The War Against Counterfeit Medicine: My Story

Chapter 12 - Special Cases

123 CHAPTER 12 SPECIALCASES NAFDAC received reports of frequent violations of our laws from different parts of the country. After investigations that usually follow such reports, the Enforcement Directorate and the Legal Division would work together to prosecute the offenders where applicable. In most cases, fines are imposed, but in the case of fake medicines, they are destroyed. We handled violations impartially, irrespective of persons and/or organisations involved in the cases. So far, we have secured 49 convictions. This chapter highlights some of the important violations and how they were handled. Drug Cases The Use of Counterfeit Medicines for Open Heart Surgery at the University of Nigeria Teaching Hospital (UNTH), Enugu We woke up on the morning of July 19, 2003, to read a frightening incident reported in the Nigerian Guardian newspaper entitled How Counterfeit Medicines Undid What Cardiologists Did. The story was that two out of thirteen children who were beneficiaries of surgery sponsored by a charity organisation, the Kanu Nwankwo Heart Foundation, founded by the Nigerian international soccer star, Kanu Nwankwo, died as a result of fake cardiac stimulants administered on them during the procedures. Alarmed by this report, we launched an immediate investigation into the claims. The nature of this incident was such that I personally took charge of the investigations and led a team of NAFDAC officers to UNTH, Enugu on July 21, 2003. We interviewed the people involved in the case, particularly key hospital personnel and participants in the operations. We inspected the hospital’s pharmacy and the drug stores and examined their drug purchase records. We also visited some pharmacies close to the hospital and the open drug markets where most of the drugs used for the surgeries were purchased. Investigations revealed that the brand of Adrenaline initially supplied for the procedures was withdrawn because the surgeons found it ineffective. It was then replaced with other brands. Four different brands and six different batches of Adrenaline were supplied and 124 The War Against Counterfeit Medicine were used during the surgical procedures. We found that only two of the hospital’s drug suppliers were duly registered and operated under the supervision of pharmacists. All the other suppliers were unregistered and non-professionals but their companies fraudulently bore the name Pharmacy. Physical examination of six batches of Adrenaline drawn from the hospital’s store revealed that one batch had no date of manufacture, another had no name and manufacturer’s address and the third had turned light brown from its original colourless nature. None of these three batches should ever have been allowed into the hospital in the first place. Laboratory analysis of other drugs such as Dextrose injection, Dextrose saline infusion, Normal saline infusion and Ringer’s lactate solution drawn from the hospital’s store showed that one of the three batches of 50 per cent Dextrose intravenous injection failed Pyrogen tests, while one of the three batches of the 10 per cent Dextrose intravenous injection failed sterility tests. (A Pyrogen test is designed to limit to an acceptable level the risk of a sudden temperature rise in a patient as a reaction to a particular injection.) In addition, the Isoplasma infusion used for the operations contained far less calcium, and had a higher pH value, than the specifications on the pack. By implication, the medicines were unfit for human use and yet they were injected into the patients before, during and after such sensitive operations. Furthermore, there were no medical records indicating the particular batches of infusions or the particular batches of Adrenaline used on each patient. Perhaps some patients survived because they received infusions and/or Adrenaline from the good batches. All the 20 drugselling outlets that were directly or indirectly involved in supplying these drugs were shut down to allow for proper investigations. The people who supplied the drugs to the hospital werearrested and made to reveal the places where they bought the fake medicines. It was in this process that we found that the three batches of fake Adrenaline were bought from an open market at Onitsha. When we apprehended the supposed seller of the drug in Onitsha market, he denied ever selling those drugs to anybody. We could not pursue this case further at the Onitsha end because the receipt given to the pharmacist by the Onitsha trader had neither name nor address. It was the word of the pharmacist against the word of the trader. The muscle relaxant (suxamethonium) used for the surgeries was found to be of...