Pharmacy World Congress

Statement of professional standards: Pharmaceutical care

Modern medicines are effective and specific in action. Of all modern therapeutic treatments available, only medicines are primarily self-administered, therefore success depends upon the active participation of patients and they require objective information if they are to derive maximum therapeutic benefit and avoid unwanted side effects from courses of treatment. Therapy with prescribed medicines is a collaborative process involving the patient, the physician, the pharmacist and other health care providers. In recent years, therefore, pharmacists have adopted a much more patient-centred approach in the professional services they provide. This ensures that both patient care and economic aspects are considered and are correctly balanced in the interests of the patient.
There is increasing use of non-prescription medicines in the treatment of common ailments and the range of effective medicines available without medical prescription is also increasing. Here the role of the pharmacist is to ensure that all necessary information and advice is given to encourage safe and effective use of a medicine. FIP considers, therefore, that within the concept of pharmaceutical care there is no essential difference in the role of the pharmacist in respect of prescription and non-prescription medicines.
The principles of pharmaceutical care are embedded in the concept of good pharmacy practice. This statement is intended as a framework within which national pharmaceutical associations can set national standards under the headings relevant in their countries.

Definition
Pharmaceutical care is the responsible provision of pharmacotherapy for the purpose of achieving definite outcomes that improve or maintain a patient's quality of life. It is a collaborative process that aims to prevent or identify and solve medicinal product and health related problems. This is a continuous quality improvement process for the use of medicinal products.

Pharmaceutical care requirements
The goal of pharmaceutical care is to optimise the patient's health-related quality of life and to achieve positive clinical outcomes. To achieve this goal a structured approach is needed, which comprises distinctive steps:
A. Pharmaceutical care requires that a professional relationship between the patient and the pharmacist must be established and maintained.
B. Pharmaceutical care requires that records of medication provided to a patient must be kept and that, with the patient's informed consent, additional patient-specific information must be collected, organised, recorded, monitored and maintained.
C. Pharmaceutical care requires that patient-specific medical information must be evaluated and, in the case of prescribed medicines, a therapy plan developed involving the patient and the prescriber.
In satisfying these requirements:

• The relationship is established and maintained on the basis of caring, trust, open communication and mutual decision-making. In this relationship pharmacists give the patient's welfare priority and use all their professional knowledge and skills on the patient's behalf. In exchange, the patient agrees to supply personal information, expresses preferences and participates in the preparation of the therapeutic plan.
• Pharmacists collect information on medicine or health related problems and decide which data are necessary to perform a critical appraisal of the patient's problem. Since this information will form the basis for decisions relating to the development and subsequent modification of the pharmacotherapy plan, it must be accurate, as complete as possible and systematically recorded to ensure that it is readily retrievable. Patient information must be maintained in a confidential manner and be updated as necessary and appropriate.
• A pharmacotherapy plan should be developed with the active participation of the patient. The pharmacist's contribution should focus on the balance between the complexity of the therapy, the cost and the likelihood of the patient adhering to the plan. The patient should be fully informed in easily understandable language of the essential elements of the plan, including their own responsibilities. The plan must be documented in the patient's record and, where appropriate, communicated to other health care providers.
• Pharmacists should be adequately remunerated for these additional services.

Practice principles
Data collection The pharmacist conducts interviews with the patient in a setting designed to ensure privacy. The data obtained are accurate, appropriately organised and kept current. Patient data are confidential and are provided to others only with informed consent of the patient or as required by law.
Evaluation of information and formulating a plan The pharmacist, collaborating with other health care providers and the patient, identifies and evaluates the most appropriate action to ensure the safety and effectiveness (including cost effectiveness) of current or planned pharmacotherapy and to minimise current or potential future health-related problems. The pharmacist documents, in the patient's record, the plan and desirable outcomes for each problem identified.
Implementing the plan The pharmacist works with the patient to maximise patient understanding and commitment to the pharmaceutical care therapy plan. The pharmacist ensures that the patient knows how to use all necessary medication and any equipment associated with monitoring or administration properly.
Monitoring and modifying the plan to ensure positive outcomes The pharmacist regularly reviews with the patient progress toward achieving the desired outcomes and provides a report to the patient's other health care providers as appropriate. As progress towards outcomes is achieved, the patient should receive positive reinforcement to encourage continuing co-operation. if the expected progress is not being achieved, then the plan should be modified, applying the principles used in formulating the original plan.
Follow-up When the desired outcomes have been achieved, a follow-up procedure should be established to ensure the continued well-being of the patient.

Joint Statement by FIP and WSMI - Responsible self-medication

1. Self-care, including self-medication, has been a feature of health care for many years.
2. Nowadays people are keen to accept more personal responsibility for their health status and to obtain as much sound information as possible from expert sources in order to help them make appropriate decisions in health care.
3. Governments and health insurers are increasingly encouraging self-care, including self-medication when appropriate, as one means of limiting the rate of in party funding of health care.
4. Pharmacists are advisers to the public on everyday health care and key figures in the supply of medicines. Their education and training equips them to provide sound advice on medicines.
5. Pharmacists and the manufacturers of non-prescription medicines share the common goals of providing high quality service to the public and encouraging the responsible use of medicines. These are best achieved by adequate labelling and by ensuring that any necessary additional information or professional advice is given by a pharmacist or physician.
6. The companies represented by member associations of WSMI provide non-prescription medicines, the quality, safety and efficacy of which are guaranteed through the granting of marketing authorisations or other legally recognised procedures, operating through regulatory authorities in individual countries.
7. Advertising is helpful in informing people about medicines that are available without prescription. It should always be responsible and should not discourage the individual from seeking advice from a pharmacist or physician.

Definition
Self-medication is the use of non-prescription medicines by people on their own initiative. Pharmacists have a key role to play in providing them with assistance, advice and information about medicines available for self-medication.

Responsibility of the pharmacist
1. Pharmacists have a professional obligation to provide sound, objective advice about self-medication and the medicinal products available for self-medication.
2. Pharmacists have a professional obligation to report to the regulatory authorities, and to inform the manufacturer, of any adverse event encountered by an individual which may be associated with the use of a medicine purchased without a prescription.
3. Pharmacists have a professional obligation to recommend that medical advice should be sought where it is recognised that self-medication is not appropriate.
4. Pharmacists have a professional obligation to encourage members of the public to treat medicines as special products to be stored and used with care and, to that end, not to take any action which could encourage people to buy excessive quantities of a medicine.

Responsibility of the manufacturer of non-prescription medicines
1. The manufacturer has a responsibility to provide medicines which are of a high standard of safety, quality and efficacy and meet all legal requirements for packaging and labelling and should work towards a world-wide standardised layout of information on labels.
2. The person responsible for the medicine, who will normally be the manufacturer but may also be the primary distributor, has a responsibility to provide all the information needed by pharmacists to enable them to provide appropriate advice to members of the public.
3. The manufacturer has a responsibility to ensure that claims made in advertising of medicines can be substantiated scientifically, meet national regulations, industry guidelines and internal company controls, and do not encourage inappropriate use.
4. The manufacturer has a responsibility to ensure that marketing methods encourage people to treat medicines with care, and, to that end, not to take any action which could encourage people to buy excessive quantities of a medicine.

Conclusion
The public interest will best be served when pharmacists and the non-prescription medicines industry work together to ensure that self-medication is responsible, is only undertaken when it is appropriate to do so and advice is always given to seek a consultation with a physician when that is necessary.
FIP and WSMI will work together to seek to ensure that pharmacists and manufacturers appropriately discharge their interacting responsibilities.

Joint Statement by the FIP and the WMA - Working relationship between physicians and pharmacists in medicinal therapy

The goal of medicinal therapy is to improve patients' health and quality of life. Optimal medicinal therapy should be safe, effective and appropriate. There should be equity of access to medicinal care and an accurate and up-to-date information base meeting the needs of patients and providers.
Physicians and pharmacists have complementary and supportive responsibilities in achieving the goal of providing optimal medicinal therapy. This requires communication, respect, trust and mutual recognition of each other's professional competence. When counselling patients, the physician may focus on the goal of therapy, the risks and benefits and side effects. The pharmacist on the other hand may focus on correct usage, treatment adherence, dosage, precautions and storage information.

The physician's responsibilities (only in relation to medicinal therapy, without reference to the physician's full range of responsibilities)

• Diagnosing diseases on the basis of the physician's education and specialised skills and in accepting the sole responsibility for the diagnosis
• Assessing the need for medicinal therapy and prescribing the relevant medicines (in consultation with patients, pharmacists and other health care professionals, when appropriate)
• Providing information to patients about diagnosis, indications and treatment goals, as well as action, benefits, risks and potential side effects of medicinal therapy
• Monitoring and assessing response to medicinal therapy, progress toward therapeutic goals, and when necessary, revising the therapeutic plan (where appropriate in collaboration with pharmacists and other care givers)
• Providing and sharing information in relation to medicinal therapy with other health care providers
• Maintaining adequate records for each patient according to the need for therapy and in compliance with legislation (medical law)
• Maintaining a high level of knowledge about medicinal therapy through continuing professional development
• Ensuring safe procurement and storage of medicines that the physician is required by law to supply

The pharmacist's responsibilities (only in relation to medicinal therapy, without reference to the pharmacist's full range of responsibilities)

• Ensuring safe procurement, adequate storage and dispensing of medicines (in keeping with the relevant regulations)
• Providing information to patients, which may include the name of the medicine, its purpose, potential interactions and side effects as well as correct usage and storage
• Reviewing prescription orders to identify interactions, allergic reactions, contra-indications and therapeutic duplications Significant concerns should primarily be discussed with the prescriber (physician)
• Contributing to the preparation and revision of therapeutic plans involving treatment with medicines, in collaboration with physicians and other care givers
• On request of the patient, discussing medicine-related problems or concerns with regard to the prescribed medicines
• Advising patients on the selection and the use of non-prescription medicines and the patient's management of minor symptoms or ailments (accepting the responsibility for such advice). Where self-medication is not appropriate, advising patients to consult their physician for diagnosis and treatment.
• Reporting adverse reactions to medicines to health authorities, when appropriate
• Providing and sharing general as well as specific medicine-related information and advice with the public and heath care providers
• Maintaining a high level of knowledge about medicinal therapy through continuing professional development

Conclusion
The patient will best be served when pharmacists and physicians collaborate together, recognising each other's roles, to ensure that medicines are used safely and appropriately to achieve the best health outcome.

The World Medical Association and the International Pharmaceutical Federation, in the knowledge that no medicine is risk free, are firmly of the view that medicines should not be promoted by means of "special price" offers or by marketing techniques such as the provision of free samples or "free gifts", "holiday competitions", "buy one, get one free" or similar promotions which may stimulate impulse purchases or persuade someone to buy more of a medicine than is needed at the time. These techniques are used to increase sales of general goods but the two organisations insist that they are inappropriate for application to medicines.
People must be encouraged to treat medicines as special products to be stored and used with care, in accordance with appropriate professional advice. They will not be persuaded to do that if aggressive marketing techniques are permitted to be used in their sale.

All governments should take steps to ensure the quality, safety and efficacy of all medicinal products available in their countries. This applies whether they are branded or generic products, for both the private and public sectors, for imported and locally manufactured products.
Pharmacists, particularly in developing and newly emerging countries, should stress to governments that, in the interest of public health, generic substitution policies should be introduced only when the necessary regulatory safeguards are in place to ensure the quality of all products on the market.