Friday, July 20, 2012

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,, 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.

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.

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Advocating patient safety

February 25, 2011
Medicine Cabinet -- By Reiner W. Gloor

Medicines, apples, oranges and a pair of shoes -- which does not belong to the group? This was how Dr. Shanthi Pal, acting program manager of the World Health Organization’s (WHO) Pharmacovigilance Programme in Geneva, opened her lecture in Manila recently.

During the forum entitled "Patient Safety: The role of medicines management and the WHO strategies," Dr. Shanthi said that the medicine, not the pair of shoes as many thought, was the one that was out of place. She explained that the nature of medicines is that it saves lives. While the forum organized by the Asian Institute of Management was participated in mostly by government regulatory officers and health care professionals, Dr. Shanthi stressed that public understanding of pharmacovigilance is crucial. She said that public education about pharmacovigilance will improve people’s "respect" for medicines and compliance towards treatment. No medicine is risk free.

Pharmacovigilance (PV), as discussed in an earlier column, is the science relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The WHO also stated that PV is a vigilant assessment of the risks and benefits of medicines which applies throughout the life cycle of a medicine from the pre-approval stage until the time they are already approved and being used by the patients.

As a backgrounder, the R&D (research and development) process involves pre-clinical testing and the three phases of actual clinical trials in humans. During clinical trials, up to 5,000 volunteers from different countries are needed to establish that a drug produces the desired effects as well as note any side effects. Continually monitoring medicines after the manufacturing stage will establish new and emerging safety and efficacy data.
One of the purposes of pharmacovigilance is to detect adverse drug reactions (ADR) or the unintended harmful reactions to medicines that occur at doses normally used for treatment.

Dr. Shanthi explained that ADRs could be due to the pharmacological characteristics of the medicine or in some cases, it might be some type of a genetic predisposition. It could also be dose related, or due to an interaction with another medicine including traditional medicines, some types of foods, or due to contaminants or irrational use (not complying with the prescribed dose).

The good news is that many of the ADRs are preventable. Therefore, consulting a physician before taking a medicine is one practical step to lessen the risk of ADRs.

Pharmacovigilance and medicine surveillance are tasks that the pharmaceutical industry take seriously. PHAP member companies have established monitoring and reporting systems to ensure careful patient monitoring and scientific data collection. This is also true for medicines for children where there are fewer available clinical trial studies than on adults.

Meanwhile, factors such as globalization, consumerism, the explosion in free trade and communication across borders and the increasing use of the Internet have given rise to new kinds of medicine safety issues, said the WHO.

With existing and emerging challenges, the WHO Programme for International Drug Monitoring provides a center for member states to collaborate in the monitoring of drug safety around the globe. Since 1978, the Programme has been carried out by the Uppsala Monitoring Centre (UMC) in Sweden. As of this writing, 6.2 million reports have been received from designated National Center for Pharmacovigilance from various member countries. This central database is aimed at helping in the work of national drug regulatory authorities, improve the safety profile of medicines and help avoid further disasters. In the Philippines, various initiatives have been undertaken to improve patient safety. The Department of Health has recently issued a Memorandum directing retained hospitals to orient health workers about the need to report any suspected ADRs. Serious ADRs must be reported within 24 to 72 hours, the memo said.

Moreover, the FDA has launched a public reporting program where patients could report ADRs to hotline numbers 807-8275 and 0909-2080500. A link on the FDA (Food and Drug Administration) Web site also directs us to the National Pharmacovigilance Center’s Adverse Drug Reactions Online Reporting System (

The Safe Medicines Network, a multi-stakeholder alliance advocating patient safety where PHAP is a member, likewise receives reports via 1-800-10-FAKEMED.

PV is not only a concern of the government, health care professionals and the pharmaceutical industry. For PV to work, the public must be involved in reporting.

See also:
RUM 1: Reducing Medicine Abuse, January 25, 2012
RUM 2: SARAH, Drug Dependence, January 30, 2012
RUM 3: On Combining Drug Molecules and Alaxan FR, February 03, 2012
RUM 4: Dealing with Drug-Resistant Diseases, April 24, 2012
RUM 5- Cheaper Medicines and AMR, May 08, 2012

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