Executive Order On The Danish Medicines Agency's Electronic Registration Of Individual Citizens ' Medication Information

Original Language Title: Bekendtgørelse om Lægemiddelstyrelsens elektroniske registrering af de enkelte borgeres medicinoplysninger

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Overview (table of contents) Annex 1



Annex 2



Annex 3



Annex 4 The full text of the Executive order on the Danish Medicines Agency's electronic registration of individual citizens ' medication information

Under section 157, paragraphs 5, 7 and 10, as well as § 271, paragraph 4, in health law, see. lovbekendtgørelse nr. 913 of 13. July 2010, as amended by Act No. 1546 by 21. December 2010, fixed: § 1. The Danish Medicines Agency is responsible for operating an electronic registration of each citizen's medical information, including the prescription, purchase, supply, intake, dose modification, termination, health persons instructions about use of medications as well as information related to citizens ' medical information, see. health law § 157, paragraph 1.

(2). Information about individual citizens ' medical information, see. paragraph 1 shall be registered in the Danish Medicines Agency's prescription server, in the Danish Medicines Agency's register of personal electronic Medication profiles (medicine) and in The Common Medication card (FMK).

(3). The Danish Medicines Agency's electronic registration of individual citizens ' medication information contains information about the following types of drugs: 1) drugs prescribed on the prescription) medicines dispensed after 2 prescription for pharmacy, 3) medicines dispensed in hospital or hospital outpatient department, and 4) medicines dispensed by general practitioner, specialist physician and dentist in Prison institutions, on housing provision and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability and in ambulances , as well as 5) drugs, etc., are not prescribed on the prescription, as a citizen or a grantee health person with the consent of the citizen has reported in his medicine cabinet, see. § 25.

§ 2. The Danish Medicines Agency's registration of each citizen's electronic medical information contains information about individuals who 1) within the past 24 months have been prescribed medicines on prescription, 2) within the last 24 months has purchased or been provided with medicinal products on medical prescription at a pharmacy, 3) within the last 24 months has been provided with drugs at a hospital or hospital outpatient clinic, 4) within the past 24 months have been provided with medicines at a general practitioner specialist, doctor or dentist 5) within the past 24 months have been provided with medicines in the Prison institutions, residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability and in ambulances, 6) are subject to a doctor's or dentist's reporting of cave, see. paragraph 5, or 7) reported the information in his medicine cabinet, see. § 25.

(2). The Danish Medicines Agency's registration of each citizen's electronic drug information provides information about doctors and dentists ordination on the prescription of medicinal products to persons covered by paragraph 1, nr. 1, including sorting, grouping, and compression of the display of prescription prescriptions in order to show an up-to-date picture of the patient's ongoing drug prescriptions.

(3). The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information reported by pharmacists on the handling of medicinal products to persons covered by paragraph 1, nr. 2:1) Dispatch site P-number.

2) Dispatch number (applicable to the individual prescription) and prescription number (applicable to the individual prescription).

3) Ekspeditionstids point, see. section 17, paragraph 1.

4) the person's social security number or a unique identification number and date of birth, see. § 3.

5) Ekspedientens user identification.

6) the physician's or dentist's provider number or hospital department code.

7) physician's otherwise the dentist's autorisationsID.

8) item number and the quantity of that item number.

9) name of the medicinal product.

10) free text that is relevant in the context of expedition of the prescription and dispensing of the medicinal product.

11) Ordinationens dosing code.

12) Ordinationens dosing text.

13) Ordinationens indication code.

14) Ordinationens text indication.

15) Dispatch type.

16) Back row of expedition.

(4). The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information reported by the hospitals and hospital outpatient clinics for the extradition of drugs to persons covered by paragraph 1, nr. 3:1) Applier device ID.

2) Reporting time.

3) person's social security number or a unique identification number.

4) Drug ID.

5) Dose quantity and unit.

6) the time of commencement and termination of treatment with that drug ID.

(5). The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information reported by doctors and dentists about cave for persons covered by paragraph 1, nr. 6:1) the physician's or dentist's ID (autorisationsID or personal number).

2) person's social security number 3) Drug ID.

4) ATC-code level.

5) free text about the cave.

6) Reporting time.

7) Status for cave (active/inactive).

(6). The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information reported by hospital staff pharmacists and pharmaconomists about medication review or vote: 1) the pharmacist or farmakonomens ID (personal identification number).

2) the pharmacist or farmakonomens employment.

3) citizen's social security number.

4) free text that is relevant in relation to medication review or vote.

5) Reporting time.

6) evidence that the hospital management has authorized pharmacist or farmakonomen to the patient-and drug safety reasons to make medication review or vote.

(7). The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information reported by employees in the Prison institutions for delivery of medication to inmates: 1) the employee's ID (personal identification number).

2) the employee's employment.

3) citizen's social security number.

4) free text that is relevant in relation to the dispensing of medicine.

5) Reporting time.

(8). The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information about ambulance care providers with specific competences management of medical information or dispensing of medications: 1) Ambulance behandlerens ID (personal identification number) 2) Ambulance behandlerens employment.

3) citizen's social security number.

4) identification of drug-Drug ID.

5) Dose quantity and unit.

6) free text that is relevant in relation to the handling of medical information or dispensing of medications.

7) Reporting time.

(9). The Danish Medicines Agency registration of each citizen's electronic medical information must contain the following information about the staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, which after the delegation from a doctor, provide medication for citizens with reduced physical or mental functional ability: 1) the employee's ID (personal identification number).

2) the employee's employment.

3) citizen's social security number.

4) free text that is relevant in relation to the dispensing of medicine.

5) Reporting time.

Paragraph 10. The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information reported by the local government, including nursing homes, home nursing home sygeplejens comments on citizen's use of medicines: 1) the employee's ID (personal identification number).

2) the employee's employment.

3) citizen's social security number.

4) free text that is relevant in relation to the citizen's drug use.

5) Reporting time.

Paragraph 11. The Danish Medicines Agency's registration of each citizen's electronic medical information must contain the following information on the reporting of the individual citizen's medicine cabinet, see. (1). 7, and section 25:1) the citizen's social security number.

2) identification of the medicinal product-Drug ID/free text.

3) free text.

4) Reporting time.

5).

§ 3. If a person who is covered by the health care law, do not have a social security number, personal number is replaced with a unique identification number that is assigned automatically.

§ 4. The Danish Medicines Agency are conducting a logging of all uses and transfers of the information covered by this announcement. medication

§ 5. The following persons have access to enter information in the Danish Medicines Agency's registration of each citizen's electronic drug information: 1) doctors, dentists, midwives, nurses, health visitors, social and healthcare assistants and nursing home assistants, who have an individual in treatment, 2) hospital staff pharmacists or pharmaconomists, who after the designation of hospital management of patient and pharmaceutical safety reasons make medication review or vote, 3) staff in Prison establishments as part of their profession , provide medication to inmates, 4) ambulance practitioners with special competences as part of their profession in acute situations, handles medical information or give out medicine to patients, 5) staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, as part of their profession after a delegation from the citizen's doctor, provide medicine to a citizen,
6) pharmacists and pharmacy staff who, in the course of processing a prescription has access to the registered information, 7) the data subject himself and 8) the Danish Medicines Agency.

Access to the register



§ 6. A doctor has access to in § 2, paragraph 2-7, referred to information for patients, as the doctor currently in treatment, when it is necessary for the treatment of individual patients. General practitioners may also use the register to find own patients being treated inappropriately with medicines. Specialist practitioners may also use the register to find patients who special doctor has prescribed one or more medicinal products and which are treated inappropriately with medicines. Such information may only be used in order to ensure the quality, safety and efficacy of the medicine's use of medicines. The doctor can delegate access rights to his assistant.

(2). A doctor has electronic access to an overview of which persons have access as an Assistant for the doctor, as well as what actions assistants have made.

(3). A doctor can transfer referred to in § 2, paragraph 2-11, referred to information about patients, which the doctor currently in treatment for his local patient record system for the purpose of updating patient records. The doctor organises the transfer so as to ensure that the doctor has access to updated information in the patient records, when the information is used for the treatment of the patient.

(4). The Danish Medicines Agency can stop the transmission of information pursuant to section 6, paragraph 3, if the agency determines that the recipient systems do not meet data protection requirements applicable at any time.

§ 7. A dentist, a midwife, a nurse, a health care professional, a health and social care assistant and a nursing home clerk, has access to those listed in section 2, paragraph 2-11, referred to information for patients, as the dentist, midwife, nurse, health visitor, social-and sundhedsassistenten and plejehjemsassistenten currently have in treatment when it is necessary for the treatment of individual patients. Such information may only be used in order to ensure the quality, safety and efficacy of the medicine's use of medicines. The dentist, midwife, nurse, health visitor and public health and social sundhedsassistenten may delegate his or her access rights to his assistant.

(2). A dentist, a midwife, a nurse, a health care professional and a social-and healthcare Assistant have electronic access to a list of the persons who have access as an Assistant for the health care professional, as well as what actions assistants have made.

(3). A dentist, a midwife, a nurse, a health care professional, a health and social care assistant and a nursing home Assistant can transfer referred to in § 2, paragraph 2-11, referred to information about patients, dentist, midwife, nurse, health visitor, social-and sundhedsassistenten and plejehjemsassistenten currently in treatment for his local patient record system for the purpose of updating patient records. The transfer must be organised in such a way as to ensure that the dentist, midwife, nurse, health visitor, social-and sundhedsassistenten and plejehjemsassistenten have access to updated information in the patient records, when the information is used for the treatment of the patient.

(4). The Danish Medicines Agency can stop the transmission of information pursuant to section 7, paragraph 3, if the agency determines that the recipient systems do not meet data protection requirements applicable at any time.

§ 8. Pharmacists and pharmacy staff have access to in § 2, paragraph 2, referred to information registered about ordinations when access is required for the expedition of a prescription.

(2). Pharmacists and pharmacy staff have access to in § 2, paragraph 3-11, referred to information when medicine user has given explicit consent, and access is appropriate in relation to the instructions of the relevant medication use. Such information may only be used in order to ensure the quality, safety and efficacy of the medicine's use of medicines.

(3). By explicit consent shall mean any freely given specific and informed assertion, whereby medicine user agrees that the information related to him, be the subject of treatment. Consent may be withdrawn at any time.

(4). Pharmacists and pharmacy staff can transfer referred to in § 2, paragraph 2, referred to information to pharmacies system in connection with the expedition of a prescription on the prescription of a medicinal product.

(5). The Danish Medicines Agency can stop the transmission of information pursuant to section 8 (4) if the Agency assess that the received systems do not meet data protection requirements in force at the time.

§ 9. Hospital staff pharmacists and pharmaconomists, who after the designation of hospital management of patient and pharmaceutical safety reasons make medication review or vote, has access to those in article 2, paragraph 2-11 information referred to, when access is necessary for the person's treatment of the patient. Such information may only be used in order to ensure the quality, safety and efficacy of the medicine's use of medicines.

(2). A hospital employee pharmacist or business consultant, see. (1) can transfer referred to in § 2, paragraph 2-11, referred to information about patients, as the question currently in treatment for his local patient record system for the purpose of updating patient records. The transfer must be organised in such a way as to ensure that the person concerned has access to updated information in the patient records, when the information is to be used for medication review or vote in relation to the individual patient.

(3). The Danish Medicines Agency can stop the transmission of information pursuant to section 9, paragraph 2, if the agency determines that the received systems do not meet data protection requirements applicable at any time.

§ 10. Staff in Prison establishments as part of their occupation provide medication to inmates have access to in § 2, paragraph 2-11 information referred to, when access is necessary for the person's treatment or care of the patient. Such information may only be used in order to ensure the quality, safety and efficacy of the medicine's use of medicines.

(2). An employee of the Probation, see. (1) can transfer referred to in § 2, paragraph 2-11, referred to information about patients, as the question currently in treatment for his local patient record system for the purpose of updating patient records. The transfer must be organised in such a way as to ensure that the person concerned has access to updated information in the patient records, when the information is used for the treatment or care of the patient.

(3). The Danish Medicines Agency can stop the transmission of information pursuant to section 10, paragraph 2, if the agency determines that the received systems do not meet data protection requirements applicable at any time.

§ 11. Ambulance practitioners with special competences as part of their profession in acute situations handles medical information or give out medicine to patients, have access to those listed in section 2, paragraph 2-11 information referred to, when access is necessary for the person's treatment or care of the patient. Such information may only be used in order to ensure the quality, safety and efficacy of the medicine's use of medicines in an emergency situation.

(2). An ambulance treats with special skills, see. (1) can transfer referred to in § 2, paragraph 2-11, referred to information about patients, as the question currently in treatment for his local patient record system for the purpose of updating patient records.

(3). The Danish Medicines Agency can stop the transmission of information pursuant to section 11, paragraph 2, if the agency determines that the received systems do not meet data protection requirements applicable at any time.

§ 12. Staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, as part of their profession after a delegation from the citizen's doctor, provide medicine to a citizen, has access to those listed in section 2, paragraph 2-11 information referred to, when access is necessary for the person's treatment or care of the citizen. Such information may only be used in order to ensure the quality, safety and efficacy of the medicine's use of medicines.

(2). An employee at a residential housing and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, see. (1) can transfer referred to in § 2, paragraph 2-11, referred to information on citizens, which it currently in treatment for his local patient record system for the purpose of updating patient records.

(3). The Danish Medicines Agency can stop the transmission of information under article 12, paragraph 2, if the agency determines that the received systems do not meet data protection requirements applicable at any time.

§ 13. The data subject shall have direct electronic access to those listed in section 2, paragraph 2-11, referred to information that is recorded about him or her and for a log of accesses to the registered information of others without prejudice. § 4.
§ 14. The Danish Medicines Agency and any operator on behalf of the Danish Medicines Agency leads the Danish Medicines Agency's registration of each citizen's electronic medical information, have access to the registered information, when this is required by operating technical reasons or consequences of the Danish Medicines Agency's obligations, etc. as the data responsible. Information may only be used for the purpose of securing the operation and the data quality of register, see. However, paragraphs 2 to 4.

(2). The Danish Medicines Agency have access to the registered information, when it is necessary for the use of the Agency's treatment of adverse reaction reports, see. health law § 157, paragraph 8, 1. PT.

(3). The Danish Medicines Agency has access to find statistical information on drug consumption in the recorded information in so far as this information is not available via the Danish Medicines Agency register of medicinal product statistics, see. health law § 157, paragraph 8, 2. PT.

(4). The Danish Medicines Agency may disclose information about individual citizens ' electronic medication information about prescribed and delivered vaccines to the Danish Vaccination register for the purposes of the registration of the vaccination status of individual citizens.

(5). The Danish Medicines Agency continuously monitors that the registered information is updated correctly with the information referred to in article 6. § 5, reported by from doctors, dentists, midwives, nurses, health visitors, social and healthcare assistants, nursing home assistants, hospital staff pharmacists and pharmaconomists, employees in probation, ambulance professionals with special skills, pharmacy, staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, medicine users as well as hospitals and outpatient clinics.

(6). The Danish Medicines Agency ensures continuous, that information is deleted in accordance with § 27.

(7). The Danish Medicines Agency verifies that the pharmacies, doctors and dentists, including at hospitals and hospital outpatient clinics, the municipal home nursing, including nursing homes, hospital staff pharmacists and pharmaconomists, employees in Probation, ambulance practitioners with special competences as well as employees of residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, shall report in accordance with the rules set out in sections 17 to 24.

§ 15. The health protection agency has access to solicit those in article 2, paragraphs 2 to 4, said information from the Danish Medicines Agency, when it is necessary for the supervision of doctors and dentists prescribing addictive drugs and antipsychotics, or if there is a need to view the full ordination image as part of the professional assessment of the appropriateness of a prescription of addictive drugs and antipsychotics, and circumstances not uncovered enough information as the health protection agency is already in possession of the basic regulation. law on pharmacies business § 11 (4).

§ 16. No addition to the sections 6-15 referred to persons and authorities have access to the information contained in the Danish Medicines Agency's registration of each citizen's electronic medical information.

Reporting to the register



§ 17. Pharmacies are obliged to report to in § 2, paragraph 3, the information referred to at the time when the pharmacist shall supply or submit the drug to the drug user.

(2). Pharmacies are obliged to report to in § 2, paragraph 2, the information referred to at the time when the pharmacist handle the prescription, if the information is evidenced by a paper-, phone-or fax prescription.

(3). The pharmacist shall, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic medical information, make the necessary corrections or refer the person to the reporter or the Danish Medicines Agency in cases where the pharmacist does not have the necessary access to make corrections. The Pharmacy has only the ability to edit any information, which the pharmacy itself has reported.

(4). Apoteket's reporting to the Danish Medicines Agency's registration of citizens ' electronic medical information must be in accordance with the technical specifications laid down in annex 1.

§ 18. A doctor or dentist at a hospital or outpatient clinic are obliged to report in section 2, paragraph 4, the information referred to at the latest at the time the drug user is printed from the hospital or after completion of each hospital ambulatory visits.

(2). A doctor or dentist at a hospital or outpatient clinic shall, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic medical information, make the necessary corrections or refer the person to the reporter or the Danish Medicines Agency in cases where the doctor or dentist at the hospital or hospital outpatient departments do not even have the necessary access to make corrections. Doctor or dentist at the hospital or hospital outpatient departments have only the ability to edit any information, which the doctor or dentist at the hospital or hospital outpatient departments themselves have reported.

(3). The doctor's or dentist's reporting to the Danish Medicines Agency's registration of each citizen's electronic medical information must be in accordance with the technical specifications laid down in annex 2.

§ 19. A doctor or a dentist shall report in section 2, paragraph 2, the information referred to, when the doctor or the dentist making out an electronic prescription.

(2). A doctor or dentist can report referred to in section 2, paragraph 6, referred to information (cave) as well as any amendments thereto.

(3). A doctor or dentist must, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic medical information, make the necessary corrections or refer the person to the reporter or the Danish Medicines Agency in cases where the doctor or dentist does not even have the necessary access to make corrections. A doctor or dentist has only the ability to edit any information, which the doctor or the dentist even has reported.

(4). The doctor's or dentist's reporting to the Danish Medicines Agency's registration of each citizen's electronic medical information must be in accordance with the notice, see in prescription Executive Order No. 155 of 20. February 2007 and its subsequent amendments laid down requirements for writing electronic prescriptions.

§ 20. The municipal home nursing, including nursing homes, the report referred to in section 2, paragraph 10 referred to information as well as any amendments thereto.

(2). The municipal home nursing, including nursing homes, must, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic drug information, make the necessary corrections or refer the person to the Danish Medicines Agency in cases where the municipal home nursing, including nursing homes, do not even have the necessary access to make corrections. The municipal home nursing, including nursing homes, has only the ability to edit any information, such as district nursing, including nursing home, even has reported.

§ 21. Hospital staff pharmacists and pharmaconomists, who after the designation of hospital management of patient and pharmaceutical safety reasons make medication review or vote, they can report in section 2, paragraph 6, referred to information, as well as any amendments thereto.

(2). Hospital staff pharmacists and pharmaconomists, see. paragraph 1 of this article, shall, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic drug information, make the necessary corrections or refer the person to the Danish Medicines Agency in cases where the hospital staff pharmacist and business consultant, does not even have the necessary access to make corrections. Hospital staff pharmacists and pharmaconomists has only the ability to edit any information, as the question itself has reported.

§ 22. Employees in Probation, as part of their occupation handle medical information or provide medication to inmates, they can report in section 2, paragraph 7, referred to information as well as any amendments thereto.

(2). Employees in Probation, see. paragraph 1 of this article, shall, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic drug information, make the necessary corrections or refer the person to the Danish Medicines Agency in cases where the employees of the Probation does not even have the necessary access to make corrections. Employees of Probation has only the ability to edit any information, as the question itself has reported.

§ 23. Ambulance practitioners with special competences as part of their occupation handle medical information or provide medication in acute situations, they can report in section 2, paragraph 8 referred to information as well as any amendments thereto.

(2). Ambulance professionals with special skills, see. paragraph 1 of this article, shall, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic drug information, make the necessary corrections or refer the person to the Danish Medicines Agency in cases where ambulance care provider does not have the necessary access to make corrections. Ambulance professionals with special skills have only the ability to edit any information, as the question itself has reported.
§ 24. Staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, as part of their profession after a delegation from the citizen's doctor, provide medicine to a citizen, they can report in section 2, paragraph 9 referred to information as well as any amendments thereto.

(2). Staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, see. paragraph 1 of this article, shall, at the request of people who have found errors in information about a private person in the Danish Medicines Agency's registration of each citizen's electronic drug information, make the necessary corrections or refer the person to the Danish Medicines Agency in cases where the staff member on botilbuddet and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, do not even have the necessary access to make corrections. Staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, have only the ability to edit any information, as the question itself has reported.

§ 25. Drug user, or the person concerned shall designate for this purpose can report in section 2, paragraph 11 referred to information (medicine cabinet). At the medicine cabinet "means the part of the register, in which the individual citizen can make reporting of medicine purchases that are not prescribed on the prescription.

(2). The user can at any time delete medicine carried reports.

Correlation, deletion, etc.



section 26. Information in the Agency's electronic registration of citizens ' medical information may not be cross-referenced with information in other public or private registers than those provided for in §§ 6-15 mentioned patient record systems.

§ 27. Information about medicine's social security number be erased 2 years after medication the user has died.

(2). Information registered in accordance with article 2, paragraph 5 (cave), and § 2, paragraph 11 (medicine cabinet), should be deleted at the latest 2 years after the medicine the user has died.

(3). Information registered in accordance with section 4 (retention), must be erased 2 years after they are registered at the Danish Medicines Agency electronic registration of citizens ' electronic medication information.

(4). Other information in the Danish Medicines Agency's electronic registration of citizens ' medical information than those referred to in paragraphs 1 to 3, mentioned, must be erased 2 years after registration.

section 28. Unless a higher penalty is inflicted for other legislation, is punishable by a fine: 1) it wrongly collect, disclose or exploit information in the Danish Medicines Agency's electronic registration of citizens ' medical information in accordance with § § 6-12 and 14-15, 2) pharmacists who fail to report information to the Danish Medicines Agency's electronic registration of citizens ' medical information under section 17, paragraph 1, 3) pharmacists who fail to correct the misrepresentations in the Danish Medicines Agency's electronic registration of citizens ' medical information under section 17 (3), (4)) a physician or dentist at a hospital or outpatient clinic who fail to report information to the Danish Medicines Agency's electronic registration of citizens ' medical information under section 18, paragraph 1, 5) a physician or dentist at a hospital or outpatient clinic that fails to correct the misrepresentations in the Danish Medicines Agency's electronic registration of citizens ' medical information under section 18, paragraph 2, 6) a physician or dentist who fails to correct misrepresentations of the Danish Medicines Agency electronic registration of citizens ' medical information pursuant to section 19 (3) and 7) the municipal home nursing, including nursing homes that fail to correct the misrepresentations in the Danish Medicines Agency's electronic registration of citizens ' medical information pursuant to section 20 (2).

8) hospital staff pharmacists and pharmaconomists who fail to correct the misrepresentations in the Danish Medicines Agency's electronic registration of citizens ' medical information under section 21 (2).

9) employees in Probation who fail to correct the misrepresentations in the Danish Medicines Agency's electronic registration of citizens ' medical information pursuant to section 22, paragraph 2.

10) ambulance practitioners with special skills who fail to correct the misrepresentations in the Danish Medicines Agency's electronic registration of citizens ' medical information under section 23, paragraph 2.

11) staff at residential facilities and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental functional ability, who fail to correct the misrepresentations in the Danish Medicines Agency's electronic registration of citizens ' medical information under section 24, paragraph 2.

(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.

Date of entry into force of



section 29. The notice shall enter into force on 16 September. May 2011.

(2). Executive Order No. 990 by 2. October 2006 on the Danish Medicines Agency's register of personal electronic Medication profiles (PEM) is repealed.

Ministry of the Interior and health, the 11. May 2011 Bertel Haarder/Dorthe Eberhardt Søndergaard



Annex 1 Field Summary: reporting to the pharmacists ' Medication profile Nr.





Description





Type/length





Typical value quantities/

Validation/Comments







1.





Person number





Text string of 10 characters





Person number







2.





Identification number





Text string of 10 characters





Unique identification number for persons without a social security number.







3.





Date of birth if the identification number





Date





YYYY-MM-DD







4.





The dispatch site P-number





10 integer between 0 and 9



 





5.





Dispatch number





Numeric value





between 0 and 999,999,999,999







6.





Prescription number





N2

Numeric value





between 0 and 999,999,999,999,999







7.





Pharmacy-timestamp





N14 national road

The date and time





Date and time of delivery, expressed in the form

YYYY-MM-DDTHH: MM: SS

Example:

1999-05-31T13:20:00

read: 31. May 1999 23:00. 13.20







8.





Ekspedientens user identification





An8

Text string at 1-10 characters





Field is filled in with the user ID of the person who carries out the function, resulting in the reporting of the transaction.







9.





Provider number or hospital department code





Text string at 1-17 characters





The field may be filled in, in different ways, with an outer number replacement code or hospital/department code.







10.





Authorization-

identifier





Text line on 1-8 characters





The doctor's and dentist's approval number







11.
Item number





Numeric value





The item number of the sold item = item number for drug statistics.

From 1 to 999,999







12.





Number of packages





Integer, minimum 1





If the alert relates to the dose dispensing, please fill in number of packages with the number of units.







13.





Free text that is relevant in the context of expedition of the prescription and dispensing of the medicinal product





Text string in maximum 245 characters



 





14.





Dosing code





Text string at 1-8 characters





The program fills in this field with the code for dosage, when this is shown by the prescription.







15.





Dosing text from electronic prescription





Text string on 1-70 characters



 





16.





Indication code





Text string at 1-17 characters





The program fills in this field with the code for indication when this is shown by the prescription.







17.





Indication of text from electronic prescription





Text string on 1-70 characters



 





18.





Dispatch type





Text string 2 characters





Field is filled in with the dispatch type corresponding to the dispatch type, as transmitted to the pharmacy medicinal product statistics













Annex 2 Field Overview: technical hospital and ambulatoriers hospital reporting to the medicine profile Nr.





Description





Type/length

N = Numeric

An = Alphanumeric





Typical value quantities/

Validation/Comments







1.





Person number





N10





Social security number of the person reporting concerns.

Be specified without hyphen.







2.





SKS code for reporting device





AN20





Code for the Hospital Department alert originated.







3.





Pull-out time





N14 national road





The time the information is calculated in an EHR System.

YYYYMMDDTTMMSS







4.





Directed from ID



 



By modifying an existing alert set ID for the alert that must be corrected.

Otherwise empty.







5.





Drug IDENTIFIER





N11





Identification of the medicinal product, notification addresses.







6.





Total dose quantity





N20





Amount of the drug the patient has received.







7.





Dosage unit





AN10





Device as the total quantity is specified in the dose.







8.





Start of treatment





N14 national road





The start time.

YYYYMMDDTTMMSS







9.





End of treatment





N14 national road





The end time

YYYYMMDDTTMMSS







10.





Identification number





N10





Identification number under which the previously reported.

xLLLnnnnnn, where x is 4, LLL a country code and a serial number nnnnnn. The identification number is the modulus-11 correctly.







11.





SKS code for reporting device





AN20





Code for the hospital department that wants to change the identification number for a personal identity number.













Annex 3 viewing information about reported cave Nr.





Description



 

 





1.





Indberetters name and organization



 

 





2.





Date of transmission



 

 





3.





Medicinal product



 

 





4.





ATC code and text for drug



 

 





5.





Reaction



 

 





6.





Description



 

 





7.





Date of deletion



 

 





8.





Name and organization that has deleted
 

 











Annex 4 display of information in the citizen's medicine cabinet Nr.





Description



 

 





1.





Date



 

 





2.





Product name, form and strength



 

 





3.





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