C.F.R. § 1306.04(a) sets out the legal requirement:
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.2
Generally, incorrectly determining whether one prescription was issued for a legitimate medical purpose does not pose an issue. Rather, case law suggests that parties violate Corresponding Responsibility through a pattern of neglecting red flags over a long period of time.3
To provide further requirements to prevent prescription opiate abuse, the Indiana General Assembly passed a law effective December 2013 for establishing standards and protocols for physicians prescribing controlled substances for pain management. The new requirements include, but are not limited to, treatment agreements between physician and patient, regular face-to-face examinations, random tablet counts, and consent to drug monitoring by the patient.4
The new law presents some additional challenges for pharmacists in Indiana relative to the implications the law has on a pharmacist exercising his corresponding responsibility appropriately. The Indiana Board of Pharmacy released a statement after several discussions at Board of Pharmacy meetings providing their interpretation and subsequent guidance.5
Butler University College of Pharmacy and Health Sciences convened a panel of professionals in and around the topic of corresponding responsibility in June, 2014. The panel included: Ms. Betsy Ferguson, Senior Vice President and Assistant General Counsel at CVS/Caremark, Dr. Andrew Trobridge, a leader in the Indiana State Medical Association for this legislation, a physician in Indiana, and a current pain specialist with a fellowship in pain management and previous training in addiction medicine, and a representative of the Drug Enforcement Agency (DEA).
Prior to the panel discussion, the DEA representative introduced the topic of Corresponding Responsibility. Table 1 discusses the tools for resolution of red flags and the red flags for pharmacists under corresponding responsibility and controlled substance prescriptions.
Tools for Resolution of Red Flags by Pharmacists:
· Ensuring provider has a valid DEA number
· Utilizing professional judgment, training and experience;
· History and knowledge of and with the patient;
· Experience with the prescribing practitioner.
Patient Red Flags
Appropriateness of Therapy
Prescriber Red Flags
Scope of Practice
Appropriateness of Therapy
Source: East Main Street Pharmacy, 75 Fed. Reg. 66149 (Oct. 27, 2010)
The panelists then discussed several cases. The audience had a digital response system to post questions and comments of their own anonymously during the 1 hour session.
• TT is a 40 YO female presenting to the outpatient pharmacy claiming to have lost her bottle of hydrocodone & acetaminophen 10 mg/325 mg that was previously filled 5 days ago.
• The patient has no prior history of taking other pain medication according to INSPECT (Indiana’s PDMP). However, you the pharmacist have had previous encounters with this particular doctor and their suspect prescribing habits.
• You call the doctor to get the new fill authorized and sure enough it is authorized without hesitation.
What is the pharmacist’s corresponding responsibility?
The panelists offered the following commentary.
Betsy Ferguson (BF): “Generally, I would want the following additional information, some of which I can learn from INSPECT and the patient, and some from the prescriber before making a call on whether or not this prescription was legitimate, and thus, whether or not a pharmacist could fill it:
· Why is she taking this medication?
· How long has she been on this medication?
· Has she ever lost a prescription before/is there a history of early refills?
· How far does the patient live from the prescriber (travel distance)?
· If the patient has been on the drug for a long time period, it might be appropriate to ask if the doctor has a pain contract and is doing urinalysis, although you don’t need to obtain a copy of either.
Andrew Trobridge (AT): “Rather than asking for authorization for a refill right out of the gate, it would be great if the pharmacist called me and started asking open ended questions to start a healthy dialogue, such as ‘I have a patient of yours here, and I have some concerns. They tell me they’ve lost their prescription. Have they failed a urine drug screen, or lost prescriptions in the past?’”
“At least that way you’d have an attempt at starting a conversation – it’s a series of open ended questions, rather than just asking for a refill. If a pharmacist can lead with the concern they have, I can then either determine as a physician whether or not something is awry or if I can put the pharmacist at ease based upon my own history with the patient.”
“I had a similar case just recently. I had a pharmacist in IL call me and state that he just ran an INSPECT report on a patient and had filled a pain script a week ago and is now in IL trying to fill another script. That’s a fruitful and positive conversation. It could be a cancer patient and that patient traveled to another city for their care and that is an appropriate. In this particular case, the patient was doctor shopping. But this was the perfect example of teamwork and everyone following Corresponding Responsibility, because the pharmacist did his job, and I in turn called the patient’s primary care doctor and got the appropriate care for his/her addiction, which is in the best interest of that patient. If we aren’t following up, we’re not giving the best care and the treatment that the patients need.”
Erin Albert (EA): “The audience commented that they would want to know if the patient was on other drugs such as tramadol that would not show up on INSPECT, which is a good suggestion. Someone else commented that when calling the doctor, they often only get voicemail to the nurse, which can be frustrating.”
AT: “This is a legitimate concern. Sometimes I can’t get back right away. But, I want to be called anytime a pharmacist has a concern. We’ve all been inundated over the last few months, and there are a lot of gun-shy providers right now, but the vast majority of us want to know if you have a red flag raised. State your concerns, be candid, and anything you have factually, non-confrontationally, with a patient- centric approach. That’s a constructive dialogue.”
“Last, I will say that patients on chronic pain medications don’t lose their prescriptions. If it happens once and there are no other red flags, I’ll heighten monitoring and investigate. If it happens a second time, something else is going on and I know that’s a trigger for me to intervene and possibly stop prescribing opioids. Lightening doesn’t strike twice in the same place.”
• A pharmacist regularly observes a husband and wife pair filling hydrocodone & acetaminophen 5 mg/300 mg prescriptions at your pharmacy.
• Based on her observations and discussion with patient the pharmacist strongly suspects that the wife is filling her script for the husband’s use.
• What is the pharmacist’s corresponding responsibility?
EA: “The audience responses initially to this case included asking the patient presenting why she is taking it, asking the wife if she runs out of medicine if she’s borrowing her husband’s meds, and checking to see if the husband’s and wife’s prescriptions are being filled on the same day.”
AT: “Another case where I’d appreciate the call from a pharmacist. It’s OK to call if it is just a gut feeling that something is wrong by the pharmacist. I’m going to call those patients in. Bad things happen to good people. Husband/wife team with wife in chronic cancer pain and husband has another type of pain, both may need chronic opioids and start on meds for the right reasons, and suddenly go off track to addiction. The spouse can also become an enabler.”
“If the pharmacist is concerned, I appreciate that call so I can call the husband and wife team in with a random pill count and urinalysis in order to see if medications are being taken as prescribed. Something else I can do is put the husband/wife team on different medications. That way if sharing is going on, I can conduct a random drug screen and know pretty quickly whether or not they are sharing.”
EA: “There is a huge push right now in healthcare for interprofessional education. Is this a place where we need more?”
AT: “That would be very valuable and the key is communication. Challenges come from primary care. We in medicine definitely need more education around pain management. But, we’re all on the same team, we all want to do what’s best for our patients and protect our patients’ interests and protect our communities. It all comes down to communication and fostering an open dialogue – not to waste anyone’s time – but these are dangerous medications and a couple minutes of conversation can be really helpful.”
BF: “Yes, working together is definitely in the best interests of the patient and the providers-both pharmacist and prescriber. Unfortunately, these conversations can be fraught with issues for both parties. Pharmacists are required by law to obtain information that give them comfort that a prescription has been issued for a legitimate medical purpose, and this may include asking for information that is not typical. The prescriber working with the pharmacist to provide the information allows for the best outcome for the patient.”
In conclusion, pharmacists must identify red flags, and use their professional judgment to resolve if possible and exercise Corresponding Responsibility when appropriate. A partnership between the legitimate healthcare provider and pharmacist assists pharmacists in satisfying their legal obligation and ensures patients have the best outcomes. When the healthcare team truly works together in a collaborative spirit, the patient benefits by receiving better care. It is our duty as healthcare professionals to ensure we all work together in the best interest of our patients.
1. Rannazzisi, Joseph T. Office of Diversion Control, DEA. “Controlled substance and legend drug diversion; a law enforcement and regulatory perspective.” Presented at the 11th Annual Butler University COPHS CE Symposium, June 6, 2014.
2. 21 C.F.R. § 1306.04(a). Unofficial version at DEA’s website: http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm.
3. East Main Street Pharmacy, 75 Fed. Reg. 66149 (Oct. 27, 2010); US v. Rosen, 582 F.2d 1032 (5th Cir. 1978).
4. LSA Document #13-495(E), Indiana Register, effective December 15, 2013. http://www.in.gov/legislative/iac/20131030-IR-844130495ERA.xml.pdf. A summary of this new law as it concerns providers is available at the website of the Indiana State Medical Association. http://www.ismanet.org/pdf/Legislation/ResponsiblePrescribing-RedefiningtheStandardsofCare.pdf.
5. “Corresponding responsibility guidance,” Indiana Professional Licensing Agency. March 10, 2014. http://www.in.gov/pla/files/Corresponding_Responsibility_Guidance_Document.pdf.
Erin Albert is an associate professor and director of continuing education and preceptor development at Butler University College of Pharmacy and Health Sciences in Indianapolis, Ind. Contact her through the website www.erinalbert.com.