BY ANNELIA NIXON

Tribune Business Reporter

anixon@tribunemedia.net

A quality assurance and “pharmacovigilance team” has been assembled after the government has been advised “to rethink their policy of utilising the Caribbean Public Health Agency as a standard or guidelines for approval of pharmacy companies”.

Speaking on the National Prescription Drug Plan, Bahamas Pharmaceutical Association (BPA) president Marvin Smith, said (BPA) views the Caribbean Public Health Agency as being “misled, misinformed and misguided as to how it interacts with pharmaceutical companies”. 

“So one of the things that we have been advising the government on is to rethink their policy of utilising the Caribbean Public Health Agency as a standard or guidelines for approval of pharmacy companies,” Dr Smith said. “We believe that this agency is misled, misinformed and misguided as to how it interacts with pharmaceutical companies, because any agency that says we can only use product out of the United States, Britain, Europe or Canada, is crazy. It’s crazy. You can’t be an intelligent pharmacy person and come up with that. So you have to be crazy.

“The association has sent a formal document to the minister and to the NHIA team on this. We’ve had a meeting. We’ve had meetings we were able to discuss. They’ve asked us to put together a team related to quality assurance and pharmacovigilance. And I have a well-qualified, long time distributor who does a lot of imports, working with that team and one of our most senior pharmacists, who’s actually trained in pharmacovigilance from the global pharmacovigilance centre in Sweden, from Uppsala. So, they’re working on the team with NHIA. So you know we don’t just got people throwing numbers around. Our pharmacists are qualified and they’re trained, and we’re here. None of them are government workers, but we’re here, working with the government to make this thing happen.”

He said India manufactures 60 to 70 percent “of the branded product” and “they manufacture up to 80 percent of the world’s generic supplies adding that its one of the most regulated markets for international supply. He suggested that their “gold standards” be utilised.

“But we know that there’s a process in place, and we’ve given to the Minister a paper that outlines how we believe The Bahamas utilising normal global standards that come from the World Health Organization - we ain’t creating nothing new, we ain’t asking them to make nothing new, we’re not asking any company to create a document,” Dr Smith said. “We’re saying that there are documents that if a company is a legitimate, fully regulated company under the World Health Organization, which is the gold standard, they will have these documents. Just let them provide it. Let them provide it, and then you move ahead with utilising their products and not do the silly idea of single product registration, where you have to register every single product in every single version from every single company that makes that product.

“So the smart thing is, utilise systems in place, like the establishment and evaluation of the Pharmacopeia of a product, which is the basically the recipe. There’s a British one, there’s the American one, there’s a European one. They basically all say the same thing, with very slight differences, but not clinically different. Let’s utilise that. And if these countries and manufacturers are adhering to those standards, then we don’t need to sit and register them. That makes no sense. And there’s an easy way for us to validate when it comes here, we simply ask them to provide with each shipment, the certificate of analysis for that batch. And again, we’re not asking them to create nothing. Every company has to do this for every batch. So they already have the document. Tell them send us a copy. Let me check it. We can check it against the standard. If it’s if it’s made with USP, United States Pharmacopeia, we look at the certificate of analysis. It’s going to list all of these chemical factors.”

Dr Smith said relations between BPA, the Minister of Health and Wellness Michael Darville and the permanent secretary, had gone well as they were invited to the table to discuss the prescription plan. He said they’ve had the opportunity to view it and they sent recommendations and questions.

“For example, the act spoke to suppliers generally and then international suppliers,” Dr Smith said. “It didn’t really specify pharmacy wholesalers. And we felt it was particular that, that needed to be added in the language, because nobody who is not a registered pharmacy wholesaler should be providing medicines in the country. So we needed that to mimic the terminology used in the Pharmacy Act, so that all the laws spoke in the same voice. They took that recommendation and they made that change. 

“We had questions about the inclusion or exclusion of certain diseases, and they were able to answer why certain things were there and why certain things weren’t, and that that those were coming in some other things. We had a question that came about as it related to promotion of Bahamian made medical products, and they indicated that that would come under another Act that they’re still working on. So, we had questions, they were able to give us updates. They took some of our recommendations. They made the changes and we’re confident that what we see there is a good structure. It lays out the disease states. 

“It lays out who is established to be providers, who are established to be prescription providers, who are established to be suppliers, and that the qualifications and all these things have to be in place. It talks about the establishment of of the NHIA and how that will run. And more importantly, it gave a clear path about how the amalgamation of supply is going to be done, because you can’t have one set of drugs for NIB, another set of drugs in the Public Hospitals Authority and then, if you go to Doctor’s Hospital and you’re on the plan, you can’t get nothing, because that’s not what they carry and so on and so forth. This is going to allow for a streamlining of a product listing that people know they can get, and what now remains is for the government to come up with regulations and policies that will not create an interrupted supply. That is critical.”

Dr Smith said: “Now the regulations are going to have to come, the policies are going to have to come. And those are really the fine tuning details that will either make the plan work or make it crash.”

He praised the minister and his team for the work on the issue, saying: “I really have to, on behalf of the association, give them kudos. We believe that if we continue to work with the government to put this plan in place, that we can come up with something that the Bahamian people will get service. The government will have a sustainable way to fund it, and pharmacy owners and pharmacy persons will be in a profession that is growing and thriving. We believe everybody can win in this process.”