The Tribune

By Adrian Gibson

ajbahama@hotmail.com

For the last two weeks, I’ve been researching the local pharmaceutical industry, particularly after reading a report about an alleged counterfeit drugs scheme involving a pharmacy in Freeport (Grand Bahama) and hearing complaints - by reliable sources - about the propensity of some Bahamian importers and pharmacists to “pass off” fake pharmaceutical drugs as genuine and to engage in parallel imports of drugs from countries whose reputational standing is shot.

What is even more troubling is the fact that the Pharmacy Act (2009) is a weak piece of legislation that packs little to no punch and, even more frightening, that there is no regulatory body overseeing the importation of drugs into this country.

Indeed, the issue of counterfeit and parallel imports is a muted, yet huge problem in the Bahamas which, ultimately, results in countless lives being placed at risk on a daily basis. One source - a surgeon - told me that the biggest problem is parallel imports, where there is a company with exclusive rights to the import and distribution of a product from a manufacturer but there is another wholesaler or retailer who has no respect for such rights and pursues to purchase the same products on the “grey” market.

Notably, Turkey - the second largest counterfeiter of prescription medication in the world - is a hub for grey market imports into the Bahamas. What’s more, countries such as Sri Lanka, Saudi Arabia and, I’m told, even Afghanistan, are also used by certain local wholesalers/retailers for imports.

I spoke to a number of reliable sources, two physicians and three pharmacists closely affiliated with the Bahamas’ Pharmacy Council on grounds of anonymity. Relative to parallel imports, I’ve been told that medicines are purchased from certain parts of the world from producers who sell them for between 10-25 cents on the dollar, that these medicines often don’t have the right labelling or English labels and that, more often than not, these medicines are imported in trailers where temperature controls and conditions may not be optimum.

One of doctors interviewed told me that he felt that such medication many times lacked the necessary potency expected to help an ailing patient.

The surgeon said: “Can you imagine buying these cheap grey market meds for 10-25 per cent of what they would cost from a manufacturer and still being greedy enough to mark them up to the point that you make a 200-300 per cent profit, charging the same rates or even more than the locally authorised distributors?

“It’s not long before someone gets hurt or dies from imports of counterfeit or grey market drugs and I can’t say that some haven’t died already! Imagine if you go to get chemotherapeutic drugs but those meds aren’t stored right - they definitely wouldn’t work as they are supposed to. I find that one or two wholesalers in engage in such imports and some of the smaller, independent pharmacies are no longer selling brand name stuff!”

The fact that successive governments have refused to deal with ensuring greater regulatory oversight of pharmaceutical imports is troubling. There is a general lack of enforcement of rules and regulations concerning the importation of drugs and, quite honestly, the Pharmacy Council appears to have a limited mandate, which merely concerns the monitoring and regulation of pharmacy outlets.

Whilst the aforementioned Act has provisions (sections 27, 28) that address the importation of drugs, there are no regulations and no regulatory body to reinforce that which is espoused by these sections. Indeed, there appears to a need for a greater understanding of pharmaceutical drugs and product registration.

Who screens the prescriptions drugs coming into the Bahamas and determines if they have passed certain protocols? The unfortunate answer is - no one. We run an open market and have yet to catch up with jurisdictions such as Jamaica and Trinidad and Tobago who have bodies set up to register and oversee drug imports.

The second physician I spoke with told me that the government is now in the market of generic prescription medication (in all truth, generics are really copies of brand name products, referred to by one of the pharmacists as “off brand stuff”). The public does not know the difference since, for the most part, many of us are fixated on the costs and are overjoyed about getting a reduced rate.

The second doctor interviewed - a consultant and prominent physician at both PMH and Doctors Hospital - told me that the government is “the biggest user of prescription medication and they have opted, almost across the board, to change their acquisition of drugs from brand name to generic.”

He said: “While switching from brand name to generic can be cost saving, and although they try to justify it by saying that they are using products from some of the biggest generic drug makers, if there’s a problem with a drug, who does one turn to?”

According to reliable sources - physicians within the hospital- the government purchases generic medicines from two Asian companies, Cipla (in Mumbai, India) and Ranbaxy (in Gurgaon, Haryana, India). Though both companies are said to have good quality control and the drugs are markedly less expensive than those produced by a brand name company, the physicians told me that often local doctors are writing prescriptions for drugs that are brand names though some pharmacists simply substitute the generic drug when filling a prescription.

Let me take this opportunity to also note that whilst there are crooked and/or second-rate producers of generic drugs, there are bona fide generic drug producing companies. Notably, some brand name companies also make generic drugs, for example, the company that makes Tylenol also makes a generic version known as acetaminophen, which one can commonly find on shelves in Walmart, QVS and several other pharmacies in the US.

Now, one must also note that there are huge, multinational trafficking rings of prescription drug pushers, many times these drugs coming from grey markets or being counterfeit. Of late, there was a report about the alleged import of counterfeit pharmaceutical products, namely counterfeit Lipitor, Singulair, Celebrex, Hyzaar, Plavix, among others, to pharmacy in Freeport.

However, I’m told that traffickers of counterfeits (and grey market) drugs take such risks as it yields even far more lucrative returns than an illicit drug such as cocaine and because the penalties are nothing more than a slap on the wrist. According to my sources, some of the largest numbers of counterfeit drugs trafficked - among others - are Januvia (treats diabetes), Crestor (a prescription cholesterol medication), Lipitor (cholesterol lowering meds) and Viagra (treats erectile dysfunction).

“If there’s a problem with a drug, to whom does one take their concerns, especially if it’s a grey or black market or counterfeit drug consumed by a person, but made in someone’s bathtub after their wife or whomever was just done bathing in it? These are the kinds of drugs that are being imported in some quarters and pawned onto the Bahamian public,” the surgeon told me.

The Bahamas has a weak and impotent legal framework as it concerns parallel/grey market and/or counterfeit imports. Whilst parallel importers of sub-par drugs may even think that it is unethical and immoral, they can assuage their consciences by simply saying that it’s not illegal. There is nothing in place to protect the Bahamian public against counterfeits or drugs brought into this country without the proper cooling facilities and quality controls and shipped and stored under conditions that are less than desirable.

I was reliably informed that if a brand importer goes through the right channels - as opposed to parallel imports and counterfeits - whatever drug they bring in is manufactured for a certain market and many times the expiry date is changed by the manufacturer and packaged depending on the market it’s being shipped to. An example cited was the Bahamas, where one of my sources said that manufacturers would account for the warmer, more humid temperatures when packaging, labelling and shipping as opposed to if it is shipped to Canada.

Relative to purchases from gray markets, I am told one does not take into account the same guidelines relative to exports. My sources told me that when medicines are directly imported - as opposed to parallel imports - there are devices attached to both the outside and the inside of containers holding medications and that once that shipment arrives, they must detach such devices and upload data into the computer for the manufacturer and then wait for the manufacturer to render an assessment as to the state of the drugs and wait for permission to sell the drugs once the manufacturer verifies the legitimacy and status of the shipment.

Another concern brought to my attention was the fact that some drugs enter the Bahamas with the seals broken and/or the labelling not in English. The Consumer Protection Act provides, at section 21 (1):

“At any time before payment is made for any item of goods of, or above a prescribed value (whether sold as used or unused), a provider shall provide, both orally and in writing, all information in the English language to the consumer concerning the goods being sold including, where applicable, the origin, price in the currency of the Bahamas, care terms, components, hazards, proper use, assembling, installation, weight and size of the goods and where chargeable, the professional fees of the provider being charged in respect of the goods.”

I’ve been in food stores of late where I’ve seen food stuffs on shelves that have no semblance of English on boxes/containers. Next time, I will take a picture of the item on the shelf, purchase it, keep the receipt and name those offenders.

That said, why are medicines being imported into the Bahamas and packaged and labelled in Turkish? What I’m told is also happening is the repackaging of such drugs, where certain pharmacists would simply take the drugs out of its original packaging and dispense those drugs in small Ziploc bags and other containers - filling a doctor’s prescription and writing in how much times a patient should take a particular med.

Patients take drugs expecting to get well, particularly if such prescription drugs are provided by the government or a licenced physician which causes there to be an element of trust built in their minds.

As one of my physician sources told me: “The truth of the matter is that it is a crapshoot and nobody is going to do anything about this until someone dies. One of the other problems - beyond one or two of the wholesalers - is that every Bahamian who gets a pharmacy licence wants to go an open up a pharmacy and so some of them get desperate and start to import low-grade or counterfeit medication.

The problem further arises when a wholesaler engages in both wholesale and retail of pharmaceuticals, making it near impossible for people to compete if they have to buy certain brand name drugs.”

“Don’t get me wrong, the legitimate wholesalers have to hire pharmaceutical reps to educate the physician/medical community about their drugs, they must show that their inventory is safe, if there is an international recall they must ensure that the drugs they have supplied are recalled properly and they must monitor to ensure that such drugs are used properly.

“Admittedly, it provide good paying jobs for Bahamians and, because of these jobs and the precautionary measures taken before issuing their drugs, this perhaps adds to the costs of medicine that they may sell. Generic manufacturers or bulk importers are not known to take on such legwork” he said.

He added: “As a doctor, I don’t know if I’m writing a prescription that will lead to the patient getting grey market drugs or parallel imports or counterfeits or anything. Sometimes, even if we specify a brand name or a generic that we trust, there is no guarantee that that is what the patient will get. Nowadays, brand carriers have added holograms on boxes - similar to what’s seen on the money - so as to identify their batch because counterfeiters and others can sometimes have a box that is identical.”

The Bahamas has gained a reputation for importing counterfeits, from hand bags to watches and so on. However, when it comes to the lives of Bahamians, it then becomes a totally different kettle of fish.

If the government is engaged in the purchase, or facilitating the purchase, of “almost as good” drugs, one wonders if the persons who are making such decisions would be willing to use the medicines brought in from certain suppliers or if they would instead prefer to use brand names or generic drugs from legit producers? I would say that much like the educational system, where, over the years, many of the top brass/decision-makers in education have traditionally sent their children to private schools whilst encouraging others to attend the public schools for which they have oversight but demonstrate no belief in since they themselves don’t send their own children there.

Is there a Pharmacovigilance programme in effect in the Bahamas to ensure the quality of medical products/medicine?

Should doctors be informed of questionable products being imported into the Bahamas? Should patients be informed? Should insurance companies be informed?

How can the public be on the lookout for counterfeit drugs or drugs coming through the backdoor?

Since the Pharmacy Act - passed in 2009 - lacks teeth, was it prematurely passed and why has it not been amended as yet? Who vets the drugs being imported into our country?

To credit of the Customs Department, a source told me that there are times when the Pharmacy Council would be called to inspect a shipment, particularly if it belonged to an unrecognised importer. In such cases, the Council is called out to also identify the drugs and to distinguish those that are over-the-counter drugs and those that are prescription drugs. At this rate, it appears that there is currently a need for a pharmacist or a team of pharmacists to be hired and assigned to assist relative to such items entering the country.

There are a number of great pharmacists and pharmaceutical suppliers in this country and so therefore I would want the public to know that all is not lost but to also be cautious and to ask questions.

The government needs to put together a qualified group of professionals who could either work with the Ministry of Health or in that ministry or starts the process of product registration in the Bahamas. We have quite a number of qualified pharmacists in this country. In getting the registration ball rolling, such a grouping could automatically register the drugs that have been approved by the US (FDA), Canada and the UK. As it relates to imports from Turkey and elsewhere, the importer should be made to show that the drug qualifies for registration. The implementation of proper checks and balances is long overdue.

The Ministry of Health and the Pharmacy Council has a responsibility to protect the health and welfare of consumers and, as it relates to our medicinal imports, it is high-time that they get on with doing just that!

CONTROVERSY SURROUNDING CONSTITUTIONAL REFERENDUM

One notes that the controversy is starting to brew about the proposed November 6 Constitutional referendum, which is daily becoming deeply mired in the political and historical hangovers and jostling of the failed 2002 referendum.

It seems to be gradually evolving into a FNM versus PLP thing, where there are those within who think it’s time to return the favour and yet others who are pressing for a favourable vote as this exercise supersedes all political partisanship.

As the days go on, I have heard arguments ranging from bill number four being advanced to “backdoor in same sex marriages” to persons expressing feelings that if bill number two is passed, “foreign men will come into the Bahamas, marry our women, get citizenship off of them, kick them in their (expletive) and then bring in the woman who they truly love, only to give her and their children citizenship.”

The government needs to dispel such feeling among the populace or risk seeking all of its Bills and the referendum itself go up in smoke!

Indeed, we need to eliminate all forms of discrimination from our constitution. In 2002, an effort - that was voted on by all Parliamentarians - sought to do so. However that was subsequently torpedoed by the PLP, who sought to gain political mileage leading into the 2002 general election.

I had just entered college before that referendum and I recall much of the narrative that was heavily weighted with much of the language we see being used today, from “Haitians will come and breed up our women,” to “Englishmen will come, sex our women, get citizenship and then bring in their true loves” to “the government is trying to promote sissying”, and so on.

Yes, Bahamians are - quite honestly - xenophobic, anti-gay and there is a very deep, religious/conservative movement. Combined with the failed gambling referendum and the government’s disregard of the people’s vote and a belief that this government is not entirely honest in its proclamations to the Bahamian people - unless we have a moral purgation in the next three months - these bills will fail. The bills won’t fail because they are wrong, but because of what I have stated above and the fact that they seem rushed.

I will review and further breakdown each one of the Bills next week, but based on everything I’m seeing and hearing, everyone seems to be fanning the flames at this time. Let me say that whatever changes are made relative to the removal of discrimination from the Constitution, the government needs to constantly and consistently clarify - along with the church - that there is absolutely no chance of same sex marriages occurring in this country due to any constitutional changes.

People are very, very concerned about that. The referendum seems rushed and many Bahamians are under the impression that the government is ramming it down our collective throats. November 6 needs to be reconsidered in order to allow for an educational campaign. That said, at this rate, I’m willing to predict that the Bills will be pulled as the Christie Administration would perhaps soon perceive that they cannot pass in such a short span of time.

I’ve talked to several women and men this week and more women than men have told me that they will vote no. One notes that a lot of the prejudices we see today are deeply rooted and, in many ways, relate to the reality of life in the Bahamas where the vast majority of children are born out of wedlock (among other social issues).

The fact that Sean McWeeney shockingly said that the Constitutional Commission has “no horse in the race” reminds people of Mr Christie’s comments about the gaming referendum last year, before the government turned around and decided that they would move to legalise web shop gaming (against the outcome of that referendum). Mr McWeeney’s use of that metaphor represented a less than ideal choice of words of his part and conjured up memories in the minds of the public that I am certain the government would wish to be forgotten.

As the conversation heats up, the governing party’s own rhetoric - circa 2002 - seems to be coming back to haunt them. I would say that before irreparable damage is done to the standing of our country and future referenda, the government should delay the referendum by three to four months to allow for proper education and increase the likelihood of questions being voted on favourably.