The logistics in getting specialized formula to Canadian infants

by Cassandra Szklarski THE CANADIAN PRESS

The day Jordan Papineau Roch and his wife met with a specialist to discuss their very sick newborn they were presented with an unusually intricate treatment plan – one that included a primer on the supply chain woes of the infant formula industry.

Their daughter Elisabeth happened to be born weeks after Abbott Nutrition shut down a massive factory that produced the specialty food she needed because of a genetic condition. It was unclear if appropriate formula would be available, and the hospital’s own stash was in short supply.

What was clear was this would not be an isolated problem – another baby in Hamilton needed the same specialized formula, recalled their physician Dr. Pranesh Chakraborty.

“We were going through, really, a complicated medical management plan. It’s the first time I’ve ever had to include a complicated supply chain conversation in that. That was an added stress for the family,” says Chakraborty, a metabolic specialist at the Ottawa children’s hospital known as CHEO and director of Newborn Screening Ontario.

“We were talking about the safety of the supply chain – what’s in our control and what’s not. I’m hoping I don’t have to do that again.”

The heart-wrenching consult brought into focus the severe consequences of a highly concentrated industry dominated by just a few players.

No baby left behind

The issue quickly galvanized experts across the country to build a network that makes sure no ill baby is left behind, says clinical dietitian Erica Langley, also of CHEO.

She credits an impromptu working group of doctors and dietitians with averting catastrophe by rationing and directing supplies to where they’re needed most.

“Because of all of this co-ordination, we’ve managed to take a potential level 10 crisis and make it manageable,” says Langley.

“We haven’t solved it. We’ve made it manageable, but it continues.”

Over at the Hospital for Sick Children in Toronto, the section head of metabolic genetics says they typically have months of supply on hand for all disorders. Not now.

“We’re sort of looking at empty shelves and thinking nervously about the possibility of children being born with specific conditions. It makes us very uncomfortable that we might quickly need a formula and not have enough on hand,” says Dr. Neal Sondheimer.

“The supply has dropped so far that when we’re admitting patients with these disorders we are telling them to bring their own formula from home, rather than supplying it ourselves?. We never do that.”

Government support

A key measure to bridge the Abbott shortfall has been enlisting Health Canada and the Canadian Food Inspection Agency to import more formula.

The chief operations manager of the National Food Distribution Centre, which supplies food to more than 60 percent of Canadians with hereditary metabolic diseases, recalls a flurry of phone calls between himself, doctors and federal officials on March 8.

Within four hours a plan was in place, says Roman Bhattacharya, and an interim policy that eased labelling and composition requirements on additional imports was announced March 10.

But the vast shortage meant that even the emergency import supply was limited – formula maker Mead Johnson sent just two cases when the centre’s users typically consume nearly 40 per month, he says.

“Everybody in the world was asking for these products,” recalls Bhattacharya, whose centre feeds more than 1,300 patients per year, including children, teens and adults.

“I even went into the States and ordered five cans online … and had one of my employees go and get it. She was visiting her mom who lives there so I said, ‘Do you mind if I use your mom’s address?”’

Fourteen of the 20 new imports temporarily approved by Health Canada are for those born with genetic diseases, including 11 for infants, he says. The rest are sold over the counter at pharmacies and retail outlets, including five regular formulas and one hypoallergenic product.

The Abbott shutdown has been particularly devastating for Canadian infants who depend on a very specialized diet, says Bhattacharya. He says Abbott is the centre’s sole supplier of infant formula for three disorders, and supplies more than 80 percent of the formula for two others.

Safety recall

The company’s Michigan factory closed in February after a safety recall involving several products, none of them specialized brands for metabolic conditions. However, the closure ceased all work at the plant and triggered secondary shortages among other manufacturers trying to fill the gap, sending many parents scrambling in the United States.

The Retail Council of Canada has reported sporadic shortages here but notes a different supply chain has cushioned the impact. A council spokeswoman said Monday that its members largely reported shelves stocked with regular and specialty formula and that any shortages have been variable and temporary.

Sondheimer says the shortage of specialty formula has been less severe for colleagues in the United States who could turn to alternate products from Mead Johnson and Nutricia – but these were unavailable in Canada until the interim import policy.

He says regular communication with other hospitals about the formula supply ensures “we’re staying out of trouble.”

“But it’s not a comfortable situation, and it is creating a lot of work for the dietitians,” Sondheimer notes.

These efforts ensured Elisabeth and her Hamilton counterpart were both fed without compromising supplies elsewhere in Canada, adds Langley.

Papineau Roch says Elisabeth is now doing well on a combination of breast milk, regular powder and a newly imported product from Mead Johnson. But he worries about the supply of regular formula she needs, noting one big retailer has limited how much he can purchase online and he doesn’t have the luxury of just switching to another brand.

“We order more and we keep in storage. Of course, we follow the situation very closely because that’s a risk for her,” Papineau Roch says from Gatineau, Que.

Sondheimer says he wishes he had known more about how baby formulas were made and how vulnerable Canada’s supply really was.

“The failure to predict what happens when you have a single supplier is really on all of us,” he says.

“It’s not Health Canada’s fault, it’s really a failure of imagination of all of us. We just hadn’t considered this possibility.”