1184911_10152216864610550_1855419568_a-217x300Since its introduction into the Ghanaian medical fabric, Ergometrine & Oxytocin had received an overwhelming measure of attention as they were? tagged to be the number one solution to excessive bleeding following childbirth (post-partum haemorrhage).

Out of a post surveillance {Post-Market Quality Surveillance Project Maternal Healthcare Products (Oxytocin And Ergometrine) On The Ghanaian Market Report Of First Round} carried out to assess the quality of Oxytocin and Ergometrine on the Ghanaian market between August and September2012, it came out that Eighty-Six per cent (86%) of the sampled Oxytocin found on the market were manufactured in China, where as 90.68% of Ergometrine samples were manufactured in India. Of those collected and tested according to the report, all the Ergometrine tablets were from companies that did not hold marketing authorizations. 10% of the Oxitocin and 4.24% of the ergometrine samples could not be established.

Additionally, it was observed that almost all of the injectables were not stored according to the recommended storage conditions (20-80C). These medicines lose their sterility when they are not properly stored especially when Ghana continues to experience power fluctuations.

Out of the 169 Oxytocin samples assayed, 55.62% failed. Of the 99 Ergometrine injection samples, 73.74% failed, and all of the 11 (100%) Ergometrine tablets tested failed assay. Two (2) samples of Oxytocin injection and three (3) samples of Ergometrine tablets (two of the three Ergometrine tablets had the same batch number) were determined to be counterfeit products.

Quite revealing, of the 40 Oxytocin samples randomly selected for sterility testing, 97.5% failed either Assay or Sterility testing, or both; 94.87% of the 40 Ergometrine injection samples tested for sterility failed either Assay or Sterility testing, or both.

The results of this project established that an extremely high percentage of Oxitocin and Ergometrine available on the Ghanaian market do not meet required standards of quality. This situation could have serious implications for maternal mortality in the country.

A number of regulatory actions are believed to have been taken by the Ghana FDA, including product recalls, and those suspected of being involved in criminal acts have been referred to the police. But let us deep deeper to the source because these are frontline medicines that are crucial to saving lives in Ghana. Who procures these drugs? My literal understanding (I stand to be corrected) is that these drugs are procured by Ministry of Health (MoH) and imported into the Ghana without being checked by Foods and Drugs Authority (FDA). These are the only drugs FDA has no controlling power over (again, I stand to be corrected)

This report raises a lot of issues; how we allow these drugs into the country. Who are the contractors, regulators, and safety compliance processes to make sure that the drugs are adequate and standard to prevent bleeding in pregnant women?

There is a direct correlation between the quality /potency of a medicine and its ability to work effectively. When a woman is in labour or birthed with excessive bleeding, it becomes an emergency medical situation. It has been medically established that a woman in labour who bleeds for over an hour risk the chance of losing her life. In Ghana for example, bleeding has been stated to be one of the leading causes of maternal deaths. This is compounded by the ever-bleeding national blood banks.

Worst of all, if women just after birth continues to bleed and are administered ergometrine and oxitocin in an attempt to saving their lives, your guess is as good as mine. Most probably, they are given these sub-standard or fake medicines as the related cases of late Jennifer Sebuabe and Perfect Daba who were featured in Maternal Health Channel Television Series Programmeshttp://www.mhcghana.com/av/83ec612bf1, and?http://www.mhcghana.com/av/34f5990c9d. What is common to both is that they bleed to death. In these situations, should they have been given these sub-standard medicines, the probability of their survivals would still amount to zero. Our women are literally dying.

We need an eclectic approach to remedy the ?developed cold feet? by Ministry of Health (procurement unit) and other procuring agencies towards actions that cam ameliorate the effects of these drugs on unsuspecting users. The government itself, the academia, NGOs, policy institutions, and above all individuals must come to the rescue of our lovely mothers who on daily basis carries the human resource of our dear nation.

Indications are that efforts being ?promulgated? towards tackling this challenge echoes the bell of been thrown into history dustbin. I was flabbergasted when a health professional commended on a post by Maternal Health Channel Television ?Heard about it on the news today. As I listened, a few questions came to mind?that is??how many women have died out of this and even as a health care provider?? how do i tell the difference?

Systems just don?t work in Ghana. God save us.? Ministry of Health and its partners at this critical point must be ready with a ?lightning speed? to roll-out its red carpets welcoming all constructive measures from diverse angles to recall these drugs from the system for the betterment of our lovely mothers or mothers to be.

As I pen my thoughts on these drugs, Sophia Webster, a gynecologist who is traveling in a light aircraft across 26 African countries to promote maternal health on a mission dubbed ?Flight For Every Mother? stepped into my office. Her observation from our premier tertiary hospital (Korle Bu Teaching Hospital) is that ?though sub-standard, ergormetrine is in short supply at the hospital. I just came out from the theatre in dying need of ergormetrine for a bleeding woman?.

Now let?s understand what these drugs are.

In pharmacology, a drug is ?a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. In this sense, Ergometrine is a type of medicine called an ergot alkaloid. It is used to help prevent and control bleeding after childbirth. It has a medical use in obstetrics to facilitate delivery of the placenta and to avert over-flow of blood after childbirth by causing smooth muscle tissue in the blood vessel walls to slim, in so doing reducing blood flow. It is usually combined with oxytocin (Syntocinon) as syntometrine.

Ergometrine acts on three different types of receptors created in the walls of the blood vessels and in the uterus. When these receptors are stimulated by ergometrine they cause the blood vessels to constrict and the uterus to contract. The contractions help the placenta to be pushed out. Both actions reduce blood flow to the uterus, which helps to reduce blood loss as the placenta comes away from the wall of the uterus.

Ergometrine injections can also be used in the active management of the third stage of labour. The third stage of labour lasts from the time the baby is delivered to the time the placenta has been delivered. Weak contractions of the uterus help to clear away the walls of the uterus, which helps to deliver the placenta.

An ergometrine injection can be given into the thigh muscles as the baby is born, or immediately after, in order to cause contractions that help speed up delivery of the placenta and reduce the risk of heavy bleeding as the placenta comes away.

This sounds timely relief to pregnant women who usually experience excessive blood flows after birthing. It is believe to control excessive bleeding following childbirth (post-partum haemorrhage). Again, helps the uterus contract back and controls blood loss. But to manage the third stage of labour ergometrine is usually given in combination with oxytocin (Syntometrine), which also helps the uterus to contract.

Like any medicine, there are restrictions. Some category of women have been cautioned in its utilization; women with moderate liver, kidney, and heart diseases. The list continues with women with high blood pressure, hereditary blood disorders and women who have delivered more than one baby.

Watch out carefully because under the following conditions am about to reveal, it has been recommended Not to be used. Its use has been prohibited during first and second stages of labour, severely decreased kidney function, severely decreased liver function, and severe heart disease. additionally, disease involving the blood vessels (vascular disease), Very high blood pressure (hypertension), blood poisoning (toxaemia), Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).

To its extreme, this medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Since my main concern borders maternal health, it is critical to understand when this medicine is appropriate. This medicine is administered by a qualified doctor, nurse or midwife as the baby is delivered, or immediately after delivery. It should not be given at any other point during labour, or during pregnancy.

A single dose of ergometrine administered at delivery understandably should not prevent a mother from breastfeeding her baby. However, if repeated doses are given following the birth, this can interfere with the production of breast milk. It could also cause problems in the nursing infant, since the medicine can pass into breast milk. This medicine is not recommended for women who are already breastfeeding.

Though each medicine has side effect(s), the case of ergometrine among birthing women on daily babies has been revealing. It has been linked to: headache, dizziness, abdominal pain, nausea and vomiting, awareness of your heartbeat (palpitations), sensation of ringing, or other noise in the ears (tinnitus), chest pain, irregular or slow heart rate (arrhythmias or bradycardia), shortness of breath, narrowing of the blood vessels in the extremities of the body (vasoconstriction), increase in blood pressure, skin rash, and heart attack (very rare).

The writer, Victus K. Sabutey is the Research & Productions Co-ordinator, Maternal Health Channel Television Series,[email protected]?+233 249 114 32


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