Early last month, 65,000 kilogrammes of unused and expired medicines – among other pharmaceutical waste - from various hospitals, chemists and clinics across the country were destroyed by industry regulators.
The destruction of the products worth over Sh1.29 million was done at the Envirosafe Limited incinerator at the Export Processing Zone, Athi River.
The Pharmacy and Poisons Board (PPB) and the Pharmaceutical Society of Kenya (PSK) in collaboration with the Kenya Ports Authority collected the products in a span of one year. The National Environmental Management Authority (NEMA) was also involved.
According to PSK, controlled medicines meant for disposal can lead to deaths if consumed hence the destruction.
But a lack of public awareness on how to dispose of expired drugs obscures the public eye which ought to act as a watchdog when inappropriate disposal takes place.
Sources of unwanted pharmaceuticals range from unsolicited medicines especially in situations of duress like wars, famine, natural disasters or when authorities seek for help from well-wishers or expiry of medicinal supplies that are routinely used.
Poor quality products which may be mouldy, adulterated or inappropriate for human and animal consumption are also a factor for disposal, said PSK president Philip Mwaniki.
Lead to death
“Change in treatment guidelines or new discoveries, which render some pharmaceuticals obsolete thereby leading to need to dispose of them like when a drug used to treat malaria in the 1990s (Amodiaquine) was rendered ineffective due to drug resistance leading to the switch to Artemether/Lumefantrine(AL) -can also be reason for disposal,” said Dr Mwaniki.
“We have seen incidents of members of the public getting their hands on controlled medicines meant for disposal. These have led to deaths.”
He added: “Most public facilities do not have the capacity to destroy medicinal waste at the required standard that assures safe disposal.”
There are more than 10,000 health facilities in Kenya, ranging from the smallest clinic to the largest referral hospitals under public and private hospitals.
These health facilities generate medicinal waste through routine use and the expiry of supplies.
But in most instances, expired medicinal supplies are kept away probably in a store or simply under a shade.
Sometimes it is just heaped somewhere within the health facility to create room for storage of new useful supplies due to shortage of space.
The biggest challenge for health facilities is lack of space to serve as storage for waste.
“The way it is being done in all public facilities is causing more harm and pollution than just keeping them locked up somewhere,” said Dr Mwaniki.
Pharmaceuticals are largely destroyed at very high temperatures (at more than 1,200°C), according to PSK.
That means that for one to incinerate pharmaceuticals, he or she needs special incinerators that can attain such temperatures and with adequate control of emissions.
The brick and motor incinerators doting most public health facilities can hardly generate high temperatures (of over the required 1200°C) for proper incineration of drugs, most of them can do about 300°C.
The price of poor pharmaceutical waste disposal will be borne by generations for decades to come as harmful toxic pollutants from low temperature incinerators and open pits found in most public facilities get lodged in the air, deposited on land and consumed by people over time.
These are known to cause cancers – a menace that is on the rise, Dr Mwaniki said.
Costly to dispose
Expired pharmaceuticals cost a lot of money, and counties have hundreds of tonnes of waste.
To dispose of the expired commodities, a responsible pharmacy professional and representatives of a waste disposal company should be involved.
The cost for disposing of one kilogramme of pharmaceutical waste, for instance, used to range between Sh200 to Sh400 in the 1990s, based on the type of waste, but the cost has since come down to about Sh25 to Sh30.
Anti-cancer drugs, for instance, need over 3,000°C to be safely destroyed. Apart from the Kenya Medical and Research Institute, there is no other public facility with such capacity.
Kenyatta National Hospital (KNH), the largest public referral facility in the eastern Africa, for instance, has a 1,700°C incinerator according to Louis Machogu, thus it does not meet the required recommendation.
Dr Machogu is a PSK National Governing Council member and the PSK Nairobi Branch Interim Chairman. He is also the founder of the Haltons Pharmacy chain.
Dr Machogu said the private sector has not prioritised incinerators as it “tries as it has arrangements with suppliers to return products six months to expiry”.
Approval must be sought
“Incinerators cost a lot of money to run and no private hospital wants to have it on its books. Outsourcing is what they do,” said Dr Machogu.
Dr Mwaniki said, however, that in order for a country or organisation to dispose of harmful pharmaceuticals approval must be sought from the appropriate authority.
“In our country, authority must be sort from the Ministry of Health through the drug regulatory authority,” he said.
Before devolution the Health principal secretary who is also the ministry’s accounting officer was in charge of commissioning the disposal, according to PSK.
But with the formation of counties the PS is now only in charge of national referral facilities like KNH, Mathare Mental Hospital, the National Spinal Injury Hospital, and Moi Teaching and Referral Hospital.
“The bulk of public health facilities which include dispensaries, health centres and sub-county and county hospitals were put under counties.
Therefore, the County Chief of Health (CoH) should take up that mantle. There is a big gap here as our CoHs are not resourced to destroy expired medicines,” said Dr Mwaniki.
He added: “There is need for funding, necessary expertise, human resources, professional time, space, equipment, material and available disposal options for proper disposal of medicinal supplies. This is essential before practical steps can be taken to start disposal in counties.”
Also, cost estimates of expired medicines need to be made as they have an impact on financial reporting and accountability for both public and private facilities.
Expired pharmaceuticals do not represent a serious threat to public health or to the environment if stored appropriately, said Dr Machogu.
However, he added, improper disposal may be hazardous as it can lead to not only contamination of water supplies or local sources used by communities and wildlife but also pilfering and theft from stockpiles of waste drugs may result in their being diverted to the market for resale and misuse.
Expired drugs may also land in the hands of scavengers and children if a landfill is insecure.
A landfill is a constructed pit purposely for disposal of waste.
The consequences of inefficient and insecure sorting and disposal of medical waste may allow drugs to be diverted for resale to the general public, hence rent-seeking businessmen may alter expiry dates on vials, packing materials and bottles and hoodwink the public into buying the unsafe medicine.
“In our country scavenging in unprotected insecure landfills is a hazard driven by poverty and pure greed for a quick kill,” said Dr Machogu, a pharmacist by profession.
“Most pharmaceuticals that are past their expiry date become less efficacious and some may become more toxic leading to adverse drug reactions.”
Some categories of expired drugs or defective disposal practices carry a public health risk.
Controlled substances like narcotics and psychotropic drugs, for instance, require tight security and control to avoid theft and resale in the market.
Dr Machogu said that there are instances where drug addicts set up homes in disposal sites when a government institution or hospital inappropriately disposes of expired dugs in the hope of landing substances to inhale, inject or sell at a profit.
“If pharmaceuticals must be discarded directly to a landfill, then they must be covered immediately with a large quantity of municipal waste,” Dr Machogu said.
Landfills, he said, must be constructed in a way that minimises the possibility of underground seepage to avoid waste entering an aquifer, surface water or drinking water system.
Non-biodegradable antibiotics, anti-cancer drugs and disinfectants should not be disposed of into the sewage system as they may kill bacteria necessary for the treatment of sewage hence endangering the ecosystem through growth of undesirable microbes.
“The public should not flush expired anti-cancer drugs into watercourses as they may damage aquatic life or contaminate drinking water,” he said.
Burning pharmaceuticals at low temperatures or in open containers also spells doom as it results in the release of toxic pollutants into the air.
“This should be avoided as it may lead to the proliferation of undesirable medicinal conditions like Asthma, Bronchitis and a host of other allergic manifestations.”
Dumping into a county site is not a good idea either.
The Dandora dumping site continues to bear the brunt of receiving all sorts of waste including toxic electronics and harmful pharmaceutical products.
Antibiotics dumped at the site may seep into the food chain through being consumed by animals such as chicken feeding on the dumpsite, as well as soil and water contamination leading to unintended exposure by humans and animals to the drugs.
“Dumping antibiotics in communal pits might lead to drug resistance to microbes like Vibrio Cholera, especially in cases of poor human waste management,” said Dr Machogu.
“County governments, their environmental and health departments together with the pharmacy board should look into this. We as professionals and the private sector have capacity to support.”
Dump sites not ideal
Open dump sites like Dandora are not ideal for disposal of medicinal supplies. Experts advise for highly professional sanitary landfills, which are dug to a level where they do not reach the aquifer to avoid water contamination.
These should ideally be located away from human settlements and properly secured.
The government has a return-back mechanism for some supplies such as vaccines which are returned to sub-county public facilities for onward disposal.
Most public health facilities have regular incinerators, a sewerage system and an open pit for disposal of general waste.
Save for a few syrups like multivitamins and paracetamol, which can be disposed through the sewerage system, these county facilities can hardly be used for disposal of antibiotics, anti-cancers and other controlled medicines.
Dr Mwaniki said there is a need to develop a national policy on the disposal of medicinal supplies, which will then be followed up by guidelines on how to dispose of them.
Each county should then be required to establish a high capacity incinerator for disposal of medicinal waste.
“It is not just about disposal but safe disposal of medicinal waste. More harm comes from substandard medicinal waste management,” said Dr Machogu.