Dispensing of Schedule II Medications
This petition request is not necessary. As a Standard of Practice, most if not all pharmacists would question a patient when filling a Schedule II medication if the date written is more than a few days before the date of the request to fill the prescription. The majority of Schedule II prescriptions are transmitted electronically so a pharmacist would have time to contact the provider or even call the patient to discuss the delay in filling a medication in this class. The major exceptions are medications for ADHD and pain management. In at least these two cases multiple prescriptions are issued on the same day with "Do Not Fill Dates" on the second and third prescriptions. In these situations the intent is communicated by the "Do Not Fill" dates. Currently, following a conversation with either the provider and/or the patient, a stale dated prescription could be filled based upon professional evaluation and clinical judgement by the pharmacist. This petition is an attempt, probably not the intention, to remove professional/clinical decision making on the part of a licensed pharmacist. Currently a pharmacist could refuse to fill the prescription, make clinical notes on the prescription/sign the prescription, and either keep the prescription (if requested by provider) or return the prescription to the patient. This petition would make the prescription invalid when presented for filling. What if the provider intended the prescription to be used "in case the previously treated condition presented suddenly"? This petition would not allow such an option. The petition is unnecessary and adds an excessive burden to the decision making ability of a pharmacist. I respectfully ask this petition not be considered for adoption.
Current CDC guidelines for opioid prescribing are:
Acute pain-"Clinicians should prescribe the lowest effective dose of immediate release opioid and no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less is often sufficient; more than 7 days is rarely needed" (cdc.gov).
Chronic pain- "Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic use or of dose escalation. Clinicians should evaluate benefits and harm of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh the harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower doses or to taper and discontinue opioids"(cdc.gov).
Current VA law states:
"A prescription for a Schedule II drug shall be dispensed in good faith but in no case shall it be dispensed more than six months after the date on which the prescription was issued"(18VAC110-20-290, law.lis.virginia.gov).
Decreasing the length of time during which an opioid prescription is viable for dispensing will more effectively align VA law with the CDC guidelines, and reinforce the current Virginia laws regarding treatment with opioids. This change will hold all parties more accountable for responsible opioid use.
Regarding acute prescriptions: the intention of any acute treatment is immediate mitigation or resolution. The CDC guidelines state that opioid prescriptions for acute conditions "should be for a quantity no more than the expected duration of pain severe enough to require opioids", and more than a 7 day supply is rarely required. Additionally, Virginia law currently states that "a prescriber providing treatment for acute pain shall not prescribe a controlled substance containing an opioid in a quantity that exceeds a 7 day supply as determined by the manufacturer's directions for use, unless extenuating circumstances are clearly documented in the medical record" (18VAC85-21-40, law.lis.virginia.gov). It therefore logically follows that a prescription issued for an acute condition should be filled immediately and a 7 day window from the date written is a reasonable time frame during which said prescription should be dispensed. Beyond 7 days the pain should either be at a level controllable by non-opioid measures, or the patient should be re-evaluated.
Regarding chronic prescriptions: the CDC guidelines state that (stable) patients should be re-evaluated at a minimum of every 3 months. Additionally, current Virginia law states that prescribers treating chronic pain "shall document the rationale to continue opioid therapy every 3 months" (18VAC85-21-70, law.lis.virginia.gov). It therefore is a reasonable expectation that a prescription issued for a chronic condition should be dispensed within 3 months from the date written.
Both scenarios support the argument that opioid prescriptions should be viable for less than 6 months. Additionally, opioid prescriptions are required to be electronically issued (54.1-3408.02, law.lis.virginia.gov), which affords clinicians tighter control over prescribing, determines where the opioid is dispensed, and allows greater visibility of patient compliance. This further upholds the recommendation of curtailing the expiration date of opioid prescriptions. The opioid epidemic continues. The intention of this petition is to block unnecessary dispensing of potentially therapeutically irrelevant opioids. I earnestly ask that this Board actively considers this petition.
cdc.gov. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016.MMWR. (www.cdc.gov/mmwr).
Administrative Code of Virginia. (law.lis.virginia.gov).
VSHP recommends referral to Regulation Committee
The Virginia Society of Health-System Pharmacists (VSHP) supports a collaborative, multidisciplinary approach to opioid stewardship. This petition may not address systemic issues with current challenges that dispensing pharmacists encounter in enforcing or maintaining certain stewardship practices. VSHP understands the intent of the petition; however, this is a complex issue and deserves further consideration by the Regulation Committee, as well as the Board of Medicine. VSHP recommends referral of this matter to the Board of Pharmacy's Regulation Committee.