Pharmacy, regulator in compounding vs manufacturing conundrum

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Pharmacy, regulator in compounding vs manufacturing conundrum

THE medical world is grappling with distinguishing between manufacturing and compounding of medicine after a local pharmacy was accused by the Namibia Medicine Regulatory Council of running a small-scale manufacturing operation.

Novecy Pharmacy approached the High Court seeking redress when the NMRC on 21 May 2021 ordered Methealth Namibia Administrators not to pay claims for its compounded products. This is after the regulator allegedly claimed the pharmacy was working outside the law and operating a small-scale manufacturing operation disguised as compounding.

According to pharmacist Riana Potgieter of Novecy Pharmacy, NMRC confiscated its compounded medicine and those it had compounded for and stocked by other pharmacies. 

She said the company is an expert compounding pharmacy, with eight years of extensive compounding experience. 

This is despite the fact that they sell compounded medicine as opposed to other pharmacies that only sell manufactured medicine.

Potgieter said the actions of NMRC are impacting the health of patients who rely on them for critical medication that overseas manufacturers do not sell to Namibia because of the small market. 

She said most of their clients are cancer patients from the Namibia Oncology Centre who critically need their medicine to survive.

“Without Novecy’s assistance in those circumstances, any patient suffering from cancer is unfortunately destined to die, and die very soon, much sooner than would otherwise be the case,” said Potgieter.

She said the compound medicines such as Rubociclib capsules, Lenalidomide capsules, Temozolomide capsules, Ibrutinib, Trametinib, Dabrafenib, and Palonosetron (anti-nausea medicine) as well as Premarin vaginal cream, Bupropion, Dexamethasone, and Nevirapine syrup would not be available to patients if they were not being compounded.

“The reason why the need for compounding in Namibia is critical is because almost every day there is no stock of certain manufactured medicines,” said Potgieter.

She said compounding is not manufacturing because it is tailored to a patient’s prescription and not mass production. Thus, Novecy only owns compounding equipment. 

In response on behalf NMRC, the ministry of health and registrar of medicines, Fransina Nambahu said compounding is a process of combining, mixing, or altering FPP to create a medication tailored to the needs of an individual person. The process also includes combining two or more medicines.

Thus, all pharmacies are entitled to compound for individual patients. 

She said NMRC received complaints and investigated Novecy’s activities. Novecy is registered as a community pharmacy. 

The investigations concluded that Novecy was irregularly compounding medical products and continued its small-scale manufacturing of medicines under the guise of compounding. 

This Nambuhu said resulted in Novecy’s products being confiscated and the company was instructed to stop its operations – but it did not comply.

The investigations further revealed that Novecy’s compounded medicine is kept on the shelf longer than the prescribed 30-day period. This is a risk to the patients and the public, said Nambahu.

He said the company is also in violation of the law as the compounding is not for a particular patient, rendering it not specific for any ailment or disease. Furthermore, the compounding is not going through a safety, efficacy, and quality assurance process that all manufactured medicines are subjected to as stipulated by law.

Nambahu said it is questionable that Lodewikus Jacobus van Zyl who is responsible for Novecy’s operations, is also the responsible pharmacist at the Namibia Oncology Centre – a company they compound medicine for. 

“The applicant (Novecy) is seeking an order from this court to in effect nullify the functions of the inspectors and for their findings in order to bypass the statutory requirements applicable to manufacturing of medicine,” said Nambahu. 

She said Novecy needs to confine its compounding processes to the legal framework which states that it can only compound a treatment regime for a particular patient, of which such medicine may not be used for more than 30 consecutive days from the day of dispensing. 

The case is being heard before Judge Shafimana Ueitele. –