By: Karen Davila
Pharmacies and their pharmacists are in a very tough spot in the current regulatory enforcement environment. This is particularly true with dispensing controlled substances. Headlines like the below are commonplace:
DEA RAIDS PHARMACY AS PART OF LOCAL DRUG SWEEP
PHARMACY PAYS $500,000 IN PENALTIES FOR CONTROLLED SUBSTANCES ACT VIOLATIONS
MAN ARRESTED USING DOCTOR’S PRESCRIPTION PAD TO WRITE FRAUDULENT RX’S
So, how do you avoid filling a fraudulent prescription for controlled substances? Before getting into the nitty gritty, it is important to lay the foundation of standard of care and the corresponding responsibility so pharmacies and pharmacists can evaluate what steps are most likely to mitigate these risks.
As background, federal law states that the primary responsibility for prescribing controlled substances rests with the prescriber. However, that same law places a “corresponding responsibility” on the pharmacist to assure each prescription is written for a legitimate medical purpose pursuant to a valid patient-prescriber relationship. 21 CFR §1306.04(a).
Under Florida law:
- A pharmacist may not dispense a Schedule II-IV controlled substance to any patient or patient’s agent without first determining, in the exercise of her or his professional judgment, that the prescription is valid. F.S. §893.04 (2)(a).
- A prescriber or dispenser must consult the prescription drug monitoring system, eForce, to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance.S. §893.055
Once you have a clear understanding of a pharmacist’s liability, you can then consider ways to mitigate the inherent risks in filling controlled substance prescriptions.
POLICIES AND PROCEDURES
First and foremost, the pharmacy should establish unambiguous policies and procedures that, while allowing the pharmacist to exercise his/her professional judgment, set minimum expectations for evaluating whether to fill each controlled substance prescription. Broadly, those policies and procedures should incorporate at a minimum:
- Mandatory validation of patient identification, including reviewing and documenting the review of an individual’s identification.
- Review of the patient’s drug regimen or profile in the pharmacy’s operating system if the patient is a current patient.
- Regardless of whether the patient is new or existing, mandatory review of the state’s prescription drug monitoring platform (in Florida, eForce) to review other information concerning the patient, including:
- Other controlled substances dispensed to the patient by other pharmacies; and
- Whether the patient sees multiple prescribers for his/her controlled substance prescriptions.
- Direct contact (preferably by telephone) with the prescriber to validate the prescriber has examined and is familiar with the patient, knows the patient’s diagnosis and wrote the prescription.
- Documentation of each refusal to fill, including patient name, prescriber name, drug name/strength/quantity/directions. Where possible, keep a copy of the prescription refused, but return the original if requested by the patient.
- Mandatory reporting to local law enforcement of any prescription believed to be fraudulent.
More than just looking at each prescription as it is presented/filled, the pharmacy and pharmacist should periodically evaluate the totality of the data related to its controlled substance dispensing. Pharmacy data analysis should be conducted and documented as part of an ongoing compliance and quality review within your pharmacy. A single data point- such as an individual prescription, an individual patient, an individual doctor- provides a very myopic, focused view. That is not an adequate lens through which to view a pharmacy’s dispensing practices. And it is certainly not what the DEA will see. However, each data point, like the pixels in our electronic devices, when taken collectively with all other data points, may reveal patterns and behaviors that might assist you in further mitigating the risks of filling risky prescriptions.
When looking at the data, the pharmacy should consider conducting a deeper dive from at least three different perspectives:
- Geographic Patterns
- Prescriber Patterns
- Familial Patterns
The pharmacy should compare the data from each of these perspectives to develop a 3-dimensional view of their dispensing practices. No single perspective provides the full picture.
Certainly, knowing the patient and prescriber and reviewing the patient’s profile on the state’s prescription drug monitoring program platform (in the case of Florida, eFORCE) are great initial steps. But they are not sufficient. Other key factors to consider:
- Where is the patient traveling from?
- Where is the physician?
- What is the explanation between any geographic distances?
Distance to Pharmacy. If proper procedures are following when filling each prescription, and valid addresses are obtained for patients, a geographic picture should emerge, helping the pharmacy to identify whether its patients are traveling long distances (often driving past other, closer pharmacies) to obtain their controlled substances. The distances travelled by patients who are not receiving controlled substances can be compared to identify anomalies. In an urban area, distances should generally be shorter. In a rural area, it might make sense for those patients to travel greater distances. If patients are traveling significant distances, the pharmacist should understand the reasons.
Also, geographic data may reveal large groups of patients that are traveling significant distances to the pharmacy, but all from a small geographic area (e.g., same address, same block, same street, same apartment building). While this data pattern may just be a coincidence, it could indicate that patients are communicating with each other the ease with which controlled substance prescriptions are filled at a given pharmacy.
Distance to Prescriber. Additionally, it is important to look at the distance travelled by the patient to the controlled substance prescriber as this is yet another perspective on the pharmacy’s dispensing data. If patients are traveling significant distances to see their prescribers and doing so frequently (as in the case of CII’s), there may be legitimate reasons, such as the patient recently moved and continues to see his/her original prescriber in a distance geographic location, or the physician is a highly sought-after specialist. However, there may be reasons associated with how easy it is to get prescriptions from a particular prescriber for the desired controlled substances.
Distance between Prescriber and Pharmacy. When a pharmacy is near a prescriber’s office, it may not be unusual to expect to see many those prescriptions filled at the pharmacy, even if the patient is from a distant geographic area. The data and the patterns that emerge simply needs to be considered. When it is necessary to explain away a significant number of anomalies or there is no explanation, then the pharmacy may need to reevaluate its policies and procedures and assure they are being followed.
Analysis of data on a prescriber level may reveal that the prescriber routinely prescribes the same dose, quantity, and instructions for a vast majority of the prescriber’s patients. Where that pattern reveals that certain highly sought-after and abused narcotics are usually prescribed, the pharmacy should take notice and consider what steps to take to mitigate the attendant risks. Of course, the pharmacist should take into consideration the prescriber’s specialty as that is yet another indication of what prescribing patterns would be expected to look like. Chronic pain management prescribers are under strict guidance to consider alternatives to prescribing immediate release high-dose opioids for patients over long periods of time.
Prescriber-level data also may reveal that the prescriber uses only a very limited number of diagnostic codes for all his/her patients. This again should be a red flag to the pharmacist and pharmacy. However, if the pharmacy never analyzes the data in this way, it is difficult to see the patterns and the concerns that the DEA might have.
Evaluating the geographic patterns along with the prescriber patterns provides a fair amount of information that can be used to assist in revamping and reinforcing policies and procedures. But familial patterns are frequently telltale as well. Multiple family members on the same controlled substances from the same prescriber is yet another red flag. And it is even more suspect when that family member is on the same controlled substance. Frequent pick-up of controlled substances by one family member for another family member should be examined thoroughly. Merely verifying with the patient that the family member is authorized to pick up the prescription is not sufficient.
As you can see above, in addition to evaluating each prescription, a pharmacy and its pharmacists should participate in data analysis to develop the three-dimensional perspective necessary for ongoing improvement of pharmacy operations and controls. Where there are a series of unusual circumstances or explanations (“justifications”) as to why the data looks the way it does, the pharmacy should consider tightening up its policies and procedures and raise awareness of the risks incumbent in filling controlled substance prescriptions. Contact us today if you need assistance with pharmacy operations and the legal challenges faced by pharmacies/pharmacists today.