Standards for Pharmacy Practice
INTRODUCTIONThis document contains quality standards for pharmacies in Norway in areas defined as the pharmacies’ core activities.
The quality standards express quality requirements, which the trade itself imposes on the operation of pharmacies towards customers/patients and the health service.
The standards have been developed by the Norwegian Pharmacy Association on behalf of the pharmacy trade, in cooperation with The Norwegian Association of Pharmacists and The Association of Pharmacy Technicians, the professional organizations for pharmacy employees.
BACKGROUND
The World Health Organization (WHO) and the international organization for pharmacists Federation Internationale Pharmaceutique (FIP) have issued a joint document, ”Good Pharmacy Practice (GPP) – in Community and Hospital Settings”, defining the pharmacies’ core activities and giving guidelines for the work of the pharmacies within the core areas. The organizations have also recommended that national quality standards within these areas be developed.
The document is accepted by all member countries of WHO.
The starting point for the Norwegian standards is the document ”Nordic Guidelines for Good Pharmacy Practice”, developed and approved by the Nordic pharmacy associations. This document express Good Pharmacy Practice, adapted to the Norwegian situation.
FOCUS ON THE CUSTOMER/PATIENT
The Nordic Guidelines for Good Pharmacy Practice are based on the principle that the needs and expectations of the customer/patient shall be the focus of the pharmacies’ work.
In their operations, the pharmacies shall show respect for the customer/patient’s independence and integrity.
THE PURPOSE OF THE STANDARDS FOR PHARMACY PRACTICE
The standards shall form a basis for the trade’s own monitoring of the quality of pharmacy services.
The minimum requirements for pharmacy operations are laid down in laws and regulations.
The pharmacy trade wishes to lay down common requirements for pharmacy operations that emphasize, deepen or exceed the minimum requirements imposed by the authorities. The standards shall express what customers/patients, the health service and authorities can expect from pharmacies and, where possible and relevant, give opportunities for testing the quality of pharmacy services.
The document ”Nordic Guidelines for Good Pharmacy Practice” defines the pharmacies’ core activities and expresses overriding objectives within the individual areas.
The standards go further and express quality requirements for the activities that pharmacies must carry out in order to fulfil the overriding objectives. The standards give a basis for pharmacy chains and individual pharmacies in assuring and improving quality.
The standards shall be used in developing routines and objectives.
Pharmacy chains and individual pharmacies may develop further quality requirements for their operations.
By setting standards, monitoring whether they are complied with and regularly revising them, the pharmacy trade is proving that it is taking responsibility for the standard of practice and the professional development of pharmacies.
1. PRESCRIPTIONS AND REQUISITIONS
Pharmacies supply medicines by dispensing prescriptions to individual customers/patients, and supply professional end users (hospitals, care homes, physician’s surgeries, etc) with medicines according to requisitions.PHARMACY ACTIVITIES – PRINCIPLES FOR WORK
Pharmacies shall
- assess the prescription and follow up use of medicines at customer/patient level from a pharmaceutical point of view
- have working routines that ensure customer/patient safety
- give advice and counselling with the aim of making the customer/patient understand the purpose of his/her treatment
- contribute to solving drug-related problems for individual customers/patients
- co-ordinate advice and counselling with the local health service
- offer pharmaceutical services that support and contribute to the rational use of medicines and promote the objective of the treatment
- document their health assistance
- evaluate and follow up requisitions from professional end users
- be efficient in supplying medicines and other health-related products
QUALITY REQUIREMENTS
PRESCRIPTIONS TO CUSTOMERS/PATIENTS
• PREMISES
Pharmacies shall be designed
- so that customers/patients easily can orientate themselves in relation to the pharmacy’s system for dispensing prescriptions
- to facilitate undisturbed conversation with the customer/patient
- to safeguard the need for discretion when dispensing prescriptions
• INTERACTION WITH CUSTOMERS/PATIENTS
Pharmacies shall
- unprompted, and in dialogue with the patient, give information that is individually adapted in order to achieve rational use of medicines and promote the objective of the treatment
- give advice and counselling in respect of generally accepted therapy recommendations
- evaluate possible risks of irrational use, as well as under- or over-consumption of medicines
- actively use written information material when giving advice and counselling. The material shall be of a quality that the pharmacy can vouch for.
- label the medicines in accordance with generally accepted professional standards
- document their dispensing in a way that makes it possible to follow up customers/patients over time
- consult the prescriber when needed to clarify circumstances concerning the prescribing of and treatment with medicines
- be able to recommend literature/reference works/internet pages concerning the therapy in question
• DOCUMENTATION
Pharmacies shall
- document and follow up the quality and safety of dispensing, any discrepancies, notifications of defects and customer/patient complaints
- use quality-assuring IT support system when such are available within the pharmacies’ dispensing systems or document that equivalent quality is assured in other ways
REQUISITIONS FROM PROFESSIONAL END USERS
• CUSTOMER CONTACTS
Pharmacies shall
- be available for contact and give follow-up advice and counselling on medicines issues
- give advice and counselling about choice of medicines in respect of generally accepted therapy recommendations
• DOCUMENTATION
Pharmacies shall
- document and follow up the quality and safety of dispensing, any discrepancies, notifications of defects and complaints
GOODS
• STORAGE AND HANDLING
Pharmacies shall
- set targets for and document their capability and safety of supply
- receive and deal with the destruction of pharmaceutical waste and medicines returned from customers/patients
2. SELF-CARE
Self-care means the customer’s/patient’s measures to prevent and treat complaints and diseases, and to preserve good health – with or without the use of non-prescription medicines and health-related products.PHARMACY ACTIVITIES – PRINCIPLES FOR WORK
On the basis of customer/patient needs, pharmacies shall
- uncover the customer’s/patient’s needs and health-related problems through dialogue
- recommend self-care or refer to physicians or other health personnel
- give advice and counselling adapted and understandable to the customer/patient relating to the symptoms and other health-related needs presented
- give advice in accordance with generally accepted professional standards
-offer and sell non-prescription medicines and health-related products
- promote the customer’s/patient’s ability to prevent and treat complaints and diseases him- or herself – with or without medicines and health-related products
QUALITY REQUIREMENTS
• PREMISES
Pharmacies shall
- be designed, furnished and signposted so that customers/patients easily can orientate themselves in relation to important product groups
- hold relevant brochures and information material of a quality the pharmacy can vouch for. The material shall be easily accessible for the customer/patient.
- be designed to facilitate undisturbed conversation with the customer/patient
- have professional staff easily available
• INTERACTION WITH CUSTOMERS/PATIENTS
Pharmacies shall
- give advice and counselling through dialogue
- give advice and counselling about medicines and health-related products based on generally acknowledged therapy recommendations and professional evaluation
- actively use written information material when giving advice and counselling
- be able to recommend literature/reference works/internet pages concerning the therapy in question
• COMMODITIES
Pharmacies shall stock commodities
- that naturally can be combined with the pharmacies’ sale of medicines and other health-related products
- that are compatible with the pharmacies’ role as serious actors within the health service
- that have a quality and characteristics that correspond to the current standards for such products
- that are safe, secure and environmentally friendly
• PRODUCT EXPOSURE
Pharmacies shall
- locate medicines so that accepted therapy recommendations are reflected and other professional considerations are taken into account
- locate medicines and commodities so that they promote the customer’s/patient’s ability of making suitable choices
- locate medicines and potentially dangerous products suitably with regard to their availability to children
• MARKETING
The marketing and exposure of products and services of pharmacies shall
- contribute to the promotion of rational use of medicines
- reflect the fact that pharmacies are serious actors within the health service
3. RATIONAL PRESCRIBING AND USE OF MEDICINES
Pharmacies dispense and supply medicines to customers/patients on prescription and for self-care. The direct contact with users of medicines together with the contact with prescribers and other health personnel give pharmacies insight into the population’s use of medicines. The pharmacies are responsible for documenting and conveying this insight to the authorities and the rest of the health service. The contribution made by the pharmacies is important for an overall view of the population’s use of medicines.PHARMACY ACTIVITIES – PRINCIPLES FOR WORK
Activities aimed at the individual are dealt with under part 1 “Prescriptions and requisitions”.
Pharmacies shall
- actively evaluate and follow up the prescribing and use of medicines from a pharmaceutical point of view in order to achieve rational use of medicines by the population.
- work towards rational use of medicines through co-operation with prescribers
- offer pharmaceutical services to relevant customer/patient groups
- use suitable IT tools to monitor the prescribing and use of medicines
- convey statistical background material to authorities concerning the prescribing and use of medicines
- develop and participate in information programmes that promote rational use of medicines
- participate in the reporting of adverse drug reactions to the authorities
- participate in local and national campaigns/initiatives in co-operation with authorities, health services, relevant organizations, and user and patient groups
- participate in health-related economic and epidemiological studies
QUALITY REQUIREMENTS
• IN RELATION TO THE AUTHORITIES/COMMUNITY
Pharmacies shall
- document the dispensing in a way that contributes to an overall view of the population’s use of medicines
- convey experiences and observed trends in the area of medicines
- contribute to the co-ordination of patient-oriented information about medicines locally and nationally in co-operation with authorities, health services, relevant organizations, and customer and patient groups
• IN RELATION TO CUSTOMERS/PATIENTS AND PRESCRIBERS
Pharmacies shall
- base the pharmaceutical services and follow-up on generally accepted professional standards
- use suitable IT tools to assist in the discovery and documentation of drug-related problems
- offer prescribing profiles and prescription statistics to co-operating prescribers
- be able to pass on to prescribers information about new medicines, update information about medicines on the market and refer to sources for such information
4. PROMOTION OF HEALTH AND PREVENTION OF ILL-HEALTH
Promotion of health and prevention of ill-health are activities that make people able to gain better control over their health and to improve it. Pharmacies shall participate in health-promoting activities in co-operation with authorities, health services, relevant organizations, and customer and patient groups.PHARMACY ACTIVITIES – PRINCIPLES FOR WORK
Pharmacies shall
- contribute to ensuring that the population as far as possible avoids illness, and achieves and maintains good health
- contribute to the promotion of a healthy lifestyle through providing information about, among others, diet, exercise and various risk factors, such as use of tobacco and alcohol
- co-operate with authorities, the health service, relevant organization, customer and patient groups in national and local information campaigns and activities that promote public health
- offer advice, counselling and information within the public health area to individuals and groups
QUALITY REQUIREMENTS
The pharmacies’ activities shall
- be based on generally accepted professional grounds
- be based on public health targets
- be carried out in according to evaluated and quality-assured programmes (individual and group activities)
CONCLUSION
IMPLEMENTATION
The standards for pharmacy practice express quality requirements for the pharmacies’ activities towards customers/patients. The requirements constitute a common base for the pharmacies’ work with quality development. The quality requirements shall be reflected in the pharmacies’ customer/patient-related practice.
COMPETENCE
As health personnel, pharmacy employees have duties and rights laid down in laws and regulations.
The regulatory framework imposes requirements on competence and proper professional conduct. Pharmacies must have staff resources that make it possible to fulfil the requirements laid down in the regulatory framework and adopted quality standards. One precondition for achieving this is that the pharmacy staff systematically maintains and develops its competence.
DOCUMENTATION
Pharmacies shall document their operation and experiences. Such documentation is important for the follow-up, development and renewal of the pharmacies’ work towards the customers/patients and the community. The documentation shall also be used in the dialogue and co-operation with authorities and the health service.
REVIEW AND FOLLOW-UP
The regulatory framework sets requirements for internal control systems for pharmacies. These requirements must be co-ordinated with other quality requirements for pharmacies, and must be followed up through documented quality work.
By means of the quality work, the pharmacy trade shall identify quality problems and development areas.
The efforts shall constitute the basis for improvement. This will lead to continuous developments, both of local quality targets and the standards for pharmacy practice.
The pharmacy trade is responsible for following up and revising the standards.
Oslo, 7 April 2003
Norwegian Pharmacy Association
The Norwegian Association of Pharmacists
The Association of Pharmacy Technicians