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VIGIL: A Regrettable Necessity for Opioid Prescribing and Dispensing

By David B. Brushwood, R.Ph., J.D.
University of Florida
July 15, 2005

Protecting the public health and protecting public safety are vital and complimentary vocations, but they are poles apart in their goals and practices. Those who protect the public health are supposed to be trusting, caring and conciliatory. Those who protect public safety are supposed to be suspicious, aggressive and confrontational. Health care providers should not have to become law enforcement officers to prescribe and dispense opioid analgesics for patients in chronic pain; they should leave policing to the police. By the same token, police should recognize they lack understanding of health care and they should refrain from interfering with doctors and pharmacists who are caring for chronic pain patients.

But the current state of affairs is not as it should be. The police, including state and federal drug regulators, are interfering with medical and pharmacy practice. Their suspicious, aggressive and confrontational approach creates a chilling effect on the provision of opioid analgesics to patients suffering from chronic pain. It has led to the conclusion that there is no "safe harbor" for the prescribing of opioids in the current regulatory climate. Doctors and pharmacists have tried to find a way to work with the police, but it is impossible to do it. The Prescription Pain Medication FAQ fiasco is ample evidence that efforts at "meeting them half way" will fail because the police refuse to take the steps half way toward common ground. You can't meet someone half way if they aren't there. So doctors and pharmacists who want to do the right thing for their patients in pain will have to step all the way over to the other side and become police. It is regrettable, but it is necessary, if patients in pain are to be helped in any meaningful way.

Progress that is currently being made by patient advocates and others suggests that the day will come when health care providers no longer must act like police to do the right thing for their patients. This is, of course, very welcome news. Fundamental system change will better meet the needs of everyone, including law enforcement. Until that paradigm shift occurs, however, those of us who teach doctors and pharmacists how to do the right thing for patients are stuck with giving advice that flies in the face of every principle we hold dear. We must teach health care providers to adopt a police mentality in their practices. Our students resent learning it as much as we resent teaching it. But there is no other option if patients are to receive the opioid analgesics they need.

In the past, many teachers of future doctors and pharmacists have tried to deliver a reassuring message about the hazards of practice in the face of misguided drug control authorities. This "soft" approach to teaching regulatory risk management has been spectacularly unsuccessful. The simplistic advice to "maintain complete records" and to "just practice good medicine and you'll be okay with the regulators," is inconsistent with the reality that some of the country's most conscientious documenters and fully competent primary care providers have been accused of drug trafficking. Instructions to never prescribe opioids without a written "pain management agreement" have led many primary care providers to the conclusion that pain management is a hassle they should just leave to others. No laminated scale used to assess pain and no tearoff form used to document clinical activities will keep regulators from becoming suspicious about a practice, because nothing about the inner workings of a practice is known to the regulators before they become suspicious. Good clinical practices may get someone out of trouble once they are in it, but it won't keep anyone out of trouble to begin with.

The five-step "hard" approach I now teach is called VIGIL. It is certainly not perfect. Even when the VIGIL process is used, suffering chronic pain patients may still be denied necessary opioid analgesics, and occasionally criminals will dupe doctors and pharmacists into providing them with unnecessary opioids. VIGIL is an approach that will be useful to some health care providers, but not to all of them. It will be deemed satisfactory by some regulators, and not by others. The purpose of VIGIL is to meet the needs of pain patients while scaring away the drug diverters.

One of the most difficult aspects of VIGIL is deciding when to use it. The VIGIL process is not necessary for every patient. If there is no threat of diversion, then VIGIL should not be used. On the other hand, VIGIL is not useful when diversion is known to be occurring. It cannot transform an invalid prescription into a valid one. Any time a prescriber or dispenser feels "uncomfortable" about providing opioids to a chronic pain patient, and VIGIL can provide the level of comfort necessary to get the patient the medications the patient needs, the process should be used. This probably means that when no more than a 7 day supply or 30 dosage units are indicated or prescribed there will be no need to use the process, because there is no reason to be uncomfortable with these small amounts. However, if there is a need to create a comfort level, even under these circumstances, VIGIL should be used to comfortably provide patients with necessary medication.

The VIGIL process has five steps: Verification, Identification, Generalization, Interpretation and Legalization.

Verification

Before prescribing Schedule II opioids or hydrocodone/acetaminophen, doctors should satisfy themselves that the patient can be expected to use these drugs responsibly. This satisfaction can come from consultation with a previous care provider who can vouch for the patient, or from one's own experience with the patient by using other drugs before trying opioids. This means that opioids should not be used as the first option with a patient who is unknown to the doctor and who has no references.

Before dispensing a Schedule II opioid or hydrocodone/acetaminophen to a patient for the first time, the pharmacist should verify the legitimacy of the prescription with the prescriber. When making that contact, pharmacists should try to find out the purpose of the medication (not the diagnosis) and document that purpose on the prescription.

Most chronic pain patients will welcome the opportunity to be verified, because it validates their need for medications. Most diverters will shy away from verification, because it imposes a barrier to access.

Identification

Anyone who is given a prescription at a clinic or is given medication at a pharmacy should be required to produce government-issued photo identification. This includes the patient or anyone else acting on behalf of the patient. The photo identification should be photocopied, or if not photocopied all relevant information from the identification should be documented.

Most chronic pain patients will welcome the opportunity to identify themselves and be personally known by their doctor or pharmacist. Most diverters will want to avoid providing identification.

Generalization

It is important to establish the parameters of the provider-patient relationship. This need not be done in writing, but it must be done. Patients need to know that their doctor and pharmacist acknowledge a responsibility to provide services and products promptly and respectfully. Patients also need to know their own responsibilities when they are being entrusted with drugs that have a huge potential street value. The responsibilities that should be explained to patients may include:

• Keep your drugs locked up as you do your money and jewelry.
• No sharing drugs with anyone.
• If you run out of your medication more than 20% too early, don't go to the pharmacist and ask for more, contact your doctor, even if you have refills remaining.
• Take prescriptions for newly prescribed opioids to your pharmacy during hours when your doctor can be contacted for verification.
• There will be no "emergency" verbal refills when there is no emergency.

These are just some suggestions among the many conditions that may be appropriate to impose in a provider-patient relationship.

Most chronic pain patients want to know the rules and they will strictly adhere to them. Most diverters will have no patience with the conditions and they will violate them.

Interpretation

Ultimately, a decision will have to be made whether to prescribe or dispense opioids. This is a decision that should be made free from external factors such as bias and prejudice. The decision may be improved by using one of several questionnaires that have been developed to help predict the likelihood that a patient will abuse prescribed opioids. These include the Drug Abuse Screening Test (DAST), the Webster Assessment Test (WAT) and the Screener and Opioid Assessment for Patients in Pain (SOAPP).

It is completely reasonable to require a patient to maintain a diary and/or to require the patient to produce a family member or friend who can describe the patient's functionality while using prescribed opioids. There is no point in continuing to prescribe drugs that do not improve functionality, and functionality can best be assessed by talking with people who see the patient between visits to the clinic and pharmacy.

Chronic pain patients will usually not mind filling out a questionnaire, keeping a diary or having a family member describe how they are doing. Diverters will have a difficult time with this

Legalization

State and federal laws for controlled substances change from time-to-time, and the drugs on the list of controlled substances change also. It is important to keep up-to-date and to conform to all legal requirements. The conduct of a physical examination seems to be a litmus test among some regulators. Based on findings from the physical exam, some explanation for the use of opioids should be made in the patient care record. Documentation should be complete but concise. Any documented suspicion of addiction should be followed up quickly and the followup documented. The advantages and disadvantages of opioids should be discussed with patients. For clinicians who prefer not to focus on administrative tasks, it is worthwhile to hire an office administrator who is not afraid to describe legal requirements to all personnel and fire those who cannot comply.

VIGIL is not inordinately time consuming and it is not offensive to patients if operated in a pleasant way. It is also not fool proof. It can be gamed as can any effort to distinguish chronic pain patients from drug diverters. Hardened criminals will quickly adapt to the requirements of VIGIL. But the less street wise diverter will be daunted by the requirements of VIGIL. There is enough police mentality in VIGIL to deter a significant amount of diversion without offending chronic pain patients. For the open minded drug regulator, VIGIL will provide evidence that honest efforts are being made to prevent diversion. There is no protection from the inquiries of a closed minded drug regulator.

David Brushwood is Professor of Pharmacy Health Care Administration at the University of Florida in Gainesville. He is a Mayday Scholar with the American Society of Law, Medicine and Ethics (ASLME). For information about ASLME pain policy projects, go to ASLME.