Prefilled syringes, premixed drugs reduce errors
Eliminating the need for nurses and doctors to figure out dosage, based on a patient’s weight and medical condition(s), is a documented way to reduce medication error. American Society of Health-System Pharmacists guidelines (ASHP guidelines: minimum standard for pharmacies in hospitals. In: Best Practices for Hospital & Health-System Pharmacy. Position & Guidance Documents of ASHP, 2004-2005. Bethesda, MD: ASHP; 2004:325-330.) strongly suggest, "Whenever possible, medications shall be available for inpatient use in single-unit packages and in a ready-to-administer form. Manipulation of medications before administration . . . should be minimized." Shannon Gore, manager, public affairs, Hospira Inc., Lake Forest, IL, cited a study by Leape et Al. (JAMA 1995;274:35-43.) that found that "the preparation of medications accounts for 3 percent of all medication errors, 11percent of pharmacy dispensing errors, and 5 percent of nurse administration errors." More recently, the Institute of Medicine’s widely publicized study, To Err is Human: Building a Safer Healthcare System, estimated that, among the 98,000 who die each year from medical errors, 7,000 deaths involve medication. In 2001, the Agency for Healthcare Research and Quality reported that more than 770,000 patients experience adverse drug events, many of which could have been prevented by reducing medication error.

University of Miami research team: Indushekhar Persaud, Lindsey Malik, Kathryn Russell, Niven Narain

Gore highlighted her company’s position on medication errors, patients, and healthcare personnel: "Hospira has taken a proactive approach to improving both patient and healthcare worker safety. This approach resulted in the organization pioneering the availability of premixed solutions and prefilled syringes to minimize mixing and handling errors and to provide products that prevent needlestick injuries among healthcare workers. Prefilling syringes and premixing drugs can promote safety," observed Gore, because "there is no need to calculate dose, concentration, or volume, and there is no thawing or admixing required. Our systems offer standard doses, bar coded labels, and needle-free products, which also can enhance safety."

Nosing around
Another needleless product is the BD Accuspray nasal spray system by BD Medical Pharmaceutical Systems, Franklin Lakes, NJ. BD (Becton, Dickinson and Company) is a medical technology company that develops and manufactures drug-delivery systems such as the BD Accuspray. BD Medical Pharmaceutical Systems develops sterile, clean, ready-to-fill, prefillable syringes for pharmaceutical companies, who fill them with drugs.

No doubt you’ve heard of FluMist, a flu vaccine from MedImmune, which utilizes Accuspray technology; but did you know that migraine and osteoporosis drugs can be delivered nasally, too? Sherry Dean, product manager for BD, offered a glimpse into future applications for Accuspray technology: "The nasal-delivery market is expected to grow by 20 percent by 2008. A lot of drugs are in development that can be delivered nasally, utilizing Accuspray."

Bioject Inc. Needle-free injection system

Advantages of nasal delivery (or internasal delivery), according to Dean, are that "it’s more effective and faster-acting than oral medication because it bypasses the gastric system; it’s needle-free, so sharps injuries are decreased; patients experience no pain; and, because it’s a prefilled dose, nurses don’t have to manipulate the syringe or medication in any way, eliminating dosage confusion. It reduces medication error because it’s prefilled with a fixed amount of drug."

The challenge faced by manufacturers of nasal-delivery methods is that, "because it’s a newer delivery method, the market is taking time to grow," said Dean.

Cream for cancer
If you’ve never been totally blown away by medical news, here’s something that will do it. Groundbreaking news on cancer treatment emerged from the University of Miami recently. Ever heard of the Q10 coenzyme? If you haven’t yet, you most certainly will. Currently, it’s used in cosmetics and in treating heart disease, but researchers at the University of Miami have found another application for it, with astounding results.

Q10 restores cancer cells’ natural ability to kill themselves, as normal cells eventually do, and stops those that don’t die from growing. Because Q10 is delivered topically in a cream, it’s a noninvasive treatment. Better yet, it doesn’t damage normal cells, unlike traditional cancer treatments. Best yet, researchers have demonstrated an approximately 60 percent reduction in tumor size within 30 days in animal tests.

Principal investigator Bob Hsia, professor of the department of dermatology and cutaneous surgery, Miller School of Medicine, University of Miami, Florida, talked to Healthcare Purchasing News about their latest discovery: "Q10 is present in every cell. That our formulation kills cancer cells is a new finding."

TAXUS Express Paclitaxel-Eluting Coronary Stent

Liposomes, microscopic particles that can penetrate skin, are used to deliver Q10 in formulations of 1percent to 10 percent. Dr. Hsia explained: "Q10 and our vehicle combine so closely, they become one unit, imitating natural biological membranes. What’s fascinating about this combination is that it doesn’t hurt normal cells. It’s amazing."

Niven R. Narain, director of transdermal delivery/cutaneous cancer research, explained that, because Q10 is a natural product, "it significantly reduces toxicity or side effects. It’s also important to note that, with Q10, there are no known contraindications with other medications. There won’t be any interaction with other drugs, no reduction of the efficacy of other drugs, and it’s highly improbable that Q10 would decrease the efficiency of other cancer drugs."

Hsia commented, "Usually, cancer treatment, radiation or chemotherapy, is very harsh. A lot of cancer cells are killed, but even more normal cells are killed. We’re trying to treat the cancer without hurting normal cells, by making cancer cells to go into what we call apoptosis, which is natural cell death."

Indushekhar Persaud, chief bioengineer for drug delivery theraputics, added: "With a lack of apoptosis, the cells just grow uncontrollably. This is the first time a group has taken two natural components of the cell itself and joined them together in a manner that stabilizes normal cells and also restores cancer cells’ ability to go through apoptosis. We’ve induced melanoma tumors in nude mice and find, in addition to apoptosis, that our treatment is reducing angiogenesis, growth of new blood vessel cells. Tumor cells’ rate of producing blood cells is higher than normal cells. Obviously their requirements for nutrition are a lot higher than that of normal cells; so, their rate of producing blood cells is extremely higher. Topical treatment of Q10 disrupts vascularity, resulting in a remarkable inhibition in tumor size. In our study, melanoma tumors were reduced in size by approximately 60 percent in 30 days. That’s pretty remarkable, because melanoma is one of the fastest growing and most malignant tumors."

"This summer, Dr. Nouri, of the Sylvester Cancer Center, University of Miami, will commence clinical trials on skin cancer," added Narain.

It doesn’t stop with transdermal delivery. Persaud told HPN about other research in progress or on the horizon: "Currently, we are working on studies delivering Q10 via infusion. Oral delivery is not good, because more than 60 percent is excreted or degraded. Infusion will enable us to treat tumors that cannot be reached dermally, as in the gastrointestinal tract, prostate, and metastasized cancers. Said
Narain: "The first target organ for Q10 is the liver; so, we hypothesize that, for patients with liver cancer, we should see high efficacy rates, also for kidneys."

Another unique and singular advantage of treating cancer with Q10, said Hsia, is that Q10 boosts energy production. "Patients usually feel better and have more energy, unlike with chemotherapy and radiation."

Aside from doing much good for patients, treating cancer with Q10 cream has other practical benefits. Narain outlined some of them: "From a healthcare perspective, this is going to reduce strain on the US Public Health Service, because, by applying a cream to patients, as opposed to treating them with an intravenous line for chemotherapy or radiation, the healthcare costs are tremendously diminished."

Perhaps the most gratifying results of their research on Q10, said Hsia, is this: "We have confidence it won’t hurt anybody. Chances are it will do the patient a lot of good without doing any harm. It makes us feel good inside."

New take on stents
Unfortunately, not all treatments can be noninvasive; yet, there are noteworthy advances in that arena, too. A prime example is the TAXUS drug-eluting stent manufactured by Boston Scientific Corporation Inc. (BSCI), Maple Grove, MN. Eric Simso, vice president of marketing, told HPN that bare metal stents (BMSs) are on their way out, because results with drug-eluting stents have reaped such remarkable results. "In 2 or 3 years, we will quit making BMSs. Currently, 85 percent of stents on the market are drug-eluting; 15 percent are BMSs."

Simso explained how the TAXUS stent works: "The standard stainless-steel stent is about the size and shape of a ballpoint-pen spring. It’s mounted on the outside of an angioplasty balloon catheter, which is snaked to the lesion in the coronary artery. The balloon is then inflated, which opens or "deploys" the stent; when the balloon is deflated, the stent is left behind. The stent is coated with a polymer that contains the drug paclitaxel. The coating is about 10 microns thick, so a TAXUS stent looks identical to a traditional BMS. The drug elutes from the polymer coating over a short period of time; in 4 to 5 weeks, no drug release can be detected."

The purpose of the drug is to prevent restenosis, a repeat narrowing of the blood vessel. Whereas the blood vessel originally was narrowed by plaque, a mixture of lipids, glycoprotein, smooth muscle cells, and inflammatory cells, the regrowth is comprised largely of smooth muscle cells, similar to scar tissue. Results reaped by using the drug-eluting stent are impressive. "Approximately 15 percent of patients with a BMS will have recurrence of the disease, or restenosis, within 1 year," said Simso. "TAXUS reduces that to about 5 percent."

"The TAXUS stent is more expensive than a BMS, but the long-term cost savings can be meaningful. A BMS costs about $1,000 per procedure as opposed to a TAXUS stent at $2,500. However, studies have shown that drug-eluting stents can reduce costs because patients don’t have to come back for a second procedure, at a minimum cost of $10,000."

Simso recounted the advantages of delivering the drug via the stent: "It’s easy for the doctor and transparent to patients. Compared to systemic drug delivery, less drug can be used, reducing the chance of side effects. Physicians don’t have to be retrained or change anything they’re doing. Occlusive heart disease is unique because cardiologists are worried about treating only the affected area, often a discrete area of only 15 to 20 mm; they don’t want to affect the rest of the body. The stent delivers drug only to the intended lesion. Alternative approaches, such as infusing drugs, would rely on the physician to customize the optimal dose for the patient, based on the patient’s weight and medical condition. BSCI has done extensive research to understand the minimal effective dose and provides that on the TAXUS stent. Multiple stents and overlapping stents work fine. The goal is ease of use."