Public sector medicines below par?

Private sector ensures minimum standards for storage, transport; Public sector cannot…

By Husna Inayathullah

Despite the country’s rise to ‘middle-income status’, the population is yet to access clean and safe pharmaceuticals, a blot on our once-proud health system. While private sector medical services do ensure minimum safety standards for pharmaceutical storage and transport, the impoverished state medical system, which serves the bulk of the population, cannot.

Dr. Namal Gamage

The pharmaceutical storage mechanism within the state sector is not safe and does not conform to the proper methods in transporting and storing the drugs in hospitals, a senior consultant says,

“Government health institutions all over the country have to use their own vehicles to transport their required drug quota from the Medical Supplies Division (MSD) in Colombo. Almost all these vehicles – generally, lorries, are devoid of air conditioning. Anyone can imagine what happens to the quality of drugs stored inside these vehicles for over 24 hours in soaring temperatures, during their long journey from the MSD to their respective institutions,” Consultant Cardiothoracic Surgeon, Teaching Hospital, Karapitiya, Dr. Namal Gamage says.

Transportation

These lorries reach the MSD in the morning with hospital pharmacists. They are parked at the MSD premises under the hot sun. Pharmacists start collecting various items from various outlets of the MSD and stacks them in the lorries. Drugs, gauze, saline, surgical consumables, are among the items. Lorries remain parked the whole day until this process is over, and leave MSD in the afternoon. The loaded items are not unloaded the same day at the provincial hospital, but the following day morning only, according to Dr. Gamage.

“The Health Department should understand the importance of storing drugs in the proper manner until they reach the patient,” he said, in an interview with the Sunday Observer.

Dr. Gamage said, the drugs are transported in lorries with no air conditioning, which is contrary to Parliamentary Act No 27 of 1980, according to which drugs have to be transported in air-conditioned vehicles. The National Medicinal Product Regulatory Authority (NMRA) has been established according to this Act. He stressed that all drug labels state they should be kept below 30 to 25 degrees to safeguard the active materials contained in the drugs. “The public must be made aware of this pathetic situation where drugs are transported in an unsafe manner, which could cause ill-effects. Medical students and pharmaceuticals have forgotten what they have studied. I have made several complaints to the Health Director regarding the unsafe method of transporting drugs, but it has been of no avail,” Dr Gamage said.

"Sri Lanka being a tropical country, generally, has ambient temperatures above 30 degrees Celsius and during daytime may reach much higher. Almost all drugs must be kept below 30 to 25 degrees Celsius all the time to avoid decomposing active ingredients which are not heat resistant. Therefore, air conditioning is a must for any place where a drug is kept for any length of time."

“Reputed multinational drug companies always have mechanisms to safeguard their drugs from various adverse conditions which could occur throughout the long journey of transportation. Therefore, automatically, the prices of such drugs stay high. It is one reason why company drugs are expensive in the open market. Companies are blamed, but they survive and thrive, as they provide quality drugs to patients. They are the only quality drug providers we have,” the doctor said.

Temperature

If doctors come to know that a particular brand of drug is not as effective, they are reluctant to prescribe that brand, which could be detrimental to the sustainability of the company. Therefore, companies are aware they must be vigilant to preserve the quality of the drugs for their own sustainability. In a life and death situation, doctors do not take a risk but use the best available brand of the required drug, but of course the patient must be able to afford it, Dr. Gamage said.

“Sri Lanka being a tropical country, generally, has ambient temperatures above 30 degrees Celsius and during daytime may reach much higher. Almost all drugs must be kept below 30 to 25 degrees Celsius all the time to avoid decomposing active ingredients which are not heat resistant. Therefore, air conditioning is a must for any place where a drug is kept for any length of time. In this country, especially, when transporting drugs during daytime in a closed vehicle with no air conditioning, the temperatures could rise up to 80 or 90 degrees Celsius,” he said.

Dr. Gamage said, the NMRA is empowered to issue licence to drug transporting vehicles in Sri Lanka. The NMRA officials check the vehicle’s proper functioning of air conditioning before they issue the permit which is given only on an individual basis, for the RMV registration number of the vehicle. “Any private vehicle transporting drugs without such licence will be raided and seized by Food and Drug Inspectors (FDI) even if the vehicle is suitably air conditioned for the purpose. If found guilty in court, the victim is fined up to Rs. 100,000 and the person responsible must publish, clearly shown apologizing notices in three well known daily newspapers, in the three mediums,” he said.

He said, most of the time, doctors are blamed for using branded drugs which are expensive and have to be bought from outside, but it is the only alternative available. “Company drugs are protected twofold, by the company mechanism and by the government law. Government drugs are not protected by either mechanism.

The government must provide a solution to this issue by supplying air-conditioned trucks. It is not something impossible for the government to do. The government spends a huge amount of money annually for importing drugs but it is a waste”, he added.

The private sector

Kelum Gimendra Jayasuriya

The Sunday Observer also spoke to an official of the Pharmaceutical Society of Sri Lanka (PSS) to find out about the storage, transportation and distribution facilities of medical drugs in private hospitals. According to him, the Drug and Therapeutic Committee introduced by the World Health Organization (WHO) and the NMRA are responsible for the quality control of the drugs. “The main problem in Sri Lanka is that people go for brand names of drugs prescribed by doctors and this causes inconvenience to them. The quality of the drugs differs with the brand name, because extra ingredients are added to them,” he said.

Manager, Quality Standards for Asiri Group Pharmacy Services and Vice President of PSS, Kelum Gimendra Jayasuriya, said, “The private health sector gets the accreditation of quality drugs through a process called Joint Commission International (JCI) which looks into patient safety and the quality of the drugs. The Medication Management and Usage (MNU) and Prevention and Control of Infection (PCI) approval under this accreditation are mandatory. We do not sell or approve any drugs not approved by the NMRA. A new drug introduced to the market should be approved by the Food and Drug Authority (FDA). It has to undergo four phases, but it is sad to say that Sri Lanka does not proceed after the third phase. The last phase is known as Post Marketing Surveillance which the Sri Lankan drugs do not undergo,” he said

Jayasuriya added; “We do not accept drugs from suppliers if they do not possess an NMRA licence and approval. We have an application form in the private hospitals which the medical suppliers should fill and get it endorsed by the NMRA and a doctor, and we do it in order to look into quality control,” he said

“A drug’s efficacy should be the same until its expiry. We do not take in brands more than seven and ensure that we have the original brand. We have a process to identify quality failure. At least one or two quality failures per month are reported. The prescription pattern in Sri Lanka where antibiotic is prescribed for a minor and a major problem is incorrect. We inspect warehouses and suppliers and assure that they have air conditioning to safeguard the quality of the drugs.

We depend on the government for vital drugs, but sometimes they too go out of stock,” Jayasuriya said. The WHO says, we have to control the humidity to safeguard the quality of the drugs, but it does not happen everywhere. “The WHO and the government also advise that no drugs should be stored on the refrigerator doors. We have record temperatures and alarm bells in private hospital warehouses to make sure that the temperature is at the correct level. No fluctuation happens in temperature in private hospitals, and we have generators as well. We safeguard our drugs from adverse conditions and that is why we have a high demand when compared with the government sector,” he said.