CAN THE BASICS ASSIST IN ALLEVIATINGMEDICINES AND MEDICAL SUPPLIES SHORTAGE BEING FACED BY MALAWI?

The issue of medicines and medical supplies (pharmaceuticals) shortage in our beloved country does not need introduction any more as many of us are aware. With most of the population relying on the public health system for their health care need, the government in general takes much of the blame as it has the responsibility of ensuring that all our social needs including health care are met. Central Medical Stores (CMS) being the institution charged with the responsibility of providing pharmaceuticals to the public health facilities is also mostly blamed. Whilst agreeing to the fact that CMS currently is facing a huge burden to meet this daunting task, I would want us to think of going to the basics of our pharmaceuticals supply line and concentrate on the basics and see if they can be of assistance to alleviating this problem.

Just like any other commodity, the principle of demand versus supply also applies to pharmaceuticals. From the introduction, I would probably be right that the concentration has been on supply and less if any on the demand side. In our country, pharmaceutical utilization audits are non-existent as such the utilization of the scarce precious resource cannot be ascertained. All we know is that our country procured pharmaceuticals worth so much as a result.

Malawi as a country has got an Essential Medicines List (MEML) which was updated in 2009. This list has over 300 products in it classified according to: (i) level of use as H (health centre), D (district hospital) and C (central hospital); (ii) therapeutic priority as V (vital), E (essential) and N (non-essential); and (iii) procurement priority as A and B. In this list however, all non-essential medicines were removed. I do not have to go into the nifty gritty of these categorizations but I would want to mention that various combinations can be made like HVA, HEA, DVA, DVB, DEA, DEB, CVA, CVB, CEA, CEB etc. Thus from a supply point of view, the last categorization holds a very crucial key and thus I put some details to it.

This categorization specifies how CMS and the public health care facilities will procure pharmaceuticals. Class A-list items are those ones required for large numbers of patients or clients and this includes all health centre level medicines. These routinely will be procured and stored by CMS for distribution. Class B-list items are those generally required for a limited number of patients or clients. These are not routinely procured and stocked by CMS and annual estimates and advance payment from individual user units are supposed to be made to CMS for supply. Currently, the supply line policy gives responsibility to the user units to make ultimate decision as to which products to select and/or procure for their own use and as such the categorization made in the MEML is supposed to aid that process.

The policy makers anticipated the challenge of funding and hence proposed that where funds are limiting then priority should be given to VA (vital and A-list) items. The situation of late does not seem to suggest that this is being implemented to the later as there are very critical shortages of all classes of medicines. This raises many questions than answers and probably that is why much of the blame is pushed to these two entities. As a stop gap measure probably, government also allows District Health Offices and Central Hospitals to procure from private suppliers upon acquiring an approval of such. Whether this stop gap measure is benefitting Malawians at large is not the subject of discussion now.

Against this background I would want to suggest the following; firstly, CMS should prioritize the procurement of VA-items as a matter of urgency. This is a very basic issue in our supply policy and through its total implementation we will ensure that the health care need of most Malawians is met. Second, government should make a deliberate policy which will allow Central Hospitals procure C-level medicines on their own from private suppliers following current good procurement practices (cGPP) and applicable procurement laws and regulations of Malawi. This will also free some funds from CMS which can then be utilized to take the first suggestion. It is much easier to exercise control over the four central hospitals than to control all the district health offices and central hospitals as is the case currently. And in addition, medicines utilization audits should instituted and/or supported in our health facilities which will ascertain the appropriateness of medicine utilization thus ensuring transparency and accountability.

MEDICINES AND DRUGS ARE TOO EXPENSIVE: Developing Countries are Being Cheated by International Pharmaceutical Giants

by David Kulemela

Read the heading on the poster inviting people to come and enjoy the heated up public debate between the final year Bachelor of Pharmacy (Hons.) students of the College of Medicine, who were for the motion and Professor John Reid, Regius Professor of Medicine, University of Glasgow in the United Kingdom on 11th February 2009. Indeed, the debate proved time worth as both sides had convincing and compelling arguments but at the end of it all it was for the audience to judge who was more compelling of the two. I would forgive the professor, he was alone. Despite trying to buy the audience’s vote he did not succeed (joking! Idzangobwera ACB). The students had technology on their side (powerpoint).

Here is how the two presented their arguments;
The Students [represented by Collins Minyaliwa and Lumbani Makwakwa (no need for salutations (Mr) since they are all male in their class! No offence.)]

i. INTRODUCTION
• Medicines improve, extend and save lives
• A well-functioning health system ensures equitable access to essential medicines of assured quality, efficacy, safety & cost-effectiveness.
• But this is far from being achieved in developing countries. For large sections of the global population essential medicines, even if available, are unaffordable

ii. PATENTS
• Patents are temporary monopolies granted by government.
• Too long- under international rules patents are granted for a minimum of 20yrs.
• Drugs are still high even after patent period is over
• Patents cannot generate innovations where there is no market e.g. only 13 of 1393 new drugs developed between 1975 – 99 are for Tropical diseases.
• If patented medicines are too expensive, developing countries must be supported to use safeguards in the TRIPS agreement to produce or import lower-priced
• The purpose of drugs is to help those people who need them but unfortunately being in a capitalist environment profits come before people's lives
• Patents are just a sign of GREED, infact the profit motive by pharmaceutical companies is UNETHICAL…people are dying

iii. CLINICAL TRIALS
• Clinical trials, even though usually the most expensive part of bringing a drug to market, most are done in developing countries and in animals;
- free
- no insurance for volunteers
- No strict policy
• Yet when drugs are developed the developing-country partners are charged alot
• Research and development is not geared towards the needs of people in poor countries.
• Drugs and diagnostic tools are being developed on the basis of their future market potential rather than on patients’ needs.
• 1% of all drugs in the last 30 yrs were developed for tropical diseases (- toxic and resistance)

iv. CONCLUSION
• Every human being has a right to access essential medicines and to live with dignity. Food and medicines constitute the basic necessities for the survival of the humanity
• The war on life-threatening diseases can be considered as much significant as the war on terrorism itself
• Poor countries should be allowed to bypass patents for concerns in relations to public health
• Developing countries as partners in development of new drugs should have access to cheap medicines as benefit for offering free participation in clinical trials.

"More than 90% of all death and suffering from infectious diseases occurs in the developing world," (James Orbinski, president MSF)

THANK YOU!

Professor Reid
In his argument which dwelt on drug search and clinical trials he said that it was an expensive process on which big pharmas spend millions of dollars. As such patents were the only way that they would be ensured of recovering these funds for further investment in new drug search. As such the big pharmas in his opinion were justified and that patents as far as his knowledge was concerned were for about ten years.

The Audience
The audience was given an opportunity also to contribute and almost all the contributions were against the big pharmas. Some of the arguments raised were; the margin of profit realised by the big pharmas, availability of alternative drug development methods like combinatorial which would reduce development costs if utilised, ethical issues surrounding profits realised by the big pharmas.

Then a vote was cast in which those in favour of the motion won after both sides were given time to summarise their arguments.

NB: Professor Reid’s arguments were summarised by the author but the student’s arguments are original as presented.

IMPROVING ACCESS TO MEDICINES USING THE PRIVATE SECTOR, AN INNOVATION THAT MALAWI HAS NEVER TRIED.

by David Kulemela

Most Malawians especially in the rural areas rely on the public facilities to access health care services. This pose a very big challenge to both the government and the people themselves; the government has to pump in very big chunk of its budgeted money into health while the people have to often travel some distance before they get to a facility and to get the required treatment (usually medicines) is another. In the 2008/09 budget, Malawi government allocated mk31.4 billion to the health sector which was the second largest allocation in the budget. In the recent years, generally there has been improvements in the public health sector medicines availability which has also resulted in people easily accessing them. This does not mean that the role other non-formal players in the health sector has to be overlooked.

Malawi, like many developing countries, most people access their medicines from retail drug sellers, which constitute the largest group of recognized (although often unaccredited and unregulated) outlets for non-prescription drugs. Though care-seeking patterns differ according to culture, geography, wealth and health condition often people buy medicines from the most convenient source. Pharmacies and drug stores and private clinics are mostly found in urban centres, leaving the rural lacking and vulnerable. The availability of many retail drug sellers illustrates the potentially broad impact of improving the quality of products and services in retail drug outlets can have in order to ensure access to essential medicines. The retail drug sellers are largely untrained and therefore customers are not counseled on or sold the proper medicines, dosages or quantity to effectively treat common ailments including malaria.

The vast potential that could be exploited in partnering with these retail drug sellers is an area that Malawi has not tried out unless I am to be corrected. Considering the fact that the country has few pharmacists, who are recognized as the only cadre who can run a pharmacy business, this would offer an opportunity to many Malawians to access at least better quality pharmaceutical care services. For example Tanzania recognized this potential in the early 2000s and it conceptualized and introduced the “accredited drug dispensing outlets (ADDO)” aimed at improving access and quality of medicines to people living in the rural and peri-urban areas using a combination of training, marketing, commercial incentives, supervision, inspection and support strategies to transform the retail drug selling business into a regulated, profitable ADDOs, providing a range of quality drugs and professional services including referrals to underserved populations. These also serve as a platform for public health interventions like distribution of ITNs, condoms, information education and communication (IEC) and behaviour change communication materials. I do believe Malawi can also do something about these retail drug sellers whom our dear Pharmacy, Medicines and Poisons Board (PMPB) usually chestise without even trying to reach them with education (oh! eduQuation).

Remember that low availability of essential medicines in the public sector coupled with readily available but poorly regulated private sector drug sellers pose a major challenge in ensuring access to quality essential medicines and dispensing services in developing countries. Private-Public Partnerships that use innovative approaches example ADDO model in Tanzania are an important step in addressing this challenge. (Aziz Maija, ATIC News vol 4, issue 4 December 2008).

MEDICAL RIGHTS WATCH MEDIA CONFERENCE REPORT, “The Rights and Responsibilities of Research Participants”

By David Kulemela, Member MRW

On Saturday, 21st February 2009, Medical Rights Watch organized a Media Conference which took place in John Chiphangwi Lecture Theatre, College of Medicine, Mahatma Ghandi Campus. The broad objective was to sensitise the media practitioners about the Rights and Responsibilities of Research Participants. This was the beginning of “The Rights and Responsibilities of Research Participants” Project, which MRW is conducting in the months of February, March and April, 2009. Apart from sensitizing the media, the project will involve sensitizing medical research participants and patients at Queen Elizabeth Central Hospital and the seven Health Centres of Blantyre District. This project is being funded by the African Malaria Network Trust (AMANET) through the College of Medicine Research and Ethics Committee (COMREC), a body that oversees all medical research in Malawi.

The function was graced by Dr Dama Phiri, the District Medical Officer (DMO) for Blantyre (representing the District Health Officer) who was the Guest of Honor and Professor J. Mfutso-Bengo, Director of Centre for Bioethics in East and Southern Africa (CEBESA) and Patron of MRW, Mr Kangaude, Specialist Lawyer in Sexual and Reproductive Health Rights and Mrs. M. Kwataine, National Coordinator of Malawi Health Equity Network (MHEN) who were the speakers and the media practioners.

The Vice Chairperson, Mr Jones Chise in his welcoming remarks outlined the objectives of the Media Conference and its importance and relevance to the upcoming project. He also thanked the Guests and the media practioners for coming to the function.

In his presentation, Mr Kangaude highlighted the rights and responsibilities of pregnant women in research; concept, laws protecting rights relating to research participants, vulnerability of pregnant women and building a culture of respect for rights. The basic cornerstones of women rights participating in research include; informed decision making (consent), free decision making, privacy and confidentiality but also avoiding overburdening them.

Professor Mfutso-Bengo’s presentation dealt with patients and research participants’ rights and responsibilities. The major points tackled were; the patients charter and its importance which include protection of dignity, promotion of professionalism, prevention of professional misconduct, prevention of negligence and management of ethical dilemmas and conflict of interest. The responsibilities include; know procedure, benefits, risks, length of study and rights, not to interfere with other participants’ rights, utilize healthcare system, compliance to prescribed treatment and care of his/herself. On ethical dilemmas, Professor Mfutso-Bengo mentioned equity, privacy and confidentiality, post trial access for the research participant and follow-ups (for safety).

Lastly, Mrs. Kwataine presented on the rights and responsibilities of research participants which highlighted the reasons for conducting research and volunteering, research participation in least developing countries, the rights and responsibilities and pregnant women participating in research and their dilemma.

Following the three presentations was a question time and then the function was closed by the Guest of Honor. In her speech, Dr Phiri also scored the importance of medical research, the function and the upcoming project but also thanked MRW for organizing the function and the other guests for the presentations and the media practioners for attending it.

The Director of Ceremonies for the function was Mr Joe Khalani, member MRW and Ms Tadala Hamisi, member MRW opened and closed with a word of prayer.


February, 2009
MRW Headquaters,
Blantyre

for more information visit www.mrw.medcol.mw or write the Chairperson of MRW on tdivala@gmail.com or the Vice Chairperson on jchise@medcol.mw.

OF MACOSSANO AND THE CLINICAL TRIAL

I have been following keenly on the issue of Mr. T.O.T MacOssano and his clinical trial through your paper. I applaud the paper for its effort in informing us the general public. However, the chronology of the events looks somehow suspicious. The ................... of today gives the particulars of this gentleman clearly; trained locally as a Clinical Officer and further went to the prestigious Makerere University for a diploma in Palliative Care. Further more he has worked in Malawian Hospitals his entire career, assisting with dedication the Malawian people.

Let me point to some of the facts which I have reservations;

The time that the clinical trial took place and the time the Administrator is writing the PMP Board dissociating the Hospital from the clinical trial is questionable. It is said that the clinical trial took place in 2006 and the Administrator, Mr. Anthony Chilembwe decides to write the PMP Board in 2008, that is two years down the line. In the first place, why did the Administrator not dissociate the Hospital from the trial in 2006 when it was taking (or about to take) place?
Secondly, the Hospital allowed the trial to take place within its premises, why has it decided to dissociate itself now (through its Administrator) when the trial already took place? And should we assume that this is the only clinical trial that indeed Mr. MacOssano has done (within the Hospital or else where)?
The PMP Board is informing the nation that six people died as a result of this clinical trial. These people had cancer (Kaposi’s sarcoma) and were HIV positive, how sure is the Board that the six out of the twenty people died due to the drugs on trial and not from the two conditions? I am asking this because if we go into our hospitals many people with cancer and HIV positive die everyday. Looking at the figures 30% of the people on trial died but the results publicized do not show the individual category results within the trial.

I believe the public would also benefit if they had some background information as to what is happening at St. Luke’s Hospital. In my knowledge, the atmosphere at the Hospital is tense because Hospital Management and some of its employees are in a wrangle concerning allowances the Hospital is giving to administrative staff. Mr. MacOssano happens to be in the group that is fighting that the allowances be extended to every employee as well. Due to failure to reach an agreement by the two sides, the issue was referred to Zomba Labor Office with the employees and Management was given 18th October 2008 as deadline to have the issue resolved.

In view of the facts, I believe that the Administrator’s motive in informing the PMP Board should be questioned and I my opinion just to do away with Mr. MacOssano on the internal issue and to let the Board do this on their behalf was the smart way they opted for. As a Malawian I believe that the spirit of “kuthana naye” is the driving force behind this whole story and it cannot assist in solving the internal problems at St. Luke’s let alone any institution. And the PMP Board should investigate thoroughly before it reacts. And let us desist from referring to him as a Tanzanian whilst all these years he has been in the country.

NOTE: this article was submitted to the local Daily that serialised the issue but was not published

OUR WEDDING

On the blazing sun Saturday morning of 30th September 2006, Tigwi wakes me up & reminds me its my wedding day. 'Oh! i overslept buddy', i replied and rushed for shower. By then my anxiety had already been overcome by the ring of friends around me; John, Kondwani and Tigwi or and Wise who were encouraging me to not be afraid.

The day had arrived, the day that all along me and my fiance, Justina and of-course the Wedding Committee and friends and relatives had been planning and waiting for was finally there. 'Porridge', i declined no food was apetizing and i just wanted to get through with this and have my bride (wife) home.

Tigwi did a very nice and commendable job, he dressed me to look a handsome bride though he too looked handsome, i thought he was about to hijack me of my lovely bride!!!!!! "sijelasi koma chilungamo". Then came the wonderful service at church with the right Reverend JB Kanyochole popularly known as Rev JB among the Mulanje Mission CCAP fellows. It was all good and memorable and thats when i realised that it was real and we had done it, wedded my Justina. The ring ceremony, the marriage certificate signing and oh! the kiss the bride part. Then it was over at the church and the "mwambo" came and it went.

The reception venue was Mulanje Golf Club. It started with a luncheon and then the speeches and the "perekaniperekani", drinks and the cake ceremony. When they asked me to lift the bride, anxiety struck me again 'nkhawa koma ndikwanitsa kunyamula maiwa' i was so tired. But wow! i managed to lift her with ease i think "ndimaopa kuchita manyazi". Then the reception was over we went for a honeymoon "uh! kunakoma kwabasi kuyiwala kubwerera kumudzi" then Dad had to call as back. Thats how our honeymoon was cut short but we will have it continued soon.

Now we are proudly parents to alovely daughter Michelle, not Obama's wife of-course. We are now learning to be good and responsible parents and we are sure with the help of God she will grow into a wonderful lady as her Mum and grandmas.