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Presented By
Farzana Sultana
BPH : 04806682
Department of Pharmacy
Stamford University Bangladesh
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Rational Drug Use
Rational Use of Drugs :
The World Health Organization has defined Rational Use of Drugs as follows:
“The rational use of drugs requires that patients receive medicines appropriate to their clinical
needs, in doses that meet their own individual requirements, for an adequate period of time, and
at the lowest cost to them and the community.”
The above definition places emphasis on the following:
 Dispensing of the correct drug;
 Appropriate indication - that is, the reason to prescribed is based on sound medical
considerations;
 Appropriate medicine, considering efficacy, safety, suitability for the patient and cost;
 Appropriate dosage and quality of medicines. Quantity sufficient to last for duration of
the treatment.
 Correct dispensing including appropriate information to patients about the prescribed
medicines;
 Patient adherence to treatment.
All the above steps are integral. Observance of one or two steps to the omission or non-
observance of any step could lead to irrational use of medicines.
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HOW “RATIONAL” IS OUR USE OF MEDICINES?
In the practice of medicine, doctors recognize the importance of “the placebo effect”
phenomenon. This refers to patients getting better from an illness even if the medication used is
only a “sugar pill.” In some cases this effect can be fifty percent or higher. Many therefore may
get better because of the psychological belief that they received an effective remedy for the
illness they are suffering from. This fact alone is of great clinical significance for both the doctor
and the patient. The former will incorrectly claim effective treatment of a disease, while the
patient will assume effective treatment from the doctor. Many medical conditions are self
limiting. This means they come to an end by themselves, with or without treatment. The common
cold is a good example of this. In most cases the symptoms, if left alone, will subside in a few
days. So when doctors or pharmacists prescribe medicines for the common cold are they part of
the “rational drug use culture” which is demanded of all ethical practitioners? This particularly
applies in the use of antibiotics. In most such cases medical practitioners prescribe antibiotics for
their own psychological satisfaction and relief, not that of their patients, orto retain their
relevance and influence over their patients rather than because these drugs are absolutely
necessary for the condition concerned. Often they do so to save on the time it would take
to educate patients on the rational use of medicines. The other extreme of the spectrum
are patients who visit doctors with the expectation of receiving a prescription
for medication. Unless the doctor prescribes strong, brightly colored medicines, preferably in
capsule form, complemented by a painful injection, such patients feel the medical practitioner
has not taken their cases with sufficient seriousness. Many rural people believe the severity of an
illness is judged by the number of pills and injections required in its treatment. Conversely, the
urban rich believe the seriousness of an illness is judged by the number of investigations and
associated high cost! If one is suffering from a psychological disorder like anxiety or depression,
the physical complaints associated with these conditions may sometimes take
greater prominence than the underlying cause of the symptoms. The patient visits the doctor and
complains of pains and aches rather than that of stress and sadness.These two examples show
that, both the doctors and the patients require education on the rational use of medicines.
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Benefits of rational use of drugs
(Prescribe, educate the patient, monitor the outcome)
• Clinically significant improvement is achieved in several common diseases by appropriate drug
treatment, for example:
Hypertension (thiazides in elderly patients)
Post-myocardial infarction (aspirin, β blockers)
CHF (ACEI, ARB, β blockers)
Hypercholesterolaemia (statins)
Diabetic nephropathy (ACEI, ARB)
• Alzheimer’s disease – drug’s cost-effectiveness
• Medicines are investments if used appropriately
Incorrect use of medicines
WHO estimates that more than half of all medicines are prescribed, dispensed or sold
inappropriately, and that half of all patients fail to take them correctly. This incorrect use may
take the form of overuse, underuse and misuse of prescription or non-prescription medicines.
Common problems include:
 polypharmacy (use of too many medicines);
 overuse of antibiotics and injections;
 failure to prescribe in accordance with clinical guidelines;
 inappropriate self-medication.
In developing countries, the proportion of patients treated according to clinical guidelines for
common diseases in primary care is less than 40% in the public sector and 30% in the private
sector. For example:
 less than 60% of children with acute diarrhoea receive necessary oral rehydration therapy
yet more than 40% receive unnecessary antibiotics;
 only 50% of people with malaria receive the recommended first-line antimalarial;
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 only 50–70% of people with pneumonia are treated with appropriate antibiotics, yet up to
60% of people with viral upper respiratory tract infection receive antibiotics
inappropriately.
Consequences of incorrect use of medicines
Incorrect use of medicines occurs in all countries, causing harm to people and wasting resources.
Consequences include:
 Antimicrobial resistance. Overuse of antibiotics increases antimicrobial resistance and
the number of medicines that are no longer effective against infectious disease. Many
surgical procedures and cancer therapies are not possible without antibiotics to fight
infection. Resistance prolongs illnesses and hospital stays, and can even cause death,
leading to costs of US$ 4–5 billion per year in the United States of America and €9
billion per year in Europe.
 Adverse drug reactions and medication errors. Harmful reactions to medicines caused
by wrong use, or allergic reactions to medicines can lead to increased illness, suffering
and death. Adverse drug reactions have been estimated to cost millions of dollars each
year3,4
.
 Lost resources. Between 10–40% of national health budgets are spent on medicines.
Out-of-pocket purchases of medicines can cause severe financial hardship to individuals
and their families. If medicines are not prescribed and used properly, billions of dollars of
public and personal funds are wasted.
 Eroded patient confidence. Exacerbated by the overuse of limited medicines, drugs may
be often out of stock or at unaffordable prices and as result erode patient confidence. Poor
or negative health outcomes due to inappropriate use of medicines may also reduce
confidence.
Factors contribute to incorrect use of medicines
 Lack of skills and knowledge. Diagnostic uncertainty, lack of prescriber knowledge of
optimal diagnostic approaches, lack of independent information such as clinical
guidelines, lack of opportunity for patient follow-up, or fear of possible litigation, lead to
improper prescription and dispensing of medicines.
 Inappropriate unethical promotion of medicines by pharmaceutical companies.
Most prescribers get medicine information from pharmaceutical companies rather than
independent sources such as clinical guidelines. This can often lead to overuse. Some
countries allow direct-to-consumer advertising of prescription medicines, which may lead
to patients pressuring doctors for unnecessary medicines.
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 Profits from selling medicines. In many countries, drug retailers prescribe and sell
medicines over-the-counter. The more they sell the more income they generate, leading to
overuse of medicines, particularly the more expensive medicines.
 Unrestricted availability of medicines. In many countries, prescription medicines such
as antibiotics, are freely available over-the-counter. This leads to overuse, inappropriate
self-medication and non-adherence to dosing regimes.
 Overworked health personnel. Many prescribers have too little time with each patient,
which can result in poor diagnosis and treatment. In such circumstances prescribers rely
on prescribing habit as they do not have the time to update their knowledge of medicines.
 Unaffordable medicines. Where medicines are unaffordable, people may not purchase a
full course of treatment or may not purchase the medicines at all. Instead they may seek
alternatives, such as medicines of non-assured quality from the Internet or other sources,
or medicines prescribed to family or friends.
 Lack of coordinated national pharmaceutical policy. Less than half of all countries
implement the basic policies recommended by WHO to ensure the appropriate use of
medicines. These include appropriate measures and infrastructure for monitoring and
regulation of medicines use, and training and supervision for prescribing health workers.
What can be done to improve rational use of medicines?
WHO advises countries to implement national programmes to promote rational use of medicines
through policies, structures, information and education. These include:
 a national body to coordinate policies on medicine use and monitor their impact;
 evidence-based clinical guidelines for training, supervision and supporting decision-
making about medicines;
 lists of essential medicines used for medicine procurement and insurance reimbursement;
 drug (medicines) and therapeutics committees in districts and hospitals to monitor and
implement interventions to improve the use of medicines;
 problem-based training in pharmacotherapy and prescribing in undergraduate curricula;
 continuing medical education as a requirement of licensure;
 publicly available independent and unbiased information about medicines for health
personnel and consumers;
 public education about medicines;
 elimination of financial incentives that lead to improper prescribing, such as prescribers
selling medicines for profit to supplement their income;
 regulations to ensure that promotional activities meet ethical criteria; and
 adequate funding to ensure availability of medicines and health personnel.
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The most effective approach to improving medicines use in primary care in developing countries
is a combination of education and supervision of health personnel, consumer education, and
ensuring an adequate supply of appropriate medicines. Any of these alone have limited impact.
WHO response
To improve rational medicine use, WHO:
 monitors global medicines use and pharmaceutical policy;
 provides policy guidance and support to countries to monitor medicines use and to
develop, implement and evaluate national strategies to promote rational use of medicines;
 develops and delivers training programmes to national health professionals on how to
monitor and improve medicines use at all levels of the health system.
Requirement for rational drug use
Adequate diagnosis
For a correct diagnosis to be made, the prescriber must have adequate knowledge and
motivation, private examination facilities, and sufficient time to take a history, perform an
examination, and explain to the patient the diagnosis and treatment.
Correct prescribing
To prescribe correctly, the prescriber must know which drug to prescribe for which diagnosis or
complaint and when treatment without drugs is appropriate.
Appropriate dispensing
For correct dispensing to occur, the dispenser must be trained, have adequate time, have the
necessary materials (containers, labels), and have a dispensary where it is possible to
communicate with patients.
Patient adherence to treatment (compliance)
Patient adherence to treatment is dependent on understanding and acceptance of the treatment;
this results from effective communication between prescriber, dispenser and patient.
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Measuring drug use
In any situation, measurement of present practices, followed by investigation of the underlying
reasons for practices that represent problems, should precede the development of interventions.
Other methods may utilize aggregated information combining drug procurement and morbidity
data to calculate consumption/morbidity ratios. Computers are increasingly used to exchange
drug utilization data, there is a need to standardize coding systems, for example for health
problems, dosage forms, and the description of adverse drug reactions.
Once the priority problem has been identified, further investigations utilizing qualitative
techniques such as observation, focus group discussions, in-depth interviews, questionnaires and
simulated patients are required.
How to promote Rational Use of Medicines?
Most important tools for promoting rational use of medicines are list of essential medicines and
standard treatment guidelines.
“Essential medicines are those that satisfy the priority healthcare needs of the population. They
should be available at all times and should be selected on basis of efficacy, safety and cost”.
(WHO 2001)
For facilitating prescribers to prescribe rationally, clinical guidelines need to be developed. The
guidelines provide a benchmark of satisfactory diagnosis and treatment at all levels of health
care. The guidelines need to be developed systematically, based on evidence and through a
consensual process. They should be supplemented by formularies.
To conform with the criteria of rational use, prescribers should follow a standard process of
prescribing, starting a diagnosis to define the problem, setting up a therapeutic goal, deciding
treatment based on up-to-date drug and therapeutic information, and to achieve the desired goal
for an individual patient. The selection of drug should be based upon criteria of efficacy, safety,
suitability and cost. The route of administration and duration of treatment should be determined
taking into account the condition of the patient and proper information must be provided to the
patient about his condition and the drug. The drug should be dispensed in a safe and hygienic
manner ensuring adherence of patient to treatment and monitoring should be done for therapeutic
and adverse effects of treatment.
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WHO advocates 12 key interventions to promote more rational use:
 Establishment of a multidisciplinary national body to coordinate policies on medicine use
 Use of clinical guidelines
 Development and use of national essential medicines list
 Establishment of drug and therapeutics committees in districts and hospitals
 Inclusion of problem-based pharmacotherapy training in undergraduate curricula
 Continuing in-service medical education as a licensure requirement
 Supervision, audit and feedback
 Use of independent information on medicines
 Public education about medicines
 Avoidance of perverse financial incentives
 Use of appropriate and enforced regulation
 Sufficient government expenditure to ensure availability of medicines and staff.
Role of pharmacists in promoting rational use of medicines
A pharmacist is a crucial link between patient and other healthcare professionals. The outreach
of pharmacist is tremendous, both in hospital pharmacies as well as in community pharmacies.
Pharmacists are the first contact with the community for any illness. Above all the community by
and large has tremendous faith in them and find them easily accessible.
Pharmacists have been recognized as having key role to play in –
(a) Strengthening effective drug management.
(b) Overcoming chronic shortages of essential medicines.
(c) Combating problems with fake and inferior quality medicines, and
(d) Increasing efforts to educate public to promote compliance with drug therapy.
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To reduce the potential medication error, David U. in his column in ‘Medication Safety
Alerts’outlined the roles of pharmacists at different stages of medication use as below
Prescribing Stage
• Clarify and verify if not sure or not clear
• Establish protocols and order sets
• Monitor all medication profiles
• Maintain open communication channels with physicians
• Educate physicians about dangerous abbreviations
• Provide input to patients’ medication regimens
• Encourage physicians to use protocols and preprinted order forms
• Support and facilitate implementation of computerized physician order entry systems
• Support use of a personal digital assistant for clinical information resources
Dispensing Stage
• Automate dispensing
• Reorganize drug storage and shelving to separate drugs with similar names
• Redesign workflow to achieve efficiency and to facilitate safety checking
• Make use of computerized clinical information
• Be more vigilant with high-risk medications and high-risk patients, e.g., establish a system of
double-checks
• Communicate clearly with nurses and patients
Transcribing and Administering Stages
• Support and facilitate use of electronic medication administration records (MARs)
Ensure that each patient’s MAR is updated in a timely manner when pharmacy service is not
available
• Check and compare each patient’s MAR at least daily to ensure that orders are interpreted
correctly and carried out
• Support the use of point-of-care dispensing cabinets
• Support the use of bar coding for patients, orders, and drugs for administration
Monitoring Stage
• Follow up laboratory results and/or blood level monitoring
• Screen automatic stop orders for drugs that require reactivation
• Perform daily review of drug profiles to spot potential problems
• Establish rapport and effective communication with nurses
• Engage patients
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Specific Role of Pharmacist in National HIV/AID Control Programme
A few international intervention studies have shown that active participation of pharmacists in
antiretroviral (ARV) therapy programme for HIV/AIDS, lead to great benefits to the patients in
term of adherence to ARV therapy and outcome of the disease. Hence in India also, pharmacist
can be a powerful medium in successfully implementing National AIDS Control Programme in
the country.
Pharmacists working at Antiretroviral Therapy (ART) Centers under National AIDS Control
Organization (NACO) can actively participate and contribute in better patient outcome. The
specific roles of pharmacists are:
A. To maintain regular supply of ARV/OI medicines through better inventory management,
storage and stock management so that patients receive medicines at all times.
B. Following good dispensing practices and imparting appropriate pharmaceutical care by
educating patients on safe use of ARV medicines.
C. Participating in pharmacovigilance programme.
A. Drug Stock Management
An effective inventory management will ensure availability of ARV medicines in right quantities
at all times in ART Centers. It is important to follow set guidelines viz., determining quantity
needed, placing orders at appropriate time, receiving and checking medicines, storing
appropriately, and, monitoring consumption. Similarly, storage and stock management are
essential because if medicines are not stored in proper condition they are likely to loose their
potency before actual expiry date.
It is the responsibility of a pharmacist of ART Centre to assess requirement of medicines based
on number of patients enrolled and past consumption and put the request to medical
officer/senior medical officer for next year/interim requirement. Minimum stock of medicines for
three months should be available in the pharmacy at any given time. In case of shortage, timely
information to regional coordinator/SACS and NACO headquarters should be sent.
Accurate record for the medicines received and dispensed should be maintained. Pharmacists
should have adequate knowledge of storage of medicines, handling of “near expiry” medicines
and disposal of expired medicines. Pharmacists should train other health professionals (nurses
and other pharmacists) working at ART Centers regarding ARV/OI medicines.
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B. Good Dispensing Practices and Imparting Appropriate Pharmaceutical Care
Dispensing is an important part of practice of pharmacy, in which the pharmacist interprets
prescription given by doctors, and accordingly dispenses medicines to patients. Several studies
have shown that imparting knowledge to patients about prescribed medicines enhances
adherence to prescription and patient outcome.
ARV medicines relatively have low safety profile and cause frequent adverse drug reactions. A
substantial percentage of patients experience adverse effects. There are ample chances that
patients may discontinue the treatment.
Patient’s adherence to ARV treatment has a significant role in control of HIV/AIDS. Hence
pharmacists can be a strong promoter of health in patients suffering from HIV/AIDS. While
dispensing medicines, pharmacist should educate patients about dose, frequency, duration of
administration of each medicine. They should also educate patients about adverse drug reactions
(ADRs) that are commonly encountered and ADRs those need revisit of the patient to doctor or
pharmacist, about drug-drug interactions, and importance of strict adherence to prescribed
medicines. Pharmacist can advise on how to mange ADR. Besides providing education on
medicines, pharmacists should also counsel patients on safe use of syringes and needles,
treatment of opportunistic infections, and prevention of HIV/AIDS.
C. Participation in Pharmacovigilance Programme
Pharmacovigilance is a structured process for monitoring and detection of ADRs in a given
context. Pharmacists have important contribution to make to post-marketing surveillance and
pharmacovigilance. Data generated by pharmacovigilance centers have great relevance and
educational value in ensuring safe use of medicines.
ARV medicines are potent medicines, have low safety profile and need to be used on chronic
basis. Hence their ADR monitoring is of paramount importance. Their identification would help
in finding out alternatives and treatment strategies to deal with them. Pharmacists should be
trained to identify and report ADR of ARV medicines.
The role of pharmacist is expanding. It is beyond medicines supply and management. It is
desired that medicines are used for the maximum benefit of each individual patient and society
as a whole. A pharmacist, who is one of the key members of healthcare system, needs to
participate in achieving the goal. As documented in western world, appropriate pharmaceutical
care provided by a pharmacist will result in improvement in health as well as cost saving.
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To conform to the criteria, prescribers’ should follow a standard process of prescribing and the
pharmacists should play a crucial role in this therapeutic process by dispensing the appropriate
drugs.
In the treatment of HIV/AIDS, National Guidelines have been laid down spelling out when
therapy is to be initiated, the kind of drugs to be given, the dosage and instructions on clinical
monitoring and guidance on modifying/changing therapy due to adverse drug reaction. The
NACO programme on ARV therapy is thus an excellent example of promoting rational use of
medicines - essential medicines have been identified and are made available at ART centres and
standard treatment protocols have also been developed.
Under NACP-II focus was given to low-cost care, support and treatment of common
OIs. NACP-III, apart from further improving the availability, accessibility and affordability of
ART treatment to the poor, plans to strengthen family and community care through psycho-
social support to the individuals, more particularly to the marginalized women and children
affected by the epidemic, improve compliance of the prescribed ART regimen. These measures
should lead to better compliance to drug adherence.
All the above should be supplemented by a programme of providing information to the
patients. Patients should know dose frequency and duration of treatment for better therapeutic
outcomes. The consumer, at large, should be provided information on medicines so that they
take informed decisions on their health care.
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STEPS TO IMPROVE RATIONAL DRUG PRESCRIBING
Step:- I
Identify the patient’s problem based on symptoms & recognize the need for action.
Step:-II
Diagnosis of the disease. Identify underlying cause & motivating factors. This may be specific as
in infectious disease or non specific.
Step:-III
List possible intervention or treatment. This may be non drug treatment or drug treatment. Drug
must be chosen from different alternatives based on efficacy, convenience & safety of drugs
including, drug inter-actions & high risk group of patients.
Step:-IV
Start the treatment by writing an accurate & complete prescription e.g. name of drugs with
dosage forms, dosage schedule & total duration of the treatment.
Step:-V
Given proper information instruction & warning regarding the treatment given e.g. side
effects(ADR), dosage schedule & dangers/risk of stopping the therapy suddenly.
Step:-VI
Monitor the treatment to check, if the particular treatment has solved the patient’s problem. It
may be:
(a) Passive monitoring – done by the patient himself. Explain him what to do if the treatment
is not effective or if too many side effect occurs
(b) Active monitoring done by physician and he make an appointment to check the response
of the treatment.
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Rational Use of Antibiotics
Antibiotics are the most important weapons in our hands. Each one of them have been invented
after spending considerable amount of time, energy and money. Therefore, we cannot afford to
lose them. We must exercise considerable restraint in prescribing antibacterials and restrict the
use of antibacterials to only certain definite indications.
Indications for antibacterial therapy:
1. Definitive therapy: This is for proven bacterial infections. Antibiotics (read
antibacterials) are drugs to tackle bacteria and hence should be restricted for the treatment
of bacterial infections only. This may sound silly, but most doctors seem to forget this
simple fact! Attempts should be made to confirm the bacterial infection by means of
staining of secretions/fluids/exudates, culture and sensitivity, serological tests and other
tests. Based on the reports, a narrow spectrum, least toxic, easy-to-administer and
cheap drug should be prescribed.
2. Empirical therapy: Empirical antibacterial therapy should be restricted to critical cases,
when time is inadequate for identification and isolation of the bacteria and reasonably
strong doubt of bacterial infection exists: septicemic shock/ sepsis syndrome,
immunocompromised patients with severe systemic infection, hectic temperature,
neutrophilic leukocytosis, raised ESR etc. In such situations, drugs that cover the most
probable infective agent/s should be used.
3. Prophylactic therapy: Antimicrobial prophylaxis is administered to susceptible patients
to prevent specific infections that can cause definite detrimental effect. These include
antitubercular prophylaxis, anti rheumatic prophylaxis, anti endocarditis prophylaxis and
prophylactic use of antimicrobials in invasive medical procedures etc. In all these
situations, only narrow spectrum and specific drugs are used. It should be remembered
that there is NO single prophylaxis to 'prevent all' possible bacterial infections.
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Rational Use of Injections
Safe and appropriate use of injections can be achieved by adopting a three part strategy:
(1) Changing behaviour of health care workers and patients
Twenty years into the HIV pandemic, knowledge of HIV among patients and health care workers
in some countries has driven consumer demand for safe injection equipment and irreversibly
improved injection practices. With growing knowledge of HCV and HBV, similar patterns of
consumer demand for safe injections should emerge. HIV prevention programmes can be
expanded to include injection safety components.
(2) Ensuring availability of equipment and supplies
Simply increasing the availability of safe injection equipment can stimulate demand and improve
practices. Because the cost of safe disposable syringes is low (less than 5 US cents per unit)
when compared to the fee paid for receiving an injection (50 US cents on average), patients are
usually willing to pay a little extra for safety once they personalize the risks.
(3) Managing waste safely and appropriately
As waste disposal is frequently not an integral part of health planning, unsafe waste management
is common. However, when it is appropriately planned, significant results ensue. National health
care waste management strategies require a national policy to manage health care waste, a
comprehensive system for implementation, improved awareness and training of health workers at
all levels, as well as the selection of appropriate options for the local solutions.
WHAT IS WHO DOING TO IMPROVE INJECTION SAFETY?
WHO hosts and coordinates the Safe Injection Global Network (SIGN), which assembles all
major stakeholders to promote and sustain injection safety worldwide. Through the network,
WHO provides advice and a series of policy, management and advocacy tools to help countries
access safe, affordable equipment, promote the training of health staff and rational use of
injections.
Guidance, policy and advocacy tools
WHO develops and updates a series of evidence-based resource materials on best practices for
injection safety, waste management, health care worker protection and infection control. These
resources are published online and distributed to countries. The SIGN secretariat also regularly
provides data to assist countries for decision making, including tools to assess the state of
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injection safety in health care facilities, analyses of global burden of disease data resulting from
unsafe injections, and cost effectiveness analyses for injection devices.
Support to achieve quality and safety of injection devices
In collaboration with the International Organization for Standardization and the International
Association of Safe Injection Technologies (the umbrella organization of injection devices
manufacturers), WHO has developed a specification standard for auto-disable syringes for
immunization and curative purposes. The specification can be used by national regulatory
authorities for product review or by national authorities for procurement.
To prevent injection overuse in the curative sector, WHO urges that countriesa€™ national drug
policies promote the rational use of therapeutic injections. This may include removing
unnecessary injectable medicines from the national essential medicines list.
Support to increase access
In 2004, WHO developed "Guiding Principles to ensure injection device security", reaffirming
the need to ensure bundled supply of injectable medicines, appropriate diluents, single use
injection devices and safety boxes in sufficient quantities in each health care facility. This
requires appropriate forecasting for financing, procurement and supply management.
To further assist countries, WHO has developed a procurement guide for single use syringes and
safety boxes. WHO urges donors and lenders who finance injectable products to also finance
appropriate quantities of items and the cost of sharps waste management.
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Bangladesh Perspective
Bangladesh Government spent Tk. 5,500 crores in health only in the year 1996-1997, out of
which total spending on drugs was Tk. 2,700 crores (49%).Due to exploitative market, almost
50% of our population has no reliable access to modern medicines and the rest 50% have access
but are trapped into using non-essential, irrational and even dangerous drugs. This widespread
irrationality prevails both in the private and public sectors, leading towards serious health
problems and wastage of scarce resources.
Pharmaceutical industries of Bangladesh have flourished tremendously after the implementation
of National Drug Policy and Drug Control Ordinance 1982. Availability of essential drugs also
increased remarkably with the increase in the volume of local production of all types of
recognized drugs and the monetary value of which grew from Taka 1730 million in 1981 to
about Taka 41000 million in 2002. Quality of products has improved and substandard drugs fell
from 36% in 1970 to only 2% in 2002 and becoming a drug exporting country.But a survey
conducted in 1988 – 91 has showed that numerous small companies still market substandard
drugs in the country. Fake or substandard medicines, including lifesaving ones, with an estimated
worth of US$ 150 million per year, are flooding the domestic market.
National Drug Policy (NDP) 2005 states that only registered drugs should be allowed to
distributed and sold throughout the country under person having professional qualification or
holding valid professional license. NDP 2005 again indicates that no drugs other than OTC
should be sold or dispensed without prescriptions. Rational use of drugs (RUD) should be
ensured by conducting survey on the system of prescribing, dispensing and patient compliance.
Monitoring and reporting adverse drug reactions (ADR) should be done seriously to ensure safe
and rational use of drugs in the country. But according to the Bangladesh Chemist and Druggist
Association, there are about 70,000 illegal drugstores. Most of them are selling substandard or
fake, poor quality, smuggled and adulterated medicines and a significant proportions of these
medicines are selling without registered doctors’ prescription indicating violation of NDP. Drugs
Testing Laboratory in its annual testing of 5,000 local samples found 300 either counterfeits or of
very low quality.Weak enforcement of the provision of laws of National Drug Policy and Drug
Control Ordinance 1982 like punishment by imprisonment or fine for those who manufacture or
sell substandard drugs might endanger the situation.
F. Ahmed et al. in their study showed that 13.33% of Metronidazole tablet and 20% suspensions
of the same under investigation were less potent.Again, a study involving a sample of 15 brands
of ciprofloxacin collected for chemical and bioassay revealed seven brands contained active
ingredient less than the USP specification. Another report noted that 69% of Paracetamol tablets
and 80 per cent of Ampicillin capsules produced by small companies were of substandard
quality. It is widely alleged that adulteration flourishes in the country because of poor
government vigilance and supervision over drug manufacturers and sellers. Unfortunately, a
section of corrupt physicians and government officials is involved in this underhand dealings.
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Mohammed Hanif et al. in their study in 1995 found that Paracetamol elixirs with Diethylene
Glycol as a diluents were responsible for a large outbreak of fatal renal failure in Bangladesh.
Recently same incident has been repeated after taking Paracetamol syrup where about 34
children with renal failure were admitted at the Dhaka Shishu Hospital and the Bangabondhu
Sheikh Mujib Medical University (BSMMU) and 25 were died out of them. Following this
tragedy, a probe committee which examined 300 samples of Paracetamol and Vitamin syrup
produced by 10 different pharmaceutical companies and found the presence of poisonous
Diethylene Glycol in the Paracetamol syrup manufactured by one of those companies.
Rational drug use is an important part of health policy ensuring that patients receive medications
appropriate to their clinical needs, in doses that meet their own requirements for an adequate
period of time and at the lowest cost to them and their community. Numerous studies showed
irrational prescribing both from developed and developing countries consisting of polypharmacy,
use of drugs that are not related to the diagnosis, unnecessary use of antibiotics, irrational self-
medication, or drugs taken in insufficient quantities.Guyon et al. in their studies focused some
factors behind inappropriate prescriptions like poor consulting period of doctors (average 54
seconds only); short dispensing time (avg. 23 seconds only) and patients’ misunderstanding
about medicine dosage (only 55% patient can understand correctly). It was estimated that more
than half of medicines were inappropriately prescribed, dispensed or sold. Shapna Sultana et al.
in her study showed that several prescriptions lack even the basic information such as the
identity of the practitioner and patient. The clarity of instructions was inadequate for more than
half of all prescriptions whereas poly-pharmacy was present with about 90% of prescriptions and
a significant proportion of which received 5 or more medications.
The prescription procedure of antibiotics in Bangladesh deviates from ideal practice and in most
of the cases these are prescribed mainly on the patient’s complaints. All available antibiotics
were prescribed in inappropriate doses and duration. Antibiotics are sold without any
prescriptions, and even ordinary people without any knowledge of medicine ask the drug seller
for specific antibiotics. One study showed that 26% of purchased drugs were antibiotics for
children aged 0-4 year(s) and 48% of antibiotics were purchased in quantities of less than a
single day's dose. Misuse of antibiotics even in some diagnoses incurring significant financial
berden.
Over the counter (OTC) drugs have emerged recently as drugs of serious misuse across
Bangladesh, and other neighboring countries. One report estimated that there are four million
drug misusers in the South Asian region, with Bangladesh accounting for nearly 500,000.
32
Self
medications in a population with low literacy level like Bangladesh are very challenging, which
poses risks such as incorrect diagnosis, absence of knowledge of alternative treatments, irrational
use of drugs and neglecting side effects and drug interactions etc. Study showed that around 30-
40% of underprivileged population including the women, elderly, ethnic minorities, poor/ultra-
poor undertake self-medications for managing illness.
20
REFERENCES
 MEDICATION PRACTICES IN ----- ROLES OF PHARMACISTS AT
CURRENT CIRCUMSTANCES
-MANIK CHANDRA SHILL, ASISH KUMAR DAS
 Rational Use of Drugs to Maximise Health Outcomes and Quality of Life
- Thomas Y.K. Chan
 Rational Use of Antibiotics in Hospital- and Community-Acquired Infections
- Fatma A. Amer
 PROMOTING RATIONAL USE OF MEDICINES
 RATIONAL DRUG USE
-Dr Sneha Ambwani, Dr A K Mathur
 Managing For Rational Medicine Use
 NCC MERP (National Coordinating Council for Medication Error Reporting and
Prevention), 2009. “About Medication Errors.”
(http://www.nccmerp.org/aboutMedErrors.html).
 ISMP (The Institute for Safe Medication Practices). 2008. “Heparin Errors
Continue Despite Prior, High-Profile, Fatal Events.” ISMP Newsletter, July 17,
2008. (http:// www.ismp.org/Newsletters/acutecare/ articles/20080717.asp).
 Kohn LT, Corrigan JM, and Donaldson MS. To Err is Human: Building a Safer
Health System. Washington, D.C.: National Academy Press, Institute of Medicine,
1999. (http://www.nap.edu/ books/0309068371/html).
 Lazarou J, Pomeranz B, Corey P. Incidence of Adverse Reactions in Hospitalized
Patients: A Meta-analysis of Prospective Studies. JAMA 1998; 279: 1200–1205.
 Pirmohamed M, Atuah KN, Dodoo ANO, Winstanley P. Pharmacovigilance in
Developing Countries. BMJ 2007; 335: 462.
 Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, et al. Incidence of
adverse drug events and potential adverse drug events, Implications for prevention.
JAMA 1995; 274: 29-34.
 Bhatt AD, Healthcare Management, 2002.
(http://www.expresshealthcaremgmt.com/20020630/edit2.html).
 Chowdhury SAR. Prescribing a rational drug. Bangladesh Journal of Physiology
and Pharmacology 1991; 7: 182-187.
21
 Bangladesh National Health Accounts, 1996-1997. Health Economic Units, Ministry
of Health and Family Welfare, Bangladesh.
(http://www.apnhan.org/territories/bgd/docs/BangladeshNHA1996-97.pdf).
 Bangladesh Public Health Conference, 2008
(http://www.unnayan.org/reports/Report_BPC_08.pdf).
 National Drug Policy 2005, Ministry of Health and Family Welfare, Government of
the People’s Republic of Bangladesh.
(http://www.ddabd.org/download/drug_policy_2005_eng.pdf).
 Roy J. The menace of substandard drugs. World Health Forum 1994; 15: 406-407.
 Smith G. What FIP and WHO are doing to fight the problem of counterfeit drugs?
Pharm J 2004; 273: 394-396.
 Govt. deprived of revenue, adulterated medicines being sold: Mushroom growth of
pharmacies, 70,000 shops trading

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Rational drug use

  • 1. 1 Presented By Farzana Sultana BPH : 04806682 Department of Pharmacy Stamford University Bangladesh
  • 2. 2 Rational Drug Use Rational Use of Drugs : The World Health Organization has defined Rational Use of Drugs as follows: “The rational use of drugs requires that patients receive medicines appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and the community.” The above definition places emphasis on the following:  Dispensing of the correct drug;  Appropriate indication - that is, the reason to prescribed is based on sound medical considerations;  Appropriate medicine, considering efficacy, safety, suitability for the patient and cost;  Appropriate dosage and quality of medicines. Quantity sufficient to last for duration of the treatment.  Correct dispensing including appropriate information to patients about the prescribed medicines;  Patient adherence to treatment. All the above steps are integral. Observance of one or two steps to the omission or non- observance of any step could lead to irrational use of medicines.
  • 3. 3 HOW “RATIONAL” IS OUR USE OF MEDICINES? In the practice of medicine, doctors recognize the importance of “the placebo effect” phenomenon. This refers to patients getting better from an illness even if the medication used is only a “sugar pill.” In some cases this effect can be fifty percent or higher. Many therefore may get better because of the psychological belief that they received an effective remedy for the illness they are suffering from. This fact alone is of great clinical significance for both the doctor and the patient. The former will incorrectly claim effective treatment of a disease, while the patient will assume effective treatment from the doctor. Many medical conditions are self limiting. This means they come to an end by themselves, with or without treatment. The common cold is a good example of this. In most cases the symptoms, if left alone, will subside in a few days. So when doctors or pharmacists prescribe medicines for the common cold are they part of the “rational drug use culture” which is demanded of all ethical practitioners? This particularly applies in the use of antibiotics. In most such cases medical practitioners prescribe antibiotics for their own psychological satisfaction and relief, not that of their patients, orto retain their relevance and influence over their patients rather than because these drugs are absolutely necessary for the condition concerned. Often they do so to save on the time it would take to educate patients on the rational use of medicines. The other extreme of the spectrum are patients who visit doctors with the expectation of receiving a prescription for medication. Unless the doctor prescribes strong, brightly colored medicines, preferably in capsule form, complemented by a painful injection, such patients feel the medical practitioner has not taken their cases with sufficient seriousness. Many rural people believe the severity of an illness is judged by the number of pills and injections required in its treatment. Conversely, the urban rich believe the seriousness of an illness is judged by the number of investigations and associated high cost! If one is suffering from a psychological disorder like anxiety or depression, the physical complaints associated with these conditions may sometimes take greater prominence than the underlying cause of the symptoms. The patient visits the doctor and complains of pains and aches rather than that of stress and sadness.These two examples show that, both the doctors and the patients require education on the rational use of medicines.
  • 4. 4 Benefits of rational use of drugs (Prescribe, educate the patient, monitor the outcome) • Clinically significant improvement is achieved in several common diseases by appropriate drug treatment, for example: Hypertension (thiazides in elderly patients) Post-myocardial infarction (aspirin, β blockers) CHF (ACEI, ARB, β blockers) Hypercholesterolaemia (statins) Diabetic nephropathy (ACEI, ARB) • Alzheimer’s disease – drug’s cost-effectiveness • Medicines are investments if used appropriately Incorrect use of medicines WHO estimates that more than half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them correctly. This incorrect use may take the form of overuse, underuse and misuse of prescription or non-prescription medicines. Common problems include:  polypharmacy (use of too many medicines);  overuse of antibiotics and injections;  failure to prescribe in accordance with clinical guidelines;  inappropriate self-medication. In developing countries, the proportion of patients treated according to clinical guidelines for common diseases in primary care is less than 40% in the public sector and 30% in the private sector. For example:  less than 60% of children with acute diarrhoea receive necessary oral rehydration therapy yet more than 40% receive unnecessary antibiotics;  only 50% of people with malaria receive the recommended first-line antimalarial;
  • 5. 5  only 50–70% of people with pneumonia are treated with appropriate antibiotics, yet up to 60% of people with viral upper respiratory tract infection receive antibiotics inappropriately. Consequences of incorrect use of medicines Incorrect use of medicines occurs in all countries, causing harm to people and wasting resources. Consequences include:  Antimicrobial resistance. Overuse of antibiotics increases antimicrobial resistance and the number of medicines that are no longer effective against infectious disease. Many surgical procedures and cancer therapies are not possible without antibiotics to fight infection. Resistance prolongs illnesses and hospital stays, and can even cause death, leading to costs of US$ 4–5 billion per year in the United States of America and €9 billion per year in Europe.  Adverse drug reactions and medication errors. Harmful reactions to medicines caused by wrong use, or allergic reactions to medicines can lead to increased illness, suffering and death. Adverse drug reactions have been estimated to cost millions of dollars each year3,4 .  Lost resources. Between 10–40% of national health budgets are spent on medicines. Out-of-pocket purchases of medicines can cause severe financial hardship to individuals and their families. If medicines are not prescribed and used properly, billions of dollars of public and personal funds are wasted.  Eroded patient confidence. Exacerbated by the overuse of limited medicines, drugs may be often out of stock or at unaffordable prices and as result erode patient confidence. Poor or negative health outcomes due to inappropriate use of medicines may also reduce confidence. Factors contribute to incorrect use of medicines  Lack of skills and knowledge. Diagnostic uncertainty, lack of prescriber knowledge of optimal diagnostic approaches, lack of independent information such as clinical guidelines, lack of opportunity for patient follow-up, or fear of possible litigation, lead to improper prescription and dispensing of medicines.  Inappropriate unethical promotion of medicines by pharmaceutical companies. Most prescribers get medicine information from pharmaceutical companies rather than independent sources such as clinical guidelines. This can often lead to overuse. Some countries allow direct-to-consumer advertising of prescription medicines, which may lead to patients pressuring doctors for unnecessary medicines.
  • 6. 6  Profits from selling medicines. In many countries, drug retailers prescribe and sell medicines over-the-counter. The more they sell the more income they generate, leading to overuse of medicines, particularly the more expensive medicines.  Unrestricted availability of medicines. In many countries, prescription medicines such as antibiotics, are freely available over-the-counter. This leads to overuse, inappropriate self-medication and non-adherence to dosing regimes.  Overworked health personnel. Many prescribers have too little time with each patient, which can result in poor diagnosis and treatment. In such circumstances prescribers rely on prescribing habit as they do not have the time to update their knowledge of medicines.  Unaffordable medicines. Where medicines are unaffordable, people may not purchase a full course of treatment or may not purchase the medicines at all. Instead they may seek alternatives, such as medicines of non-assured quality from the Internet or other sources, or medicines prescribed to family or friends.  Lack of coordinated national pharmaceutical policy. Less than half of all countries implement the basic policies recommended by WHO to ensure the appropriate use of medicines. These include appropriate measures and infrastructure for monitoring and regulation of medicines use, and training and supervision for prescribing health workers. What can be done to improve rational use of medicines? WHO advises countries to implement national programmes to promote rational use of medicines through policies, structures, information and education. These include:  a national body to coordinate policies on medicine use and monitor their impact;  evidence-based clinical guidelines for training, supervision and supporting decision- making about medicines;  lists of essential medicines used for medicine procurement and insurance reimbursement;  drug (medicines) and therapeutics committees in districts and hospitals to monitor and implement interventions to improve the use of medicines;  problem-based training in pharmacotherapy and prescribing in undergraduate curricula;  continuing medical education as a requirement of licensure;  publicly available independent and unbiased information about medicines for health personnel and consumers;  public education about medicines;  elimination of financial incentives that lead to improper prescribing, such as prescribers selling medicines for profit to supplement their income;  regulations to ensure that promotional activities meet ethical criteria; and  adequate funding to ensure availability of medicines and health personnel.
  • 7. 7 The most effective approach to improving medicines use in primary care in developing countries is a combination of education and supervision of health personnel, consumer education, and ensuring an adequate supply of appropriate medicines. Any of these alone have limited impact. WHO response To improve rational medicine use, WHO:  monitors global medicines use and pharmaceutical policy;  provides policy guidance and support to countries to monitor medicines use and to develop, implement and evaluate national strategies to promote rational use of medicines;  develops and delivers training programmes to national health professionals on how to monitor and improve medicines use at all levels of the health system. Requirement for rational drug use Adequate diagnosis For a correct diagnosis to be made, the prescriber must have adequate knowledge and motivation, private examination facilities, and sufficient time to take a history, perform an examination, and explain to the patient the diagnosis and treatment. Correct prescribing To prescribe correctly, the prescriber must know which drug to prescribe for which diagnosis or complaint and when treatment without drugs is appropriate. Appropriate dispensing For correct dispensing to occur, the dispenser must be trained, have adequate time, have the necessary materials (containers, labels), and have a dispensary where it is possible to communicate with patients. Patient adherence to treatment (compliance) Patient adherence to treatment is dependent on understanding and acceptance of the treatment; this results from effective communication between prescriber, dispenser and patient.
  • 8. 8 Measuring drug use In any situation, measurement of present practices, followed by investigation of the underlying reasons for practices that represent problems, should precede the development of interventions. Other methods may utilize aggregated information combining drug procurement and morbidity data to calculate consumption/morbidity ratios. Computers are increasingly used to exchange drug utilization data, there is a need to standardize coding systems, for example for health problems, dosage forms, and the description of adverse drug reactions. Once the priority problem has been identified, further investigations utilizing qualitative techniques such as observation, focus group discussions, in-depth interviews, questionnaires and simulated patients are required. How to promote Rational Use of Medicines? Most important tools for promoting rational use of medicines are list of essential medicines and standard treatment guidelines. “Essential medicines are those that satisfy the priority healthcare needs of the population. They should be available at all times and should be selected on basis of efficacy, safety and cost”. (WHO 2001) For facilitating prescribers to prescribe rationally, clinical guidelines need to be developed. The guidelines provide a benchmark of satisfactory diagnosis and treatment at all levels of health care. The guidelines need to be developed systematically, based on evidence and through a consensual process. They should be supplemented by formularies. To conform with the criteria of rational use, prescribers should follow a standard process of prescribing, starting a diagnosis to define the problem, setting up a therapeutic goal, deciding treatment based on up-to-date drug and therapeutic information, and to achieve the desired goal for an individual patient. The selection of drug should be based upon criteria of efficacy, safety, suitability and cost. The route of administration and duration of treatment should be determined taking into account the condition of the patient and proper information must be provided to the patient about his condition and the drug. The drug should be dispensed in a safe and hygienic manner ensuring adherence of patient to treatment and monitoring should be done for therapeutic and adverse effects of treatment.
  • 9. 9 WHO advocates 12 key interventions to promote more rational use:  Establishment of a multidisciplinary national body to coordinate policies on medicine use  Use of clinical guidelines  Development and use of national essential medicines list  Establishment of drug and therapeutics committees in districts and hospitals  Inclusion of problem-based pharmacotherapy training in undergraduate curricula  Continuing in-service medical education as a licensure requirement  Supervision, audit and feedback  Use of independent information on medicines  Public education about medicines  Avoidance of perverse financial incentives  Use of appropriate and enforced regulation  Sufficient government expenditure to ensure availability of medicines and staff. Role of pharmacists in promoting rational use of medicines A pharmacist is a crucial link between patient and other healthcare professionals. The outreach of pharmacist is tremendous, both in hospital pharmacies as well as in community pharmacies. Pharmacists are the first contact with the community for any illness. Above all the community by and large has tremendous faith in them and find them easily accessible. Pharmacists have been recognized as having key role to play in – (a) Strengthening effective drug management. (b) Overcoming chronic shortages of essential medicines. (c) Combating problems with fake and inferior quality medicines, and (d) Increasing efforts to educate public to promote compliance with drug therapy.
  • 10. 10 To reduce the potential medication error, David U. in his column in ‘Medication Safety Alerts’outlined the roles of pharmacists at different stages of medication use as below Prescribing Stage • Clarify and verify if not sure or not clear • Establish protocols and order sets • Monitor all medication profiles • Maintain open communication channels with physicians • Educate physicians about dangerous abbreviations • Provide input to patients’ medication regimens • Encourage physicians to use protocols and preprinted order forms • Support and facilitate implementation of computerized physician order entry systems • Support use of a personal digital assistant for clinical information resources Dispensing Stage • Automate dispensing • Reorganize drug storage and shelving to separate drugs with similar names • Redesign workflow to achieve efficiency and to facilitate safety checking • Make use of computerized clinical information • Be more vigilant with high-risk medications and high-risk patients, e.g., establish a system of double-checks • Communicate clearly with nurses and patients Transcribing and Administering Stages • Support and facilitate use of electronic medication administration records (MARs) Ensure that each patient’s MAR is updated in a timely manner when pharmacy service is not available • Check and compare each patient’s MAR at least daily to ensure that orders are interpreted correctly and carried out • Support the use of point-of-care dispensing cabinets • Support the use of bar coding for patients, orders, and drugs for administration Monitoring Stage • Follow up laboratory results and/or blood level monitoring • Screen automatic stop orders for drugs that require reactivation • Perform daily review of drug profiles to spot potential problems • Establish rapport and effective communication with nurses • Engage patients
  • 11. 11 Specific Role of Pharmacist in National HIV/AID Control Programme A few international intervention studies have shown that active participation of pharmacists in antiretroviral (ARV) therapy programme for HIV/AIDS, lead to great benefits to the patients in term of adherence to ARV therapy and outcome of the disease. Hence in India also, pharmacist can be a powerful medium in successfully implementing National AIDS Control Programme in the country. Pharmacists working at Antiretroviral Therapy (ART) Centers under National AIDS Control Organization (NACO) can actively participate and contribute in better patient outcome. The specific roles of pharmacists are: A. To maintain regular supply of ARV/OI medicines through better inventory management, storage and stock management so that patients receive medicines at all times. B. Following good dispensing practices and imparting appropriate pharmaceutical care by educating patients on safe use of ARV medicines. C. Participating in pharmacovigilance programme. A. Drug Stock Management An effective inventory management will ensure availability of ARV medicines in right quantities at all times in ART Centers. It is important to follow set guidelines viz., determining quantity needed, placing orders at appropriate time, receiving and checking medicines, storing appropriately, and, monitoring consumption. Similarly, storage and stock management are essential because if medicines are not stored in proper condition they are likely to loose their potency before actual expiry date. It is the responsibility of a pharmacist of ART Centre to assess requirement of medicines based on number of patients enrolled and past consumption and put the request to medical officer/senior medical officer for next year/interim requirement. Minimum stock of medicines for three months should be available in the pharmacy at any given time. In case of shortage, timely information to regional coordinator/SACS and NACO headquarters should be sent. Accurate record for the medicines received and dispensed should be maintained. Pharmacists should have adequate knowledge of storage of medicines, handling of “near expiry” medicines and disposal of expired medicines. Pharmacists should train other health professionals (nurses and other pharmacists) working at ART Centers regarding ARV/OI medicines.
  • 12. 12 B. Good Dispensing Practices and Imparting Appropriate Pharmaceutical Care Dispensing is an important part of practice of pharmacy, in which the pharmacist interprets prescription given by doctors, and accordingly dispenses medicines to patients. Several studies have shown that imparting knowledge to patients about prescribed medicines enhances adherence to prescription and patient outcome. ARV medicines relatively have low safety profile and cause frequent adverse drug reactions. A substantial percentage of patients experience adverse effects. There are ample chances that patients may discontinue the treatment. Patient’s adherence to ARV treatment has a significant role in control of HIV/AIDS. Hence pharmacists can be a strong promoter of health in patients suffering from HIV/AIDS. While dispensing medicines, pharmacist should educate patients about dose, frequency, duration of administration of each medicine. They should also educate patients about adverse drug reactions (ADRs) that are commonly encountered and ADRs those need revisit of the patient to doctor or pharmacist, about drug-drug interactions, and importance of strict adherence to prescribed medicines. Pharmacist can advise on how to mange ADR. Besides providing education on medicines, pharmacists should also counsel patients on safe use of syringes and needles, treatment of opportunistic infections, and prevention of HIV/AIDS. C. Participation in Pharmacovigilance Programme Pharmacovigilance is a structured process for monitoring and detection of ADRs in a given context. Pharmacists have important contribution to make to post-marketing surveillance and pharmacovigilance. Data generated by pharmacovigilance centers have great relevance and educational value in ensuring safe use of medicines. ARV medicines are potent medicines, have low safety profile and need to be used on chronic basis. Hence their ADR monitoring is of paramount importance. Their identification would help in finding out alternatives and treatment strategies to deal with them. Pharmacists should be trained to identify and report ADR of ARV medicines. The role of pharmacist is expanding. It is beyond medicines supply and management. It is desired that medicines are used for the maximum benefit of each individual patient and society as a whole. A pharmacist, who is one of the key members of healthcare system, needs to participate in achieving the goal. As documented in western world, appropriate pharmaceutical care provided by a pharmacist will result in improvement in health as well as cost saving.
  • 13. 13 To conform to the criteria, prescribers’ should follow a standard process of prescribing and the pharmacists should play a crucial role in this therapeutic process by dispensing the appropriate drugs. In the treatment of HIV/AIDS, National Guidelines have been laid down spelling out when therapy is to be initiated, the kind of drugs to be given, the dosage and instructions on clinical monitoring and guidance on modifying/changing therapy due to adverse drug reaction. The NACO programme on ARV therapy is thus an excellent example of promoting rational use of medicines - essential medicines have been identified and are made available at ART centres and standard treatment protocols have also been developed. Under NACP-II focus was given to low-cost care, support and treatment of common OIs. NACP-III, apart from further improving the availability, accessibility and affordability of ART treatment to the poor, plans to strengthen family and community care through psycho- social support to the individuals, more particularly to the marginalized women and children affected by the epidemic, improve compliance of the prescribed ART regimen. These measures should lead to better compliance to drug adherence. All the above should be supplemented by a programme of providing information to the patients. Patients should know dose frequency and duration of treatment for better therapeutic outcomes. The consumer, at large, should be provided information on medicines so that they take informed decisions on their health care.
  • 14. 14 STEPS TO IMPROVE RATIONAL DRUG PRESCRIBING Step:- I Identify the patient’s problem based on symptoms & recognize the need for action. Step:-II Diagnosis of the disease. Identify underlying cause & motivating factors. This may be specific as in infectious disease or non specific. Step:-III List possible intervention or treatment. This may be non drug treatment or drug treatment. Drug must be chosen from different alternatives based on efficacy, convenience & safety of drugs including, drug inter-actions & high risk group of patients. Step:-IV Start the treatment by writing an accurate & complete prescription e.g. name of drugs with dosage forms, dosage schedule & total duration of the treatment. Step:-V Given proper information instruction & warning regarding the treatment given e.g. side effects(ADR), dosage schedule & dangers/risk of stopping the therapy suddenly. Step:-VI Monitor the treatment to check, if the particular treatment has solved the patient’s problem. It may be: (a) Passive monitoring – done by the patient himself. Explain him what to do if the treatment is not effective or if too many side effect occurs (b) Active monitoring done by physician and he make an appointment to check the response of the treatment.
  • 15. 15 Rational Use of Antibiotics Antibiotics are the most important weapons in our hands. Each one of them have been invented after spending considerable amount of time, energy and money. Therefore, we cannot afford to lose them. We must exercise considerable restraint in prescribing antibacterials and restrict the use of antibacterials to only certain definite indications. Indications for antibacterial therapy: 1. Definitive therapy: This is for proven bacterial infections. Antibiotics (read antibacterials) are drugs to tackle bacteria and hence should be restricted for the treatment of bacterial infections only. This may sound silly, but most doctors seem to forget this simple fact! Attempts should be made to confirm the bacterial infection by means of staining of secretions/fluids/exudates, culture and sensitivity, serological tests and other tests. Based on the reports, a narrow spectrum, least toxic, easy-to-administer and cheap drug should be prescribed. 2. Empirical therapy: Empirical antibacterial therapy should be restricted to critical cases, when time is inadequate for identification and isolation of the bacteria and reasonably strong doubt of bacterial infection exists: septicemic shock/ sepsis syndrome, immunocompromised patients with severe systemic infection, hectic temperature, neutrophilic leukocytosis, raised ESR etc. In such situations, drugs that cover the most probable infective agent/s should be used. 3. Prophylactic therapy: Antimicrobial prophylaxis is administered to susceptible patients to prevent specific infections that can cause definite detrimental effect. These include antitubercular prophylaxis, anti rheumatic prophylaxis, anti endocarditis prophylaxis and prophylactic use of antimicrobials in invasive medical procedures etc. In all these situations, only narrow spectrum and specific drugs are used. It should be remembered that there is NO single prophylaxis to 'prevent all' possible bacterial infections.
  • 16. 16 Rational Use of Injections Safe and appropriate use of injections can be achieved by adopting a three part strategy: (1) Changing behaviour of health care workers and patients Twenty years into the HIV pandemic, knowledge of HIV among patients and health care workers in some countries has driven consumer demand for safe injection equipment and irreversibly improved injection practices. With growing knowledge of HCV and HBV, similar patterns of consumer demand for safe injections should emerge. HIV prevention programmes can be expanded to include injection safety components. (2) Ensuring availability of equipment and supplies Simply increasing the availability of safe injection equipment can stimulate demand and improve practices. Because the cost of safe disposable syringes is low (less than 5 US cents per unit) when compared to the fee paid for receiving an injection (50 US cents on average), patients are usually willing to pay a little extra for safety once they personalize the risks. (3) Managing waste safely and appropriately As waste disposal is frequently not an integral part of health planning, unsafe waste management is common. However, when it is appropriately planned, significant results ensue. National health care waste management strategies require a national policy to manage health care waste, a comprehensive system for implementation, improved awareness and training of health workers at all levels, as well as the selection of appropriate options for the local solutions. WHAT IS WHO DOING TO IMPROVE INJECTION SAFETY? WHO hosts and coordinates the Safe Injection Global Network (SIGN), which assembles all major stakeholders to promote and sustain injection safety worldwide. Through the network, WHO provides advice and a series of policy, management and advocacy tools to help countries access safe, affordable equipment, promote the training of health staff and rational use of injections. Guidance, policy and advocacy tools WHO develops and updates a series of evidence-based resource materials on best practices for injection safety, waste management, health care worker protection and infection control. These resources are published online and distributed to countries. The SIGN secretariat also regularly provides data to assist countries for decision making, including tools to assess the state of
  • 17. 17 injection safety in health care facilities, analyses of global burden of disease data resulting from unsafe injections, and cost effectiveness analyses for injection devices. Support to achieve quality and safety of injection devices In collaboration with the International Organization for Standardization and the International Association of Safe Injection Technologies (the umbrella organization of injection devices manufacturers), WHO has developed a specification standard for auto-disable syringes for immunization and curative purposes. The specification can be used by national regulatory authorities for product review or by national authorities for procurement. To prevent injection overuse in the curative sector, WHO urges that countriesa€™ national drug policies promote the rational use of therapeutic injections. This may include removing unnecessary injectable medicines from the national essential medicines list. Support to increase access In 2004, WHO developed "Guiding Principles to ensure injection device security", reaffirming the need to ensure bundled supply of injectable medicines, appropriate diluents, single use injection devices and safety boxes in sufficient quantities in each health care facility. This requires appropriate forecasting for financing, procurement and supply management. To further assist countries, WHO has developed a procurement guide for single use syringes and safety boxes. WHO urges donors and lenders who finance injectable products to also finance appropriate quantities of items and the cost of sharps waste management.
  • 18. 18 Bangladesh Perspective Bangladesh Government spent Tk. 5,500 crores in health only in the year 1996-1997, out of which total spending on drugs was Tk. 2,700 crores (49%).Due to exploitative market, almost 50% of our population has no reliable access to modern medicines and the rest 50% have access but are trapped into using non-essential, irrational and even dangerous drugs. This widespread irrationality prevails both in the private and public sectors, leading towards serious health problems and wastage of scarce resources. Pharmaceutical industries of Bangladesh have flourished tremendously after the implementation of National Drug Policy and Drug Control Ordinance 1982. Availability of essential drugs also increased remarkably with the increase in the volume of local production of all types of recognized drugs and the monetary value of which grew from Taka 1730 million in 1981 to about Taka 41000 million in 2002. Quality of products has improved and substandard drugs fell from 36% in 1970 to only 2% in 2002 and becoming a drug exporting country.But a survey conducted in 1988 – 91 has showed that numerous small companies still market substandard drugs in the country. Fake or substandard medicines, including lifesaving ones, with an estimated worth of US$ 150 million per year, are flooding the domestic market. National Drug Policy (NDP) 2005 states that only registered drugs should be allowed to distributed and sold throughout the country under person having professional qualification or holding valid professional license. NDP 2005 again indicates that no drugs other than OTC should be sold or dispensed without prescriptions. Rational use of drugs (RUD) should be ensured by conducting survey on the system of prescribing, dispensing and patient compliance. Monitoring and reporting adverse drug reactions (ADR) should be done seriously to ensure safe and rational use of drugs in the country. But according to the Bangladesh Chemist and Druggist Association, there are about 70,000 illegal drugstores. Most of them are selling substandard or fake, poor quality, smuggled and adulterated medicines and a significant proportions of these medicines are selling without registered doctors’ prescription indicating violation of NDP. Drugs Testing Laboratory in its annual testing of 5,000 local samples found 300 either counterfeits or of very low quality.Weak enforcement of the provision of laws of National Drug Policy and Drug Control Ordinance 1982 like punishment by imprisonment or fine for those who manufacture or sell substandard drugs might endanger the situation. F. Ahmed et al. in their study showed that 13.33% of Metronidazole tablet and 20% suspensions of the same under investigation were less potent.Again, a study involving a sample of 15 brands of ciprofloxacin collected for chemical and bioassay revealed seven brands contained active ingredient less than the USP specification. Another report noted that 69% of Paracetamol tablets and 80 per cent of Ampicillin capsules produced by small companies were of substandard quality. It is widely alleged that adulteration flourishes in the country because of poor government vigilance and supervision over drug manufacturers and sellers. Unfortunately, a section of corrupt physicians and government officials is involved in this underhand dealings.
  • 19. 19 Mohammed Hanif et al. in their study in 1995 found that Paracetamol elixirs with Diethylene Glycol as a diluents were responsible for a large outbreak of fatal renal failure in Bangladesh. Recently same incident has been repeated after taking Paracetamol syrup where about 34 children with renal failure were admitted at the Dhaka Shishu Hospital and the Bangabondhu Sheikh Mujib Medical University (BSMMU) and 25 were died out of them. Following this tragedy, a probe committee which examined 300 samples of Paracetamol and Vitamin syrup produced by 10 different pharmaceutical companies and found the presence of poisonous Diethylene Glycol in the Paracetamol syrup manufactured by one of those companies. Rational drug use is an important part of health policy ensuring that patients receive medications appropriate to their clinical needs, in doses that meet their own requirements for an adequate period of time and at the lowest cost to them and their community. Numerous studies showed irrational prescribing both from developed and developing countries consisting of polypharmacy, use of drugs that are not related to the diagnosis, unnecessary use of antibiotics, irrational self- medication, or drugs taken in insufficient quantities.Guyon et al. in their studies focused some factors behind inappropriate prescriptions like poor consulting period of doctors (average 54 seconds only); short dispensing time (avg. 23 seconds only) and patients’ misunderstanding about medicine dosage (only 55% patient can understand correctly). It was estimated that more than half of medicines were inappropriately prescribed, dispensed or sold. Shapna Sultana et al. in her study showed that several prescriptions lack even the basic information such as the identity of the practitioner and patient. The clarity of instructions was inadequate for more than half of all prescriptions whereas poly-pharmacy was present with about 90% of prescriptions and a significant proportion of which received 5 or more medications. The prescription procedure of antibiotics in Bangladesh deviates from ideal practice and in most of the cases these are prescribed mainly on the patient’s complaints. All available antibiotics were prescribed in inappropriate doses and duration. Antibiotics are sold without any prescriptions, and even ordinary people without any knowledge of medicine ask the drug seller for specific antibiotics. One study showed that 26% of purchased drugs were antibiotics for children aged 0-4 year(s) and 48% of antibiotics were purchased in quantities of less than a single day's dose. Misuse of antibiotics even in some diagnoses incurring significant financial berden. Over the counter (OTC) drugs have emerged recently as drugs of serious misuse across Bangladesh, and other neighboring countries. One report estimated that there are four million drug misusers in the South Asian region, with Bangladesh accounting for nearly 500,000. 32 Self medications in a population with low literacy level like Bangladesh are very challenging, which poses risks such as incorrect diagnosis, absence of knowledge of alternative treatments, irrational use of drugs and neglecting side effects and drug interactions etc. Study showed that around 30- 40% of underprivileged population including the women, elderly, ethnic minorities, poor/ultra- poor undertake self-medications for managing illness.
  • 20. 20 REFERENCES  MEDICATION PRACTICES IN ----- ROLES OF PHARMACISTS AT CURRENT CIRCUMSTANCES -MANIK CHANDRA SHILL, ASISH KUMAR DAS  Rational Use of Drugs to Maximise Health Outcomes and Quality of Life - Thomas Y.K. Chan  Rational Use of Antibiotics in Hospital- and Community-Acquired Infections - Fatma A. Amer  PROMOTING RATIONAL USE OF MEDICINES  RATIONAL DRUG USE -Dr Sneha Ambwani, Dr A K Mathur  Managing For Rational Medicine Use  NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention), 2009. “About Medication Errors.” (http://www.nccmerp.org/aboutMedErrors.html).  ISMP (The Institute for Safe Medication Practices). 2008. “Heparin Errors Continue Despite Prior, High-Profile, Fatal Events.” ISMP Newsletter, July 17, 2008. (http:// www.ismp.org/Newsletters/acutecare/ articles/20080717.asp).  Kohn LT, Corrigan JM, and Donaldson MS. To Err is Human: Building a Safer Health System. Washington, D.C.: National Academy Press, Institute of Medicine, 1999. (http://www.nap.edu/ books/0309068371/html).  Lazarou J, Pomeranz B, Corey P. Incidence of Adverse Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies. JAMA 1998; 279: 1200–1205.  Pirmohamed M, Atuah KN, Dodoo ANO, Winstanley P. Pharmacovigilance in Developing Countries. BMJ 2007; 335: 462.  Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, et al. Incidence of adverse drug events and potential adverse drug events, Implications for prevention. JAMA 1995; 274: 29-34.  Bhatt AD, Healthcare Management, 2002. (http://www.expresshealthcaremgmt.com/20020630/edit2.html).  Chowdhury SAR. Prescribing a rational drug. Bangladesh Journal of Physiology and Pharmacology 1991; 7: 182-187.
  • 21. 21  Bangladesh National Health Accounts, 1996-1997. Health Economic Units, Ministry of Health and Family Welfare, Bangladesh. (http://www.apnhan.org/territories/bgd/docs/BangladeshNHA1996-97.pdf).  Bangladesh Public Health Conference, 2008 (http://www.unnayan.org/reports/Report_BPC_08.pdf).  National Drug Policy 2005, Ministry of Health and Family Welfare, Government of the People’s Republic of Bangladesh. (http://www.ddabd.org/download/drug_policy_2005_eng.pdf).  Roy J. The menace of substandard drugs. World Health Forum 1994; 15: 406-407.  Smith G. What FIP and WHO are doing to fight the problem of counterfeit drugs? Pharm J 2004; 273: 394-396.  Govt. deprived of revenue, adulterated medicines being sold: Mushroom growth of pharmacies, 70,000 shops trading