pharmaceutical drugs and ways of maintaining chain of custody for schedule 1 drug

7/25/2019 Pharmaceutical Drugs And Ways Of Maintaining Chain Of Custody For Schedule 1 Drug.

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PharmaceuticalDrugsAndWaysOfMaintainingChainOf

CustodyForSchedule1Drug.

Bibek Singh Mahat , M. Pharm.

Health experts call the drugs journey a supply chain. It begins with the ingredients a

manufacturer uses, carries through the manufacturing process, and continues through the

distribution system of wholesalers, warehouses, and transportation to the dispensing retail and

institutional pharmacies all the way to the consumer, the patient. The Food and Drug

Administration (FDA) expects manufacturers to have systems in place that will quickly discover

and correct problems in medical products before they enter the market place.

The modern pharmaceutical supply chain is complex. Medicines are made from ingredients

sourced from different countries. Final formulations are then exported. Packaging, repackaging,

and sale can happen in many other countries. Drugs change hands many times between the

manufacturer and patient; every transaction is an opportunity for falsified or substandard

products to infiltrate the market. Changes to the drug distribution system could improve drug

quality around the world.

Chain of Custody refers to the document or paper trail showing the seizure, custody, control,

transfer, analysis, and disposition of physical and electronic evidence. In practice, this most

often applies to illegal drugs which have been seized by law enforcement personnel. In such

cases, the defendant at times disclaims any knowledge ofpossession of the controlled

substance in question. For drug testing, it is the course of action of documenting the management

and storage of a specimen from the moment a donor gives the specimen to the collector to the

final destination of the specimen and the review and reporting of the final result.

The increasingly complex drug supply chain, from raw source materials to finished products for

consumers, presents multiple opportunities for the product to be contaminated, diverted, or

otherwise adulterated. Our efforts to secure the supply chain include minimizing risks that arise

anywhere along the supply chain continuum, from sourcing a products ingredients through the

overseeing of a products manufacture, storage, transit, sale, and distribution. A breach at any

point in this continuum could lead to dangerous and even deadly outcomes for patients.


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The first level or "Schedule 1" drugs are the drugs or other substances which has a high potential

for abuse. Chain of custody ensures that the original sample is the same as the one that is tested

and ensures that the integrity of the sample is preserved during transport. Tampering,

substitution, or alteration of the sample prior to being tested or prior to reach the patient is

prevented by the chain of custody process, which ensures that, it has been handled only by the

donor, a qualified collector, and lab testing personnel. A multipart Chain of Custody form and

other supplies are used to complete the Chain of Custody process. These supplies would include

packaging type, seals and other relevant information to be included for verification upon

transport and turnover to the respective testing facility. Information is added to the Chain of

Custody form as specimen travels from person to person. This provides for specimen integrity

and accountability of a sample.

The Chain Of Custody Form has been given a status of a legal document for it has the ability to

invalidate a specimen that has been tampered with and does not have the complete information

written on it. A broken or mismatched seal on the specimen bottle will also invalidate the

specimen being tested. Being a legal document, tampering or mishandling the Chain of Custody

form is subject to investigation and subsequent penalization in accordance with the law.

Documentation should include the conditions under which the evidence is gathered, the identity

of all evidence handlers, duration of evidence custody, security conditions while handling or

storing the evidence, and the manner in which evidence is transferred to subsequent custodians

each time such a transfer occurs (along with the signatures of persons involved at each step).

Controlled substances are secured in a drug storage vault/area where additional security

measures can be effectively implemented. After issuance, additional security controls, (e.g.

sample storage, inventory) are implemented. For the controlled substances (schedule 1 drug) the

sample Custodian must be responsible for the initial and final stages of sample storage. Samples

must be secured in a storage area where additional security measures can be effectively

implemented. The analyst is responsible for the integrity, security, and proper handling of thesample while it is in his or her possession. All portions of the sample in the analysts possession

must be kept in locked storage (e.g., analysts lockable cabinet) when not under the analysts

control. The analyst can use temporary seals when appropriate. When locked storage is not

possible (e.g. sample needs refrigeration and is stored in an unlocked, common laboratory


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refrigerator overnight), a temporary seal is used to demonstrate that sample integrity was

maintained. When the temporary seal is broken, the seal is initialed and dated.

Hospital executives and pharmacists alike are no strangers to the importance of safeguarding

their narcotics supplies. The possibility of loss, theft or diversion is real and can threaten thedelivery of the right medication, in the right dose to the right patient at the right time. The drug

wholesale system is a weak point where the licit and illicit supply chains mix. Better controls on

the wholesale market could improve the security of the distribution chain. Drug tracking systems

could also improve security by preventing products that leave the legitimate supply chain from

returning to it. These solutions can improve drug safety as long as the supply chain does not

disintegrate at the point closest to the patient. The first step on this chain is the drug wholesale

market. Around the world, drug wholesale is a common point of vulnerability to falsified and

substandard medicines. In developed countries, comparatively few large firms control the market

and regulatory authorities require some chain of custody documentation. In low- and middle-

income countries, the system is vastly more complicated.

FIGURE 1: The private, public, and NGO drug distribution systems for essential medicines in developing countries


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The drug distribution system in low- and middle-income countries has the same basic steps as

that described in Figure 1, but with more intermediaries between the manufacturer and patient.

Instead of having one coordinated distribution chain that reaches the whole country, there are

many small chains and many small companies at every step. The above figure describes the drug

flow for public, private, and nongovernmental organizations, and their separate, but sometimes

overlapping, intermediaries.

A manufacturer may sell directly to a dispenser, but usually sells to a primary wholesale

distributor. The primary wholesale distributor may sell directly to a dispenser or may sell to a

secondary wholesale distributor who sells it to the dispenser. A dispenser may return unopened

and unexpired medication to the wholesaler who may then sell it to another dispenser or to

another wholesaler or return it to the manufacturer. The combinations are numerous. Interspersed

throughout the chain may be third-party logistics providers who transport or warehouse the drug

under contract to the manufacturer, distributor, or dispenser. At each change of hands, the drug

could be vulnerable to theft, mishandling, adulteration, and tampering.

The drug distribution system is not sufficiently closed to prevent abuse of drug samples. Each

person who is engaged in the wholesale distribution of a drug (a prescription drug) and who is

not the manufacturer or an authorized distributor of record of such drug shall, before each

wholesale distribution of such drug (including each distribution to an authorized distributor of

record or to a retail pharmacy), provide to the person who receives the drug, a statement

identifying each prior sale, purchase, or trade of such drug (including the date of the transaction

and the names and addresses of all parties to the transaction).

One way to strengthen the chain of custody process is for the organization that ultimately carries

the liability to deploy a solid track-and-trace system by using one core identifier that carries

through from manufacture to dispense or point of care.

Hence having a thorough understanding of the legal requirements and establishing a chain ofcustody is critical for schedule 1 drug. The critical factor that a narcotics prosecutor must

establish are that the drugs at issue have remained in police custody throughout and that the

chemist receive a sealed, identifiable container holding those drugs. So, it is recommended that

the manufacturers should trade with authorized trading partners, provide transaction information

to trading partners. Also the government should quarantine and investigate the suspected


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products at the mean time identify and remove illegimate products and notify it to the trading

partners. Participating in electronic traceability system by assigning a unique product code for

product identification and providing transaction and information to trading partners in electronic

formatcan minimize the chances of breaking the chain of custody.Chain-of-custody is a critical

component of maintaining the veracity and integrity of evidence in the criminal justice system or

it has to be maintained throughout the product life cycle such that unreliable and compromised

evidences does not underestimate the entire legal system.

References:

1. Chain of custody. In Wikipedia. Retrieved from http://en.wikipedia.org/wiki/ Chain of

custody.

2. Committee on Understanding the Global Public Health Implications of Substandard,Falsified, and Counterfeit Medical Products; Board on Global Health; Institute of

Medicine; Buckley GJ, Gostin LO, editors. Washington (DC): National Academies Press

(US); 2013 May 20.

3. G. Beth, The Race is on: Chain of custody in the pharmaceutical supply chain. April

2015.

4. T. Susan, Pharmaceutical supply chain, Congressional research services, Oct 2013.

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