Thursday, June 30, 2011

RATIONAL USE OF MEDICINES AND ROLE OF PHARMACISTS IN PROMOTING RATIONAL USE OF MEDICINES


Guidelines for pharmacists to promote rational use of medicines



Objectives:


To provide information to pharmacists on


    >  the importance of rational use of medicines;
    >  the adverse impact and factors influencing the rational use of medicines;
    >  the national guidelines for HIV/AIDS;
    >  the useful role pharmacists can play in promoting rational use of medicines; and
    >  the importance of patient education.



What is 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. 

Main drug use problems

Overuse of drugs and injections 

Multi-drug use or polypharmacy – The number of drugs in prescription is often more than needed ranging from two to up to ten drugs where one or two drugs would have sufficed.  

Incorrect drug use - the wrong drug for a specific condition   

Self medication – leading to inappropriate drug use   

The above all are instances of irrational use of drugs.  The consequences of inappropriate or irrational use have the following effects on health.

  • Adverse, possibly lethal effects, e.g. due to antibiotic misuse or inappropriate use of drugs in self-medication.
  • Limited efficacy e.g. in the case of under-therapeutic dosage of antibiotics, tuberculosis or leprosy drugs.
  • Antibiotic resistance, due to widespread overuse of antibiotics as well as their use in under-therapeutic dosage.
  • Drug dependence, e.g. due to daily use of painkillers, was already described in 1978, and still exists today; and of tranquilizers.
  • Risk of infection, due to improper use of injections: injection related disorders are, among others, abscesses, polio, hepatitis and AIDS.

The inappropriate use of medicines can have a significant adverse effect on the quality of health care and significantly, make health care needlessly costly quite apart from its adverse impact on the quality of patient care.

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.

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. 


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.

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.

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.

Key responsibilities of a pharmacist in ART Centres

  • Facilitate receipt of medicines and Medicine Stock Management at ART Centre.
  • Ensure that the centre has stock of ARV medicines for at least 3 months.
  • Inform ART SMO/Incharge MO/Nodal Officer of the centre as and when the stock falls below 3 month backup stock.
  • Dispense medicines for OI and ARV medicines.
  • Maintain medicine stock and medicine dispensing registers and generate “Daily Due List” for Medicine Collection for next working day.
  • Handover the completed list “Daily Due List” of each day after completion of medicine dispensing for the particular day, to Counselor for contacting MIS cases.
  • Advise patient and family about importance of adherence during each visit.
  • Advise patient on possible adverse reaction of ARV and OI medicines and also explain the importance of reporting ADR to pharmacist/doctor during each visit.
  • Maintain a monthly sheet for expiry of medicine stock.
  • Do pill count and provide necessary data to Data Manager related to medicines for preparation of Monthly Reports.
  • Facilitate and monitor supply of ARV medicines to LACS as per the number of patients linked out.

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