Monday, October 22, 2012 - Page
updated at 04:00 a.m.
By RONI CARYN RABIN
By RONI CARYN RABIN
The New York Times
When Julie Auslander's son was sick and struggling to take his pills, she
turned to a pharmacist, who made medicated patches for him to use instead.
A few years later, when Auslander's mother, who had dementia, needed anti-anxiety drugs but couldn't swallow, Auslander turned again to a pharmacist, who prepared a special tablet that dissolved under the tongue.
In each instance, said Auslander, 53, a businesswoman in Montvale, N.J., she vetted the pharmacy herself.
"I looked at the operation, just like I'd do with anything else I'm buying," she said. "I can't do the same job as the FDA, but you get a feel for a place when you walk in."
Tailored to individual
Although most people these days pick up their antibiotics or diabetes medications from a drugstore, some prescriptions need to be specially mixed or altered — a process called compounding — to suit individual needs.
Drugs that come only in adult doses are often compounded for children or turned into bubble-gum or grape-flavored liquids. Dye-free or gluten-free formulations can be made for patients with allergies; chicken- and tuna-flavored medicine is compounded for cats and dogs.
Virtually every acute-care hospital has a compounding pharmacy on-site that prepares drugs for patients.
But it now appears that an injectable painkiller compounded in huge batches by a pharmacy in Massachusetts was contaminated with fungus and has caused a multistate outbreak of meningitis. More than 20 people have died, and more than 280 are ill.
Regulations fall short
The episode has renewed debate about the weak regulation of compounding pharmacies, some of which have mushroomed into mini drug factories even though they are regulated mostly by state boards, whose standards vary.
While a doctor prescribing a compounded medication on an outpatient basis will often direct the patient to a special pharmacy capable of filling the prescription, many patients aren't aware they are receiving compounded drugs.
"The IV bags hanging by people's bedsides — not all of them but a large number — are compounded in the hospital pharmacy," said Anne Burns, senior vice president for professional affairs of the American Pharmacists Association.
Chemotherapy agents administered in clinics or doctors' offices are also often compounded to suit the patient's treatment needs and body weight, she said. "Just like in the hospital setting, if a patient is getting a compounded product from a physician, they probably aren't even going to know," Burns said.
Sometimes even a doctor at a hospital may not know where the drug originated and whether the institution purchased a commercially available drug from an independent compounding pharmacy rather than a manufacturer, said Michael Carome, deputy director of the health research at the watchdog group Public Citizen.
The meningitis outbreak shows that patients will have to begin asking questions about the source of their medications, he added.
Generally, experts say, compounding is appropriate as long as the formulation has been prepared specifically for the patient and is based on a doctor's prescription, contains drugs approved by the Food and Drug Administration and is not available from a manufacturer.
But the compounding center in Massachusetts appears to have acted more like an unregulated drug company. Its compounded painkiller, a steroid that can be injected into the spine, was shipped to 23 states and given to some 14,000 patients.
"The red flag that they had overstepped was that they were producing 17,000 units of this steroid," said Marcus Ferrone, associate professor of clinical pharmacy at the University of California, San Francisco, and director of the Drug Products Service Laboratory, which compounds products and runs a course on compounding for pharmacy students.
Expiration date
Another red flag: the expiration dates on the drug bottles.
Photographs published by news outlets show that some of the vials appeared to have arrived with an expiration date of Feb. 6, 2013.
"Manufacturers spend a lot of time determining an expiration date, but compounders can't do that," Ferrone said. "We don't have the data."
Although he did not want to comment on the specific drug implicated in the outbreak, he said that when high-risk sterile products for spinal injections or for total parenteral nutrition are involved, "we give them a 24-hour expiration date."
Ferrone said patients should be asking "not just if the medication is compounded but is everything done here on-site?"
And if a drug is compounded elsewhere, he said, the next question should be, "Who has looked at it and done the due diligence with respect to the quality assurance of that off-site vendor?"
Patients should be especially vigilant about any drug administered intravenously or through injection, which must be prepared under sterile conditions.
While the gastrointestinal tract has mechanisms to fight bacteria and other contaminants that may end up there inadvertently, "once something is directly injected into your circulatory system, there are fewer options," said Cynthia Reilly, director of the practice development division for the American Society of Health-System Pharmacists.
More advice
Reilly and other experts offered additional advice about compounded drugs:
• Ask your doctor if your medication requires compounding, and if it does, ask why and whether a standard FDA-approved drug is available in a form ready to be administered — even if it costs more. If you need a unique prescription that requires compounding, choose a pharmacy as you would any other health-care provider.
Start with recommendations, but make sure it's licensed by the state and hasn't been penalized.
• Inquire about the training of the pharmacists and ask if they have additional accreditation. Make a visit and see the facilities for yourself.
• Ask the pharmacy whether it is familiar with your prescription and has experience preparing it.
Ask for directions about storing and using the product and inquire about side effects, risks and contraindications.
• Check the FDA website for warning letters on lack of compliance. The agency, however, has only limited authority over compounding pharmacies.
• Avoid buying drugs directly from your doctor and try to use the same pharmacy for all your prescriptions.
If a product container doesn't have a manufacturer's logo and the label doesn't include directions and warnings, it may have been compounded. If you receive a product like this, ask the pharmacist if the doctor asked for it to be compounded.
• Be especially vigilant about the source of injectable or IV drugs and eye medications. Some dental products, especially anesthetic gels, may also be compounded, as are many pain medications and skin treatments.
• If you're having an elective procedure that requires a medication available only from a compounding pharmacy because of a shortage, consider postponing the procedure.
Source found here
A few years later, when Auslander's mother, who had dementia, needed anti-anxiety drugs but couldn't swallow, Auslander turned again to a pharmacist, who prepared a special tablet that dissolved under the tongue.
In each instance, said Auslander, 53, a businesswoman in Montvale, N.J., she vetted the pharmacy herself.
"I looked at the operation, just like I'd do with anything else I'm buying," she said. "I can't do the same job as the FDA, but you get a feel for a place when you walk in."
Tailored to individual
Although most people these days pick up their antibiotics or diabetes medications from a drugstore, some prescriptions need to be specially mixed or altered — a process called compounding — to suit individual needs.
Drugs that come only in adult doses are often compounded for children or turned into bubble-gum or grape-flavored liquids. Dye-free or gluten-free formulations can be made for patients with allergies; chicken- and tuna-flavored medicine is compounded for cats and dogs.
Virtually every acute-care hospital has a compounding pharmacy on-site that prepares drugs for patients.
But it now appears that an injectable painkiller compounded in huge batches by a pharmacy in Massachusetts was contaminated with fungus and has caused a multistate outbreak of meningitis. More than 20 people have died, and more than 280 are ill.
Regulations fall short
The episode has renewed debate about the weak regulation of compounding pharmacies, some of which have mushroomed into mini drug factories even though they are regulated mostly by state boards, whose standards vary.
While a doctor prescribing a compounded medication on an outpatient basis will often direct the patient to a special pharmacy capable of filling the prescription, many patients aren't aware they are receiving compounded drugs.
"The IV bags hanging by people's bedsides — not all of them but a large number — are compounded in the hospital pharmacy," said Anne Burns, senior vice president for professional affairs of the American Pharmacists Association.
Chemotherapy agents administered in clinics or doctors' offices are also often compounded to suit the patient's treatment needs and body weight, she said. "Just like in the hospital setting, if a patient is getting a compounded product from a physician, they probably aren't even going to know," Burns said.
Sometimes even a doctor at a hospital may not know where the drug originated and whether the institution purchased a commercially available drug from an independent compounding pharmacy rather than a manufacturer, said Michael Carome, deputy director of the health research at the watchdog group Public Citizen.
The meningitis outbreak shows that patients will have to begin asking questions about the source of their medications, he added.
Generally, experts say, compounding is appropriate as long as the formulation has been prepared specifically for the patient and is based on a doctor's prescription, contains drugs approved by the Food and Drug Administration and is not available from a manufacturer.
But the compounding center in Massachusetts appears to have acted more like an unregulated drug company. Its compounded painkiller, a steroid that can be injected into the spine, was shipped to 23 states and given to some 14,000 patients.
"The red flag that they had overstepped was that they were producing 17,000 units of this steroid," said Marcus Ferrone, associate professor of clinical pharmacy at the University of California, San Francisco, and director of the Drug Products Service Laboratory, which compounds products and runs a course on compounding for pharmacy students.
Expiration date
Another red flag: the expiration dates on the drug bottles.
Photographs published by news outlets show that some of the vials appeared to have arrived with an expiration date of Feb. 6, 2013.
"Manufacturers spend a lot of time determining an expiration date, but compounders can't do that," Ferrone said. "We don't have the data."
Although he did not want to comment on the specific drug implicated in the outbreak, he said that when high-risk sterile products for spinal injections or for total parenteral nutrition are involved, "we give them a 24-hour expiration date."
Ferrone said patients should be asking "not just if the medication is compounded but is everything done here on-site?"
And if a drug is compounded elsewhere, he said, the next question should be, "Who has looked at it and done the due diligence with respect to the quality assurance of that off-site vendor?"
Patients should be especially vigilant about any drug administered intravenously or through injection, which must be prepared under sterile conditions.
While the gastrointestinal tract has mechanisms to fight bacteria and other contaminants that may end up there inadvertently, "once something is directly injected into your circulatory system, there are fewer options," said Cynthia Reilly, director of the practice development division for the American Society of Health-System Pharmacists.
More advice
Reilly and other experts offered additional advice about compounded drugs:
• Ask your doctor if your medication requires compounding, and if it does, ask why and whether a standard FDA-approved drug is available in a form ready to be administered — even if it costs more. If you need a unique prescription that requires compounding, choose a pharmacy as you would any other health-care provider.
Start with recommendations, but make sure it's licensed by the state and hasn't been penalized.
• Inquire about the training of the pharmacists and ask if they have additional accreditation. Make a visit and see the facilities for yourself.
• Ask the pharmacy whether it is familiar with your prescription and has experience preparing it.
Ask for directions about storing and using the product and inquire about side effects, risks and contraindications.
• Check the FDA website for warning letters on lack of compliance. The agency, however, has only limited authority over compounding pharmacies.
• Avoid buying drugs directly from your doctor and try to use the same pharmacy for all your prescriptions.
If a product container doesn't have a manufacturer's logo and the label doesn't include directions and warnings, it may have been compounded. If you receive a product like this, ask the pharmacist if the doctor asked for it to be compounded.
• Be especially vigilant about the source of injectable or IV drugs and eye medications. Some dental products, especially anesthetic gels, may also be compounded, as are many pain medications and skin treatments.
• If you're having an elective procedure that requires a medication available only from a compounding pharmacy because of a shortage, consider postponing the procedure.
Source found here
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