I write with great concern for the safety of Basotho nation. This letter is specifically related to the matter of regulations in the Pharmaceutical sector and their impact on the safety of the nation. I am sure you will agree that from the point of production through the dispensing, all medications should be rigorously analysed, evaluated and then approved, continually monitored for safety and professionally dispensed by qualified personnel.
Pharmaceutical Regulation in Lesotho
As the Ministry of Health, your department is responsible for ensuring that all medicines (traditional, conventional and contemporary) and medical devices are of good quality, efficacy and safety. On its behalf, the Drug Regulatory Bodies/ Medicines Regulatory Unit’s (MRU) main role is to ensure registration of medicines available in the country, uphold high standards in licencing of medicines and medical devices, monitoring of medicines utilization and most importantly to make provision and regulation of clinical trials for medicines as these are very crucial stages that a new medicine has to undergo in order to determine its efficacy, dosage and safety before it could be used for human consumption. It is to our detriment that the MRU has not been established by law, and that the Medicines and Medical Devices Bill has been pending for enactment for years and, at the moment, is at the door of a closed parliament.
Pharmaceutical dispensing in public clinics/health centres
In the Ministry’s efforts to reduce probable harm to patients, it is responsible to ensure medicines are in the hands of the qualified, registered and well regulated professionals (Pharmacists and Pharmacy Technicians). Yet, despite the significant number of qualified, unemployed pharmacists, nurses and nursing assistants are allowed to dispense medicines in the clinics. Their lack of training and professional certification in pharmacy complicated by the often high demand, unacceptable patient/practitioner ratio, severely compromises the quality of pharmaceutical care that the nation needs.
Honourable Minister, a great danger with medicine-related errors is that, 1) a goal to effectively treat a patient fails so a patient deteriorates 2) harmful effects (toxicity) of medicines may be potentiated causing new health issues to a patient 3) some medicines (antibiotics) lose potential to ever be helpful for such a patient where they have been used irrationally. Dear Minister, this country has medicine experts, people to prevent all these and to ensure that all patients get the best and effective medical treatment available. Do we want to see these preventable errors prevail even in the fight against the pandemic while there are highly qualified health professionals who can even make a fight against COVID-19 a winning game with their medical expertise?
We applaud the government’s initiative to employ exclusively additional Nursing staff to handle the pandemic. However, we kindly wish to bring to the attention of our health ministry & government that based on the scope of practice of Nursing professionals, they are already burdened with more healthcare services that are beyond their scope. Being beyond their scope means they are not experts in such fields and may as a result, do medical errors in their service. Honorable Minister, I wish to let you know that a common slogan in John Hopkins Hospital, a best & highly-ranked hospital in the world, is that “the clinical space is the most unforgiving environment, simply because errors in the clinical practice cost a life”. Let alone errors in relation to medicines!
It is important to consider that an equal number of patients to be served by the nursing staff need to be served at the pharmacy. Therefore, there is need to engage a proportional number of pharmacy staff to serve these patients. The pharmacy department has always been overwhelmed due to disparities in the staffing patterns for pharmacy personnel versus nursing staff in our facilities and is overly overwhelmed as a result of this pandemic. I therefore implore you to review and strengthen the human resource capacity of the pharmacy cadre through hiring a number of pharmacy personnel (pharmacists and pharmacy technicians) comparative to the nursing staff.
Research and best practices support the significantly improved treatment outcomes for chronic and infectious diseases under the pharmaceutical care of qualified pharmacists and pharmacy technicians (Mafisa et al. (2019), Thinyane et al. (2014), Mugomeri et al. (2016). Diseases that are inadequately managed at primary health care appear more in the secondary healthcare (hospitals) regularly with significant financial and outcome costs on patients and the government.
The Ministry of Health’s responsibility to regulate both the public and private health sector.
I draw your attention to the lack of regulation in the management of medicines in Lesotho. For example, a cough mixture alleged to be certified by NUL Innovation Hub was recently released into the market, with claims that it has passed safety tests in South Africa, despite having passed no clinical trials, having no safety profile, no information on who licenced it, and yet it is being sold in our local pharmacies. It is clearly unethical and potentially extremely dangerous for medicines which have not been approved and licenced by any pharmaceutical regulatory body to make rounds in our markets. This issue of poorly regulated pharmaceutical sector should be regarded as a “public health emergency”.
Due to poor enforcement of available laws to regulate the private pharmaceutical sector, Retail pharmacies are often run by high school leavers; schedules of medicines are dispensed like over-the-counter medicines, potentially causing serious harm, adverse reactions, or death. This lack of oversight by professionals leaves the door open for illegal, counterfeit ‘fake’ medicines, such as those professing to ‘cure’ or prevent COVID-19. In the absence of Drugs Regulatory Authority (DRA) which will be legally introduced by the Medicines and Medical Devices bill, MOH through Pharmaceutical directorate and public health sector, can apply Public Health order of 1970 to remove these medicines from the shelves and take the perpetrators to court. I urge the government to consider this a priority, to ensure that our people are safe.
Registration of Pharmacists and Pharmacy Technologists/Technicians
According to the Medical, Dental and Pharmacy Order 1970, anyone who claims to be a pharmacist/ pharmacy technician must be registered with the Lesotho Medical, Dental and Pharmacy Council as such. The Ministry of Health and the LMDPC have a mandate to ensure that all pharmacists and pharmacy technicians working in both public and private sector are regulated through registration with the LMDPC to ensure that highest standards of professional practice regarding medicines are exercised. In my opinion, this mandate has not been adequately implemented and needs immediate attention. I implore you to address this issue.
Professional registration fees at the Lesotho Medical, Dental and Pharmacy Council (LMDPC)
It is to be noted that the LMDPC professional registration fees and annual increases are prohibitively high and much higher than comparable countries, such as Eswatini and Botswana. The use of the office at the Ministry of Health headquarters for the LMDPC secretariat would offset the high running cost. On behalf of the practitioners in Lesotho, I request that the operations and functionality status of the council according to their mandate go under review with its fees and the financial statements of the council made public.
Honourable Minister, as a citizen in this country, the health of this nation must be top priority. As a pharmacist and a custodian of medicines, it saddens me that our people are exposed to so much harm that comes with poorly regulated health system, especially in the pharmaceutical sector. We can’t continue like this. Something needs to be done.
As a Mosotho and professional pharmacist, I urge the government to put in place all structures necessary to protect both our patients and their medications by urgently passing the Medicines and Medical devices bill into Law and establishing the Drugs Regulatory Authority (DRA) to increase the rigorous monitoring of the dispensing of medicines.
It is my humble request that You Honourable Minister treat matters in this letter with the urgency that they are and require. May I kindly request that you respond to this letter within seven working days.
Khotso, Pula, Nala!
Pharmacist (Bachelor of Pharmacy-NUL, Master of Health Sciences_ Antibiotics Stewardship and Conservation-UKZN)
The Prime Minister of Lesotho
The Deputy Prime Minister
The Deputy Minister of Health
The President-Lesotho Medical, Dental and Pharmacy Council
National University of Lesotho