Nursing Protocol On The Usage Of Ritodrine

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In the first stage of the study, the medical treatment notebook of the ... understood by the workers. Keywords: Nursing protocol, nursing care, medication errors.
*Nursing Protocol On The Usage Of Ritodrine Hydrochloride (Prepar) Feride ENGIN YIĞIT**, Deniz SAYINER***, Hediye ARSLAN****, Nurdan DEMIRCI**, Özlem CAN GÜRKAN**, Zübeyde EKŞI**

ABSTRACT Objective: Case- controlled, retrospective survey was planned to analyze ongoing applications in the treatment of preterm labor, which occurs in 7-10 % of all pregnancies, and to test a certain new protocol to standardize applications in the light of the collected data. Materials and Methods: The study was initiated on April, 2001 in the maternity clinic of The Eskişehir Maternity and Child care center and constituted of five stages. In the first stage of the study, the medical treatment notebook of the service was screened retrospectively and the numbers of the patients were determined. In the second stage, the protocol, that is subject of this paper, was formed. Later, the nurse/midwife took a 2-day course to be introduced to the protocol and to be informed on how it was going to be used. In the fourth step, the protocol was put in to use. In the last step the records were evaluated for treatment, care and follow up and the results were compared with the results collected before the application of the protocol. Results: It was determined that the groups, which had Prepar treatment before and after the protocol were similar. Conclusion: Although the use of the protocol improved the nurse/midwife follow up and care the desire level was not reached. This might be because of the insufficiency of the number of the nurse/midwife and the significance of the protocol not being fully understood by the workers. Keywords: Nursing protocol, nursing care, medication errors

ÖZET Ritodrine Hydrochloride (Prepar) Kullanimi İçin Hemşirelk Protokolü Amaç: Çalışma tüm gebelerin yaklaşık % 7-10’unda görülen erken doğumun tedavisindeki uygulamaları analiz etmek ve toplanan veriler ışığında standart bir protokol geliştirmek amacıyla retrospektif vaka-kontrolü şeklinde planlanmıştır. Gereç ve Yöntem: Eskişehir Kadın ve Çocuk Hastalıkları hastanesinin kadındoğum kliniğinde Nisan 2001 yılında başlanan çalışma 5 aşamadan oluşmuştur. Çalışmanın ilk evresinde retrospektif olarak servisin hasta dosyaları taranmış ve hasta sayısı belirlenmiştir. İkinci aşamada protokol geliştirilmiştir. Daha sonra ebe/hemşirelere protokolün nasıl kullanılacağı konusunda iki günlük bir kurs verilmiştir. Dördüncü aşamada protokol uygulamaya sokulmuştur. Son aşamada tedavi, bakım ve izlem konusundaki kayıtlar incelenmiş ve toplanan veiler protokol öncesi uygulamalarla karşılaştırılmıştır. * IXth Congress of European Society for the Study and Prevention of Infant Death (ESPID). Prenatal Health Care and Postnatal Development İstanbul/Turkey October 2-6, 2001’de poster olarak sunulmuştur. ** Marmara Üniversitesi Hemşirelik Yüksekokulu Doğum ve Kadın Hastalıkları Hemşireliği Anabilimdalı *** Osman Gazi Üniveristesi Sağlık Yüksekokulu **** Maltepe Üniversitesi Hemşirelik Yüksekokulu Müdürü

Nursing Protocol On The Usage Of…

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Bulgular: Prepar tedavisi alan grupların protokol öncesi ve sonrası benzer özellikler gösterdiği belirlenmiştir. Sonuç: Protokol kullanımı ebe/hemşirelerin izlem ve bakımlarını arttırmasına karşın istendik düzeye ulaştıramamıştır. Bu ebe/hemşire sayısının yetersizliğinden ve protokolün çalışanlar tarafından yeterince anlanmadığından kaynaklanabilir. Anahtar Kelimeler: Hemşirelik protokolü, hemşirelik bakımı, ilaç hataları

INTRODUCTION Medication errors are among common causes of iatrogenic morbidity and mortality (Kozer, Scolnic, Macpherson et al 2002). Medical errors are prevalent among hospitalized patients, with adverse events occurring in an estimated 3.7 % to 16.6-19 % of hospital admissions (Barker, Flynn, Pepper et al 2002; Freedman, Jesse and Kerber 2002; Weingart, Wilson, Gibberd et al 2000). Medications errors can be made by anyone involved in the prescribing, transcribing, preparation, dispending, and providing treatment (Atabek 1994; Ekizler 1991). Wolf and Smetzer conducted a content analysis of human error and medication error literature to determine patterns indicating healthcare providers’ responses to making drug errors (2000). Nurses are given extensive training on procedures so that they are relatively less likely to make mistakes. Yet nurses do make errors (Erlen2001). Eight categories of nursing errors representing a board range of possible errors and contributive or causative factors were identified: lack of attentiveness; lack of agency/fiduciary concern; inappropriate judgment; lack of intervention on the patient’s behalf; medication errors; lack of prevention; missed or mistaken MD/healthcare provider’s orders; and documentation errors (Benner, Sheets, Uris, Malloch et al 2002. Correct and complete administration of drugs and reducing mistakes is responsibility of the institutes as well as that of the personnel. Institutes need do form drug policies; inform their staff regarding new developments in drugs and to establish mechanisms that will enable instant spotting and reporting faults. One of these mechanisms is the development of protocols regarding certain medicine (Kayaalp 2005; Uzun 1991; Webster and Anderson 2000). Nursing Interventions &Clinical Skills, defines a protocol as a written and approved plan specifying the procedures to be fallowed during an assessment or in providing treatment (Elkin, Perry and Potter2000). Preterm labor refers to births that occur between 20 and 37 weeks of pregnancy involving a fetus with an estimated weight between 500 and 2499 g.( Fiscella, Franks, Kendrick et al 2002; Goldenberg 2002; Landau, Xie, Dishy et al 2002; Simpson and Careehan 2001). Regular contractions occur at less than 10-min intervals over a 30-to 60-min period that is strong enough to result in 2 cm cervical dilatation and 80 % effacement. Preterm labor occurs in approximately 5 % to 10 % of all births(Simpson and Careehan 2001). Despite 15 years of research both preterm birth and low birth weight rates continue to increase (Moore and Freda 1998).

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The ultimate goal of treating preterm labor is to prolong the pregnancy long enough to decrease the incidence of neonatal mortality and morbidity associated with prematurely while minimizing maternal end fetal risk (Witcher 2002). Treatment options for women with spontaneous preterm birth are limited. A number of interventions have been found to be ineffective and are not correctly recommended. They include bed rest, hydration, home uterine monitoring, maintenance tocolysis, and antibiotics. Tocolysis is widely used to arrest preterm labor (Simpson and Careehan 2001). Although several agents are commonly used as tocolytics, currently only Ritodrine Hydrochloride is approved by the U.S. Food and Drug Administration for the treatment of preterm labor (Kayaalp 2005). Ritodrine Hydrochloride (Prepar) is one of the agents for use as a tocolytic in Turkey (Kayaalp 2005; Taşkın 2002). All tocolytic agents place the mother at some risk, and the risk is increased significantly if dual tocolytic therapy is used, especially when administered intravenously. Careful, expert-nursing care is essential for all women who receive tocolytic therapy (Simpson and Careehan 2001). Aims of the Study The aim of this study is to develop a protocol regarding Prepar medicine and test the outcomes of the proposed protocol on preterm labor instances by analyzing ongoing applications in hospitals for treatment of preterm labor. Research Hypotheses The following hypotheses were tested against their respective alternative hypothesis: Hypothesis 1: If the nurses will use the proposed protocol when the drug is administered, medical errors can be reduced. Hypothesis 2: If the nurses will use the proposed protocol when the drug is administered, side effects can be determinate early. METHODS In the first step of the study, which was formed of five steps; the medical treatment notebook of the service was screened retrospectively and the number of the patients (a total of 47) which had Prepar treatment between the dates 1 April-31 May 2001 were determined. The selected patient files were searched files in the archive and 30 files were inspected, as 17 of the files were not in the archive. The files collected were evaluated for treatment, care and follow up. In the second step, a Ritodrine Hydrochloride application protocol proposal was prepared according to the data collected literature knowledge and the ability and the politics of the clinic.

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Afterwards to demonstrate the protocol and to teach the application of it, education was given to the midwives and nurses working (a total of 15) between the dates 27-28 the June 2001. Before the education, the decisions of the nurses/midwives were taken. In the fourth step, the developed protocol was put in to use. For this stage, the records of a total of 30 pregnant women who had Prepar treatment staying in the clinic between the dates of July-August 2000 were evaluated for treatment, care and follow up and the results were compared with the results collected before the application of the protocol. Before and after protocol group differences for categorical variables were evaluated by means of chi-square tests, and normally distributed continuous data were evaluated with percentage, arithmetic means, chi-square, student's t tests. Analyses were performed with Statistical Package for the Social Sciences (SPSS) software, version 9.0. FINDINGS Having inspected the decision of the nurses/midwives working in the clinic where the study was carried out, it was determined that they have observed the side effects occurring by the use of the medicine. They declared that there was no Prepar protocol in the clinics, because of, which they had to call the doctor when they experienced the side effects, and that the presence of such a protocol was an important necessity. We examined if the nurses had taken an education on this subject before. Table 1. The Characteristics Of The Patients Characteristic

Number patients

of Average Standard Deviation

t

p

.895

P>0.05

Age (Year) Before The Protocol

30

24.4

5.38

After The Protocol

30

24.6

4.37

When the inspected the characteristics of the patients who had the undergone treatment of Prepar (Table 1), the age average of the group which had treatment, before the improvement of the protocol (BP) was 24.4 years and the pregnancy week average was 36.58. The averages of the group who had treatment after the protocol (AP) were similar. Also the further analyze the differences between two groups, parameters age and gestational age data were subjected to t test with null hypothesis being the given parameter’s mean (i.e. age, gestational age) for two groups being equal, while the alternative hypothesis states otherwise. Alpha level was taken to be 5% for both tests. The t and p values showed that two groups did not possess significant differences, the groups were observed to be the same. The reasons of the patients for the coming to the hospital before the protocol and after the protocol were similar and most of the patients in the groups (BP 96.7%, AP 80.0 %) attended to the hospital because of pain (Table 2).

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Table 2. The Reasons For The Coming To The Hospital Before Protocol After Protocol The Reason

Number

Only Pain

29

% Number

Total

% Number

%

96.7

24

80.0

53

88.4

Only Rupture of membranes -

-

2

6.7

2

3.3

Only Vaginal Bleeding

-

3

10.0

3

5.0

3.3

1

3.3

2

3.3

100

30

100

60

100

Pain + membranes Total

Rupture

of 1 30

When the distribution of the results of the treatment is investigated in table 3; it can be seen that the results were similar and the groups went to their houses after passing to the oral treatment in similar rates (BP 70.0%, AP 63.3 %). BP one patient was sent to her house without being given any medicine while AP nobody was sent to the house without beginning to the oral treatment. Table 3 . The Distribution Of The Results Of Treatment Before Protocol After Protocol The Result Of Treatment n

%

n

Discharged after without 1 being given Prepar

3.3

-

Discharged after passing 21 oral treatment

70.0

8 30

Birth TOTAL

%

Total n

%

-

1

1.7

19

63.3

40

66.7

26.7

11

36.7

19

31.6

100

30

100

60

100

It was determined that most of the patients were treated for Prepar intravenous first and then they were treated Prepar orally later (BP 70.0%, AP 83.3%), (Table 4.).

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Table 4 . The Distribution Of The Shape Of Treatment Treatment

Before Protocol

After Protocol

Total

n

%

n

n

%

Before Intravenous after Oral

21

70.0

25

83.3

46

76.7

Only Intravenous

2

6.7

2

6.7

4

6.6

Only Oral

7

23.3

3

10.0

10

16.7

TOTAL

30

100

30

100

60

100

%

Before the protocol the proportion of the patients who took only oral treatment was 23.3%, this proportion decreased to 10.0% after the protocol. When the pulses follow up frequency before and after the protocol was compared. It was determined that this follow up rouse to three times a day (63.3%) after the protocol and there were highly significant differences between the two groups was statistically (Table5). Table 5 . The Pulse Follow Up Frequency Pulse Follow Up Before Protocol n

%

After Protocol

Total

n

n

%

%

One times a day

15

50.0

3

10.0

18

30.0

Two times a day

1

3.3

8

26.7

9

15.0

Three times a day 14

46.7

19

63.3

33

55.0

TOTAL

100

30

100

60

100

X2=15.69

30

P=0.000

When the blood Pressure follow up frequency before and after the protocol was compared (Table 6) it was seen that the frequency of this follow up rouse to three (66.7%) after the protocol and the difference between the two groups was of highly significant statistically.

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Table 6 . The Blood Pressure Follow Up Frequency The Blood Pressure Before Protocol Follow Up n %

After Protocol

Total

n

n

%

One times a day

15

50.0

2

6.6

17

28.3

Two times a day

2

6.6

8

26.7

10

16.7

Three times a day

13

43.4

20

66.7

33

55.0

TOTAL

30

100

30

100

60

100

X2=16.60

%

P=0.000

DISCUSSION The averages of the group who had treatment after the protocol were similar and the differences between the groups were not statistically significant. The groups were observed to be similar to each other. The reasons of the patients for the coming to the hospital before the protocol and after the protocol were similar and most of the patients in the groups attended to the hospital because of pain. In the literature, the most common symptom in the preterm labor action is also considered to be pain (Fiscella et al 2002; Goldenberg 2002; Landau R et al 2002; Kee and Hayes 2000). Ritodrine Hydrochloride, a beta-sympathomimetic drug that is yet controversial about its efficiency and safety has persisted. In general, beta-sympathomimetics appear to stop contractions for 24 to 48 hours, with questionable beneficial effects on neonatal morbidity, ritodrine treatment may result in higher frequency of potentially serious maternal side effects (Kee and Hayes 2000). Side effects include tremors, malaise, weakness, dyspnea, tachycardia (maternal and fetal), increased systolic pressure and decrease diastolic pressure, chest pain, nausea, vomiting, diarrhea, constipation, erythema, sweating, hyperglycemia, and hypokalemia, More serious adverse reactions include pulmonary edema, dysrhithmias, ketoacidosis, and anaphylactic shock (Ruiz 1998). Before the protocol, one patient was sent to her house without being given any medicine while after the protocol, nobody was sent to the house without beginning to the oral treatment. Together with the medicine treatment the risk of the beginning of the birth action is 45-56% and the risk is said to be much higher when the administration of the medicine is halted (Fiscella et al 2002; Goldenberg 2002; Landau R et al 2002). It was determined that most of the patients were treated for Prepar intravenous first and then they were treated Prepar orally later. When the protocols for the use of Ritodrine in the studies conducted are investigated it is suggested that the beginning treatment should be intravenous and that the treatment should be passed on to oral treatment (Taşkın 2002).

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Nursing care is a critical component of therapy for women experiencing preterm labor (Jones and Collins 1996). Nurses can use their assessment skills to help identify women at risk for preterm labor and delivery (Ruiz 1998). Nursing Interventions, •

Monitor and asses uterine activity and FHR



Maintain client in left lateral position as much as possible.



Monitor maternal and fetal vital sing every 15 min when client is receiving IV dose.

• Report systolic blood pressure decreases, diastolic blood pressure decreases, and pulse increases. • Report auscultated cardiac dysrhythmias. An electrocardiogram (ECG) may be ordered. • Auscultated breath sounds every 4 hours. Notify health care provider if respirations are > 30/min or there is a change in quality (wheezes, riles, coughing). •

Monitor daily weight to assess fluid overload; monitor strict input and output.



Provide passive range of motion of legs.

• Report fetal baseline hearth rate >180 beats per min. or any significant contractions from pretreatment FHR baseline. •

Report persistence of contractions despite tocolytic therapy.

• Report leaking of membranes, any vaginal bleeding, or complaints of rectal pressure. • Be alert to presence of hypoglysemia in the newborn delivered within 5 hours of discontinued beta-sympathomimetic drugs. •

Administer only clear solutions of drugs if using IV route.

Assist clients on bed rest and home tocolytic therapy to plan for assistance with selfcare and family responsibilities (Kee and Hayes 2000; Simpson and Careehan 2001). Before the protocol the proportion of the patients who took only oral treatment was 23.3%, this proportion decreased to 10.0% after the protocol. This gave the thought that the doctors were also affected by the protocol in their practices. It is a significant and positive result that the blood pressure and the pulse follow up frequencies have rouse after the improvement of the protocol. But the lack of the recording of the fetal heart rate (FHR), contraction, the liquid taken in and given out follow ups give the thought that the systematic recording habit has not been acquired. It was evaluated that before the improvement of the protocol the drop number Per minute was never followed but after the protocol every IV application was done by controlled infusion tests (dose-flow) and the number of the drops were controlled. This was determined to be a useful practice brought by the use of the protocol. Although the use of the protocol improved the nurse/midwife follow up and care the desired level was not reached. According to protocol, nurses must follow up every 4-6 hours, but nurse numbers not enough to this follow up limitation three times a day. This

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might associated with insufficiency of the number of the nurse/midwife and the importance of the protocol not being totally understood by the workers. For this reason the suggestions are as follows;

The education given to the nurses/midwives might be repeated, Meetings with the directors of the association could be arranged to raise the number of the workers,

Knowledge could be provided to the other members of the team, The evaluation of the protocol could be repeated one year later The study could be repeated in more populated woman-birth clinics where data would be abundant. Limitations Of Study Study conclusions should be interpreted in light of design limitations. Because the study was conducted at hospital in a single country, findings may not be representative of practices elsewhere. Only one hospital was included, therefore these characteristics are not necessarily typical of all hospitals. REFERENCES AtabekT (1994). İlaç hatalarının önlenmesinde hemşirenin sorumlulukları. Hemşirelik Bülteni,5: 97-105. Barker KN., Flynn EA., Pepper GA., et al (2002). Medication errors observed in 36 health care facilities. Arch. Inter., 6: 1897-1903. Benner P., Sheets V., Uris P, Malloch K.,et al (2002). Individual, practice, and system causes of errors in nursing: a taxonomy. J. Nurs. Adm.,10: 509-523. Ekizler H (1991). Doğumda ve yenidoğanda sık kullanılan bazı ilaçlarda hemşirelik girişimi. Marmara Üniversitesi Hemşirelik Dergisi, 1:15-23. Elkin MK., Perry AG., Potter PA (2000). Nursing Interventions and Clinical Skills. St. Louise.C.V. Mosby Company, 9-12, 973. Erlen J (2001). Medications errors: ethical implications. Orthop Nurs., 4: 82-85. Fiscella K., Franks P., Kendrick JS., et al (2002). Risk of preterm birth that is associated with vaginal douching. Am J Obstet Gynecol., 6:1345-1350. Freedman JE., Jesse LR., Kerber R (2002). Medication errors in acute cardiac care. Circulation, 106: 2623. Goldenberg RL (2002). The management of preterm labor. Obstet Gynecol., 5:10201037. Jones DP., Collins BA(1996). The nursing management of women experiencing preterm labor: clinical guidelines and why they are needed. J. Obstet. Gynecol Neonatal Nurs., 7:569-592. Kayaalp SO (2005). Rasyonel Tedavi Yönünden Tıbbi Farmokoloji 2. Cilt. Ankara. Hacettepetaş Yayınları, 988-989.

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Kee JLF, Hayes ER (2000). Pharmacology. A Nursing Process Approach. 3rd ed. Philadelphia: WB Saunders, 213-214. Kozer E., Scolnic D., Macpherson A., et al (2002). Associated with medication errors in pediatric emergency medicine. Pediatrics, 4: 737-742. Landau R., Xie HG., Dishy V.,et al (2002). Beta2- adrenergic receptor genotype and preterm delivery. Am. J. Obstet. Gynecol., 5:1294-1298. Moore ML., Freda M (1998). Reducing preterm and low birthweight births: Still a nursing challenge. MCN, The American Journal of Maternal/Child Nursing, 4: 200-208. Ruiz RJ (1998). Mechanisms of full-term and preterm labor: factors influencing uterine activity. J. Obstet. Gynecol. Neonatal Nurs., 6: 652-60. Simpson KL., Careehan PA (2001). Perinatal Nursing. Philadelphia. Lippincott, 207219. Taşkın L (2002). Doğum ve Kadın Hastalıkları Hemşireliği, Genişletilmiş III. Baskı, Ankara. Sistem Ofset, 295-297. Uzun Ö.M (1991). Hemşirelerin ven içi sıvı uygulamalarında yaptıkları hataların ve sıklıklarının saptanması. Hemşirelik Bülteni, 5: 83-91. Webster CS., Anderson DJ (2000). A pratical guide to the implementation of an effective incident reporting scheme to reduce medication error on the hospital ward. Int. J. Nurs. Pract., 4:176-83. Weingart SN., Wilson RM., Gibberd RW., et al (2000). Epidemiology of medical error. BMJ, 320: 774-777. Witcher PS (2002). Treatment of preterm labor. J. Perinat. Neonatal Nurs., 1: 25-47. Wolf ZR., Smetzer J (2000). Responses and concerns of healthcare providers to medication errors clinical nurse specialist. The Journal for Advanced Nursing Practice, 6: 278. Address for correspondence: Feride Engin Yiğit Marmara Üniversitesi Hemşirelik Yüksekokulu Haydarpaşa/İstanbul –Turkey 34 Phone:0 216 4181606/07-1140 E-Mail: [email protected]

Fax:02164183773