I'm old enough to remember watching the pharmacist at my grandfather's medical clinic mashing pills with a mortar and pestle.
After he ground up the solid medication into a fine powder, he added a liquid solution and poured it into a glass bottle, then turned to his electric typewriter to type the label for the glass bottle. That was in the 1950s, and the pharmacist was compounding the medication, making it specifically for one patient in the needed form and dosage.
Today, I am a “fast food” pharmacy consumer, using the drive-through at my neighborhood retail pharmacy. If I need a refill, I scan the barcode on the bottle with my iPhone.
I really don't think too much about what is inside the pills or where they were manufactured. I have learned most are made in pharmaceutical “batch production” factories, then sold to distributors who resell them to retail and hospital pharmacies.
Whether the substances we take into our body are pills, peanut butter or medications injected into us, we are increasingly disconnected from the process of how those chemicals and foods go from the initial point of production to the point of impact on the cells and organs within our bodies.
That disconnect was made ever more real in the past few weeks with the unfolding story of deaths, strokes, affected joints and potentially other life-threatening complications from fungus-contaminated injected steroids made at New England Compounding Center (NECC), a Framingham, Mass., pharmaceutical company.
As of Friday, the Centers for Disease Control reported 20 deaths, including two in Indiana, are linked to the contaminated drug. More than 250 individuals in 16 states — including 35 in Indiana, as of mid-day Friday — have been sickened with fungal meningitis after receiving the steroids to control pain and inflammation, usually in the back.
Federal officials say as many as 14,000 people are at risk because they were given injections of the steroid from the contaminated lots. In Indiana, 1,507 people have been identified as having been given the steroid, said Ken Severson, Indiana State Department of Health spokesman.
Just one Fort Wayne clinic, Fort Wayne Physical Medicine, is listed by the CDC as having received some of the tainted steroid.
The irony is that NECC is not a pill mill but a compounding pharmacy. Massachusetts Gov. Deval Patrick said it appears NECC was operating outside the parameters of its licensure.
“What they were supposed to be doing is filling specific prescriptions for specific patients …,” Patrick said, according to The Associated Press. “What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license.”
Injectable drugs must be made under sterile technique with stringent environmental standards involving air flow management and other safety measures. According to several news reports, the building housing NECC is also home to a recycling center.
The two identified fungi linked to the meningitis cases are normally found in soil. The revelation in coming weeks of the path of contamination is likely to be replayed on the Big Screen or in a made-for-TV movie in the near future.
While the NECC problems are spurring U.S. lawmakers to ask for more stringent federal oversight of compounding pharmacies, the safety issues should prompt all of us to be more mindful of the medicines and foods we consume.
Registered pharmacist Gregg Russell is owner of Fort Wayne Custom Rx, 414 E. Dupont Road, one of three or four independent pharmacies in Fort Wayne specializing in compounding. Custom Rx is also one of just 200 such pharmacies accredited by the U.S. Pharmacopeial Convention's (USP) Pharmacy Compounding Accreditation Board.
The nonprofit USP sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements made and sold in the United States and around the world. The FDA and USP work hand in hand, with the FDA the regulatory body overseeing development, manufacturing and storing of medicines.
Russell opened the business in 2004 when he saw a growing niche for making customized medications at dosages not available through standard drug manufacturers. In some cases, patients may be allergic to the dyes or another ingredient in a standard drug formula. Compound pharmacists make custom-dosed medicines and might replace or omit ingredients such as preservatives or fillers.
Accreditation is a long process requiring additional training of the pharmacist and staff, on-site inspections and ongoing testing of drugs.
“I spent a lot of money testing products last year, to make sure our processes do work for potency and are the right strain to ensure they are not only safe but accurately made. I'll spend a lot testing this year, too,” Russell says.
Only about 1 percent to 2 percent of all prescriptions are compounded, Russell says, pointing out, “We are not trying to fill the prescriptions of every person in the city.” Most insurance companies don't cover the extra cost involved, but for the patients who need micro-dosing or other customized medications, “We fill a vital need.”
Dr. Angela LaSalle concurs. She is medical director for Integrative Medicine for Parkview Health and for the Women's Health Center at Parkview Regional Medical Center. In Indianapolis where she formerly worked and now here, she often refers patients to a compounding pharmacy for customized dosing of thyroid or other hormones, but she says not all such pharmacies are equal.
“Before I use a compounding pharmacy, I check them out, looking at the credentials of the pharmacist and talking to them about what kind of compounding they do,” she says. “Having sterile equipment is very important.”
She tells patients do to their own homework, too, and cautions them about online compounding pharmacies. Though a pharmacy may not fill prescriptions for sterile drugs, such as injectables, clean technique must be maintained. No one should be mixing meds barehanded.
Russell says the current situation with NECC may have given compounding pharmacies “a small black eye, but it's kind of like saying there's one bad doctor in the state of Indiana, so all doctors are bad.”
Errors are made by major pharmacies, too, LaSalle says, so it's every consumer's responsibility to check the name, dosage and prescribing information before swallowing that pill.