HB2248: A BILL TO PROTECT VIRGINIA PATIENTS AND IMPROVE OVERSIGHT OF THE DRUG SUPPLY CHAIN
INTRODUCTION
HB2248 is a bill which seeks to further advance the regulation of powerful controlled substances and empower the Virginia
Boards of Health and Pharmacy to more thoroughly enforce drug safety rules. Strengthening these bodies’ oversight function
will help protect Virginia patients from substandard or i icines, and crack down on black markets for powerful
controlled substances. The Bill’s provisions safeguard the integrity of the legitimate drug supply chain.
HB2248 has been authored and introduced by Delegate John Bell of Loudoun County. Delegate Bell’s efforts to increase drug
safety in Virginia are inspired by his personal experience supporting his son through a struggle with opioid addiction, which he
developed after receiving powerful pain medication following a serious accident. Delegate Bell has a track record of introducing
bipartisan drug safety legislation, including a bill to improve overdose treatment which led to a 27% decrease in fatal overdoses
in Delegate Bell’s district.
HB2248 recognizes the essential role that the Board of Pharmacy, Board of Health, and compounding pharmacists play in our
communities, and this legislation is designed to further strengthen the invaluable expertise of these entities and individuals.
The bill has three key effects:
1, Strengthening the Boards of Health and Pharmacy to oversee the drug supply chain
2. Ensuring a black market for powerful controlled substances does not develop from execution drug procurement
3. Ensuring state regulatory bodies are fully equipped to properly oversee and understand the practice of pharmaceutical
compounding
1, STRENGTHENING THE BOARDS OF HEALTH AND BOARD OF PHARMACY
Virginia's Boards of Health and Pharmacy are critical protectors of public health and safety in the Commonwealth. As such, it is
imperative that the General Assembly be made aware of their work, and in particular, any steps they have taken to combat the
opioid epidemic, ensure patients’ access to safe compounded medicines, and to comply with federal “Track and Trace
legislation,” which requires that every vial of medicine be accounted for and tracked.
In addition to more information being made available to the General Assembly, this legislation allows the Board of Pharmacy
to investigate any pharmacy for which the Board has reason to believe has violated state or federal law, or as otherwise deemed
necessary by the Board to protect the health and safety of the public.
Itis vital that the Boards of Health and Pharmacy are granted the authority to share their progress, ensure pharmacy compliance
with the law, and ensure that the needs of compounding pharmacies and their customers are prioritized.
HB2248’s provisions:
= Mandate the Board of Health and Board of Pharmacy to report annually to the General Assembly on steps taken to combat
the opioid epidemic, ensure the safe use of compounded medicines, and ensure compliance with federal “Track and Trace”
legislation in Virginia;
- Empower the Board of Pharmacy to inspect any pharmacy they have reason to believe violated state or federal law.
2. ELIMINATING A POTENTIAL BLACK MARKET FOR POWERFUL CONTROLLED SUBSTANCES.
HB2248 takes no position on the issue of capital punishment in Virginia but seeks to ensure that the state’s procurement of
medicines for use in lethal injection does not inadvertently allow illicit or substandard medicines into Virginia’s wider patient
population. The bill does not seek to restrict Virginia's use of the death penalty but would ensure that the pharmacy supplying
execution drugs is subject to scrutiny by the Virginia Board of Pharmacy to safeguard patients and the public.
Over the past year, pharmaceutical experts and regulators have warned that that US prisons’ efforts to secure compounded
drugs for use in executions may result in black market, contaminated medicines entering the US supply chain and putting
patients at risk.
In 2018, a coalition of drug regulators and experts — including a former FDA Commissioner and Deputy Commissioner — filed a
brief in the US Supreme Court warning that death rows’ efforts to obtain lethal injection drugs could end up causing a ‘public
health crisis’.”' This submission draws from a recent study published in the Journal of the American Pharmacists Association
(JAPhA) which warns that death penalty states could end up causing a public health emergency through their efforts to source
lethal injection drugs.
The authors of the JAPhA study state that secrecy laws such as Virginia’s create a “regulatory loophole” exempting the
pharmacies supplying the state with execution drugs from complying with essential public safety and sanitary requirements.
The study finds that “there are no safeguards in place to prevent pharmacies from exploiting loopholes created by these laws,
allowing poor quality medicines to infiltrate the market, putting the public, as well as prisoners, at risk.” The authors further
warn that allowing unregulated pharmacies to operate in Virginia with impunity increases the likelihood “that substandard
execution drugs may fall directly into the wider patient population,” creating a “product safety emergency” causing "patient
injury and death.” Virginia has increasingly sourced compounded execution drugs from secret sources, and as a result, Virginians
are particularly exposed to the risk of receiving unsafe medicines from unregulated sources. Under the current law, it is virtually
impossible to avoid the risk that contaminated, substandard, or counterfeit drugs may enter the state.
Virginia’s efforts to procure unreg and unapp ion drugs are hidden from public scrutiny by an execution
secrecy law, despite warnings from Republican lawmakers like Delegate David B. Albo that “If this all remains secret, then
there’s no way to make sure people are following the law.” This law bars the disclosure of any information regarding where
prisons’ stocks of lethal injection drugs originated or how they were transferred to state officials for use in execution.”
Governor Northam has indicated that he would support greater transparency in this area through a change to this aspect of the
law, expressing the view that if capital punishment remains the law in Virginia, itis critical that it be carried out “not in secret
with i that i work and i don’t work.”
HB2248's provisions:
~ Give the Board of Pharmacy oversight of any drugs obtained for the purpose of lethal injection executions;
- Ensure the Freedom of Information Act applies to the supplier of medicines used for lethal injection executions.
3. EQUIPPING STATE BODIES TO OVERSEE AND SUPPORT PHARMACEUTICAL COMPOUNDING
Compounding pharmacies are an essential part of community medicine and serve a significant role for patients whose
specialized medical needs cannot be met by an FDA-approved drug product. As such, ensuring the quality of compounded drugs
for consumers in Virginia is of the utmost importance. In 2012, badly icines led to a nationwide outbreak of
fungal meningitis which claimed 64 lives, with many victims throughout Virginia. According to the 2018 FDA Compounding
Priorities Plan, it is necessary to better define and separate the legitimate practice of pharmacy compounding from a growing
number of enterprises that, like the in New England, “were acting as large-scale drug manufacturers seeking to operate outside
of the purview of FDA oversight by operating under the guise of a pharmacy license.” Running a pharmacy requires doing
things by the book and paying scrupulous attention to every detail. As Virginia pharmacist and President of the American
Pharmacists’ Association Foundation, Dr. Leonard Edloe has noted, inspection and regulation of pharmacies are critical,
“because mixing medicines without proper scrutiny is reckless and wrong.
This legislation does not seek to undermine the mission or import of community compounding pharmacies; rather, it enshrines
expertise in compounding into Virginia law, and grants compounding pharmacists representation in state regulatory bodies.
Moreover, it ensures that patients who rely on compounded medicines receive safe products. As FDA Commissioner Scott
Gottlieb has stated, it is critical “to preserve patient access to compounded drugs to meet patients’ individual medical needs
while also protecting patients from the risks of contaminated or otherwise harmful products.”
HB224: Ike}
Mandate the Bosrd'ot Héslth ta Taclida compounded medicines in its public education outreach efforts;
= Ensure one member of the state Board of Health holds expertise in the practice of compounding medicine.
REFERENCES
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