As it
stands now, any pharmacist in Florida can create specialized medications for
patients who have a doctor's prescription. But recent mistakes by so-called
pharmaceutical compounders — pharmacists who produce these kinds of medications
in large quantities — have brought intense public scrutiny on the practice,
along with calls for greater regulation.
So on
Tuesday, the State Board of Pharmacy ordered a committee of its colleagues to
come up with a series of state permits that pharmacists would have to be granted
before they could create and sell specialized medicines. The three-person
committee will come back with recommendations at a later date.
"It
helps us as a regulatory body to know exactly what type of practices … are
occurring in any kind of pharmacy," said Board of Pharmacy Chairwoman Cynthia
Griffin of the proposed new rules.
She and
other board members met in Tallahassee to explore other ways to best protect
Florida consumers from bad drugs, like the contaminated pain medication that was
manufactured by a Boston-area compounding lab and is blamed for an outbreak of
fungal meningitis that has sickened nearly 600 people and killed 37 across 19
states.
The
proposed permits would allow state health inspectors to keep track of
medications being created by pharmacists.
Currently, Florida's pharmacy license and
permitting process doesn't give regulators much information about what medicines
are being made by the state's 8,000 pharmacists.
In
addition to creating a permitting process, the Board of Pharmacy also wants the
committee to consider requiring compounders to use a consulting pharmacist to
ensure they follow guidelines for making sterile drugs, and it wants to require
out-of-state pharmacies doing business in Florida to provide proof of their
latest health inspections.
Tuesday's meeting was the second in two months
for the Board of Pharmacy, which has acknowledged that compounders operate
without enough oversight of the drugs they make and sell. Last month, the board
said it wasn't even sure how many pharmacists are engaged in compounding and
ordered a survey to try to determine which ones are compounding and what drugs
they are making.
The
Florida Department of Health reported Tuesday that more than 90 percent of
Florida pharmacies completed the mandatory survey. A voluntary survey previously
ordered by health officials garnered only a 10 percent response rate from
pharmacists.
The
recent meningitis outbreak was traced to contaminated lots of methylprednisolone
acetate from the New England Compounding Center (NECC) in Massachusetts. Most of
the Florida contamination cases were in Marion County involving three local
clinics that injected the medicine into patients, mostly to relieve back
pain.
Compounding pharmacies make medications and
other medical preparations from scratch. They cannot make copies of commercially
available medications and can only make medications when they are ordered by a
doctor. Most make uniquely formulated medicines required by patients who are
unable to use medications manufactured by commercial producers. But more
recently, pharmacies are mass producing drugs, especially medicines for which
there are otherwise shortages.
These
medicines, critics say, are created without the same stringent oversight that
commercial drug makers endure.
Currently, licensed Florida pharmacists are
allowed to compound medications without any additional accreditation.
Pharmacists making non-sterile medicines encounter minimal inspections while
those making sterile medicines for injection purposes — such as the contaminated
medicines behind the outbreak — require a higher level of regulation.
In
addition to the meningitis outbreak, compounders have been blamed for other
high-profile errors that caused serious health problems. In recent years, two
such episodes were traced to Franck's Compounding Lab in Ocala.
In one
case, Franck's mixed a bad dose of vitamin supplements that killed two dozen
prized polo horses. In another, it was blamed for creating bad batches of eye
medications that blinded eye surgery patients in several states.
That
last mistake caused owner Paul Franck to sell his business to Wells
Pharmacy.
While
the Board of Pharmacy works on creating a permitting process for compounders, a
key state health official admitted Tuesday that health inspectors may not be up
to the task of inspecting compounders to ensure the medicines they are making
are safe.
Jeane
Clyne, with the Florida Department of Health, told the board that some of her
inspectors had little experience inspecting compounding pharmacies. The board
recommended she consider hiring consultants to create an inspection process that
better takes into account the type of compounding the businesses are performing
and creating the necessary records of their findings.
Board
members during the meeting also expressed frustration with how to ensure
out-of-state pharmacies remain safe and follow good practices. Florida law
doesn't allow for Florida inspectors to travel outside the state for inspections
nor can they force other states to conduct more frequent inspections or meet
Florida compounding standards.
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