Flawed practices plaguing drug procurement, distribution
It is an open secret that provision of health care in Ethiopia is beset by multitudes of problems, one of which is procurement and then distribution to patients of vital medications, often times life-saving ones. Since the normal chain of drug procurement and distribution is inefficient at best, many patients in need of drugs are left to their own devices. While those well-off or connected can afford to buy unavailable drugs at exorbitant prices or get them sent to them from kith and kin abroad, those with limited means resort to informal channels that can potentially expose them to substandard, adulterated or even expired products. In this issue of The Reporter, Tibebeselassie Tigabu highlights the issue of drug procurement and distribution.
When Lealem Belachew was told she had beaten ovarian cancer three years ago, it was a time of joy and relief for her family. The good news marked the end of a dreadful routine that has been synched to a chemotherapy calendar ever since her diagnosis.
Her brother Kiflom witnessed the ravages of the chemotherapy. "It was killing every follicle in her body," said Kiflom.
That is the sacrifice cancer-battling patients have to make and Kiflom and his family shared Lealem’s agony with nausea and mouth sores, not to mention frequent emergency hospitalizations.
Lealem’s beating of cancer reminds one of a line by African American writer Octavia Butler that goes, “In order to rise from its own ashes, a phoenix must first burn.”
The fighting did not stop there and then. Rather, Lealem and her family had a constant issue to worry about – remission, which many a cancer survivor has to grapple with.
In addition to the remission, they also found out that the waste residues from anti-cancer drugs used in chemotherapy could create complications.
Kiflom did not imagine the level of the complications; but in his worst nightmare, he did not expect it to be fatal. Their happiness turned into grief when she was admitted to the emergency ward of Bete Zata Hospital due to complications caused by waste residues.
Things happened fast; her kidney failed and her other vital organs were failing; and devastatingly her body was giving up. She completely stopped eating and was dependent on glucose. To boost her immune system, the doctors prescribed a potent glucose. Kiflom, one of the main caregivers, was disappointed when he found out that the glucose type was not available in the hospital.
He did not lose hope, though. Kiflom elected to convince himself that it would be available at other pharmacies or hospitals. On this life-and-death issue, Kiflom reached out to every contact known to him in search of the glucose, but hope was fading away fast.
On the first day, Lealem had a small amount that she used. On the second day, the glucose dried up and her body started caving in. “We felt totally helpless, and there was nothing we could do about it,” Kiflom recalled.
On the third day, they were miraculously able to find the glucose but the inevitable had already happened to her. Her passing away left the family with anguish; and resentment with the system, among other things.
This resentment and frustration is shared by the loved ones of many patients that could not access medication, especially those who are in critical condition.
For those who are passing through this exhausting process with no cure in sight, going to health-care facilities is a futile exercise.
The list of grievances is long if one conducts a random survey of ordinary residents of Addis Ababa. They have things to say about issues such as shortage of medicine, interruption of supplies, substandard as well as expired medications.
Interviews with a few Addis Ababa residents revealed that the following drugs were in short supply: painkillers; ORS (oral rehydration therapy); insulin; asthma medication Seretide; surfactant (a drug which helps premature babies); artane trihexyphenidyl (a treatment for Parkinson’s disease).
Frustrated by the situation, some people use informal channels to procure cures for such a basic human right as healthcare. Many seek help from air stewardesses, overseas relatives, and others to get hold of medicine they need to keep body and soul together.
For some, finding a drug becomes a Mission Impossible sequel and one of those who had such experience while looking for anti-D is Yodit.
The suffix of the blood type ‘–negative’ induces shock, especially among women. Some of Yodit’s friends were also shocked at the time of finding out her blood type was ‘O-negative’ and looked at her sympathetically with the assumption that she might not bear a child.
Fortunately, Yodit, who is now in her 28th week of pregnancy, is aware of what the suffix ‘–ve’ stands for and the complication it causes.
Culturally known as shotelay, studies conducted on rhesus negative blood types show that they are missing the rhesus factor, a protein substance present in the red blood cells of other humans.
A complication occurs when an Rh-negative mother's blood is exposed to blood from her Rh-positive fetus during pregnancy. This situation causes the mother to mount an immune response by producing antibodies against the Rh factor, a process known as Rh-sensitization.
This process destroys the fetus’s red blood cells, potentially endangering its viability. According to reports, brain damage, fluid build-ups, swelling of a baby’s body, difficulty with movement, hearing and speech impairment, seizure, anemia, organ failure, and in extreme cases, death are the causes of Rh disease.
Researches in the area show that despite the high prevalence of the Rh-negative phenotype in other categories, its incidence is actually lower among Africans. Yet, due to lack of care, it remains a major cause of perinatal morbidity in sub-Saharan Africa.
Still associated with “curse”, “evil spirit”, the label Lijochuan yebelach, literally translated as ‘a mother who ate her children’ is given to mothers who lose their children during or after pregnancy. Thanks to progress made in medicine, it has now become possible to give birth to a healthy baby.
Living in Addis Ababa, a cosmopolitan city, Yodit assumed case management and obstetric care is available and that anti-D immunoglobulin drug is widespread.
The reality was to the contrary. This week she faced difficulties accessing the anti-D medicine in Addis Ababa. Though her examination at one of the private hospitals indicated that she is not sensitized, and did not produce antibodies, to be on the safe side she wanted to get an injection of anti-D immunoglobulin.
Naturally, she started the search from the private hospital she was admitted to, and when it was not available there, she headed to other pharmacies such as the various branches of Gishen, Ras Desta Hospital, Dinberua Maternal Hospital, Zemene Yohannes, Alem Tena and Kenema.
She checked at more than 20 pharmacies but to her surprise, the medication was not available. She contacted various people in the medical field as well as pharmaceutical importers, but could not find anti-D.
Her two-day search of medicine finally paid off when she went to a pharmacy around the Ginfle area. Imported from Switzerland, the medication set her back 2,800 birr – double the usual price.
Many women do not have contacts like her and would have given up hope but she was persistent in her quest. Finally, through a close friend who is a medical doctor at one of the government hospitals, she was admitted to one of the government hospitals in order to get the anti-D.
Hearing the many complaints from people, it begs the question of where the gap is. How are the drugs distributed down to the individual level?
Shortage might be the last worry when one finds out the presence of expired drugs in the country’s warehouses. This might create a doubt and shock in the country’s drug distribution system.
Last May, the auditor general presented a shocking report to parliament on the performance of the federal Pharmaceutical Fund Supply Agency (PFSA).
The report revealed a flawed bidding process, noncompliance with government procurement guidelines, storage of expired drugs, medical equipment, and some unexpired drugs worth a staggering half a billion birr rotting away in warehouses.
Some of these expired drugs were found mixed with drugs with future use-by dates.
A June 5, 2014 report by the Waste Removal Management Committee revealed documentation issues with agency warehouses in Addis Ababa, and that 256, 701,046 birr worth of expired drugs and medical supplies without date of purchase, and with end-users not identified, were found.
On the other hand, according to a letter from the Adama branch warehouse dated February 3, 2015, drugs worth 34,863,848 birr but with quality defects were discovered. The discovery includes an accumulation of 569,833,919.27 birr worth of expired drugs and pharmaceuticals, which were found mixed with other usable drugs.
The auditor general’s report, which covered three years and a quarter covering the period 2012/13-2015/16, had as its input information from interviews with higher officials of the agency and a survey of the various branches of the agency's warehouses.
From the years plan executing report of the agency's Bahir Dar branch warehouse 71,372,697; Dire Dawa branch warehouse17, 387,474; Jimma branch warehouse 38, 528,315; Mekele branch warehouse 13,979,155; Hawassa branch warehouse 26,576,756.0; Nekemt branch warehouse 11,250979.12; Gondar branch warehouse 7,988,702.96; Negele Borana branch warehouse: 4,318,389.17; Adama branch warehouse 50,752,837.67; Dessie branch warehouse; 20,021,973.13Addis Ababa branch 16,091,745.39 birr worth of expired medicine were discovered.
Some of the justifications that were mentioned in the report from the agency related to misplanning; some of the already purchased drugs were also replaced by new ones per recommendation from the World Health Organization and the lack of budget from the health facilities. The justification of the agency states that some of these drugs were purchased for emergency cases such as Ebola, diarrhea, bird flu, were not used so the drugs were out of use. All in the entire agency could not justify why these medicines were not removed. They also could not produce evidence from World Health Organization.
In the findings, there also damaged drugs, which are imported by mistake. However, the agency claims it is a responsibility of Food, Medicine and Health Care Administration and Control Authority (FMHACA) but from the authority's letter, the auditor general understood that FMHACA’s mandate is to give orders but it is the agency’s responsibility to remove the spoiled drugs and to follow up on the return, get replacement drugs or return of the money. In addition to that, FMHACA also notified the auditor general that drugs which the authority imports were damaged by exposure to the elements for 76 days. Even interviews from the drug manufacturers show that the agency does not take delivery of drugs on time. Though the agency claimed to have a shortage of warehouse space, the report reveals negligence in this case.
However, Adna Bere, public relation of PFSA, did not want to comment on the auditor general’s report the shortage, interruption, and embezzlement of fund news are not new to the PFSA, which was established pursuant to Proclamation No. 553/2007.
This agency has 17 branches in different parts of the country. According to the proclamation, this agency was established with the aim of implementing efficient and effective procurement and distribution systems to deliver, by using the Drug Fund and focusing on the country’s major health problems, quality-assured pharmaceuticals at affordable prices sustainably to public health institutions. Adna acknowledges the shortage and the continuous interruption of the drugs but the reason according to her is multidimensional. PFSA purchases various drugs as per the request of various government health hospitals. In addition to that, the agency procures program drugs such as those for HIV, malaria, and family planning. What’s more, the agency obtains supplies of various drugs through donation.
According to Adna, for HIV, malaria, family planning programs, TB, leprosy and some others, there is always a planning ahead of time, and hence, there is no shortage. Contrary to that, the report found a loophole regarding the program drugs. Though it was necessary to establish a technical team to plan annual and three years program with the exception of HIV and malaria, there was no technical team and there was no planning for the other program drugs. The planning loophole is not only to program drugs rather emergency medicines. Without following the procurement guideline, the agency purchased drugs worth 16,643,113,342.61 birr. In addition to that, with the exception of acute watery diarrhea (AWD) outbreak that was caused by drought and water shortage, which was approved by the Ministry of Health for others, they could not produce any proof regarding the other drugs’ procurement. There is actually a discrepancy in the timing of the purchase.
One of the drugs, Propylthiouraci l100 mg, was purchased at the cost of 4,248,323.06 on March 13, 2015, and the emergency request came on June 3, 2015, which begs the question, ‘if it’s an essential emergency medicine, why it was not purchased in a proper manner?’ In addition to this discrepancy, the lack of record on every procurement, budget, and variety of medicines also shows the agency’s problem in dealing with purchase and the agency’s inability to determine the medicine’s emergency status.
The public health institutions place orders to the agency for the supply of essential pharmaceuticals. Their order has to be in sync with the country’s Food, Medicine, and Health Care Administration and Control Authority’s (FMHACA) essential medicine list. According to Adna, a shortage might occur if some of the medicines are not included in the list.
FMHACA’s main mandates include the registration, licensing and inspection of health professionals, pharmaceuticals, food establishments, and health institutions. It also has a list of essential medicines list based on drugs, which are required by the majority for prevention, diagnosis, treatment, mitigation, and rehabilitation of diseases affecting the majority of Ethiopians
Painkillers, anti-tubercular, antibacterial, antiulcer, antilipemic (lipid-lowering agent) are some of the drugs in the list. Samson Abraham, public relations and communications director of FMHACA also believes the country's medicine list is very short. However, there are requests from various health institutions and drug importers. Samson the process of updating the list is very slow. However, there are many requests the committee, which is comprised of various stakeholders, is looking up to 1,500 varieties of medicines to update the list. Samson strongly believes the current list is creating a shortage of drugs in the country. "With the exception of the outbreak, we are strictly obliged to stick with the list which limits the variety of the drugs. There are countless varieties of drugs which did not yet get approval so this creates a shortage," Samson said.
As a rule, the agency purchases generic drugs. Generic drugs are bioequivalent to a brand in dosage form, safety, performance and intended use. Since they are typically sold at substantial discounts, the agency in principle buys generics, saving billions. So the gap, according to Adna, is doctors might order medicine, which is not in FMHACA list, or branded medicine. Consumers’ experience contradicts this assumption. In search of anti-D, the elder doctor who checks on her every month pointed that it might be difficult to find a specific brand of anti-D immunoglobulin and suggested to look for any kind of brand or generic anti-D immunoglobulin. Consumers The Reporter talked to also suggested that doctors and pharmacists give an alternative to brand drugs.
The other reason Adna mentions relates to various health institutions’ lack of budget, unmatched place of order, and distribution. "The health institutions might not plan the amount and type of medicine. In this case, there might be shortage or surplus in some medicines," Adna said.
The auditor general’s finding reveals that only 30 percent of the government’s health care facilities’ request was fulfilled. Adna, quoting the proclamation, states that if the agency fails to supply the pharmaceuticals, it has to advise institutions of the best alternatives thereof. The report stated that the agency could not fulfill its obligation, and as a result caused inconvenience for consumers and compromised the budget of various government health institutions.
Since the agency could not fulfill their request, the following health institutions were forced to procure drugs from various vendors. The institutions and their outlays were: the Addis Ababa University College of Health Science’s Black Lion Hospital and Black Lion Specialized Hospital (13, 681, 122); St. Paul Hospital Millennium Medical College (10,131,830.12); Ministry of Defense (45,199,910.8); Federal Police (15,097,626.37); Zewditu Hospital (1,100, 170.96); Gandhi Memorial Hospital1 (698,378.00); Menelik II Hospital (18, 495,260.12). In sum, a total of 105,404, 299.37 birr was spent by the above-mentioned health care facilities.
Though consumers do not know where the gap is, they request information on the platform they get. One of the platforms that are made available by the agency is the toll-free line 8772. Following that, in a couple of months, more than 35 varieties of drugs were reported on this line. One of the drugs which was repeatedly reported as being in short supply is called folic acid. Folic acid is mainly taken by pregnant women in order to prevent birth defects of baby's brain and spinal cord. The agency received this drug through donation but according to Adna many of the health facilities were facing a shortage. The agency had to investigate this situation and headed to the Bole sub-City Administration Health Office that is responsible for nine health centers. Their finding, unfortunately, shows that the health office hoarded the drug for four months without distributing it. "The health center’s justification for not distributing it is the health offices did not request this medicine which clearly shows a gap in the distribution process,” Adna said, and added, “In addition to the supply of the medicine, there has to be a tight and clear procedure on how to distribute these drugs.”
From customs, there are also various reports regarding smuggling of illegally traffic drugs. Yodit’s quest for anti-D also led her to a finding that individuals acquired this medicine in an “unknown” (or probably illicit) manner.
She decided to contact a prominent gynecologist who advised her not to purchase from individuals since the condition of an incorrectly stored product cannot be guaranteed.
Anti-D drugs should be stored between two to eight degree Celsius and the product should be brought to room or body temperature before use. According to this gynecologist, since these individuals do not follow a strict procedure of storage the safety might be compromised. However, the audit report revealed a flawed bidding process of the agency, including noncompliance with government procurement guidelines, abuse-prone procurement, delays in delivery, resulting in wasting of taxpayers’ money and also compromising the health of patients. The report, in addition, shows that the agency violated procedures laid down by the Public Procurement and Property Administration Agency on many occasions.
In addition to that, many of the agency's international, local bidding is done without following the proper procurement guidelines. The report identified that there was no proof of bidding, the amount the tenders proposed, in which the report found a flaw in the tender process worth in the amount of 16,643,113,342.61 birr. On some occasions, even though the agency claimed to conduct various international and local tenders there was no evidentiary proof.
Some of the tenders were also done without a tender negotiating committee even if in the case of a sole supplier, Article 52/2 of the Procurement Proclamation states to have a negotiating committee and approval of higher officials that puts the entire agency’s stake in the hand of individuals. However, the Public Procurement and Property Administration Agency dictates the bidding tender process such as the tender advertisement, tender result, and signed agreements should be uploaded on the agency’s website as well as on the public procurement and property agency. Rather, most of the tenders were kept secret in such a way as to forestall complaints from potential plaintiffs.