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End-to-end pharmacovigilance is a must–Unilab

NOT all medicines—even those with the same generic names—are created equal. And in numerous cases, the difference—particularly in quality, divides the line between life and death for patients.

Lawyer Jose Maria Ochave, senior vice president at United Laboratories (Unilab), said the problem nowadays is that commercialization and the need to become price competitive are forcing pharmaceutical companies to sacrifice the quality of their medicines, to the detriment of the public.

“The fundamental problem with medicines is that the consumers, and even the doctors, cannot tell if the product is of good quality or not. You can only know it once you’ve taken the medicine. But what if it is life-saving, you could die, or something like a maintenance [drug], you would not know until you have diagnostic tests later on so it would take months for you to know,” Ochave, who is also a chemical engineer, told the BusinessMirror.

This, he said, is why vigilance of the pharmaceutical company (pharmaco) is very important. And pharmacovigilance*, Ochave stressed, should be end-to-end.

With lives at stake, trust should be established and maintained.

“When it comes to quality, we have to help the consumers and the doctors know whether the product is of good quality or not. There has to be certain indicators. It’s not like a pair of jeans or shoes that you can see immediately, so trust is very important in the pharmaceutical sector. The patient has to trust the doctor and doctor has to trust the medicine that he is prescribing to the patient,” Ochave said.

To ensure quality, the senior official of Unilab said pharmaceutical companies should look at the entire system because “there can be a failure of quality at every stage.”

This, he said, begins right at the source of the active pharmaceutical ingredients (APIs), or the raw materials.

“That has to come from a quality source, and when I say quality source, the company should be producing it in accordance with specifications and will not make shortcuts. So you as a [drug] manufacturer will have to inspect and will have to check also the source of the APIs. Then, when you do the finished formulation or what we call the formulations plan, that has to comply with what we call the current good manufacturing practices [CGMP],” Ochave said.

Food and drug administrations (FDA) in different countries including the United States strictly monitor the CGMP of pharmacos before they are allowed to sell their products.

According to the US FDA, the CGMP regulations for drugs contain minimum requirements for the methods, facilities and controls used in manufacturing, processing, and packing of a drug product.  The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for new drug and generic drug marketing applications includes a review of the manufacturer’s compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment and skills to manufacture the new drug for which it has applied for approval.   Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.

Ochave explained that for the use of equipment alone, the pharmaco needs to follow a cleaning protocol.

“You may be producing a product, let’s say for diabetes there and then later on you are producing a product for cardiovascular, so you don’t know if mixing or contamination will happen. Remember you are dealing with micro quantities, sometimes with milligrams and sometimes even at micrograms,” he said.

After that is warehousing. Ochave said pharmacos have to make sure that medicines are properly warehoused and that the storage temperature required for a particular medicine will not be exceeded because the stability of the product may be affected and certain compounds in it may deteriorate, particularly the APIs.

Next is the distribution. Ochave said firms should follow good distribution practices, which include not letting the temperature inside the vans exceed 40 degrees and that the products are properly handled during transit from the source to any part of the country.

Then at the pharmacy level, medicine manufacturers should also monitor if their partner-retailers are following the “good pharmacy practices.” The pharmacy, Ochave said, should have a pharmacist to properly assist the consumers and temperature-controlled facilities where the medicines are stored.

And finally, Ochave said pharmacovigilance should be continued even after the patient has taken the medicine.

“Once you have put it out to the market, you should monitor if there are what we call adverse events. Other companies don’t have the capability to do that and the patients are left to themselves. This is particularly true with small companies that are just importing their medicines. They don’t monitor, they do not have a complaint desk and don’t even have doctors in their plantilla,” he said.

This is the biggest problem in the industry today, Ochave stressed. “Some pharmaceutical companies just sell their products, which should not be the case. Quality should be ensured end-to-end, from the selection of the active pharmaceutical ingredients and other raw materials, the packaging materials, and the pharmacovigilance until the time the patient has taken it and you have monitored the effect on the patient.”

For imported medicines, Ochave said every batch should be tested. The problem, however, with companies that do not have the capability to conduct tests is that they just rely with the certificate of analysis of the manufacturer. “But we’ve had many instances when the certificate of analysis, when we tested it ourselves, the result would be different [from the claims in the certificate]. So if you buy from outside, you should have to have the capability to validate whatever is there in the certificate of analysis.”

This, he said, is particularly important today with the proliferation of fake medicines.  Aside from pharmacovigilance, Ochave said the country’s FDA should be strengthened.

The FDA, he said, is still the country’s first line of defense so ample resources should be given to it by the government because of its critical role.

“The FDA audits the facilities here. But as of now they are not able to audit the facilities outside. According to them they are going to start testing the facilities outside already. But now they don’t, which is unfortunate because in most countries, before you can export to their country, you need to be audited by their regulatory authority. That is true with the US, Europe, Japan and even in Africa. It is true in Mali and Uganda. So before you export to Uganda, their FDA authorities will come over to inspect your facilities. Unfortunately we don’t do that,” said Ochave.

With this, he said the public can only depend on the reliability of the pharmaceutical company, which is very tricky nowadays due to the practice called “licensing.” There are medicines that carry the names of the big manufacturers in their labels. However, these medicines were only manufactured by small companies through a licensing agreement.

Some importers, Ochave said, look around for small manufacturers that have the cheapest price. This makes the quality of their medicine questionable. The price, Ochave said, has to be so low because after the trader, the medicine will go through several middlemen before it reaches the retailers.

Some even source medicines from the so-called high-risk countries. “They [traders] will make sure they get it from a source that can produce it cheaply. This means there will be no capital investments, no proper air handling system, no sound equipment and the source of raw materials is not good.”

Fortunately for Filipino consumers, there are about 50 local pharmaceutical companies that can do end-to-end quality monitoring. The multinational companies also do strict monitoring, although they now mostly bring in imported medicines.

Around 45 percent of the medicines in the market, volume-wise, are produced locally. In terms of value, the share of local producers is about 35 percent.

Unilab, which is investing heavily for its manufacturing facilities, only imports about 10 percent of the medicines that it is selling in the market.

Ochave said consumers should only buy medicines from known manufacturers that maintain pharmacovigilance to safeguard the quality of their products.

“You cannot just do the buy-and-sell model for pharmaceuticals because you are dealing with people’s lives. It’s not like selling candies. You should have the technical competence to evaluate the products, inspect your outside sources, and invest in good facilities to manufacture the products. Also, the obligation of the pharmaceutical company does not end with the sale. It has to make sure the patient takes the right medicine and then monitor the effect of the medicine,” Ochave said.

 

*Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Program for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Center for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Program. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.—World Health Organization


In Photo: The Bayanihan mural seen behind United Laboratories (Unilab) Senior Vice President Jose Maria Ochave serves as the symbol of the company. The mural, a masterpiece of Filipino National Artist Carlos “Botong” Francisco and commissioned by Unilab founder Jose Y. Campos in 1962, is displayed at Unilab’s corporate headquarters in Mandaluyong City.


 

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