Originally Published PMPN July 2002
SpecialDrug Delivery Finds Its Way Home
The growth of the home healthcare market is fueling the development of simple, intuitive drug-delivery systems that ease self-administration.
by Kassandra
Kania, Managing Editor
As a result of this shift, it is safe to assume that recovery and chronic conditions
are being managed at home, and many probably require the delivery of complex
drug regimens. According to Gerhard Mayer, PhD, director of marketing and business
development for Becton Dickinson Pharmaceutical Systems (BD; Franklin Lakes,
NJ), self-injection is becoming a common form of drug delivery in the home,
with diabetes patients constituting the majority of that group.
 |
|
An auto-injector from Meridian is used to self-administer medication in an emergency situation,
while prefilled syringes from Becton Dickinson can help manage chronic
diseases.
|
Another growing segment consists of rheumatoid arthritis patients, who are turning to self-administration of injectable drugs. To help these patients, pharmaceutical companies are coming up with innovative drug-delivery systems that make it safer and easier for them—particularly those whose physical abilities may be impaired by their disease or condition—to administer drugs themselves on a routine basis.
Easing Injections
Often, says Mayer, when patients need to administer their own drugs, they use
a prefilled, single-dose syringe. Benefits include ease of use and convenience,
and less risk of misidentification and contamination. In many cases, drugs require
reconstitution prior to administration, and there are a number of drug-delivery
systems available to assist patients. BD supplies a dry reconstitution system
that contains a syringe prefilled with diluent, which the patient attaches to
a vial containing the dry drug. After reconstitution, the patient draws back
the syringe and injects himself or herself.
Duoject (Bromont, Quebec, Canada) offers a novel double-chamber reconstitution
device called Inter-Vial Plus in which the traditional wet/dry positions have
been reversed. With its new Set-to-Process (STP) technology, the company's Vari-Vial
cartridges can be prefilled on standard powder fillers, or its prefilled liquid
contents can be lyophilized in conventional freeze dryers. "By reversing the
positions of the drug and diluent, less expensive commercially available WFI
[water for injection] vials can now be connected to the vial receptable section
of our system," explains Dan MacDonald, director of engineering services. "Our
clients therefore now have the option of either liquid filling, powder filling,
or lyophilizing their drug in a cartridge for use with our reconstitution device."
The Inter-Vial and Inter-Vial Plus systems are also designed to prevent accidental
needle sticks. "Needle sticks are avoided because the transfer needle through
which admixture transfer takes place is automatically detached and discarded
with the vial section after reconstitution," says MacDonald. "End-users
can then connect the syringe to needle-free sites, syringe pump infusion tubing,
or attach their own sterility-assured needles."
Amgen's SimpleJect system, which won a 2002 Medical Design Excellence
Award and a Compliance Package of the Year Award from the Healthcare Compliance
Packaging Council, addresses both the physical and psychological hurdles patients
face when self-injecting. The system was designed to administer Kineret, a daily
self-injectable drug to treat rheumatoid arthritis. "This disease can be
very crippling and painful," says Craig Lester, marketing manager for Amgen
(Thousand Oaks, CA). "It may be difficult to extend your thumb or fingers,
and light pressure on the joints can be painful. We had to design a device that
would allow for simple administration of a drug where patients' lack of
dexterity is a concern."
The patient opens the lid of the SimpleJect case and drops a prefilled syringe
of Kineret into the syringe housing. He or she then removes the blue handle
from the case and pushes it onto the blue rod in the middle of the case until
a click is heard. Next, the handle is attached to the syringe housing, which
is then pulled from the case and applied to the injection site. The patient
pushes down on the handle until it clicks, which starts the injection process.
After 10 seconds, the injection is complete. The patient unscrews the handle
from the syringe housing and discards the syringe.
Through research, Amgen found that patients often have psychological issues
with self-injection, particularly related to watching a needle penetrate their
skin. So the company designed SimpleJect to automatically remove the needle
cover and hide the syringe from the patient's view during the injection process.
In fact, the whole injection process takes less than a minute. "The patient
doesn't see the needle until after they've injected the drug," says Lester.
Single-dose prefilled syringes are also being used to self-administer drugs
in emergency situations. Meridian Medical Technologies (Columbia, MD) sells
auto-injectors to the U.S. military for nerve-agent antidotes and drugs taken
for treatment of nerve-agent casualties. The company's number one commercial
seller, based on the military design, is the EpiPen, which is used to treat
anaphylaxis, a severe allergic response to triggers such as food, medications,
insect bites, or latex. "People who have an allergic reaction don't
have the luxury of waiting for the ambulance to arrive," says Tom Handel,
vice president–sales. "They have seconds or minutes to get treatment
or that's it; there's no other opportunity for rescue."
The patient removes the safety pin and safety cap from the EpiPen and pushes
the point down on the injection site, which activates the device, driving the
syringe forward and depositing the drug in the tissue. "What we've
found with these products is you need to make them exceptionally simple to use,"
says Handel. "You can't have a number of different steps because a
patient's functional and mental capacity is really compromised in these
situations. A lot of people give these to their children for food allergies,
so they have to be simple, intuitive, and rugged. People carry these outside
the case. Some may take an injection hours after getting the product; others
may never use it. So it's important that the labeling is clear and conducive
to someone just picking it up and using it."
While single-use disposable systems make sense for emergency drugs, Handel admits that they can be expensive for drugs used on a routine basis, and it becomes difficult to justify the cost. In these instances, reusable pen systems may be more appropriate. BD manufactures reusable pen systems, which are commonly used for diabetes patients. However, as Mayer notes, pen systems have their limitations as well. "If you use a pen system, it needs to have a preservative, and a lot of biotech products don't have preservatives." Another limitation is the amount of product the pen system can hold. "Typically, pen systems are limited to 3 ml. So if you have a dosage that is 1 ml or greater, you're not going to get more than three doses out of that pen."
Easing Set-up
Manufacturers are also paying attention to the design features of secondary
packaging and other supplies that will help patients self-inject medication.
Multivac (Kansas City, MO) has sold packaging equipment to PCI Services (Philadelphia)
for the packaging of home healthcare kits for arthritis and multiple sclerosis.
The arthritis kit has Tyvek lidding designed to overhang the tray by two inches
so that someone with arthritis can easily grip and open the packaging. The multiple
sclerosis kit also has a Tyvek overhang with two holes punched in it so that
the patient can put two fingers in the holes and pull the package open. "In
the case of the extended lidding with the holes in the Tyvek, we had to design
a special hole-punching unit that could easily and smoothly cut through the
Tyvek without leaving any particulate on it," explains Marty Moscowitz,
Multivac's regional manager.
The package also incorporated a feature whereby the vial can stand up. "If
you have multiple sclerosis, it may be difficult to hold the vial steady enough
to fill the syringe," he says. "There's a feature in the package
where you can stand the vial up in a circle that's formed in the package.
It stands upright and is fairly secure, so you can take the syringe and put
it in the vial to fill it."
West Pharmaceutical Services (Lionville, PA) has developed systems to provide
added safety and quality assurance for at-home patient care. One of West's drug
delivery devices, the Clip'n'Ject, reduces the complexity of administering the
growing number of lyophilized drugs. Another product, West's D-I-D System (Decoration-Identification-Differentiation),
uses the company's unique technology to print vital information regarding the
contents of a vial—dosage, strength, storage, and disposal—on the
aluminum seal, the plastic button, or both. Another helpful advantage is that
these seals can be color coded to differentiate them from other pharmaceuticals.
This is helpful for patients who cannot read the type on the seal.
"Many drugs given in the home healthcare environment have to be mixed with diluent and then injected," says Bill O'Dell, vice president, global marketing of West Pharmaceutical Services, "It's often a complex process, and there are issues with compliance and safety. Products like Clip'n'Ject and the D-I-D System were specifically designed to simplify these processes and to improve parenteral drug delivery."
Beyond the Syringe
Syringes aren't the only novel means of administering product. Advancements
are also happening with nasal, transdermal, and oral delivery systems (see sidebar,
"Taking the Sting Out of Oral-Dose Syringes"). West Pharmaceutical
Services is working on a drug-delivery system that delivers a microdose of pharmaceutical
active compound to the eye. "With a traditional dropper bottle, you overdose
the eye," says Scott Young, ATOMist program manager. "ATOMist accurately
administers a small dose that can barely be felt by the patient. The patient
is more likely to stay in compliance with his dosing regimen, and the drug manufacturer
will not have to overfill the container to compensate for lost product. It's
a win-win situation."
"Home healthcare of any type is something that's increasing considerably," says Moscowitz. Pharmaceutical companies are responding to this increase with packaging that helps patients self-administer drugs safely and easily.
Copyright ©2002 Pharmaceutical & Medical Packaging News
