Hospital and community-based drug utilization evaluation and assessment of the quality of pharmaceutical care among pregnant women of Kashmiri origin

Pregnancy is a special physiological condition where drug treatment presents a special concern because the physiology of pregnancy affects the pharmacokinetics of medications used and certain medications can reach the fetus and cause harm. Careful consideration of the benefits to the mother and the risks to the foetus is required while prescribing drugs during pregnancy and lactation. The use of drugs during pregnancy calls for special attention because in this case in addition to the mother, the health and life of her unborn child is also at stake. 

 

Due to ethical constraints whenever a new drug hits market, it is almost never tested in pregnant women and hence its effect on the fetus and newborn remains uncertain. Most of the drugs therefore are labelled as ‘not to be used in pregnancy'. These constraints put pregnant women and their physicians in a difficult situation worldwide. Furthermore in case of unplanned pregnancies most of the fetuses are exposed to drugs before even being aware of pregnancy.

 

World Health Organization (WHO) has reported that 50% of all medicines are prescribed, dispensed or sold inappropriately, while 50% of patients also fail to take their medicines appropriately. This often leads to problems such as ineffective treatment, health risks, patient non-compliance, decreases the quality care of population and increases morbidity and mortality besides leading to excessive spending on pharmaceuticals and wastage of financial resources by patients as well as health care system. For these reasons, WHO has evolved the concept of Drug Utilization Evaluation (DUE) whose primary aim is to facilitate the rational use of drugs in populations.

 

Methodology:

 

The study design will be a cross sectional baseline study based on the methods contained in WHO manual "How to investigate the use of medicines by consumers” and WHO methodology on Drug Utilization Research as outlined in WHO guide "Introduction to drug utilization research." Study will be conducted at all the three levels of primary, secondary and tertiary care hospitals including both government and private antenatal clinics. Study units shall include a leading government, tertiary care gynecological hospital based at Srinagar, the capital city of J&K state, few community health centres and primary health centres spread across Kashmir valley and a few private antenatal clinics. Sampling of health facilities shall be done on the basis of their geographical distribution in accordance with PPS (probability proportional to size) approach so as to ensure that the findings are representative of the entire Kashmir province. 

 

Data shall be collected using a self-administered, pre-designed and pre-tested questionnaire after obtaining necessary ethical clearance. Pregnant women reporting at study units during the study period shall be interviewed in local language, after obtaining their informed consent. Their statements shall be corroborated with the written records and medicines that are available with them. All prescriptions during the study period shall be audited for drug utilization and cost analysis. Information shall be collected and analyzed for various study parameters including demographic and anthropometric details, duration of pregnancy, family per capita income per month, number of antenatal visits, self-medication practices, number of drugs used, number of herbal/homeopathic drugs used etc. All drugs used during the first (first 12 weeks), second (13th to 24th week) and third (24th week onwards) trimester of pregnancy shall be classified into category-A, category-B, category-C, category-D and category-X, as per the classification for drug use during pregnancy, given by the US Food and Drug Administration (FDA). ATC-DDD classification of drugs as prescribed by WHO shall be used wherever necessary. 

 

Main objective of the study shall be as under: 

 

Ø  To evaluate the prescribing patterns of doctors among the pregnant women presenting to antenatal clinics of a gynecological hospital, primary and community health centres and those reporting at private gynecological clinics.

Ø  To ascertain the choice, strength, dosage forms and duration of treatments prescribed to the pregnant women at study units and stratify them as per WHO ATC/DDD methodology wherever applicable.

Ø  To perform cost analysis of drugs prescribed to pregnant women.

Ø  To evaluate the prescribing patterns using WHO drug use indicators among the study population.

Ø  To evaluate the pharmaceutical care services including patient counseling, drug information and pharmacovigilance services available to patients at the study hospital.

Ø  To assess prescribing practices of the prescribers and dispensing practices of pharmacists.

Ø  To assess the use of traditional remedies by the pregnant women.

Ø  To evaluate the adherence of patients towards their prescribed medications using Morrisky’s patient adherence questionnaire.

 

Data from a random sample of prescription slips shall be captured on the day of the facility visit (roughly 20-25 slips per facility). Prior consent of the respective medical heads of the facilities shall be sought in addition to the oral consent of the patients. Analysis of prescription slips is required to contribute towards understanding the level and pattern of irrational prescription practices, if any.

 

Feasibility:

 

Information on the use of drugs during pregnancy is scarce and rather anecdotal. Careful consideration of the benefit to the mother and the risk to the fetus is required when prescribing drugs during pregnancy. Total avoidance of pharmacological treatment in pregnancy is not possible and may be dangerous because some women enter pregnancy with medical conditions that require ongoing and episodic treatment (e.g. asthma, epilepsy, hypertension). Also during pregnancy new medical problems can develop and old ones can be exacerbated (e.g. migraine, headache) requiring pharmacological therapy. The fact that certain drugs given during pregnancy may prove harmful to the unborn child is one of the classical problems in medical treatment.

 

Drug utilization studies on pregnant women focus on the potential teratogenic effects traditionally. However drugs can influence foetus during entire time of pregnancy. Furthermore toxic manifestations of intra uterine drug exposure may not be revealed many years after the time of birth. The potential long term consequences of intra uterine exposure to drugs emphasise the importance of studying drug exposure during pregnancy and prolonging follow up beyond the time of birth.

 

The health sector in Jammu and Kashmir is unique Indian state beset by many challenges. A combination of weak institutional capacity, limited access to modern equipment and infrastructure, and shortage of healthcare personnel has limited the effectiveness of health service delivery in the State. Patients are deprived of good pharmaceutical care services on the use of medicines like patient counseling services, drug information services, adverse drug reaction monitoring services etc due to non-availability of qualified clinical pharmacists in either government or private sector. However the reasons for and consequences of such a drug utilization pattern have not been documented anywhere in the literature.