RUM 7: Leptospirosis and Doxycycline

Leptospirosis and other water-borne diseases are very common during heavy flooding where tens or even hundreds of thousands of houses are submerged in water. People have no option but to walk in dirty waters and hence, risk getting any of these diseases.

Like treating infectious and pediatric diseases, I grant that there is government role in dealing with this kind of disease outbreak. I am no health anarchist, unlike some other shades of free marketers. I post below two articles, one a DOH advisory posted in facebook today, the potentials of doxycycline in dealing with lepto and related diseases, but also its limits. There is rational use of medicines (RUM) here, it cannot be used by (a) pregnant women, (b) children below 8 years old, and according to wiki, (c) "taking doxycycline with food and dairy products may decrease the amount of medication absorbed."

I am also posting portions of Reiner Gloor's article on the subject, to show healthcare-based civil society role in dealing with this and related diseases.

(1) DOH Advises Public on Drug Prices

Press Release - 12 August 2012
by Department of Health (Philippines) on Sunday, August 12, 2012 at 8:34am ·

Health Secretary Enrique T. Ona today provided some pointers for the general public in purchasing doxycycline and other drugs and medicines, in the light of the expected surge in leptospirosis and other diseases due to flooding caused by the southwest monsoon.

“We want the public to be able to make informed decisions and get the best prices on doxycycline and other drugs and medicines”, Ona said.

Doxycycline is an antibiotic that is currently recommended to prevent leptospirosis among those with increased risk of exposure.

The Department of Health has already distributed free doxycycline for rescue and relief teams and residents in evacuation centers. Individuals with similar risk should consult a physician prior to intake.

However, doxycycline does not totally protect against leptosirosis. "Those who will develop fever even after taking doxycycline should go to their doctor for examination. Doxycyclin is not recommended for pregnant women and children below eight years of age," Ona explained....

At present, the price of generic doxycycline 100 mg capsules varies from P2.00 to P 15.00 depending on the manufacturer. Generic doxycycline 100 mg capsules are available in government hospital drugstores and commercial drugstores.


(2) Health during disasters

Medicine Cabinet -- Reiner Gloor
Posted on 05:55 PM, August 09, 2012
http://www.bworldonline.com/weekender/content.php?id=56533

RECENT extreme weather disturbances have recently resulted in loss in lives and property in Metro Manila and the rest of Luzon.

The Pharmaceutical and Healthcare Association of the Philippines (PHAP), through the PHAPCares Foundation, earlier called on its members to again extend help to victims of massive floods in Metro Manila and affected Luzon provinces. Last week, the PHAPCares Foundation turned over P500,000 worth of medicines to National Disaster Risk Reduction and Management Council (NDRMMC). In coordination with our government partners, we intend to roll out a medicine donation caravan to assist the disaster victims....

Realizing that people are physically and emotionally vulnerable to health risks during calamities, PHAP, through the PHAPCares Foundation, signed a Memorandum of Agreement (MoA) with the NDRRMC to renew the industry commitment to provide needed medicines during calamities. The aim of the "Gamot Agad Program" is to deliver essential and life-saving medicines to victims at the quickest possible time alongside the other equally crucial relief items such as food, water and blankets.

Under the MoA, industry members will provide the government P50 million, or P10 million annually, for the next five years worth of life-saving medicines for use during disasters and emergencies.

Dr. Posadas said that common medicines needed during these times are those that afford remedies to common ailments such as anti-pyretic/analgesic/anti-inflammatory medicines, decongestants and expectorants, anti-diarrheal/oral rehydrating solutions, antibiotics and topical medicines for wounds.

One common rule to remember is that medicines should be kept in a secure container that will shield them against the elements. One simple way is to put these medicines in a plastic container, tightly sealed to protect the medicines, especially from moisture and dirt. Aside from the medicines, some basic medications for wounds like alcohol, hydrogen peroxide, betadine, cotton, scissors, dressing tape, gauze, topical antibiotics and elastic bandage are useful....
--------

See also:
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
RUM 6: Pharmacovigilance and ADR, 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,  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.
------------

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.

RUM 5- Cheaper Medicines and AMR

Getting cheap, if not free, medicines and vaccines is a primacy concern for many people, especially the poor. And understandably so. But people seldom realize that while drugs can heal, they can also kill -- via non-rational use of medicines (RUM) and its variants: non-rational storage, non-disposal of possibly expired or ineffective medicines. And one adverse health outcome due to non-RUM is the development of anti-microbial resistance (AMR).

Below are some discussion papers about proper use, care, storage, and disposal of medicines. One from the  World Health Organization (WHO) and three from Reiner Gloor, PHAP Executive Director, in his columns in BusinessWorld (www.bworldonline.com) last year.

1. Antimicrobial resistance -- from WHO
2. Disposing medicines -- from Reiner Gloor
3. Storing medicines
4. Ensuring patient safety

Enjoy reading.
------------

(1) Antimicrobial resistance
http://www.who.int/mediacentre/factsheets/fs194/en/

Fact sheet N°194
Reviewed March 2012

Key facts

* Infections caused by resistant microorganisms often fail to respond to conventional treatment, resulting in prolonged illness and greater risk of death.
* About 440 000 new cases of multidrug-resistant tuberculosis (MDR-TB) emerge annually, causing at least 150 000 deaths.
* Resistance to earlier generation antimalarial medicines such as chloroquine and sulfadoxine-pyrimethamine is widespread in most malaria-endemic countries.
* A high percentage of hospital-acquired infections are caused by highly resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).
* Inappropriate and irrational use of antimicrobial medicines provides favourable conditions for resistant microorganisms to emerge, spread and persist.

What is antimicrobial resistance?

Antimicrobial resistance (AMR) is resistance of a microorganism to an antimicrobial medicine to which it was previously sensitive. Resistant organisms (they include bacteria, viruses and some parasites) are able to withstand attack by antimicrobial medicines, such as antibiotics, antivirals, and antimalarials, so that standard treatments become ineffective and infections persist and may spread to others. AMR is a consequence of the use, particularly the misuse, of antimicrobial medicines and develops when a microorganism mutates or acquires a resistance gene.....


(2) Disposing medicines

Medicine Cabinet -- By Reiner W. Gloor
May 6, 2011

Medicines offer a promise to provide prevention, management and cure for simple to complex illnesses. Many of us find it necessary to take some personal medicines at home. But when the time comes when medicines are no longer needed, disposing them properly is important to avoid causing unnecessary harm to people, animals, food supply chain and the environment.

Proper medicine storage is as important as its proper disposal. The same applies to antibiotics, which inappropriate and irrational use lead to anti-microbial resistance (AMR).

One of the industry medical directors, Dr. Luis Abola of Bayer said that patients must not self-medicate to avoid developing AMR.

Storing leftover antibiotics even after the course of treatment is completed increases the chances of self-medication the next time around.

A number of safe methods for safe disposal of medicines were outlined by the WHO (World Health Organization) Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies. Developed in 1999, the document stressed that the improper disposal of medicines may be hazardous if it leads to contamination of water supplies or local sources used by nearby communities or wildlife.

If medicines are not disposed properly, they may end up with scavengers, children and animals or may even be diverted to the market for resale and misuse.

In the Philippines, the proper disposal of medicines became an issue when expired products were found buried in a provincial government compound in 1999. About 26 kinds of medicines were reportedly dug up in a 10-foot-deep pit in the engineering office compound in a northern province.

Earlier, the Department of Health (DoH) and the Department of Natural Resources (DENR) produced the Health Care Waste Management Manual with the goal of minimizing health and environmental concerns associated with the disposal of unneeded medicines, among others.

RUM 2: SARAH, Drug Dependence

(This is the continuation of my notes on the DOH consultation meeting with consumers and civil society groups on rational use of medicines (RUM), see RUM 1: Reducing Medicine Abuse which I posted last January 25.)

Ms. Marianne Dioso, also of NCPAM, presented the SARAH approach in the PMP:

Safety and effectivity of medicines,
Affordable and accessible,
Rational use of medicines,
Accountability and transparency of health players, and
Healthcare systems that are adequate.

She started with a quote from Dr. Alran Bengzon, a former DOH Secretary, saying that drugs and medicines are the key component of the Philippine healthcare system. Then showed these data:

- P124 billion pharmaceuticals market (2010)
- 40 percent of total health expenditures
- 30 percent of PhilHealth reimbursements
- 10 percent of DOH budget
- 10 to 12 percent of total pharma market accounted for by the public sector
- 70 percent of the P124 is accounted for the MNCs by value, and 60 percent by the national companies (NCs) by volume.

It is true that there is both demand and supply of high medicine use, from both the patients and physicians, but not in all cases. Some patients and physicians emphasize preventive healthcare like having the proper and nutritious diet and non-sedentary lifestyle, to take medicines only when really necessary, like when the disease is spreading fast.

The FDA is monitoring not only good manufacturing practices (GMP), but also good storage (GSP) and good distribution practices (GDP). There is also the "generics only" prescription policy in the public sector, covering physicians in government hospitals and clinics. And FDA will have a "generics fast lane" to fast track the entry of more new generic players.

RUM also covers antimicrobial resistance (AMR) program, truthfulness in medicines promotion, prescription audits, rational prescribing and dispensing guidelines.

RUM 1: Reducing Medicine Abuse

I am starting a new thread in healthcare, the "rational use of medicines" or RUM. This will be the 7th thread or sub-topic under health topics in this blog. The other 6 and their latest issues are:

1. Drug Price Control 24: Forcing Drug Firms to Report Payment to Doctors, January 24, 2012
2. PhilHealth Watch 11: Hospital Bill Deductions (b), January 19, 2012
3. Lifestyle Diseases 14: Transformative Education on Health, January 18, 2012
4. IPR and Medicines 20: Scherer Paper on Pharmaceuticals R&D, January 12, 2012
5. Healthcare Competition 14: Centralization vs. Deregulation of Healthcare, December 31, 2011
6. Generic Drugs Asia 4: Vaccines from China, November 29, 2011

The reason why I open a new thread on RUM is because I attended the DOH Consultative Meeting on the National Framework on Rational Use of Medicines (NaFRUM), Consumer Group, yesterday at the DOH compound. The DOH is planning to issue a new Administrative Order (AO) on RUM, and they are doing a consultative meeting for various sectors (academe, government agencies, pharma industry, hospitals and drugstores, consumer groups).

I was actually curious what's this new initiative by the DOH, why another AO, can't this subject be not implemented under existing programs? That is why I attended the consultation. Almost all participants who came yesterday were also from member-NGOs of the Coalition for Health Advocacy and Transparency (CHAT). Like leaders from HealthWatch and MeTA-Philippines (former Gov. Obet Pagdanganan, Cecile Sison), COPA, Botika Binhi, AltHealth, Woman Health, Kilos Damit, HAIN, etc.

The event was organized by the National Center for Pharmaceutical Access and Management (NCPAM), the lead agency under the DOH in implementing the Philippine Medicines Policy (PMP), like generics promotion, Botika ng Barangay (BnB) or village pharmacy, P100 or Compact Treatment program, drug price control and related programs and policies.

New NCPAM Director, Dr. Ma. Virginia Ala, MD, Director IV, gave the opening and welcome message. She mentioned some pathetic sights like so many softdrinks in elementary kids' canteen and diet, junk and fatty/preserved foods on toddlers and children's diet, which are  unhealthy food and contribute to future diseases someday, which will require new medicines and other treatment. That was a good observation by Dr. Ala. She bolstered my repeated argument: healthcare is first and foremost, personal and parental/guardian responsibility, secondarily as government responsibility. I believe that government should come in only in controlling infectious and communicable diseases, in treating  pediatric diseases, and helping people with mental and physical disabilities because the treatment and theraphy for such conditions are usually very high and expensive.

Dr. Irene Farinas of NCPAM gave an overview about their office and its major activities, as well as some facts on Philippine health and pharmaceutical situation. Here are some interesting facts (at least for me) that she shared:

1. Drug price control via maximum retail price (MRP) -- but the illegal terms and concepts GMAP and MDRP are still used by the DOH -- is now a regular (and long-term?) policy under "Affordable medicines" program.

2. Lots of interventions to keep drug prices as low as possible, some to be given out free as regular entitlements for the poor. Such interventions aside from MRP are the BnB, mandatory 20 percent discounts for senior citizens (RA 9994), generics promotion, etc.

I have argued in the past in this blog that drug price control policy -- forcing the more popular, more saleable branded drugs by the innovator and MNC companies to become -- contradicts and defeats the generics promotion policy, as people shift from the lesser known generics to the more popular innovator branded drugs. The DOH never took notice of this. Or they may, but the politics behind such policy declaration in 2009 has overtaken it and the politics of the current administration still prevails to keep that wrong policy.

3. BnB is a popular program that contributed to cheaper and more accessible medicines in more barangays or villages nationwide. Here are the relevant slides she presented.

But the program is also problematic not only in terms of maintenance but also because it is easily hijacked by the local politicians during elections. Now there are 16,350 BnBs nationwide (as of June 30, 2011) that cost the DOH P567 million so far, and there are variants, like Botika ng Manggagawa (workers' pharmacy), Botika ng Taumbayan (people's pharmacy). Seed capital is P50,000 per outlet, targetting 100 outlets or P5M.

4. The P100 or Compact Treatment program is tied up to the DSWD's 4Ps or conditional cash transfer (CCT) program, provided the poor are registed with the DSWD and are PhilHealth member under the sponsored program.

Makes one think, it really pays to remain poor forever for some people: free cash, free PhilHealth membership, super-subsidized medicines, free education, subsidized housing, etc. And since these programs have no titmetable, they are forever programs, why aspire to get out of poverty? Or why not pretend to be poor even if actual income has actually increased? But I digress....

5. Entitlement (or free) medicines program, at least for fixed number of beneficiaries: leukemia (ALL-L2), breast cancer (stages 1 and 2), anti-rabies, Vitamin A for pregnant women, TB (AFB smear, insulin (for diabetics), Fluids (for DOH hospitals), Valsartan (for hypertensive), Rotavirus (for 0-6 months old babies), BEMONC (for women of reproductive age).

6. Outpatient benefits (OPB) will soon be shouldered by PhilHealth, by 2016. This will be both good news and bad news. The good news is that all members, not just the sponsored or indigent group, will be covered by OPB; the bad news is that this will most likely require more or higher monthly contribution, both employers and employees.

These are the additional entitlement medicines. They will not just be "cheaper medicines" but "free medicines", for certain diseases.

7. Electronic drug price monitoring system (EDPMS), forcing drugstores, chain or non-chain, to regularly upload their drug prices to the DOH's EDP, to enable the consumers to compare prices of drugs among competing drugstores and pharmacies. I think this is cool, if the cost of compliance is low. If compliance cost is high, say for the small chain (2-3 stores) or single drugstores with a non-computerized system, this requirement means additional cost which they will have to pass on to the consumers, resulting in higher drug prices. The website of the EDPMS is http://uhmis.doh.gov.ph/eedpms.

In a free market situation, sellers develop their own brand and corporate image. Say drugstore chain A is very clean, all outlets are air-con, in strategic places and corner stores, have licensed pharmacists all the time, etc., and their drug prices are generally high. Drugstore chain B is also clean, all outlets are air-con, in malls, and their prices are a bit lower or higher than A. Drugstore chain C have cheap drugs but their outlets are non-air con, in less convenient areas, the staff may not be licensed pharmacists, etc. And so on. So people and consumers can expect certain drug prices even without checking the DOH's EDP and the internet. There is a tradeoff between drug prices and convenience, of being in a good brand or lesser-known brand drugstore.

There was a discussion and exchange after Dr. Farinas' presentation. Gov. Obet asked what constitutes "generic medicines" and "branded medicines". I followed it up by asking if all products of Unilab for instance, a domestic generic manufacturer, can be considered as "branded medicines" since all their products have brands (Biogesic and Tempra for paracetamol, for instance). NCPAM guys said Yes.

I shared what I learned from Lyle Morrel of Watsons, and from Joey Ochave of Unilab, that there are 3 types of generic drugs in the Philippines:

a. product-branded generics
b. company-branded generics
c. generic-generics.

Examples of (a) are Biogesic, Tempra, etc. (for paracetamol)
Examples of (b) are RiteMed, "Unilab yan", "Pharex yan", "Alagang Pfizer", etc.
(c) would have no product brand, only the name of the molecule, and a small label for the name of the manufacturer, its address, etc.

The Generics Law of 1988 actually referred to (c) only and would consider (a) and (b) as belonging to "branded medicines" already. The (c) constitutes a very small portion of Philippine pharmaceutical products, perhaps just 5 percent, or even less.

The discussion later shifted to lifestyle diseases. I am happy to hear that more NGO leaders now realize the need to focus on preventive healthcare as the bulk of DOH and LGUs' health activities are focused on treatment and curative healthcare. People are sick of various diseases,  government instantly think of medicines and how to make them more affordable, more accessible.

(To be Continued...)

Counterfeit Drugs 4: Drugs Can Kill

(Note: this is my article yesterday at thelobbyist.biz)

Drugs and medicines are among the highly emotional and political commodities in any society because they are associated with people’s health, People almost always look at drugs as compounds or substances that can heal or cure them from their illness. Thus, the endless political intrusion in drug pricing, trading and manufacturing in many countries.

But do many people realize that while drugs can heal, drugs can also kill?

There are many ways that drugs can kill, directly or indirectly.

One is when patients take counterfeit or substandard medicines. The counterfeits are those that do not contain the necessary ingredients and hence, cannot deliver the substances to control or kill a particular disease. Substandard drugs are those that contain the sufficient ingredients but at insufficient amount, usually below 80 percent of the required active pharmaceutical ingredients. When patients take these drugs, the virus, bacteria, or other disease molecules in their body either multiply or evolve to something more serious or more deadly. As days pass by, either the patient does not get well, or becomes even more sickly.

Two is when patients take the correct, non-fake, and manufactured at good standard drugs, but mis-stored and mis-handled, reducing their efficacy and safety. For instance, drugs that should be stored at 20 to 30 deg. C at all times, when brought to a place at 31 C or warmer for an extended period of time, will lose their full efficacy and safety. These drugs may deliver the same negative result as taking the fake or substandard ones.

Three is when there is irrational drug use. When patients self-medicate and take just any drugs that they heard from other people or saw in tv or billboard advertising, without professional supervision by a pharmacist or a physician. This case happens more often if drugs are given away for free or are sold cheaply. So patients may take the wrong drugs, or the right drugs but at the wrong dosage, and so on.

Four is when patients take expired drugs and hence, have almost zero efficacy and are unsafe. These drugs may be in some cabinet in the house for a long time, or given away for free by some local government units but the drugs are not well-supervised and monitored by professional pharmacists. There have been reports where useful drugs, expired drugs, cockroach, garbage and other dirty materials are mixed up in one room with no temperature control by some municipal or city or provincial pharmacies.

Five is when patients take drugs that are well-stored, well-handled, produced at good manufacturing practices, but were developed in other countries and continents. The various clinical trials have been conducted on people from the tropics or poorer countries in the temperate zones, the trials produced good results, but may have harmful results on patients in the northern hemisphere and richer countries. This is a tricky subject, and there is a long discussion about this at Deadly Medicines. I suggest that readers visit that article.

There should be other factors that can contribute to “drugs can kill” cases. That phrase actually came from a Filipino pharmacist friend who emphasized the importance of professional supervision by trained pharmacists and physicians when people are sick.

So the next time we are sick, we should not take just any drugs that we heard from friends or we saw on tv or newspaper or billboard ads. Perhaps we may not need drugs at all, perhaps we may need only more rest, more water, and less or zero undesirable food and drinks that can trigger some adverse health results in our body. Seeking health professionals’ advice and maintaining healthy lifestyle will produce better health outcome, than just taking any drugs, even if these drugs are priced very low or given away for free.
--------

See also:
Counterfeit Drugs 1: On the Growing Fake Drugs Worldwide, December 21, 2007
Counterfeit Drugs 2: IPN Report on Fake Drugs in Poor Countries, May 29, 2009
Counterfeit Drugs 3: The SCLD, RA 8203, June 04, 2009