The 1999 World Congress of Pharmacy and Pharmaceutical Sciences took place in Barcelona, Spain, from September 5 to 10. Our coverage continues with reports of decisions made by the International Pharmaceutical Federation council during the congress and of sessions on health promotion and pharmaceutical care
The council of the International Pharmaceutical Federation has approved statements on managing the risk of medication errors associated with prescribed medicines and on the detection and elimination of counterfeit medicines.
The statement on medication errors (see panel below) is a statement of professional standards. It sets out guidance on detecting, investigating and correcting errors and gives recommendations for prescribers, for manufacturers, for pharmacists and for health care organisations with the aim of minimising the risk of medication errors.
The statement on counterfeit medicines (see panel, p462) is a council policy statement which sets out the FIP’s support for international initiatives to combat counterfeiting, urges national administrations to take action on counterfeiting and commits the FIP to distributing information about counterfeiting problems and helping developing nations find ways of setting up systems for detecting and eliminating counterfeiting. The statement also sets out a range of obligations for national pharmacy organisations and for individual pharmacists.
Draft versions of the two statements were presented to the FIP council by its public policy committee at a meeting on September 5. They were then submitted for comment to the assembly of pharmacists and pharmaceutical scientists on September 8. Proposals made at the assembly were taken into account by the FIP public policy committee at a meeting on the same day, and final draft statements were adopted at a meeting of the council on September 10.
Medication errorsPresenting the draft statement on medication errors to the assembly of pharmacists and pharmaceutical scientists, Dr John Gans (United States) said that medication errors should be looked at as a systematic problem. The answer was not just to try to find someone on whom to place the blame. There was a need to introduce fail-safe systems, and the statement made it clear that the pharmacist should provide leadership in this. |
John Gans: pharmacists shoudl provide leadership in introducing fail-safe systems |
Dr Gans added that the statement was mainly directed towards the FIP’s ordinary members (which are principally national pharmaceutical organisations). The federation hoped that they would incorporate it into their own standards and report back on its success. The statement would also be communicated to the FIP’s international partners, such as the World Medical Association, the International Federation of Pharmaceutical Manufacturers Associations and the World Self Medication Organisation.
The statement on medication errors is reproduced in full in the panel below, apart from an appendix. The appendix gives a definition of medication error drawn up by the National Co-ordinating Council for Medication Error Reporting and Prevention in the United States, plus the same body’s medication error index, which classifies types of medication error on a scale ranging from Category A (no error occurred but there were circumstances or events that had the capacity to cause error) to Category I (an error occurred that resulted in patient death). During the assembly, a representative of the NCCMERP explained that the error categories were currently being revised.
Counterfeit medicinesPresenting the statement on counterfeit medicines to the assembly, the chairman of the public policy committee, Mr John Ferguson (United Kingdom), said that counterfeiting of medicines was a serious risk to public health. He pointed out that it was not only expensive medicines that were subject to counterfeiting: the top three countefeit drugs were long-established and well-used antibiotics. |
John Ferguson: counterfeiting of medicines presents a serious risk to public health |
Mr Ferguson said that the statement complemented recently published World Health Organisation guidelines for the development of measures to combat counterfeit medicines. They also complemented the FIP/IFPMA joint statement on "Ensuring the quality and safety of medicinal products to protect the patient” which was adopted at the 1998 FIP congress (PJ, September 12, 1998, p429).
The need for a statement on counterfeit medicines was also emphasised by the FIP president (Mr Peter Kielgast) at a press conference later in the week. He said that counterfeiters tended to target the world’s poorer and more vulnerable countries. A global fight was needed against this unscrupulous trade.
Policies aimed at managing risks are an important integral part of a framework of systematic quality assurance and improvement. Pharmacists must take the leadership role in seeking to prevent and eliminate medication errors by detecting, investigating and correcting any that occur. This statement should be regarded as complementary to the FIP Statement of Professional Standards in Pharmaceutical Care and should be used in conjunction with that Statement.
FIP acknowledges that the safe and appropriate use of medicines is an important aspect of optimising health care outcomes. Human errors are always a possibility in the delivery of health care. However, both the incidence and severity of errors can be reduced dramatically through the adoption of systematic approaches to error prevention. Medication errors can also be reduced when pharmacists have access to relevant patient records including information such as pregnancy, kidney failure, etc, which have implications for medication.
The principles of quality management as applied to medication error prevention should seek to improve the system within which an individual functions rather than to assign blame for an adverse outcome. Systematic quality assurance and continuous quality improvements establish the foundation to create a safer environment for patients to use medicines.
This document proposes a definition for medication error and, for countries where none is currently in use, a standard nomenclature categorising medication errors and their severity. These appear as an Appendix. The document also makes recommendations to members of the health care delivery system designed to improve safety in the manufacturing, ordering, labelling, dispensing, administration and use of medicines.
FIP encourages collaboration among industry, regulators, standard-setters, health care professionals and patients to design systems that minimise the likelihood of errors.
FIP will cooperate with other international bodies representing health professionals and international bodies which are concerned with patient safety on this important topic.
The FIP emphasises that illegibility of prescriptions has led to medication errors resulting in injuries to, or deaths of, patients. The FIP, therefore, makes the following recommendations to help minimise errors.
1. All prescriptions must be legible and in plain language. Prescribers, whenever possible, should adopt a direct, computerised, order entry system, recognising the need for care in product selection from any list. Pharmacists should be vigilant in relation to potential prescribing errors arising from computer use.
2. To guard against decimal point errors, a zero should always precede expression of less than one, and a terminal zero should never be used (eg, 0.5g, not 0.50g). Ten-fold errors in strength and/or dosage have occurred due to the use of a trailing zero or the absence of a leading zero.
3. Abbreviations for names of medicines (eg, HCTZ for hydrochlorothiazide), Latin abbreviations in directions for use (eg, bid for twice daily) and Roman numerals should be avoided.
4. Prescriptions should always include directions for use. Imprecise instructions such as "Take as directed” should not be used. Where appropriate, the intended duration of treatment should be stated.
5. Prescription orders should include a brief notation of purpose (eg, "for cough”). Notation of purpose can help ensure that the correct medicine is dispensed, create an extra safety check in the process of prescribing and dispensing a medicine and help to ensure proper use by the patient or person providing care. The FIP does recognise that, as an exception, some medicines and disease states may warrant maintaining confidentiality.
6. Prescribers should include the name, the age (preferably by stating date of birth) and, when appropriate, the weight of the patient. The age and weight of a patient help pharmacists who are dispensing medicines in their double check of the appropriate dose.
7. The prescription should include the name of the medicine, the dosage form, and the strength or concentration in the metric system, except for therapies that use standard units such as insulin, vitamins, etc. Units should be written in full and the units specified rather than writing an abbreviation such as a "U”.
The FIP encourages regular and systematic review of product labelling and packaging by regulatory authorities and manufacturers with a specific aim of minimising medication errors.
1. The packaging and labelling of prescribed medicines should be designed with a view to minimising errors in selection and use. To this end:
2. Machine-readable coding (eg, bar coding) should be employed on labelling of all medicines. The FIP recognises the importance of standardisation of these codes for this use.
3. Expiry dates should be in plain language, not coded and should be clearly indicated. The date of manufacture should not appear as this can cause confusion.
4. The batch number should be plainly indicated.
1. Pharmacists should use only properly labelled and stored medicinal products and labels should be read several times during the dispensing process or computer technology should be used to check the selection.
2. Pharmacists and other health care professionals involved in administering medicines should read the label when selecting or preparing the medicine, immediately prior to administering the medicine and when discarding the container or returning it to its storage location.
3. Pharmacists and other health care professionals should report, in confidence, actual and potential medication errors to the appropriate reporting programmes, details of which should be readily available to all health care professionals, for the purpose of securing improvements in the process.
4. Health care professionals should share error-related experiences, case studies, etc, with their colleagues through newsletters, journals, bulletin boards, and the internet.
5. Where calculations are necessary in the administration and/or dispensing of medicines, a double-check system should be incorporated.
6. Pharmacists should have written standard operating procedures for the dispensing and administration of medicines.
7. Pharmacists providing medicines should ensure that the patient or the person caring for the patient understands how the medicine should be used to ensure maximum therapeutic benefit and to avoid untoward effect or error in use of the medicine. Preferably this should be reinforced by a label attached in the pharmacy.
8. When national systems require repackaging of medicinal products, policies and procedures should be designed to minimise errors and as many as possible of the requirements in this document relating to labelling should be observed.
Organisations that provide health care (eg, hospitals, community pharmacies, nursing homes, etc) should establish systems to report, analyse and prevent medication errors. The same practice should be applied in community pharmacies. The organisations’ readers should foster a culture and systems that include the following key elements:
1. An environment which focuses on improvement of the process involving the use of medicines use process and systems for internal reporting of actual and potential errors should include strategies that encourage reporting.
2. Systematic approaches within the organisation to identify and evaluate actual and potential causes of errors.
3. Processes for taking appropriate action to prevent future errors through improving both systems and individual performance.
4. Education and training programmes should be provided for pharmacists and other health care professionals, technical support personnel, patients and those providing care for patients that address methods for reducing and preventing medication errors.
During the 1998 FIP congress, the Section of Laboratory and Medicines Control held a symposium on the dangers of counterfeit medicines. This followed the adoption of a resolution at the World Health Assembly in 1988 and international meetings co-sponsored by WHO and the International Federation of Pharmaceutical Manufacturers Associations.
The FIP is seriously concerned about the risk to public health represented by counterfeiting, particularly in countries where legislation governing the manufacture and distribution of medicines or the enforcement of legislation is ineffective.
Counterfeit medicines are difficult to detect. They can escape all controls and so contribute to the burden of substandard and fake medicinal products that are undermining the credibility of the public health services in many countries. Counterfeiting is attractive because relatively small quantities of counterfeit medicines can provide huge profits to the counterfeiter; and trading in them is seen to carry less risk than trafficking in the field of addictive drugs. Counterfeiting is undertaken for both long established and innovative medicines.
The key to the reduction in the availability of counterfeit medicines is the integrity of the manufacturing and distribution chain for medicines. Unfortunately, pressure on margins at the pharmacy and wholesaling levels can lead to purchases of medicines from outside the normal supply chain, increasing the risk of purchase of counterfeit medicines. This should be recognised by national authorities.
A separate joint FIP/IFPMA statement entitled "Ensuring the quality and safety of medicinal products to protect the patient” was adopted at the 1998 FIP congress. That statement emphasises the need for effective regulatory safeguards to ensure that the patient is protected from the hazards of poor quality, substandard and counterfeit medicines. This FIP policy statement on counterfeit medicines is complementary to the 1998 statement.
In this statement, counterfeiting in relation to medicinal products means the deliberate and fraudulent mislabelling with respect to the identity, composition and/or source of a finished medicinal product, or ingredient for the preparation of a medicinal product. Counterfeiting can apply to both branded and generic products and to traditional remedies. Counterfeit products may include products with the correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with fake packaging.
National organisations representing pharmacists should
Pharmacists in all fields of practice should