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Will latest crackdown win war against pharmacy quacks?


Getting rid of quacks

Unlicensed individuals put financial gain over patient safety.

In Kibera, an informal settlement in Nairobi, a man in a white coat goes about his business selling medication at a chemist.

Two years ago, his chemist was closed for a month due to lack of a licence. His most recent license expired last May and he says that the Sh15,000 he needs to renew his annual licence is enough to buy stock instead, and if he is caught by the board’s inspectorate team, he’ll pay the Sh5,000 fine and continue with business.

Not too far from this chemist, are other chemists, whose owners admit that they are not licensed to dispense drugs, but they are able to sell medication without having to be cleared by the regulator anyway.

“If they are talking about greed and people out to kill Kenyans, it is not us, but the licensed manufacturers who sell us drugs without bothering to find out if we are licensed to run retail pharmacies or not,” said one of the sellers, adding that they supply cheap drugs to patients.

So it is in many chemists across Kenya – men and women in white coats, some of whom are not licensed to do so, selling medication across the counter.

Yet, according to the Kenya Household Health Expenditure Survey of 2013, pharmacies are the third most popular service providers for outpatient care after public health centres and dispensaries and public hospitals.

The survey found that one in 10 Kenyans consult a pharmacist, instead of going to hospital, when they are sick, while 31 per cent of Kenyans buy medication over the counter without seeking any medical practitioner’s advice.

Among the leading reasons why Kenyans seek outpatient health services, including at pharmacies, are cases of malaria or fever and diseases of the respiratory system including pneumonia, which have not been confirmed by a doctor.

These patients go to chemists believing that they will find relief there, while saving on doctors’ consultation fee, but Pharmacy and Poisons Board CEO Fred Siyoi says that what they find are greedy individuals who put financial gain over patient safety.

ADVERSE EFFECTS

Silvia Opanga, a clinical pharmacist at the Nairobi Hospital and senior lecturer at the University of Nairobi School of Pharmacy told HealthyNation that inasmuch as medicine is meant to cure disease, when not taken correctly, drugs can have adverse effects on major organs, hence why they should only be dispensed by qualified personnel.

“Drugs are poisonous, and in the hands of the wrong people, they can kill,” said Dr Opanga, who has seen patients with skin and breathing complications, as well as heart and kidney complications from medicines they bought over the counter. She added that an unqualified person might not know what to do when a patient experiences adverse effects from medication they dispensed.

“This is why we always insist that medicine be prescribed by qualified doctors and dispensed by qualified pharmacists,” she said.

Data from the World Health Organisation shows that preventable medication errors affect more than seven million patients annually, costing billions of dollars in damages.

Adverse drug reactions can range from mild and temporary effects to serious, and sometimes fatal reactions. Moreover, as many as 9,000 people in the world die each year from medication errors.

“Errors can happen anywhere along the patient-care timeline, some prescription errors are simply accidents, while others are caused by medical malpractice,” states the WHO.

In Kenya where 16 per cent of urban residents and 12 per cent of people in rural areas seek healthcare in pharmacies, these effects could befall many, as the person behind the counter may not be licensed to dispense medication.

HealthyNation sampled 35 chemists in Nairobi, Kisumu, Mombasa, Kiambu and Kitale, and found that 20 were unregistered. Proof of registration is usually a visible safety code, which patients can send to 21031 via SMS to get the registration status of the chemist.

In Dandora, Mathare North, Kariobangi North and Kawangware areas of Nairobi where 10 pharmacies were sampled, only two had a safety code at the door.

NOTORIOUS REGIONS

Last month, the board closed 86 chemists in the western region including 20 chemists in Kakamega, 10 in Bungoma, seven in Vihiga and two in Busia, for operating without valid licenses.

By July last year, the board had registered 5,840 pharmacies. Nairobi had the most chemists – 1,850, followed by the central region with 870 pharmacies, South Rift Valley with 610 chemists, coast with 590, Nyanza with 470, North Rift with 460, lower eastern with 330, western with 330, upper eastern with 270 and North Rift with 60 chemists.

From the registered chemists the board has inspected 3,383 chemists and closed 738 chemists.

According to the board’s senior inspector of drugs Julius Kalui, the pharmacies were closed for not having licenses, for having unqualified personnel running them and due to unlawful possession of a part one poisonous drug.

Mr Kalui told HealthyNation that Nairobi, Mombasa, especially Likoni, Kiambu, Webuye, Kakamega, Busia AND Malaba are the most notorious regions for flouting the pharmacy regulations. In Nairobi, Kibera, Dandora, Kawangware and Korogocho have the highest number of illegal chemists.

Earlier this month, PPB chairman Jackson Kioko launched yet another crackdown on unlicensed pharmacies and practitioners.

But the targeted people have learnt to play hide and seek by opening shop in the evening to avoid raids.

“It is very unfortunate how they want to play with the lives of Kenyan, but we are not going to give them any chance. We have started weekend crackdowns. we are arresting them from their hideouts,” said Dr Siyoi.

POOR REGULATION
However, some practitioners feel that not enough is being done. In March, Pharmaceutical Society of Kenya President Louis Machogu wrote to the Attorney General decrying the poor regulation of the local pharmaceutical market, which has led to the proliferation of unqualified persons practising pharmacy contrary to the law and contrary to best global practices stipulated by the World Health Organisation.

But inspectorate officials insist that there are regular crackdowns to ensure that all pharmacies are operated by qualified personnel and to ensure the safety and efficacy of drugs in the market, even though there have been challenges in getting rid of the quacks.

According to Dr Siyoi, some people are licensed to sell general medicines, but with time, they begin to sell medicine they are not authorised to sell.

For instance, some medicines referred to as part one poisons are stocked by chemists which are not licensed to dispense them. Such medicines need to be dispensed by practitioners who know how to handle any adverse effects, and such practitioners should go beyond dispensing to giving additional information to patients.

The other challenge had been that the fine for operating an illegal chemist was not deterrent enough. Unlicensed chemists used to be fined a minimum of Sh5,000, which they would pay and return to the trade.

Moreover, unregistered practitioners used to be fined Sh20,000 for practising pharmacy contrary to the law, which Dr Siyoi said had led to the proliferation of quacks.

However, the Health Amendment Act 2018 recently assented to by President Uhuru Kenyatta provides for a Sh1 million fine for operating a pharmacy in the absence of a registered pharmacist or qualified pharmaceutical technologist.

GAP FILLED BY QUACKS

While Dr Siyoi says there are enough practitioners – there are currently 3,582 pharmacists and 10,126 number of pharmaceutical technologists – he notes that 50 per cent of all registered practitioners are concentrated in Nairobi, thereby creating a gap in other regions, which is filled by quacks.

According to the Kenya Health Service Utilisation Survey, in 2013, most of the pharmacists in private practice were in Nairobi (602), followed by Mombasa (90), Bungoma (88), Kiambu (87), and Kisumu (62); and most pharmaceutical technologists were practising in Nairobi (1,141), Kiambu (431), Mombasa (286), Uasin Gishu (252) and Nakuru (229).

Counties with the lowest number of pharmacists were West Pokot (1), Wajir (3), Tana River, Samburu and Marsabit (4 each), while those with the lowest number of pharmaceutical technologists were Turkana (9), Tana River and Lamu (11 each) and Isiolo (16).

Isaac Kibwage, a lecturer at the School of Pharmacy at the University of Nairobi, adds that the market is full of practitioners from unaccredited colleges.

“These are the people who hawk medicines,” said Prof Kibwage.

Currently, there are seven universities training pharmacists and 20 colleges authorised to train people in pharmaceutical technology.

Graduates are supposed to practise pharmacy at a certain level defined by the type of drugs they can dispense. Before then, they have to register with the board after training at an accredited institution.

They must also sit a board examination. Pharmacists must have a five-year bachelor’s degree followed by a year of supervised work (internship), while technologists are required have a three-year diploma including a seven-month attachment.

Pharmacists can practise in four main areas – regulation and control of medicines, hospital pharmacy, manufacturing industry and community (retail) pharmacy.

REQUIREMENTS

Practice licenses should be renewed annually upon fulfilling all requirements, but this does not apply to those practising in the public sector.

In addition, registered pharmacists and pharmaceutical technologists are required to practise in licensed premises. The person in charge of the facility applies for registration and the board inspects the facility to decide whether it should be licensed.

However, these regulations have not stopped quacks from setting up shop and putting patients at risk.

In the recent crackdown, the board seized drugs of poor quality, including anti-malaria drugs, lifestyle drugs (slimming pills and sexual enhancement products), toothpastes, painkillers, and a wide range of antibiotics.

To protect themselves from quacks, the board advises Kenyans to use the Health Safety Code, which should be displayed visibly in the chemist, to identify registered pharmacies by sending it through a free SMS to 21031.

The code provides registration details of legitimate pharmacists, the location of their premises, the name of the chemist and the name of the person running the chemist.

“Customers should always verify the authenticity of the outlet using the displayed banner SMS code before buying medicines,’’ Dr Siyoi told the HealthyNation, adding that any chemist without the banner should be treated as an illegal one since the banners are picked after registration.

“We are going to weed out all the unlicensed pharmacists and only those that meet basic operation criteria will be left to continue operating,” said Dr Siyoi.

Dr Machogu says that a national self-regulatory framework that empowers pharmacists to take individual and collective responsibility could be just what Kenya needs to get rid of quacks.

“Our PSK branches and Green Cross local caucuses will act like Nyumba Kumi, devolving self-regulation and collective responsibility of reporting quacks and malpractice,” he told HealthyNation, adding that this would work in the same way matatu Saccos are penalised for an errant member.

“Each professional must belong to a local Green Cross caucus to help with enforcement. It’s very hard or near impossible for PPB to bear burden of enforcement by itself. This is next level for Green Cross, which we started back in 2014.”