Kansas City, Mo. Med 4 Home a compounding pharmacy that allegedly failed to comply with Missouri rules regarding the recall of contaminated drugs has
by Brook Raflo
April 1, 2003

Kansas City, Mo. Med 4 Home — a compounding
pharmacy that allegedly failed to comply with Missouri rules
regarding the recall of contaminated drugs — has spurred
regulatory activity that could threaten the viability of small
compounding pharmacies throughout the state, according to the
International Academy of Compounding Pharmacists.

The story became public March 10, when the Missouri Board of
Pharmacy asked a judge to issue a temporary restraining order
against Med 4 Home, a subsidiary of Clearwater, Fla.-based
Lincare.

“Board investigators determined that Med 4 Home had not
followed proper recall and notification procedures for a batch of
albuterol/ipratropium solution it had compounded,” said Kevin
Kinkade, the board's executive director. “Quality assurance
tests conducted by the pharmacy revealed contamination in at least
two lots of the product.”

However, Med 4 Home recalled only partial batches of the product
and did not explain to patients the reason for the recall, Kinkade
explained. “They did not tell [patients] they had potentially
contaminated products — only that it was a quality assurance
problem,” he said.

Responding to the board's findings, state officials last week
renewed their focus on enacting a rule that governs the way
compounding pharmacies operate, the Kansas City Star
reported. The proposed rule, which could take effect as early as
this summer, would require pharmacies to:

  • ensure the sterile compounding of certain drugs;
  • notify the state board every time they issue a drug;
  • maintain better records of complaints; and
  • log the amounts of drug ingredients they use, by volume.

But IACP called the rule's approach to sterile compounding
“fundamentally flawed.”

Because it places emphasis on end-product testing, the rule
“is inefficient, extremely expensive and only partially
effective for assuring product quality,” IACP said.
“With millions of dollars at stake for both pharmacies and
patients, IACP recommends that the Missouri Board of Pharmacy
consider an alternative approach to the regulation of sterile
products — the implementation of systematic process
controls.”

In a Jan. 31, 2003, letter to the Missouri Board of Pharmacy,
IACP requested that the board not issue compounding standards
hastily. “The implications and impact of the proposed
regulations on Missouri pharmacies warrant provision of additional
time for discussion, research, evaluation and revision.”

For breaking news, go to www.homecaremonday.com, the electronic news service
of the home medical equipment industry.