Title of Regulation: 18VAC150-20. Regulations Governing the Practice of Veterinary Medicine (adding 18VAC150-20-174).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information:

February 8, 2018 - 9:05 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, 2nd Floor Conference Center, Henrico, VA

Public Comment Deadline: February 09, 2018.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Veterinary Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4468, FAX (804) 527-4471, or email leslie.knachel@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Veterinary Medicine the authority to promulgate regulations to administer the regulatory system. Pursuant to § 54.1-3408.4 of the Code of Virginia (Chapters 794 and 812 of the 2017 Acts of Assembly), the board is required to adopt regulations for veterinarians to be able to prescribe buprenorphine.

Purpose: The purpose of the regulatory action is to establish requirements for prescribing of controlled substances containing opioids to address the overdose and addiction crisis in the Commonwealth. The goal is to provide veterinarians with definitive rules to follow so that they may feel more assured of their ability to treat pain in an appropriate manner to avoid under-prescribing or over-prescribing and to discourage pet owners from using their animals to obtain drugs.

Substance: Regulations specify that nonpharmacologic and non-opioid treatment for pain should be considered, but if an opioid is necessary, it should be prescribed in the lowest effective dose for the shortest period of time, not to exceed 14 days. Regulations for management of chronic pain, terminal illness, or chronic conditions beyond 14 days include requirements for evaluation and treatment, including a treatment plan, consultation with an owner about storage and security, and recordkeeping. Regulations for prescribing of buprenorphine include a limitation of a seven-day supply with reexamination required to prescribe beyond that period.

Issues: The primary advantage to the public is a reduction in the amount of opioid medication that is available in Virginia communities. Although veterinarians prescribe opioids for animals, there is sufficient evidence to indicate that a small percentage of opioids are being diverted for human use. Therefore, a limitation on the quantity of opioids that may be prescribed should result in fewer people becoming addicted to pain medication, which sometimes leads them to turn to heroin and other illicit drugs. The primary disadvantage to the public may be that more explicit rules for prescribing may result in some owners having to bring their animals for more frequent visits in order to continue receiving opioid medication.

The primary advantage to the Commonwealth is the potential reduction in the number of persons addicted to opioids and the number of deaths from overdoses. There are no disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Veterinary Medicine (Board) proposes to amend its regulations to set rules for the prescribing of opioids other than buprenorphine for animals in need of acute or chronic pain treatment. Separately, the Board proposes to set rules for the prescription of buprenorphine for animals. This proposed regulation will replace an emergency regulation that became effective June 26, 2017 and will expire December 25, 2018.

Result of Analysis. There is insufficient information to ascertain whether benefits will outweigh costs for these regulatory changes.

Estimated Economic Impact.

Board's Purpose: The agency background document (ABD) states that the Board's purpose for promulgating these regulatory changes is to establish the "requirements for prescribing of controlled substances containing opioids to address the overdose and addiction crisis in the Commonwealth." The ABD also notes that the proposed regulation's "primary benefit is a reduction in the amount of opioid medication that is available in our communities."

Proposed Regulatory Requirements: Prior to the promulgation of the expiring emergency regulation, there were no specific laws or regulations that set requirements for veterinarians' prescribing of opioids. In this proposed regulation, and the emergency regulation it will replace, the Board now proposes to require that veterinarians consider nonpharmacologic¹ and non-opioid² treatments for pain before considering an opioid. Veterinarians will also be required to perform a history and physical exam, as well as assess the patient animal's history as part of an initial evaluation. If an opioid medication is prescribed for the treatment of acute pain, the Board proposes to require that it be prescribed in the lowest effective dose appropriate to the size and species of the animal patient and for the least amount of time possible. For acute pain, the Board proposes to limit any prescriptions for opioids to a 14-day supply.

The Board proposes to specify that treatment with opioids past an initial 14-day supply may only occur if that prescribing is within the accepted standard of care and is for the treatment of chronic pain, end-of-life pain, or for certain chronic conditions.³ The Board proposes to require that animal patients being treated for chronic or end-of-life conditions be seen and evaluated for the continued need for opioid treatment after the initial 14-day prescription. For any opioid treatment that will last longer than 14 days, veterinarians will be required to develop a treatment plan that includes "measures to be used to determine progress, further diagnostic evaluations or modalities that might be necessary, and the extent to which the pain or condition is associated with physical impairment." Thereafter, the Board proposes to require re-evaluation of the patient animal every six months and that justification for continued prescribing of opioid medication be documented in the patient animal's records.

The Board also proposes to limit the prescribing of buprenorphine (for out-patient administration) to (1) a dosage, quantity and formulation appropriate for the patient animal, (2) an initial prescription of seven days, with any extension requiring a re-examination of the patient animal. The veterinarian will be required to document in the patient animal's records the re-examination, and that continued treatment with buprenorphine is consistent with an appropriate standard of care.

Prior to prescribing any opioid medications, the Board proposes to require veterinarians discuss with pet owners the known risks and benefits of opioid therapy, the owners' responsibility to secure opioid medications while in use, and how to properly dispose of any unused medication. Veterinarians will be required to document these discussions. The Board also proposes to specify that "continuation of treatment with controlled substances shall be supported by documentation of continued benefit from the prescribing." If a patient animal's progress is unsatisfactory, the Board proposes to require that veterinarians assess the appropriateness of continued opioid therapy and consider the use of other treatments. Additionally, the Board proposes to require that any medical record for prescribing controlled substances include "signs or presentation of pain or condition, a presumptive diagnosis of the origin of the pain or condition, an examination appropriate to the complaint, a treatment plan, and the medication prescribed to include the date, type, dosage and quantity prescribed."

Benefits and Costs for Proposed Regulatory Requirements:

As noted above, the primary benefit identified by the Board is a reduction in the amount of opioid medication available in Virginia communities. Other benefits identified in the ABD include:

·         the "potential reduction in the number of persons addicted to opioids and deaths from overdoses;"

·         providing "veterinarians with definitive rules to follow so they may feel more assured of their ability to treat pain in an appropriate manner to avoid underprescribing or over-prescribing;" and

·         to "discourage pet owners from using their animals to obtain drugs."

The magnitude of the opioid crisis in Virginia is described in the ABD, which notes that by the end of 2016 the numbers of fatal opioid overdose deaths were expected to increase by 77 percent, compared to five years ago. (This includes heroin and fentanyl.) Moreover, in the first half of 2016 the total number of fatal drug overdoses in Virginia increased 35 percent, when compared to the same time period in 2015. The ABD also notes that many individuals who become addicted to heroin started with an addiction to prescription drugs, and the federal Drug Enforcement Administration observes that "fentanyl can serve as substitute for heroin in opioid dependent individuals."⁴ Therefore, in order to stem the tide of addiction, the Board states that practitioners need enforceable rules for proper prescribing of opioids.

Analysis of Regulatory Effects Is Hindered by Lack of Key Information. The ABD appears to suggest that the opioid crisis substantially results from prescription opioids. The harm the regulation is intended to address occurs either directly, from misuse of prescription opioids, or indirectly, wherein misuse of prescription opioids leads to misuse of other substances. No data appear to exist, however, that could be used to analyze the magnitude to which this may occur in Virginia. As noted below, available data indicate that prescription opioids are a leading cause or contributing factor in overdoses in Virginia. On the other hand, data indicate that the driver of fatal drug overdoses in Virginia is illicit fentanyl, not prescription opioids. Moreover, no data appear to exist that indicate the number of Virginians who misuse a prescription opioid and then become addicted to, or fatally overdose on, a non-prescription opioid. To the extent that the regulation reduces the amount of opioids in Virginia communities, and the number of persons addicted to opioids or deaths from overdoses, a benefit would be conferred. However, given the lack of data available to measure these outcomes, DPB staff were not able to calculate the extent to which this benefit may result.

Most of the drug-related deaths in Virginia since 2015 have resulted from sources other than prescription opioids. The Office of the Chief Medical Examiner (OCME) reports that "there has not been a significant increase or decrease in fatal prescription opioid overdoses" in the nine-year period from 2007 to 2016.⁵ Instead, the OCME notes that fentanyl "has caused the significant rise in all fatal opioid overdoses in the Commonwealth since 2012." More specifically, OCME data indicate that prescription opioids (excluding fentanyl) caused or contributed to, on average, 443 deaths each year during this time period. In contrast, during 2015 to 2016 alone the OCME reports that "fatal fentanyl overdoses increased by 176.4 percent," accounting for 622 deaths in 2016, an increase from 225 in 2015.⁶

These drug-related deaths, however, are often caused by more than one drug. Accordingly, the data reported by OCME on the number of deaths from a given drug frequently include deaths where more than one drug was "on board." As noted by the OCME, a single cocaine, heroin, and alprazolam overdose death will be counted three times: once under each class of drug. Because of the frequency of these "polypharmacy" results, no specific data exist on the number of deaths in Virginia that result from just one drug, such as prescription opioids.

DPB staff were not able to identify any data indicating the number of persons in Virginia who have become addicted to or died from opioids as a result of diversion or misuse of opioids, including prescriptions to animals. In part this results from the presence of the polypharmacy results noted above, which hinder an assessment of the actual number of people who die from prescription opioids. And though national survey data⁷ and other studies indicate that 65 to 75 percent of heroin abusers began with prescription opioids,⁸ no discrete data appear to exist on the number of Virginians who become addicted or the deaths that may occur.

Regulatory Requirements Affecting the Commonwealth. According to the ABD, there is sufficient evidence to indicate that a small percentage of opioids prescribed by veterinarians for animals are being diverted for human use. Although not specifically stated in the ABD, it appears that the kind of diversion the regulation is intended to address would occur outside of the veterinarian's office, by either the pet's owner or other persons who gain access to the prescribed opioid. DPB staff were able to identify an instance of "veterinarian shopping" that occurred in Fairfax County in 2016. According to a brochure published by the Franconia District, Drug Diversion Information for Veterinarians,⁹ a dog owner brought his pet to six different veterinarians and received multiple prescriptions for Xanax and Tramadol (an opioid).

Regulatory Requirements Affecting Veterinarians. The ABD also indicates that veterinarians will benefit from the presence of definitive rules for prescribing opioids. Any benefit that might be realized from this proposed regulation would have to be weighed against costs that may be incurred by veterinarians. To the extent that veterinarians' current record keeping and drug consultation practices differ from the requirements proposed by the Board, they will likely incur time and record keeping costs on account of the proposed regulation. Some veterinarians may also incur costs defending against Board disciplinary actions regarding their decisions to prescribe opioids, their record keeping, or other practices.

Regulatory Requirements Affecting Pet Owners. The benefits accruing to pet owners appear to be mixed, depending upon the species, the nature of their health concerns, and the efficacy of non-opioid treatments. The ABD notes that because of a bill passed during the 2017 Session,¹⁰ "without these regulations, Virginia law would prohibit all prescribing of buprenorphine mono-product for animals." Accordingly, the regulation would confer a benefit by allowing prescriptions for buprenorphine mono-product. Board staff report, in the Board's answer to a commenter at the emergency stage of this regulation, that the most common use of buprenorphine in veterinary medicine is to treat pain in cats.¹¹ Board staff further reports that the dosages typically prescribed for felines are small and are unlikely to be abused by humans.

As noted by the Board in the ABD, some other pet owners, whose animals are prescribed opioids other than buprenorphine, may incur additional fees for additional office visits.¹² These fees are most likely for owners of pets with chronic or end-of-life conditions, or whose otherwise need a prescription that exceeds 14 days. DPB staff obtained one estimate of approximately $50 for a simple office visit¹³ with no tests ordered or vaccines given. Costs incurred at any individual veterinarian's office may vary from that estimate.

In addition, to the extent that this proposed regulation leads veterinarians to order more nonpharmacologic treatments rather than, or in addition to, prescribing opioids, pet owners will likely incur increased costs for those treatments. The potential exists for any reduction in medication to result in unrelieved pain in animal patients, but the extent to which this may occur could not be determined. DPB staff obtained several estimates for the cost of animal acupuncture¹⁴ that ranged from $146 to $160 for initial consultation and approximately $85 for each treatment thereafter.¹⁵ Again, costs incurred at any individual veterinarian's office may vary from these estimates.¹⁶

Businesses and Entities Affected. These changes will affect all veterinarians in Virginia as well as all pet owners who use their services. Board staff reports that there are 4,342 veterinarians licensed by the Board, and that almost all veterinarians work for veterinary practices that would be considered small businesses.

Localities Particularly Affected. No localities will be particularly affected by this proposed change.

Projected Impact on Employment. This regulatory action is unlikely to have any effect on employment in the Commonwealth.

Effects on the Use and Value of Private Property. This proposed regulatory change is unlikely to affect the use or value of private property in the Commonwealth.

Real Estate Development Costs. These proposed regulatory changes are unlikely to affect real estate development costs in the Commonwealth.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Small businesses veterinarians will likely incur additional time and record keeping costs on account of this proposed regulation.

Alternative Method that Minimizes Adverse Impact. There are likely no alternative methods that would both further minimize costs for affected small businesses and meet the Board's aims in promulgating this regulation.

Adverse Impacts:

Businesses. Veterinary practices will likely incur additional time and record keeping costs on account of this proposed regulation.

Localities. No locality is likely to suffer adverse impacts on account of this proposed regulatory change.

Other Entities. Some affected pet owners are likely to incur additional office visit costs for their pets on account of the proposed regulation's requirement that (1) pets being treated for chronic pain with opioids other than buprenorphine be seen by their veterinarian after 14 days and every six months thereafter, and (2) that animals being treated with buprenorphine be re-examined after seven days. Pet owners may also incur additional costs for nonpharmacologic treatments for their pets if this proposed regulation causes veterinarians to order those treatments more frequently. Cat owners may be disproportionately affected by the limitations on prescription of buprenorphine.

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¹Board staff reports that nonpharmacologic treatments can include such treatments as acupuncture, physical therapy, hydrotherapy and heat therapy.

²Board staff and other sources reports that non-opioid treatments include ibuprofen, acetaminophen and aspirin.

³The proposed regulation lists chronic heart failure, chronic bronchitis, collapsing trachea "or other related conditions" as chronic conditions that would allow a veterinarian to prescribe opioids.

⁴https://departments.arlingtonva.us/wp-content/uploads/sites/6/2017/06/heroin_fentanyl_brochure.pdf

⁵http://www.vdh.virginia.gov/content/uploads/sites/18/2016/04/Fatal-Drug-Overdoses-Quarterly-Report-Q1-%202017_Updated.pdf

⁶OCME data indicate that more than 90 percent of fentanyl-related deaths result from illicit fentanyl.

⁷https://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-heroin-abuse/prescription-opioid-use-risk-factor-heroin-use

⁸Fentanyl in the US heroin supply: A rapidly changing risk environment, International Journal of Drug Policy 46 (2017) 107–111.

⁹https://www.washingtonpost.com/r/2010-2019/WashingtonPost/2017/08/30/Health-Environment-Science/Graphics/Drug-Diversion-Brochure.pdf?tid=a_inl

¹⁰https://lis.virginia.gov/cgi-bin/legp604.exe?171+ful+CHAP0794

¹¹According to the agency background document, small doses of a trans-mucosal (liquid) formulation of buprenorphine are prescribed for cats.

¹²DPB called several veterinarians' offices and found that re-examination policies varied from office to office with some offices already having policies similar to those in the Board's proposed regulation and some only requiring annual re-examination if an animal is doing well on their opioid prescription.

¹³Most re-examinations would likely be simple office visits with no additional charges.

¹⁴DPB also obtained cost estimates for laser treatments from one veterinarian's office. Those treatments at that office are $52 per treatment or a bundle of six treatments for $277. Another veterinarian's office that offers underwater treadmill treatments reported that the initial consultation for those treatments is $160 with additional charges for each treatment thereafter.

¹⁵One source also reported that frequency of required visits would vary. Treatment for acute conditions would usually require a series of treatments over several weeks and treatment for chronic conditions would usually require less frequent treatments which could be once a month or once every several months.

¹⁶These costs would likely be incurred either in addition to, or instead of, the costs for opioid medications. DPB obtained an estimate of $20 for the cost of filling a prescription for 100 tablets of tramadol of a dosage appropriate for an 85-pound dog. This cost would likely vary for different medications, dosages and number of pills dispensed and may vary by veterinarian's office or pharmacy.

Agency's Response to Economic Impact Analysis: The Board of Veterinary Medicine does not concur with the result of the analysis of the Department of Planning and Budget for the proposed amendments to 18VAC150-20, Regulations Governing the Practice of Veterinary Medicine. Regulations developed by veterinarians on a regulatory advisor panel and board members are consistent with the current standard of care. It is the professional judgment of veterinarians that prescribing consistent with provisions of the emergency regulations will benefit patients and the public at large.

Summary:

The proposed amendment establishes requirements for prescribing controlled substances containing opioids by veterinarians. The regulation provides for the management of (i) acute pain to include requirements for the evaluation of the patient, limitations on quantity and dosage, and recordkeeping and (ii) chronic pain (i.e., prescribing an opioid beyond 14 days for certain chronic conditions or terminal illnesses) to include requirements that allow for prescribing of buprenorphine in a dosage, quantity, and formulation appropriate for an animal according to species and size. Finally, requirements are included for continuation of treatment and for the content of the medical record.

18VAC150-20-174. Prescribing of controlled substances for pain or chronic conditions.

A. Evaluation of the patient and need for prescribing a controlled substance for pain.

1. For the purposes of this section, a controlled substance shall be a Schedules II through V drug, as set forth in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), which contains an opioid.

2. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids. Prior to initiating treatment with a controlled substance, as defined, the prescriber shall perform a history and physical examination appropriate to the complaint and conduct an assessment of the patient's history as part of the initial evaluation.

3. If a controlled substance is necessary for treatment of acute pain, the veterinarian shall prescribe it in the lowest effective dose appropriate to the size and species of the animal for the least amount of time. The dose shall not exceed a 14-day supply.

B. If the prescribing is within the accepted standard of care, a veterinarian may prescribe a controlled substance containing an opioid for management of chronic pain, terminal illnesses, or certain chronic conditions, such as chronic heart failure, chronic bronchitis, osteoarthritis, collapsing trachea, or related conditions.

1. For prescribing a controlled substance for management of pain after the initial 14-day prescription referenced in subsection A of this section, the patient shall be seen and evaluated for the continued need for an opioid.

2. For any prescribing of a controlled substance beyond 14 days, the veterinarian shall develop a treatment plan for the patient, which shall include measures to be used to determine progress in treatment, further diagnostic evaluations or modalities that might be necessary, and the extent to which the pain or condition is associated with physical impairment.

3. For continued prescribing of a controlled substance, the patient shall be seen and reevaluated at least every six months, and the justification for such prescribing documented in the patient record.

C. Prior to prescribing or dispensing a controlled substance, the veterinarian shall document a discussion with the owner about the known risks and benefits of opioid therapy, the responsibility for the security of the drug, and proper disposal of any unused drug.

D. Continuation of treatment with controlled substances shall be supported by documentation of continued benefit from the prescribing. If the patient's progress is unsatisfactory, the veterinarian shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

E. Prescribing of buprenorphine for outpatient administration shall only occur in accordance with the following:

1. The dosage, quantity, and formulation shall be appropriate for the patient; and

2. The prescription shall not exceed a seven-day supply. Any prescribing beyond seven days shall be consistent with an appropriate standard of care and only after a reexamination of the patient as documented in the patient record.

F. The medical record for prescribing controlled substances shall include signs or presentation of the pain or condition, a presumptive diagnosis for the origin of the pain or condition, an examination appropriate to the complaint, a treatment plan, and the medication prescribed to include the date, type, dosage, and quantity prescribed.