I recently went through the website of the Food and Drug Administration (FDA) of the USA in trying to get updates on counterfeit medicines. Some reports at the site caught my eye.
On 16th April, 2015 a report is filed alerting health care practitioners and the public about the presence of a counterfeit version of Botox in the USA which may have been sold to doctors’ offices and medical clinics across the country.
Significantly the counterfeit Botox was sold by an unlicensed supplier who is not authorised to ship or distribute drug products in the USA. The FDA warned that the counterfeit Botox was unsafe and should not be used.
The FDA could not confirm that the manufacture, quality, storage, and handling of the suspect Botox followed U.S. standards.
Uses of Botox injection include treatment of bladder dysfunction, chronic migraine, upper limb spasticity, cervical dystonia (to reduce the severity of abnormal head position and neck pain associated with cervical dystonia), primary axillary hyperhidrosis (excessive sweating), blepharospasm (uncontrollable blinking), strabismus (misaligned eyes).
The FDA report went on to describe the differences between the FDA-approved Botox and the counterfeit Botox products. The FDA-approved Botox injection manufactured by Allergan has Onabotulinum toxin A as the active ingredient while the counterfeit Botox has Botulinum Toxin Type A as the active ingredient.
The FDA further stated that the counterfeit Botox could be identified by one or more of the following: there is no lot number on the vial; the outer carton does not have any entries next to the LOT, MFG, EXP. It means there are no stated manufacturing and expiry dates on the outer carton.
The FDA advised health practitioners to check with Allergan to make sure that the distributor they purchased from is authorized to distribute Botox.
The FDA warned that medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.
In Ghana innovator products have local representations that can be relied upon to assist in product verification.
Another report dated January 21, 2015 was alerting consumers and health care professionals that counterfeit versions of Cialis 20 mg tablets have been found in the mail on its way to a U.S. consumer. While this shipment was stopped, FDA was concerned about other possible mail shipments to consumers.
FDA laboratory analysis showed the counterfeit versions of Cialis contained multiple active ingredients, which if used could result in adverse effects or harm. Consumers should only buy prescription medicines from state-licensed pharmacies located in the U.S.
FDA could not confirm that the manufacturing, quality, storage, and handling of these products followed U.S. standards because these products were from an unknown source and therefore considered unsafe and should not be used.
FDA-approved Cialis tablets made by Eli Lilly contain the active ingredient, tadalafil, and are used for the treatment of erectile dysfunction and other approved indications.
The FDA considered Eli Lilly’s authentic product safe and effective for its intended uses. The FDA said there was no indication that the legitimate supply chain was at risk.
The FDA provided information about differences between authentic and counterfeit versions of Cialis. The counterfeit Cialis bottle label:
l lists “AUSTR81137” on the front of the bottle;
l does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets;
l does not include the tablet strength in a coloured box;
l has different patterns and colors; it has yellow and darker green designs on the front label;
l has misspellings; “CLALIS is a product of: Eli Lilly Australia PTY Limited” on the side of the bottle;
l lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and
l lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle.
The FDA warned consumers not to use products that matched one or more of these descriptions.
Anytime I am asked by a consumer the measures you have to put in place at your facility to insulate us from counterfeit/fake medicines, my response among others was to make sure you acquire products from approved sources.
It is clear that even within highly developed economies counterfeit medicines are able to infiltrate the drug supply chain if health practitioners do not acquire products from approved sources and only allow monetary gains to influence decisions.
As a result, a health care professional charged with saving lives, you end up putting your clients’ lives at serious risk. Another measure you could take is constantly being in touch with your local regulators, and local representations of ethical pharmaceutical companies. So as to get first-hand information on happenings within the pharmaceutical sector.
You also need to constantly monitor the sites of major drug regulatory agencies across the globe to get information among others on counterfeit/fake medicines.
It is also important to remember that organised crime find trade in counterfeit/fake medicines lucrative and far less problematic than dealing in narcotics.
Global sales of counterfeit drugs were expected to reach $75 billion in 2010, a 92% increase from 2005 (Combating counterfeit drugs. Lancet 2008; 371:1551). As I put it to someone we do not have trained dogs at the ports of entry to sniff counterfeit medicines!
I feel uneasy at the news of insecurity or conflicts within the sub-region because of implications on health care delivery.
By Edward O. Amporful