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OFFICIAL JOURNAL OF THE PHARMACEUTICAL SOCIETY OF KENYA Pharmaceutical The of Kenya Vol. 22, No. 1 | September 2014 9 770378 228009 ISSN 0378-228X 2 CONTENTS 3 9 13 19 23 Editorial: Pharmacy and Technology Correct inhaler technique of pressurized metered dose inhaler resulting in asthma control at Kenyatta National Hospital In vitro activity of tea tree oil produced in Tanzania against standard bacteria and fungi. Safe handling of anti- cancer medicines The future of evidence based practice The evolution of pharmaceutical supply systems in the county devolved governments PJK

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Page 1: The Pharmaceutical Nov PRINTED.pdf · PJK. Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 2014 Fast and Effective Relief from Cold and Flu SINUS HEADACHE NASAL & CHEST

OFFICIAL JOURNAL OF THE PHARMACEUTICAL SOCIETY OF KENYA

PharmaceuticalThe

of KenyaVol. 22, No. 1 | September 2014

9 770378 228009

ISSN 0378-228X

2

CONTENTS

3

9

13

19

23

Editorial: Pharmacy and Technology

Correct inhaler technique of pressurized metered dose inhaler resulting in asthma control at Kenyatta National Hospital

In vitro activity of tea tree oil produced in Tanzania against standard bacteria and fungi.

Safe handling of anti- cancer medicines

The future of evidence based practice

The evolution of pharmaceutical supply systems in the county devolved governments

PJK

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 2014

Fast and Effective Relieffrom Cold and Flu

SINUS HEADACHE

NASAL & CHEST CONGESTION

RUNNY NOSE

FLU

COLD

DOSE: Adults & Children over 12 years: One to two capsules to be taken every four to six hours. Do not exceed eight capsules in any 24 hours. Children under 12 years: Not Recommended. Or as directed by a Doctor. DO NOT EXCEED THE STATED DOSE. If symptoms persist seek medical advice.

REGAL PHARMACEUTICALS LTD. Manufacturers of Quality Pharmaceutical Products

Plot No. 7879/18, Off Baba Dogo Road, Ruaraka. P.O. Box 44421 - 00100, Nairobi. www.regalpharmaceuticals.com

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 2014 1

EDITOR IN CHIEFJennifer A. Orwa,

PhD, MSc, B.Pharm, FPSK, OGW

EDITORSDr. Nelly G. Kimani, B.Pharm, MPSK

Dr. Apollo Maima, M. Pharm, B. Pharm, MPSKDr. Esther Karimi, B. Pharm, MPSK

Dr. Eveline Wesangula, M.Pharm, B.Pharm, MPSK

ASSISTANT EDITORDr. Nadia Butt, B.Pharm, H.BSc., MPSK

PSK NATIONAL EXECUTIVE MEMBERSDr. Paul Mwaniki - President

Dr. Nelly G. Kimani - Deputy President Dr. Michael Kabiru - National Treasurer

PUBLISHED BY:Pharmaceutical Society of Kenya

Hurlingham Woodlands Road, Opp. Department of Defense (DOD)P.O. Box 44290-00100 GPO Nairobi, Kenya

Tel/fax: +254 20 2738364/18Mobile: +254 722 817 264 / 0723 310 942

E-mail: [email protected]: www.psk.or.ke

The views expressed in ‘The Pharmaceutical Journal of Kenya’ are those of the respective authors and do not necessarily reflect those of the Editor-in-Chief or Members of the Editorial Board or those of the Pharmaceutical Society of Kenya. The Editor welcomes contributions from readers on subjects of interest to the pharmaceutical industry and the health sector in general. Articles may be shortened or modified for

clarity or brevity or rejected in totality without assignment of reason or explanation.

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 20142

With the turn of the century there have been leaps made in managing diseases world over. Technology has ensured that there is improved service delivery with

focus on the end consumer, the patient. Computer technology has revolutionized many industries. The role of computer technology is to mainly relieve man from carrying routine, repetitive and monotonous tasks to be conducted with consistent accuracy.

However, it was only recently in late 2000 that automated dispensing was implemented in developed countries. These machines have shown huge advantages in reducing dispensing errors and increasing efficiency, leaving room for pharmacists to explore other specialized areas to deliver patient-centered services. Introduction of electronic ward cabinets in hospitals is highly advantageous because of reduced chances of missed doses, especially for critically ill in-patients, reduced chances of supply delays, stock outs and wastage. However this has not been fully explored because of the cost impact.

Information Technology (IT) has enabled automated information processing, storage of patient and medication records, electronic prescribing and dispensing, labeling, ordering and stock control. It has provided a basis for monitoring the efficacy and safety of medicines in use. This has indeed enabled professionals to provide high quality care and help patients make the most of their medicines. Despite the fact that pharmacies have embraced IT, we are yet to optimize these resources. Since we are continuously improving operational systems, IT could be used as modules to handle patient centered services, such as medicines use reviews or prescription interventions. The huge amount of data held in National Health Information Systems could be evaluated and used by research bodies as well as in informing policy decision making.

PHARMACY AND TECHNOLOGYDr Esther Karimi | [email protected]

EditorialThe internet is a wealth of information that pharmacists have access to by way of journals, e-books, Pharmacopoeias, articles, social groups and a key tool in the dissemination of information on medicines and health from Pharmacies. Web-based platforms are available from various providers to support enhanced pharmacy services and public health initiatives.

Mobile phone applications have tangentially gained popularity. The use of mobile telephones is widespread in society. Some Pharmacies use text alerts to remind patients that repeat prescriptions are ready or to offer services, but sophisticated applications have been developed for disease monitoring, for example, recording of peak flow readings in asthma, monitoring of blood glucose levels, medication adherence support and health education. These applications will have a greater impact on Pharmacy practice in future. A manufacturing company in Kenya has developed a system in which their customers can send the batch number of the product through an SMS platform and get information on the authenticity of the product. This was an initiative to curb counterfeiting. The Pharmaceutical Society of Kenya also intends to implement a mobile phone application to manage Continuous Professional Development points system in order to improve efficiency and ease of accessibility of the articles by pharmacists in Kenya.

Another new way of working is tele care, which involves the use of digital communications technology (audio and visual) to provide health care consultations and services to patients remotely at home. This would be of benefit to patients who have reduced mobility and places them at the centre of their care supporting personalized medicine. Another advantage would be the reduction in transportation costs. In pharmacy, use of remote consultations and an internet pharmacy supply service could transform the way that pharmacy services are provided. However, adoption of tele care in Pharmacy would be dependent on the availability of reliable communications and the willingness of Pharmacy operators and those in homes to invest in digital technologies.

In conclusion, the potential use of technology to support pharmacy processes is enormous and the need to embrace and harness these technologies in time is critical.

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 2014 3

CORRECT INHALER TECHNIQUE OF PRESSURIZED METERED DOSE INHALER RESULTING IN ASTHMA CONTROL AT KENYATTA NATIONAL HOSPITALLangat GK, Kuria KAM, Mwangangi EM, Menge TB. | e-mail: [email protected]

AbstractA hospital based cross-sectional descriptive study was carried out to find out the outcome of incorrect inhalation techniques and asthma control at Kenyatta National Hospital. Systematic sampling was used to enrol a total of 100 asthmatic adult patients aged 12 years and above refilling pressurized metered dose inhalers at Kenyatta National Hospital. The mean age of those interviewed was 55.7 years (SD 15.8) with an age range of 29 to 90 years, 57% were female. Recent retraining on inhalation technique by a health worker was reported by 35% of the patients. No patient performed all the steps of inhalation technique correctly. All patients took off the cap. Correct performance of five or most of the critical steps was significantly associated with good asthma control. Re-training of inhaler technique at every clinic visit is recommended to improve asthma control.

KEYWORDS: Asthma, Pressurized metered dose inhaler, Re-training, Asthma control.

DECLARATION OF FUNDINGThe funding for this study was shared equally between the lead author and Tenwek Hospital.

IntroductionAccording to the Global Initiative for Asthma (GINA), the goal of asthma management is to achieve clinical control¹. When asthma is not controlled it results in absenteeism at work, school, and places a significant

social and economic burden on patients and their families².

Inhalation therapy is the current most efficacious and widely used method in delivering medication for asthma to the intended site of action. Contemporary inhalation therapy began in the nineteenth century in India, several centuries after the evolution of inhalation therapy. The first pressurized metered dose inhaler was introduced in 1956 by George Maison, a medical consultant at Riker Laboratories, USA³. This route assures the active ingredient is delivered to the lungs, where its actions relieve symptoms of asthma. Inhaled pressurized Metered Dose Inhaler (pMDI) can be used in every clinical and environmental situation, their dosing is convenient and highly reproducible, but their efficient delivery remains highly technique dependent⁴.

Good inhaler technique has been demonstrated in many studies to improve asthma control. Giraud et al demonstrated that in patients with good inhaler technique, their asthma was stable (which comprised 29% of patients under the study)⁵. Inhaler technique influences asthma control and should be taught at all contact points where health care professionals interact with the patient⁶.

Inhalation techniques can be improved by demonstration from a health professional or any other person trained in correct technique. Amount of instructions on inhaler technique given by health care professionals influences patient’s likelihood of correct technique. Another media for training includes interactive videos, which appeal more to adolescents than written instructions. One-on-one teaching sessions is effective especially for the elderly⁷.

One study showed that 25% of patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) had never received verbal inhaler technique instructions. Amongst those trained, instruction was often rushed, and of poor quality and not reinforced⁸.In a study carried out by Hersh et al, it showed that between the years 2000 and 2001 the asthma related visits to primary care physicians was 50%, but when education was instituted, there was a reduction of 12% of asthma related visits between 2005 and 2006⁹.Inhaler technique monitoring in every visit is recommended by Expert Panel Report 3, as an important part in management of asthma¹⁰. As much as training on correct inhaler technique is important, rechecking at regular intervals must be emphasized.

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 20144

According to National Asthma Council Australia, 90% of patients were unable to perform correct inhalation techniques during clinical trials in patients using Dry Powder Inhaler (DPI) or pMDI¹¹. A European study reported incorrect inhalation technique of 91% in Spain⁷. Giraud et al found 71% of patients performed incorrect inhalation technique, majority of which (47%) was due to poor coordination⁵. In a study in Memphis, 94% of patient committed at least one error¹².At Kenyatta National Hospital a study carried out by Machira et al concluded that among the paediatric patients and their care providers, 55% were unable to perform correct inhalation technique¹³. In a Korean study involving 10 University hospitals, 23.4% performance grade was inadequate in asthmatic patients using pMDI. Success rate for “exhale slowly to residual volume” step ranged from 24.2% to 28.5%¹⁴.Increase in unscheduled health care resource use and poor clinical control is associated with poor inhaler techniques¹⁵. In a study by Hammerlein et al, 80% of patients committed at least one error of inhalation technique¹⁶. There is need for checking inhalation technique during every clinic visit because decline in inhalation technique occurs over time¹⁷.

Health care givers can help patients overcome the problems of hand breath co-ordination associated with pMDIs usage by educating the patient during every clinic visit¹⁸. According to Desalu et al, amongst the subjects under study, 69.3% had uncontrolled asthma and this was strongly associated with incorrect inhaler technique among other variables¹⁹.

MethodologyApproval for this study was sought from Kenyatta National Hospital (KNH) / University of Nairobi Ethical and Research Committee. A cross sectional survey was conducted at the Kenyatta National Hospital out-patient pharmacy between June 2013 and October 2013. Kenyatta National Hospital is a teaching and referral hospital located in Kenya’s capital city, Nairobi. It was founded in 1901 and currently has a bed capacity of 1800. Patients are referred to Kenyatta Hospital from across the country and sometimes from neighboring countries. Observation was made on patient’s inhaler techniques using a check-list based on the United States National Heart, Lung and Blood Institute asthma management guidelines. The study population was

selected from asthmatic patients 12 years and older who attended the adult Chest Clinic at Kenyatta National Hospital and filled their pMDI prescriptions at Kenyatta National Hospital.

Only patients who had been on pMDI for more than one month and had given consent to be included in the study were sampled. The Principal Investigator (PI) presented himself at pharmacy 15 on Tuesdays and Fridays between 9 am to 1pm. The sampling technique that was employed was Systematic Random Sampling. Every second patient presenting themselves at the Pharmacy was approached for recruitment into the study. Data was collected by the Principal Investigator from these patients. The patients were first interviewed and the responses entered in the questionnaire form. Spirometry test was then taken to measure Forced Expiratory Volume (FEV1) in one second. The patient’s inhalation technique was then assessed. A check list as per United States NHLBI guidelines (Table 1) was used to assess inhalation technique. Patients were asked to demonstrate inhalation technique using a placebo inhaler provided by the Principal Investigator (PI) or using their own inhaler, whichever they preferred. The overall score was termed incorrect or correct. Correct was performance of all the inhalation steps without missing any. After the demonstration by the patient, the PI demonstrated the correct inhalation technique regardless of whether the patient performed correct or incorrect inhalation technique.

Table 1. Inhalation Steps

1. a. Take off the cap* b. Shake the inhaler2. Breathe out all the way3. Hold your inhaler in upright position*4 a. As you start breathing in slowly through your

mouth, press down on your inhaler once. *If using a chamber, first press down on the inhaler. Within 5 seconds, begin to breathe in slowly.

b. Breath in through the mouth.*5. Keep breathing in slowly after actuating.*6. Hold your breath as you count to 10 slowly, if you

can.7. For quick-relief medicine (beta2 agonists), wait for

15-30 seconds between puffs.

*Critical errors²⁰

The data from this study were analyzed using SPSS version 17. Correlation between critical steps

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 2014 5

Table 2. Characteristics of adult asthma patients using pressurized metered dose inhalers at KNH

Percent

Residence

Urban 50.0

Rural 50.0

Gender

Male 43.0

Figure 1. Age distribution of adult asthma patients on pMDI at KNH

performance and asthma control was analyzed by use of Pearson’s Chi square test. P value less than 0.05 was considered statistically significant.

ResultsDuring the study period a total of 100 adult asthma patients attending KNH for refilling of pressurized metered dose inhalers were recruited.

The average age of participants was 55.7 years (SD 15.8) with an age range between 29 and 90 years. Figure 1 shows that most (26%) asthma patients were in the age group 40-49 years. Females comprised 57% of participants with most (62%) patients being unemployed.

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 20146

Table 3. Critical steps performance and level of asthma control.

Level of asthma control

Controlled Partly controlled Uncontrolled Chi P Value

One or < one 60 47.1 5.7 30.72 <0.001

More than one 40 52.9 94.3

As shown in table 3, most (94.3%) patients who missed more than one critical step were significantly associated with uncontrolled asthma (p = <0.001).

Correct performance of three out of the four critical steps was significantly associated with level of asthma control (table 4): pressing inhaler (p < 0.001), keep breathing after actuating (p < 0.01) and breathing through the mouth (p < 0.001).

Female 57.3

Occupation

Employed 38.0

Unemployed 62.0

Monthly income

Less than Kshs 2500 58.0

Kshs 2500 and above 42.0

Highest level of formal education

No formal education 41.0

Primary 16.0

Secondary 17.0

Tertiary 26.0

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 2014 7

DiscussionThis study was to determine the outcome of incorrect inhalation technique. The total number of patients sampled in this study was 100.

Amongst all the asthma patients interviewed none was able to demonstrate all the steps of inhalation correctly without committing at least one error. In other similar studies, Mohammed et al reported that none of the patients could perform all the steps of pMDI inhalation correctly²¹. In another study by Giraud et al found 71% of patients performed incorrect inhalation technique, while in Self et al, 94% of patient committed at least one error⁵,¹². All patients interviewed were able to open the inhaler cap, and other steps most often performed correctly were holding of inhaler in an

Table 4: Specific critical steps performance and level of asthma control.

Level of asthma control

Controlled Partial Uncontrolled Chi P value

Holding inhaler in upright position

Correct 29 16 47 NA 0.28

Missed 1 1 7

Pressed inhaler

Correct 18 10 7 23.3 < 0.001

Incorrect 11 7 44

Missed 0 0 2 NA NA

Keep breathing

Correct 22 10 5 37.1 <0.001

Incorrect 8 6 46

Missed 0 1 2 NA NA

Breathing through mouth

Correct 9 1 1 23.3 <0.001

Incorrect 15 14 49

Missed 6 2 3

upright position and shaking the inhaler; 91% and 86% respectively while in Bryant L et al it was 93% and 84% respectively and all study subjects were able to perform step one correctly. These results are much comparable with these findings²². In this study the least correctly performed step by 11% of asthma patients was breathing in through the mouth. There are five critical steps of inhalation technique as per Newman et al: taking off the cap, holding inhaler in an upright position, breathing in slowly and simultaneous actuation of inhaler, breathing in through the mouth, and keep breathing in slowly after actuation²⁰. These steps are critical for proper delivery of active ingredient to the lungs, which is the site of action. Twenty nine percent of patients were able to perform all or four critical steps correctly. According to Rootmensen et al, subjects committed a mistake in at least one critical

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 20148

step using pMDI with or without spacers were 47% and 81% respectively, and the most critical steps missed were coordinating actuation and inhalation, which was missed by 72% of subjects while 31% could not continue to inhale after end of actuation²³.This study has demonstrated that correct inhaler technique is necessary for asthma control. Patients who performed less critical errors were more likely to control their asthma (p = <0.001). Good inhalation technique delivers the drug to the intended organ and is able to induce the intended therapeutic effects. Patients are also encouraged to maintain proper inhalation techniques when their asthma is controlled so as to reduce hospital visits. Many studies have demonstrated that good inhaler technique improves asthma control. A study by Desalu et al reported 69.3% had uncontrolled asthma and this was strongly associated with incorrect inhaler technique among other variables¹⁹. In a Randomised Clinical Trial by Muheys et al, patients on intervention group performing correct inhaler technique significantly increased (p=0.004) at the end of six months. Of patients who had partly controlled asthma as baseline had their Asthma Control Test (ACT) score significantly increased (p=0.038) at the end of six months study period²⁴.

In conclusion this study has demonstrated that asthma control will be difficult to achieve without correct inhaler technique. Since this study focused only on inhalation technique and asthma control, a study on training and asthma control is recommended. A study on health care providers knowledge on inhalation steps is recommended.

Acknowledgement

We are most thankful to the pharmacy department at Kenyatta National Hospital and especially staff of pharmacy Number 15 under the leadership of Mrs. Ayende, for their support without which this study would not have been completed, KAPTLD, through Mr. Sammy Arithi who donated placebo inhalers for this study, Phillip Ayieko who created time to analyze the data and Tenwek Hospital who sponsored part of the study. Lastly, we cannot forget to thank the asthmatic patients who volunteered to be interviewed.

References

1. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. Updated 2012. Available at: http://www.ginasthma.org Accessed on 2/12/2013.

2. Chung HW, Steven RE. The Association between Asthma and Absenteeism among Working Adults in the United States: Results from the 2008 Medical expenditure Panel Survey. J Asthma. 2012; 49:757-764.

3. Graham C. A brief history of inhaled asthma therapy over the last fifty years. Prim Care Respir J. 2006; 15:326-331.

4. Virchow JC, Crompton GK, Dal NR et al. Importance of inhaler devices in the management of airway disease. Respir Med. 2008; 102:10-19.

5. Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. EurRespir J. 2002; 19:246-251.

6. Partridge MR, Hill SR. Enhancing care for people with asthma: the role of communication, education, training and self management. 1998 world asthma meeting education and delivery of care working group. Eurresp J. 2000; 16: 333-48.

7. Crompton GK, Barnes PJ, Broeders M et al. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med. 2006; 100:1479-1494.

8. Kirenga JB, Okot-Nwang M. The proportion of asthma and pattern of asthma medications prescriptions among adult patients in chest, accident and emergency units of a tertiary healthcare facility in Uganda. African Health Sciences. 2012; 12:48-53.

9. Hersh AL, Orrell-Valente JK, Maselli JH et al. Decreasing Frequency of Asthma Education in Primary Care. J Asthma. 2010; 47:21-25.

10. National Heart, Lung and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the diagnosis and

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 2014 9

AbstractBackground: Tea tree oil is an essential oil obtained by steam distillation from foliage and terminal branchlets of Melaleuca alternifolia (Maiden and Betche), (family: Myrtaceae). Melaleuca alternifolia which is native to the northeast coast of New South Wales, Australia and was recently introduced and grown at Amani, Tanga region. The oil is distilled at the same place. Oil from its leaves has been proven to be a powerful natural antiviral, antibacterial and antifungal medicine. Tea tree oil can be useful to treat skin diseases which are mainly due to fungal or bacterial infection and are the most common diseases seen in primary care settings in

In vitro activity of tea tree oil produced in Tanzania against standard bacteria and fungi.Kapacee F. F., Mbwambo Z. H. | Muhimbili University of Health and Allied Sciences,P. O. Box 65001, Dar -es Salaam, Tanzania. | Email: [email protected]

management of Asthma, 2007.

11. Fink JB. Identifying asthma patient education materials that support National Heart Lung and Blood Institute guidelines. Chest. 1999; 116:195S-196S.

12. Self TH, Wallace JL, George CM. Inhalation therapy: Help patients avoid these mistakes. FamPract. 2011; 60:714-721.

13. Machira EPM, Obimbo EM, Wamalwa D et al.. Assessment of inhalation technique among asthmatic children and their carers at Kenyatta National Hospital, Kenya. African J Respir Med. 2011; 7:19-22.

14. Sang ML, Yoon-Seok C, Cheol-Woo K,et al. Skills in Handling Turbuhaler, Diskus, and Pressurized Metered Dose Inhaler in Korean Asthmatic patients. Allergy Asthma Immunl Res. 2011; 3(1):46-52.

15. Andrea SM Marco B, Vincenzo C et al. Inhaler mishandling remains a common in real life and is associated with reduced disease control. Respir Med. 2011; 105:930-938.

16. Hammerlein A, Muller U, Schulz M. Pharmacist-led intervention study to improve inhalation technique in asthma and COPD patients. J Evaluation Clin Pract. 2010; doi:10.1111/j.1365-2753.2010.01369.

17. Bosnic-Anticevich SZ, Sinha H, So S Reddel H. Metered Dose inhaler technique: the Effect of Two Educational Interventions Delivered in Community Pharmacy Over Time. J Asthma. 2010; 47: 251-256.

18. Walia M, Paul L, Satyavani A,et al. Assessment of inhalation technique and determinants of incorrect performance among children with asthma. Paediatr pulmonol. 2006; 41: 1082-1087.

19. Desalu O.O, Fawibe A.E, Salami AK. Assessment of the Level of Asthma Control among Adult Patients in Two Tertiary Care Centers in Nigeria. J Asthma. 2012; 49(7):765-772.

20. Newman SP. Inhaler treatment options in COPD. EurRespir Rev 2005; 14: 96, 102-108.

21. Mohammed AA, Abdurrahman A. Assessment of

inhalation technique in primary care asthmatic patients using metered-dose inhalers with or without a spacer. Ann Saudi Med. 2003; 23:264-269.

22. Bryant L, Bang C, Chew C et al. Adequacy of inhaler technique used by those people with asthma or chronic obstructive pulmonary disease. J Prim Healthcare 2013; 5(3): 191-198.

23. Rootmensen GN, Van Keimpema ARJ, Jansen HM, De Haan RJ. Predictors on Incorrect Inhalation Technique in Patients with Asthma or COPD: a Study Using a Validated Video taped Scoring Method. Journal of Aerosol Medicine and Pulmonary Drug Delivery 2010; 23(5):1-6.

24. Muheys E, Van Bortel E, De Bolle L et al. Effectivenenss of Pharmacist Intervention for Asthma Control Improvement. EurRespir J 2008; 31: 790-799.

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Vol. 22, No. 1 | Pharmaceutical Journal of Kenya | September 201410

tropical areas.

Objective: To conduct in vitro activity of tea tree oil produced in Tanzania against standard bacteria and fungi.

Methodology: In vitro antifungal and antibacterial activity of locally produced tea tree oil against Candida albicans, Cryptococcus neoformans, Staphylococcus aureus, Pseudomonas auriginosa, Salmonella typhi and Escherichia coli was proven by broth microdilution test.

Results: Tea tree oil showed in vitro antifungal as well as antibacterial activity against the tested organisms. Conclusion: The study indicates that Tea tree oil produced in Tanzania has in vitro antifungal as well as antibacterial activity.

Key Words: Tea tree oil; in vitro activity; skin diseases.

IntroductionIn assigning health priorities, skin diseases are sometimes thought of as small-time players in the global league of illness compared with diseases that cause significant mortality, such as HIV/AIDS, Malaria, community-acquired pneumonias, and tuberculosis. However, skin problems are generally among the most common diseases seen in primary care settings in tropical areas1.

Skin diseases have a significant impact on quality of life. For instance, the World Health Organization’s 2001 report on the global burden of disease indicated that skin diseases were associated with mortality rates of 20,000 in Sub-Saharan Africa2.

Although mortality rates are generally lower than for other conditions, there is need for safe and cost effective remedies for skin diseases because patients with skin diseases particularly children present in such a large number in primary care settings. Secondly some skin diseases lead to morbidity which is significant through disfigurement, reducing quality of life and contributes to social isolation. Thirdly, many families cannot afford expensive treatments1. Skin diseases are mainly due to viral, fungal or bacterial infection. Several antimicrobial and antifungal agents are found in the market e.g. azoles and polyenes. Many of them are

very expensive and the existence of clinical resistance has been reported for some products3.

Clinical resistance to antifungal agents was rare until the late 1980s, with only isolated cases in patients with chronic mucocutaneous candidiasis4,5. The incidence of fungal infections, including resistant infections, has increased during the last 10 years, reflecting increased incidence of immunodeficiency associated with cancer chemotherapy, organ and bone marrow transplantation, and the HIV epidemic5,6. Although the prevalence of drug resistance in fungi is below that observed in bacteria, many mycologists consider that selective pressure will, over time, lead to increased widespread resistance5.

Hereby arises need for development of new drugs with different mechanisms of action. Plants have been a rich source for new drugs. A number of studies have been conducted for the in vitro evaluation of antifungal and antibacterial activity of Melaleuca alternifolia (tea tree). Oil from its leaves has been proven to be a powerful natural antiviral, antibacterial and antifungal medicine.

Tea tree oil or melaleuca oil is a clear to very pale golden color essential oil with a fresh camphoraceous odour. It is produced from the leaves of Melaleuca alternifolia which is native to the northeast coast of New South Wales, Australia. It is an evergreen shrub that can grow to 6 meters tall. Its narrow, 4 cm, “needle-like” leaves release a distinctive aroma when crushed. The fruits grow in clusters, and its white flowers bloom in the summer.

In Tanzania, Tea tree (Melaleuca alternifolia) is grown at Amani, Tanga region and the oil used in this study was distilled at the same place.

Problem statementAntifungal and antibacterial resistance has become a problem and many antifungal and antibacterial products are expensive and not affordable by all people in developing countries. Therefore, there is a need to search for alternative drugs from plant origin with different modes of action and establish their safety, dosage and efficacy.

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ResultsSusceptibility data for fungi and bacteria tested against Tea tree oil

Organisms MIC with T.T.O mg/ml MIC with Fluconazole mg/ml MIC with Gentamycin mg/ml

Candida albicans 1.10 0.25 -

Cryptococcus neoformans

2.20 >1 -

Salmonella typhi 2.20 - 0.00391

Escherichia coli 4.41 - 0.00391

Staphylococcus aureus

8.81 - 0.00098

Pseudomonas auriginosa

8.81 - 0.00195

RationaleMelaleuca alternifolia has been investigated for its antifungal and antibacterial activity therefore it is important to exploit it for clinical purpose.

Study ObjectiveTo conduct in vitro activity of tea tree oil produced in Tanzania against standard bacteria and fungi.

MethodologyMaterials;• Tea tree oil• Distilled water• Agar plates, Tryptone Soya broth, Sabouraud’s

Dextose broth, Tween 80, Dimethyl sulphoxide (DMSO), Iodo- Nitro Tetrazolium (INT) and Thiazolyl Blue Tetrazolium Bromide (approx 98% TLC)

Equipments;• Beakers and Gloves• 96 well Microtiter plates, Micropipette, Universal

microtips, Conical flask, Petri dish, Universal bottles, Disinfectant, Cotton wool

Antifungal and antibacterrial agents;Tea tree oil was kindly supplied from Amani Forest Reserve in Tanga Region. Fluconazole and Grisefulvin

was obtained as an injection available in hospital and community pharmacy. Stock solutions were prepared in dimethylsulphoxide.

Bacterial and fungal isolates; Following bacterial isolates were used, Gram +ve; Staphylococcus aureus and Gram –ve; Escherichia coli and Pseudomonas auriginosa, Salmonella typhi. Fungal isolates used include Candida albicans and Cryptococcus neoformans.

Preparation of inoculum;Inocula solutions equivalent to 0.5 McFarland suspension were prepared in 10mls of broth or distilled water.

Broth Microdilution Method;Broth microdilution testing was based on reference method7. A series of double dilutions of tea tree oil ranging from 4 to 0.002%v/v was prepared in a 96-well microtitre plate, with a final concentration of 0.001% v/v Tween 80 to enhance tea tree oil solubility. After the addition of inocula, plates were incubated at 370C for 24 hours. 1 hour before the end of incubation 0.2% w/v of indicator solution was added in each well and incubated for another one hour. The assay was run in triplicate. The lowest concentrations tea tree oil showing no visible growth was recorded as the minimum inhibitory concentration (MIC).Gentamycin and Fluconazole was used as the positive control for bacteria and fungi respectively, while negative control comprised the test organism with DMSO. Results are shown in the Table below.

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DiscussionThis study has illustrated that tea tree oil has antifungal as well as antibacterial activity. Of the tested organisms, Tea tree oil was most active against Candida albicans with MIC of 1.1mg/ml and less active against Staphylococcus aureus and Pseudomonas auriginosa with MIC of 8.81mg/ml. Few previous studies have investigated the activity of tea tree oil against many fungi and bacterial species, and data suggest MICs in the range of 0.02-70.0mg/ml8. Mechanism of antibacterial action: The mechanism of action of TTO against bacteria has now been partly elucidated. Prior to the availability of data, assumptions about its mechanism of action were made on the basis of its hydrocarbon structure and attendant lipophilicity. Since hydrocarbons partition preferentially into biological membranes and disrupt their vital functions, 9 TTO and its components were also presumed to behave in this manner.

ConclusionThe study indicates that Tea tree oil produced in Tanzania has in vitro antifungal as well as antibacterial activity.

Recommendations1. There is need to conduct in vivo test of Tea tree oil

for antifungal and anti bacterial activity.2. Chemical analysis should be done to determine the

composition of locally produced tea tree oil.3. Promote production of Tea tree oil in Kenya as well

and conduct in vitro activity test against standard bacteria and fungi.

4. Formulate pharmaceutical products like creams, ointments, mouthwash etc.

References 1. Hay R. J., Estrada R., Alarcon H., Chavez G., Lopez

L. F., Paredes S., Andersson N. Wastage of Family Income on Skin Disease in Mexico. British Medical Journal. 1994; 309:848.

2. Mathers, C. D., Lopez, A. D., and C. J. L. Murray. 2006. The Burden of Disease and Mortality by

Condition: Data, Methods, and Results for 2001. In Global Burden of Disease and Risk Factors, eds. A. D. Lopez, C. D. Mathers, M. Ezzati, D. T. Jamison, and C. J. L. Murray. New York: Oxford University Press.

3. Margaret M. T. Hudson. Antifungal resistance and over-the-counter availability in UK: a current perspective. Journal of Antimicrobibial Chemotherapy. 2001; 48:345-350.

4. Marichal, P. & Vanden Bossche, H. Mechanisms of resistance to azole antifungals. Acta Biochimica Polonica 1995; 42: 509–16.

5. Stephenson, J. Investigators seeking new ways to stem rising tide of resistant fungi. Journal of the American Medical Association. 1997; 277:5–6.

6. White, T. C., Marr, K. A. & Bowden, R. A. Clinical, cellular and molecular factors that contribute to antifungal drug resistance. Clinical Microbiology Reviews 1998; 11:382–402.

7. Eleoff, J. N. A sensitive and qiuck microplate method to determine the MIC of plants extracts for bacteria. Planta Medica 1998c; 64:711-713.

8. Carson C F, Hammer K A and Riley T V. Melaleuca alternifolia (Tea Tree) oil; a Review of antimicrobial and other medicinal properties. Clinical Microbiology Reviews, 2006; 50-62.

9. Sikkema, J., J. A. M. de Bont, and B. Poolman. Mechanisms of membrane toxicity of hydrocarbons. Microbiol. Rev. 1995; 59:201-222.

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Wata David - Kenyatta National Hospitale-mail:[email protected]. P.O. Box 74348 - 00200 Nbi

Safe Handling of Anti-cancer Medicines

AbstractCancer chemotherapy involves use of antineoplastic drugs to destroy malignant cancer cells. These drugs are cytotoxic and thus exhibit toxic side effects. Health workers that are exposed to antineoplastic drugs are also at risk of experiencing these adverse effects. Exposure can occur through various routes but health workers are predominantly exposed during the handling and preparation of these drugs. It is thus important for institutions offering cancer chemotherapy services to invest in equipment ie., Personal Protective Equipment (PPE) and training of safe handling of these drugs. The Occupational Safety and Health Act of Kenya (2007) requires institutions to implement measures that minimize these risks and also to train and inform health workers on the same.1

IntroductionThe cases of cancer in Kenya are on the increase. It is estimated that global cancer rates will increase by 50% from 10 million in 2002 to 15 million cases in 20202. Of the world’s new cancer cases, 50% are now occurring in developing countries and 80% of these individuals are already incurable at the time of diagnosis2.It is also estimated that by the year 2020, approximately 70% of new cancer cases will occur among individuals in developing countries, and a substantial fraction of these are likely to be breast malignancies3, 4.

The Government of Kenya in response to this fact has published a policy statement, the policy brief for the situational analysis of cancer in Kenya. This is a National Assembly report prepared for the Parliamentary Committee on Health in February 2011. Cancer in Kenya is on the rise, with over 82,000 new cases reported annually. Kenyatta National Hospital (KNH), the only Public institution that hosts the most Cancer Experts and Technologies in Kenya, is currently overwhelmed with Inpatient and Outpatient Cases.

Cancer ranks third among the main causes of death in Kenya after infections and Cardiovascular related diseases. Cancer accounts for up to 18,000 deaths annually in Kenya; up to 60 per cent of those who perish are in the most productive years of their lives5.

Fortunately there has also been an increase in health facilities that offer cancer treatment services. Currently, chemotherapy services are offered in KNH, Moi Teaching & Referral Hospital (MTRH), Coast Provincial General Hospital (PGH), Nyeri PGH, New Nyanza PGH, Kakamega PGH. Private institutions that offer chemotherapy services include Aga Khan University Hospital (AKUH), Nairobi Hospital, MP Shah Hospital, Getrudes Garden Children’s Hospital, Mater Hospital and various other smaller hospitals and private clinics.

Cancer is treated using mainly three methods: radiotherapy, surgery and chemotherapy. Chemotherapy involves use of cytotoxic medicines (drugs) to kill cancer cells. These drugs act by killing the rapidly multiplying cells in the body. They act on both the abnormal cancer cells and the normal dividing cells. The action on normal dividing cells is what causes some of the side effects that are experienced by chemotherapy patients. Surgery is used to diagnose, treat and even prevent cancer in some cases. Most solid tumors require surgical resection. Surgery often offers the best chance for cure especially if there is no metastasis, if the tumor margins are well defined, and if the tumor is surgically resectable.

Radiotherapy uses high energy ionizing radiation to destroy cancer cells. The radiation causes production of free radicals in the target tissue which eventually destroys that tissue. It is used alone or in combination with the other forms of treatment.

Cytotoxic Drug ExposureCytotoxic drugs are commonly administered by injection of single doses or by continuous infusion. Some are given orally as tablets, capsule or liquid form. The potential for exposure to the antineoplastic drugs exists during drug reconstitution and mixing, connecting and disconnecting intravenous tubing, and disposing of waste equipment or patient waste6.The more common routes of exposure are contact

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with skin or mucous membranes (e.g. spillage/splashing), inhalation (e.g. over-pressurizing vials) and ingestion (e.g. through eating, drinking or smoking in contaminated areas or from poor hygiene). Less likely routes of exposure include needle stick injuries which may occur during the preparation or administration of drugs. Research has shown that the external surfaces of vials are usually contaminated with the antineoplastic drugs. Some of the drugs are able to cross the gloves and contact the palms and hands of health care workers6.The concern with this is that health care workers may be exposed not only from spillages of the drugs, but also via contact with patients’ body fluids, such as vomit, sweat, and urine which are known to contain cytotoxic drugs7.

Effects Of Cytotoxic Drug ExposureThere has been concern for many years about potential exposure and subsequent effects in health care workers who handle cytotoxic or antineoplastic drugs9. Many of these drugs have mutagenic, teratogenic, or carcinogenic properties, where no effect threshold dose can be identified. Studies have been reported on the cancer risk and adverse effects on pregnancy outcome9, 10, and some indication of genotoxic damage in peripheral lymphocytes of nurses has been found10.

Exposure to these drugs in the workplace has been associated with acute and short-term reactions, as well as long-term effects9. Anecdotal and case reports in the literature range from skin-related and ocular effects to flu-like symptoms and headache9. Two controlled surveys have reported significant increases in a number of symptoms including sore throat, chronic cough, infections, dizziness, eye irritation, and headaches, among nurses, pharmacists, and pharmacy technicians routinely exposed to hazardous drugs in the workplace8. Reproductive studies on health care workers have shown an increase in fetal abnormalities, fetal loss, and fertility impairment resulting from occupational exposure to these potent drugs10-12. Antineoplastic drugs are known to cause chromosomal aberrations13. They are genotoxic and this may lead to many health adverse effects13-15.

Prevention Of ExposurePublic hospitals and smaller private clinics are implementing chemotherapy administration services without due consideration of these adverse effects. Many of the staff handling chemotherapy drugs are not aware of the safety implications involved. Implementation of chemotherapy services requires investment in safety handling features, so as to enable patients to access the service without adversely affecting the health of the health professionals involved in this procedure. The government is yet to fully acknowledge this, since policy makers lack knowledge of oncology treatment risks for health care workers. Protection of the health worker from exposure to cytotoxic drugs requires several measures.Preparation of cytotoxic drugs requires use of personal protective equipment (PPE). Effective protection will only be obtained if the PPE chosen is suitable for the task, is suited to the wearer and environment, is compatible with other PPE in use, is in good condition and worn correctly6. These include protective gloves, gowns, safety goggles and face masks. Protective gloves must be provided for employees. The gloves recommended for this are non-powdered and non-latex gloves, preferably nitrile gloves6.

Eye and face protection is imperative, particularly where cytotoxic drugs are being handled outside an enclosed system and where there is a risk of splashing. A number of options are available including a face shield or visor, goggles and safety spectacles6.Preparation of cytotoxic drugs should be carried out in a suitable safety cabinet or pharmaceutical isolator. Currently, Class 3 biological safety cabinet is recommended for this work6. It provides complete isolation of the health worker from the antineoplastic drug. The negative pressure in the biological safety cabinet ensures that any powder and aerosol formed is drawn out away from the health worker. However, if it is not reasonably practicable to control exposure using total enclosure/local exhaust ventilation, one needs to consider respiratory protective equipment if exposure to powders or aerosols is possible6.

Drugs such as cyclophosphamide, ifosfamide and anthracyclines have this property of aerosolisation.Surgical masks will not protect against the inhalation

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of fine dust or aerosols. Closed system transfer devices can be deployed in cases where there is no biological safety cabinet. These are devices that allow for transfer of diluent to powder drug in a vial and transfer of solution in such a manner as not to allow exposure to the health worker6.

Protective clothing such as gowns and aprons can help prevent contamination of clothes, and subsequently the skin. The choice of material is important as their absorptive properties may vary. Standard laboratory coats are unsuitable as cytotoxic drug solutions may soak through them. Lint free disposable gowns are recommended for this6.

DiscussionIn hospitals where preparation of cytotoxic drugs produces a significant workload, it should preferably be centralized in a pharmacy under the direction of a suitably trained and experienced Pharmacist. The work area should be clearly designated for drug preparation and access restricted to authorized staff6. Currently, there is no specific training for this in Kenya. However, hospitals such the Red Cross Hospital Groote Schuur Hospital in South Africa offer hospital attachments for Pharmacists where there is on-site training for safe handling of antineoplastics. Pharmacists should insist that appropriate measures be utilized in all health care settings, thus ensuring patient and health care workers’ safety. The Kenya Occupational Health and Safety Act (2007) provides for the protection of staff from exposure to hazardous substances.

OCCUPATIONAL HEALTH AND SAFETY ACT(2007)

84. (1) Every manufacturer, importer, supplier or distributor of chemicals shall make available to employers, material safety data sheets for chemicals and other hazardous substances, containing detailed essential information regarding their identity, supplier, classification of hazards, safety precautions and emergency procedures.

85 (1) Every supplier of hazardous substances, whether as manufacturer, importer or distributor of hazardous substances shall ensure that containers filled with hazardous substances, are—

(a) plainly painted, marked or labeled in a distinctive and uniform manner, with a legible, durable label indicating the hazard, and which is easily understood by persons employed; and

(b) Accompanied with instructions for the safe handling of the contents and

(c) The measures to be taken in case of spillage or accidental exposure to persons employed.

101 (1) Every employer shall provide and maintain for the use of employees in any workplace where employees are employed in any process involving exposure to wet or to any injurious or offensive substance, adequate, effective and suitable protective clothing and appliances, including, where necessary, suitable gloves, footwear, goggles and head coverings.

102 (1) Every employer shall provide suitable goggles or effective screens to protect the eyes of person employed engaged in any of the processes specified in the Eighth Schedule.

All these are provisions of the Occupational Health and Safety Act (2007) that relate to handling of hazardous substances and chemotherapy drugs which directly fall into this group. With the backing of this law, pharmacists in institutions that offer cancer chemotherapy service should ensure all safety measures are implemented.

Implementation of these measures is a costly affair. A biological safety cabinet ranges in cost from 1 million to 10 million Kenya shillings depending on the source and the manufacturer. Closed system transfer devices cost about 400 Kenya shillings per piece which is a single use disposable device. This increases the cost of the chemotherapy which the patient has to bear. These costs should not be viewed as prohibitive for those who want to invest or have invested in cancer chemotherapy services. The staff handling the drugs, from pharmacists who do the preparation to clinicians and the nurses who administer, must be protected from exposure related adverse effects. The costs of treating the health effects related to exposure and handling legal suits arising from the same may be more costly than investing in prevention mechanisms.As the government considers implementing decentralization of chemotherapy services to Level 5 hospitals, they must consider the expenses involved in purchasing the required equipment, training

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Pharmacists on use of the equipment and safe handling of antineoplastic drugs, in addition to procurement of drugs. Since, oncology health care workers cannot wear simple ‘exposure monitors’ like radiation workers, it is necessary to have strict guidelines in place that will reduce both initial contamination of the environment and possible exposure – both percutaneous and via inhalation. Oncology pharmacists are in the perfect position to mandate the use of such guidelines within their institutions, but there is the need for financial backing of their institutions to ensure that the guidelines can be fully implemented16.

Public hospitals that have chemotherapy drug services are currently not compliant with this law. KNH has currently installed a biosafety cabinet. This is the hospital with the highest number of patients requiring anticancer chemotherapy. Nairobi hospital, AKUH and MP Shah hospital already have biological safety cabinets. The staff at these hospitals are able to handle and prepare chemotherapy without undue exposure. The public hospitals do not offer these mechanisms of exposure prevention for health care workers, and therefore are in contravention of this law.

Drug manufacturers also have a role in minimizing exposure. Many pharmaceutical companies have improved the presentation of their anti-cancer drug products in several ways. The drugs are generally presented, when stability allows, in liquid form which means less manipulationis required in the preparation of a dose. The drugs are generally packaged in plastic containers which allows for less chance of vial breakage. When compatibility problems arise and do not permit plastic packaging, and glass containers are required, these are generally protected to avoid breakage and leakage e.g., an ‘overcoat’ of plastic material is placed over the vial16. These factors should be considered during procurement of antineoplastics, such that all manufacturers shall be forced to present their products in a manner that minimizes undue exposure.

The injectable drugs should not be formulated in ampoules, since spillage often occurs while breaking the ampoules. At the same time, microscopic fragments of glass easily contaminate the drug. 5-fluorouracil is commonly manufactured in ampoules and less commonly in vials. Institutions should avoid purchasing ampoules to force the manufacturers to comply with this requirement.

A stakeholder’s forum should be convened by the Ministry of Health to discuss how best to ensure that Kenyan cancer patients access chemotherapy services in a manner that does not compromise their safety or that of health care workers.

References1. Laws of Kenya. The Occupational Safety and

Health Act. No. 15 of 2007 (Revised Edition 2010). National Council for Law Reporting with the authority of the Attorney General.

2. Callaway M, Ferris F D. Advancing Palliative Care: the Public Health Perspective. J of Pain and Symptom Management. May 2007; Vol.33 No.5.

3. Jones SB. Cancer in the developing world: a call to action. British Medical J. 1999; 319:505–508.

4. World Health Organization. Life tables for 191 countries: mortality in 2000. URL: http://www.who.int/whosis/life/life_tables/life_tables.cfm?path_whosis,burden_statistics, life, life_tables&language_English. [Accession date, 2000].

5. Department of Research, National Assembly, Government of Kenya. Policy brief on the situational analysis of cancer in Kenya. February 2011.

6. Safehandling of cytotoxic drugs. HSE information sheet.

7. Venitt S, Crofton-Sleigh C, Hunt J, et al. Monitoring exposure of nursing and pharmacy personnel to cytotoxic drugs: urinary mutation assays and urinary platinum as markers of absorption. Lancet 1984; 1:74–6.

8. Baxter P. Research in occupational medicine. The UK National Health Service. J Soc Occup Med 1991; 41:7–9.

9. Rogers B. Health hazards to personnel handling antineoplastic agents.Occup Med. 1987; 2:513–24.

10. Hansen J, Olsen J. Cancer morbidity among Danish female pharmacy technicians. Scand J Work Environ Health. 1994; 20:22–6.

11. Skov T, Marrup B, Olsen J, et al. Leukemia and

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Muhoro K.1, Wafula L.M.1

1 Jomo Kenyatta University of Agriculture and Technology, College of Health Science. Email: [email protected]

THE FUTURE OF EVIDENCE BASED PRACTICE

IntroductionProfessionalism lies at the heart of health care provision, and inculcating the values associated with it in future generations of health care workers is a primary responsibility of health sciences academia. In order that its interactions with industry consistently reflect the principles of professionalism, academic medical centers should take pains to impart the qualities of professionalism both through teaching and displaying professional behaviors of faculty and staff. Professional standards should also be reflected

reproductive outcomeamong nurses handling anti-neoplastic drugs. Br J Ind Med 1992; 44:855–61.

12. Valanis B, Vollmer W, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses andpharmacists. J Occup Environ Med 1999, 41:632–8.

13. Burgaz S, Karahalil B, Bayrak P, et al. Urinary cyclophosphamide excretion and micronuclei frequencies in peripheral lymphocytes and in exfoliated buccal epithelial cells of nurses handling antineoplastics. Mutat Res 1999; 439:97–104.

14. Anwar W, Salama S, el Serafy M, et al. Chromosomal aberrations and micronucleus frequency in nurses occupationally exposed to cytotoxic drugs. Mutagenesis 1994; 9:315–17.

15. Fucic A, Jazbec A, Mijic A, et al. Cytogenetic consequences after occupational exposure to antineoplastic drugs. Mutat Res 1998; 416:59–66.

16. Davis J, McLauchlan R and Connor H T. Exposure to hazardous drugs in Healthcare: An issue that will not go away. J Oncol Pharm Pract 2011; 17: 9

and continuously reinforced in each institution’s policies and practices in the areas of education, clinical practice, and research.

From knowledge to practice Unless the products of the nation’s clinical data utility and research enterprise are disseminated and applied in practice, their results are meaningless. Current systems that generate and implement new clinical knowledge are largely disconnected and poorly coordinated. While clinical data contribute to the development of many effective, evidence-based practices, therapeutics, and interventions every year, only some of these become widely used. Many others are used only in limited ways, failing to realize their transformative potential to improve care1.

Historically, research discoveries in health care have been disseminated through the publication of study results, typically in medical journals. Clinicians are expected to set aside time to read these published results, consider how to integrate them into their practice, and ensure that practices are changed accordingly. Extraordinary numbers of journal articles outstrips any clinician’s ability to read and process the information. Even if a clinician could read all of this information, its growth is rapidly outstripping human cognitive capacity to integrate the full body of literature when considering a specific clinical situation and a specific patient. This growth in complexity can hamper a clinician’s ability to make decisions. Moreover, clinicians’ patterns for seeking out information have changed. This change in information-seeking behavior has consequences for how medical information can be organized and publicized in a way that maximizes its chances of being implemented in clinical practice. Unfortunately, evidence suggests that simply providing information, albeit more quickly, rarely changes clinical practice2.

Multiple reasons may explain this situation. Sometimes, clinicians fail to change their behavior because they are unaware that new knowledge exists. Sometimes they may disagree that a research discovery would improve care for their patients. At other times, they do not perceive a great enough benefit to outweigh the

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burden of changing established practices.The challenge, therefore, is how to diffuse knowledge in ways that facilitate uptake by clinicians. Many approaches currently are used to disseminate knowledge throughout the health care system, and these could be leveraged to increase the rate at which knowledge is disseminated. A further challenge is to disseminate knowledge that is useful for the clinical decisions for individual patients. To this end, traditional dissemination methods must be modified so that general research knowledge is adapted to the particular circumstances faced by each patient. While logistically demanding, this adaptation holds promise for improving the effectiveness and value of care while meeting the aim of improved patient-centeredness.

One technological tool for bringing research results into the clinical arena is clinical decision support. A clinical decision support system integrates information on a patient with a computerized database of clinical research findings and clinical guidelines. The system generates patient-specific recommendations that guide clinicians and patients in making clinical decisions3.One study, for example, found that digital decision support tools helped clinicians apply clinical guidelines, improving health outcomes for diabetics by 15 percent. Tools under development may tailor the information to the individual patient, allowing the clinician to predict how an intervention would affect that patient. This would further enhance the clinicians’ predictive capacities through advanced informatics and simulation systems that can use data to model likely outcomes for similar patients receiving various treatments or supportive services. Clinical decision support systems also can help address cognitive errors such as attribution, availability bias, and anchoring, all of which may contribute to errors and wrong diagnoses4.

Greater adoption of clinical decision support could be achieved through advances in interoperability with EHR (Electronic Health Record) and computerized physician order entry (CPOE) systems from multiple vendors, allowing this technology to be embedded seamlessly in the standard clinical workflow5.

Regardless of the channels used to distribute new clinical knowledge, the clinical research system needs to account for the many factors that promote (or inhibit) the use of this knowledge. These factors will vary in their importance according to different types of clinicians, health care organizations, geographic locations, patient populations, and other factors.

In general, the dissemination of a research discovery is dependent on three broad categories of factors: attributes of the discovery, characteristics of the potentially adopting clinician or health care organization, and environmental factors. As depicted, the process of diffusion and scale-up is messy, organic, and dynamic. An individual or organization does not move linearly from research to development to implementation, but rather moves between these stages based on perceived needs and individual concerns6.

The most obvious factor affecting the dissemination of a research discovery is its relative advantage over other competing interventions, therapeutics, or practices7 - 9. Simply put, people are more likely to implement a new idea if they believe it can help them with a problem. In a health care context, this relative advantage could take multiple forms, from improved clinical effectiveness over existing treatments, to convenience in delivering the intervention, to reduced cost. While relative advantage is an important factor, other characteristics of a research discovery also have been found to be important, including whether the discovery’s results can be observed easily and quickly, whether a potential adopter can try it without committing to it, its perceived complexity, and its ability to be modified to fit local circumstances10 - 12. Many of these factors are not objective measures, but are based on the perceptions of potential adopters. This means the factors change based on the setting, the potential adopter, and time6, 7.Attribution denotes a clinician’s use of social stereotypes or attributes to link certain diagnoses to certain patients4. Availability bias occurs when memorable cases or frequent clinical phenomena influence a clinician’s diagnosis. Anchoring is a cognitive shortcut in which the first piece of clinical information heard by the clinician has an undue influence on the clinician’s thought process going forward.

In a related way, the dissemination of a research discovery will depend on individual clinicians’ values and culture, as well as their inclination to experiment with new ideas7, 13, 14. For instance, some individuals are more willing to try new ideas, while others favor traditional methods. Dissemination will also depend on the clinician’s social networks and those networks’ views of the knowledge, practice, or technology8, 11, 15, 16.

This cluster of factors changes when the potential

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REFERENCES1. Alston, C., and L. Paget. 2012. Communicating

evidence in health care: Engaging patients for improved health care decisions.

2. Avorn, J., and M. Fischer. 2010. Bench to behavior: Translating comparative effectiveness research into improved clinical practice. Health Affairs 29(10): 1891-1900.

adopter is an organization instead of a clinician. For potentially adopting hospitals and health care organizations, dissemination will vary based on the type of hospital and its resources, especially whether it has resources available for implementing new ideas16. Specific capabilities that promote the adoption of new ideas are the support of the organization’s leadership and management, the existence of robust channels for sharing knowledge, and the presence of structures that can discover potentially beneficial ideas from outside of the organization9, 14, 17 - 20.

Finally, environmental factors that are distinct from the previous two clusters affect the dissemination of research discoveries. One of which is the communication strategy used to disperse information on a discovery. Some successful strategies have involved using in-person educational methods, providing feedback on the process, employing opinion leaders or developing champions, or outlining an overall vision21 - 26.

Another successful communication strategy is the creation of learning or improvement networks27. Such networks provide a structure for the exchange of information and include those individuals necessary for the implementation of change on a larger scale28.This type of tool may be useful for managing the high degree of variation across the health care field, as information can be shared about how to customize guidelines, practice patterns, and other knowledge to fit local conditions23.

Conclusion As the pace of knowledge generation accelerates, new approaches are needed to deliver the right information in a clear and understandable format to patients and clinicians as they partner to make clinical decisions.

3. IOM. 2010a. Redesigning the clinical effectiveness research paradigm: Innovation and practice-based approaches: Workshop summary. Washington, DC: The National Academies Press.

4. Blue Cross Blue Shield of Massachusetts Foundation 2007.

5. Wright A and D.F Sitting (2008) A four phase model for the evolution of clinical decision support architectures. International Journal of Medical Informatics, 77(10):641-649.

6. Greenhalgh,T.,G.Robert, F. Marcfarlane, P. Bate and O.Kiriakidou (2004) Diffusion of innovations in service organizations: Systematic review and recommendations Milbank quarterly 82(4):581-629.

7. Berwick, D. M. 2003. Disseminating innovations in health care. Journal of the American Medical Association 289(15):1969-1975.

8. Cain,M. and R.Mittman,( 2002) Diffusion of innovation in healthcare. Oakland, CA: California HealthCare Foundation.

9. Della Penna R, H. Martel E.B Newirth, J.Rice, M.I Filipski (2009). Rapid spread of complex change A case study in palliative care. BMC Health Service Research 9:245.

10. Rogers, E.M, (2003) Diffusion of innovations, 5th Edition, New York: Free Press.

11. Shih,C and E.Berliner, (2008) Diffusion of new technology and payment policies: coronary stents. Health Affairs 27(6):1566-1576

12. Vos,L M.Duckers, C.Wagner, G van Merode (2010) Applying the quality improvement collaborative method to process redesign: A multiple case study. Implementation science 5:19.

13. Bate, P., G. Robert, and H. Bevan. 2004. The next phase of healthcare improvement: What can we learn from social movements? Quality & Safety in Health Care 13(1):62-66.

14. Green, P. L and Plsek, P. E. 2002. Coaching and leadership for the diffusion and innovation of health care: A different type of multi-organization

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improvement collaborative. Joint Commission Journal on Quality Improvement. 28(2): 55-71.

15. Dopson, S., L. FitzGerald, E. Ferlie, J. Gabbay, and L. Locock. (2002). No magic targets! Changing clinical practice to become more evidence based. Health Care Management Review. 27(3):35-47.

16. McCullough, J. S. 2008. The adoption of hospital information systems. Health Economics 17(5):649-664. Institute Monograph (35):106-112.

17. Ferlie, E. B and Shortell, S. M. 2001. Improving the quality of healthcare in the United Kingdom and United States: A framework for change. Milbank Quarterly. 79(2): 281-315.

18. Nolan, K., Schall, M. W., Erb, F and Nolan, T. 2005. Using a framework for spread: The case of patient access in the Veterans Health Administration. Joint Comission on Quality and Patient Safety. 31(6): 339-347.

19. Norton, W. E and Mittman, B. S. 2010. Scaling- up health promotion/ disease prevention programs in community settings: Barriers, facilitators and initial recommendations. West Hartford. CT: The Patrick and Catherine Weldon Donaghue Medical Research Foundation.

20. Pisano, G. P., Bohmer, R. M. J and Edmondson, A. C. 2001. Organizational differences in rates of learning: Evidence from the adoption of minimally invasive cardiac surgery. Management Science. 47(6): 752-768.

21. Davis, D. A., and A. TaylorVaisey. 1997. Translating guidelines into practice—a systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. Canadian Medical Association Journal 157(4):408-416.

22. Flodgren G, E.Palmelli, G. Doumit, M.Gattellari, M.A O’Brien, J. Grimshaw and M.P Eccles (2011) ‘Local opinion leaders: effects on professional practice and health outcomes’ Cochrane database of systematic reviews (8): CD000125.

23. McCannon C.J, M.W Scall, D.R Calkins and A.G Nazen (2006). ‘Saving 100,000 lives in US hospitals. British Medical Journal 332(7553): 1328-1330.

24. O’Connor G.T, S.K Plume, E.M Olmstead, J.R Morton, C.T Maloney, W.C Nuget, F. Hernandez, R.Clough, B.J Leavitt, L.H Coffin, C.A Maerin, D. Wennberg, J.D Birkineyer, D.C Charlesworth, D.J Malenika, H.B Quinton and J.F Kasper (1996) ‘A regional intervention to improve the hospital mortality associated with coronary artery bypass graft surgery. The northern New England cardiovascular disease study group. Journal Of America Medical Association 275 (11): 841-846.

25. Schectman J.M, W.S Scroth, D.Vermmes and J.D Voss (2003) ‘Randomised controlled trial of education and feedback for implementation of guidelines for acute back pain’. Journal of general internal medicine 18(10): 773-780.

26. Soumerai S.B, T.J McLaughlin, J.H Gurwitz, E. Guadadroli, P.J Hauptman, C. Borbas, N.Morris, B. McLaughlin, X.Gao, D.J Willison, R.Asinger and F.Gobel (1998). ‘Effect of local medical opinion leaders on quality care for acute myocardial infarction. A randomized controlled trail’. Journal Of America Medical Association 279 (17) :1358-1363.

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28. Carnegie Foundation for the Advancement of Teaching, 2010.

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By Dr R T Kamau, BPharm, MPH, HSCEmail: [email protected]

THE EVOLUTION OF PHARMACEUTICAL SUPPLY SYSTEMS IN THE COUNTY DEVOLVED GOVERNMENTS

AbstractDevolution of health care services to the counties is a new phenomenon and an aspect of implementation of Kenya’s Constitution 2010. Counties are now required to set up health care systems, often borrowing from the national government. However, what gets borrowed from the national government can only be generic. County health systems require to be customized to the peculiar needs of each County and to reflect the social, cultural and economic needs of its people. One of the most important health care systems that counties will have to grapple with is the pharmaceutical supply chain management systems. The rationale for these is rooted in the Kenya’s Constitution 2010, the fact that pharmaceutical services is a specifically devolved service, Kenya’s vision 2030 and how all these are related to the millennium development goals. The Kenya Constitution 2010, has important provisions which have direct impact on supply of medicines and their safe use. In this connection, the earliest Article in the Constitution is about availability of information to citizens (read patients).

The Constitution states that every citizen has the right of access to information held by the state and that held by another person and which may be required for the exercise or protection of any right or fundamental freedom. In this respect, it becomes a constitutional obligation to avail medicines consumer information which will be useful for safe use of medicines. In the same constitution, distribution of functions between the national government and the County governments is such that the national referral health facilities, the health policy and the veterinary policy will be the function of the national government. The Constitution further clarifies the health functions that fall under the county governments.

IntroductionDevolvement of health care services to the counties is a new phenomenon and an aspect of implementation of Kenya’s Constitution 2010. Counties are now required to set up health care systems, often borrowing from the national government. However, what gets borrowed from the national government can only be generic. County health systems require to be customized to the peculiar needs of each County and to reflect the social, cultural and economic needs of its people. One of the most important health care systems that counties will have to grapple with is the pharmaceutical supply chain management systems.

RationaleKenya’s constitution 2010. Kenya is now under a new constitutional dispensation after voting in a new Constitution on 4th August 2010. The new constitution was promulgated by the president on 27th August 2010, which effectively makes the new supreme law the basis of all legislations and social order in the country, including that of health. The new constitution has important provisions which have direct impact on supply of medicines and their safe use. In this connection, the earliest Article in the Constitution

These are the county health facilities and the county pharmacies. Kenya’s Vision 2030 is a long-term development blueprint for Kenya, which is motivated by collective aspiration for a much better society by the year 2030. Health services come under the social pillar, and in this vision document, Kenya’s vision for health is to provide equitable and affordable health care at the highest affordable standard to its citizens. To realize this vision, medicines will be required. The Millennium Development Goals has 8 major goals, but the most relevant goal with respect to medicines is goal number six, combating HIV/AIDS, malaria and other diseases. To achieve these health goals, medicines will be required as a major tool. The question is, what is the level of preparedness for counties to handle huge amounts of medicines considering the kind of interests medicines attract anywhere in the world? This is the reason why County governments must come up with policies and legal frameworks that are geared towards ensuring that medicines are available at all times within their sociopolitical jurisdiction. It is a clear a case for a devolved County Pharmaceutical Policy.

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is about availability of information to citizens (read patients). Article 35 of the Constitution states that every citizen has the right of access to information held by the state and that held by another person and which may be required for the exercise or protection of any right or fundamental freedom. In this respect, it becomes a constitutional obligation to avail to medicines consumer information which will be useful for safe use of medicines.

Article 43, which is on economic and social rights, adds that every person has the right to the highest attainable standard of health, which includes the right to health care services and reproductive health. Provision of safe medicines as part of health care services is by interpretation enshrined in the new constitution. Under the general enshrinement of the consumer rights, there are further provisions for consumers of medicines. Section 46 of the Constitution provides consumers with a right for goods and services of reasonable quality and the information necessary for them to gain full benefit from safe use of the goods (read medicines) and (health) services. The article further provides for the protection of their health, safety and economic interest and to compensation for loss or injury arising from defects in (pharmaceutical) goods or (health) services. This means that the constitution has placed a fresh and more explicit responsibility on the health care provider to provide pharmaceutical health care that is of a quality that is beyond reproach. Article 46 (3) clarifies that it does not matter whether the medicines were provided by a government hospital, by a private institution or a person or persons. The consumer has a right for compensation if harm is occasioned by consumption of medicines.

For the reason that older people are likely to be on medicines more often than the younger persons because of the myriad health afflictions that come with advanced age, the constitution recognises this and makes provisions that protect geriatric health by providing for medicines that do not further endanger their already fragile health. Article 57 (d) states that the state shall take measures to ensure the rights of older persons to receive reasonable care and assistance from their family and the state.

Pharmaceutical Service as a Devolved Function. In the new constitution, distribution of functions between the national government and the County governments is such that the national referral health

facilities, the health policy and the veterinary policy will be the function of the national government (Fourth Schedule, Part 1; Sections 23, 28, 30). The Constitution further clarifies the health functions that fall under the county government. These are the county health facilities (read district hospitals, health centres and dispensaries) and the “county pharmacies” (Fourth Schedule, Part 2, Sections 2a). It is not clear what interpretation will be given to “county pharmacies”, but what is not in doubt is that the county government will have a clear constitutional mandate to ensure that consumers of pharmaceutical services, whether public or private do get medicines that are safe and efficacious. It must be noted here, pharmacy service is a specific inclusion in the constitution, bringing to the fore the importance of quality of medicines in the Kenyan health care industry. In furtherance of the spirit of the right to quality healthy life, the Fourth Schedule, Section C provides for promotion of primary health care and veterinary services (excluding its regulation) as well as refuse disposal. This is important because safe use medicines include safe disposal of medicines that cannot be used for various reasons including expiry and obsolescence. Control of drugs is provided for as a function of the county government (Fourth Schedule, Part 2, Sections 13).

Once again, the dual meaning of the word “drug” will require interpretation. All medicines are drugs but not all drugs are medicines. But, if the word ‘drug’ in this constitutional context also mean ’medicines’, then the control of medicines will be a function of a county government. This implies that there will be devolvement of the Ministry of Health’s Pharmacy and Poisons Board to the counties. It may also imply the devolvement and restructuring of the branches of the professional organisations like Pharmaceutical Society of Kenya and the Kenya Pharmaceutical Association along the county boundaries. Moreover, and with an appropriate leadership, it will now be much more easier to bring all health professions to form one health association in the counties that will address professionalism, health inadequacies and be a lobby group for better services to the citizenry. It is worth noting that the constitution requires that legislation for consumer protection (Article 46) be in place in four years from the date of promulgation. Suffice is to say, the new Kenyan constitution has clear provisions for safe use of medicines by consumers, which is a crucially important inclusion if the safe use of medicines by consumers is to be assured and achieved.

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Kenya’s Vision 2030. Kenya’s Vision 2030 is a long-term development blueprint for Kenya, which was motivated by collective aspiration for a much better society by the year 2030. The aim of Kenya Vision 2030 is to “achieve a globally competitive and prosperous country with a high quality of life by 2030.” The vision has three pillars: the economic pillar, the political pillar and the social pillar. Health services come under the social pillar, and in this vision document, Kenya’s vision for health is to provide “equitable and affordable health care at the highest affordable standard” to the citizens. To realize this vision, medicines will be required.

The Millennium Development Goals. The Millennium Development Goals has 8 major goals, but the most relevant goal with respect to medicines is goal number six A; combating HIV/AIDS, malaria and other diseases. Goal number six is cascaded down into smaller targets all to be achieved by 2015 as follows: Target 6A, to halt and begin to reverse the spread of HIV/AIDS by 2015, target 6B; to achieve universal access to treatment for HIV/AIDS and other diseases for all those who need itby 2015, and target 6C; to halt and begin to reverse the incidence of malaria and other major diseases by 2015. To achieve these health goals, medicines will be required as a major tool.

ChallengesMedicines have over the ages evolved from simple decoctions and mixtures of herbal, mineral earth and animal sources. Today’s medicines are a complex mixture of chemistry, pharmaceutics and packaging science whose goal is not only to protect the medicines and retain their effectiveness, but also to provide elegance and visual appeal to the consumer. In the world today, it is now a reality that there cannot be health care without medicines. Availability of good quality medicines is now synonymous with good quality health care services. This is further exemplified in areas where medicine supply is erratic. Villagers only troop to the health facilities when word passes round that medicines have been delivered.

And there lies the challenge; what is the level of preparedness for counties to handle huge amounts of medicines considering the kind of interests medicines attract anywhere in the world? Many times, the medicines are available – somewhere – but are not able to reach those who need them at the

right quantities, at the right place, at the right time and at a price they can afford. This is the essence of pharmaceutical supply logistics. Pharmaceutical management science as a discipline comes to address key issues that are core to sustainable supply of medicines and their safe and rational use. The position of medicines in any national health and socioeconomic life is non-substitutable with anything.

A Case for County Pharmaceutical Policy

This is the reason why County governments must come up with policies and legal frameworks that are geared towards ensuring that medicines are available at all times within their sociopolitical jurisdiction. The policies and legal framework should provide clear guidelines to governments on the drug management cycle: the selection of needed medicines, the procurement process, the distribution activities, and the rational prescribing and dispensing of medicines. In addition, there has to be policy and leadership in consumer education, so that people taking medicines can have more than casual understanding of medicines, how they work and the potential harm they carry. In providing these guidelines, county and national governments must come up with drug management support systems that allow for seamless management of county drug programs, monitoring and evaluation of the pharmaceutical supplies and services and which allows community participation in decision making with regard to medicines they consume and be key partners in the security of medicines supplied to them as a community.

In addition, sustainability of the drug supplies is closely tied up with availability of a medicine budgets and medicine financing mechanisms and strategies. Since no government is ever self sufficient with all funds needed to purchase all the needed medicines, it becomes prudent to carefully plan for the available funds so as to stretch the purchasing capacity of each shilling to the greatest extent possible thereby ensuring socioeconomic development of a people and a clear political relevance of a government. This means, even though medicines are a tool of socioeconomic advancement, they are also a powerful political tool, and this should attract more than average interest to the political and the administrative class in the counties. For these reasons, the need for a County Pharmaceutical Policy cannot be overemphasized.

Management of Medicines Supply Chain in the County

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But medicines cannot manage themselves. County governments must invest heavily on the availability of trained human resource who will efficiently manage medicines supply systems. It is now possible for county governments to partner with national regulatory authorities to mount training programs that ensure self sufficiency in good and well trained personnel to roll out pharmaceutical services in the counties. This is in realization that it does not matter what good diagnostic and curative services the doctors and laboratory personnel are offering in a hospital. It matters little what excellent nursing care is available in the hospital. If medicines are not available, patients and public fail to see the good services other health care personnel are providing. And that is not all. Lack of medicines in a hospital set up is highly demoralizing to health care staff. Hence, availability of medicines is so crucial because regardless of how good other sectors of health care are managed, if the medicines component is poorly managed, patients and public see a poorly managed health care service. Since management of such programs require generation, storage, manipulation and retrieval of information, it is prudent for authorities to invest in Pharmaceutical Management Information Systems (PMIS) that facilitate fast and accurate decision making at the policy, strategic and operational levels with regard to medicine supplies.

ConclusionCounty governments will not only be concerned with pharmaceutical activities in the public sector only. Even though much government’s time, energy and effort will be spent on ensuring that the common citizen has access to good quality and efficacious medicines in the public hospitals, a good proportion of citizens will seek their services from private providers. County government must establish linkages & partnerships with national medicines regulatory authority to ensure that medicines and services being offered in the private sector do not harm people. It should be appreciated that even though medicines work like magic when used professionally, they are deadly chemical weapons when in the wrong hands. It will be a good thing, therefore, for county government to forge working partnership with national government to protect unsuspecting medicine consumers from harm of medicines in the wrong hands, mainly business people who are likely to see medicines as ordinary articles of commerce.

Bibliography1. Kenya. Government of Kenya. The Constitution of

Kenya. 2010.

2. Kenya. Government of Kenya Vision 2030. 2002.

3. J D Quick et al. Managing Drug Supplies. Geneva, Switzerland: Kumarian Press; 1997.

4. United Nations. Millennium Development Goals. 2005.

5. World Health Organization. Developing Pharmacy Practice.Geneva, Switzerland.2006.

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PHARMACEUTICAL JOURNAL OF KENYA (PJK)Guidelines for Contributors:1.0 General: The Pharmaceutical Journal of Kenya is the official publication of the Pharmaceutical Society of

Kenya, and is published Quarterly in January, April, July and October. The PJK accepts, in English, review articles, articles for educational fora, original research articles (full length and short communications), letters to editor, case reports, book reviews, new literature surveys and other interesting fillers. Articles concerning all aspects of pharmacy Training, Practice, Research, Law and Policy will be considered. Articles of general interest (e.g. human and veterinary medicine, dentistry, methods, therapeutics, medical education, new drug information and commentary topical issues) are also welcome. Review papers will only be at the request of the editor.

2.0 Editorial Policy: The PJK accepts only original communications/articles/write-ups submitted exclusively to the journal. Prior and duplicate publications are not allowed. Publication of abstract under conference proceedings will not be considered as prior publication. It is the duty of the contributors to inform the PJK about all submissions and previous reports that might be considered prior or duplicate. Manuscripts for publication will be considered on their individual merits.

2.1 Peer Review: All manuscripts will be subjected to peer review by at least two reviewers and their comments along with the editorial board’s decision will be forwarded to the contributor for further action. Where authors are required to make corrections, corrected proofs must be submitted to the editor within the deadline specified. Ordinarily, the contributors may suggest referees working in the same area for manuscript evaluation but the final choice of reviewers is a preserve of the Editorial Board.

2.2 Ethics: The PJK highly values ethical practices in both human and animal experiments. Evidence of approval by a local Ethics and Research Committee must be supplied by the authors on demand. Animal experimental procedures should be as ethical as possible and the details of anaesthetics and analgesics used should be clearly stated. The ethical standards of experiments must meet the highest internationally accepted standards. The journal will not consider any paper which is ethically unacceptable. A statement on Ethics & Research Committee permission and ethical practices must therefore be included in all research articles under the ‘Materials and Methods’ section.

2.3 Plagiarism: The PJK Policy is strongly against plagiarism. Any reproduced work, whether texts, tables, figures or illustrations from other sources, must therefore be appropriately cited. All accepted papers are subject to editorial changes.

3.0 Copyright: Any article accepted for publication/published in the PJK will be the copyright of the Journal. The Journal will have the right to publish the accepted articles in any media (print, electronic or any other) any number of times. The contributors should agree to transfer copyright and sign a declaration to this effect.

4.0 Format and Style of Manuscript: Authors should keep their articles simple, explicit and as short as possible. Recent issues of the PJK should be consulted as a guide for the general format adopted in respect to various elements of a paper. Identity of the author(s) must NOT appear anywhere in the manuscript, except on the first page.

4.1 Submission of Articles: Contributors should submit one original typed and printed manuscript AND one electronic copy in Ms Word on an IBM compatible PC as follows;

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4.1.1 Formatting of document body; Font style: Book Antiqua Font size: 10 Page set up: 1 inch margin on all sides Pagination: Consecutively (page 1 of x)

4.1.2 Formatting of document Title; Font style: Concise Font size: 14 Lines: Not more than 2 Abbreviations: None

1.1.1 Presentation of Articles: ) Article length: 1–12 pages b) Authors: Lead author’s name first, surname followed by 2 initials e.g. Njuguna A. K. c) Authors’ affiliation (e.g. Institution), complete postal and email addresses. d) Abstract: Not exceeding 150 words excluding the title and the key words. No abbreviations. Abstract not

required for short communications. Presentation of Abstract to be in the same format as the Format for Article Content below. However, the Title should not have authors’ names or affiliations. The abstract must be concise, clear and informative.

e) Key words: 3-6 key words to be listed. f) Declaration of sources of funding, technical or any other support related to the research/article. g) Format for content: • Introduction • Aim/Objective • Materials & Methods • Results/Findings • Discussion • Conclusion and Recommendations • References 1.0 References Vancouver style: References are to be cited in the text by superscripted number and should be in

the order in which they appear. References cited only in tables or in legends to figures should be numbered in accordance with a sequence established by the first identification in the text of the particular table or illustration. As far as possible, mentioning names of author(s) for reference should be avoided in the text. The number of references should normally be restricted to a maximum of 25 for a full paper, most of them preferably being articles published in the last 5 years. Papers which have been submitted and accepted but not yet published may be included in the list of references with the name of the journal and indicated as “In press”. Use of abstracts as references should be avoided. The “unpublished observations” and “personal communications” may not be used as references but may be inserted (in parentheses) in the text. The Reference list should begin on a new page and typed double spaced in the Vancouver style.

2.0 Right to Reject Article: The editors reserve the right to reject an article for publication if it does not meet the requirements of the Pharmaceutical Journal of Kenya. If an Article is adjudged suitable and publishable in PJK, the editors will have the final say on the Journal number and Section in which it will appear.

3.0 Articles should be submitted to: The Editor-in-Chief, Jennifer A. Orwa, PhD., Msc, BPharm, FPSK, OGW Pharmaceutical Journal of Kenya, P.O. Box 44290 – 00100 GPO, NAIROBI - KENYA. Email: [email protected]

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