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Pharmacies struggling to deal with drug shortages

It is becoming an ever growing challenge these days for pharmacists who are attempting to fill your prescription needs.
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Pharmacist Larry Preddy

It is becoming an ever growing challenge these days for pharmacists who are attempting to fill your prescription needs.

It is a province-wide problem it seems, with no immediate solution in sight according to those who dispense the drugs and those who make them.

One local pharmacist, Larry Preddy of Henders Drugs, said that in the 40 years he has been in the business, the past eight months have been the most challenging in terms of procuring pharmaceutical supplies.

"We might have to phone the physicians and ask them to adjust prescriptions because what they are requesting can't be found, or they might have to switch the dosage amounts and therefore the manner in which the patient takes the tablet or drug," said Preddy, noting for instance, that if the call is made for a certain drug in a 10 mg dosage, if none are available at 10 mg, they might be asked to provide a 20 mg. dose with instructions for the patient to take a half-tablet when directed.

Preddy said he recalls on several occasions searching for certain prescription supplies as far away as Winnipeg.

"It's been going on for awhile and it's getting worse, not better," Preddy said.

Kayla Barry, a pharmacist at the Estevan Wal-Mart location, echoes that sentiment.

"We're hearing that there are a lot of manufacturing shortages, which is pretty obvious," she said.

Sometimes that means a combination drug can't be located, so the patient will be asked to ingest two separate medicines to achieve the same effect.

Both pharmacists said the problem is the most severe in the generic drug supply chain although there are some shortages being seen in the name brand supply these days too.

"I'm not 100 per cent sure why the shortage continues like this. We'll get a date from the supplier as to when the product is expected to arrive, and then it doesn't," said Barry.

Preddy said one generic drug company sold a lot of Canadian-made product into the United States, but then the manufacturing plant didn't reach their Federal Drug Administration certification standards, which meant they had to regroup. But he didn't know if that necessarily bit into the Canadian supply chain.

"There is also the economy of scale factor to consider. Saskatchewan is a pretty small market," said Preddy. He also noted that drug costs are regulated which could be considered as being part of the dilemma.

"Canada doesn't regulate the price of gas, but they (government) do regulate prices of pharmaceuticals," he said.

Preddy and Barry said that local pharmacies do communicate among themselves in an attempt to meet the local demands lending supplies, selling to one another or swapping when necessary whatever works to get the consumer needs met.

"But quite often when one of us is short, we all are," said Preddy.

When potency change or combination drugs can't be used, then the pharmacists once again find themselves on the phone with the physicians, attempting to reach a suitable alternative for the patient. Sometimes that requires a move to a name-brand drug.

"If it's a single supplier source situation, then it can get tough," said Preddy. "You get hooped sometimes."

Barry and Preddy said the problem has been going on for at least eight months, probably more.

The Saskatchewan College of Pharmacists is apparently looking at the problem, but Preddy suggested that their abilities to attack the problem are probably limited too. He said it would be interesting to see how other provinces like Ontario are dealing with the situation.

"We don't manufacture drugs here and don't control those that do. In all the years of being in this business, I've never encountered this before," said Preddy.

But on the manufacturing side, the issue is quite clear.

Eli Betito, director of public and governmental affairs for ApoTex Inc. of Toronto, the largest Canadian owned manufacturer of generic drugs, suggested it's a clean-cut issue of trying to catch up in a regime that calls for thousands upon thousands of checks, rechecks and safety balances.

"It's not a business like any other," said Betito, noting that Apo as it's referred to, is under the gun in a number of instances and "we can't just change vendors whenever we want to. What happens takes nine to 11 months, generally speaking to have all issues ironed out. We work in a highly regulated and technical world and we're dealing now with evolving regulatory bodies that are currently revising standards so it's very difficult meeting the demands," Betito added.

Generic supplies have particularly unique problems to face at times too, he noted. New drugs can be protected under patent laws for 20 years, but often just before the patent expires, the name brand manufacturer will tweak the formula or buy out a company that is one of the few suppliers of a raw product that is instrumental in manufacturing a particular drug, making it almost impossible for the generic drug production community to get access for a lower-cost, but still similar drug.

Apo manufactures over 300 different generic medicines, producing about one billion tablets or doses a month.

"All the North American regulatory bodies are working together trying to get on the same page so that one system will be in concert with the other, but as you can guess, it's a slow process. If we try to get one original batch of one product through the system, it will take no less than 66,000 signatures before it'll get approved for regulated standards procedures. So you see what we're up against? Like I said, we are a business like no other business," Betito said.

Add to that such things as unannounced audits to ensure safety standards are being met, and you come up with the current blockade of generic drug supplies.

Betito said that the larger name brand, multi-national drug manufacturers might deal with 50 or fewer pharmaceuticals in their repertoire whereas Apo and others, have several hundred. Then when the supply chain is played with, as noted earlier, "we can't just change suppliers easily," Betito said.

"Then with these evolving regulatory bodies, trying to find common ground, well you can guess the regulations are becoming even more stringent. But with the audits and the stiffer regulations, the drugs are being made safe and at the end of the day, isn't that what we all want? If we do have a pandemic, you all will want and you all will get regular, safe supplies."

Betito said that some pharmaceutical manufacturers have moved to offshore sites to avoid some of the regulatory nuisances. He said Apo is one of the few major drug manufacturers left in Canada, employing over 5,000 people in 20 locations, mostly in and around Toronto. The company is currently supplying drugs to meet requirements set out by each and every provincial government as well as other jurisdictions.

"If we can get one regulatory approval across Canada a federal mandate, that would be a big step forward," Betito said.

In the meantime, patients will have to show patience as will the pharmacists trying to juggle supplies with demands.

It is quite apparent that this is a problem that isn't going away any time soon.