Missouri Executed 17 Prisoners With Drugs Secretly Obtained From ​‘High-Risk’ Pharmacy Cited for Hazardous Practices

BuzzFeed News inves­ti­ga­tion has dis­closed that Missouri car­ried out sev­en­teen exe­cu­tions between 2014 and 2017 using sup­plies of the drug pen­to­bar­bi­tal it secret­ly obtained from a phar­ma­cy the Food and Drug Administration had clas­si­fied as ​“high risk” because of repeat­ed seri­ous health vio­la­tions. The February 20 exposé describes a com­plex sys­tem of clan­des­tine meet­ings, code names, and undoc­u­ment­ed cash pay­ments that Missouri employed to con­ceal the iden­ti­ty of Foundation Care, a sub­ur­ban St. Louis com­pound­ing phar­ma­cy that reporter Chris McDaniel dis­cov­ered ​“has been repeat­ed­ly found to engage in haz­ardous pharmaceutical procedures.” 

Foundation Care — which was report­ed­ly paid more than $135,000 for exe­cu­tion drugs — is alleged to have engaged in ille­gal prac­tices, medicare fraud, and numer­ous man­u­fac­tur­ing impro­pri­eties and, McDaniel reports, its cofounder has been accused of ​“reg­u­lar­ly order­ing pre­scrip­tion med­ica­tions for him­self with­out a doctor’s pre­scrip­tion.” Two for­mer senior employ­ees of the com­pa­ny — includ­ing the head of phar­ma­cy oper­a­tions — have alleged in a law­suit that Foundation Care vio­lat­ed gov­ern­ment reg­u­la­tions by reselling drugs returned by patients, inten­tion­al­ly omit­ting the names of ingre­di­ents in drugs it pre­pared, and fail­ing to noti­fy oth­er states about a $300,000 set­tle­ment with Kansas over alle­ga­tions of Medicaid fraud. Another suit by a for­mer employ­ee alleges that she was fired after com­plain­ing to her super­vi­sors and the Missouri Board of Pharmacy about ​“seri­ous operational violations.” 

Missouri switched to Foundation Care after reporters dis­cov­ered the iden­ti­ty of the state’s pri­or secret sup­pli­er of exe­cu­tion drugs — an Oklahoma com­pound­ing phar­ma­cy called The Apothecary Shoppe. Reporters learned that The Apothecary Shoppe was not licensed to sell drugs in Missouri and had admit­ted to near­ly 2,000 health and safe­ty vio­la­tions.

Foundation Care first came to the atten­tion of FDA inves­ti­ga­tors after a doc­tor com­plained to the agency that a patient he was treat­ing had devel­oped ​“a ​‘life threat­en­ing’ ill­ness” after tak­ing a drug that had been pre­pared by the phar­ma­cy. At that time, the inves­ti­ga­tors found that the phar­ma­cy had shipped drugs to patients with­out con­duct­ing tests for steril­i­ty and bac­te­ria, and a lab sam­ple revealed drugs that had been con­t­a­m­i­nat­ed with bac­te­ria. In 2013, the FDA des­ig­nat­ed Foundation Care as a ​“high-risk” com­pound­ing phar­ma­cy, and cit­ed it as an exam­ple as to why greater fed­er­al over­sight of com­pounders was nec­es­sary. A sec­ond inspec­tion of the com­pa­ny that year found ​“mul­ti­ple exam­ples” of prac­tices that could lead to con­t­a­m­i­na­tion, and that Foundation Care had failed to ​“assure that drug prod­ucts con­form to appro­pri­ate stan­dards of iden­ti­ty, strength, qual­i­ty and puri­ty.” In a February 2014 let­ter to the Missouri Board of Pharmacy, the FDA warned that the pharmacy’s prac­tices ​“could lead to con­t­a­m­i­na­tion of drugs, poten­tial­ly putting patients at risk.” 

The pos­si­bil­i­ty of drug con­t­a­m­i­na­tion is one of the cen­ter­pieces of pris­on­er chal­lenges to Missouri’s exe­cu­tion process, and experts in the case have indi­cat­ed that con­t­a­m­i­na­tion could cre­ate a ​“sub­stan­tial risk of pain and suf­fer­ing.” However, in a depo­si­tion in the Missouri pris­on­ers’ legal chal­lenge, state offi­cials refused to say whether they were aware of any prob­lems with their drug man­u­fac­tur­er, and lawyers for the state have affir­ma­tive­ly used Missouri’s secre­cy pro­vi­sions to deny pris­on­ers’ access to infor­ma­tion about its drug sup­pli­er and the com­pa­ny’s safe­ty record, while at the same time argu­ing the pris­on­ers have not proven that the exe­cu­tion may be unconstitutionally cruel. 

Foundation Care was acquired by AcariaHealth, a sub­sidiary of health-care giant Centene Corporation, in October 2017. After McDaniel’s report was pub­lished, the com­pa­ny issued a state­ment that, “[u]nder Centene’s own­er­ship, Foundation Care has nev­er sup­plied, and will nev­er sup­ply any phar­ma­ceu­ti­cal prod­uct to any state for the pur­pose of effectuating executions.”

Compounding phar­ma­cies are drug pro­duc­ers that mix small batch­es of med­ica­tions to meet the spe­cial­ized needs of patients for whom mass pro­duced med­i­cines are not avail­able. Regulated pri­mar­i­ly by states, their drugs are report­ed to have a sig­nif­i­cant­ly high­er fail­ure rate than drugs pro­duced by FDA-reg­u­lat­ed man­u­fac­tur­ers. An esti­mat­ed twen­ty per­cent of drugs cre­at­ed by Missouri com­pound­ing phar­ma­cies failed to meet Missouri Board of Pharmacy standards.