Legal and regulatory aspects of opioid prescriptions – Part I
An Interview with Jayne Pawasauskas, Pharm.D.
| Each month, Dr. Lynette Menefee tackles pressing issues in pain management with one of the nation's leading practitioners. This month, Dr. Menefee speaks with Jayne Pawasauskas, Pharm.D., clinical assistant professor at the University of Rhode Island. She speaks with us this month about opioid prescriptions. |
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Questions
1: What exactly makes a valid opioid prescription?
 2: Who makes rules regarding opioid prescriptions?
3: Well, first tell us about the prescription pads themselves. Who makes the rules about those? Is there a standard color and size…and who is allowed to make them?
4: I’ve seen in opioid treatment agreements an item that tells a patient never to accept a partial prescription from a pharmacy. How much diversion goes on among pharmacy personnel?
5: Is there any way a physician can learn whether a particular patient has ever altered a prescription?
6: What are the most common alterations made by a patient to obtain opioids?
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-------------------------------------------------------------------------------------------------------------------------- Dr. Lynette Menefee: Thank you for talking with us Dr. Pawasauskas. Today, we would like to talk with you about the legal and regulatory aspects of opioid prescriptions.
What exactly makes a valid opioid prescription? Jayne Pawasauskas, Pharm.D.: First, there has to be a genuine doctor-patient relationship for any prescription that is written. The health care provider writing for an opioid must have authority to prescribe controlled substances for the state in which they are licensed to practice. The provider must also be registered with the DEA. That is, they must have a valid DEA number.
In addition, a prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient’s full name and address, and the practitioner’s name, address, and registration number. The prescription must also include the drug name, strength, dosage form, quantity prescribed, directions for use, and number of refills. The prescription must be manually signed by the practitioner. 
LM: Who makes rules regarding opioid prescriptions? JP: There can be many different agencies involved. The Controlled Substances Act initially determines many variables, such as how a particular drug may be scheduled and who may prescribe it. Then, an individual state may have laws that are more strict in regard to such issues, so the exact rules may vary from state to state. Typically, licensing boards such as the Boards of Pharmacy or Medicine will also be involved in determining who may prescribe opioids, or specifics related to the dispensing of the opioid (for example, how many days supply can be given or how long the prescription is valid for.).
LM: Well, first tell us about the prescription pads themselves. Who makes the rules about those? Is there a standard color and size…and who is allowed to make them? JP: The answer to this question will vary, depending on the state. I don’t believe there is a particular template that must be followed in every case. Rather, some states allow orders for opioids to be written on the same type of prescription pads as those used for non-controlled substances. Other states require that duplicate or triplicate types of prescription pads be used for any order for a controlled substance. In the state where I practice, we used to use triplicate forms years ago, but this is no longer necessary. I have noticed that some hospitals (emergency departments, mainly) are using computer-generated forms for their prescriptions. This eliminates any confusion that may be due to messy handwriting!
LM: I’ve seen in opioid treatment agreements an item that tells a patient never to accept a partial prescription from a pharmacy. How much diversion goes on among pharmacy personnel? JP: I am not aware of the actual statistics to answer this question, but I would assume the number is fairly low. Pharmacists have access to hundreds of drugs on a daily basis, however, most have no intention of engaging in illegal drug-related activity. Furthermore, many states have laws that do not allow partial fills on prescriptions for controlled substances.
LM: Is there any way a physician can learn whether a particular patient has ever altered a prescription? JP: The most common way for this to occur is if the pharmacist or other health care provider notifies the physician. This often occurs when the pharmacist calls the physician to attempt to verify the prescription. Otherwise, unless the patient has a criminal record, I don’t know how else they would find out if a patient has altered a prescription.
LM: What are the most common alterations made by a patient to obtain opioids? JP: Probably the most commonly altered thing is the quantity. It would be fairly easy to change a quantity of 10 to 40, 70, or 100. For this reason, physicians should be encouraged to write out the quantity (ex: “ten”) instead of using numerals. Patients may also try to alter the strength of the dosage form, although this is a little bit trickier, since one would have to have knowledge of the exact dosage formulations of the prescribed drug. Patients may also try to alter the date of the prescription if it happens to be beyond the legal time period to fill the prescription, depending on the state.
LM: Stay tuned for next month’s interview with Dr. Pawasauskas, as she continues to explore the legal and regulatory aspects of opioid prescriptions. Dr. Pawasauskas will look specifically at some scenarios where prescriptions might be in question.
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