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Current trends in treatment of hypertension in Karachi and cost minimization possibilities.

Byline: Izhar M. Hussain, Baqir S. Naqvi, Rao M. Qasim and Nasir Ali

ABSTRACT

Objective: This study finds out drug usage trends in Stage I Hypertensive Patients without any compelling indications in Karachi, deviations of current practices from evidence based antihypertensive therapeutic guidelines and looks for cost minimization opportunities.

Methods: In the present study conducted during June 2012 to August 2012, two sets were used. Randomized stratified independent surveys were conducted in doctors and general population - including patients, using pretested questionnaires. Sample sizes for doctors and general population were 100 and 400 respectively. Statistical analysis was conducted on Statistical Package for Social Science (SPSS). Financial impact was also analyzed.

Results: On the basis of patients' doctors' feedback, Beta Blockers,and Angiotensin Converting Enzyme Inhibitors were used more frequently than other drugs. Thiazides and low-priced generics were hardly prescribed. Beta blockers were prescribed widely and considered cost effective.This trend increases cost by two to ten times.

Conclusion: Feedbacks showed that therapeutic guidelines were not followed by the doctors practicing in the community and hospitals in Karachi. Thiazide diuretics were hardly used. Beta blockers were widely prescribed. High priced market leaders or expensive branded generics were commonly prescribed. Therefore, there are great opportunities for cost minimization by using evidence-based clinically effective and safe medicines.

KEY WORDS: Cost minimization, Stage I hypertension, Initial therapy, Evidence-based therapeutic guidelines, Compelling indications.

INTRODUCTION

Hypertension is the major risk factor for cardio- vascular disease. The WHO declared it the number one killer' in The World Health Report of year 2001. It is important to note that hypertensive patients have four times greater chances for stroke and Two times greater chances myocardial infarction (a heart attack) than those who have normal blood pressure.1 The chances of complications increase with rise in level of blood pressure. It is reported that a 5mmHg drop of blood pressure, reduces risk of stroke by 14%, coronary heart disease by 9% and overall chances of mortality by 7%.

Hypertension is the most common cardiovascular disease in Pakistan as well. The National Heath Survey of Pakistan reported incidence of high blood pressure in 18% of adults over 18 year of age and 33% of adults over 45 years. There are different reports showing different figures of rates of prevalence, awareness, treatment and control. The experts developed guidelines for safe and better management of hypertension for the health providers and general public on the basis of clinically and scientifically sound and validated evidences. Juxtaposing, different guidelines (Table-I) for initial or Stage I therapy for hypertension without compelling indications use of Thiazide Diuretics, Angiotensin Converting Enzyme Inhibitors (ACEIs) or Calcium Channel Blockers (CCB) are widely recommended. The JNCVII Guidelines strongly recommends thiazide for "most of the patients". Pakistan Hypertension Leagues' guideline has more or less adopted NICE (UK) recommendations.

NICE recommends ACEIs to patients younger than 55years whereas CCB and diuretics to patients 55 years or blacks. Beta Blockers (BBs), once considered as key medication, are not recommended for initial or Stage I therapy for hypertension except in compelling conditions. Combinations of more than one drug are also encouraged to achieve therapeutic goal. Use of generic drugs is recommended to reduce prescription cost.

Key issues, globally, are lack of adherence to therapeutic guidelines for hypertensive therapy by the doctors, and lack of patients' awareness of disease as well as compliance to their doctors' recommendations. In Pakistan, the situation is not different; there are reports of very low awareness of disease and observance to doctors' advicein patients and wide deviations to the therapeutic guidelines available for health providers in Pakistan. Jafar et al. (2005) asked for special efforts to encourage doctors (particularly general practitioners) for prescribing cost effective regimen.2 In another study by Hameed et al. (2004) reported misconceptions in understanding and treatment of hypertension among a group of doctors. He found that 50% of the general practitioners (GPs) attending a Continuous Medical Education (CME) workshop on hypertension could not define hypertension, whereas 75% of them believed that anxiolytics were the first line therapy for hypertension.3

The major hurdles in the management of hypertension that emerged from the reports were financial constraints, non-compliance to treatment regime and lack of follow-up with physicians.4

Table-I: Summary of National and International Guidelines for the Management of Hypertension.

S.###Excerpts###Evidence-based clinically ascertained guidelines for the management of hypertension

No.###from the

###Guidelines

###PHL13###JNC VII14###WHO/ISH15###NICE16###South Africa17

1###Initial###Step 1: Younger than###Thiazides for###ACEIs, CCBs and###Step 1: Young-###For the majority of pa-

###Drug###55 years and non-###most of the pa- Diuretics###er than 55 years###tients without a com-

###Choice:###black: ACEIs and old-###tients###and non-black:###pelling indication for

###er than 55 years or###ACEIs and older###another class of drug.

###black: CCBs and Diu-###than 55 years###A low cost diuretic

###retics###or black: CCB###should be considered

###and Diuretic###as first choice therapy

###on the basis of com-

###parative trial data,

###availability and cost.

2###Cost###"Diuretics, being###Recommended###Recommended###Recommended###A thiazide-like diuret-

###reducing###very economic drugs###ic is advisable when

###measures:###may be used as a first###consideration for cost

###line therapy in coun-###of therapy is relevant.

###tries like Pakistan,.."

3###Use of BBs###More recently the###Not###Not###BBs not to be###Not recommended

###for initial###BBs are deempha-###recommended###recommended###preferred for

###therapy:###sized due to their###initial hyper-

###diabetogenic poten-###tension thera-

###tials.###py (except for

###compelling

###condition).

Impact of hypertension on healthcare cost is huge. In USA, it cost US$ 73.4 billion in the year 2009. The financial requirements for antihypertensive therapy in Brazil was US$ 9.6 billion in 2012 with 24% increase during the year 2010 -2012.5,6 Search and efforts for reducing cost of antihypertensive therapy has been intensive worldwide i.e. Brazil, Caribbean countries, Malaysia, Poland, and USA.7-10 It was found by the American Heart Association (ASA) that the medication cost was 45% of total direct cost of therapy.11To reduce cost of therapy, Fischer (2004) after studying more than two million prescriptions for antihypertensive medications in 2001, costingUS$ 48.5 million per annum(363 dollars per patient), identified that 40% of prescriptions of medication for which an alternative evidence-based expert recommended cost-effective regimen was available.

He calculated that this change would have saved the costs to payers in 2001 by US$11.6 million (nearly a quarter of program spending on antihypertensive medications). Moreover, he suggested replacement was evidence-based for clinical appropriateness on global basis. The largest potential saving was due to replacement of calcium channel blockers.12

Our objective was to find out drug usage trends in Stage I Hypertensive Patients without any compelling indications in Karachi, deviations of current practices from evidence based antihypertensive therapeutic guidelines and looking for cost minimization opportunities.

METHODS

Three pronged approach was used. Two randomized stratified surveys were conducted in health providers (doctors) and health receivers (general population including patients) using pretested questionnaires. Sample size for doctors was 100 (58 general practitioners and 42 doctors working in hospital OPDs) and for general population was 400 (200 males and 200 females) from different socio-economic areas of Karachi. Specialists and consultants were excluded from the study. Data of prescriptions, prescription trends, and drug prices were obtained from authentic sources.Statistical analysis was conducted on Statistical Package for Social Science (SPSS). Financial impact was also analyzed.The study was conducted during June 2012 to August 2012 and it was approved by Ethics Review Committee of Liaquat National Hospital Karachi.

RESULTS

The present study aims to determine the drug usage trends in Stage I hypertension without any compelling indications in Karachi, identifies deviations of current prescribing practice from the evidence based antihypertensive therapeutic guidelines, and looks for therapeutic cost minimization opportunities.

The Table-II tabulates hypertensive patients' feedback (N=400) on their first prescribed hypertensive drug. It was found that majority of them were prescribed Beta Blockers (33%), followed by Angiotensin Converting Enzyme (18%), and Calcium Channel Blockers (13%). Diuretics were prescribed to 8% of them. The diuretics included furosemide and amiloride with furosemide. Nobody got thiazide diuretics. Usage of combination drugs was found in 3% of the respondents. It was also found that majority of them got high priced brand leader (original patent). 17% patients could not recall names of their antihypertensive drugs.

Table-II: Which drug was given to you when doctor decided to start treating your high blood pressure (Primary Data Patients --- N=83).

S. Antihypertensive Class###Score of responses###Main drugs used (name and score)

No.###Number###%

1 Beta Blockers (BB)###27###33%###Atenolol # 19 (68% Brand Leader)

###Propranolol # 8

2 Angiotensin Converting Enzyme Inhibitors (ACEIs) 15###18%###Ramipril # 6

###Enalapril # 6 (100% Brand Leader)

3 Calcium Channel Blockers (CCB)###11###13%###Amlodipine # 9

###Nimodipine # 1

###Verapamil # 1

4 Angiotensin Receptor Blockers (ARBs)###7###8%###Losartan # 7 (14% on Brand Leader)

5 Non-Thiazide Diuretics###7###8%###Furosemide # 6 (16% Brand Leader)

###Amiloride with Furosemide # 1

6 Antihypertensive Combinations###2###3%###HCTZ + ACEI # 1

###HCTZ +ARB # 1

7 Thiazide Diuretics (HCTZ)###none###0###No prescription

8 Could not recall drug's name###14###17%

Table-III: Doctors' first line antihypertensive therapeutic agents and perception of cost effectiveness (Primary Data) [N=100].

S.###Classes of###Doctors' choice of drug for initial antihypertensive

No Antihypertensive Drugs###herapy and perception of cost effectiveness

###Q: Which is the drug you would like to###Q: Which is the most cost effective

###use as the first line hypertensive in###antihypertensive drug in

###patients without compelling indications###your opinion

###General###Hospital###Overall###General###Hospital###Overall

###Practitioners###Doctors###Total###Practitioners###Doctors###Total

###N###%###N###%###N###%###N###%###N###%###N###%

1 Diuretics###9###16%###8###19%###17###17%###5###9%###7###17%###12###12%

2 Angiotensin Converting###20###34%###14###33%###34###34%###9###16%###9###21%###18###18%

Enzymes Inhibitors (ACEIs)

3 Calcium Channel Blockers (CCBs)###3###5%###1###2%###4###4%###3###5%###4###10%###7###7%

4 Angiotensin Receptor###-###-###-###-###-###-###4###7%###0###4###4%

Blockers (ARBs)

5 Beta Blockers (BBs)###19###33%###15###36%###34###34%###16###28%###13###31%###29###29%

6 Combinations###-###-###-###-###-###-###7###12%###0###-###7###7%

7 Not mentioned###7###12%###4###10%###11###11%###16###28%###7###17%###22###22%

Total###58###42###100###58###42###100

Table-III shows doctors response to two queries. When the doctors (N=100) were asked about their choice of first line (Step I) antihypertensive agents in patients with no compelling indications, they preferred Beta Blockers (34%) and ACEIs (34%) over other antihypertensive agents e.g. diuretics (17%), Calcium Channel Blockers (4%), and others (11%). Responding to query asked for their perception of the most cost-effective drug, 29 % of the doctors opined Beta Blockers, followed by Angiotensin Converting Enzymes inhibitors (18%) and diuretics (12%). There was no significant difference in the initial choice of drugs for patients of Stage I hypertension with no compelling indications and perception about cost effectiveness in general practitioners and doctors working in the hospitals.

Table-IV gives picture of non-pharmacologic interventions in hypertension mentioned by the patients. 84% of the patients acknowledged doctors' advice for physical exercise whereas 95% remembered doctors' recommendations for changing dietary habits. Most of the patients recalled medical advice for 30-minute brisk walk for five days a week and salt, fat-rich and high sugar intake reduction.

Table-V gives comparison of annual cost of therapy to a patient. It shows that hydrochlorothiazide (HCTZ) from a national company is the most cost-effective antihypertensive costing only Rs. 367 yearly per patient.When Branded Market Leaders of ACEIs, CCBs, BBs and ARBs annually cost Rs. 3,041; Rs. 6,532; Rs.3,652; and Rs. 28,278 respectively. The Branded Market leaders are 8 to 77 times costlier than above mentioned HCTZ. Even the generic drugs of chemical moieties' average prices are 5 to 19 times whereas the lowest priced generics are 2 to 8 times more expensive than HCTZ. Price difference between the generics and the branded market leaders ranges from 1.2 to 4 times more expensive. Branded market leaders are 4 to 9 times more expensive than their lowest priced generic drugs.

Table-IV: Non-pharmacologic intervention for controlling high blood pressure (Patients' Feedback)

S. Survey Questions###Subject's Feedback (N=83)###Additional Feedback related

No.###to Survey Questions.

###Yes###No###No Response

###N###%###N###%###%

1###Has your doctor advised you for###70###84%###12 14%###2%###30-minute brisk walk five

###physical exercise as a measure###days a week

###to control hypertension

2###Has your doctor or any other###79###95%###3###4%###1%###Reduce Salt intake

###health professional ever advised###Avoid fatty high sugar

###you to change your dietary habits###containing food.

###for better control of hypertension

Table-V: Comparison of Annual Cost of Therapy (per Patient).

Antihypertensive Groups###Annual Cost###Other###Branded Market###Branded Market

###of therapy###Antihypertensive###Leader Vs.###Leader Vs. Generic

###(Rs)###Vs.HCTZ###Generic product###product

###(Average)###(Lowest price)

Diuretics : Thiazides

Hydrochlorothiazide (HCTZ)###367###1

[Triamterene:50mg,Hydrochlorothiazide:25mg]1,2433

Angiotensin Converting Enzyme Inhibitors (ACEIs): Captopril

Branded Market Leader###3,041###8

Generic products (Average)###2,453###7###1.2

Generic product (Lowest price)###682###2###4

Calcium Channel Blockers (CCBs): Amlodipine

Branded Market Leader###6,532###18

Generic products (Average)###2,869###8###2.3

Generic product (Lowest price)###630###2###10

Beta Blockers (BBs): Atenolol

Branded Market Leader###3,652###10

Generic products (Average)###1,944###5###1.9

Generic product (Lowest price)###860###2###4

Angiotensin Receptor Blockers (ARB): Losartan

Branded Market Leader###28,278###77

Generic products (Average)###7,035###19###4.0

Generic product (Lowest price)###2,984###8###9

DISCUSSION

Table-I contains relevant points from one national and four international evidence-based therapeutic guidelines for the management and treatment of hypertension. All these guidelines recommend use of thiazide diuretics as the drug of first choice in patients of Stage 1 hypertension without any compelling indications. JNC VII (even JNC VIII) recommends initial therapy with diuretics in such cases. Both the UK's National Institute of Clinical Excellence (NICE) and Pakistan Hypertension League (PHL) recommend ACEIs for non-black and those younger than 55 years and CCBs and diuretics for black and those older than 55 years. Diuretics are recommended because of safety, cardiovascular protection, and economy. Besides diuretics, ACEIs and CCBs are also recommended. Another important but worth considering point is de- emphasis on use of beta blockers as initial therapy (except for compelling indications). PHL asked for de-emphasize on BBs because of their diabetogenic effects.

All these guidelines underscore use of cost effective drugs to minimize cost of therapy.

Feedback received from the patients and the doctors in Karachi showed that non pharmacologic recommendations were given to the patients as per the guidelines. However, gaps were identified in adherence to therapeutic guidelines by the doctors. Deviations in therapy from the guidelines were evident on different counts. For instance, diuretics were not used as recommended and expensive branded leaders were usually prescribed. Beta blockers were extensively used despite strong recommendation by different therapeutic guidelines in hypertensive patients without compelling conditions to deemphasize them because their diabetogenic potential and abstruse cardio protective role.

The perception of cost effectiveness was not clear to doctors. That's why most of doctors considered Beta Blockers or ACEIs more cost effective than diuretic of thiazide group. Consider a patient taking a thiazide diuretic, would pay Rs. 367 only for a year-long treatment. But if other drugs were used instead of diuretics e.g. beta blockers, ACE Inhibitors, Calcium Channel Blockers or ARBs, yearly medicine cost would go up to Rs. 3,652, Rs. 3,041, Rs.6,532, Rs. 28,278 respectively for corresponding branded market leaders; Rs. 1,944, Rs. 2,452, Rs. 2,869, Rs 7,035 for generic substitutes (average priced) of branded market leaders; and Rs. 860, Rs. 682, Rs. 630, Rs. 2,984 for the lowest priced generic substitutes of branded market leaders registered by the Health Authorities in Pakistan.

Because of choice of drugs, cost of therapy could increase many folds ranging from 2 to 77 times depending upon the choice of drugs.

CONCLUSION

Feedbacks showed that therapeutic guidelines were not followed for choosing pharmacologic agents by the doctors practicing in the community and hospitals in Karachi. Thiazide diuretics were hardly used. Beta blockers were widely prescribed. High priced market leaders or expensive branded generics were commonly prescribed. Therefore, great opportunities for cost minimization by used evidence-based clinically effective and safe medicines. It is concluded that national and international evidence-based therapeutic guidelines for the management of Stage I hypertension in patients without compelling indications were not followed in the selected samples of population and doctors in Karachi. The doctors have misconception about the cost effectiveness of certain antihypertensive agents. The outcomes of this study should be reflected for designing plans for patient awareness and education of health providers; and also considered for periodically updating therapeutic guidelines for blood pressure control.

Limitations of the study: Some final considerations need elaboration relating to limitations of the study. First, doctors' viewpoints, for not complying with international therapeutic guidelines, were not explored. Secondly, patients' opinion about the therapy they were using was also not sought. Moreover, the present work focused in Karachi region only, hence, limiting the targeting population to specific city and could not generalize the results to Pakistan as a whole.

ACKNOWLEDGEMENT

I would like to acknowledge support given to me by Dr. Naeem-uz-Zafar and Dr. Sajjad Haider of IBA, valuable suggestions given by Syeda Faiza Hassan (Center for Executive Education, IBA, Karachi) for textual change, and recommendations given by Dr. Faiza Hussain (Ziauddin University) for medical aspects. No financial support has been received for this work from any quarter.

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Publication:Pakistan Journal of Medical Sciences
Article Type:Report
Geographic Code:9PAKI
Date:Oct 31, 2015
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