The rat infestation in the Plaine-Lauzun medicine warehouse has damaged a good number of medicines, as reported in the National Audit Report 2022 – 2023. This observation calls into question the integrity of medicines distributed in public health services. .
Consumption of adulterated medicines can have harmful effects on the health of patients and even be dangerous. Hence the imperative that they be kept in optimal conditions. However, the report from the Audit Office 2022-23, made public on Tuesday April 2, threw a wrench in the pond.
In addition to the expenses and various shortcomings, the rat infestation at the Central Supplies Division (CSD) in Plaine-Lauzun was highlighted. Among the problems identified by the Audit Office, we note the presence of rats having damaged numerous medicines, despite the measures taken by the Ministry of Health to resolve the problem.
It was also observed, during visits to three warehouses in August and September 2023, that a significant quantity of medicines and pharmaceutical products were stored in inadequate, unsafe and unsanitary conditions. Audit office officers also noted water leaks in various places and the ceilings of some warehouses in a deplorable condition, thus posing a major health risk, as mentioned in the report.
These findings call into question the integrity of medications. What do we understand by this term? The concept of integrity of medicines refers to the assurance of their quality, authenticity and safety throughout their life cycle, from their manufacture to their use by patients. It encompasses several essential aspects: the quality of medicines, which must be manufactured according to the standards required to guarantee their effectiveness and safety; authenticity, in order to certify that they conform to what they are supposed to be; safety, medicines must be free of any contamination that could present risks to patients.
Faced with criticism from the Audit Office, the Ministry of Health affirms that the integrity of medicines is respected. It is argued that all pharmaceutical products must be registered with the Pharmacy Board (PB) by wholesale pharmacies before being marketed in Mauritius. And to specify that the registration of pharmaceutical products involves a complete process of evaluation of files by a qualified pharmacist, in accordance with international guidelines to guarantee the quality, safety and effectiveness of the products.
However, some pharmacists, including Ashwin Dookun, president of the Pharmaceutical Association of Mauritius (PAM), are skeptical. “All pharmacists, whether working in the public or private sector, are expected to follow a Code of Practice. However, it seems that this is not always the case,” he notes. According to several of his colleagues, in the event of a mistake made by a pharmacist in the private sector during an inspection, he risks various harassments, even sanctions. They question the treatment reserved for pharmacists responsible for the medicine warehouses of the Ministry of Health, believing that there is clearly a two-tier policy.
These private pharmacists also argue that we cannot rely entirely on the documents submitted by suppliers. They recall the period of the COVID-19 pandemic, when anyone could import pharmaceutical products, even from sources not previously registered with health authorities and recognized for their integrity and ethics.
Faced with this situation, Siddique Khodabocus, of the Association of Small and Medium Importers of Pharmaceutical Products, and Ashwin Dookun are of the opinion that it would be appropriate to set up an organization responsible for the systematic analysis of samples of medical products arriving in Mauritius. The objective is to ensure that they contain the necessary active pharmaceutical ingredients and that the Certificate of Analysis (CA) is compliant.
In addition to these checks, it is essential, given the risks posed by altered medicines, to guarantee that medicines are correctly stored and that the cold chain, where it is necessary, is respected at all stages, particularly during transfers.
Still, despite the fears expressed and the problems observed in the pharmaceutical warehouses of the Ministry of Health, a health professional affirms that the integrity of medicines is maintained “as best as possible”, thanks to various measures such as storage at required temperatures. However, he concedes that it is high time to set up a modern warehouse equipped with all the necessary facilities, a project announced many times, but which is slow to materialize.
With this new warehouse and the centralization of products in a single location, it will be easier to manage stock and guarantee the correct packaging of products, he argues. He also believes that more staff would be needed to ensure better control and better maintenance of the premises. By observing better control of temperatures and humidity, he believes there is a greater chance that the concept of drug integrity will be respected.
However, for now, none of this is a given, while medicine integrity aims to ensure that they are high quality, authentic and safe, with the aim of protecting health and well-being patients.
Recovery Center
It is widely supported by various pharmacists and healthcare professionals, with whom we have spoken, that it is not good practice to allow expired or unused medications to end up in the wild or to be stored at home. Like Ashwin Dookun, everyone regrets the absence of a system for recovering expired medicines so that they can be disposed of properly, because these pharmaceutical products could fall into the wrong hands and prove dangerous.
According to our information, each patient disposes of their medication according to their convenience: in the toilet or in their trash bin with other household waste, which can be harmful to the environment. Our stakeholders therefore believe that the recovery and disposal of medications should be the responsibility of the Ministry of Health. A system could be set up in public service hospitals to recover these pharmaceutical products intended for destruction.
A pharmacist explains that there are various ways to dispose of medications, including incineration, depending on the nature of the product. He emphasizes that it is not recommended to dispose of them anywhere or in any way, as some products may contain harmful molecules after expiration and thus contaminate the environment.
Code of Practice
According to the Code of Practice for Pharmacists of 2021, it is stipulated in section IV – Professional Responsibility that:
- Any registered pharmacist, when providing a pre-professional service or intervention, does so on the basis of their qualification and expertise.
- Every wholesale pharmacist must manage his stock so as to ensure an adequate supply of pharmaceutical products to each approved pharmacy.
We also note, under section 24 of the Pharmacy Act, entitled Quality of pharmaceutical products, that it is prohibited to sell:
(a) a pharmaceutical product that:
(i) is adulterated or impure;
(ii) does not conform to a specified requirement or standard;
(b) any medication:
(i) which is not of good quality and in perfect condition for medical use; Or
(ii) whose shelf life has expired;
(c) any medicine containing ingredients that affect its quality.
Regarding the standards applicable to therapeutic substances, according to article 31:
(1) Subject to the provisions of section 32, no person shall manufacture or sell any therapeutic substance mentioned in the Sixth Schedule, if it does not conform to the specified standards.
(2) The Permanent Secretary may order the confiscation of any therapeutic substance which does not comply with the provisions of subsection (1).
