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Formularium

 
 
 
 
 

MANUAL 
CARIBBEAN NETHERLANDS 
FORMULARY 
NO RIGHTS CAN BE DERIVED FROM THIS MANUAL.
CONTENTS 


FOREWORD
In accordance with article 1.6.1 subsection 1a of the BES Healthcare Insurance Claims Regulation,
the pharmaceutical care encompasses handing of or advice and guidance as pharmacists normally
provide for medication evaluation and responsible use of medications, included in a formulary to be established by the BES Healthcare Insurance Office. Based on this article the “Formularium Caribisch Nederland” or Caribbean Netherlands Formulary (FCN) has been developed. The principle in the development thereof is the quest for a responsible use of medication. When evaluating the inclusion of medications in the FCN the emphasis lies on the therapeutic value and effectiveness. The medication evaluations by the ‘Commissie Farmaceutische Hulp’ or Committee for the Reimbursement of Medicines (CFH) are the basis for the FCN. The CFH consisting of twenty external experts gives the ‘College van Zorgverzekeringen’ (CvZ) or Healthcare Insurance Board advice on the medications to be reimbursed in the Netherlands. The CFH recommendations are In addition the experience of local pharmacists on Bonaire, St. Eustatius and Saba was used, who frequently gave comments and observations and recommendations to the BES Healthcare Insurance Office during the creation of the FCN, for which the Healthcare Insurance Office expresses its gratitude. Despite the effort of the BES Healthcare Insurance Office towards completeness, there may still be drugs that have not been included in the FCN while these do qualify for reimbursement. Therefore, the BES Healthcare Insurance Office recommends, in case of doubt, to always consult the CFH advice concerning the drug on the website and to act in accordance with this advice. The logical consequence of this is that the FCN is not a static list but a list that is subject to change. Furthermore, the BES Healthcare Insurance Office would like to emphasize that the FCN is a formulary for the so-called “external pharmacies” and not for the hospital pharmacies. For hospital pharmacies is it applicable that they can carry a wider range of medications. The BES Healthcare Insurance Office hopes that the FCN will serve as a basis for a responsible use of medications by the insured of the BES Healthcare Insurance Office on the islands of Bonaire, St. Eustatius and Saba.
I INLEIDING
THE FCN consists of four lists, namely:
2. the FCN on therapeutic value; 3. a list of nutritional supplements, and 4. a list of Over-The-Counter (OTC) products. The medicines on the first two lists are generally reimbursed, although that maybe subject to conditions. If the latter is the case, reference is made to the CFH advice on the website . The list of nutritional supplements gives about eleven food supplements and about five special baby foods that qualify for reimbursement subject to conditions, namely if the insured suffers 2. a severe food allergy; 3. a severe resorption disorder, or; 4. a severe disease related malnutrition or risk thereof, determined via a validated screening Finally, there is the list of OTC products. The drugs on this list do not qualify for reimbursement with the exception of two medicines that are covered in case of chronic use. The following chapters address successively the lists, the quantities, the legal basis and the possible procedures for adjustment of the package including the medications. 1 BES Healthcare Insurance Claims Regulation article 1.6.1, subsection 1 b. 2 These are Cetirizine and Loratadine. See CFH advice on www.fk.cvz.nl. FORMULARY CARIBBEAN NETHERLANDS
Article 1.6.1, subsection 2 of the BES Healthcare Insurance Claims Regulation states that the a. medications of which the application does not serve a rational therapy; b. medications that can be replaced by an equivalent, but less expensive medication;c. medications in case of risk of disease when traveling; i. the insured is younger than twenty one years; ii. the medication serves to treat endometriosis, or; iii. the medication serves to treat menorrhagia involving anemia holding a hemoglobin value lower than the reference values used in the guidelines of the respective professions. e. medications that are available without prescription.
The FCN in alphabetical order is the list of medications reimbursed by the BES Healthcare Insurance Office in alphabetical order. The list consists of the following columns: : quantity of substance name/substance names; : mcg, mg, g, ml, dosis, percentage (%) oe IE; : for example ampoule, tablet, dispersion, and etc.; : the Anatomical Therapeutic Chemical Classification and; : Basic Formulary, Conditions. See CFH advice, Not Included in the GVS (Medicine Reimbursement) system, ‘Not registered in the Netherlands’ and ‘OTC, with the exception of With regard to the columns, the classification under the List-column is of importance whether a medication is reimbursed or not. If the classification indicated is: - ‘Basic Formulary’, then the medication is reimbursed; - ‘Conditions. See CFH advice’, then the medication is reimbursed subject to certain general it is applicable that for this category of medications there must be a certain syndrome and that the medication must be prescribed by a specialist; - ‘Not included in the GVS system’, then that means that, the therapeutic effect and effectiveness of the medication have not (yet) been assessed by the CvZ. This category of medications qualifies for reimbursement by the BES Healthcare Insurance Office until further notice. - ‘Not registered in the Netherlands’, then that means that the medication is not accepted in the Netherlands. If the drug is listed in the FCB and was listed as a drug prior to January 1, 3 Article 1.6.1, subsection 2b forms the legal basis for the use of for example generic drugs. 4 Article 1.6.1, subsection 2e forms the legal basis for the exclusion of reimbursement of OTC drugs. 5 There are 14 applications of 12 medications that fall under the classification ‘No included in the GVS system’. 2011 in the drug registry of the former Netherlands Antilles, than the drug is reimbursed by the BES Healthcare Insurance Office based on transitional law until the registration term of the drug expires (up to 5 years after December 31, 2010) 6; ‘OTC, with the exception of chronic use.’, then that means that the respective medications are only reimbursed in case of chronic use. The principal rule is that if a medication is not listed on the FCN, the medication in question is not reimbursed. There are three exceptions to this basic rule: 1. If the insured demonstrably, that means by a recently taken allergy test can demonstrate that the insured has an allergy for the respective medication; 2. Epileptics can keep on using the medications against epilepsy that they used before 3. Patients who suffer from pulmonary hypertension can, if they have demonstrably been using the medication Viagra for more than 1 year, keep on using the medication. For pharmacy preparations reference is made to the advice of the CFH (see 6 There are 57 applications f 35 medications that fall under the classification: “Not registered in the Netherlands’. III QUANTITIES

In the BES Healthcare Insurance Claims Regulation additional guidelines are set for the
prescription practices regarding the pharmaceutical care.
2. Per prescription the insured is entitled to medications for a period of up to: a. one year if it concerns oral contraceptives; b. three months if these are drugs for the treatment of a chronic disease, with the exception c. fifteen days if these are drugs to fight acute conditions with antibiotics or chemo 3. In contravention to the second subsection, the insured put on medication that is new to him, is entitled to delivery of medications during a period of fifteen days. 4. The second and third subsections are not applicable to the extent that longer periods have been agreed upon in a protocol agreed upon between the respective care provider and the As of January 1, 2011, based on article 5 of the BES Decree on the Reimbursement of Medicine Expenses an implementation rule regarding the prescription practices has been established by the Head BES Healthcare Insurance Office in contravention to article 1.6.2, subsection 2 of the BES Healthcare Insurance Claims Regulation and in the absence of a protocol as described in subsection 4 of article 1.6.2 of the BES Healthcare Insurance Claims Regulation. The implementation rule of January 1, 2011 nr. 4 authorizes the provision of medicines by a doctor, dentist or obstetrician for a longer period than determined in article 1.6.2, subsection 2 of BES Healthcare Insurance Claims Regulation, subject to the conditions that: - the prescribing doctor, dentist or obstetrician record and motivate in his (patient) administration on what grounds he/she is of the opinion that the provision of medicines is indicated for a - the prescribing doctor, dentist or obstetrician inform the BES Healthcare Insurance Office with regard to which insured the decision was made to provide medication for a longer period while mentioning medication and period, and; - the prescribing doctor, dentist or obstetrician upon request cooperates with the evaluation of his decision by or on behalf of the BES Healthcare Insurance Office. If upon subsequent review it is determined that the need for the provision of the medication for a longer period was not present, the BES Healthcare Insurance Office can decide to withdraw this approval for the respective care provider. The following is a list of dosage forms of medications, arranged alphabetically in the first column, followed – in the second column- by the maximum quantity per prescription that qualifies for 7 Article 1.6.2, subsection 2, subsection 3 and subsection 4 of the BES Healthcare Insurance Claims Regulation. 8 Implementation rule of January 1, 2011, nr. 4 Extended provision of medications. This list is not strictly applicable to patients who are staying in a nursing home or care homes. DOSAGE FORM
MAXIMUM QUANTITY
Ampoules (with the exception of. Recormon – for use for 1 Cream, gel, liniment and ointment for the skin Inhalation preparations - inhalers (for asthma and COPD) Shampoo (among others tar shampoo for psoriasis) When prescribing flasks and/or tubes without specification, the smallest size will be reimbursed. The following list includes a number of specific medications of which the maximum quantity to be delivered is an exception to the abovementioned general list of dosage forms. These medications are arranged alphabetically in the first column, followed by the dosage form and in the last column mention of the maximum quantity per prescription that qualifies for reimbursement. SUBSTANCE NAME
DOSAGE FORM
MAXIMUM QUANTITY
The following is a list of bandages and aids, arranged alphabetically in the first column followed by mention of the maximum quantity per prescription that qualifies for reimbursement. This list is not strictly applicable to patients who are staying in a nursing home or care homes. BANDAGES AND AIDS
MAXIMUM QUANTITY
Hydrophile bandages; all sizes (4-6-8-10 cm.)
BES Healthcare Insurance Decree

In accordance with article 6 subsection 1f of the BES Healthcare Insurance Decree, the insured are entitled to pharmaceutical care as provision of medical care. This claim is further detailed in paragraph 6 Pharmaceutical care of the BES Healthcare Insurance Claims Regulation based on the BES Healthcare Insurance Decree.

BES Healthcare Insurance Claims Regulation

Subsection 1 of article 1.6.1 of the BES Healthcare Insurance Claims Regulation states:
Pharmaceutical care includes the following:
a. handing of or advice and guidance such as pharmacists, established on the BES-islands, are used to provide for medication evaluation and responsible use of medication, listed on a formulary to be determined by the BES Healthcare Insurance Office. b. polymer, oligomer, monomer and modular dietary preparation if the insured cannot manage with adjusted standard nutrition and other products of special nutrition, and if the insured suffers from a: 1º. severe metabolic disorder; 2º. severe food allergy; 3º. severe resorption disorder, or; 4º. severe disease related malnutrition or risk thereof, determined via a validated screening instrument. Subsection 2 of article 1.6.1 of the BES Healthcare Insurance Claims Regulation states: a. medications of which the application does not serve a rational therapy; b. medications that can be replaced by an equivalent but less expensive medication; c. medications in case of risk of disease when traveling; 1º. the insured is younger that twenty one years, 2º. the medication serves to treat endometriosis, or 3º. The medication serves to treat menorrhagia involving anemia, holding a hemoglobin value lower that the reference values used in the guidelines of the respective professions; e. medications that are available without prescription. In article 1.6.2 of the BES Healthcare Insurance Claims Regulation additional guidelines are set for the prescription practices regarding the pharmaceutical care: 1. The insured only is entitled to pharmaceutical care if the care is prescribed by a doctor, dentist or obstetrician whose care the insured sought through this regulation. 2. Per prescription the insured is entitled to medications for a period of up to: a. one year in case of oral contraceptives; b. three months in case of medications for the treatment of a chronic condition, with the c. fifteen days in case of medications to fight acute conditions with antibiotics or 3. In contravention to the first subsection the insured put on medication that is new to him, is entitled to delivery of medications for a period of fifteen days. 4. The second and third subsections are not applicable to the extent that longer periods have been agreed upon in a protocol agreed upon between the respective care provider and the
Implementation rule of January 1, 2011 nr. 4

As of January 1, 2011, based on article 5 of the BES Decree on the Reimbursement of Medicine
Expenses an implementation rule regarding the prescription practices has been established by the
Head BES Healthcare Insurance Office in contravention to article 1.6.2, subsection 2 of the BES Healthcare Insurance Claims Regulation and in the absence of a protocol as described in subsection 4 of article 1.6.2 of the BES Healthcare Insurance Claims Regulation. The Implementation Rule of January 1, 2011 nr. 4 reads:
Implementation rule of January 1, 2011, nr. 4
Subject: authorization for providing medications for a period longer than determined in
article 1.6.2, subsection 2 of the Regulation


1. Introduction
Based on article 1.6.2, second subsection of the BES Claims Regulation the doctor, dentist or obstetrician can prescribe medications for a maximum period. Article 1.6.2, fourth subsection makes it possible to prescribe for a longer period based on a protocol between care provider and Healthcare Insurance Office. In this implementation rule it is approved when and under what terms and conditions, medications can be prescribed for a longer period of time in the absence of a protocol.
2. Considerations
The authorization by the BES Healthcare Insurance Office aims to safeguard the legality and effectiveness of the care. The implementation of the healthcare costs regulations in the Caribbean Netherlands prior to 2011 has shown that the prior authorization leads to significant administrative burdens for the care provider and the executor of the insurance and inconvenience for the insured. The prior authorization also fails to reflect the trust that ought to be placed in the care provider. After all it is the care provider who based on his professionalism and the guidelines of his profession determines if there is a medical need for referral and for contents and duration of the treatment (normal criterion). Therefore the BES Claims Regulation makes it possible to replace the prior authorization by working in accordance with protocols and guidelines with subsequent review. Agreements have been made with the care providers to start with the introduction of protocols and guidelines in 2011. Therefore, in principle the procedure of prior authorization is applicable in 2011. Due to delays in the implementation of good ICT-support the BES Healthcare Insurance Office however, cannot realize a swift processing of authorization requests. This circumstance and the trust in the care providers are reason to approve for the year 2011 that in a number of cases prior authorization can be omitted.
3. Approval
It is approved that the prescribing doctor, dentist or obstetrician can prescribe medications for a longer period than intended in article 1.6.2, second subsection.
4. Conditions for approval
The approval mentioned under 3 is subject to the following conditions: - the prescribing doctor, dentist or obstetrician records and motivates in his (patient) administration on what grounds he/she is of the opinion that the provision of medication is indicated for a longer period; - the prescribing doctor, dentist or obstetrician informs the BES Healthcare Insurance Office with regard to which insured the decision was made to provide medication for a longer period while - the prescribing doctor, dentist or obstetrician upon request cooperates with the evaluation of his decision by or on behalf of the BES Healthcare Insurance Office. If upon subsequent review it is determined that the need for the provision of the medication for a longer period was not present, the BES Healthcare Insurance Office can decide to withdraw this approval for the respective care provider. The Minister of Health, Welfare and Sport, On his behalf The Head BES Healthcare Insurance Office
Other legislation
In connection with the pharmaceutical care the following legislation is also important:
2. the BES Decree on Reimbursement of Medicine Expenses, and; 3. the BES Decree on packaged medicine.
V PROCEDURE

All lawful residents of the Caribbean Netherlands are entitled to a free choice of pharmacy in the
Caribbean Netherlands as well as reimbursement of all medications and bandage aids, prescribed
by a medical professional, packaged and registered on the FCN. The reimbursement is 100% of the medication to the extent that these have been designated by the BES Healthcare Insurance Office. Incidentally, prescriptions prepared at the pharmacy are also covered unless these are preparations of medications that are not listed on the FCN. Based on article 1.6.2., the Head BES Healthcare Insurance Office can agree by protocol that repeat prescriptions are allowed for reasons of efficiency. Such a protocol was not agreed upon on April 8, 2011 and therefore, repeat prescriptions are NOT allowed. AMENDMENTS CARE CLAIMS
As of January 1, 2011, the BES Healthcare Insurance Decree replaced the public law insurances for curative care as well as the “Algemene Verzekering Bijzondere Ziektekosten” – the General Insurance for Exceptional Medical Expenses - (AVBZ) on the BES-islands. This combines the claims on curative care and the claims on long term care in one single healthcare insurance. The insured package of the BES healthcare insurance offers vital, curative as well as long term care that has been tested against the requirements of demonstrable effect, cost efficiency and need for collective financing. The composition and contents of the package will differ from the Dutch package due to differences in health status between the Dutch and Caribbean Netherlands population. The claims package is not a static given but can be amended based on various criteria (requirements of demonstrable effect, cost efficiency and need for collective financing) as well as developments in healthcare. In the BES Healthcare Insurance Claims Regulation the possibility has been created for the Minister of Health, Welfare and Sport to decide following a so called package advice of the “College voor Zorgverzekeringen” – the Healthcare Insurance Board (CVZ) to implement a possible amendment in the claims package provided by this regulation. Prior to doing so the Minister seeks the advice of the Head BES Healthcare Insurance Office. Although strictly speaking this is a redundant provision because it goes without saying that a Minister can request the advice of his officials, this has been explicitly stipulated, because the BES – due to economies of scale – do not have local package authority, as is the case at the Dutch Zvw and AWBZ. Mandatory advice by an expert in the field of healthcare insurance who is familiar with the local situation is important. With reference to the CVZ package advice, it is being facilitated that the BES claims package will correspond to the Dutch claims package in the future. This regards the claims package of the

Source: https://www.rijksdienstcn.com/rijksdienstcn.com/up1/ZuubdtuIyV_HANDLEIDNG_BIJ_FCN_01-04-2011_ENG_26-4-11secured.pdf

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