A pharmacist led TPN unit service for neonates in Farwaniya Hospital / Kuwait

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Executive Summary:

pharmacist led TPN unit service for neonates, The aim of this project is to establish a total parenteral nutrition service for neonates in Farwaniya hospital. Similar services already exist in different hospitals in Kuwait; however, it is not available in the private sector either due to the demand of the service in terms of health professional’s shortage or due to the cost of such service.
The cost of care in NICU in hospitals is quite expensive and this service can reduce hospital stay even with the high cost to start this service.
TPN service can reduce the hospital spending in more than one way e.g. reducing the risk of infection, reducing the daily fluid consumptions, reducing the hospital stay for patients and it will give other health professionals more time to do clinical care to patients in the ward.
Unfortunately, there is no evidence about how TPN service can affect hospital stay in Kuwait, but there is some literature regarding the cost-benefit of TPN service across the world.
TPN service is such a high quality and complex service before starting such a service, planning and implementing the right tools to start is crucial in order to continue to have this service.
Once I started to do this project and collecting some data from Kuwait, our hospital administration in Farwaniya have had talks with our pharmacy department and they agreed to start to implement the service.
I have started this project few years back in Kuwait but the hospital administration always thought it is not a priority.
I gained a lot of experience and knowledge from this project with different prospects and different ideas of different models. In addition, the finance and marketing point of view are not our specialty, however, it is been great thing to know, learn, and discuss.
At the end probably some of the data are estimated and may be not exactly accurate but it will be near reality in practice. This project will be beneficial to our pharmacy department in Kuwait as well as to the hospital administration.

“(Establishing a TPN unit in a general hospital serving neonatal wards) Farwaniya Hospital Kuwait”

“1.1) Introduction:”
In healthcare environments, whether it is a primary, secondary or tertiary centres patient’s care has more than one side. Usually healthcare professionals concentrate more on medications and neglect the nutritional side of patients.
Nutritional support plays a fundamental side in patients care for all type of patients.
For neonatal care nutritional support is very crucial and it is part for neonatal recovery and it is considered as the first option to be considered in the first few days of neonate’s life.
“Sometimes in neonates nutritional requirements cannot be fulfilled through eternal feed through gastrointestinal tract, in that case nutrients must be given using alternative ways and one of the alternative methods is intravenous infusions.”
Parenteral nutrition is the term used to feed patients and that needs careful assessment to start and monitor PN according to the clinical condition of any specific patient.
Methods of prescribing, compounding and administration of PN requires planning and effective communication from specialist multidisciplinary team of doctors, nurses, pharmacists and pharmacy technicians. In addition, other health professionals are integrated in this team like dieticians and biochemists.
There are different stages of this process should be carried out and they all have their own risks that is why a trained professional staff are needed to preform each tasks.
Although safe methods are reported without adverse events, occasionally some serious incidents have caused patient’s death. (“ PAEDIATRIC CHIEF PHARMACISTS GROUP REPORT, 2011)”
Moreover, hospital especially general hospitals should have maternity departments and at “least two wards of neonatal care (NICU and SCBU) should have a TPN unit.”
“1.2) Preterm birth (WHO update 11/2014)”

“Key facts”
• “Estimated 15 million babies are born preterm and the number is constantly rising. Preterm means babies are born before 37 completed weeks of gestation.”
• “One of the leading causes of death among children under 5 years of age is preterm births and an according to a survey in 2013, nearly 1 million children died because of preterm birth.”
• ”Employment of cost-effective interventions can help in saving at least three-quarters of them.”
• ”The rate of preterm birth is ranged 5% to 18% across 184 countries.”

The most vulnerable time for a child’s survival after preterm birth is the first 28 days after birth. According to a survey conducted in 2012, 44% under-five deaths occurred in this period, pharmacist led TPN unit service for neonates a 7% increase as compared to the survey conducted in 1990. Even if the under-five mortality rates decrease over time, at the same time neonatal mortality rate is increasing. The increasing rate of mortality shows the importance for health care interventions that specifically address the issue of neonatal deaths. There are health care interventions to study under-five deaths and how to decrease the mortality rate but there is a need for interventions that address the causes and solutions of neonatal deaths.
“As far as the issue of mortality rate of children under the age of 5 is concerned, studies suggest that under or malnutrition is the primary cause of death among children under less than 5 years age. According to an estimate 45% of deaths among children less than 5 years old is due to under nutrition. Between 1990 and 2012 there is a decline in the percentage of underweight children from 25% to 15%, i.e. globally the number of malnourished children declined from 160 million in 1990 to 90 million in 2012.”
Recently a new global target has been set, to reduce the number of stunted children by 40% by 2025 against 2010 as base year. The other five targets set along with the reduction of stunted children is maternal, pharmacist led TPN unit service for neonates infant and young children nutrition. Old targets have been successful, e.g. “between 1990 and 2012, number of stunted children declined from 257 million to 162 million, representing a global decrease of 37%.”(WHO, 2012)
As mentioned earlier preterm birth is one of the leading causes of infant mortality. According to a studies conducted by WHO in 2014, preterm birth complications is number 4 among the 20 leading causes of premature mortality globally. The results show that neonatal care should have governments’ support in terms of providing support for any new developments to provide patient care.
1.3) Statistics of Kuwait

Table (1) shows some figures from Kuwait from “(Survey update report from MOH 2013)”

“Total population (2013) 3,269,000”
“Gross national income per capita (PPP international $, 2011) 88,170”
“Life expectancy at birth m/f (years, 2012) 78/79”
“Probability of dying between 15 and 60 years m/f (per 1 000 population, 2012) 59/43”
“Total expenditure on health per capita (Intl $, 2012) 1,377”
“Total expenditure on health as % of GDP (2012) 2.5”

Figure (1). Kuwait’s Map according to WHO Region. Located in Eastern Mediterranean Region(EMR).

1.4) Health situation (Survey update report from MOH 2013): –

• “Since Kuwait is one of high-income countries, where government provides social services i.e. health care and education, people in Kuwait enjoy a high standard of life similar to developed countries. Therefore, Kuwait’s health indicators are similar to the health indicators of developed countries.”
• “Kuwait’s population mainly suffers from diseases that can be prevented provided proper care is given to the patients. According to research more than 76% of cases of death in Kuwait are due to “non-communicable diseases, with an increase in incidents of coronary heart diseases, cancer and accidents. Moreover, diabetes, obesity, dyslipidemia and physical inactivity are showing high occurrence and are emerging and major risk factors.”

“The factors above show that there is a need to shift from curative to preventive medicine. Thus, in Kuwait there is a need for reform in the health sector and strong commitment to preventive health services in order to address the issue of increase in non-communicable diseases.”

1.5) Demographic profile (Survey update report from MOH 2013):

“Kuwait’s demography is unique given the large number of expatriates in Kuwait. Large number of expatriates in Kuwait causes the two population groups to vary over the last four decades, in addition the expatriates population has never been less than 55% of the total population.”
“When age and gender composition of the country is considered, groups significantly vary from each other. Where Kuwaiti population is usually of “low mortality-high fertility” similar to the countries of Middle East and North Africa region, establishing a perfect symmetry between two sexes. “The non-Kuwaiti population is mainly working age groups and is completely asymmetrical between the sexes.””
According to studies, it is expected to have greater population of elderly Kuwaitis, along with higher life expectancy. Higher life expectancy of elderly Kuwaitis places a bigger challenge on Kuwaiti health sectors. Elderly population will need better and more health services than younger population. Thus, there will be a shift towards the delivery of management of long-term chronic diseases.
In 2009, out of total population of 3,442,945 individuals there were 2,340,460 non-Kuwaitis. As compared to past there is an increase in native Kuwaiti population primarily due to increase in natural growth i.e. “high fertility and low mortality”. Growth in non-Kuwaiti population is mainly due to increase in number of expatriates because of labour requirements necessary to fulfil labour requirements to implement development plans.
1.6) Epidemiological profile (Survey update report from MOH 2013):
“A national mortality and cause of death report is present by MOH annually. In this project, along with morbidity information data on notifiable communicable diseases, non-communicable diseases and injuries is also presented.”
“The epidemiological profile of Kuwait reflects the on-going demographic and epidemiological transitions in Kuwait. According to the data presented, population aging effects of the demographic transitions also affect the epidemiological transition. According to the report, elderly population of Kuwait will live longer and represent larger proportion of the population. The demographic changes mentioned above will cause the shift in burden of the diseases from communicable to injuries and non-communicable diseases. The shift will consider changing lifestyle habits and other behaviours that can affect health i.e. diet, inactivity, smoking, substance abuse and rash driving. As mentioned earlier the combination of all of the above factors i.e. “population aging and changing risk factors” will cause change in burden of the disease continuously both in terms of mortality and morbidity for the future.”
Reports suggest that the incidents of communicable diseases in Kuwait have declined greatly since the late 80s. The decrease in incidents is mainly because of the “broad-based immunization efforts by the Kuwaiti health authorities”. It is believed that due to an improvement in health sector no cases of polio or diphtheria was reported since 1985. Kuwaiti disease control authorities have managed to reduce the non-communicable diseases greatly but several diseases i.e. chickenpox, diarrhoea, viral hepatitis, tuberculosis and salmonella still pose a public health challenge for Kuwaiti disease control authorities.
1.7) Health policies and system (Survey update report from MOH 2013):
“The four year national health plan, 2010-14 for Kuwait mainly focused on expansion of the health sector. In the Middle East region Kuwait has one of the most modern health care infrastructures. Major contribution is from the public sector but involvement of private sector in health care is also increasing.”
Hospitals and health care centres are equipped with experts’ health care staff, equipment and medicine to provide best health care to people. Kuwait’s modern health care infrastructure demonstrates her strong commitment to health care, high standards of health care and sufficient resources allocated to public health.
The public health system in Kuwait is primarily built on three core principles:
1. Primary
2. Secondary
3. Tertiary
“A strong health care system has been developed with a clear vision and the”integration of non-communicable diseases and mental health within the system.”At the moment there are 92 primary health care centres in the country that provide services to people in 6 health regions. As other GCC countries, health workforce in Kuwait depends mainly on expatriate health workforce.”
Figure (2):
Different Governorates and their Distribution in Kuwait.

“Table (2) shows Kuwait’s Governorates and they are numbered accordingly as shown by the map above. (Survey update report from MOH 2013)”
“No Gov. Name Area (Km2) Population Census (2005) Health services Comments
1 Jahra 12,130 272,273 Primary care centres in each town and 1 general hospital Jahra hospital has a maternity department and neonatal ICU, so there is a TPN unit in the pharmacy department
2 Asimah 200 261,013 Primary care centres in each town and 1 general hospital The hospital is called Amiri hospital, no maternity department, patients are referred to Sabah health area
3 Farwaniya 190 622,123 Primary care centres in each town and 1 general hospital Farwaniya hospital has a maternity department and neonatal ICU, so there the need for TPN unit is very essential in the pharmacy department
4 Hawalli 84 487,514 Primary care centres in each town and 1 general hospital The hospital is called Mubarak Alkabeer general hospital, no maternity department and patients referred to Sabah health area
5 Mubarak Alkabeer 94 176,519 Primary care centres in each town and 1 general hospital The hospital is called Adan hospital; the pharmacy department has a TPN facility to serve the neonatal ICU.
6 Ahmadi 5120 393,861 Primary care centres in each town and 1 general hospital but it is for the Kuwait oil company staff and relatives

Patients in this area are referred to Mubarak Alkabeer health area (Adan hospital)
Total 17,818 2,213,403
7 Sabah health district This is a centralized health area for the whole of Kuwait It consists of different tertiary specialized hospital Examples: Maternity hospital, Chest and Heart hospital, Cancer center, psychotropic hospital etc. Patients all over Kuwait can be referred to Sabah health area whether to see a specialist or if the service is not available in their own area e.g. Maternity”
“NB: Jahra area (1) and Ahmadi area (6) have quiet large area, but people are congregating in small area because most of these areas are owned by the Kuwait oil company for the presence of oil fields.””

Table (3): Data from MOH General Hospitals in 2009. (Health, Kuwait 2009)
Hospital No of beds Discharges Outpatient visits Emergency Physicians Nurses
Jahra 753 35481 149460 538411 354 1371
Amiri 398 14203 179307 170287 417 994
Farwaniya 866 31335 325645 664525 522 1411
Mubarak Alkabeer 439 18138 192518 386652 561 891
Adan 563 28877 219076 515170 465 1371
Sabah 498 20060 156148 310578 390 1123

• The numbers shown in the table above have changed during last five years, however, Farwaniya hospital have more than 1000 hospital beds now. In order to reduce the burden on these 6 general hospitals new general hospitals and health care units will be established in Kuwait.

• As shown in the table distribution of health care staff mainly physicians and nurses is not proportional to the number of beds. The unproportioned because of the centralized administration.

• “One of the reasons from the lack of proportional distribution is that the money comes from the government (MOH) to these hospitals,“which put hospital administrations under the huge burden to provide hospital staff for all the departments in their hospitals.””
“One of the solutions presented recently to solve the problem of shortage is to use private sector to provide the hospital with staff and facilities to accommodate more staff in different departments of these hospitals.”However, one of the drawbacks of the solution can be that staff provided by private sector will need training and the time to understand and settle and the companies will not provide those facilities. Thus, if the staff is provided by private sector hospitals will need to provide them with extensive and good quality training programmes.

“Figure (3):
A graph of the number of beds in relation to the number of
Physicians and nurses in 6 General Hospitals across Kuwait.”

“As shown in figure (3) Farwaniya hospital which has the greatest number of beds does not have good number of physicians because of the central administration in MOH.”

1.8) Recent Health indicators (WHO)

Table (4) Shows related recent health indicators from WHO in Kuwait (2012 data)
Kuwait Regional average Global average
“Total fertility rate (woman)” 2.6 3.2 2.5
“Under 5 mortality rate (deaths per 1000 live births)” 11 57 48
“Infant mortality rate (deaths per 1000 live births)” 10 44 16
“Neonatal mortality rate (per 1000 live births)” 6 26 10
“Mortality due to neonatal sepsis %” 1 8 6
“DTP3 immunization among 1 year olds” 98% 83% 94%
“Preterm births per 100 births (2010)” 10.6 Average Arab Gulf 8.75 6-14.3, 14.3 being highest and 6 being lowest
“Births attended by skilled health personnel” 99% 58% 96%
“Preterm birth rate (per 100 live births)” 11 12 10
“Measles immunization 1 year old” 99% 83% 93
“Health workforce per 10,000 (physicians)” 17.9 11.4 12.8
“Pharmaceutical personnel per 10,000“ 3 6.1 2.4
“Health workforce per 10,000 (nurses and midwives) “ 45.5 16.1 28.4

1.9 Clinical approach in the NICU in the proposed service:

In Kuwait in general there is no clinical pharmacy approach in any hospital, however, in our proposed TPN service we can start in clinical approach by visiting the NICU ward. The pharmacist in charge of the TPN service should attend in the NICU ward and he/she should be dedicated only to the nutritional aspects of neonates. Once there is a clinical pharmacy service applied in the hospital a separate pharmacist should be appointed to the ward. So here I am only proposing the role of the TPN pharmacist in the ward.

First of all, we can start by insuring that the product should have the following to be provided for:
– Providing a suitable storage place for the finished TPN bag e.g. a suitable fridge to keep TPN bags
– Discussing any problems with the TPN request forms with physicians and nurses if they have any errors
– Checking some specific aspects regarding neonates especially (neonatal fluid physiology, fluid losses, basal fluid requirements and monitoring fluid status)
– Checking electrolytes requirements (Sodium, Potassium, Calcium and magnesium)
– Checking if any neonatal patient have any complications such as (Hyper-hypo-glycaemia, hypocalcaemia, Hyper-hypo-manesaemia and Hyperkalaemia) and making the appropriate adjustments after discussing it with the physician in charge
– Checking the nutritional need for each patient (Dextrose, amino acids, Lipid emulsions, vitamins and minerals)
– If a manual model is adapted the pharmacist should do the appropriate calculations in all the TPN bag contents
– Caloric requirements, it is estimated that 80-105 kcal/kg/d is needed for a premature infant. (Steven M. Donn, MD)

1.10 Current situation in Farwaniya Hospital:

Current situation in the NICU regarding neonatal nutrition involves ordering from doctors through pharmacy books of the total bottles of IV fluids from they need per day as an urgent request from the pharmacy. Then asking the nurses to deliver to deliver the solutions to the neonates individually.
Recently, in our hospital a new departments have been opened (Quality control and infection control) and they always stressed that in-patients especially critically ill patients need to use injections, infusions and any disposable items individually (not to share anything even if there is a remainder of any solutions). As a result all bottles used in the NICU will be considered wastage. Hence, new IV solutions are being ordered everyday.
This subject is a major issue in our hospital simply because around 20 neonates need IV parenteral nutrition support and in order to do the calculations, ordering and administering these solutions to all neonates is a time consuming and hard work for nurses and physicians as well.

In top of that, both the quality control and the infection control departments were complaining every month about this in terms of risk of infections and how nurses dealing with IV solutions where they have no experience and knowledge of the stability, compatibility, risky environment and calculations needed to deliver the right amount of the daily needs for the neonates.

The risk of contamination is far higher when parenteral products are prepared in uncontrolled environments.(Beaney, 2006)
In addition, bottles of PN administered several times daily per patient have had higher infection rates and patients will cost more because they will use more antibiotics compared to patients with once daily administration of commercially TPN bag.

2.1) PEST Analysis Table (5

2.2) SWOT Analysis Table (6)

2.3) Proposed Models:

“Models from Kuwait’s different hospitals such as Jahra and Adan hospitals where they have used TPN units can be proposed and considered for Farwaniya hospital with minor changes and alterations. For example if the model is considered for Farwaniya hospital it will be more appropriate because TPN supplies are expensive and need a special budget and order.”

Figure (4) Shows the some of the items needed for the service

(Photos from personal communication)

“2.4) Proposed models from Literature review and from London local hospital (GOSH):”

Studies compared a group that received a standardized computerized protocol and a group that received individual regimen carried out by neonatologists, a wide diversity of formulations are used in the second group (Maria and Skouroliakou, 2009). Different factors that were recorded are number of days of hospitalization, body weight, blood count and biochemical profile at the beginning and end of parental nutrition support. The outcome of the study showed that utilization of standardized protocols in preterm neonates results in proper provision nutrients, better weight and blood count as compared with protocols prescribed by individual physicians. Thus, patients that were under care in the hospitals had better results than patients obtaining treatment from individual physicians (Maria and Skouroliakou, 2009).

“Indications for TPN in the hospitalized patients (Vadana, 1999):”
(A prospective review of evolving practice by Vandana Nehra and et al 1999)
– “The prospective review explains the importance of nutritional support services. According to the review there should be a NSS respomsible for indications of TPN and should contain members of different clinics. Committee should consist of members such as physician, dietitian, nurse and pharmacist, and each member should have his or her own task and each member will play an important role in parental nutrition. Moreover, committee is also responsible for developing protocols, guidelines and in-service quality assurance.”
– “Other studies have different name of this team i.e. “multi-disciplinary team that consists of a biochemist, microbiologist and infection control clinical nurse. (Hamilton, 2000).”
– Great Ormond Street Hospital for Children (GOSH)
“On Contacting GOSH, they provided with information on the positive things that they are doing. One of the positive things that they are doing is providing parents with useful information about TPN, i.e. providing leaflets about TPN to explain in simple terms as following:”
• “What is TPN?”
• “Why they are using TPN?”
• “How TPN can work to neonates?”
• “The monitoring process and any risks of TPN use (especially for home TPN)
This is very useful to include in the TPN service because a lot of parents and public can be confused and cannot differentiate between TPN and IV infusion of medications.”
Their Procedure guideline can be found in the (The Great Ormond Street Hospital Manual Of Children’s Nursing Practices) (Macqueen et al., 2012)

Table (7) shows some of the procedure guidelines that can be used in our TPN unit model; these guidelines should be followed from all healthcare professionals dealing with TPN solutions
Statement Rationale
Inform the Family Reasons for TPN use, duration, Side effect, Benefits
Child need a Neonatologist To determine type of IV access
Baseline parameters should be measured To determine effectiveness of TPN
Observations should be recorded before starting TPN Temperature, heart rate, respiratory rate and BP
Weight and height should be recorded To monitor growth
Nutritional blood and urine samples To correct any imbalance in electrolytes, vitamins, trace elements and to prevent any metabolic complications
Venous access, long term TPN should be administered via central venous access device To minimise risk of extravasation injury and phlebitis
A dedicated nutrition line should be used whenever possible To reduce risk of infection
All healthcare professionals when dealing with TPN bag should check -Name, date of birth and hospital number
-That the bag is intact
-TPN has been stored in a fridge, and removed 1-4 hours before use
-The temperature of the fridge is recorded daily
Preparation of TPN in designated area, where access is restricted -Best to have an aseptic area for preparation to minimise risk of infection
TPN should be discarded after 24 hours and new administration set and filter should be used To reduce risk of infection
TPN solution should be checked for leakage and precipitate To avoid fluid contamination and reduce risk of infection
“When lipid is not included in the TPN and vitamins were added, the bag should be covered” Some vitamins are light-sensitive
Do not add any drug to the TPN bag To maintain the stability of the solution and reduce the risk of infection

ITH-pharma (Company that provide TPN preparations to several hospitals in the UK and to my placement hospital NMUHT)

“An incident significant to this research that happened in the company during TPN preparations was an incident of death of one baby and 14 poisoned from contaminated drips. After the incident hospitals across England developed septicemia to avoid any mishaps because of infected drips. (Donnelly, Smitth and Martin, 2014). Th incident and precautions after the incident indicate the importance of having professionals and maintaining good services at all times. Therefore, it is important to have both quantity and quality assurance. Moreover, it is better to have a developed quality assurance protocol that is not connected to the service provider of the TPN.”

Table (8) shows the proposed model that should be adapted

Item/service Comments and explanations
Store “A private store should be provided to TPN unit, preferably near the unit”
Two rooms “Two rooms separated by a changing area, which in one side is the entrance and preparation area. The other side is a clean aseptic room, where it is a specially constructed to have an aseptic environment”
TPN daily disposable supplies “TPN bags, TPN valves, two trolleys, 70% alcohol pump to sterilize everything that will go to the aseptic room and two aluminum trays”
TPN electrolytes fluid and nutrients “Usually they are available in the hospital, but once a TPN unit is open large quantities are needed for the pharmacy department: -Dextrose, Nitrogen (Pediatric amino-sol), Sodium, Potassium, Phosphate, Calcium, Magnesium, Pedi-trace (trace elements), Solu-vit (vitamins), and Lipids (vita-lipid) all these IV solutions come in different concentrations, so the company that provide the TPN use should setup with the nutritional team what strengths should be used”
Isolator “Where the mixing of the sterilized electrolytes and nutrients will take place. It should be for two people to work on”
Compounder “The machine that mixes the electrolytes and nutrients (careful setup should be taken and have a regular pathway for each solution and these pathway should be fixed). Two compounders should be provided, where one is used and the other one should be on stand-by just to make sure that when one compounder break down the other one can be used. This is important to make sure that the service will not be disrupted in any conditions”
Computer “Two computers with a fixed programme, usually provided by the company that will establish the service to the hospital. Maintenance of the programme and the whole service also provided.”
Nutritional service team “A committee team that meet in a regular bases, which evaluate the service, provide training and monitor TPN service”
TPN unit team “Two pharmacists and two pharmacy technicians. One pharmacist can be the chief of the unit. Usually one pharmacist and one technician should be on-duty to do the daily work and the others can work in any of the pharmacy department, but they should be prepared to step in if they needed. The chief pharmacist should arrange any holiday leave between the 4 members in this team”

3.1) Daily work in TPN unit:

-There are 3 types of prescriptions (Adult, paediatrics and neonates), but in the proposed unit we will start with neonates and they are the main population to be targeted in this TPN unit.

-Calculations for neonates are according to the body weight “per kg”

3.2) Procedure of requesting TPN: –

1. Request or prescription should come from the physician in charge of the patient and usually a special request form is written to indicate that this patient is neonate to differentiate it from adult and paediatrics forms.
2. According to Laboratory results, the physician and pharmacist can finalise the prescription
3. For any new patient the pharmacist must check the prescription for patient name, the file number, location on ward and weight. Then must check the ingredients and total volume of the preparation to make sure that it will be possible to prepare.
Calculation and preparing for compounding: –
1. The pharmacist must do a proper calculation to get the right volumes for each ingredient. The used calculation for TPN is to convert the quantity requested in millimoles or milligrams to volume using the available concentrations.
2. Usually these calculations done by using the Abacus TPN software to get accurate results and save time (an example is proposed in section 4.2). Just feeding the software with required quantity for each patient does it and at the end it will provide a label of the ingredients for each patient including the patient data and the bag volume.
3. One of the advantages of this operating software that it is linked to the entered data and the operating software, which operates the compounder.
4. After printing the ingredient list, the pharmacist should prepare the required items to take them to the aseptic room (bags, tubes, solutions, syringes, and needles should be taken through the hatch connected between the computer room and the clean room.
5. Everything gets to the clean room should be cleaned and sprayed with 70% alcohol.
6. The technician should enter the room and finish the work at once. This is done to reduce the chances of contamination and particulates generation.

Compounding: –
1. Before starting the compounding process, the technician must clean and disinfect the isolator properly with alcohol 70%.
2. A stainless steel tray must be used in the hatch room to use it in transferring the items into and out of the aseptic chamber of the isolator.
3. First thing to enter the isolator (alcohol spray, sterile gauze, small stainless steel tray) to clean the isolator from inside.
4. Then all other items should be entered through the chamber (ampoules, syringes, needles, small vials, blood agar plates, waste flask and the Bactic bottles for sterility testing)
5. At this point, the process of filling the syringes with solutions from ampoules and vials should be under way to attach them into the compounder into defined numbers ports in the compounder (these numbers should be assigned at first then maintained permanently to make the work easier with time and to avoid any error)
6. After filling all ports with the required ingredients, the mixing process of solutions should start and this is done automatically by reading the barcode for each bag.
7. The compounder automatically weighs the bag after the mixing and it should be within ±3%.
8. If the weight is acceptable, the bag should be clipped and labeled and put in the transfer hatch, if not re-compounding should be done to any faulted preparation.

3.3) TPN regimen from the literature:

“TPN regimen for neonates can be designed according to the guidelines of the American society of parenteral and enteral nutrition (ASPE).”Then, the regimen can be integrated to computer software. Protocols will be defined according to gestational age, birth weight and everyday body weight.(Skouroliakou et al., 2009)

Table (9) shows an example of computerized daily TPN requirements protocol for gestational age of 28-32 weeks

Day of life Fluids ml/kg Amino-acid
g/kg Dextrose mg/kg/min Fat
g/kg Sodium
mEq/kg Calcium mg/kg
1 90 1 6 0 0 30
2 110 1.3 8 1 0 40
3 130 1.8 9 1.5 3 50
4 140 2 10 2 3 55
5 150 2.2 11 2.5 3 60

“This standardized protocols resulted in a better provisions of nutrients, weight gain and better blood count values compared with protocols prescribed by individual neonatologists”.(Skouroliakou et al., 2009)
This computerized protocol will be adapted and used in our established unit and it will be provided from Baxter company (Abacus software).

4.1) Financial Plan:

– The service that the TPN unit will provide to NICU and SCBU in Farwaniya hospital will be free of charge.
Critical patients have a free of charge service in governmental hospitals in Kuwait, especially in ICU, NICU and PICU wards.

Financial aim of TPN service is by cost avoidance some existing aspects such as, reducing the hospital stay for neonates and reducing the incidences of infections.

The source of funding usually is from hospital administration and management team. The ministry of health in Kuwait provides budgets to hospital managers to establish new units or new services.

4.2) Start-up cost:
Table (10) calculating the start up cost and cost estimation in the first 12 months from local hospital engineering office.

Cost for 12 months staff salaries+building clean room
= 1500+(1300+850)×12= 27,300 KD (clean room+staff salary in the first year)
Table (11) calculating the start up cost and cost estimation in the first 12 months for items provided from private company (BAXA)

Cost for 12 months= 35,000+10,000+(0.5×400)+(10×400)+3650= 52,850 KD

Total Cost for start up and 12 months supply of items, clean room and staff salaries for the TPN unit service (27,300+52,850)= 80,150 KD

4.3) Fixed cost:

Table (12) calculating the fixed annual cost
Total annual fixed cost = (1310+860×12)+(400×0.5+400×10+3650)= 33,890 KD (cost of the 2nd year), the 3rd year we add 240 KD =34,130 KD, the 4th year we add 240 KD 34,370 KD, and the 5th year we add 240 KD 34,610 KD.

This is the annual fixed cost and every year we add 240 KD the increment salary of staff. However, after 5 years a larger increase in salary is expected so, TPN staff can be rotated with junior pharmacist and junior pharmacy technician to avoid a bigger increase in costs.

Table (13) of other items that are needed that usually provided free from (BAXA) company

4.4) Cost avoidance:

Table (14) Cost avoidance of TPN service from the literature
Literature Details Financial benefit Comments
(Bagri et al., 2015)
Impact of malnutrition on critically ill children Reducing the severity of malnourished children in the PICU reduces hospital stay Non-malnourished children will stay ≤7 days in PICU, this can be related to neonates in NICU but each neonates may have different condition
(Parish and Bhatia, 2008)
“Early aggressive nutrition for the premature infants” Prolonging the survival rates of neonates may increase the NICU stay but it will prevent death which is one of the goals for the WHO (quality service) PN gave neonates a chance to survive and prevent malnutrition and starvation
(Skouroliakou et al., 2005)
Computer assisted TPN can optimize pharmacists work Electronic prescriptions and calculations can prevent any errors in TPN used bags and safe unwanted wastage of products and solutions Using a computerized system does not mean manual calculations should be neglected, regular training is needed and complete understanding is a must
(Yu et al., 1979)
“TPN found to be effective and safe even with very low birth weight infants <1200g” PN developed with time, complications these days still exist and can cost more money, however even without TPN there are neonatal complications New and professional TPN service should be provided to minimize complications from TPN e.g. (infections, sepsis, and candida infections) (Stephens et al., 2009) “First week protein and energy intake in extremely low birth weight infants can prevent any developmental outcomes measured in 18 moths time” Financially preventing any developmental and mental problems can safe a lot of money in terms of future costs in healthcare services It is hard to put figures and numbers on how much money we can safe from this because still there is no definite average how many neonates can be prevented from any development problems further research is needed to assume the costs (Berlana et al., 2013) Cost analysis of premixed TPN bags vs. compounded TPN in the pharmacy Compounded TPN bags financially beneficial only when > 15 bags per day are used In Farwaniya hospital it is estimated that the average daily preparations around 20 bags daily (according to the NICU, SCBU departments)
(Simmer et al., 2013)
Benefits of standardised PN “Better provision of nutrients and electrolytes, less administration and prescription errors, decreased risk of infections and cost savings” Better to have a standardized compounded TPN bags than ready made TPN bags because neonates often need electrolytes and nutrition adjustments and this is can be manually adjusted in the compounding phase
(Dice et al., 1981)
Comparison between PN in NICU with pharmacist’s monitoring and standard service without pharmacist monitoring Intervention of pharmacists is cost effective in terms of providing TPN service Nurses are usually busy, so providing a TPN service will be beneficial for nurses and it will provide more time for them because they are delivering PN in separate bottles in a non-aseptic environment
An electronic article from UAE
(Emirates 24/7 NEWS) 6/6/2012 discussing a family which have a twins in the NICU in UAE The daily cost of NICU is 3900 AED= 319 KD Due to lack of evidence from Kuwait we can estimate that the daily stay in NICU is 300 KD per patients per day
(Petrou and Khan, 2012)
Economic costs of moderate and late preterm infants Moderate preterm infant hospital stay 22 days and their total cost per live birth 13,639 GBP 13.639 GBP=6099 KD
6099 KD÷22= 277KD which is relatively near the previous number in UAE
(Boyle et al., 2015)
“Neonatal outcomes and delivery of care for infants” Infants divided into 3 groups
-32-33 weeks needed TPN for 8 days and stayed 16 days in hospital
-34-36 weeks patients needed TPN for 4 days
-> 37 days patients needed TPN for 3 days
-Not all infants needed TPN but it showed younger infants needed TPN more and infants between 34-37 weeks needed NICU stay less and TPN is essential part in delivery of care, however there is no specific and definite evidence suggesting how many days that TPN reduce the length of stay for infants in NICU. However, from neonatologists from Farwaniya hospital we can assume it can help to reduce the length of stay in NICU by 3 days if the infant needed 10 days without TPN. It provide growth and prevent infection
(Durand-Zaleski et al., 1997)
Infection risk between TPN commercial bags and glass bottles Infection rate found to be reduced when commercial TPN bags was used daily compared with glass bottles 3 times daily but it cost more money This study was on adults, in neonates more infections are imminent, so we can say saving money from infection reduction in infants could be at minimum

4.5) Break-even point:

We can calculate cost avoidance from reducing hospital stay, reducing the use of antibiotics (might even out if there is a complication) and by reducing the total amount of IV PN solutions when, they are mixed by compounding.

So by calculating cost avoidance through the reduction of the total amount of solutions used everyday during the current situation, which was explained in section (1.10) earlier.

As mentioned before in section (1.10) each patient is using daily individual bottles of PN and the remainder of any amount used solution is discarded as waste.

Table (15) shows the daily consumption of different fluids/day/patient 20 neonatal patients at the current situation
IV fluid Cost/bottle Total cost/day for 20 patients Total cost/year for 20 patients

Vaminolact 100 ml 2.1 KD 42 KD 15,330 KD
Vamin 9 Glucose 100ml 1.9 KD 38 KD 13,870 KD
Lipofundin 10% 100ml 3.7 KD 74 KD 27,010 KD
Peditrace (trace elements) 1.7 KD 34 KD 12,410 KD
Solivito N (vitamins) 0.9 KD 18 KD 6570 KD
Total 10.3 KD 206 75,190 KD
The cost of fluids obtained from the BNF for children 2014/2015 and usually it is cheaper compared to Kuwait and the rate converted according to 1 KD= 2.1 UKP

Table (16) shows the daily consumption of different fluids/day/patient (20 neonatal patients if TPN compounding and mixing the fluids is used) the total amount of bottles used from Aljahra and Aladan hospitals where they have TPN service
IV fluid No. Of fluid needed for 20 patients and daily cost Total cost/year Cost avoidance between table and table
Vaminolact 500 ml 3 bottles=6.3 KD 2299.5 KD 13030.5 KD
Vamin 9 Glucose 500 ml 7 bottles=13.3 KD 4854.5 KD 9015.5 KD
Lipofundin 10% 500 ml 4 bottles=14.8 KD 5402 KD 21,608 KD
Peditrace (trace elements) 4 vials=6.8 KD 2482 KD 9928 KD
Solivito N (vitamins) 6 ampules=5.4 KD 1971 KD 4599 KD
Total 46.6 KD 17009 KD 58,181 KD

– So let us say cost avoidance is 4848 KD/month to make it easier, the fixed cost of TPN every year can be divided to the monthly payments of salaries and the annual cost of disposable that it should be paid at the beginning at the year

Table (17) shows the cost of the service for 5 years and the cost savings or avoidance
Year Cost of the TPN service Cost avoidance Comments
1 80,150 KD 58,181 KD Start up cost
2 33,890 KD (114040 KD) 116,362 KD Raise in salaries 240 KD per year
Break even after 2 years (24 months)
3 34130 KD (148,170) 174,543 KD
4 34,370 KD (182,540 KD) 232,724 KD
5 34610 KD (217,150 KD) 290905 KD
6 34850 KD (252,000 KD) 349086 KD

Figure (4) showing break-even point in the 5th year of starting TPN service

4.6) Sensitivity analysis

Table (18) shows best worst-case scenario
“Best case scenario” “Worst case scenario”
-Starting to prepare for the service in terms of place construction and staff training
-Good training is essential as well as selecting professional and dedicated staff
-Starting with TPN preparations samples for probably 2-3 weeks and do quality assurance tests, to ensure there is no contamination
-Before any official opening certain departments need to know (later on marketing)
-Essential to have written local guidelines for the service compatible with other TPN services on Kuwait and complying with the company that supplying the TPN service and TPN items
-Once the service is up and running documentations, surveys and audits are essential to do in regular basis
-Maintaining the stock of TPN supplies is very important to make sure that items not running out, that is why it is important to have a storage near the TPN unit -There are probably many bad scenarios may happen, however, the worst of them all is to get a contaminated TPN bags into neonates and cause any infection that may result into death of any patients
-This will result into the closure of the service, and all this money will be spend into a service that was badly handled and closed
-To prevent that from happening a professional training programme should be followed in other hospitals and from the private company that will supply the TPN service supplies and items

– For a TPN service to be established, the best scenario needs to be achieved at all times because it is a service for critically ill patients. There is no middle ground in this service you either need to be at your best in providing this service or not. Any below par service will result directly to the worst scenario where you will lose all the start-up finance over
Nothing and the unit will be shutdown once and for all.

5.1) Marketing plan:

The service will target neonates in Farwaniya hospital in NICU & SCBU wards for around 40 beds with a target of 20 preparation bags per day.

5.2) Stakeholders:

Table (19) shows the stakeholder that the TPN service can be associated with the TPN service
Stakeholder Comments
MOH and hospital administration (Financial power)
The main stakeholder responsible to provide money to start, maintain and construct the service (low impact in terms of service application)
Pharmacy department (Application power) Responsible in the daily work and functioning of the service (High impact and high power, it is a pharmacist led service)
Neonates patients (High impact) The neonates patients in the NICU, SCBU in Farwaniya hospital and probably neonates in any near private hospitals (if applicable) will benefit directly from this service
Physicians (Prescription power) Neonatologists need adequate knowledge on writing TPN prescriptions and the scheme of regimens of TPN feed. (Medium impact but still play major role in the service)
Nursing staff (Delivery power) The nursing staff in the NICU and SCBU wards will benefit directly from the service and also need training on how to administer TPN bags whether through central or peripheral lines
Other pharmacy department in any other governmental hospital (Training power) In terms of training exchange and providing training expertise from and to this service, because the MOH is trying to make a chain in all governmental hospitals
Pharmaceutical administration MOH (Staffing and training power) They are the centre for providing adequate staff and distributing pharmacists and pharmacy technicians and providing schemes of training for different services across Kuwait. Having a TPN service in Farwaniya hospital will definitely attract more pharmacists to train in Farwaniya hospital and this probably promote the chance for them to work at Farwaniya hospital.
Kuwait Pharmaceutical Association (Marketing power) KPA play a vital role especially in promoting and introducing the service and campaigning to other healthcare professionals and to the public

5.3) Marketing Strategy:

Table (20) shows the marketing plan and the related Logos that can be used to promote the service (The 4 P’s model)
4 P’s Comments Logo example
Product TPN bag feed provided for 24-hour use, it is a new product to be used in Farwaniya hospital. All healthcare staff that will get in contact with it will need to be educated about it.
The logo of the private company can be used on the product and the office to provide few items free for example (furniture, computers, stationaries and free training)
Place The place of the TPN unit will be in Farwaniya hospital in the pharmacy department providing the service to neonates in the hospital and other hospitals in need if applicable in the future
Price The service will be free for all neonates, MOH in Kuwait provide free service for all public with critical conditions, MOH logo when appear in a product means it is a quality product, even if it is not applicable to use the logo on the label just using it in the documentation means the service is a quality service from MOH
Promotion Promotion for the service can be done free in the hospital by inviting TV stations, Newspapers and Radio stations they will come free because the service is a governmental service
Also promotion can be done free in the Kuwait Pharmaceutical Association (KPA) to promote the service for the public and other healthcare professionals and all media can present and Baxter company will provide a dinner in the hall of the KPA and all that will be free and the logo of all sponsors can be used as well as the KPA logo

6.1) Quality Assurance (QA): –

The unit should work under aseptic environment and sterile preparations, all procedures and equipment should be tested and approved (Usually from a local committee and another unbiased committee).
The QA covers the product, personnel and the environment.

6.2) The product:

-It is tested in three different tests:

1. Visual test: -The TPN bag should be checked for colour change, precipitation, creaming/cracking in the fatty emulsion solutions
2. Sterility test: – A 20 ml sample is taken randomly from any prepared bag. The sample is injected into Bactec media 5ml in the aerobic and 10ml anaerobic media. Then the media should be incubated for 5 days in the microbiology lab.
3. The content: – The finished product must be weighed to check the delivered quantity.

QA for the environment applied on the isolator: -The filters for the isolator should be changed regularly (according to the company advice and they should provide enough filters for that). The main pre-filter should be changed every 6 months; the main HEPA (High efficiency particulate arrestance) filter should be changed every year. Filters should be provided from the company and it is part of the maintenance programme to the TPN unit.

The personnel: – Any pharmacist or technician working in the unit should have adequate training.
The staff should perform in a professional manner especially in the clean room. They are not allowed to eat or drink in the room; watches or rings should not be worn in the room because they may collect contamination.
All staff working in the unit should wear sterile gown, gloves, head cover, mask and medical slipper.

Validation: Operators, procedures, the working environment, and equipment should be initially validated and thereafter regularly monitored. Records of validations and checks should be monitored.

6.3) Documentation:
-Any procedure done in the unit must be documented and double-checked. A complete record of all operations and preparations should be maintained.
-The documents are a proof that, the procedures are running in the right way and the pharmacist must sign after finishing each step.
-Documentation, including written procedures and preparation records, should be numbered and appropriately stored and they should include:
a. Personal training and maintaining records
b. Quality assurance and procedure records
c. Patient records (as computerized files)
d. Authorization reports and Mixcheck reports (should be kept for one year)
e. Stock orders for special items
f. Labels and worksheet design should be taken into account of all TPN batch production or dispensing activity

6.4) Distributions and Storage:

1. Storage of the prepared TPN bags should be in..