This describes a "Model Act" provision in the Virginia Code that excludes pen needles from restrictions related to prohibition of distribution of hypodermic needles, relating to Virginia's relating to Drug Control Act.
Pen needles are attached to pen injectors, which are used for sub-Q injections, typically for insulin, GLP-1 agonists and other pharmaceuticals taken by sub-Q injection using a pen injector device. The pen needles are typically sold in boxes of 100 pen needles, which are often purchased from a variety of sources separately from the pharmaceutical item.
Pen needles were introduced in 1985, by Novo Nordisk with a 12.7 mm length to administer insulin products, and came into widespread mostly after 2010 to 2020. Currently, most pen needles are in the range of 3.5 to 6 mm length, with 4 mm being the most common.
A related item concerns autoinjectors, which are single use devices with a built-in needle similar to a pen needle. The autoinjector is delivered filled with the prescription drug, and the needle is integral with the autoinjector, so autoinjectors are not relevant to Virginia's Model Pen Needle Act.
As a commodity item, "open market" purchases of pen needles are often economical; often at a cost of 1/4 the co-pay cost through medical insurance. Consequently, it is common to purchase pen needles from a variety of sources.
The problem is obvious -- if a law restricts distribution of hypodermic needles, the law would read on pen needles unless pen needles are exempted from the restriction.
Since pen needles are impractical for use with street drugs and other restricted use, it was desired to exclude pen needles from most restrictions applied to hypodermic syring needles.
Removing restrictions to pen needles would of course provide easy access for users who obtain their opiates, crack and meth, which perhaps are supplied in multi-dose pen injectors.
</sarcasm> but...There are social issues related to purchase restrictions being applied to hypodermic syringe needles which may be used for street drugs.[1]
Nevertheless, pen needles are impractical for use with street drugs for several reasons:
(Of note, Epi-pens use autoinjectors for IM injection, but those are autoinjectors; not pen needles, and IM is still different from venipuncture.)
- Pen needles are designed for sub-Q injection and as such are difficult to "main line" into a vein. It is possible to order 12.7 mm pen needles, but even that takes a degree os skill to "main line". The more common ones are injected at 90°, which is not very useful for venipuncture.
- If it is possible to use, for example a 12.7 mm pen needle for venipuncture, there would be no reason for someone to learn that skill.
- Street drug "works" are not configured for accepting pen needles.
- Street drugs are taken up by the syringe. There are ways to use a syringe (typically a blunt syringe or a filter syringe) to fill some pen injectors, but that would not be done with street drugs. Again, there are no reports of adapting pen needles for venipuncture.
More significantly ... the very purpose of sub-Q injection is to achieve slow delivery of the pharmaceutical, which is why the injection is injected into the subcutaneous adipose layer (hypodermis layer of the skin; hence "sub-Q"). This can be 30-60 minutes for regular insulin to a week or longer for pharmaceuticals with lipid encapsulation, such as many GLP-1 agonists. That onset of action is of course not quite the "delivery system" desired for street drugs.
Virginia's Model Pen Needle Act modified the law related to distribution of hypodermic needles or syringes by excluding pen needles:
VA Code § 54.1-3467 D
§ 54.1-3467. Distribution of hypodermic needles or syringes, gelatin capsules, quinine or any of its salts.
...
D. Notwithstanding the provisions of subsection A, nothing in this section shall prohibit the distribution of hypodermic needles that are designed to be used with a reusable injector pen for the administration of insulin.
This highly controversial provision passed 24-Feb-2023:
- House: Adoption 24-Feb-2025 (95-Y 0-N);
- Senate: Conference report agreed to by Senate 21-Mar-2023 (40-Y 0-N);
- Signed by Governor same day (21-Mar-2023 - 1-Y 0-N)The Virginia Model Pen Needle Act can easily be copied verbatim by the legislature (of a different state), with changes made to the term "hypodermic needles" to fit the state terminology. (For NY, CT, Calif, no wording change required; Florida, minor change in wording - remove "hypodermic". It's simply a matter of identifying the new sub-section of the state statute.)
The effect of Virginia's Model Pen Needle Act is more than trivial. In addition to issues with obtaining Rx documentation, the insurance co-pay for pen needles is often significantly higher than the direct open market and on-line cost. (Typical on-line cost is $15/100 for good quality generic pen needles and $20-$40/100 for brand name pen needles.) Pharmacies are able to bypass insurance (if requested by the customer), but their pricing structure is still keyed to pricing through the pharmaceutical supply chain.
It is possible for a clinician to assign a pen needle Rx to an on-line pharmacy, but this tends to eliminate third-party sellers and other non-Rx sellers.
Apparently Rx restrictions for purchase of pen needles are generally not enforced in Calif and are loosely enforced in Florida. At least one well-known specialty mail order outlet only restricts pen needle shipments to NY and CT.
On skoozeme.com :
- The Needle Phobia Page
- Needle phobia and addressing trypanophobia (needle phobia)
first posted 7-Feb-25; rev 1-Mar-25 This page copyright 2025, Stan
Protigal