State tries to regulate compound medications
Pharmacies warn proposed law will cause price spikes
By Anna Bitong
Pharmacies that sell sterile compounded drugs in California may soon have to meet stricter standards following nationwide reports of injury and death from contaminated medications. Opponents say the regulations would drive up costs and hurt consumers.Sterile compounded drugs may be injected, inhaled or dropped into the eye. Unlike non-sterile compounded medications, which can be swallowed or applied to the skin, sterile drugs pose an increased risk for harm to patients because of how and where they are administered.
Compounded products accounted for up to 3 percent of the $320 billion spent on prescription drugs in the United States in 2011, according to a report from the California State Board of Pharmacy.
Licensed pharmacies may compound, or mix, both sterile and non-sterile drugs to customize prescribed medications by adjusting dosage strength, ingredients and formula to meet individual patient needs. They may also compound existing formulas to reproduce medications that are in short supply from manufacturers.
But the process of sterile compounding has produced some frightening results.
In October 2012, for example, the Massachusetts-based New England Compounding Center shipped tainted epidural steroid injections used to treat pain to 75 medical facilities in 23 states, including California.
The treatments were later linked to cases of fungal meningitis and other infections.
As of last month, of the 14,000 patients who received the injections, 61 people died and about 700 became ill.
Compounded products accounted for up to 3 percent of the $320 billion spent on prescription drugs in the United States in 2011, according to a report from the California State Board of Pharmacy.
Licensed pharmacies may compound, or mix, both sterile and non-sterile drugs to customize prescribed medications by adjusting dosage strength, ingredients and formula to meet individual patient needs. They may also compound existing formulas to reproduce medications that are in short supply from manufacturers.
But the process of sterile compounding has produced some frightening results.
In October 2012, for example, the Massachusetts-based New England Compounding Center shipped tainted epidural steroid injections used to treat pain to 75 medical facilities in 23 states, including California.
The treatments were later linked to cases of fungal meningitis and other infections.
As of last month, of the 14,000 patients who received the injections, 61 people died and about 700 became ill.