Health Transparency 13: MeTA International Visit to Manila

Last Wednesday, April 10, 2013, the International MeTA Secretariat (IMS) visited Manila to meet up with Medicines Transparency Alliance (MeTA) Philippines Council officers and members, and attend the MeTA Discussion Series on PhilHealth's primary care benefit (PCB) new packages. I am one of the members, that's why I was there.

The three visitors from IMS were Dr. Tim Reed, Executive Director, Health Action International (HAI), Ms. Renee Vasbiner, Administrative Coordinator - MeTA Secretariat, HAI, and Ms. Deirdre Dimancesco. Technical Officer, Medicines, Access and Rational Use, Department of Essential Medicines and Health Products, WHO HQ. 

Tim Reed here speaking during the meeting with MeTA Philippines members, headed by Chairman Roberto "Obet" Pagdanganan (former Bulacan Governor, former PITC President) and Ms. Cecile Sison, MeTA Secretary General. 

The morning meeting was mainly on internal matters, like updates on both the international and Philippines offices of MeTA. There was a brief discussion though on pharmacovigilance, presented by Dr. Mariano Lopez. It is a joint project by the Philippine College of Physicians (PCP), MeTA Philippines, and the Rotary Club of Manila, in coordination with the FDA. Gov. Obet is also the club President this rotary year 2012-13.

The plan is to conduct random drug tests from selected drugstores and hospital pharmacies in terms of drug quality and safety. Any anomaly that will be detected, FDA can quickly act. The results of the FDA laboratory test will be (1) shared among the hospital therapeutics committees to improve drug procurement on the basis of good quality drugs and/or; (2)announced to the general public with considerations for possible litigations and/or; (3)left to FDA’s discretion and regulation.

For me this is a good initiative. Civil society organizations like PCP, MeTA and some Rotary Clubs can and should initiate this kind of projects to further protect patients. One participant narrated that they conducted a similar pharmacovigilance survey in the past, and they encountered difficulty getting the support and cooperation of some government hospitals, especially those run by the LGUs. For instance, they discovered that in a provincial hospital in Bohol, an IV supplied to the hospital was improperly packaged in a mineral water bottle (!).

RUM 6: Pharmacovigilance and ADR

For many groups in the health sector in the Philippines or in many other countries, the main concern is medicine prices and access. While this is understandable on the important premise that drugs can heal, there is also a rather silent issue that drugs can also kill. And that is where concerns on rational use of medicines (RUM), substandard and counterfeit medicines, adverse drug reaction (ADR), anti-microbial resistance (AMR) and pharmacovigilance (PV) would come in.

It is not just cheaper medicines, free medicines, accessible medicines, that should be the focus of public healthcare. I have argued before that preventive healthcare is as important, if not more important, than curative healthcare. RUM and PV are among the important components of healthcare.

A physician friend, Dr. Kenneth Hartigan-Go, shared with me a short but useful article from Pharma IQ,  www.pharma-iq.com/, below. It describes five challenges and issues on PV focusing on Asia. I think the five challenges there are true. On #5 alone, medication errors resulting in ADR, I wrote about the case of my friend who has been suffering from 20 days of continued fever, body rashes, and how a misdiagnosis by the first doctor that they have consulted, the failure of the other doctors to see the problem, has resulted in prolonged pain and agony, and bigger expenses, for the patient and the family. See here,  Health Transparency 10: Physician Misdiagnosis, Dispensing Medicines.

After that article, I included a paper by Reiner Gloor posted in BusinessWorld last year, on PV, ADR and RUM.
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Asia Focus: Top 5 Challenges around Pharmacovigilance

There are several challenges around pharmacovigilance in Asia and perspectives are different for Industry, regulatory authorities, academia and healthcare professionals. Dr Deepa Arora MD, Global Head, Drug Safety & Risk Management at Lupin Limited, tells Pharma IQ what she considers to be the Top 5 most common challenges around pharmacovigilance in Asia.

Challenge 1: Poor availability of trained manpower and lack of systematic material to learn about pharmacovigilance are major issues faced in all sectors. The situation is consistently improving over thelast few years as some big projects have been awarded by MNCs to BPOs based in Asia, therefore, these BPOs have hired and trained staff in PV. Several institutes are also offering training courses in PV for beginners.

Challenge 2: The pharma industry in Asia expects detailed guidance from regulators and better harmonisation of regulations for pharmacovigilance. As regulatory authorities don’t have necessary manpower, this in turn leads to poor implementation of regulations, delays in planning and regulatory action.

Challenge 3: The safety of herbal drugs / allied medicine-herbal and herbo-mineral drugs are a challenge more specific to Asia than other regions due to the extensive usage of these drugs. Efforts are on-going to define the methodology for monitoring the safety of such drugs. Several regulatory-academia-industry workshops have been organised and extensive work has been done in collaboration with WHO.

Challenge 4: Like Western countries, challenges faced by the industry in Asia include poor reporting and poor quality of spontaneous reports. A lack of awareness regarding PV amongst healthcare professionals and consumers is a major issue and probably the most important target for improvement, as growing awareness amongst healthcare professionals and consumers is likely to result in a significant improvement in overall implementation of PV by all sectors, especially regulatory authority and Pharma industry.

Challenge 5: Medication errors are an important cause of adverse reactions resulting in significant morbidity and mortality. Due to poor reporting, it is quite difficult to estimate the extent of medication errors in Asian countries. Various forums are being used to increase the awareness of HCPs regarding the importance of collection of ADR data.

Health Transparency 9: Physician Misdiagnosis, Dispensing Medicines

Note: I originally posted this last Monday, expanding this today to include some updates...
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July 16, 2012

I posted this last night in my facebook wall to help a friend of mine....

Seeking advice from lawyers and physicians: A good friend of mine has been sick, almost 3 weeks fever, they consulted 3 physicians, they all gave different diagnosis. A 4th doctor said he shd be confined. The family felt robbed by the 3 previous doctors. Any remedial action?

A friend commented why sue doctors for having different opinions. I replied that suing a doctor is a last resort due to the high costs and legal hassles involved. That is why I was asking other remedial measures/actions. For now, the immediate concern is how the patient can recover, 19 days of fever. They hope the 5th doctor can give a more correct diagnosis.

This is how the disease has dragged on, as narrated to me by the wife of the patient. Well, she's my friend too.

July 4, wife bought him to The Medical City Satellite clinic in Antipolo. Had fever for about 3-4 days already. Doctor advised him to have CBC, urine test, Xray. After 30 mins the 2 tests were released and he was asked to take antibiotics for his UTI. He was asked if he has allergies, there is none. Next day, wife took the XRay results.

Patient still suffering from high fever, brought him back to TMC clinic. Again cbc tests, but doctor had an emergency and results was never read. Wife had limited money at that time, was told another doctor can see them but then she/he will ask for another consultation fee. Wife got pissed because they already paid the previous doctor w/o prescribing them and interpreting the tests results.

So they looked for another doctor in a different clinic. Come Sunday, rashes in the patient's body mostly from tummy. And still suffering from fever. Wife thought those rashes were reaction from the Med he was taking.

Come Monday they went to Clinica Antipolo and decided to have another blood tests before seeing new doctor. Wife explained to the doctor what transpired in their consultation at TMC Clinic. Gave her all the previous and present tests results . And the rashes have come out almost all of his body. Doctor said those were measles. She advised wife to stop giving patient those antibiotics and instead to take Vitamin C with Zinc and Paracetamol if with fever.

The fever continued and so paracetamol was given to him every 4 hours. Last Friday, wife noticed that in his personal urinal, he only peed few from the previous night. So come Saturday monitored all his water intake and his Urine. From the 5 glasses that he drunk the whole day he ony peed only about half glass.

Wife was alarmed, called up his doctor that told them earlier that it was measles, advised them to have another urine and blood tests. At this time, patient was already weak and manas na sya. So after results was released this morning, new doctor from Clinica Antipolo advised her to confine the patient. New doctor said that those rashes weren't measles but instead Stevens-Johnson, wife was shocked.

Two of my friends made these observations:

1. Erwin, a physician: "Mukhang nag ACUTE RENAL FAILURE."
2. Arnel, a lawyer: "If legal remedy, none, based on the facts; consultation lang naman, at humingi ka ng second opinion."

I thanked them and others who pitched in short advice.
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July 20, 2012

The wife posted this yesterday in facebook, patient still in the hospital:

Confirmed he's suffering from Stevens Johnson. His case is a severe allergic reaction from taking antibiotics. He is now under close supervision from his 2 doctors....


The steroids made him awake for more than 24 hours. And so we ask the doctors to give remedy for his being awake. He had his 8-hour seep after given half of the sleeping pills. The first time I've seen him sound asleep. I enjoyed my sleep too :-)


Finally, he was able to eat his complete meal. No more struggling from pains, no more fever. I think he is on his way to recovery :-)

So it's a clear misdiagnosis or medication error by the first doctor from The Medical City who prescribed the antibiotics. Perhaps if the same doctor saw the patient the next day, he could have advised to discontinue the antibiotics but as the wife narrated above, that doctor attended to an emergency case of another patient.

Adverse drug reaction (ADR) is an important issue in healthcare and pharmacovigilance. Drugs can heal, but drugs can also kill. I briefly wrote about it here,  Counterfeit Drugs 4: Drugs Can Kill.