A taint­ed eye in­jec­tion—brought in­to Trinidad and To­ba­go via “il­le­git­i­mate im­por­ta­tion chan­nels”—has left sev­en di­a­bet­ic pa­tients blind (ei­ther in both eyes or one). In the past four months, the pa­tients have un­der­gone eye re­moval surgery and are cur­rent­ly be­ing out­fit­ted with pros­thet­ic glass eyes.

The Gov­ern­ment re­called the im­port­ed in­jec­tion which con­tains Tri­am­cineclone Ace­tonide as its main in­gre­di­ent back in Ju­ly, but by then the dam­age was al­ready done. The spe­cif­ic drug which con­tained the Tri­am­cineclone Ace­tonide was a prepa­ra­tion from an In­dia-based com­pa­ny.

In its Ju­ly re­call state­ment the Gov­ern­ment said that the drug which con­tained Tri­am­cineclone Ace­tonide BP was re­called due to “pos­si­ble bac­te­r­i­al con­t­a­m­i­na­tion” and that it was not reg­is­tered in T&T.

“It would have had to be brought in­to the coun­try via par­al­lel il­le­git­i­mate im­por­ta­tion chan­nels. The Chem­istry, Food and Drug Di­vi­sion of the Min­istry of Health has al­ready seized stocks of this drug from the sup­pli­er,” the min­istry stat­ed.

De­spite the is­sue of il­le­git­i­mate im­por­ta­tion, the sup­pli­er is still in busi­ness and the on­ly ac­tion tak­en against the com­pa­ny was that it is no longer al­lowed to par­tic­i­pate in gov­ern­ment ten­ders.

There is con­flict­ing in­for­ma­tion as to who is pay­ing for the surg­eries and sub­se­quent treat­ment that the sev­en pa­tients un­der­went since Ju­ly.

Guardian Me­dia was able to con­tact three of the af­fect­ed pa­tients but none want­ed to speak about the mat­ter.

One man said that he need­ed le­gal clear­ance be­fore he could say any­thing about the mat­ter. When asked if he had sought le­gal ad­vice on how to pro­ceed, he said he did not.

“I haven’t spo­ken to a lawyer,” he said.

When pressed as to why he would need to seek le­gal clear­ance, the pa­tient said he could not talk about it.

“I can­not give any in­for­ma­tion,” he added.

Bac­te­ria-laden drug

The bac­te­ria-laden drug was ad­min­is­tered by un­wit­ting oph­thal­mol­o­gists in Ju­ly and one doc­tor alert­ed the Min­istry of Health when he re­alised the sever­i­ty of the in­jec­tion.

The reti­na spe­cial­ist, who re­quest­ed anonymi­ty, spoke with Guardian Me­dia last week Fri­day and said the pa­tients were still un­der­go­ing fol­low-up treat­ment from the taint­ed in­jec­tions.

Be­fore this batch came in, the in­jec­tions were in use by oph­thal­mol­o­gists in T&T for years.

This taint­ed batch, how­ev­er, came in dif­fer­ent pack­ag­ing but was man­u­fac­tured by the same In­dia-based com­pa­ny and dis­trib­uted by the same lo­cal com­pa­ny.

The in­jec­tions were sold to oph­thal­mol­o­gists through­out the coun­try and ad­min­is­tered to pa­tients with di­a­bet­ic eye prob­lems. Each in­jec­tion cost pa­tients be­tween $500 and $1,000.

“It is trau­mat­ic to have to tell a pa­tient that they could die if we do not re­move their in­fect­ed eyes,” the doc­tor said.

The doc­tor, who al­so worked in­ti­mate­ly with the taint­ed batch of med­ica­tion, said one day af­ter ad­min­is­ter­ing a rou­tine in­jec­tion to one of his pa­tients he re­ceived a call about an in­fec­tion.

“It’s not un­usu­al to have in­fec­tions from the in­jec­tions but it usu­al­ly takes about four to five days be­fore an in­fec­tion shows. I was alarmed to see the state of the in­fec­tion af­ter on­ly one day,” the doc­tor told Guardian Me­dia.

He said he con­tact­ed a group of oph­thal­mol­o­gists who al­so used the drug and told them to stop im­me­di­ate­ly.

“We ad­min­is­ter sev­er­al of these in­jec­tions a day. If we did not stop when we did, that count could have been be­tween 40-50 pa­tients,” he said.

The bac­te­ria, the doc­tor said, was a “mul­ti-drug re­sis­tant pseudomonas,” which meant it did not re­spond to reg­u­lar treat­ments for bac­te­r­i­al in­fec­tions and re­sist­ed an­tibi­ot­ic treat­ment.

“Noth­ing was killing the bac­te­ria. We pri­vate­ly formed a group to try and fig­ure out what to do to help the pa­tients. Be­cause the eye is so close to the brain we had to act fast,” the doc­tor said.

“It was a storm, every­thing hap­pened so fast. With­in a week all sev­en pa­tients had to have surgery,” the doc­tor added.

The surgery to re­move an eye­ball is not done in pub­lic hos­pi­tals and the doc­tors had to have them done pri­vate­ly.

“We were able to have the doc­tors waive the costs be­cause none of the pa­tients should have to pay for this surgery,” the doc­tor said.

The reti­na spe­cial­ist said the pa­tients would con­sid­er le­gal ac­tion against the sup­pli­er once their treat­ment was com­plet­ed.

“I don’t know the de­tails on how it was reg­is­tered in the coun­try,” the doc­tor said.

Pri­vate clin­ic con­tact­ed

Guardian Me­dia con­tact­ed the pri­vate clin­ic—based along the East-West Cor­ri­dor—but was told that the mat­ter was con­fi­den­tial and they could not pro­vide in­for­ma­tion on “the amount of surg­eries or the cost of such a surgery.”

“Some­thing needs to be done. This shouldn’t be al­lowed to hap­pen and scare peo­ple away from hav­ing these treat­ments,” the doc­tor said. “It is a rare oc­cur­rence.”

A sec­ond doc­tor as­so­ci­at­ed with the pri­vate clin­ic, how­ev­er, con­firmed to Guardian Me­dia that he was aware of the sev­en surg­eries that re­sult­ed from the taint­ed drug.

He too could not con­firm the cost of the pro­ce­dures.

Guardian Me­dia was told that the surgery cost de­pend­ed on the type of anaes­thet­ic that the pa­tient need­ed and that with gen­er­al anaes­the­sia the surgery would cost up­wards of $10,000.

He said that he was not aware that the cost of the surg­eries were “waived”.

“I know the clin­ic was paid,” he said.

Lo­cal dis­trib­u­tor re­sponds

In a brief in­ter­view last Thurs­day, the own­er of the dis­tri­b­u­tion com­pa­ny said he was aware of the taint­ed batch of in­jec­tions and that the Min­istry of Health had is­sued a re­call of the drug.

Guardian Me­dia was able to con­tact the own­er of the lo­cal dis­tri­b­u­tion com­pa­ny and he said that back in Ju­ly when the drug was re­called he met with "the of­fi­cials."

"We com­plied with the min­istry and pro­vid­ed all the doc­u­ments that were re­quest­ed," he said.

How­ev­er, he said he did not hear about the in­jec­tions caus­ing blind­ness or that pa­tients had to have their eyes re­moved af­ter be­ing giv­en the in­jec­tions.

Guardian Me­dia at­tempt­ed to con­tact the own­er again on Tues­day and Wednes­day, and on Thurs­day vis­it­ed the sup­pli­er. Se­cu­ri­ty at the Cen­tral-based fa­cil­i­ty said he was un­avail­able. Guardian Me­dia al­so vis­it­ed and called again on Fri­day but was told that he was still un­avail­able.

Ex­pert med­ical in­for­ma­tion

GML re­quest­ed med­ical in­for­ma­tion from an ex­pert oph­thal­mol­o­gist on this is­sue and the fol­low­ing is the re­sponse from the group.

“This re­sponse was ac­tu­al­ly from a team of ex­perts which I col­lab­o­rate with on this mat­ter.

1) the ac­tive in­gre­di­ent in the in­jec­tion is the steroid Tri­am­ci­nolone Ace­tonide. Tri­am­ci­nolone is used to treat a va­ri­ety of in­flam­ma­to­ry con­di­tions across var­i­ous med­ical spe­cial­i­ties. In Oph­thal­mol­o­gy, its us­es are mul­ti-fold. How­ev­er, in the cas­es which you de­scribe, it was used to treat mac­u­la oede­ma.

2) The treat­ment of mac­u­la oede­ma with steroids is a tried and trust­ed treat­ment world­wide and has been stud­ied and re­port­ed in the Oph­thal­mol­o­gy press count­less times. These stud­ies have shown re­peat­ed­ly the good safe­ty and ef­fi­ca­cy of this treat­ment.

Sev­er­al thou­sand such in­jec­tions are giv­en by thou­sands of oph­thal­mol­o­gists every day across the globe in­clud­ing USA and UK. It has FDA ap­proval for use in the eye in the US.

3) As far as we know, Tri­am­ci­nolone Ace­tonide is a reg­is­tered drug in Trinidad and To­ba­go.

We are not able to com­ment on the reg­is­tra­tions of in­di­vid­ual prepa­ra­tions of the drug as there will be many com­pa­nies sell­ing it un­der var­i­ous trade names.

4) When pa­tients are seen for con­sul­ta­tion, many fac­tors will in­flu­ence the surgery that is need­ed and so costs can vary. In light of this, it would be very dif­fi­cult to com­ment on costs with­out see­ing the pa­tient. Eye re­moval surgery as you have en­quired is avail­able at our pub­lic hos­pi­tals.

How­ev­er, I am un­able to com­ment on the pro­cess­ing time to get this pro­ce­dure at these in­sti­tu­tions.

Min­is­ter's di­rect re­sponse Via What­sApp:

1. Sep­tem­ber 27, 2019

Guardian Me­dia for­ward­ed the re­call no­tice to the min­is­ter.

GML: Was the co re­spon­si­ble for bring­ing in the taint­ed in­jecta­bles ever ques­tions or had their li­cence re­voked?

TD: Will have the cmo re­search it.

GML: Thank you

2. Oc­to­ber 3, 2019

GML: Sir, have you been in touch with the CMO about the grav­i­ty of this re­call?

TD: Yes i have

GML: Can you share what you've learned?

TD: The cmo is look­ing afy­er (sic) it amd (sic) we will al­ways act in the coun­try's best in­ter­est as we al­ways do. He will is­sue the nec­es­sary state­ment or re­call when war­rant­ed.

GML: But are you aware that 7 peo­ple had their eyes re­moved be­cause of the in­fec­tion caused by the taint­ed in­jec­tions?

TD: Oh that mat­ter. We act­ed swift­ly a time long ago on thay (sic) mat­ter. Im­porter sanc­tions etc.

TD: Al­so we of­fered the pa­tients to be seen in yhe (sic) pub­lic sec­or as this was re­strivt­ed (sic) to pri­vate prac­tice. We ful­filled all our le­gal and eth­i­cal oblig­a­tions. Pa­tients may wish to pur­sue it fur­ther.

GML: Can you ex­plain the im­porter sanc­tions?

TD: Be­ing pre­vent­ed from pa­tivopat­ing (sic) in ten­ders. oth­er ac­tions can be ap­plied as au­th­pri­ties (sic) see fit es­poe­cial­ly (sic) by pa­tients. Thanks you.

GML:What are the il­le­git­i­mate chan­nels that were used to to bring in the taint­ed in­jec­tions?

TD: I have told you every­thing I know as fact. Thanks you.

Min­istry of Health's re­sponse

Guardian Me­dia Ltd sought more in­for­ma­tion from act­ing CMO Dr Har­ry Smith about what in­ves­ti­ga­tions were con­duct­ed with the dis­trib­u­tor and what mea­sures were put in place to en­sure that taint­ed drugs are not brought in­to the coun­try.

Smith sent those ques­tions to the Min­istry of Heath. GML al­so emailed the fol­low­ing ques­tions to the Min­istry of Health's com­mu­ni­ca­tions de­part­ment:

1. Is the drug reg­is­tered in T&T?

2. Is it's main in­gre­di­ent, Tri­am­cineclone Ace­tonide reg­is­tered in the coun­try?

3. In the Min­istry of Health's Ju­ly 25, 2019 re­call of the drug, it states that "par­al­lel il­le­git­i­mate im­por­ta­tion chan­nels" were used to bring the drug in­to the coun­ty. Can you ex­plain what that means? How does the Gov­ern­ment keep these chan­nels closed?

4. What ac­tion was tak­en with the sup­pli­er? Did the min­istry's of­fi­cials meet with the com­pa­ny?

5.Can you say what pro­to­cols, if any, were im­ple­ment­ed to en­sure that this doesn't hap­pen again?

The min­istry did not re­spond to those ques­tions specif­i­cal­ly but did con­firm that the prod­uct is not

reg­is­tered in the coun­try.

"The Food and Drugs Act and Reg­u­la­tions man­dates that all new drugs must reg­is­tered, hence the im­por­ta­tion of this prod­uct/brand was in con­tra­ven­tion of the Di­vi­sion-3-New Drugs Sec­tion 2 (1) (a) and (b)," the re­sponse said.

The min­istry re­it­er­at­ed that the drug is not ap­proved and "the Chem­istry, Food and Drug Di­vi­sion (CFDD) nev­er gave the re­quired ap­proval/en­dorse­ment/re­lease for the im­por­ta­tion of this drug by the im­porter. In fact, CFDD was not con­tact­ed by the bro­ker/com­pa­ny or the ship­ping car­ri­er to pro­vide clear­ance for the prod­uct," the Min­istry of Health said.

The drug was in use, with­out ap­proval and would have con­tin­ued to be ad­min­is­tered to pa­tients if the doc­tors did not re­port the sever­i­ty of the side ef­fects to the min­istry.

"The di­vi­sion re­ceived an anony­mous let­ter on the mat­ter. In­spec­tors vis­it­ed and met with of­fi­cials from the im­porter (dis­tri­b­u­tion com­pa­ny) and sam­ples of the prod­uct were seized," the Health Min­istry said.