The prevalence of psychiatric disorders in both developed and developing countries has been documented to be very high and there is a large burden of unmet need for care among people with serious disorders.^19-22The drug utilization among this class of patients has been largely described as inappropriate which results from irrational prescribing, dispensing and administration of medications.²³

The success of medication treatment is dependent on a patient’s adherence to the medication regimen. Non-adherence among the psychiatric patients, which has been identified in several studies, is responsible for the poor clinical outcomes and high resource utilization seen in this patient population.^34-38

The findings following several works done on this subject matter revealed irrational drug utilization and poor patient adherence in psychiatric settings, therefore, the following questions are then raised about Psychiatric Hospital, Uselu, Benin City:

1. What is the current drug utilization pattern at the Federal Psychiatric Hospital, Uselu?
2. What is the level of drug availability at the hospital pharmacy?
3. What is the current level of adherence to psychotropic drugs by patients at the Psychiatric Hospital, Uselu?
4. What are the factors responsible for non-adherence in this setting and how can the factors be addressed?

Drug utilization review assesses the patterns of drug use in a particular clinical context and such evaluation can identify problems in drug use, reduce adverse drug reactions, optimize drug therapy and minimize drug-related expenditures.⁶¹

This can be achieved by examining the quantitative and qualitative aspects of drug utilization. These include the medical, social and psychological factors and consequences of drug use in relation to specific patient groups and specific population groups, as well as the population in general.⁶⁴

A major goal of drug utilization research is the improvement of drug therapy and the assessment of drug use in the population as a whole, encompassing both prescription-based and self-administered medications. In addition, drug utilization research also fulfills an important public health role by not only monitoring and controlling drug expenditure, but also providing data that serve to answer health policy questions as well as contributing to the management and planning of public health policies.⁶⁴

In the United States, just like in many other countries, non-adherence is a serious problem causing thousands of premature deaths and demanding care that would have been unnecessary.⁶⁴ One hundred and twenty five thousand (125 000) Americans die annually (i.e three hundred and forty two  people daily) as a result of poor medication adherence.⁶⁵Furthermore, non-adherence is the most common cause of treatment failure which in turn affects the psychological well-being of a patient⁶⁶. Failure of the medication treatment may lead the clinician to decide on alternative therapies which might lead to elimination of potentially effective medications or may expose the patient to risks of adverse effects of drugs. The patient on the other hand may turn to other clinicians or sources (traditional medicine for instance) for cure. This results in more danger to the patient as well as an increase in disease-related medical costs.

The local data on both drug utilization and patient adherence at the Federal Psychiatric Hospital, Uselu, Benin City are very scanty. The studies done on adherence by James and Omoaregba and drug prescribing by Agbonile and Famuyiwawere both conducted in 2009.^39,49 Therefore, there is a need to ascertain the current level of patients’ adherence in this setting and also to re-examine the factors responsible for poor adherence. Moreover, the previous study on drug prescribing did not use the WHO core drug use indicators in assessing the prescription pattern. The WHO drug use indicators which were employed in this study allow comparison to be made between the prescription pattern of prescribers at the Psychiatric HospitalUseluand that of the WHO reference standard and this will go a long way in influencing the prescribers’ pattern of prescribing.

It is hoped that the findings of this study would help both patients and practitioners better understand the factors responsible for non-adherence in this setting and how such factors could be addressed in a more collaborative manner.

It would also help the prescribers adjust their prescription pattern to be in tune with the WHO reference standard. This study will also reveal other drug use grey areas to which future drug use intervention programs by both the government and other bodies could be centered on.

The simplest way to conceptualize a psychiatric disorder is as a disturbance of cognition (i.e. thought) or conation (i.e. action) or affect (i.e. feeling) or any disequilibrium in the three domains. Another way to define a psychiatric disorder is as a clinically significant psychological or behavioral syndrome that causes significant distress (subjective symptomatology), disability (objective symptomatology) or loss of freedom; and which is not merely a socially deviant behavior or an expected response to a stressful life event (e.g. loss of a loved one).Conflicts between the society and the individual are not considered mental disorders. A mental disorder should be a manifestation of behavioral, psychological, and/or biological dysfunction in that person.¹³⁵

The results of a prospective study on the prevalence of psychiatric disorders in the Dutch population aged 18-64 revealed that psychiatric disorders were quite common.¹⁹

According to the study, 41.2% of the adult population under 65 had experienced at least one DSM-IV-TR¹³⁵ disorder in their life time, among them, 23.3% within the preceding year. No gender differences were found in overall morbidity. Depression, anxiety and alcohol abuse and dependence were most prevalent and the study also revealed a high degree of co morbidity. The prevalence rate encountered for schizophrenia was lower (0.4% life time) than generally presumed.

Mental disorders are also common in the United States and in a given year approximately one quarter of adults were diagnosable with one or more disorders.²⁰ While mental disorders are widespread in the population, the main burden of illness is concentrated among a much smaller proportion (about 6 percent, or in 1 in 17) who suffer from a seriously debilitating mental illness. A 12-month prevalence of mental disorders among U.S adult population is 26.2% while 22.3% of these (e.g. 5.8% U.S. adult population) are classified as severe.²¹

“Lifetime and 12-month prevalence of mental disorders in the Nigerian survey of mental health and well-being” was a study conducted to ascertain the prevalence of mental disorders in Nigeria. Of the 4984 people interviewed (response rate 79.9%) 12.1% had a lifetime rate of at least one DSM-IV disorder and 5.8% had 12 month disorders. Anxiety disorders were the most common (5.7% lifetime, 4.1% 12-month rates) but virtually no generalized anxiety or post-traumatic stress disorders were identified. Of the 23% who had seriously disabling disorders, only about 8% had received treatment in the preceding 12 months. The study concluded that the observed low rates of psychiatric disorders seem to reflect demographic and ascertainment factors. And that there was a large burden of unmet need for care among people with serious disorders.²²

The two major classifications in psychiatry are the ICD-10 (International Classification of Diseases, 10^th Revision, 1992)²³ and the DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, IV Edition, Text Revision, 2000).¹³⁵

While ICD-10 is the WHO’s classification for all diseases (and not only psychiatric disorders), DSM-IV-TR is the American Psychiatric Association’s classification of mental disorders. ICD-10 will be adopted for classification of psychiatric disorders in this study because it has been tested extensively all over the world (51 countries, 195 clinical centers), and has been found to be generally applicable across the globe.

Chapter “F’’ of the ICD-10 classifies psychiatric disorders as mental and behavioral disorders (MBDs) and codes them on an alphanumeric system from F00 to F99.²³

F00-F09: Organic, including symptomatic mental disorders

This group includes mental and behavioral disorders due to demonstrable cerebral disease or disorder, either primary (primary brain pathology) or secondary (brain dysfunction due to systemic disease). The disorders in this section include: delirium, dementia, organic amnestic syndrome, and other organic mental disorders.

F10-F19:Mental and behavioral disorders due to the use of one or more psychoactive substances

The disorders that constitute this class include: acute intoxication, harmful use, dependence syndrome, withdrawal state, amnestic syndrome, and psychotic disorders due to psycho-active substance use.

F20-F29: Schizophrenia, schizotypal and delusional disorders

This group includes mental and behavioral disorders characterized by prominent disturbance of thought, perception, affect, and/or behavior.

The disorders in this section include: schizophrenia, schizotypal disorder, persistent delusional disorders, acute and transient psychotic disorders, induced delusional disorder and schizoaffective disorders.

F31-F39: Mood (affective) disorders

This group includes mental and behavioral disorders characterized by a prominent disturbance of mood. The disorders in this section include manic episode, depressive episode, bipolar affective disorder, recurrent depressive disorder and persistent mood disorder.

F40-F48: Neurotic, stress-related and somatoform disorders

This group comprises mental and behavioral disorders that were earlier labeled as neurotic disorders with an emphasis on psychological causation.

The disorders here include: anxiety disorders, phobic anxiety disorders, obsessive compulsive disorder, dissociative (conversion) disorders, somatoform disorders, reaction to stress and adjustment disorders, and other neurotic disorders.

F50-F59: Behavioral syndrome associated with physiological disturbances and physical factors

This group includes mental and behavioral disorders that were earlier called psychosomatic disorders. The disorders in this section include: eating disorders, non-organic sleep disorders, sexual dysfunctions (not caused by organic disorder or disease), mental and behavioral disorders associated with puerperium and abuse of non-dependent producing substances.

F60-F69: Disorders of adult personality and behavior

This group includes mental and behavioral disorders that are the persistent expression of an individual’s characteristic lifestyle and mode of relating to self and others.

This group comprises: specific personality disorders, enduring personality changes, habit and impulse disorders, gender identity disorders, disorders of sexual preference and psychological and behavioral disorder associated with development and orientation.

F70-F79: Mental retardation

This group includes disorders with arrested or incomplete development of the intellectual abilities and adaptive behavior which may or may not be associated with other physical or mental disorder. The disorders in this section include mild, moderate severe and profound mental retardation.

F80-F89: Disorders of psychological development

This group includes mental and behavioral disorders with an onset during infancy or childhood and characterized by an impairment or delay in the development of functions that are strongly related to biological maturation of the central nervous system. The disorders here include specific disorders of speech and language, specific developmental disorders of scholastic skills, specific developmental disorders of motor function, mixed specific developmental disorders and pervasive development disorders.

F90-F98: Behavioral and emotional disorders with onset usually occurring in childhood and adolescence

This group includes miscellaneous mental and behavioral disorders that have an onset in childhood and adolescence.These disorders include hyperkinetic disorders, conduct disorders, mixed disorders of conduct and emotions, tic disorders and other disorders.

The principal aim of drug utilization research is to facilitate the rational use of drugs in population¹ and to suggest measures to improve prescribing habit. Irrational use of drugs is a widespread global phenomenon cutting across all levels of care. The consequences of irrational medicines use include increased mortality, morbidity, adverse drug reactions as well as economic wastages.

Drug utilization and pharmacoepidemiological studies in different countries and practice settings during the last twenty five years have basically tried to describe who are using the drugs and how much are being used.⁶¹ On a macro level, factors influencing drug consumption include but not restricted to: the size of population, age and gender distributions, occupational structure, income levels, availability of health services, number and type of health facilities, number and type of personnel, social insurance and reimbursement mechanisms.⁶¹

However, the pioneering work of Arthur Engel and Pieter Sideriusin Sweden and Holland²⁶respectively alerted many investigators to the importance of comparing drug use between countries and regions. Their demonstration of the remarkable differences in the sales of antibiotics in six European countries between 1966 and 1967 inspired WHO to organize its first meeting on “Drug consumption” in Oslo in 1969.²⁷This led to the constitution of the WHO European Drug Utilization Research Group (DURG).

The ultimate goal of drug utilization research must be to assess whether drug therapy is rational or not. To reach this end, methods of auditing drug therapy towards rationality are very pertinent. Drug use studies have also been used to identify different types of ‘irrational’ use, e.g. overuse of psychotropics and antibiotics (such as people using them when not indicated, for too long periods, habitual use of analgesic every morning without a medical reason).

There has also been a lot of interests on the ‘underuse’ of drugs for major chronic diseases like hypertension, diabetes and elevated lipids ( not starting or stopping treatment, unsupervised drug holidays, taking only half of what is prescribed etc.) Underuse together with misuse has been one of the main focuses of many studies⁶². From some of those studies, we know something about the use of medicines, and its clinical, social, and economic consequences.⁶¹

Drug utilization research also provides insight into the efficiency of drug use, i.e. whether a certain drug therapy provides value for money and the results of such research can be used to help to set priorities for the rational allocation of health care budgets. Rational use of drugs, however, implies the prescription of a well-documented drug at an optimal dose,along with the correct information at an affordable price. Without knowledge of how drugs are being prescribed and used, it is difficult to engage in a meaningful discussion on rational drug use or to suggest measures to improve prescribing habits. Therefore, drug utilization research can increase our understanding of how drugs are being used as follows.²⁷

1. It can be used to estimate the numbers of patients exposed to specific drugs within a given time period. Such estimates may either refer to all drug users, regardless of when they started to use the drug within the selected period.
2. It can describe the extent of use at a certain moment and/or in a certain area (e.g. in a country, region, community or hospital) such descriptions are most meaningful when they form part of a continuous evaluation system, i.e. when the patterns are followed over time and trends in drug use can be discerned.
3. Researchers can estimate (e.g. on the basis of epidemiological data on a disease) to what extent drugs are properly used, overused or underused.
4. It can determine the pattern or profile of drug use and the extent to which alternative drugs are being used to treat particular conditions.
5. It can be used to compare the observed patterns of drug use for the treatment of a certain disease with current recommendations or guidelines.
6. It can be used in the application of quality indicators to patterns of drug utilization. An example is the DU 90% (Drug utilization 90%).

The DU 90% segment reflects the number of drugs that account for 90% of drug prescriptions and the adherence to local or national prescription guidelines in this segment. This general indicator can be applied at different levels (e.g. individual prescriber, group of prescribers, hospital or region) to obtain a rough estimate of the quality of prescribing.

1. Drug utilization data can be fed back to the prescribers. This is particularly useful when the drug prescribing by a particular individual can be compared with some form of “gold standard” or best practice and with the average prescriptions in the relevant country, region or area.
2. The number of case reports about a drug problem or adverse effects can be related to the number of patients exposed to the drug to assess the potential magnitude of the problem. If it is possible to detect that the reaction is more common in a certain age group, in certain conditions or at a given dose level, improving the information on indications, contra-indications and appropriate dosages may be sufficient to ensure safer use and avoid withdrawal of the drug from the market.

A review of the study conducted by Babalola et al in Osun State, Nigeria showed that polypharmacy practice is high at the grassroots in Osun State (south west) Nigeria.³⁰ The study also revealed that there is shortage of highly skilled manpower such as doctors and pharmacists for qualitative healthcare delivery at grassroots. It also showed that the use of antibiotics and injections were too high and there may therefore be the need to establish protocols for the prescription and administration of both antibiotics and injections.

Utilization of psychiatric drugs is often a subject of drug utilization studies.²⁸Increasing researchers interest in prescribing and utilization of psychiatric drugs is noted worldwide.²⁸ Over the last decade, drug utilization studies on the usage of psychiatric drugs have been conducted. These studies have addressed certain major issues: drug use patterns, prescribing behavior, gaps between guidelines and actual utilization and factors responsible for poly-pharmacy.²⁸

In a review of some of the studies done in Serbia, it revealed a trend of domination of typical antipsychotic prescription and tendency towards co-prescribing (especially within the same class), low consumption of antidepressants and high still increasing trend of the utilization of anxiolytic/hypnotic drugs. Among positive trends, steady increase in the use of atypical antipsychotics and Selective Serotonin Reuptake Inhibitors (SSRIs) antidepressants were noted.

Furthermore, a study conducted by Kapoor in 2003 at a hospital in Jammu City, India which assessed two parameters – adherence to prescription format and rationality of prescription, indicated that majority of prescriptions did not adhere to the ideal pattern of prescription writing. Important demographic information like age and sex were not written in the majority of the cases.²⁹ He also noted that weight of patient which is so important in calculating the dose of drug in pediatric patients was missing in 88% of such prescriptions. Directions regarding total amount of drug to be dispensed and instructions regarding use of drug were inadequate in 50% and 39% of the prescriptions respectively.²⁹

Another disturbing revelation of drug utilization research is the identification of high rate of polypharmacy especially among psychiatrists. A study done in Kaduna, Northern Nigeria established that 92% of respondents were given two or more psychotropic drugs.³¹ The high rate of psychotropic polypharmacy found in the study above is consistent with those reported by studies from the southern Nigeria^32,33 and other parts of the world.³¹ That the figure is similar to those reported by studies carried out in the country over a decade ago suggests a persistent trend in the use of psychotropic polypharmacy in psychiatric practice and efforts should be made to check and curtail this trend.

Improving the public understanding of drugs:During the last few years, there have been different attempts both in developed and developing countries to improve the knowledge and understanding about drugs among the general public.⁶¹This can be seen as an attempt to influence and improve the social knowledge related to drugs and health in general. Campaigns like ‘ask about your medicines’, are good examples of this kind of activity. A more balanced partnership between patients and health care providers is one of the goals in such activities. Also a better appreciation of the limit of medicines and a lessening of the belief that there is a ‘pill for every ill’ are examples of the goals of such efforts.

The general public also needs to develop a more critical attitude toward advertising and other commercial information, which may often fail to give objective information about drugs. Drug use should be seen within the context of a society, community, family and individual, recognizing cultural diversity in concepts of health and illness or how drugs work. Improvement of the public’s knowledge about drugs should start at school. To facilitate informed choices on drug use, public education should be accompanied by supportive legislation and controls on drug availability. Effective public education requires a commitment to and understanding of the need for improved communication between health care providers and patients. This should also be reflected in the basic and continuing education of health care professionals.

Ensuring the safety ofdrugs:Because most people will use medicines and related services in a regular basis, the functioning of the sector is of utmost common interest. There are also many parties involved- patients, healthcare providers, manufacturers and sales representatives and therefore, detailed rules for interaction and functioning is highly required. History has shown that informal controls are not sufficient or respected.⁶⁹

Legislation and regulation include different health-related laws, pharmacy law, trademark and patent laws, criminal law, international treaties ( e.g. on narcotic and psychotropic drugs) and government decrees. Sometimes there may be a lack of political will or a weak infrastructure to enforce the laws as is the case in most of the developing countries. When looking at the legal situation in the drug sector in different countries the problem seem to be more often in the enforcement of legislation than the lack of lagislation⁶¹

Drug registration is a key tool in assuring the safety, quality and efficacy of a new drug being introduced into the market. In this connection the new medicine will also be scheduled to a certain category such as POM or OTC drugs. The infrastructure that will assure drug quality, safety and efficacy can be ascertained by licensing and inspection of manufacturers, distributors and the premises, and also by setting some standards on the professionals working there.

Pharmacoepidemiological studies are used to assure the safety of new medicines after theyhave been accepted on the market. This kind of information can supplement that availablefrom premarketing studies, it can also give a better quantification of the incidence of known adverse drug reactions but also beneficial effects. For ethical and other reasons it is not always suitable to perform clinical trials on certain patient groups such as children, elderly, and pregnant women in the early phase of a new product. It is also important to establish how other medicines and diseases may alter the positive effects. New types of information not available from the premarketing studies such as rare undetected adverse drug reactions, long term effects that manifest only after long use, and effects with low frequency are also the concern of pharmacoepidemiological studies.

Ensuring the availability of medicines: Availability of medicines is one of the key requirements in a functioning drug service system.⁶¹This includes a functioning manufacturing and importation system of medicines, good procurement and distribution practices. In developing countries, the maintenance of a constant supply of medicines, keeping them in good condition, minimizing losses due to spoilage and expiry (by observing, for instance the rule of ‘ first to expire first out’ and the use of reorder levels in drug procurement), are issues that need to be solved to assure the availability of medicines to the population.

Rational drug use (RDU) is defined as the use of an appropriate, efficacious,safe and cost-effective drug given for the right indications in the right dose and formulation, at right time intervals.⁷⁰The promotion of rational drug use involves wide range of activities such as adaptation of the essential drug concept, continuous training of health professionals and the development of evidence based clinical guidelines. Unbiased and independent drug information, consumer education and regulatory strategies are also essential to promote rational drug use.⁷¹ Drug related problems include medication error (involving an error in the process of prescribing, dispensing or administering a drug, whether there are resultant adverse consequences ornot), adverse drugreactions (any response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease, or for the modification of physiologicalfunctions) and drug interactions.⁷²These drug- related problems are frequent and may result in reduced quality of life, and even increasedmorbidity and mortality.⁷³The overuse, underuse or misuse of medicines result in wastageof scarce, economic resources and widespread health hazards. Examples of irrational use of medicinesinclude: use of too many medicines per patient (“poly-pharmacy”); inappropriate use of antimicrobials, often in inadequate dosage, for non-bacterial infections; over-use of injections when oral formulations would be more appropriate; failure to prescribe in accordance with clinical guidelines; inappropriate self-medication, often of prescription-only medicines; non-adherence to dosing regimes.

The problem of irrational prescribing: Irrational prescribing is a global problem.¹⁰⁰ Numerousstudies, both from developed and developing countries, describe a pattern that includes polypharmacy⁷⁴, the use of drugs that are not related to the diagnosis⁷⁵ or unnecessarily expensive⁷⁶, the inappropriate use of antibiotics⁷⁷and irrational selfmedication⁷⁸ with drugs frequently taken in underdose.⁷⁹ The problem is worsened by a global shift from public to private sector spending, which, in many developing countries without adequate regulation and inspection, usuallyresults in a large proportion of drugs being purchasedwithout any prescription at all.

Measuring drug use: Rational drug use cannot be defined without a method of measurement and a reference standard.²These same tools are even more necessary to measure the impactof an intervention, to make comparisons between facilities, districts or regions, and for supervisory purposes. Knowledge of the prescriber has sometimes been used as an output measure of interventions.⁸⁰However, adequate knowledge on rational drug usedoes not always result in rational prescribing behavior. Actual behavior is therefore preferred as a measurement. Over the past few years, the International Network for Rational Use of Drugs (INRUD) and the WHO Action Programme on Essential Drugs (APED) have closely collaborated in developing and testing a set of 12 quantitative indicators to measure some key aspects of prescribing and the quality of care.⁸¹These indicators, which are now also recommended by UNICEF, are listed below. A detailed manual on their use is available from WHO.⁸²The second important requirement in studyingrational drug use is a standard.  In practice this implies that the prescriptionshould be compared with an agreed treatment protocol or with a list of therapeutic alternatives. This is also a core principle of medical audit. The following are the Drug use indicators⁸²

Prescribing indicators

1 Average number of drugs per encounter

2 Percentage of drugs prescribed by generic name

3 Percentage of encounters with an antibiotic prescribed

4 Percentage of encounters with an injection prescribed

5 Percentage of drugs prescribed from essential drugs list orformulary

Patient care indicators

6 Average consultation time

7 Average dispensing time

8 Percentage of drugs actually dispensed

9 Percentage of drugs adequately labeled

10 Patient knowledge of correct dosage

Facility indicators

11 Availability of copy of essential drugs list or formulary

12 Availability of key drugs

Strategies to promote rational prescribing and their possible impact

The various interventions used in promoting rational prescribing are best classified as educational,managerial and regulatory.⁸³ Educational strategiesinclude printed materials, seminars,bulletins and face-to-face interventions. Managerial methods refer to various restrictions onprescribing, e.g. restrictive lists, a maximum number of drugs per prescription, budgetary or cost restrictions, endorsement by higher qualified consultants, patient co-payment strategies,price measures, structured prescription forms or a maximum duration for inpatientprescriptions (automaticstop-orders). Regulatory measures include procedures to critically evaluate drugs and productinformation (e.g. data sheet, patient information leaflet) before market approval is granted, scheduling drugs for different sales levels (over the counter,pharmacy only, prescription only) and specifying for each drug a minimum level ofprescriber or health facility (for example, no injectible antibiotics at health centers).

Several studies have critically reviewed the available evidence to identify the most effectiveinterventions⁸⁴, and the following provisional conclusions may be drawn. An importantobservation is that printed materials alone hardly influence prescriber behaviour⁸⁵, and that any such influence is usually of short duration.⁸⁶ Most of these interventions assume that the main reason for incorrect prescribing is a lack of knowledge and that ifprescribers had the correct information, their prescribing would automatically improve. This is not always the case in view of the many other factors influencing prescribing, like drug promotion by pharmaceutical representatives, patient demand, intentional use of placebo drugs and prescriber preference based on personal experience rather than peer reviewed standards.⁸⁷

Technical information on cost and side effects of the drugs is of much less influence, as shown in the Netherlands.⁸⁸ Another aspect of the problem is that prescribers with irrational prescribing behavior are the very ones that are less likely to read the educational material mailed to them. Proven cost-effective interventions are face-to-face education focused on a particular prescribing problem in selected individuals⁸⁹, structured prescription forms⁹⁰, and focused educational campaigns together with widely discussed and frequently revised treatment guidelines. An example of the latter is the success of the Australian antibiotic guidelines.⁹¹ Most recently, a review of 59 published evaluations of the effect of clinical guidelines concluded that all but four of these studies detected significant improvements in the process of care after the introduction of guidelines, and all but two of the 11 studies that assessed the outcome of care, reported significant improvements. However, the size of the improvements in performance varied considerably.⁹²

Essential drugs lists together with an educational programme and follow-up are probably effective as well. As mentioned above, most evidence suggests that printed materials alone are ineffective.^85,86,88 It is likely that this also applies to essential drugs lists and treatment guidelines if these are just distributed to prescribers without an introduction campaign and without intensive follow-up, and especially if the prescribers had not been involved in the development process. A general problem is that many interventions have only been tested in developed countries and that the results can therefore not automatically be extrapolated to developing countries where conditions are so different. In the absence of well conducted studies, Laing has attempted to give provisional advice to developing countries with regard to possible effective interventions.⁹³ He suggests that basic and postbasic medical education should include specific training in rational prescribing; that essential drugs lists and therapeutic guidelines should be developed through wide consultation and feed-back and be disseminated by means of intensive educational programmes as recorded from Yemen⁹⁴, Uganda⁹⁵and Zimbabwe⁹⁶; that general limitations on prescribers(maximum number of drugs per prescriptions, maximum quantities, maximum costs etc) may have unexpected effects which should be avoided through careful studies before such measures are taken; that face-to-face education may be effective but expensive; and that printed materials, including treatment guidelines, are ineffective without educational programmes and follow-up activities. The overall impact of drug bulletins is not clear. Experience from developed countries is not encouraging, but this may be due to the fact that prescribers receive so many promotional and other materials that some of them did not even recognize a carefully designed set of academic detailing material as different fromcommercial material.⁹⁷ However, in most developing countries the lack of information,promotional or otherwise, is so serious that any unbiased material sent out to prescribers might be studied with more care. Bulletins, especially when geared to actual day-to-day prescribing problems, may therefore have more impact in developing countries than elsewhere. This hypothesis is worth examining.

The role of medical schools and teaching hospitals:

The impact of medical education on subsequent prescribing behavior is difficult to evaluate, as most studies have measured knowledge rather than actual performance. Moreover, immediately after leaving medical school the young doctors are exposed to many other factors influencing their prescribing. It is now increasingly being recognized that the traditional medical education concentrates too much on an accumulating quantity of facts, including the drugs of the day, rather than teaching the student techniques of problem solving and making a rational choice between drug treatment alternatives, which includes the skill to evaluate critically any new drugs of the future.⁹⁸

With regard to rational prescribing this implies that the objectives of clinical pharmacology training need to be defined better, with more emphasis on the practical needs of the future prescriber. This has shown to result in better therapeutic knowledge and skills of the students.⁹⁹An undergraduate course in clinical pharmacology and therapeutics should stress the principles of rational evaluation of therapeutic alternatives and help the students to develop their own personal formulary on the basis of a rational comparison of therapeutic alternatives. Such a course could also ‘immunize’ the students against the disturbing influences they are likely to encounter in their professional life, such as patient pressure, drug promotion and irrational prescribing by peers.  The introduction of such a revised course in clinical pharmacology alone will not be enough. In many teaching hospitals bedside training emphasizes the need to make a correct diagnosis, with much less time spent on choosing the correct treatment.

And even if treatment guidelines exist, students are usually told to follow them rather than being taught on what grounds the guidelines had been developed, and how they should choose their own treatment in the future. Under these circumstances students entering the wards can do little more than copy the behaviour of residents and consultants. Unfortunately the prescribing practice in teaching hospitals, that inevitably serves as a role model for the students, is often irrational and inconsistent, as has frequently been described from developed and developing countries. For example, numerous reports¹⁰⁰ on the inappropriate use of antibiotics in teaching hospitalsshows that as many as 41-91% of all antibiotic prescriptions in teaching hospitals were considered inappropriate; a slightly better picture  emerged from medical and paediatricbwards but the situation in surgical and gynaecological wards was usually worse. Unnecessary treatment was by far the most common reason for irrational prescribing, followed by Wrong duration, misguided prophylaxis and poor selection of the drug. Not only antibiotics are misused in teaching hospitals. Polypharmacy was considered a serious problem in the medical and surgical wards of Singapore general hospital¹⁰¹ and vitamins were heavily overprescribed in the Kenyatta Teaching Hospital.⁷⁵ In the teaching hospital in Aden (Yemen) 68% of all patients with hypertension were prescribed diazepam, and 54% received Frusemide⁸⁰; 80% of patients with osteoarthritis received vitamins.

In the teaching hospital in Benin city (Nigeria) 74.3% of all pediatric  prescriptions were considered inappropriate, mostly because of polypharmacy, the use of unnecessary drugs and suboptimal dosage schedules.¹⁰² In Ilorin teaching hospital in Nigeria 33.1% of patients admitted to the surgical and medical wards received psychotropic drugs, 91.4% being tranquillizers.¹⁰³ The potential long term impact of such a lack of structured therapeutic training in the wards should not be underestimated. Teaching hospitals have a special responsibility towards society to promoterational prescribing by their staff and, through these, by future generations of doctors. The best approach seems that each clinical department in the teaching hospital should develop a departmental prescribing policy through a process of consultation and consensus building, in which clinical pharmacologists are involved. Such prescribing policies can later be integrated into a hospital formulary and should be used, and enforced, as the basis for prescribing, teaching, examinations and medical audit. This is already the case in several medical schools in the United Kingdom¹⁰⁴ and elsewhere; amongst developing countries Zimbabwe is a good example.¹⁰⁵ Ideally, medical students would then be trained in the principles of rational prescribing before they enter the wards; and these concepts would be reinforcedduring the clinical training with bedside teaching, examinations and actual prescribing by senior staff all based on the same principles.

The purpose of the Anatomical Therapeutic Chemical Classification/Defined Daily Dose (ATC/DDD) system is to serve as a tool for drug utilization research in order to improve quality of drug use. One component of this is thepresentation and comparison of drug consumption statistics at international andother levels.A major aim of the Centre and Working Group is to maintain stable ATC codes andDDDs over time to allow trends in drug consumption to be studied without thecomplication of frequent changes to the system. Thereis a strong reluctance tomake changes to classifications or DDDs where such changes are requested forreasons not directly related to drug consumption studies. For this reason theATC/DDD system by itself is not suitable for guiding decisions aboutreimbursement, pricing and therapeutic substitution.It has to be noted that the classification of a substance in the ATC/DDD system is not a recommendation for use, nor does it imply any judgements about efficacy or relative efficacy of drugs and groups of drugs.⁴⁰ In the ATC classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Drugs are classified in groups at five different levels. The drugs are divided into fourteen main groups (first level), with pharmacological/therapeutic sub groups (second level). The third and fourth levels are chemical/pharmacological/therapeutic sub groups and the fifth level is the chemical substance. The 2^nd, 3^rd and 4^th levels are often used to identify pharmacological sub groups when that is considered more appropriate than therapeutic or chemical sub groups.

The complete classification of metformin, for instance, illustrates the structure of the code.

A                                 Alimentary tract and metabolism (1^st level, anatomical main group).

A10                             Drugs used in diabetes (2^nd level, therapeutic sub group).

A10B                          Blood glucose lowering drugs, excludinginsulins (3^rd level, pharmacological sub groups).

A10BA                       Biguanides (4^th level, chemical sub group).

A10BA02                   Metformin (5^th level, chemical substance).

Thus, in the ATC system, all plain metformin preparations are given the code A10BA02.

For amitriptyline.

N                                 Nervous system (1^st level, anatomical main group).

N06                             Psychoanaleptics (drugs that cause arousing effect) (2^nd level, therapeutic sub group).

N06A                          Antidepressants (3^rd level, pharmacological sub group).

N06AA                       Tricyclic antidepressants (4^th level, chemical sub group).

N06AA09                   Amitriptyline (5^th level, chemical substance).

Therefore, all plain amitriptyline preparations are given the code N06AA09 in the ATC classification system.

The DDD is defined as the assumed average maintenance dose per a day for a drug used for its main indication in adults. A DDD will only be assigned for drugs that already have an ATC code. It should be emphasized that DDD is a unit of measurement and does not necessarily correspond to the recommended or prescribed daily dose (PDD). Doses for individual patients and patient groups will often differ from the DDD as they must be based on individual characteristics (e.g. age and weight) and pharmacokinetic considerations.

The DDD is often a compromise based on a review of the available information about doses used in various countries. The DDD may even be a dose that is seldom prescribed, because it is an average of two or more commonly used dose sizes.

When drug utilization studies are carried out in an outpatient setting, the figures should ideally be presented as numbers of DDDs per 1000 inhabitants per day which is calculated using the following equation.

DDD/1000 inhabitants =

Prescription data presented in DDDs per 1,000 inhabitants per day may provide a rough estimate of the proportion of the study population treated daily with a particular drug or group of drugs. For instance, the figure 10 DDDs per 1000 inhabitants/ day indicates that 1% of the population on average might receive a certain drug or group of drugs daily.

In medicine, adherence describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to the adherence to drugs or medications, but it can also apply to other situations such as medical device use, self care, self-directed exercises, or therapy sessions. Both the patient and health care provider affect adherence and a positive physician-patient relationship is the most important factor in improving adherence, ⁴¹ although the cost of prescription medications also plays a major role.⁴²In a study, it was found that being married, older, employed, not smoking or drinking were associated with higher adherence⁶². The most common reason given by patients for failure of adherence is being fed up with the disease and the therapy, forgetful or too busy.⁶³

Worldwide, non-adherence is a major obstacle to the effective delivery of healthcare. Estimates from the World Health organization (2003) indicate that only about 50% of patients with chronic diseases living in developed countries follow treatment recommendations.⁴¹ In particular, low rates of adherence to therapies for asthma, diabetes, and hypertension are thought to contribute substantially to the human and economic burden of those conditions.⁴¹

Adherence rates may be overestimated in the medical literature, as adherence is often high in the setting of a formal clinical trial but drops off in a “real world” setting.⁴³ Major barriers to adherence are thought to include the complexity of modern medication regimens, poor health literacy and lack of comprehension of treatment benefits, the occurrence of undiscussed side effects, the cost of prescription medicine, and poor communication or lack of trust between the patient and his or her health care provider.^44,45,46 Efforts to improve adherence have been aimed at simplifying medication packaging, providing effective medication reminders, improving patient education and limiting the number of medications prescribed simultaneously.

Age by itself is not a determining factor in medication nonadherence.⁵⁰Rather, there are many factors that may combine to render older persons less able to adhere to their medication regimens. However, there is evidence to suggest that, with the proper motivation, education and support, older persons can overcome many barriers to medication adherence.⁵⁰

FACTORS AFFECTING MEDICATION ADHERENCE IN THE ELDERLY

Adherence is a multidimensional phenomenon determined by the interplay of five sets of factors, termed “dimensions” by the WHO.⁵¹The various dimensions and the factors influencing them are as follows:

Social/Economic Dimension

• Limited English language proficiency
• Low Health literacy
• Lack of family or social support network
• Unstable living conditions; homelessness
• Burdensome schedules
• Limited access to health care facilities
• Lack of Health care insurance
• Inability or difficulty accessing pharmacy
• Medication cost
• Cultural and lay beliefs about illness and treatment
• Elder abuse.

Health care systems Dimensions

• Provider-patient relationship
• Provider communication skills (contributing to lack of patient knowledge or understanding of the treatment regimen)
• Disparity between the health beliefs of the Health care provider and those of the patients.
• Lack of positive reinforcement from the Health care provider
• Weak capacity of the system to educate patients and provide follow up.
• Lack of knowledge on adherence and of effective interventions for improving
• Patient information materials written at too high literacy level
• Long waiting time
• Lack of continuity of care.

Condition-related Dimension

• Chronic conditions
• Lack of symptoms
• Severity of symptoms
• Depression
• Psychotic disorders
• Mental retardation/ developmental disability.

Therapy-related Dimension

• Complexity of medication regimen
• Treatment requires certain techniques ( injections/ inhaler)
• Duration of therapy
• Frequent changes in Medication regimen
• Lack of immediate benefit of therapy
• Medications with social stigma attached to use
• Actual or perceived unpleasant side effects
• Treatment interferes with lifestyle or requires significant behavioral changes

Patient-related Dimensions

1. Physical Factors

• Visual impairment
• Hearing impairment
• Cognitive Impairment
• Impaired mobility/dexterity
• Swallowing problems

1. Psychological/Behavioral factors

• Knowledge about desease
• Perceived risk/ susceptibility to disease
• Understanding reasons medication is needed
• Expectations or attitudes towards treatment
• Perceived benefit of treatment
• Confidence in the ability to follow treatment regimen
• Fear of dependence
• Frustration with health care providers/system
• Alcohol/substance abuse.

Patient-related factors are just one determinant of adherence behavior.The common belief that a person is solely responsible for taking their medications often reflects a misunderstanding of how other factors affect people’s medication-taking behavior and their capacity to adhere to treatment regimens⁵¹. Factors associated with each dimension are listed above.

It is clear that adherence is a complex behavioral process strongly influenced by the environments in which people live, health care providers practice, and health care systems that deliver care. Adherence is related to people’s knowledge and beliefs about their illness, motivation to manage it, confidence in their ability to engage in illness-management behaviors, and expectations regarding the outcome of treatment and the consequences of poor adherence^51.

It is important to recognize that a person may have multiple risk factors for medication nonadherence. Also, factors that can influence a patient’s medication-taking behavior may change over time.Therefore, it is important to continually assess a person’s adherence throughout the course of therapy. In addition, because there is usually no single reason for medication nonadherence, there can be no “one size fits all” approach to improving adherence.

Many of the interventions used to improve adherence especially in the elderly focus on providing education to increase knowledge; simplifying the medication regimen (fewer drugs or fewer doses); or making it easier to remember (adherence aids, refill reminders).

However, simplifying a dosage regimen is unlikely to affect a patient who does not believe that taking medications is important or that the therapy will improve his/her health, and the available evidence shows that knowledge alone is not enough for creating or maintaining good adherence habits.⁵¹

Based on published studies⁵², it is evident that single interventions are less successful than multiple, long term interventions in affecting adherence. The studies show that the most successful interventions have some follow-up component and address the underlying reasons for nonadherence. Comprehensive interventions should address a variety of issues, including knowledge, motivation, and social support and individualizing therapy based on a patient’s concerns and needs.⁵²

The ideal time to initiate adherence interventions is when therapy first begins. Interventions that are initiated early in the course of therapy can support older persons through a period when they are most likely to have questions or to experience side effects from the therapy.

Poor medication adherence is common in children and adolescents with chronic illness, but there is uncertainty about the best way to enhance medication adherence in this group and this is due to the fact that no studies have identified effective interventions for young people with established poor adherence.⁵⁴

Most existing reviews of adherence-promoting interventions have focused on the adults. However, many young people experience chronic illness^55,56 and poor medication adherence.^54,57 Involvement of families in medication routines^57,58 and varying developmental capacities of children and adolescents⁵⁹ may influence medication adherence, reinforcing the need to identify interventions with demonstrated efficacy in young people rather than translating findings from adult research.^54,59

A review of interventions for children suggests that educational or behavioral interventions may be potentially effective for promoting adherence,⁶⁰These interventions are important as they are able to be implemented by individual health practitioners at various treatment stages.

Education typically involves providing verbal or written information about the nature of the illness, rational for treatment and benefits and adherence while behavioral management includes a range of techniques such as monitoring and goal setting, reinforcing medication taking with rewards, problem solving and linking medication taking with established routines.

Enhancing a patient’s adherence to psychotropic medication regimens is one of the challenges facing all mental health professionals and consequently has been studied for over fifty years.⁵³Mitchell and Selmes (2007) have provided a comprehensive account of the reasons that lead people with a wide range of mental disorders to miss their medications. They have illustrated many factors that such individuals share with patients with physical disorders, and also more specific to people with mental disorders.⁴⁷

Medication adherence rates reported for populations with psychiatric illness ranges from 24 to 90 percent for patients treated with antipsychotic medication and 40 to 90 percent for patients treated with antidepressants.⁷ Another set of patients will never start or will stop therapy completely within the first year and only a minority will continue taking drugs as prescribed.¹² An overview of the extensive literature on medication adherence found no differences in adherence rates between populations with physical disorders and those with psychiatric disorders.⁴⁹

Studies that seek to ascertain the patients’ adherence to psychotropic drugs have been carried out in different parts of Nigeria and also at other parts of the world with varying results obtained. In most of the studies consulted, co-morbidities, side effects, forgetfulness, high cost of medications, inability of the practitioners to explain timing and dose or benefits of medications and educational status of the patients were some of the factors associated with non-adherence.^34-38

According to the study done by James and Omoaregba in 2009, their findings were that higher frequency of medication dosing, illness severity and stigma were the significant predictors of poor medication adherence among the psychiatric patients.³⁹

One of the sections above has reviewed briefly some of the main factors which influence the adherence of elderly patients as well as other patient categories. The point has already been made that, ultimately, the patient has the right not to comply. However, it may be regarded as a professional responsibility to try to persuade the patient on the benefit of adherence. The following section considers some of the many techniques which the pharmacist can use to achieve improved adherence.

Understanding

The aim here is to ensure as high a level of understanding by the patient as possible. This means that optimum communication skills must be used. This can be done orally during patient counseling. This may simply involve passing on relevant information to the patient. However, the pharmacist need to be alert to the indications of the patient’s health beliefs, their own objectives of the treatment and any information they may already have acquired from other sources. If these are at variance with fact, an attempt may be required to correct the error.

Apart from routine counseling, it may be necessary to give additional information to fill in gaps in understanding following the patient’s consultation with the doctor. Alternatively, it could be providing information about the disease, the drug, and lifestyle advice or giving training in using the medicine. Where a patient relies on a carer, it is advisable to involve the carer in any counseling or other advice which is being given.

Along with verbal communication, written information is supplied. Labels must be clear, easy to read and unambiguous. Where necessary and possible, computers can produce print labels as well as Braille labels. Other written information must be in non-technical language to make it readily understood.

Medicines management

When adherence aids are discussed, it is usually those designed to assist medicine management which are thought of first. The aim of any actions taken is to assist patients to manage their medicine-taking. There are three main approaches which can be tried. A diary of the day, indicating on it the times at which each medicine should be taken is the simplest form of adherence chart. Colour coding may be used to link the medicine bottle and chart. Marking the chart as each dose is taken assists in preventing re-administration.

Devices designed as compliance aids can be used. There is a wide range of different designs of memory aid devices for tablets and capsules. Monitored dosage systems can be used as an alternative. The principle on which they all operate is that compartments are used to hold doses, each compartment corresponding to a time of day. The patient works through the device as the day progresses, removal of the medicine indicating that it has been remembered. Audible devices are also available. There can be some problems. Errors may be made in filling the aid, there are questions about the stability of some medicines in these devices and some patients may have difficulty getting the tablets or capsules out of the compartments. Liquids are much more difficult to handle using these aids. Some of these adherence aids include 7-day pill organizer, Automatic pill timer, Daily pillminder, Day planner, Medimax, Mediset mini, Medtime Minder (audible) and many more similar aids and new ones are being introduced continually.⁶¹

The third possibility is to review the medicines to see if the regimen can be simplified to make it easier to manage. Thus, the use of sustained-release dosage forms reduces dosage frequency and combination dosage forms reduce the total number of medicines to be    remembered. It is known that going from three or four times daily dosing to twice daily improves adherence, but there seems to be no further advantage with once daily dosing.⁶¹

Disease-related problems

Careful counseling can answer many of the problems which arise from a lack of understanding about the disease and its treatment. This can be particularly important with asymptomatic conditions or prophylactic treatments. Where the disease has reduced the manipulative ability of the patient, some adherence aids or other simple measures may be useful. The simplest is to suggest non-child-resistant closures for some elderly patients. Larger bottles can be used to make handling easier. Devices are available to get tablets from blister packs, which many people with arthritis and pakinsons disease find particularly difficult. A long-armed roller is available to assist applying ointments and creams to parts of the skin that are difficult to reach.

Drug-related problems

Many pharmacists especially those in the community find it difficult to obtain generics for dispensing which are almost always consistent in appearance. Thus it may not be possible to reduce the problems that arise from changes of color, shape and size, other than by reassuring the patient. Where some control is possible, the use of the patient medication record to record the source of tablets dispensed for an individual will reduce these variations to minimum and thereby improving the patient’s adherence. Control of side effects may require a change in prescription. However, it is sometimes possible to modify the method of taking a medicine to reduce the problems, such as avoiding tablets on an empty stomach to reduce the incidence of nausea. Where ingredients will not be acceptable to some patients, it is necessary for the pharmacist to be aware of the problem and to be in a position to suggest alternative products where possible.

Other problems

There are no simple answers to many of the other sociological and psychological factors which affect adherence. The correct prescribing decision for the patient will be more likely if a concordant approach is adopted during consultation, and adherence should increase as the goals of the treatment are the patient’s. However, in order that the pharmacist can provide counseling consistent with the decision of the prescriber, mechanisms will need to be developed for the sharing of this information, although issues of patient confidentiality and sharing of data need to be resolved.Depending on the nature of the problem, effective counseling by the pharmacist may assist with improving adherence. In other situations, it may require a concerted effort by the whole health care team to help patients understand their treatment and the personal value of compliance for them.

Adherence to medication can be a very difficult problem which may go undetected. When non adherence is recognized, the pharmacist is in a good position to offer support to the patient. The approach should be to attempt to remove obvious barriers to adherence first, e.g. by suggesting adherence aids, drawing up adherence chart or instructing in the method of administration. Some patients will always be poor compliers, but many can be helped towards effective use of their medicines.

The general objective of this study is to evaluate the drug utilization pattern and patients’ adherence to psychotropic medicines at the Federal psychiatric HospitalUselu, Benin City while the specific objectives include:

1. To evaluate the drug utilization pattern using WHO drug use indicators
2. To assess theavailability of essential medicines
3. To determine the level of patients’ adherence to medications and
4. To explore the factors influencing medication adherence at the study setting.

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